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Mintek Pacemaker LV-T User's Manual

1. Table 14 Cardiac Medications at Pre Enrollment Drug Control P Categor N 67 value Specific CHF Medications ACE inhibitors 89 66 9 45 67 2 1 000 Angiotensin receptor blockers 21 15 8 16 23 9 0 180 Beta blockers 111 83 5 55 82 1 0 843 Cardiac glycosides Digoxin 60 45 1 35 52 2 0 370 Diuretic 114 85 7 57 85 1 1 000 Inotropes 1 0 8 3 4 5 0 110 Anti arrhythmics 19 28 4 0 735 Nitrates 14 20 9 0 390 Student s t test 2 sided for means Fisher s Exact Test 2 sided for 2 possible answers Chi Square test 2 sided for more than 2 possible answers Safety and Effectiveness Results A total of 200 patients were enrolled in the OPTION CRT ATx clinical study at 25 sites There were 133 study patients and 67 active control patients in this prospective multi center randomized clinical study For the study group there were 129 successful implants 91 4 of the Tupos LV ATx CRT D system For the active control group there were 64 successful implants 92 2 of the legally marketed CRT D systems 56 Stratos LV LV T Technical Manual e There were 192 endocardial and 19 epicardial leads implanted in 193 patients Investigators were allowed to choose among any legally marketed LV lead according to their familiarity with the lead and patient anatomy The Tupos LV ATx CRT D was implanted with 7 endocardial and 4 epicardial lead models from 6 differe
2. 2 3 Timing Functions The availability of parameters and parameter values is determined by the software used for programming interrogating the CRT Ps 2 3 1 Basic Rate The basic rate is the pacing rate in the absence of an intrinsic rhythm and is programmable up to 180 ppm The interval for the basic rate is the time between two pacing pulses and is thus called the basic interval The basic rate is programmable 32 1 60 1 88 2 122 3 140 5 180 ppm In atrial controlled modes the basic interval is started by an atrial event In atrial controlled dual chamber modes the basic interval is also started by a ventricular extrasystole Stratos LV LV T Technical Manual 71 In the ventricular controlled modes the basic interval is started by a ventricular event CAUTION Programming Modifications Extreme programming changes should only be made after careful clinical assessment Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm 2 3 2 Rate Hysteresis Rate Hysteresis can be programmed in DDD R DDT R DDT R A DDI R VDD R VDT R VDI R VVI R VVT R AAI R and AAT R modes Hysteresis can be programmed OFF or to values as low as 50 bpm The Hysteresis rate is based on the lower rate and the value of the programmable parameter Hysteresis is initiated by a sensed event The resulting Hysteresis rate is always le
3. 2 14 4 Sensor Threshold The effects of rate adaptive pacing are limited to sensor signals exceeding the programmable sensor threshold Sensor signals below this threshold do not affect rate response Eigure 7 The programmable sensor threshold ensures that a stable rate at rest can be achieved by ignoring sensor signals of low amplitude that are not related to exertion If the pacing rate at rest is unstable or tends to stay above the lower rate without activity the sensor threshold should be increased The sensor threshold should be reduced if a sufficient rate increase is not observed at a given level of exertion tl tlh lh low threshold mean threshold high threshold Figure 7 Effect of sensor threshold 2 14 5 Rate Increase The rate increase parameter determines the maximum rate of change in the pacing rate if the sensor signal indicates increasing exertion The rate attack is set to standard value of 2 ppm cycle and is programmable 0 5 1 1 6 ppm cycle The programmed rate increase applies only to the sensor controlled operation and does not affect the rate changes during atrial controlled ventricular pacing 98 Stratos LV LV T Technical Manual 2 14 6 Maximum Activity Rate Regardless of the sensor signal amplitude the pacing rate during sensor driven operation will never exceed the programmed maximum activity rate MAR The maximum activity rate only limits the pacing rate during s
4. 2 22 2 Activity Report This feature operates by recording characteristic pulse generator data related to patient activity and pacing the system It is divided into three ranges e No Activity e Activity e MAR Maximum Activity Rate This data can assist in the analysis of heart and sensor activity For example a high value for the activity may indicate that the sensor gain is set too high In contrast an extremely low value for activity may indicate that the sensor gain is too low All values are expressed as percentages 2 22 3 Sensor Optimization The sensor optimization is displayed in the form of a line graph containing the length of the time intervals and the trend data The sensor parameters are simulated and displayed as a trend The thicker line represents the recorded intrinsic trend and the thinner line the simulated sensor trend A movable cursor simplifies the reading of the intrinsic and the sensor trends 2 23 Sensing Statistics P Wave Trend This is the display of the sensitivity course in the atrium The P wave trend is displayed in the form of a line chart This P wave trend is a rolling long term trend with the programmed resolution of 45 s 36 h Therefore the 240 time windows with the 36 h recording periods result in actual recordings for approximately one year The P wave trend can record amplitudes from 0 0 to 20 mV The trend is only displayed when sensed events are present During paced even
5. 4 16 7 0 248 Other Medications 5 12 2 5 10 4 1 4 2 0 656 26 Stratos LV LV T Technical Manual Table 2 Atrial Fibrillation Demographics at Enrollment Characteristic Rate Control Medication Reasons for Discontinuation Ineffective Not tolerated Other Rhythm Control Medication Reasons for Discontinuation Ineffective Not tolerated Other Cardioversion History Successful prior electrical cardioversion Transthoracic Transvenous Unsuccessful prior electrical cardioversion Transthoracic Transvenous No electrical cardioversion attempted Successful prior pharmacological cardioversion Unsuccessful prior pharmacological cardioversion No pharmacological cardioversion attempted N 17 10 58 8 8 47 1 N 22 17 77 3 6 27 3 N 42 13 31 0 13 100 0 0 0 0 15 35 7 15 100 0 0 0 0 17 40 5 5 11 9 8 19 0 23 54 8 N 20 13 65 0 7 35 0 2 10 0 N 25 20 80 0 7 28 0 1 4 0 N 49 16 32 7 15 93 8 1 6 3 14 28 6 14 93 3 2 13 3 20 40 8 3 6 1 11 22 4 29 59 2 N 13 8 61 5 6 46 2 2 15 4 N 25 10 40 0 10 100 0 0 0 0 7 28 0 7 100 0 0 0 0 9 36 0 3 12 0 7 28 0 15 60 0 P value 0 558 0 760 0 800 0 759 0 530 0 430 0 760 0 808 0 680 0 741 0 936 0 547 0 678 0 915 Chi Square test 2 si
6. 0 1 3 6 0 1 6 2 7 2 V 3 channels separately programmable Stratos LV LV T Technical Manual 153 Pulse Width 0 1 0 2 0 3 0 4 0 5 0 25 1 5 ms 3 channels separately programmable Sensitivity A 0 1 0 1 1 0 0 1 1 5 0 5 7 5 mV RV 0 5 0 5 2 5 0 5 7 5 mV First Chamber Paced RV VV Delay after Pace Sense 5 ms Ventricular Refractory Period 150 25 500 ms Atrial Refractory Period Auto 225 25 775 ms Atrial Far field Protection After Vp 30 10 220 ms After Vs 30 10 200 ms PMT Detection Termination Off On PMT VA Criterion 250 10 500 PMT Protection Auto 175 25 600 ms PMT Protection after VES 400 25 600 ms Mode Switching Off On 154 Stratos LV LV T Technical Manual Intervention Rate 100 10 250 ppm X out of 8 Activation Criterion 3 1 8 Z out of 8 Termination Criterion 3 1 8 DDI R Basic Rate 32 1 88 2 122 3 140 5 180 ppm Overdrive Modes Off On Available in the modes DDD DDTA AAI AAT with and without rate adaptation Maximum Overdrive Pacing Rate 90 5 160 ppm Overdrive Pacing Increment Rate Increase 2 2 10 ppm Overpacing Level Rate Drop After 1 1 32 cycles Post AES Pacing Off On AES Increment 5 5 40 ppm AES Prematurity 5 50 VES discrimination after As OFF 250 50 450 ms Rate Fadi
7. corrective actions may include selection of a different pacing mode or sensitivity setting 7 3 Pulse Generator Orientation The Stratos CRT Ps may be used in either the left or right side pectoral implants Either side of the CRT Ps can face the skin to facilitate excess lead wrap Stratos LV LV T Technical Manual 139 8 Lead Connection 8 1 Lead Configuration The Stratos CRT Ps allows programming of separate lead polarities for pacing and sensing Lead polarity can also be programmed separately in both the atrial and ventricular channels CAUTION Lead Configuration The polarity of the implanted lead dictates what lead configuration can be programmed for the CRT P Pacing will not occur with a unipolar lead if the lead configuration of the respective channel is programmed to bipolar see Section 8 Atrial Channel In a unipolar lead configuration the CRT P pace and sense between the tip electrode of the atrial lead cathode and the housing anode In a bipolar lead configuration the CRT Ps pace and sense between the tip and ring electrodes of the atrial lead Therefore bipolar lead polarity should only be programmed when a bipolar atrial lead is implanted Ventricular Channel The Stratos CRT Ps have a specially designed header that allows sensing with only the RV channel while pacing in both the right and left ventricles Biventricular Therapy requires programming of a bipolar or unipolar pacing configurat
8. A Trigger Pacing The triggered pacing modes are identical to the respective demand modes except that the sensing of an atrial ventricular event outside of the refractory period does not result in inhibition of pacing but instead a pacing pulse is delivered in the respective chamber The corresponding pacing modes are Demand DDD VDD DDI DVI AAI VVI Pacing Triggered DDT VDT DDIM DVT AAT VVT pacing However the following differences exist There is no AV safety interval in DDT DDI T and DVT pacing modes The safety interval is unnecessary as cross talk ventricular sensing of atrial pulses can not occur during these modes 66 Stratos LV LV T Technical Manual In the DDI T and DVT pacing modes the basic interval is not restarted if ventricular sensing occurs within the AV delay CAUTION Programmed to Triggered Modes When programmed to triggered modes pacing rates up to the programmed upper limit may occur in the presence of either muscle or external interference Triggered Modes While the triggered modes DDT DVT DDTR A DDTR V DDI T VDT VVT and AAT can be programmed permanently these modes are intended for use as temporary programming for diagnostic purposes In triggered pacing modes pacing pulses are emitted in response to sensed signals and therefore the pacing pulse can be used as an indicator or marker of sensed events for evaluating the sen
9. Amplitude RV 3 6 V LV Sensing A RV UNIP RV Refractory Auto A 250 ms V A N A Period V 300 ms 11 8 Materials in Contact with Human Tissue e Housing Titanium e Connector receptacle Epoxy resin e Sealing Plugs Silicone Rubber 11 9 Electrical Data Battery NOTE At 37 C with pacing impedance of 500 Ohms 160 Stratos LV LV T Technical Manual Parameter Stratos LV Pace Unipolar bipolar Pulse form Biphasic asymmetric Polarity Cathodic Input impedance gt 10kQ RV LV Power source Lilo Battery voltage at BOS 28V Conducting surface 37 47 Conducting Shape Flattened ellipsoidal 11 10 Mechanical Data Model Leads Size Mass Volume Stratos IS 1 6 4 x 50 3 x 57 30 85 14 0 mm Stratos LV LV T Technical Manual 161 12 Order Information Pulse Generator Type Order Number Stratos LV 338 200 Stratos LV T 338 202 162 Stratos LV LV T Technical Manual Stratos LV LV T Technical Manual 163 Appendix A Known Software Anomalies Anomaly Possible Effect on Patient or Implant Procedure General Programmer Issues If a long patient name is entered The last letters of the patient without blank spaces it may be name may be missing from cut off in the printout under the the printout However the section Patient Data patient name is not a therapy relevant parameter If this occurs the programmer must be re started so that the Stratos cannot be communicated wit
10. Please note that a gap in the trend will be displayed for the duration of an asynchronous magnet program or temporary program 2 20 4 Atrial and Ventricular Rate Histogram The Stratos CRT Ps are provided with separate atrial and ventricular histograms A bar chart displays the heart rate as a percentage and corresponding absolute value The number of times in which the heart rate occurs in specific ranges is recorded separately according to sensing and pacing The rate range between 40 and 390 ppm is divided into 10 ppm increments along a rate measuring axis The distribution of distribution of the heart rates can be displayed on the programmer as a diagram during follow up examinations Stratos LV LV T Technical Manual 113 NOTE The bars of the histogram are standardized to a rate class width of 10 ppm to avoid distortion of the rate distribution 2 21 Arrhythmia Statistics 2 21 1 Tachy Episode Trend The Tachy Episode trend can only be selected when Mode Switching has been programmed ON and for events that occur at less than 1 minute intervals are combined in the tachy episode and stored In the tachy episode trend each tachycardic mode switching episode is recorded in the statistics table with its initial date and time as well as its duration This documents both the frequency and length of the tachycardic periods which can be evaluated in the follow up Mode Switch Counter A counter reports the number of mode switches
11. The actual time when the respective increase or decrease in rate occurs may begin up to 4 minutes after the programmed time because of internal device timing The rate ppm s at which Night Mode decreases and increases is a function of the Sensor Gain decrease and increase parameters 76 Stratos LV LV T Technical Manual 2 3 6 Refractory Periods Sensed events that occur during the refractory period have no effect on pacemaker timing These atrial or ventricular sensed events are classified as unused for normal CRT P timing In the Stratos CRT Ps the total atrial refractory period has been subdivided into an atrial refractory period ARP atrial far field protection FFP and a PMT protection window PMT In terms of priority FFP is first ARP second and PMT third When mode switching is turned ON the atrial events in the atrial refractory period and the PMT protection window are used as the criteria in order to sense atrial tachyarrhythmias and to ensure high atrial rates are not transmitted to the ventricle The behavior of BIOTRONIK CRT Ps_ reacts differently depending on the timing interval in which the atrial event occurs The behavior is summarized in Table 20 Table 20 Response to Atrial Sense Events in Different Timing Intervals in Stratos CRT Ps Timing Interval Response A occurs during No consequence A is ignored unused the far field Neither the AV delay nor the ARP is protection FFP star
12. VVIR VVTR VOOR AAIR AATR AOOR DDD DDTA DDT DDI DDIT DVI DVT DOO VDD VDT VDI VVI VVT VOO AAI AAT AOO OFF VV synchronization for the Stratos CRT Ps BiV RV RV T OFF 11 2 Pulse and Control Parameters Basic Rate 32 1 60 1 88 2 122 3 140 5 180 ppm Night Rate Off 32 1 88 2 122 3 140 5 180 ppm Night Rate Start Time 00 00 00 10 23 50 Rate Hysteresis Off 5 5 90 bpm Repetitive Rate Hysteresis Off 1 1 15 Scan Rate Hysteresis Off 1 1 15 Upper Rate 90 10 180 ppm UTR Response 2 1 Wenckebach WKB Upper Tracking Rate Atrium Off 200 ppm 152 Stratos LV LV T Technical Manual Dynamic AV Delay Dual chamber only low medium high individual fixed AV Delay Values Dual chamber modes only 15 5 300 AV Hysteresis Off 10 10 100 ms Repetitive AV Hysteresis Off 1 1 10 Scan AV Hysteresis Off 1 1 10 Sense Compensation Off 10 10 120 ms Safety AV Delay 100 ms Ventricular Blanking Time 30 5 70 ms Magnet effect Automatic Auto asynchronous synchronous Asynchronous Magnet Effect paces at 90 ppm Automatic Magnet Effect 10 cycles at 90 ppm asynchronous thereafter synchronous with the programmed basic rate Synchronous Magnet Effect synchronous with programmed basic rate High Rate Protection 205 215 ppm Pulse Amplitude 0 2
13. When the Home Monitoring function is activated the transmission of a report Cardio Report from the implant can be triggered as follows e Trend report the time period daily initiates the report e Event report the pulse generator detects certain events which initiate a report e Patient report the patient initiates the report 2 17 4 1 Trend Report The time of the report transmission is programmable For periodic messages the time can be set anywhere between 0 00 and 23 50 hours It is recommended to select a time between 0 00 and 4 00 106 Stratos LV LV T Technical Manual The length of the time interval monitoring interval is preset to daily For each monitoring interval a data set is generated in the implant and the transmission is initiated at the designated time 2 17 4 2 Event Report When certain cardiac and technical events are detected by the implant a report transmission is automatically triggered This is described as an event message The following cardiac and technical events initiate a message transmission e Atrial Lead Check e Low P Wave Amplitude lt 300 and gt 3000 Ohm lt 50 safety margin e Ventricular Lead Check e Low R Wave Amplitude lt 300 and gt 3000 Ohm lt 50 safety margin e ACC Disabled e Ventricular Threshold gt 4 8V CAUTION Event Triggered Report A timely receipt of the event report cannot be guaranteed The receipt is also dependent on
14. high pacing rates with long atrial and or ventricular refractory periods may result in intermittent asynchronous pacing and therefore may be contraindicated in some patients OFF Mode The OFF mode can be transmitted as a temporary program only to permit evaluation of the patient s spontaneous rhythm see Section 2 1 11 Myopotential Sensing The filter characteristics of BIOTRONIK implantable devices have been optimized to sense electrical potentials generated by cardiac activity and to reduce the possibility of sensing skeletal myopotentials However the risk of CRT P s operation being affected by myopotentials cannot be eliminated particularly in unipolar systems Myopotentials may resemble cardiac activity resulting in inhibition of pacing triggering and or emission of asynchronous pacing pulses depending on the pacing mode and the interference pattern Certain follow up procedures such as monitoring CRT P performance while the patient is doing exercises involving the use of pectoral muscles as well as Holter monitoring have been recommended to check for interference caused by myopotentials If sensing of myopotentials is encountered corrective actions may include selection of a different pacing mode or sensitivity setting Muscle or Nerve Stimulation Inappropriate muscle or nerve stimulation may occur with unipolar pacing when using a non coated Stratos CRT P Stratos LV LV T Technical Manual 11 Atrial Sen
15. or AOO R In DDI R DDI T R DVI R and DVT R modes only the V A delay is extended by 11 This reduces the pacing rate by 4 5 11 depending on the programmed AV delay The Stratos CRT Ps indicate the need for replacement by a defined decrease of its rate after magnet application and the programmer displays it upon interrogation of the programmed parameters The magnet rate in all modes decreases as shown in Table 30 Table 30 Stratos CRT Ps behavior after reaching ERI Magnet Mode Cycles 1 10 after After Cycle 10 magnet application Automatic Asynchronous basic Synchronized with rate at 80 ppm basic rate reduced by 4 5 11 Asynchronous Asynchronous basic Asynchronous with rate at 80 ppm basic rate at 80 Synchronous Synchronized with Synchronized with basic rate reduced basic rate reduced by 4 5 11 by 4 5 11 If the CRT P is programmed to dual chamber pacing it will switch to single chamber pacing when it reaches the elective replacement indication The ERI mode varies according to the programmed pacing mode and is indicated by the pulse generator Upon reaching the replacement indication the following functions are automatically deactivated e Post AES pacing e Preventive overdrive pacing e Rate adaptation e Rate fading e Statistics e Snap shots Holter e Automatic lead check Stratos LV LV T Technical Manual 147 The following functions remain active when the replacemen
16. processing stages The programmable amplification permits adaptation of the individually programmed sensor gain to the desired rate response The optimum setting is achieved when the desired maximum pacing rate during exertion is reached during maximum exercise levels The rate increase rate decrease and maximum sensor rate settings must be checked for their suitability with respect to the individual patient before adjusting the sensor gain If the sensor driven rate is not sufficient at high levels of exertion the sensor gain setting should be increased The sensor gain should be reduced if high pacing rates are obtained at low levels of exertion see Figure 6 max exertion min max exertion min max exertion optimum gain gain setting optimum gain setting too low too hig Figure 6 Influence of sensor gain on the rate response 2 14 3 Automatic Sensor Gain Stratos CRT Ps offer an Automatic Sensor Gain setting which allows the physician to have the Sensor Gain parameter adjusted automatically Stratos LV LV T Technical Manual 97 When the Automatic Sensor Gain is activated the CRT P samples the sensor indicated rate If during the 24 hour period beginning at midnight the total time recorded at maximum sensor rate exceeds 90 seconds the sensor gain setting is reduced by one step The sensor gain will be increased by one step if for 7 consecutive days the time recorded at maximum sensor rate is less than 90 seconds each day
17. 2 0 12 24 5 28 57 7 37 75 5 2 4 1 N 25 71 5 1 6 52 to 85 N 25 13 52 0 12 48 0 N 25 267 8 22 9 23 to 420 N 25 10 40 0 15 60 0 N 25 1 4 0 2 8 0 5 20 0 6 24 0 19 76 0 7 28 0 0 534 0 553 0 395 0 189 0 125 0 216 0 792 0 031 0 348 0 007 24 Stratos LV LV T Technical Manual Table 1 Patient Demographics at Enrollment Characteristic Group1 Group2 Group3 P value Other Medical History N 29 N 36 N 17 Diabetes 13 44 8 9 25 0 4 23 5 0 287 Chronic Lung 7 24 1 16 44 4 7 41 2 0 211 Disease Thyroid Disease 12 41 4 12 33 3 5 29 4 0 791 Chronic Kidney 4 13 8 5 13 9 1 5 9 0 836 Disease Prior Ischemic 7 24 1 10 27 8 6 35 3 0 726 Stroke or TIA Prior Embolic 1 2 3 3 6 0 2 8 0 0 653 Events non cerebrovascular One way ANOVA Chi Square test 2 sided Table 2 provides a summary of the AF medical history Table 3 provides a summary of cardiac medications patients were taking at the time of enrollment Please note some categories may equal more than 100 as several categories allow more than one response In some cases complete demographic data was not provided for all patients There were no statistical differences in AF medical history and cardiac medication at enrollment between the 3 groups Stratos LV LV T Technical Manual 25 Table 2 Atr
18. 29 to 507 Median 302 00 244 00 Six Month N 93 44 Mean SE 329 73 10 82 310 70 15 49 Range 78 to 596 91 to 489 Median 335 00 313 00 Student s t test 2 sided Stratos LV LV T Technical Manual 59 There are no clinically relevant differences in the six minute walk test results between the study and the control group 2 The purpose of this secondary endpoint is to evaluate the improvement in the patient s NYHA classification Table 17 summarizes the average improvement in NYHA from Baseline to Six Months for 140 patients that were able to complete both NYHA classification evaluations Table 17 Improvement in NYHA Classification at Six Months from Baseline N 97 N 43 Change in of NYHA class Number of of Total Number of ib Patient Patient Patients MES a S s a Patients Improved 2 10 10 3 2 4 7 classes Improved 1 46 5 57 58 8 23 class Total improved No change Worsened 1 class 51 2 2 3 The study and the control group have similar NYHA classes and similar rates of improvement in NYHA class from Baseline to the Six Month follow up 60 Stratos LV LV T Technical Manual Multi site Poolability and Gender Analysis The OPTION CRT ATx clinical report includes data from multiple centers with centralized coordination data processing and reporting at BIOTRONIK All of the clinical centers followed the requirements of an identical clinical pr
19. Effectiveness RV only p value Group 3 student s Category N 53 N i 5 t test Mean SE Mean SE 2 sided AS Pa Simonis 0000 aso 0 790 ae 39 0 13 1 0 610 a z A in QOL Score 0 367 CRT Group 1 amp 2 A in QOL Score 40 4 i A 47 4 5 1 s 0 537 O Composite Rate 43 2 7 7 Hote 0 525 i p value is provided for informational purposes to show trends only clinical significance is not indicated by p values for analyses that were not prespecified 38 Stratos LV LV T Technical Manual Primary Effectiveness Endpoint Analysis and Conclusions The primary effectiveness endpoint evaluated CRT effectiveness Groups 1 and 2 compared to RV only effectiveness Group 3 as measured by the composite rate of the six minute walk test and QOL improvement from Baseline to the Six Month follow up Table 8 For this analysis both six minute walk test and QOL were equally weighted at 50 Due to the small number of patients with data available for the analysis of the primary endpoint the results lack power to demonstrate that biventricular pacing with either the Protos DR CLS or Stratos LV device is statistically different from RV only pacing with the Stratos LV device in patients undergoing an ablate and pace procedure Multi site Poolability and Gender Analysis The AVAIL CLS CRT clinical report included data from multiple centers with centralized coordination data processing and repor
20. NOTES Repetitive Hysteresis is not active during the programmed Night Mode Stratos LV LV T Technical Manual 75 Repetitive Hysteresis is only available when Hysteresis is selected on Magnet application closing of reed switch suspends 180 consecutive event counter independent of synchronous or asynchronous magnet effect There is one Standard Hysteresis interval which occurs before the programmable number of Repetitive Hysteresis occurs The repetitive rate hysteresis is deactivated in the standard setting but can be programmed to 1 1 15 cycles 2 3 5 Night Mode Programmable Night Time Begin and End in 10 minute steps The Night Mode feature allows a temporary reduction of the base rate during normal sleeping hours If selected the base rate is gradually and temporarily reduced to the programmed night pacing rate At the end of night mode the base rate gradually returns to the original values The Night Mode feature has been incorporated to allow the patients spontaneous night rhythm and may reduce pulse generator energy consumption NOTES Over time the Stratos CRT Ps internal time of day clock may exhibit a discrepancy with the actual time less than 1 hour per year This may cause a corresponding discrepancy between the programmed sleep and wake times and the actual times that the system changes the rate The programmer automatically updates the CRT P time of day clock each time the device is programmed
21. Patients Observations Corox OTW Steroid Lead Related Implant failure 0 08 Category stimulation Total 9 101 9 0 14 Atrial Lead Related Loss of re nd Total 0 02 Elevated Pacing 0 03 thresholds Total 0 03 46 Stratos LV LV T Technical Manual Table 11 Summary of Observations at 6 months Category Number of of Number of ea Patients Patients Observations year Device Related Pocket infection Pericardial 0 02 Effusion Total 0 02 Total System Relatod a Medical Arrhythmias 0 03 Shortness of breath 0 02 palpitations Total 0 05 Miscellaneous Malfunction of hemostatic 0 02 valve Improper Lead 0 02 preparation Total 0 04 Overall Observation 17 19 1 18 0 28 Totals Number of Patients 89 Number of Patient Years 63 3 There were a total of 10 patient deaths reported in the OVID study for patients with the Stratos LV device The clinical investigators determined that no deaths were related to the Stratos LV device system Stratos LV LV T Technical Manual 47 1 7 3 AVAIL and OVID Combined Primary Endpoint Complication free Rate Safety The results from for the AVAIL CLS CRT and OVID studies were pooled to evaluate the safety of the Stratos LV device The safety of the Stratos LV was evaluated based on complications adverse events that require additional invasive intervention to resolve related to the implanted CRT system which includes the Str
22. The post AES interval is never shorter than the Upper Tracking Rate Interval UTR Additionally if the post AES coupling interval is longer than the current sensor rate pacing occurs at the sensor rate NOTE When preventative overdrive pacing is activated post AES pacing is not automatically activated Both parameters can be programmed independently of one another CAUTION Post AES Before activating post AES check whether the selected program can cause Pacemaker Mediated Tachycardia PMT and whether post AES pacing results 2 14 Parameters for Rate Adaptive Pacing 2 14 1 Rate Adaptation The Stratos CRT Ps are equipped with accelerometers that located within the CRT P This sensor produces an electric signal during physical activity of the patient If a rate adaptive mode is programmed then the sensor signal controls the stimulation rate Sensing and inhibition remain in effect during sensor controlled operation In the case of high pacing rates however the refractory periods may cover a majority of the lower rate interval resulting in asynchronous operation 96 Stratos LV LV T Technical Manual The following diagnostic functions are available to tailor rate adaptive pacing for the individual patient 2 14 2 Sensor Gain The sensor gain defines the slope of the linear function between exertion and pacing rate lt designates a factor by which the electric signal of the sensor is amplified prior to the signal
23. additional function of providing atrial sensing However the timing is the same as the VVI mode The purpose of the VDI mode is to permit the use of the marker function with the IEGM for the atrial channel for example to measure the retrograde conduction time The VA conduction time between a ventricular pace or sense event with marker and the atrial sense event can be measured directly on the display or printout from the programmer or on an ECG strip chart recorder IEGM marker output function Stratos LV LV T Technical Manual 69 2 1 11 OFF ODO In this mode pacing and sensing functions are off The OFF mode is used to determine and evaluate the morphology of an intrinsic rhythm With external pulse control the OFF mode is used for electrophysiological studies The OFF mode can be programmed temporarily CAUTION OFF Mode The OFF mode can be transmitted as a temporary program only to permit evaluation of the patient s spontaneous rhythm see Section 2 1 11 2 2 Biventricular Synchronization of the Stratos CRT Ps For the Stratos CRT Ps there are 2 possible settings for the BiV Sync parameter OFF and BiV RV RV T OFF If the BiV sync parameter is set to OFF the CRT P ignores the left ventricular channel and functions like a conventional dual chamber pacemaker Consequently pacing is not delivered into the left ventricle BiV RV RV T When set to BiV RV RV T the device provides biventricular pacing with
24. application does not affect timing and sensing behavior of the CRT P Synchronous operation is of particular importance during follow up if sensing and inhibition functions are desired during magnet application Trend monitor and event counter operation is interrupted during magnet application with either Asynchronous or Synchronous magnet effect 6 5 Position Indicator The position indicator facilitates positioning of the programmer head The programmer optically and acoustically indicates whether the programmer head is in communication with the CRT P 132 Stratos LV LV T Technical Manual 6 6 Pacing When Exposed to Interference CAUTION EMI Computerized systems are subject to Electromagnetic Interference EMI or noise In the presence of such interference telemetry communication may be interrupted and prevent programming of the Stratos CRT P A sensed event occurring during the interference interval will continuously reset that interval for the corresponding chamber without resetting the basic interval Depending upon whether the interference electromagnetic interference muscle potentials etc is detected by the atrial and or ventricular channel atrial and or ventricular asynchronous pacing at the programmed timing intervals will result for the duration of the interference The interference interval has a duration of 125ms If the detected rate exceeds 480 min 8 Hz then the interference interva
25. damage to the CRT P If the procedure must be used constant monitoring is recommended including monitoring the peripheral pulse Rate Adaptive Pacing Use rate adaptive pacing with care in patients unable to tolerate increased pacing rates NIPS Life threatening ventricular arrhythmias can be induced by stimulation in the ventricle Ensure that an external cardiac defibrillator is accessible during tachycardia testing Only physicians trained and experienced in tachycardia induction and reversion protocols should use non invasive programmed stimulation NIPS High Output Settings High output settings combined with extremely low lead impedance may reduce the life expectancy of the Stratos CRT Ps Programming of pulse amplitudes higher than 4 8 V in combination with long pulse widths and or high pacing rates may lead to premature activation of the replacement indicator 1 5 1 Interactions with Other Medical Therapy Before applying one of the following procedures a detailed analysis of the advantages and risks should be made Cardiac activity during one of these procedures should be confirmed by continuous monitoring of peripheral pulse or blood pressure Following the procedures CRT P function and stimulation threshold must be checked Therapeutic Diathermy Equipment Use of therapeutic diathermy equipment is to be avoided for pacemaker patients due to possible heating effects of the CRT P and at the implant site If
26. dependent on whether the patient was physically situated in the required coverage range of the patient device at the time the event information was sent 102 Stratos LV LV T Technical Manual CAUTION Patient Activated Report The magnet effect must be programmed synchronous if the Patient Report function is activated Not for Conclusive Diagnosis Because not all information available in the implant is being transmitted the data transmitted by Home Monitoring should be evaluated in conjunction with other clinical indicators i e in office follow up patient symptoms etc in order to make a proper diagnosis Frequency of Office Follow Ups When Using Home Monitoring The use of Home Monitoring does not replace regular follow up examinations When using Home Monitoring the time period between follow up visits may not be extended The implants Home Monitoring functions can be used for the entire operational life of the implant prior to ERI or for shorter periods such as several weeks or months NOTE When ERI mode is reached this status is transmitted Further measurements and transmissions of Home Monitoring data are no longer possible 2 17 1 Transmission of Information The implant transmits information with a small transmitter which has a range of about 6 feet 2 meters The patient s implant data are sent to the corresponding patient device in configurable periodic intervals The transmissions
27. ensure pacing the pacing rate of the threshold test program should exceed the patient s intrinsic rate 124 Stratos LV LV T Technical Manual To determine the threshold the ECG must be observed continuously Based on the measured threshold the pulse amplitude for the permanent program should be adjusted Please consult the pertinent medical literature for specific recommendations regarding necessary safety margins NOTE With successful biventricular pacing of patients with congestive heart failure the QRS complex should be visibly shortened 5 2 P R Measurement Testing the Sensing Function Stratos CRT Ps provide a P R wave test for measuring the amplitude of intrinsic events during follow up examination The test determines the minimum mean and maximum amplitude values over a programmable period of time In addition these values may be printed out To permit evaluation of the sensing function the pacing rate must be lower than the patient s intrinsic rate In demand pacing the proper sensing function can be recognized if the interval between intrinsic events and the following pacing pulse equals the basic interval if no Hysteresis is programmed For evaluation of the sensing function the CRT P features an intracardiac electrogram IEGM with marker signals to indicate sensed and paced events In addition triggered pacing modes can be selected which synchronously to the detection of an intrinsic event emit a pacing
28. from Baseline to Six Months 58 Stratos LV LV T Technical Manual Primary Effectiveness Endpoint Analysis and Conclusions A composite rate of six minute walk test and QOL improvement from Baseline to the Six Month follow up is evaluated as a measure of CRT effectiveness For this analysis both six minute walk test and QOL are equally weighted at 50 The mean difference in the composite rate between study and control group was 20 53 with an associated one sided 95 confidence bound of 6 10 The p value for non inferiority within 10 is 0 030 The analysis of the composite rate in six minute walk test distance and QOL score demonstrates that the study group is non inferior to the control group and that the primary effectiveness endpoint was met p 0 030 Secondary Endpoint Results 1 The purpose of this secondary endpoint is to evaluate improvement in functional capacity as measured by the six minute walk test The six minute walk test is a well accepted measure of functional capacity and exercise tolerance Also this test more closely mimics the patient s day to day activities than maximal exercise testing Table 16 summarizes the six minute walk test distance at Baseline and the Six Month follow up for patients in the study group and the control group Table 16 Six Minute Walk Distance Distance Study Control meters Baseline N 127 61 Mean SE 283 14 9 27 269 43 13 77 Range 23 to 511
29. in Table 23 If an atrial tachycardia occurs suddenly triggering a mode switch the target rate is set to the sensor rate or basic rate The current pacing rate in the ventricle results from the current value of the Target rate before the mode switching event If the pacing rate reaches the intrinsic rate during rate decay at least four consecutive intrinsic cycles above the pacing rate are required before the pacing rate is once again adapted to the last intrinsic event Controlled rate smoothing is thereby continued during intermittent sensed events The Rate Fading feature is suspended while in magnet mode and disabled at ERI and in backup mode 100 Stratos LV LV T Technical Manual Table 23 Backup and Target Rates Feature Description Backup Rate Rate that the CRT P uses to pace when there is a sudden rate decrease This can be a maximum of 10 ppm less than the intrinsic rate and follows the Target Rate with a 1 to 6 ppm per cycle increase or 0 25 1 25 ppm per cycle If the Target Rate is less than the current Back Up Rate Target Rate The Target Rate is either the current detection rate minus 10 ppm or the sensor or basic rate The Backup Rate follows the Target Rate with the programmed rate increase or decrease Rate Fading for the prevention of sudden rate decrease Heart rate with Rate Fading Decay Rate in ppm cycle TT thout Rate a Figure 8 Rate Fading 2 17 Home Monitoring Str
30. marketed left ventricular lead i p value is provided for informational purposes to show trends only clinical significance is not indicated by p values for analyses that were not prespecified 50 Stratos LV LV T Technical Manual Primarily the study evaluates and compares the functional benefits of CRT between the two randomized groups using a composite endpoint consisting of a six minute walk test meters walked and quality of life measurement assessed using the Minnesota Living with Heart Failure Questionnaire Relevant measurements were completed twice for each patient once at the Baseline evaluation two week post implant follow up and again at a six month follow up evaluation The data collected during this clinical study was used to demonstrate equivalent treatment of CHF in both the study and control groups This study also evaluated other outcomes including the percentage of time CRT is delivered and other measures of CHF status including NYHA classification peak oxygen consumption during metabolic exercise testing and the rate of hospitalization for CHF Clinical Inclusion Criteria To support the objectives of this investigation patients were required to meet the following inclusion criteria prior to enrollment e Stable symptomatic CHF status e NYHA Class lll or IV congestive heart failure e Left ventricular ejection fraction lt 35 measured within six months prior to enrollment e Intraventricular co
31. may also be activated by the patient with the application of a magnet over the implant and by certain cardiac events as programmed The types of transmissions are discussed in Section 2 17 4 The minimal distance between the implant and the patient device must be 6 inches 15 cm Stratos LV LV T Technical Manual 103 2 17 2 Patient Device The patient device Eigure 9 is designed for use in or away from the home and is comprised of the mobile unit and the associated charging station The patient can carry the mobile unit during his or her occupational and leisure activities The patient device is rechargeable allowing for an approximate operational time of 24 hours It receives information from the implant and forwards it via the cellular mobile network or the standard telephone system to a BIOTRONIK Service Center For additional information about the patient device please refer to its manual 2 17 3 Transmitting Data The implant s information is digitally formatted by the BIOTRONIK Service Center and processed into a concise report called a Cardio Report The Cardio Report which is adjusted to the individual needs of the patient contains current and previous implant data The Cardio Report is sent to the attending physician via fax or is available on the Internet which is selected during registration of the patient For more information on registering for Home Monitoring contact your BIOTRONIK sales representative The p
32. paced or sensed events have occurred for at least 2 seconds Each occurrence of mode switching resets the corresponding counter X or Z to a value of zero Mode Switch Events are recorded in memory and are available to the user through the following diagnostics e IEGM Recordings e Tachy Episode Trends e Mode Switch Trends e Mode Switch Histogram e Mode Switch Counter Mode Switching is temporarily suspended during magnet application and are inactive during ERI 2 9 PMT Management A PMT is defined as a tachycardia caused by inadvertently tracking the retrograde P waves The PMT management feature includes PMT Protection Termination and a programmable PMT detection and termination algorithm 2 9 1 Protection Pacemaker mediated tachycardia PMT is normally triggered by ventricular depolarizations that are not synchronized with atrial depolarizations e g VES The tachycardia is maintained in a retrograde direction by intrinsic VA conduction of the stimulated ventricular depolarization and in an antegrade direction by ventricular pacing of the pacemaker that is triggered by P waves It is the objective of the atrial PMT protection interval to not use retrogradely conducted atrial sensed events for pacemaker timing but only to statistically evaluate them for detection of atrial tachycardia incidents 90 Stratos LV LV T Technical Manual To prevent occurrence of a PMT Stratos CRT Ps start an atrial PMT protection interval a
33. result Corresponding to the measured retrograde conduction time the PMT protection interval must be programmed to a correct value Stratos LV LV T Technical Manual 9 AV Hysteresis If the AV hysteresis is enabled along with the algorithm for recognizing and terminating PMTs PMT management the AV delay for recognizing and terminating a PMT has a higher priority than the AV hysteresis Sensing The Stratos CRT Ps do not sense in the left ventricle AV Conduction In patients with intact AV conduction the intrinsic atrial tachycardia is conducted to the ventricle 1 1 With the resynchronization mode activated spontaneous rate of the right ventricle mode is synchronized for a rate up to 200 ppm in the left ventricle For this reason biventricular pacing mode should be turned OFF in such cases Unipolar Bipolar If the pacing or sensing function is to be programmed to bipolar in the atrial channel it must be verified that bipolar leads have been implanted in that chamber If the atrial lead is unipolar unipolar sensing and pacing functions must be programmed in that chamber Failure to program the appropriate lead configuration could result in patient experiencing entrance and or exit block In addition if the atrial lead polarity setting within the Patient Data Memory has been set to bipolar the polarity of the corresponding implanted lead must be confirmed to be bipolar Safe Program Activating the Safe Progr
34. sensing in the right ventricle and triggering of a right ventricular sensing event in the left ventricle The biventricular synch settings can be activated together with the DDD R DDI R VDD R and VVI R pacing modes CAUTION Sensing The Stratos CRT Ps do not sense in the left ventricle AV Conduction In patients with intact AV conduction the intrinsic atrial tachycardia is conducted to the ventricle 1 1 With the resynchronization mode activated spontaneous rate of the right ventricle mode is synchronized for a rate up to 200 ppm in the left ventricle For this reason biventricular pacing mode should be turned OFF in such cases 70 Stratos LV LV T Technical Manual During biventricular pacing in the Stratos CRT Ps the right ventricle is paced first Starting from the initially paced chamber RV the intraventricular conduction time VV delay is permanently set to 5 ms after a right ventricular sensed or paced event NOTE While ventricular pacing and sensing events are synchronized synchronization does not occur during ventricular extrasystoles The following table presents in detail the effects of the standard pacing modes with the biventricular modes Table 19 Biventricular Pacing Modes Biventricular Pacing Modes BiV RV RV T Ujclole UVUliciole U U O U eaa E e E 8 RVs inhibits RVp X X X X X xX X X xX RVs triggers LVp X X X X X X X X X
35. storage temperature range is 5 to 55 C 41 131 F Exposure to temperatures outside this range may result in CRT P malfunction see Section 7 1 Low Temperatures Exposure to low temperatures below 0 C may cause a false elective replacement indication to be present If this occurs warm the device to room temperature and reset the ERI with magnet application see Section 7 1 Handling Do not drop If an unpackaged CRT P is dropped onto a hard surface return it to BIOTRONIK see Section 7 1 136 Stratos LV LV T Technical Manual CAUTION FOR SINGLE USE ONLY Do not re sterilize the CRT P or accessories packaged with the CRT P they are intended for one time use Device Packaging Do not use the device if the packaging is wet punctured opened or damaged because the integrity of the sterile packaging may be compromised Return the device to BIOTRONIK Storage magnets Store the device in a clean area away from magnets kits containing magnets and sources of electromagnetic interference EMI to avoid damage to the device Use Before Date Do not implant the device after the USE BEFORE DATE because the device may have reduced longevity If a replacement CRT P is needed contact your local BIOTRONIK representative 7 2 Opening the Sterile Container Stratos CRT Ps are packaged in two plastic containers one within the other Each is individually sealed and then sterilized with ethylene
36. that occurred since the last follow up visit Mode Switch Trend Tachy Episode Protocol The trend records up to 64 atrial tachycardia episodes that result in a mode switch The trends are available as a rolling trend and therefore contain information about the most recent events The atrial tachycardia episodes are displayed graphically as a function of time on the programmer screen NOTE When the elective replacement indication ERI has been attained the contents of the tachy episode trends as well as all memory contents are frozen and further recording is stopped 2 21 2 AF Classification To adequately record atrial fibrillation AF and reduce the number of times the recording is turned ON and OFF a lower and upper AF detection rate can be set Both the lower sensing rate as well as well as the upper resolution rate is programmable 100 10 300 2 400 ppm 114 Stratos LV LV T Technical Manual In addition to the detection rate an AF is classified using X out of 8 algorithm of mode switching If mode switching is not programmed the standard setting of 5 out of 8 is used In the statistics the AF duration 1 min 10 min 60 min 4 h 12 h 24 h 48 h gt 48 h as well as the AF start time 0 3 hours 3 6 hours 6 9 hours 9 12 hours 12 15 hours 15 18 hours 18 21 hours 21 24 hours are shown in the histograms 2 21 3 AES Statistics This function enables long term recording and analysis of at
37. the Stratos CRT Ps the trends of the three different channels are identified with different colors NOTE When a magnet is applied Stratos CRT Ps can only continue recording diagnostic data when in the synchronous magnet mode or during the first 10 cycles of the auto magnet mode 2 19 Interrogating and or Starting Statistics The recorded diagnostic data saved data contents of the pacemaker are always read transmitted through interrogation at the beginning of the follow up and saved to the programmer This allows relevant data to be displayed on the programmer at anytime All statistics can be reset with the Clear Statistics function and the Transmit function in the Parameter selection menu The start time and duration are automatically saved for all statistics Stratos LV LV T Technical Manual 111 2 20 Timing Statistics 2 20 1 Event Counter The event counter totals all of the sensed and paced events from all three channels With the event counter the following events and event sequences can be registered over several years e Atrial detection As detection during ARP ARS FFP As_FFP and the PMT window As_PMT pacing Ap e Ventricular RV sensing RV pacing and LV pacing e Ventricular extrasystoles are counted both as VES and as ventricular sense events NOTE All event counter data are transmitted to the programmer and evaluated there but not all events are displayed in deta
38. the ECG Unipolar pacing occasionally results in muscle stimulation in the device pocket or diaphragm RV only TRV only and BiV BiV RV LV with programmed VV Delay Stratos LV LV T Technical Manual 141 Lead Compatibility The Stratos CRT Ps have been designed for connection with a bipolar lead in the atrium and two bipolar leads in the ventricle All connections are IS 1 compatible Appropriate adapters e g A1 A should be fitted when using leads with a different connection NOTE Connecting systems with a 3 2 mm configuration that do not expressly claim to agree with the IS 1 dimensions generally have to be regarded as incompatible with IS 1 connectors and can only be used with BIOTRONIK products together with an appropriate adapter For questions regarding lead device compatibility consult your BIOTRONIK representative In case of device replacement ensure that the existing lead connector and leads are not damaged CAUTION Lead CRT P Compatibility Because of the numerous available 3 2 mm configurations e g the IS 1 and VS 1 standards lead CRT P compatibility should be confirmed with the CRT P and or lead manufacturer prior to the implantation of the system IS 1 wherever stated in this manual refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit Reference ISO 5841 3 1992 E 142 Stratos LV LV T Technical Manual Conne
39. the pacing voltages are programmed between 2 4 and 4 8 V The lead check feature can be programmed OFF in patients that require cardiac resynchronization therapy Care should be taken when programming Stratos CRT Ps with Lead Check ON as the device may switch from bipolar to unipolar pacing and sensing without warning This situation may be inappropriate when using a Stratos CRT P for patients with an Implantable Cardioverter Defibrillator ICD The following associated message appears when programming this feature Lead check may result in a switch to unipolar pacing and sensing which may be inappropriate for patients with an ICD Additionally Lead Check should be programmed OFF before lead connection as the feature will automatically reprogram the device to unipolar in the absence of a lead Lead CRT P Compatibility Because of the numerous available 3 2 mm configurations e g the IS 1 and VS 1 standards lead CRT P compatibility should be confirmed with the CRT P and or lead manufacturer prior to the implantation of the system 8 Stratos LV LV T Technical Manual IS 1 wherever stated in this manual refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit Reference ISO 5841 3 1992 E Lead Configuration The polarity of the implanted lead dictates what lead configuration can be programmed for the CRT P Pacing will not occur with a unipolar lea
40. the permanent program maybe selected Stratos LV LV T Technical Manual 99 2 16 Rate Fading Rate Fading is intended to prevent a sudden drop in heart rate when the Stratos CRT Ps transition from tracking an intrinsic rhythm to pacing due to an abrupt decrease in the intrinsic rate or due to Mode Switching This smooth drop in pacing rate is designed to prevent symptoms such as dizziness light headedness lack of energy and fainting spells With Rate Fading enabled the Stratos CRT Ps calculate a Backup Rate that is always active in the background As soon as the rate decreases the CRT P begins pacing at the Backup Rate The Backup Rate corresponds to a delay of the intrinsic rate corresponding to a programmable rate increase and programmable rate decrease these parameters determine the sensitivity of the controlled rate smoothing After four consecutive intrinsic events A Ags the CRT P calculates the Target Rate for the Backup Rate which is a four beat average of the intrinsic rate reduced by 10 ppm The Target Rate cannot exceed the Maximum Fading Rate programmed as Max Activity Rate and cannot increase faster than the RF Rate Increase programmable in ppm cycle When the intrinsic rate drops considerably below the Target Rate the pacing rate drops to the Backup Rate and is then decreased gradually by the programmable Decay Rate to the Sensor Indicated Rate or Basic Rate The Backup and Target Rates are defined
41. to the implanted CRT system which includes the Stratos LV device the atrial lead the right ventricular lead the left ventricular lead and the implant procedure The target complication free rate at six months was 85 Accountability of PMA Cohorts During the OVID study 84 patients were implanted with the Stratos LV CRT P and Corox OTW Steroid LV lead system Additionally 5 other patients were implanted with a Stratos LV CRT P device following an unsuccessful Corox OTW Steroid LV lead implant attempt Of these 5 patients three were not implanted with any LV pacing lead one was implanted with a non study LV pacing lead and one was implanted with a BIOTRONIK Elox P 60 BP placed in the RV outflow tract for bi focal ventricular pacing These 5 patients were excluded from the OVID study at 1 month post implant because the primary endpoint of the OVID study was the evaluation of the safety and effectiveness of the Corox OTW Steroid lead Demographics and Baseline Parameters Table 9 provides a summary of the patient demographics and medical history for the 89 enrolled patients implanted with a Stratos LV The typical patient implanted with a Stratos LV CRT P was a 68 year old male with NYHA Class III heart failure Left Bundle Branch Block LBBB a mean QRS duration of 160 ms and non ischemic cardiomyopathy 42 Stratos LV LV T Technical Manual Table 9 Patient Demographics Characteristic Results Age at Implant Years n 88 M
42. whether the patient was physically situated in the required coverage range of the patient device at the time the event information was sent Examples The programmed sensitivity is 1 0 mV A Average of the measured P R Wave amplitudes is 2 6 mV Therefore measured value is greater than 100 of the safety margin Event report is not triggered B Average of the measured P R Wave amplitudes is 1 9 mV Therefore measured value is less than 100 but greater than 50 of the safety margin Event report is not triggered C Average of the measured P R Wave amplitudes is 1 4 mV Therefore measured value is smaller than 50 of the safety margin As a result an event report is triggered Stratos LV LV T Technical Manual 107 NOTE The attending physician must notify the BIOTRONIK Service Center about which of these events he she wishes to be informed 2 17 4 3 Patient Report It is possible to trigger a transmission through magnet application over the CRT P The attending physician must inform the patient in detail about operating the device and about the physical symptoms which would warrant a magnet application by the patient CAUTION Patient Activated Report The magnet effect must be programmed synchronous if the Patient Report function is activated 2 17 5 Description of Transmitted Data The following data are transmitted by the Home Monitoring system when activated In addition to the medical data the seria
43. 3 Group 1 Group2 0 Group 2 Group 3 0 Group 3 6 Month Follow up Data Patient Death before 6 Month Group 1 0 Group2 2 Group 3 0 Withdrew before 6 Month FU Group 1 1 Group 2 1 Group 3 0 Not Reached 6 Month FU or Data Pending Completed 6 Month Follow up ea A Group 1 23 Siou 3 3 Group 2 30 6 month FU Not Completed Group 3 15 Group 1 0 Group 2 1 Group 3 0 Figure 1 Patient Accountability Demographics and Baseline Parameters Table 1 provides a summary of the patient demographics at enrollment There were no statistical differences in enrollment demographics between the 3 groups Stratos LV LV T Technical Manual 23 Table 1 Patient Demographics at Enrollment Characteristic Group Group2 Group3 P value Age Enrollment Yrs Mean SE Range Gender Male Female Six Minute Walk Distance meters Mean SE Range New York Heart Association Class Class Il Class Ill Underlying Heart Disease Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Valvular Heart Disease Coronary Artery Disease Hypertension No underlying structural heart disease N 42 73 7 1 3 56 to 90 N 42 18 42 9 24 57 1 N 42 262 7 15 1 78 to 420 N 42 23 54 8 19 45 2 N 42 8 19 0 4 9 5 12 28 6 19 45 2 37 88 1 3 7 1 N 50 72 3 1 2 51 to 86 N 50 19 38 0 31 62 0 N 50 283 6 13 8 37 to 438 N 50 18 36 0 32 64 0 N 49 11 22 4 1
44. AAA VV Iie cciie inte ad 68 DA AA Vil arenes wade ie ida 68 2 1 8 AQQ VOO Lies ii dia 68 219 DOO rita idad 68 2 410 WD e 68 ii Stratos LV LV T Technical Manual Za ORF ODO ita n 69 2 2 Biventricular Synchronization of the Stratos CRT Ps 69 2 3 Timing FUNCTIONS eran iaei aeiia a AA 70 23 1 Base Raeann a tas 70 2 3 2 Rate Hysteresis mica 71 23 3 Scan HysteresiS na n noni data is 72 2 3 4 Repetitive Hysteresis 74 2 3 5 Night Mode sasear iaiaaeaia 75 2 3 6 Refractory Periods 76 2 3 7 Atrial PMT Protection 77 2 3 8 Ventricular Refractory Period ooocononcccnnnnoniccinn 78 ZO ANV Deli id 78 2 3 10 VES Discrimination after Atrial Sensed Events 80 2 3 11 Sense Compensation ooocoocccccnnccccncococcnccnncnnnnnnnos 80 2 3 12 Ventricular Blanking Period 81 2 3 13 Safety AV Delay oe eeeeeeeeeeneeeeeeeteeeeeenaas 81 2 4 Pacing and Sensing Functions 82 24 1 Pulse Amplitude and Pulse Width 82 242 SONSHIVI ea 83 243 Lead Polar naa 83 2 5 Automatic Lead Check ocococicicicococicicininnnnenenenenininonos 84 2 6 Antitachycardia Functions s es 86 2 6 1 Upper Rate and UTR Response 08 86 2 1 Wenckebach 2 Ticoocociniorndi aci n ita 86 2 8 Mode SWIC G sorrise Tonea 88 2 9 PMT Management eriiic ai 89 2951 Protection teca te E O 89 29 2 PMT Detection moco RAE 90 2 10 Adjustment of the PMT Protection Window 91 2 11 Atrial Upper Rate oooo
45. DD DDT A VDD DDT and VDT Stratos LV LV T Technical Manual 87 Wenckebach Behavior If the end of the AV delay falls within the upper threshold rate interval ventricular pacing occurs at the end of the upper tracking interval 2 1 Behavior If the high rate atrial event occurs in the ARP the FFP or PMT protection window an AV delay is not started In Wenckebach mode the CRT P switches to ventricular timing This means that a VA delay is started after a ventricular event to avoid the atrial basic interval extend the duration of the Wenckebach mode The VA delay is calculated from the basic hysteresis interval minus the AV delay or the AV safety interval The timing of the Stratos CRT Ps ensures that the ventricular paced event Vp following the VA delay allows atrial pacing at the end of the AV delay thus terminating the Wenckebach cycle The CRT P counts the number of Wenckebach cycles In more than four Wenckebach cycles are detected a shortened VA delay is started after a right or left ventricular paced event to guarantee constancy of the ventricular rate The short VA delay is in this instance calculated from the ventricular interval of the upper tacking interval minus the AV delay or the AV safety interval If the Wenckebach mode has been terminated the counter of the CRT P is reset 88 Stratos LV LV T Technical Manual 2 8 Mode Switching Mode switching prevents the conduction of paroxysmal atrial tachycard
46. O to 10kQ The atrial and both ventricular channels are shown as different colored trends Stratos LV LV T Technical Manual 119 3 Follow up Procedures 3 1 General Considerations The CRT P follow up serves to verify appropriate function of the pacing system and to optimize the parameter settings In most instances pacing system malfunction attributed to causes such as chronic threshold can be corrected by reprogramming the CRT Ps The follow up intervals are therefore primarily determined by medical judgment taking possible pacemaker dependency into consideration The following notes are meant to stress certain product features which are of importance for follow up visit For detailed information on follow up procedures and medical aspects please refer to the pertinent medical literature A detailed description of the follow up functions and the programming procedures are provided in the corresponding software manual CAUTION Programming Modifications Extreme programming changes should only be made after careful clinical assessment Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm 120 Stratos LV LV T Technical Manual Stratos LV LV T Technical Manual 121 4 Real Time IEGM Stratos CRT Ps offer the option of real time transmission of the unfiltered intracardiac electrogram IEGM In the Stratos devices it is possible to simultaneously transmit the IEGM
47. OVID clinical study and 89 patients were implanted with a Stratos LV device 40 Stratos LV LV T Technical Manual Clinical Inclusion Criteria To support the objectives of this investigation patients were required to meet the following inclusion criteria prior to enrollment e Meet the indications for bi ventricular pacing e Age gt 18 years e Receiving optimal drug therapy for Congestive Heart Failure treatment e Give informed consent Clinical Exclusion Criteria To support the objectives of this investigation the exclusion criteria at the time of patient enrollment included the following requirements e Myocardial infarction or unstable angina pectoris e Acute myocarditis e Life expectancy lt 6 months e Planned cardiac surgical procedures or interventional measures within the next 6 months e Pregnancy Follow Up Schedule All patients were implanted with the Corox OTW Steroid LV lead system and a CRT P or CRT D pulse generator capable of providing bi ventricular pacing for the treatment of CHF The specific study procedures were performed at e Pre operative Visit e Implantation e Pre discharge follow up e One month follow up e Three month follow up e Six month follow up e Twelve month follow up Stratos LV LV T Technical Manual 41 Clinical Endpoints The safety of the Stratos LV was evaluated based on complications adverse events that require additional invasive intervention to resolve related
48. P With ventricular events right ventricular sensed or paced left ventricular paced VES the Stratos CRT Ps start an FFP interval 2 3 7 Atrial PMT Protection In all atrial controlled dual chamber modes Stratos CRT Ps start the PMT protection interval after each ventricular stimulus This prevents retrograde conduction and triggering of pacemaker mediated tachycardias PMTs Right ventricular extrasystoles begin an extended PMT interval In all dual chamber modes controlled by the ventricle the Stratos CRT Ps start the PMT protection interval after each initial right or left ventricular event The PMT protection interval after a Vp is freely programmable while the PMT interval after VES is automatically set to 225 ms greater than the PMT interval after Vp Nominal value 250 ms AUTO 175 5 600 ms If an atrial event occurs within the atrial PMT protection interval the atrial event is classified such that the AV delay is not restarted In the Stratos CRT Ps the PMT protection interval is started with a right or left ventricular paced event 78 Stratos LV LV T Technical Manual 2 3 8 Ventricular Refractory Period In all modes in which a ventricular depolarization can be sensed the Stratos CRT Ps begin a ventricular refractory period after each ventricular event using a standard value of 250 ms programmable as 150 35 500 ms 2 3 9 AV Delay 2 3 9 1 Dynamic AV Delay Programmable values Lower AV lim
49. P is possible If this procedure must be used the greatest possible distance from the point of electrical and mechanical strain should be chosen in order to minimize a_ potential interference with the CRT P Electrocautery Electrocautery should never be performed within 15 cm 6 inches of an implanted CRT P or leads because of the danger of introducing fibrillatory currents into the heart and or damaging the CRT P Pacing should be asynchronous and above the patient s intrinsic rate to prevent inhibition by interference signals generated by the cautery When possible a bipolar electrocautery system should be used 6 Stratos LV LV T Technical Manual For transurethral resection of the prostate it is recommended that the cautery ground plate be placed under the buttocks or around the thigh but not in the thoracic area where the current pathway could pass through or near the CRT P system 1 5 2 Storage and Sterilization Storage temperature Recommended storage temperature range is 5 to 55 C 41 131 F Exposure to temperatures outside this range may result in CRT P malfunction see Section 7 1 Low Temperatures Exposure to low temperatures below 0 C may cause a false elective replacement indication to be present If this occurs warm the device to room temperature and reset the ERI with magnet application see Section 7 1 Handling Do not drop If an unpackaged CRT P is dropped onto a hard surface return
50. S based rate adaptive pacing using BIOTRONIK s Protos DR CLS which is a dual chamber pulse generator with CLS based rate adaptive pacing During this study the Protos DR CLS devices were implanted with two ventricular leads the right ventricular lead was connected to the ventricular port and the left ventricular lead was connected to the atrial port Protos DR CLS was included in this study to evaluate biventricular pacing with a different type of rate adaptive sensor technology e Patients assigned to Group 2 received biventricular pacing with accelerometer based rate adaptive pacing using the Stratos LV e Patients assigned to Group 3 control group received right ventricular pacing with accelerometer based rate adaptive pacing using the Stratos LV Therefore 60 of the patients received a Stratos LV device Primarily the study evaluated and compared the functional benefits of CRT between the three randomized groups using a composite endpoint consisting of a six minute walk test meters walked and quality of life measurement assessed using the Minnesota Living with Heart Failure Questionnaire Relevant measurements were completed twice for each patient once at the Baseline evaluation prior to implant and ablation and again at a six month follow up evaluation The data collected during this clinical study was used to demonstrate superiority of CRT to RV only pacing This study also evaluated the safety of both the Protos DR CLS a
51. SA 109 2 18 6 General Statistical Information o coonn 110 2 19 Interrogating and or Starting Statistics 110 2 20 Timing Statistics senssa riei 111 2 20 1 Event Counter cocococccccccccncononcnccnnccnonnnnnonononinnnnnns 111 2 20 2 Event EpiSOdes oooocccccicococococccncccicncnnnononccnnnnnnns 111 2 20 3 Rate Trend c cccccecceeeescceeceeeeeeeeeeeseneeeeeeeees 112 2 20 4 Atrial and Ventricular Rate Histogram 112 2 21 Arrhythmia Statistics 0 2 2 eceeeeeeeeeeeeeeeeeeeeeeneeeeees 113 2 21 1 Tachy Episode Trend 0 ccceeeeeeeeeeeseeeeeeeenaes 113 2 21 2 AF Classification ccccccccceceeeseeeeceereeeeeeees 113 221 3 AES Statistics oia aia 114 2 21 4 VES Statistics 2 00 0 cececeececeeeeeeeeeeeeeeteeeeeeeees 115 2 22 Sensor Statistics cceeeeeeceeeeceeeeeeeceeeeeeeeeeeeeeeeeees 116 2 22 1 Sensor Rate Histogram ccceecceeeeseeereeeenes 116 2 22 2 Activity Report rodai reran EAA 117 2 22 3 Sensor Optimization ooooooocnnnnnnnnnnnnnccocccccnnnnnnons 117 2 23 SENSING Statistics ce aE 117 2 24 Pacing Statistics e iico ie e r E E 118 Follow Up Procedures omoocccccccccnnnanconcconcnonnnanananancnnnnnos 119 3 1 General Considerations ooooooicnnnnocccccnnnnicncnconcnccnnnns 119 Real Time JEGM iii iia da 121 4 1 IEGM Recordings eirinn a 121 iv Stratos LV LV T Technical Manual 5 Battery Pulse and Lead Data ccccconinnnconicice
52. Scan Hysteresis is not active during the programmed Night Mode Scan Hysteresis is only available when Hysteresis is selected on Magnet application closing of reed switch suspends 180 consecutive event counter independent of the magnet effect 74 Stratos LV LV T Technical Manual 2 3 4 Repetitive Hysteresis Repetitive hysteresis is expanded programmability of the Hysteresis feature Repetitive hysteresis searches for an underlying intrinsic cardiac rhythm which may exist slightly below the programmed lower rate or sensor indicated rate of the patient Following 180 consecutive sensed events this feature allows the intrinsic rhythm to drop to or below the hysteresis rate During the time when the intrinsic rate is at or below the hysteresis rate pacing occurs at the hysteresis rate for the programmed number of beats up to 10 Should the number of programmed beats be exceeded the stimulation rate returns to the lower rate or sensor indicated rate If an intrinsic cardiac rhythm is detected within the programmed number of beats between the hysteresis rate and the lower rate the intrinsic rhythm is allowed and inhibits pacing by the CRT P Lower rate Hysteresis rate o Spontaneous event A Stimulation Time REPETITIVE HYSTERESIS Figure 4 Repetitive Hysteresis Repetitive hysteresis has been incorporated to promote spontaneous cardiac rhythm and may reduce device energy consumption
53. Stratos Family of Cardiac Resynchronization Therapy Pacemakers A f Ny ow Hame toniter ing DODRY d h unipolar bipalar Oja 6011973 E Y ki Stratos LV DDDRV BIOTROMIK 151 TA Maxis in Germany ai A j i RV 6011073 Ol w BIOTRONIK l Made in Germany A _ _ Technical Manual 6 BIOTRONIK excellence for life Stratos CRT Ps Implantable Cardiac Resynchronization Therapy Pacemakers Stratos X Ray identification Radiopaque Identification A radiopaque identification code is visible on standard x ray and identifies the pulse generator Stratos LV LV T aa sy CAUTION Lead CRT P Compatibility Because of the numerous available 3 2 mm configurations e g the IS 1 and VS 1 standards lead CRT P compatibility should be confirmed with the CRT P and or lead manufacturer prior to the implantation of the system IS 1 wherever stated in this manual refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit Reference ISO 5841 3 1992 E 2008 BIOTRONIK Inc all rights reserved Stratos LV LV T Technical Manual Contents DG ii ii 1 1 1 Device Description oooooninnnccncnnnnnccnnnnononccnnnnnnnnnnnnnnnos 1 V2 INPICATIONS nna a eee desea 2 1 3 Contraindications cccccccccceeeeeeeeeeceeeeeeeesetsenneaeeees 3 1 4 Note to Physica comandada 3 1 5 Warnings and Precautions ce
54. ad system impedance programmed parameters amount of pacing and sensing required and circuit operating characteristics Service time is the time from beginning of service BOS to the end of service EOS To assist the physician in determining the optimum time for pulse generator replacement an elective replacement indicator is provided that is activated when the battery cell capacity drops to a predetermined level The following table defines the different service cycles at standard settings 37 C and with a lead impedance of 500 ohms The beginning of the replacement cycle is displayed on the programmer after pulse generator interrogation and appears on the printout Table 29 Service Cycle Definitions Abbreviation Definition Cycle BOS Normal service cycle Service battery in good condition ERI Elective Identifies the time of Replacement elective replacement Indication indication The rate occurring at ERI depends upon the programmed mode and magnet application EOS End of Identifies the end of the Service elective replacement indication period The Stratos CRT Ps indicate the need for replacement by a defined decrease in the programmed pacing rate without a magnet applied The rate change is dependent on the programmed pacing mode 146 Stratos LV LV T Technical Manual The pacing rate decreases by 11 when programmed to DDD R DDT R DOO R VDD R VDI R VDT R VVI R VVT R AAI R AAT R
55. al classes in the form of a bar chart and the total number of events Subsequent VES couplets triplets are recorded as one event VES Coupling Interval The VES coupling interval shows in which millisecond range the prematurity has occurred The intervals of the VES VES sequences are displayed from lt 200 to 1040 ms in 24 histogram classes The graphic display shows the percentage values of the individual classes in the form of a bar chart and the total number of events In the case of subsequent VES couplets triplets these are no longer included Only the first VES is classified 2 22 Sensor Statistics 2 22 1 Sensor Rate Histogram This function records how often the sensor rate is within in certain ranges The rate range is subdivided into 16 rate classes going from 40 to 180 including bins for rates lt 40 bpm and rates gt 180 bpm The percentage and total number of sensed and paced events occurring within a rate class is displayed Sensor rate recording is independent of the effectiveness of the respective pacing rate and it is not influenced by inhibition of pacing due to spontaneous events Rate data are also recorded in non rate adaptive modes Recording stops when the memory available for recording the sensor rates is full Recordings can be stored for several years The frequency distribution of the sensor rates can be displayed as a diagram during follow up examinations Stratos LV LV T Technical Manual 117
56. am is a way of quickly programming the device to multiple settings in the event of an emergency These settings include unipolar pacing with pacing output OFF in the left ventricular channel Refer to Section 6 3 for further details Programmers Use only BIOTRONIK s ICS 3000 programmer equipped with appropriate software to program Stratos CRT Ps Do not use programmers from other manufacturers Pulse Amplitude Programming of pulse amplitudes higher than 4 8 V in combination with long pulse widths and or high pacing rates can lead to premature activation of the replacement indicator If a pulse amplitude of 7 2 V or higher is programmed and high pacing rates are reached output amplitudes may differ from programmed values 10 Stratos LV LV T Technical Manual Pacing thresholds When decreasing programmed output pulse amplitude and or pulse width the pacing threshold must first be accurately assessed to provide a 2 1 safety margin EMI Computerized systems are subject to Electromagnetic Interference EMI or noise In the presence of such interference telemetry communication may be interrupted and prevent programming of the Stratos CRT P Programming Modifications Extreme programming changes should only be made after careful clinical assessment Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm Short Pacing Intervals Use of short pacing intervals
57. assword protected BIOTRONIK Home Monitoring website can be accessed at the following URL www biotronik homemonitoring com An online help menu is available in order to assist with the use of the Home Monitoring website Use of the Internet for reviewing Home Monitoring data must be in conjunction with the system requirements listed in Table 24 Additionally Table 24 provides system specifications that are recommended for optimizing usage of the Internet 104 Stratos LV LV T Technical Manual Table 24 System Requirements Recommendations System System Requirements Recommendations for Optimal Usage Screen 2 1024 x 768 Resolution Internet gt 128 kB sec Bandwidth DSL cable modem PC 600 MHz 128 MB N A RAM Internet MS Internet gt MS Internet Browser Explorer 5 0 Explorer 5 5 or or Netscape 2 Netscape 7 Mozilla Navigator 4 72 Acrobat Reader Version 5 or higher Communication Fax G3 or e mail Fax G3 e mail or Channel mobile phone Additionally the attending physician may register to be informed of the occurrence of an Event Triggered Message through email or SMS i e mobile phone with a brief text message registered for Internet availability the patient s detailed implant data can then be viewed by logging onto the Home Monitoring website Stratos LV LV T Technical Manual 105 Figure 9 Example of Patient Device with Charging Stand 2 17 4 Types of Report Transmissions
58. atients with chronic refractory atrial tachyarrhythmias 1 4 Note to Physician As with any implantable pulse generator there are certain infrequent risks associated with Stratos CRT Ps Section 1 6 lists the adverse events that have been observed or may potentially occur with these Cardiac Resynchronization Therapy Pacemakers The warnings and precautions listed in Section 1 5 should be taken under serious consideration in order to aid in avoiding device failures and harm to the patient Regular monitoring of the patient and their implanted device should be conducted to identify performance concerns and ensure appropriate therapy is being administered to the patient Please communicate any performance concerns to BIOTRONIK and to FDA All explanted devices should be returned to the manufacturer for testing to help understand device reliability and performance Refer to Section 10 for recommended procedures for handling explanted devices 1 5 Warnings and Precautions Certain therapeutic and diagnostic procedures may cause undetected damage to a Cardiac Resynchronization Therapy Pacemakers resulting in malfunction or failure at a later time Please note the following warnings and precautions 4 Stratos LV LV T Technical Manual Magnetic Resonance Imaging MRI Avoid use of magnetic resonance imaging as it has been shown to cause movement of the CRT Ps within the subcutaneous pocket and may cause pain and injury to the patient and
59. ator point ERI the NIPS feature is no longer available Ventricular pacing support is available to CRT P dependent patients during burst or programmed burst stimulation through the back up pacing program as long as the wand is within 15 cm of the CRT P Removing the programmer wand or placement to distance greater than 15 cm from the implanted device returns the CRT P to its permanent program NIPS may only be programmed temporarily NOTE High pacing rates and pulse amplitudes together with wide pulse widths may temporarily decrease the amplitude of the pacing pulse The pacing pulse must be continuously verified with an ECG to assure effectiveness To perform NIPS function the programmer wand must be placed directly over the CRT P to enable continuous telemetry 128 Stratos LV LV T Technical Manual Stratos LV LV T Technical Manual 129 6 Other Functions Features Stratos CRT Ps offer many additional functions and features to assist with the physician in the care of the pacemaker patient 6 1 Temporary Programming CAUTION OFF Mode The OFF mode can be transmitted as a temporary program only to permit evaluation of the patient s spontaneous rhythm see Section 2 1 11 A temporary program is a pacing program which remains activated while the programming head is positioned over the CRT P Upon removal of the programming head at least 10 cm away from the CRT P the temporary program will be automatically deact
60. atos LV the atrial lead the right ventricular lead the left ventricular lead and the implant procedure The target complication free rate at six months was 85 Twenty three 23 complications in these categories were seen in 21 patients with cumulative implant duration of 127 7 years 12 8 of the patients had a reported complication in these categories The rate of complications per patient year was 0 18 Details of the Stratos LV complications in the AVAIL CLS CRT and OVID studies are listed in Table 12 Table 12 OVID and AVAIL Complication Free Rate Stratos LV Number of Number of Complications Category of E TS per patient a Patients Complications Patients year LV Lead Related High Threshold No 0 02 Capture Diaphragmatic 0 02 Stimulation Dislodgement opaa 0 01 Total 0 06 High Threshold No 0 07 Capture Total 0 07 Atrial Lead Related No Capture E 1 0 01 Total 0 6 1 0 01 48 Stratos LV LV T Technical Manual Table 12 OVID and AVAIL Complication Free Rate Stratos LV Number Complications Category of a os Numi gior per patient 3 Patients Complications Patients year Device Related Pocket Infection 0 02 Total 0 02 Pneumothorax 0 01 User error 0 01 Hematoma 0 01 Total 0 02 Total Lead Deviceand 21 12 8 23 0 18 Procedure Related Other Medical Arrhythmias 0 01 Repeated 3 Bee ablation Worsening Other Medical 0 02 Non CHF cardia
61. atos LV T Home Monitoring enables the exchange of information about a patient s cardiac status from the implant to the physician Home Monitoring can be used to provide the physician with advance reports from the implant and can process them into graphical and tabular format called a Cardio Report This information helps the physician optimize the therapy process as it allows the patient to be scheduled for additional clinical appointments between regular follow up visits if necessary Stratos LV LV T Technical Manual 101 CAUTION Patient s Ability Use of the Home Monitoring system requires the patient and or caregiver to follow the system instructions and cooperate fully when transmitting data If the patient cannot understand or follow the instructions because of physical or mental challenges another adult who can follow the instructions will be necessary for proper transmission Electromagnetic Interference EMI Precautions for EMI interference with the Stratos CRT Ps are provided in Section 1 5 6 Sources of EMI including cellular telephones electronic article surveillance systems and others are discussed therein Use in Cellular Phone Restricted Areas The mobile patient device transmitter receiver should not be utilized in areas where cellular phones are restricted or prohibited i e commercial aircraft Event Triggered Report A timely receipt of the event report cannot be guaranteed The receipt is also
62. c 3 1 8 3 0 02 symptoms Total 0 09 Total All Patients and 29 17 7 35 0 27 Categtories Number of Patients 164 Number of Patient Years 127 7 Stratos LV LV T Technical Manual 49 The freedom from Stratos LV system related and procedure related complications was 87 2 with a one sided lower 95 confidence bound of 82 09 Therefore the null hypothesis was rejected and it was concluded that the complication free rate at 6 months is equivalent to 85 within 10 and the primary safety endpoint was met p 0 0002 1 7 4 Tupos LV ATx Clinical IDE Study OPTION CRT ATx The CRT functionality of the Stratos CRT P devices is based on the FDA approved Tupos LV ATx Therefore the data from the OPTION CRT ATx study supports the effectiveness of CRT The OPTION CRT ATx study was conducted on the Tupos LV ATx a device that delivers CRT but in addition also offers defibrillation therapy CRT D Study Design The purpose of the prospective randomized multi center OPTION CRT ATx study was to demonstrate the safety and effectiveness of the investigational Tupos LV ATx Cardiac Resynchronization Therapy Defibrillator CRT D in patients with congestive heart failure CHF and atrial tachyarrhythmias Patients in the study group were implanted with a BIOTRONIK Tupos LV ATx Patients in the control group were implanted with any legally marketed CRT D Patients in both the study and control groups were implanted with a legally
63. cal information The various statistics consist of such features as rate histograms event counters sensor trends VES statistics and activity reports which are described in the following sections 2 18 1 Timing e Event Counters e Event Episodes e A V Rate Histogram e A V Rate Trend 2 18 2 Arrhythmia e Tachy Episode Trend e AF Classification e AES Classification e AES vs Atrial Rate e VES Classification e VES versus ventricular rate e VES Coupling Intervals 2 18 3 Sensor e Rate Sensor Trend e Sensor Rate Histogram e Activity Report e Sensor Optimization 2 18 4 Sensing e P wave Trends e R wave Trends 2 18 5 Pacing e A V Impedance Trends 110 Stratos LV LV T Technical Manual 2 18 6 General Statistical Information e The Stratos CRT P s statistics modes are always in operation and cannot be selected OFF e The counters within the statistic features do not operate when a magnet is applied to the CRT Ps e The counters within the statistic features are reset each time the Stratos CRT Ps are permanently programmed e Event counters are displayed as bar charts showing the event totals expressed as a percentage e Histograms count how often events occur in different time or rate intervals for example how many events occurred in a 160 to 169 ppm range e Trends represent a certain number of events at a fixed point in time e g rates The trends are plotted as points that are joined together by a curve In
64. cantly reduce susceptibility to electromagnetic interference EMI However due to the variety and complexity of sources creating interference there is no absolute protection against EMI Generally it is assumed that EMI produces only minor effects if any in CRT P patients If the patient may be exposed to one of the following environmental conditions then the patient should be given the appropriate warnings 1 5 7 Home and Occupational Environments The following equipment and similar devices may affect normal CRT P operation electric arc welders electric melting furnaces radio television and radar transmitters power generating facilities high voltage transmission lines electrical ignition systems also of gasoline powered devices if protective hoods shrouds etc are removed electrical tools anti theft devices at retail stores and electrical appliances if not in proper condition or not correctly grounded and encased Patients should exercise reasonable caution in avoidance of devices which generate a strong electric or magnetic field If EMI inhibits pacing or causes a reversion to asynchronous pacing or pacing at magnet rate moving away from the source or turning it off should allow the CRT P to return to its normal mode of operation Some potential EMI sources include High Voltage Power Transmission Lines High voltage power transmission lines may generate enough EMI to interfere with CRT P operation if approached t
65. ceeeeeeeseeeeeenteeeeeees 3 1 5 1 Interactions with Other Medical Therapy 4 1 5 2 Storage and Sterilization 0 ec eeeeeeteeeeees 6 1 5 3 Lead Connection and Evaluation o 7 1 5 4 Programming and OperatiON oooococcinnncccnnnncccccn 8 1 5 5 Home Monitoring ooocccnoccccnnnocccccnononcncnnnancnnnnnnn no 11 1 5 6 Electromagnetic Interference EMI 13 1 5 7 Home and Occupational Environments 13 1 5 8 Cellular Phones c ccccceeeeeeeeeeeeeeeeeeeteeneeee 14 1 5 9 Hospital and Medical Environments 15 1 5 10 Device Explant and Disposal 000 eceee 15 1 6 Potential Effects of the Device on Health 16 1 7 Clinical Studies oooooccnnnnninnonocccnnnnccoconononcnnnnnnnnnnnnnnos 17 1 7 1 Stratos LV Clinical Study AVAIL CLS CRT 17 1 7 2 Stratos LV Clinical Study OVID study 39 1 7 3 AVAIL and OVID Combined Primary Endpoint Complication free Rate Safety 47 1 7 4 Tupos LV ATx Clinical IDE Study OPTION CRT A TX oaa Ea a eR 49 1 7 5 Conclusions Drawn from Studies 61 2 Programmable ParameterS mmocconnonicccnnnnncnnnssnnennssnnnnns 63 21 Pacing Modest ida 63 2 1 1 Rate adaptive Modes 0ocoocinnccinnnococinnnoccccnnnncnnns 63 2 12 DDD ae 63 2137 DD neti hea ee 67 24 DO Mii aii cade ed ee 67 ZLS VOD Sta annie need Na une eels 67 2 1 6
66. configuration 84 Stratos LV LV T Technical Manual The Stratos CRT Ps have a specially designed header that allows the CRT Ps to simultaneously sense and pace in both the right and left ventricles Biventricular pacing therapy requires programming of a bipolar pacing configuration in the ventricle Refer to Section 8 1 for a summary of the sensing and pacing configurations in the ventricle If a bipolar lead is connected to the CRT P unipolar or bipolar configuration can be programmed for pacing and sensing As compared to bipolar pacing the unipolar pacing pulse has the advantage of being clearly identifiable on the ECG Unipolar pacing occasionally results in muscle stimulation in the device pocket or diaphragm 2 5 Automatic Lead Check When Lead Check is activated the lead impedance is automatically measured with every pace If the impedance values are consecutively greater or less than the limits lt 200 Q and gt 3000 Q for repeated measurements the system automatically switches from bipolar to a unipolar lead configuration A bipolar lead failure is verified if the lead impedance measurement falls outside of the acceptable range for three consecutive readings When a lead failure has been detected a message is displayed on the programmer screen at the next follow up visit in order to notify the physician of the change Lead Check also may be activated with unipolar leads The pass fail criterion remains the same as with b
67. cording function has been activated please instruct the patient on how to use the magnet to trigger an IEGM recording Stratos LV LV T Technical Manual 123 5 Battery Pulse and Lead Data The following pulse battery and lead data can be measured noninvasively by means of analog telemetry Table 25 Measurable Parameters of Analog Telemetry Parameters Measuring Unit Battery voltage V Battery impedance kQ Battery current uA Pulse voltage V Pulse current mA Pulse energy uJ Pulse charge uC Lead impedance Q 5 1 Threshold Test Testing the Pacing Function Stratos CRT Ps are equipped with a high precision threshold test with a resolution of 0 1 V ranging from 0 1 V to 7 2 V The threshold test is activated as a temporary program whose specific operation is defined by the applicable software version The threshold is determined by observing the ECG Likewise all determinations of threshold or threshold margin by any means should only be performed by use of temporary programming to permit immediate reactivation of the permanent program in case of loss of capture Removal of the programmer head immediately stops the test and reactivates the permanent program Please refer to the appropriate software technical manual for a description of the threshold test operation The threshold test should be performed with the pulse width programmed to the same value as that selected for the permanent program To
68. cting the Stratos LV with the IS 1 Connector In order to avoid programming errors with the Stratos LV always connect the leads to the following ports A rn gt Bipolar lead in right atrium A _23 Bipolar lead in right ventricle a _ gt Unipolar and or Bipolar lead in left coo ventricle Figure 10 Connecting the Leads Stratos CRT Ps have a self sealing header Refer to the following steps when connecting a lead s to the CRT P First confirm that the setscrew s is not protruding into the connector receptacle To retract a setscrew insert the enclosed torque wrench through the perforation in the self sealing plug at an angle perpendicular to the lead connector until it is firmly placed in the setscrew CAUTION Setscrew Adjustment Back off the setscrew s prior to insertion of lead connector s as failure to do so may result in damage to the lead s and or difficulty connecting lead s Cross Threading Setscrew s To prevent cross threading the setscrew s do not back the setscrew s completely out of the threaded hole Leave the torque wrench in the slot of the setscrew s while the lead is inserted Rotate the wrench counterclockwise until the receptacle is clear of obstruction Then connect the pacing leads as described below Stratos LV LV T Technical Manual 143 Insert the enclosed torque wrench through the perforation in the self sealing plug at an angle perpendicular to
69. d if the lead configuration of the respective channel is programmed to bipolar see Section 8 Setscrew Adjustment Back off the setscrew s prior to insertion of lead connector s as failure to do so may result in damage to the lead s and or difficulty connecting lead s Cross Threading Setscrew s To prevent cross threading the setscrew s do not back the setscrew s completely out of the threaded hole Leave the torque wrench in the slot of the setscrew s while the lead is inserted Tightening Setscrew s Do not overtighten the setscrew s Use only the BIOTRONIK supplied torque wrench Sealing System Be sure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle Failure to do so may result in damage to the plug and its self sealing properties 1 5 4 Programming and Operation IEGM Due to the compression processes that the signals undergo the IEGM recordings are not suitable for making some specific cardiac diagnoses such as ischemia although these tracings may be useful in diagnosing arrhythmias device behavior or programming issues Post AES Before activating post AES check whether the selected program can cause Pacemaker Mediated Tachycardia PMT and whether post AES pacing results Overdrive Pacing Mode When programming the overdrive pacing mode check whether the selected program can cause PMT and whether atrial over drive pacing would
70. d to receive heart transplantation within six months e Enrolled in another cardiovascular or pharmacological Clinical investigation e Patients with an ICD or being considered for an ICD e Patients with previously implanted biventricular pacing systems e Patients with previously implanted single or dual chamber pacing system with gt 50 documented ventricular pacing e Patients with previous AV node ablation e Six minute walk test distance greater than 450 meters e Any condition preventing the patient from being able to perform required testing e Presence of another life threatening underlying illness separate from their cardiac disorder e Conditions that prohibit placement of any of the lead systems Follow Up Schedule At the enrollment screening the physician evaluated the patient to verify that all inclusion exclusion criteria have been met in accordance to the protocol and the patient has signed the informed consent After successful enrollment all patients were implanted with either a Stratos LV CRT P or Protos DR CLS device Evaluations at the Four Week Three and Six Month follow ups included NYHA classification medications and percentage of ventricular pacing Stratos LV LV T Technical Manual 21 Clinical Endpoints Primary Endpoint Complication free Rate Safety The safety of the Stratos LV was evaluated based on complications adverse events that require additional invasive intervention to resolve relate
71. d to the implanted CRT system which includes the Stratos LV the right ventricular the left ventricular lead lead ventricular lead adapters if used and the implant procedure The target complication free rate at six months is 85 Primary Endpoint Six Minute Walk Test amp QOL Effectiveness The purpose of Primary Endpoint 1 was to evaluate the effectiveness of the CRT Groups 1 and 2 compared to RV only Group 3 pacing as measured by the average composite rate of improvement in six minute walk test and QOL Accountability of PMA Cohorts After randomization and enrollment 23 patients 8 in Group 1 8 in Group 2 and 7 in Group 3 did not receive an implant The reasons for patients not receiving an implant are outlined in Figure 1 Two additional patients in Group 1 had an unsuccessful first implant attempt unable to implant the LV lead but follow up data was not received 22 Stratos LV LV T Technical Manual No implant Attempted Enrolled and Randomized Patients Withdrawal of Consent Group 1 43 Group1 2 Group 2 50 Group2 4 Group 3 25 _ Group3 3 Not Meeting Inclusion Criteria Group 1 2 Group2 2 Group3 1 Unsuccessful implant Implant Attempted Withdrawal of IC before 2nd Attempt Group 1 Group 1 4 Group 2 Group2 2 Group 3 Group3 3 Follow up to failed implant data pending Group 1 2 Group2 0 Group3 0 Ablation Ablation Data Pending Successful implant Group1
72. ded Stratos LV LV T Technical Manual 27 Table 3 Current Cardiac Medications at Enrollment i i 12 28 6 10 20 4 4 16 0 0 480 Rate Control Medications 32 76 2 43 87 8 20 80 0 0 462 Anti thrombic Agents 17 40 5 19 38 8 11 44 0 0 863 Anti Coagulants 36 85 7 40 81 6 22 88 0 0 686 ACE Inhibitors 16 38 1 16 32 7 8 32 0 0 848 Angiotensin Receptor Blockers Diuretics 30 71 4 34 69 4 13 52 0 0 255 Inotropes 1 2 4 2 4 1 0 0 0 0 803 Nitrates 3 7 1 6 12 2 2 8 0 0 714 Beta Blockers for CHF 6 14 3 9 18 4 4 16 0 0 947 Other 23 54 8 26 53 1 14 56 0 0 941 Chi Square test 2 sided 10 23 8 7 14 3 4 16 0 0 491 Safety and Effectiveness Results A total of 118 patients were enrolled in the AVAIL CLS CRT clinical study at 20 sites There were 43 Group 1 50 Group 2 and 25 Group 3 patients in this prospective multi center randomized clinical study For Group 1 there were 33 successful implants 76 7 of the Protos DR CLS system For Groups 2 and 3 there were 44 and 21 successful implants 88 0 and 84 0 respectively of the Stratos LV CRT P system 28 Stratos LV LV T Technical Manual e The study was designed to enroll 265 patients However the study was terminated early due to slow patient enrollment There were no safety issues involved in the termination decision Due to the lack of pa
73. diathermy therapy must be used it should not be applied in the immediate vicinity of the CRT P or leads The patient s peripheral pulse should be monitored continuously during the treatment Stratos LV LV T Technical Manual 5 Transcutaneous Electrical Nerve Stimulation TENS Transcutaneous electrical nerve stimulation may interfere with CRT P function If necessary the following measures may reduce the possibility of interference e Place the TENS electrodes as close to each other as possible e Place the TENS electrodes as far from the CRT P lead system as possible e Monitor cardiac activity during TENS use Defibrillation The following precautions are recommended to minimize the inherent risk of CRT P operation being adversely affected by defibrillation e The paddles should be placed anterior posterior or along a line perpendicular to the axis formed by the CRT P and the implanted lead e The energy setting should not be higher than required to achieve defibrillation e The distance between the paddles and the CRT P leads should not be less than 10 cm 4 inches Radiation The CRT P s internal electronics may be damaged by exposure to radiation during radiotherapy To minimize this risk when using such therapy the CRT P should be protected with local radiation shielding Lithotripsy Lithotripsy treatment should be avoided for CRT P patients since electrical and or mechanical interference with the CRT
74. duced by another 50 ms If additional PMTs occur the PMT protection interval is increased by another 50 ms This occurs until no more PMTs are detected In the absence of PMTs the PMT protection interval is successively reduced The initial values of the PMT protection interval in the automatic setting at 175 ms after Vp and 400 ms after VES 2 11 Atrial Upper Rate The atrial upper rate AUR prevents atrial pacing from occurring in the vulnerable phase after an atrial sensed event during the PMT protection interval and ensures that the next atrial paced event occurs after the heart s natural atrial refractory period To avoid this an atrial upper rate of 200 ppm atrial upper interval AUI 300 ms is started after a PMT As The next Ap can only be emitted after the expiration of the AUI When there are high sensor rates the atrial pacing is shifted To guarantee stability of the ventricular rate the AV delay is shortened to no less than the safety interval when the basic interval is lengthened NOTE Right atrial pacing does not occur when mode switching is activated and when the atrial upper rate is activated in DDI mode at the end of the sensor or basic interval 2 12 Preventive Overdrive Pacing Overdrive Mode The atrial pacing rate increases after each atrial sensed event that is not classified as an atrial extrasystole in an attempt to suppress atrial tachyarrhythmias The overdrive algorithm triggers atrial overd
75. e 5 4 3 Programmed Stimulation Programmed Stimulation offers burst pacing at specifically defined intervals that are user defined Programmed stimulation offers S1 51 S1 S2 S2 S3 S3 S4 S4 S5 individual intervals In addition up to 7 cycles are available containing a programmable pause of up to 50 seconds The last selected interval decrements in 0 to 100 ms steps As with Burst Stimulation the pacing mode switches to the permanent program when the wand is removed 5 4 4 Back up Pacing The back up pacing program remains active once NIPS has been selected and remains active during burst or programmed burst stimulation and within this menu This program remains active until the Stop touch key is pressed CAUTION Short Pacing Intervals Use of short pacing intervals high pacing rates with long atrial and or ventricular refractory periods may result in intermittent asynchronous pacing and therefore may be contraindicated in some patients Stratos LV LV T Technical Manual 127 5 4 5 NIPS Safety Features The BIOTRONIK offers the following safety features during NIPS sessions Before the NIPS feature can be used NIPS must be specifically selected and then is released through user acknowledgment In addition before NIPS is performed in the Ventricle the user must acknowledge that delivering NIPS into the Ventricle may induce dangerous arrhythmias When the battery voltage has reached the Elective Replacement Indic
76. e X out of 64 When a newly saved recording exceeds the programmed number of recordings per event the oldest recording is deleted An exception is the first recording and those with the longest duration for each event These are not over written NOTE The total length of each recording can be up to 10 seconds While the associated marker chain is always 10 seconds long the associated IEGM can be shorter depending on the amplitude and rate since the rate and amplitude influence the amount of data to be saved In Snap Shot Pretrigger it is possible to define the percentage of the recordings before the trigger event In addition it is possible to make a recording at the end of the tachycardia criterion for deactivation of the respective event exception patient triggered recordings that do not last At the next follow up examination the programmer automatically notes the recordings that have been made When interrogated the recording appears on the screen Note If the recording has been triggered by the patient by placing a magnet over the pacemaker make sure that the synchronous magnet effect is selected CAUTION IEGM Due to the compression processes that the signals undergo the IEGM recordings are not suitable for making some specific cardiac diagnoses such as ischemia although these tracings may be useful in diagnosing arrhythmias device behavior or programming issues If the patient triggered re
77. e 29 adverse events 18 observations in 17 patients and 11 complications in 10 patients There were no unanticipated adverse device effects reported e There were 10 patient deaths reported in the OVID study The clinical investigators have determined that no deaths were related to the Stratos LV CRT P system e The overall follow up compliance rate for the OVID study is 93 Primary Endpoint Complication free Rate Safety The safety of the Stratos LV was evaluated based on complications adverse events that require additional invasive intervention to resolve related to the implanted CRT system which includes the Stratos LV device the atrial lead the right ventricular lead the left ventricular lead and the implant procedure The target complication free rate at six months was 85 Ten 10 complications in these categories were seen in 10 patients with cumulative implant duration of 760 months 63 3 patient years 11 2 of the patients had a reported complication in these categories The rate of complications per patient year was 0 16 Details of the Stratos LV complications in the OVID study are listed in Table 10 44 Stratos LV LV T Technical Manual The freedom from Stratos LV system related and procedure related complications was 88 76 with a one sided lower 95 confidence bound of 81 69 Therefore the null hypothesis was rejected and it was concluded that the complication free rate at 6 months is equivalent to 85 wit
78. e and dual chamber pacing in a variety of rate adaptive and non rate adaptive pacing modes Pacing capability is supported by an extensive diagnostic set For motion based rate adaptation the Stratos CRT Ps are equipped with an internal accelerometer This sensor produces an electric signal during physical activity of the patient If a rate adaptive R mode is programmed then the accelerometer sensor signal controls the stimulation rate The Stratos LV T additionally also employs BIOTRONIK s Home Monitoring technology which is an automatic wireless remote monitoring system for management of patients with implantable devices With Home Monitoring physicians can review data about the patient s cardiac status and CRT P s functionality between regular follow up visits allowing the physician to optimize the therapy process Stratos CRT Ps are also designed to collect diagnostic data to aid the physician s assessment of a patient s condition and the performance of the implanted device The bipolar IS 1 connections are used for pacing and sensing right atrial and ventricle and the additional IS 1 connection is used for pacing in the left ventricle in either a bipolar or unipolar configuration depending on the left ventricular lead The pulse amplitude and pulse width of each of the three channels is separately programmable 2 Stratos LV LV T Technical Manual Stratos CRT Ps are designed to meet all indications for Cardiac Resynch
79. e over a period of twelve hours exceeds the average safety rate overdrive average rate limit OAR The average safety rate is determined indirectly from the maximum overdrive pacing rate MOR minus 10ppm If the average safety rate is exceeded the pacing rate is incrementally reduced to the basic rate If the average atrial heart rate falls below the average safety rate the preventive overdrive pacing is reactivated activation deactivation only in a 12 hour rhythm e If the function is deactivated for a third time because the average safety rate has been exceeded overdrive pacing remains OFF permanently The overdrive mode can not be reactivated until after the pacemaker has been programmed 94 Stratos LV LV T Technical Manual CAUTION Overdrive Pacing Mode When programming the overdrive pacing mode check whether the selected program can cause PMT and whether atrial over drive pacing would result Corresponding to the measured retrograde conduction time the PMT protection interval must be programmed to a correct value 2 13 AES Detection and Pacing Post atrial extrasystoles AES pacing is intended to prevent the occurrence of pro arrhythmic long short long sequences due to an atrial extrasystole which can lead to atrial tachycardias This is achieved through a shortened post AES basic interval which is incrementally lengthened again during subsequent cycles until the basic interval is attained The algorith
80. e saved as a couplet and three sequential AES are saved as a triplet AES Coupling Interval The AES coupling interval shows in which millisecond range the prematurity distance As Ap to AES has occurred The intervals of the AES AES Sequences are displayed from lt 200 to 1040 ms in 24 histograms classes The graphic display shows the percentage values if the individual classes in the form of a bar chart and the total number of events 2 21 4 VES Statistics The detected VES are ventricular events outside of the AV delay and the VER discrimination interval after As Therefore it is recommended that the atrial sensing be stable before activating the VES analysis If the atrial lead is bipolar bipolar sensing should be considered The VER prematurity histogram is subdivided into three percentage classes e 0 25 premature VES VES from 750 to 1000 ms at 60 ppm in the preceding interval e 25 50 premature for VES VES from 500 to 750 ms at 60 ppm in the preceding interval e gt 50 premature for VES VES from lt 500 ms at 60 ppm in the preceding interval The VES sequence histogram also displays single VES couplets triplets runs and VT episodes 116 Stratos LV LV T Technical Manual VES Classification VES vs Ventricular rate The VES versus the ventricular rate is likewise displayed in a histogram with 16 equidistant classes of lt 40 to 180 ppm The graphic display shows the percentage values of the individu
81. ean SD 68 10 Range 34 to 84 Gender n 89 Male 66 74 Female 23 26 QRS width ms n 70 Mean SD 160 23 Range 110 to 210 Etiology of Heart Failure n 87 Ischemic 32 37 Non Ischemic 55 63 New York Heart Association NYHA E Classification nasr Class IlI 73 84 Class IV 14 16 Atrial Tachyarrhythmias N 87 None 48 55 Atrial flutter 5 5 7 Paroxysmal atrial fibrillation 19 22 Persistent atrial fibrillation 1 en Other 5 5 7 Ventricular Tachyarrhythmias N 87 None 80 92 Ventricular fibrillation Sustained or non sustained VT 5 5 7 Other VT 2 2 3 Existing chronic leads prior to Corox n 88 OTW Steroid None 73 83 Yes due to previous pacemaker therapy 15 17 1 hon sustained VT n 4 no further information available n 1 VES n 2 Stratos LV LV T Technical Manual 43 Safety and Effectiveness Results e The cumulative implant duration was 760 months with a mean duration of 9 2 months Sixty five 77 of the patients had implant durations greater than 6 months e The implant success rate for the Stratos LV CRT P was 100 89 out of 89 The implant success of the Stratos LV CRT P in combination with the Corox OTW Steroid LV lead was 94 4 84 out of 89 e The mean LV pacing threshold at implant was 0 9 and at 6 months was 0 9 volts e The mean R wave at implant was 15 7 mV e The mean LV lead impedance at implant was 729 ohms and at 6 months was 603 ohms e There wer
82. ediated tachycardia Pneumothorax Pocket erosion Hematoma Device migration Thromboembolism Undersensing of intrinsic signals Venous occlusion Venous or cardiac perforation Stratos LV LV T Technical Manual 17 1 7 Clinical Studies The subsequent sections summarize the following three clinical studies that were used to support the safety and effectiveness of the Stratos LV LV T CRT Ps e The AVAIL CLS CRT clinical study e The OVID clinical study OUS e The OPTION CRT ATx clinical study Two of the studies AVAIL CLS CRT and OVID collected significant safety data supporting use of the Stratos LV LV T CRT P system The third study OPTION CRT ATx supports the effectiveness of cardiac resynchronization therapy CRT The OPTION CRT ATx study was conducted on a device that delivers CRT but in addition also offers defibrillation therapy CRT D 1 7 1 Stratos LV Clinical Study AVAIL CLS CRT Study Design The AVAIL CLS CRT was a multi center prospective randomized blinded clinical study designed to support approval for cardiac resynchronization therapy for a Heart Failure HF patient population not requiring back up defibrillation and that are indicated for an ablate and pace procedures All patients enrolled into the clinical study were randomly assigned to one of three groups using a 2 2 1 ratio for randomization 18 Stratos LV LV T Technical Manual e Patients assigned to Group 1 received biventricular pacing with CL
83. ensor driven operation and is independent of the rate limit The rate increase and rate decrease parameters are upper rate limited by the MAR and lower rate limited by the basic rate night rate MAR standard setting 120 ppm programmable 90 ppm 5 180 ppm The pacing rate is determined by the highest rate from the parameters of rate adaptation the overdrive rate and the post AES rate 2 14 7 Rate Decay The rate decay is set to a standard value of 0 5 ppm cycle and is programmable 0 25 0 25 1 25 ppm cycle The programmed rate decrease setting applies only to the decrease in pacing rate during sensor driven operation and does not affect the pacing rate during atrial triggered ventricular pacing 2 15 Sensor Stimulation Even when a non rate adaptive mode is programmed the behavior of the sensor is recorded if a rate adaptive mode has been selected in the Mode Switching mode The rate adaptive mode is only effective in Mode Switching The sensor stimulation indicates how a sensor would have reacted with the displayed sensor setting if a rate adaptive mode had been programmed This function is helpful to find the optimum sensor settings and to compare the sensor rate with the intrinsic rate When rate adaptation is activated sensor data are available that can be used to evaluate the sensor behavior NOTE In the sensor stimulation only values for the sensor threshold that are greater than those used for
84. erval resumes 80 Stratos LV LV T Technical Manual 2 3 9 4 AV Scan Hysteresis With AV Scan Hysteresis enabled after 180 consecutive pacing cycles the AV delay is extended for the programmed number of pacing cycles OFF 1 1 10 cycles If an intrinsic rhythm is detected within the extended AV delay and the longer AV delay remains in effect If an intrinsic rhythm is not detected within the number of scan cycles the original AV delay value resumes 2 3 10 VES Discrimination after Atrial Sensed Events Stratos CRT Ps have a special timing interval VES As VES discrimination after atrial sense events to identify ventricular extrasystoles With each As a VES discrimination interval is started in the ventricle If a ventricular sensed event occurs within the discrimination interval this event is interpreted as a Vs ventricular sensed event and no extended PMT protection interval is started In the factory setting the VES discrimination after As is set to 350 ms programmable OFF 250 5 450 ms The VES As terminates with each ventricular event If a ventricular event does not fall within the AV delay or the VES discrimination interval it is classified as a VES A ventricular event that is sensed within the VES discrimination interval but outside the AVE delay starts a VA delay after which an atrial paced is delivered 2 3 11 Sense Compensation For hemodynamic reasons it is desirable to keep constant ti
85. f the CRT Groups 1 and 2 compared to RV only Group 3 pacing as measured by the average composite rate of improvement in six minute walk test and QOL e Stratos LV Effectiveness Group 2 compared to Group 3 The average composite rate for Group 2 N 30 was 48 1 with a standard error of 12 3 The average composite rate for Group 3 N 15 was 33 0 with a standard error of 12 3 The difference in the mean composite rate between Group 2 and Group 3 is 15 1 The p value for superiority is 0 442 e Protos DR CLS Effectiveness Group 1 compared to Group 3 The average composite rate for the Group 1 N 23 is 36 8 with a standard error of 7 9 The average composite rate for Group 3 N 15 is 33 0 with a standard error of 12 3 The difference in the mean composite rate between Group 1 and Group 3 is 3 8 The p value for superiority is 0 788 Table 8 presents the average composite rate of improvement in six minute walk test distance and QOL score the average 6 minute walk test distance and the average QOL score at Baseline and at the Six Month follow up as well as the average difference in 6 minute walk test distance and QOL score between Baseline and the Six Month follow up for the CRT Groups 1 and 2 and RV only Group 3 for those patients with six minute walk test data and complete QOL data at both Baseline and the Six Month follow up Stratos LV LV T Technical Manual 37 Table 8 Composite of Six Minute Walk Test and QOL
86. flicts arise when the total decrease in rate is below 30 ppm Care should be exercised to avoid programming a Night Mode rate and hysteresis that is below what is appropriate and may be tolerated by the individual patient 2 3 3 Scan Hysteresis Scan hysteresis is expanded programmability of the Hysteresis feature Scan hysteresis searches for an underlying intrinsic cardiac rhythm which exists slightly below the programmed lower rate or sensor indicated rate of the CRT P Following 180 consecutive paced events the stimulation rate is temporarily decreased to the hysteresis rate for a programmed number of beats If a cardiac rhythm is not detected within the programmed number of beats at the hysteresis rate the stimulation rate returns back to the original lower rate or sensor indicated rate Several programmable beat intervals are available to allow a greater probability of detecting a spontaneous rhythm If an intrinsic cardiac rhythm is detected within the programmed number of beats between the hysteresis rate and the lower rate the intrinsic rhythm is allowed and the CRT P inhibits pacing Stratos LV LV T Technical Manual 73 o Spontaneous event A Stimulation SCAN HYSTERESIS Figure 3 Scan Hysteresis Scan hysteresis has been incorporated to promote intrinsic cardiac rhythm and may reduce device energy consumption The number of scan interval is programmable OFF 1 1 15 cycles NOTES
87. from all three channels as well as the IEGM marker channel The IEGM simultaneously recorded in the four channels at a scan rate of 256 Hz All the markers from the three channels are also transmitted together with the IEGM The IEGM and markers together with the surface ECG can be displayed directly on the screen of the programmer on a connected ECG recorded or they can be printed by the programmer printer NOTE When interpreting IEGM any limitations that result from applying the programmer head which contains the magnet must always be considered 4 1 IEGM Recordings The recording of the intracardiac information over a short period of time before the tachycardic phase provides valuable details about the arrhthmogenesis of the tachycardia An IEGM recoding can be triggered by the following events e High atrial rates AF recording e Mode switching recording e High ventricular rate recording e Patient triggered recording Every instantaneous recording provides information from the recording period about e The type of triggering event e Time and date of the recording e Sensed and paced events in the atrium and the ventricle including the IEGM markers and events during the refractory period an in the PMT protection window e Duration of the triggering events 122 Stratos LV LV T Technical Manual A total of 64 recordings can be stored Each of the four triggering types of recording can be assigned a specific number i
88. fter each ventricular paced event right or left If an atrial even is sensed within this PMT protection interval this will neither start an AV delay nor a basic interval The length of the PMT protection can be set to automatic Auto In this case the PMT protection window can be automatically extended after the PMT is detected and terminated NOTE The initial values of the PMT protection interval in the automatic setting at 175 ms after a Vp and 400 ms after VES 2 9 2 PMT Detection It is the objective of PMT detection to identify ongoing PMTs to distinguish them from the sinus rhythm and to terminate them The detection of a PMT starts by measuring the Vp As intervals If these lie below the programmable PMT VA criterion programming depends on the retrograde conduction time of the patient the measurement of the stability of the Vp As interval is started The Stratos CRT P s PMT detection termination algorithm consists of suspicion confirmation and termination components and is described as follows Suspicion A PMT is suspected when two criteria are met e 8 successive V pace A sense Vp As sequences have occurred with a length shorter than the VA criterion This VA criterion is programmable between 250 and 500 ms e The mean deviation of these 8 Vp As intervals is less than the Stability criterion parameter defined with respect to upper and lower values is 25 ms Stratos LV LV T Technical Manual 91 Confir
89. gnificant differences in the primary safety or effectiveness endpoints between the male and female population 1 7 2 Stratos LV Clinical Study OVID study The OVID clinical study collected significant safety data supporting the Stratos LV LV T CRT P system Study Design BIOTRONIK conducted the Corox Over the Wire Lead Evaluation OVID prospective registry outside the United States OUS of the Corox OTW Steroid LV lead in a multi center trial with legally marketed CRT D and CRT P pulse generators that provide biventricular pacing therapy Data from this registry is presented in the following sections to support the safety of the Stratos LV CRT P The multi center investigation was designed to validate the safety of the Corox OTW Steroid LV lead through a comparison of successfully implanted LV leads against a pre defined success rate threshold when no anatomical restrictions prevent access to the coronary sinus The evaluation of safety is based on the analysis of the incidence of adverse events defined as any complications or observations judged by the investigator to be in probable relationship with Corox OTW Steroid LV lead system Additionally the effectiveness of the leads was evaluated using lead parameter data including sensing amplitudes pacing thresholds and impedance values In the OVID study enrolled patients could be implanted with any legally marketed CRT P or CRT D device There were 121 patients enrolled in the
90. gs for Stratos CRT Ps Table 26 Safe Program Settings Parameter Safe Program Settings Mode VVI Pacing Rate 70 ppm Amplitude 4 8 V ventricle Pulse Width 1 0 ms Sensitivity 2 5 mV Ventricular Refractory Period 300 ms Pacing Polarity Unipolar Sensing Polarity Unipolar Single Chamber Hysteresis OFF Magnet Effect AUTO Stratos LV LV T Technical Manual 131 6 4 Magnet Effect Automatic Magnet Effect After magnet application the pulse generator paces at 90 ppm for 10 cycles asynchronously Thereafter the pulse generator paces synchronously at the programmed basic rate During asynchronous pacing the AV interval is reduced to 100 ms Asynchronous Magnet Effect When programmed to asynchronous operation magnet application results in asynchronous pacing Stratos CRT Ps pace asynchronously at 90 ppm as long as the magnet is over the CRT P Upon magnet removal the current basic interval is completed before the CRT P reverts to its original operating mode If the magnet effect is set to asynchronous the AV delay is reduced to 100 ms or the programmed AV delay whichever is shorter Shortening of the AV delay to 100 ms during asynchronous AV sequential stimulation is provided to avoid ventricular fusion beats in the presence of intact AV conduction This allows efficient diagnosis of ventricular capture or failure to capture Synchronous Magnet Effect If the magnet effect is programmed to synchronous operation magnet
91. h for about 1 minute The follow up process is delayed by this time Limited clarity and consistency in the display of measurement values from follow up testing Missing programing information in the exported data may cause user confusion Pacemaker detection disturbed after interrogation under EMI conditions Display test results on programmer screen and printout is inconsistent During transfer of follow up information from Stratos CRT Ps to the GE CARDDAS system the following data are not displayed e the programmed data and follow up data of the left ventricular channel e lead data of all channels in Stratos Interrogation data after Auto Display printout of incorrect Implant Detect 1 5 h after lead diagnostic information may attach may show an incorrect cause user confusion or superfluous entry AF episodes incorrect diagnosis detected gt 48h in the Event List AF statistics are always correctly displayed Distributed by BIOTRONIK Inc 6024 Jean Road Lake Oswego OR 97035 5369 800 547 0394 24 hour 503 635 9936 FAX M4122 A 5 08 Manufactured by BIOTRONIK GmbH amp Co KG Woermannkehre 1 12359 Berlin Germany
92. he AV delay ventricular pacing is inhibited Table_18 summarizes the intervals initiated by sensing or pacing The table distinguishes between two kinds of ventricular sensed and ventricular paced events VP at the end of the AV delay VP at the end of the safety AV delay referred to as ventricular safety pace Vsp Vs within the AV delay and Vs outside of the AV delay referred to as ventricular extrasystole VES Table 18 Timing Intervals Timing Interval Basic interval DDD Basic interval DDI Atrial refractory period Upper basic rate Ventricular Refractory X X X X Period This timing interval is also applicable to the following modes DDD R VDD R AAI R DDT VDT AAT DOO R and AOO R t In DDI R DVI R VVI R DVT R DDI T R and VOO R lower rate timing starts with Vp and or Vs and or Vs event outside of the AV delay and the VES discrimination window VES tin DDI R DDI T VDD R and VDT the atrial refractory period will also be reset upon time out of the VA interval whether or not an atrial pulse is emitted Stratos LV LV T Technical Manual 65 Table 18 Timing Intervals Timing Event E AV dela Safety AV delay oe oe oe Interference cra HEHE Interference mea ded Blanking time x A after Ap Blanking time wane ed Atrial upper rate x AUR Far field Baen x x x x grew TT CEC X X X A PMT protection x extension
93. he Six Month follow up Stratos LV LV T Technical Manual 57 Table 15 Composite of Six Minute Walk Test and QOL Effectiveness Study Group Control Group Category N 74 N 38 P value Mean SE Mean SE Distance Walked at 310 51 10 89 288 76 15 37 0 249 Baseline Distance Six Months A Distance 30 26 10 40 13 08 13 05 0 322 Walked 17 27 5 59 8 71 5 26 0 326 QOL Score at Baseline 44 39 2 78 45 53 4 13 0 817 QOL Score at Six Months 28 68 2 66 33 95 4 35 0 279 11 58 3 45 Ain QOL 15 724 2 83 0 376 o 13 42 Scoret 19 08 12 21 ua 0 281 E 18 18 7 07 2 36 17 73 0 030 The calculated p values are associated with a Student s t test 2 sided of the equality of means in the two groups except for the p value of the composite rate which is associated with a test of equivalence non inferiority t A in QOL Score is calculated as the average of the individual differences between Baseline and Six Months for each patient Negative values for mean A QOL in percent are possible when positive mean values for absolute changes in QOL are recorded In some cases small negative changes in absolute QOL scores resulted in relatively large percentage changes The Composite Rate A Distance Walked A QOL Score 2 is calculated for each patient and then averaged to obtain the Composite Rates For all calculations a positive number represents improvement
94. hin 10 p 0 0014 Observed Adverse Events Adverse events are classified as either observations or complications Observations are defined as clinical events that do not require additional invasive intervention to resolve Complications are defined as clinical events that require additional invasive intervention to resolve Of the 29 adverse events reported there were 18 observations and 11 complications in a total of 89 patients Table 10 and Table 11 provide a summary by category of each type of adverse event complications and observations Table 10 Summary of Complications at 6 months Number of Number of Complications Category of uae per patient Patients Complications Patients year Corox OTW Steroid Lead Related capture 0 03 Phrenic nerve 0 02 stimulation Total 0 05 Loss of 0 02 capture Total 0 02 Loss of 0 05 capture Elevated Pacing 0 03 thresholds Total 0 08 Stratos LV LV T Technical Manual 45 Table 10 Summary of Complications at 6 months Number Complications Category of de or Numb pret per patient Patients Complications Patients year Device Related ae 002 Total 0 02 Total System Related Sen Other Medical Arrhythmias 0 02 Total 0 02 Overall Complication 10 11 2 11 0 17 Totals Number of Patients 89 Number of Patient Years 63 3 Table 11 Summary of Observations at 6 months Observations per patient year Numberof of Number of Patients
95. ial Fibrillation Demographics at Enrollment Characteristic P value Classification of Atrial Fibrillation N 42 N 50 N 24 Persistent AF 10 23 8 17 34 6 25 2537 Permanent AF 32 76 2 33 66 18 75 Classification of Symptoms Related to AF N 42 N 49 N 25 Palpitations 32 76 2 34 69 4 14 56 0 0 236 Chest Pain 6 14 3 7 14 3 3 12 0 1 000 Dyspnea or shortness 36 85 7 40 81 6 19 76 0 0 568 of breath Fatigue 34 81 0 45 91 8 18 72 0 0 149 Lightheadedness or 17 40 5 13 26 5 9 36 0 0 329 syncope Other 9 21 4 11 22 4 10 40 0 0 205 Previous AF Ablation N 42 N 50 N 25 0 354 No 37 88 1 47 94 0 21 84 0 Yes 5 11 9 3 6 0 4 16 0 Past Medications for Rate or Rhythm Control Amiodarone N 41 N 48 N 24 Digoxin 12 29 3 10 20 8 10 41 7 0 192 Diltiazem 17 41 5 22 45 8 13 54 2 0 683 Disopyramide 17 41 5 23 47 9 12 50 0 0 804 Dofetilide 0 0 0 3 6 3 0 0 0 0 228 Flecanide 4 9 8 3 6 3 2 8 3 0 895 Ibutilide 5 12 2 5 10 4 1 4 2 0 656 es 0 0 0 244 2 0 0 0 0506 o o o ed 2 4 9 4 8 3 0 0 0 0 423 9 22 0 10 20 8 2 8 3 0 389 Verapamil 5 12 2 8 16 7 3 12 5 0 829 Metoprolol 19 46 3 28 58 3 10 41 7 0 382 Propranolol 0 0 0 0 0 0 1 4 2 0 215 Other Beta Blockers 7 17 1 15 31 3
96. ias to the ventricle Therefore after sensing an atrial tachycardia while in activated mode switching the CRT P automatically switches to an atrial controlled R mode Like the programmed atrial controlled P mode the corresponding R modes can be programmed Table 21 Mode Switching Programmed P mode Programmed R mode in case of sensed atrial tachycardias DDD DDI DDD DDIR DDDR DDIR VDD VDI VDD VDIR VDDR VDIR DDTA DDI DDTA DDIR DDTAR DDIR The Mode Switching algorithm causes the CRT P to change pacing modes when a programmed number of atrial intervals X out of 8 consecutive atrial intervals p p are faster than the programmed mode switch intervention rate X out of 8 X is programmable from 3 to 8 The rate at which an atrial interval is determined to signify an atrial tachyarrhythmia is called the mode switch intervention rate The mode switch intervention rate is programmable from 100 10 250 bpm Stratos LV LV T Technical Manual 89 Reversion back to the programmed pacing mode occurs in a similarly programmable manner If a programmable number of atrial intervals Z out of 8 consecutive atrial intervals p p are slower than the programmed mode switch intervention rate Z out of 8 the device will revert back to the permanently programmed parameters Z is programmable from 3to 8 The device will also revert back to the permanent program if 2 atrial paced events occur or if no atrial
97. il on the programmer Additionally the Stratos CRT Ps have a PMT counter and a counter for safety power down overdrive 2 20 2 Event Episodes In contrast to the event counter it is not the individual events but rather the event sequences that are counted e As followed by Vs e As followed by Vp e Ap followed by Vs e Ap followed by Vp e Vx followed by Vx The event sequence V V means two consecutive ventricular events sensing or pacing without a previous atrial event 112 Stratos LV LV T Technical Manual NOTE The VV value can deviate from the number of VES since the Stratos CRT Ps can also classify ventricular sensed events that were preceded by an atrial event such as extrasystoles via the AVES discrimination function after As In Stratos CRT Ps e RVs followed by LVp e RVp followed by LVp e LVp followed by RVp A total counter that records grand total of all conductions is located below the conduction counters 2 20 3 Rate Trend The rate trend is displayed as a line chart and consists of the heart rate trend and the pacing rate trend The atrial event the ventricular events and the events in the remaining third channel are recorded at a set time In the rate trend the heart rate in pulses per minute ppm is recorded in the upper rate chart and the percentage of pacing is shown in the lower chart In the Stratos CRT Ps the trends of the three different channels are identified by three different colors
98. imit the detection of spontaneous events or even exclude their recognition altogether WARNING Rate Adaptive Pacing Use rate adaptive pacing with care in patients unable to tolerate increased pacing rates 2 1 2 DDD The timing of the Stratos CRT Ps is based on atrial events In the case of an atrial sensed or paced event the AV delay starts the same time as the basic interval If a ventricular sensed event does not occur within the AV delay ventricular pacing is initiated at the end of the AV delay If ventricular sensing occurs within the AV delay ventricular pacing is inhibited If atrial sensing occurs outside the atrial refractory period atrial pacing is inhibited and the basic interval is restarted 64 Stratos LV LV T Technical Manual In the case of ventricular sensed events outside of the AV delay and the VES discrimination interval after a ventricular extrasystole VES or PVC the basic interval starts without simultaneously starting an AV delay To protect the atrium from retrograde conduction an extended PMT protection window is started at the same time as the basic interval If an atrial sensed event does not occur within the basic interval but outside the refractory period atrial pacing occurs after the basic interval has elapsed and the basic interval and AV delay are restarted Upon an atrial paced event the AV safety interval starts with a long basic interval If a ventricular sensed event occurs within t
99. ion in the ventricle as desired Table 28 summarizes the sensing and pacing configuration in the ventricle 140 Stratos LV LV T Technical Manual Table 28 Lead Configuration Configuration Description Sensing RV bipolar RV tip gt RV ring unipolar RV tip gt Case Pacing RV_ bipolar RV tip gt RV ring unipolar RV tip gt Case LV bipolar LV tip gt LV ring unipolar LV tip gt Case 8 2 Lead Connection Stratos CRT Ps have been designed and are recommended for use with bipolar or unipolar leads having an IS 1 connector CAUTION Unipolar Bipolar If the pacing or sensing function is to be programmed to bipolar in the atrial channel it must be verified that bipolar leads have been implanted in that chamber If the atrial lead is unipolar unipolar sensing and pacing functions must be programmed in that chamber Failure to program the appropriate lead configuration could result in patient experiencing entrance and or exit block In addition if the atrial lead polarity setting within the Patient Data Memory has been set to bipolar the polarity of the corresponding implanted lead must be confirmed to be bipolar Overview of the Lead Polarities If a bipolar lead is connected to the CRT P unipolar or bipolar configurations can be programmed for pacing and sensing As compared to bipolar pacing the unipolar pacing pulse has the advantage of being clearly identifiable on
100. ipolar leads In the event that a lead failure occurs the Lead Check feature is disabled and a message is displayed on the programmer screen at the next follow up visit to notify the physician of the lead status Stratos LV LV T Technical Manual 85 CAUTION Lead Check Lead check will not lead to disabling of cardiac resynchronization therapy It limits the use of the resynchronization features 1 Lead check is possible only when the right ventricle is paced first 2 Lead check works only when the pacing voltages are programmed between 2 4 and 4 8 V The lead check feature can be programmed OFF in patients that require cardiac resynchronization therapy Care should be taken when programming Stratos CRT Ps with Lead Check ON as the device may switch from bipolar to unipolar pacing and sensing without warning This situation may be inappropriate when using a Stratos CRT P for patients with an Implantable Cardioverter Defibrillator ICD The following associated message appears when programming this feature Lead check may result in a switch to unipolar pacing and sensing which may be inappropriate for patients with an ICD Additionally Lead Check should be programmed OFF before lead connection as the feature will automatically reprogram the device to unipolar in the absence of a lead Lead Check is temporarily suspended during magnet application and is inactive during ERI NOTE In the Stratos CRT Ps an au
101. it Nominal value 60 ppm 30 10 180 ppm Upper AV limit Nominal value 130 ppm 30 10 180 ppm AV Interval Length for Low Rate Standard value 150 ms programmable 15 5 300 ms The AV delay defines the interval between an atrial paced or sensed event and the ventricular pacing pulse The AV delay can be dynamically programmed in DDD R DDT R A and VDD R modes In all other mode the AV delay is a fixed value If the CRT P is programmed to a dual chamber sensing mode an intrinsic ventricular event falling within the AV delay will inhibit the ventricular pacing pulse If not contraindicated a longer AV delay can be selected to increase the probability of ventricular output pulse inhibition Short AV delays are available for testing purposes or if ventricular pre excitation is desired i e hemodynamic considerations When the dynamic AV delays are programmed the dynamics are calculated from the difference between two atrial sense events As or Ap Dynamic AV Delay provides independent selection of AV Delays from five rate ranges at pre set AV Delay values In addition the AV Delay after atrial pace events can be differentiated from the AV interval after atrial sense events for dual chamber pacing modes Stratos LV LV T Technical Manual 79 The Dynamic AV Delay is intended to mimic the physiologic catecholamine induced shortening of the AV Delay with increasing rate It also serves for automatic preventio
102. it to BIOTRONIK see Section 7 1 FOR SINGLE USE ONLY Do not re sterilize the CRT P or accessories packaged with the CRT P they are intended for one time use Device Packaging Do not use the device if the packaging is wet punctured opened or damaged because the integrity of the sterile packaging may be compromised Return the device to BIOTRONIK Storage magnets Store the device in a clean area away from magnets kits containing magnets and sources of electromagnetic interference EMI to avoid damage to the device Temperature Stabilization Allow the device to reach room temperature before programming or implanting the device Temperature extremes may affect the initial device function Use Before Date Do not implant the device after the USE BEFORE DATE because the device may have reduced longevity Stratos LV LV T Technical Manual 7 1 5 3 Lead Connection and Evaluation Lead Check Feature Description Lead Check is a feature that when activated automatically measures the lead impedance with every pace Based on these measurements the lead configuration will be set to either unipolar or bipolar Refer to Section 2 5 for more details regarding this feature Caution Lead check will not lead to disabling of cardiac resynchronization therapy It limits the use of the resynchronization features 1 Lead check is possible only when the right ventricle is paced first 2 Lead check works only when
103. ity and exercise tolerance Also this test more closely mimics the patient s day to day activities than maximal exercise testing 2 The purpose of this secondary endpoint is to evaluate the improvement in the patient s NYHA classification Accountability of PMA Cohorts After randomization and enrollment 7 patients 4 in the study group and 3 in the control group did not receive an implant The reasons for patients not receiving an implant are outlined in Figure 2 Stratos LV LV T Technical Manual 53 Enrolled and Randomized Patients Study 133 Control 67 No implant Attempted Withdrawal of Consent Study 2 Control 1 Not Meeting Inclusion Criteria Study 1 Control 1 Implant Attempted Study 130 Control 65 Unsuccessful implant Withdrawal of IC before 2nd Attempt Study 1 Control 0 Expired before Second Attempt Study 0 Control 1 Successful implant Study 129 6 Month Follow up Data Control 64 Patient Death before 6 Month Study 7 Control 3 Withdrawal before 6 Month Study 1 Control 2 Not Reached 6 Month FU Patients completed 6 Month or Bate ending Study 21 Follow up Control 10 Study 100 Control 49 Figure 2 Patient Accountability Demographics and Baseline Parameters Table 13 provides a summary of the pre enrollment demographics of enrolled patients 54 Stratos LV LV T Technical Manual Table 13 Patient Demographics at Pre Enrol
104. ivated and the permanent program will again be in effect Generally every pacing program displayed on the programmer screen may be transmitted as a temporary program by pressing the key designated on the programmer keyboard With few exceptions this also applies to pacing programs containing a parameter conflict which cannot be programmed as permanent programs Temporary programming facilitates follow up and enhances patient safety Test programs affecting patient safety like pacing threshold measurements in a pacemaker dependent patient should be activated as a temporary program only When interrogating Stratos CRT Ps the permanent program will always be displayed and documented even though a temporary program was activated during the interrogation During temporary program activation the rate adaptation trend monitor and the event counter are always inactive 130 Stratos LV LV T Technical Manual 6 2 Patient Data Memory Individual patient data can be stored in the Stratos CRT Ps For example the following are stored e Patient name e Patient index how the patient name is coded e Implantation date e Symptoms e Etiology e ECG indication e QRS width e LV ejection fraction e Lead polarity 6 3 Safe Program Settings Activating the preset values for the Safe Program is a quick and convenient way to provide VVI SSI pacing at a high output setting in urgent situations Listed in Table 26 are the Safe Program settin
105. l number of the implant is also transmitted The Monitoring Interval Type of Last Home Monitoring Message and Time of the Transmission of the last Home Monitoring Message provide information regarding the interval of Home Monitoring data Resynchronization Therapy e Pacing in the Atrium 24 hours e Atrial intrinsic rhythm e CRT ventricular pacing e Ventricular paces AV Delay expired e Ventricular paces triggered by RV Sense 108 Stratos LV LV T Technical Manual Heart Failure Diagnostics Mean Ventricular Heart Rate ppm Mean Ventricular Heart Rate at Rest ppm VES 24 Hour Daily Activity hours Number of Mode Switches 24 hours Duration of Mode Switching 24 hours Ventricular Rhythm Mean Ventricular Rate at Mode Switching ppm Number of Ventricular Episodes gt 8 consecutive VES Number of Ventricular Runs 4 8 consecutive VES PMTs Detected AV Conduction With Intrinsic Rhythm As Vs With Atrial Stimulation Ap Vs With Ventricular Stimulation As Vp With Atrial and Ventricular Stimulation Ap Vp Mean P Wave amplitude mV Mean R Wave amplitude mV Atrial Pacing Impedance ohms Right Ventricular Pacing Impedance ohms Left Ventricular Pacing Impedance ohms System Status Battery Voltage V Battery Impedance ohms Battery Status Stratos LV LV T Technical Manual 109 2 18 Statistics Stratos CRT Ps can store a variety of statisti
106. l remains refractory during the entire basic interval Depending on the programmed pacing mode and the channel in which electromagnetic interference EMI occurs Table 27 details the resulting pacing modes for the duration of exposure to EMI Stratos LV LV T Technical Manual 133 Table 27 Response to EMI MODE EMI A V DDD R DVD R DAD R DOO R DDI R DVI R DAI R DOO R DVI R ee DOO R a VDD R VVI R VAT R VOO R VVI R sl VOO R ay AAI R AOO R Ed Bad DDT DVT DAT DOO DDI T DVT DAT DOO DVT es DOO VDT VVT VAT VOO VDI VVT VOO VOO VVT o VOO E AAT AOO EMI Electromagnetic Interference 134 Stratos LV LV T Technical Manual Stratos LV LV T Technical Manual 135 7 Product Storage and Handling 7 1 Sterilization and Storage Stratos CRT Ps are shipped in a cardboard box equipped with a quality control seal and product information label The label contains the model specifications technical data serial number expiration date and sterilization and storage information for the particular CRT P The box contains a double blister container with the CRT P and product documentation The Stratos CRT P and its accessories have been sealed in a container and gas sterilized with ethylene oxide To assure sterility the container should be checked for integrity prior to opening If a breach of sterility is suspected return the CRT P to BIOTRONIK CAUTION Storage temperature Recommended
107. lment e Study Control P Characteristic N 133 value Age at Enrollment Years Mean SE 695 0 9 69 1 1 2 0 781 Range 43 to 88 38 to 84 Gender Male 93 69 9 51 76 1 0 407 Female 40 30 1 16 23 9 Underlying Heart Disease Ischemic Cardiomyopathy 100 75 2 54 80 6 0 294 Nonischemic Cardiomyopathy 34 25 6 15 22 4 Type of Bundle Branch Block Left Bundle Branch Block 91 68 4 49 73 1 0 877 Right Bundle Branch Block 26 19 5 10 14 9 Other 19 14 3 11 16 4 New York Heart Association Class Class III 121 91 0 60 89 6 0 800 Class IV 12 9 0 7 10 4 Intrinsic QRS Duration ms Mean SE 161 9 2 0 156 1 2 3 0 073 Range 130 to 252 130 to 200 Left Ventricular Ejection Fraction Mean SE 22 1 0 6 23 3 0 8 0 299 Range 5 to 35 10to 35 Six Minute Walk Distance meters Mean SE 2548 8 9 250 5 0 775 Range 20 to 451 11 9 27 to 447 Quality of Life Questionnaire Score Mean SE 54 3 2 1 52 5 3 1 Range 0 to 105 0 to 102 Student s t test 2 sided for means Fisher s Exact Test 2 sided for 2 possible answers Chi Square test 2 sided for more than 2 possible answers 0 638 Stratos LV LV T Technical Manual 55 Table 14 provides a summary of cardiac medications patients were taking at the time of enrollment Some categories may be more than 100 as several categories allow more than one response
108. m Post AES Stimulation is comprised of two parts First an AES must be recognized AES detection and secondly the respective stimulation Post AES Stimulation must then occur 2 13 1 AES Detection To detect atrial extrasystoles AES an AES timing window is defined the length of which is calculated from the averaging of the rates of the four paced or intrinsic cardiac events prior to an AES The AES window is shortened by a programmable percentage 5 5 50 from the averaged interval nominal setting is 25 If an intrinsic atrial event falls within this AES window and the coupling interval lt 750 ms the cardiac event is classified as an AES Stratos LV LV T Technical Manual 95 2 13 2 Post AES Stimulation The post AES stimulation pacing can be programmed for all atrial controlled modes i e DDD R DDT A R AAI R and AAT R If an AES is detected the pacemaker starts a Post AES Interval The duration of the post AES interval is equal to the coupling interval of the Post AES plus the decrement step size programmable 5 5 40 ppm After the post AES interval has expired pacing occurs in the atrium In each subsequent cycle the pacing rate is reduced by the value of the decrement step size per stimulus until the basic rate or sensor rate is again reached or until the intrinsic cardiac rhythm takes precedence again The post AES stimulation is then concluded and it is repeated after each AES
109. mation When the suspicion criterion has been met the Stratos CRT Ps slightly modify the AV delay interval or 50 ms for one cardiac cycle If the Vp As interval remains stable a PMT is confirmed Otherwise a PMT is not confirmed and the algorithm restarts Once the PMT algorithm has confirmed a PMT the cycle is terminated The upper interval limit range must be shorter than the limit of the VA delay 350 ms for example The test method is based on the length of the pacing interval or the AV delay refer to Table 22 Table 22 PMT Test Method Interval Length AV Delay Test Method gt UTI upper lt 200 ms Increasing the AV tracking interval delay by 50 ms gt UTI 50 ms gt 200 ms Reducing the AV delay by 50 ms lt UTI lt 200 ms Increasing the UTI by 50 ms lt UTI gt 200 ms Increasing the UTI by 50 ms gt UTI and lt UTI gt 200 ms Length of UTI TA 50 ms 50 ms Termination Stratos CRT Ps extend TARP Total Atrial Refractory Period for one cycle to equal the V V interval 50 ms 2 10 Adjustment of the PMT Protection Window The PMT protection window can be automatically adjusted This automatic adjustment functions in the following manner 92 Stratos LV LV T Technical Manual When the PMT is detected and terminated the PMT protection interval is extended by 50 ms If no additional PMTs arise within two days the length of the PMT protection interval is re
110. mber pacing modes To prevent ventricular pulse inhibition in the presence of crosstalk a ventricular pulse will be emitted at the end of the safety AV delay Eigure 5 When pacing is AV sequential at the pre set safety AV delay the presence of crosstalk should be considered and appropriate reprogramming performed lengthen the ventricular blanking time lower ventricular sensitivity bipolar configuration and or lower atrial pulse energy 82 Stratos LV LV T Technical Manual blanking V safety AV delay AY delay Figure 5 Ventricular blanking time and safety AV 2 4 Pacing and Sensing Functions 2 4 1 Pulse Amplitude and Pulse Width The pulse amplitude and pulse width can be independently programmed for all three channels of the Stratos CRT Ps The programmed pulse amplitude determines the voltage applied to the heart during each pacing pulse The pulse amplitude is independently programmable for the atrial and ventricular channels up to 7 2 volts The pulse amplitude remains consistent throughout the service life of the CRT Ps The pacing safety margin is therefore not reduced by a decrease in the CRT P s battery voltage Stratos LV LV T Technical Manual 83 CAUTION Pulse Amplitude Programming of pulse amplitudes higher than 4 8 V in combination with long pulse widths and or high pacing rates can lead to premature activation of the replacement indicat
111. me between an atrial and a ventricular contraction such that physiological conditions are attained To this end the AV delay after atrial sensing can be shortened by sense compensation For sense compensation the values are programmable from OFF 10 10 120 ms standard valued 50 ms The AV delay after an atrial sensing event is shorter by the programmed value after pacing The AV delay after atrial pacing then corresponds to the programmed AV delay Stratos LV LV T Technical Manual 81 2 3 12 Ventricular Blanking Period The ventricular blanking time is the period after an atrial pacing pulse during which ventricular sensing is deactivated It is intended to prevent ventricular sensing of the atrial pacing pulse crosstalk The blanking time shall be as short as possible in order to provide ventricular sensing when a ventricular depolarization could occur Crosstalk may be encountered if a shorter blanking time unipolar ventricular sensing a higher ventricular sensitivity lower value and or a high atrial pulse amplitude and pulse width are programmed Values between 30 ms and 70ms 30 10 70 ms can be set for the ventricular blanking period The value should be set as low as possible and yet high enough to ensure ventricular sensing However it must be programmed to ensure atrial pacing is not sensed in the ventricle 2 3 13 Safety AV Delay The safety AV delay set at 100 ms applies to all dual cha
112. n termination of circus movement pacemaker mediated tachycardia and for prevention of reentrant supraventricular tachycardia see PMT Management section 2 3 9 2 AV Hysteresis AV Hysteresis allows a user programmable change in AV delay that is designed to encourage normal conduction of intrinsic signals from the atrium into the ventricles An AV hysteresis interval can be programmed OFF or a value range of 10 10 1000 With AV hysteresis enabled the AV delay is extended by a defined time value after sensing a ventricular event The long AV interval is used as long as intrinsic ventricular activity is detected The programmed short AV delay interval resumes after a ventricular paced event CAUTION AV Hysteresis If the AV hysteresis is enabled along with the algorithm for recognizing and terminating PMTs PMT management the AV delay for recognizing and terminating a PMT has a higher priority than the AV hysteresis 2 3 9 3 AV Repetitive Hysteresis With AV Repetitive Hysteresis the AV delay is extended by a defined hysteresis value after sensing an intrinsic ventricular event When a ventricular stimulated event occurs a long AV delay is used for the programmed number of cycles OFF 1 1 10 cycles If an intrinsic rhythm occurs during one of the repetitive cycles the long duration AV delay interval remains in effect If an intrinsic rhythm does not occur during the repetitive cycles the original AV delay int
113. nd Stratos LV devices through an analysis of the complication free rate through six months Secondarily the study also evaluated the superiority of CRT with CLS rate adaptation compared to CRT with accelerometer rate adaptation Stratos LV LV T Technical Manual 19 Clinical Inclusion Criteria To support the objectives of this investigation patients were required to meet the following inclusion criteria prior to enrollment Meet the indications for therapy Persistent documented for more than 7 days symptomatic AF with poorly controlled rapid ventricular rates or permanent documented for more than 30 days with failed cardioversion or longstanding AF of 6 months or more symptomatic AF with poorly controlled rapid ventricular rates Eligible for AV nodal ablation and permanent pacemaker implantation NYHA Class II or III heart failure Age gt 18 years Understand the nature of the procedure Ability to tolerate the surgical procedure required for implantation Give informed consent Able to complete all testing required by the clinical protocol Available for follow up visits on a regular basis at the investigational site 20 Stratos LV LV T Technical Manual Clinical Exclusion Criteria To support the objectives of this investigation the exclusion criteria at the time of patient enrollment included the following e Meet one or more of the contraindications e Have a life expectancy of less than six months e Expecte
114. nduction delay QRS duration greater than or equal to 130 ms e For patients with an existing ICD optimal and stable CHF drug regimen including ACE inhibitors and beta blockers unless contraindicated stable is defined as changes in dosages less than 50 during the last 30 days e Indicated for ICD therapy e History or significant risk of atrial tachyarrhythmias e Willing to receive possibly uncomfortable atrial shock therapy for the treatment of atrial tachyarrhythmias e Able to understand the nature of the study and give informed consent Stratos LV LV T Technical Manual 51 Ability to tolerate the surgical procedure required for implantation Ability to complete all required testing including the six minute walk test and cardiopulmonary exercise testing Available for follow up visits on a regular basis at the investigational site Age greater than or equal to 18 years Clinical Exclusion Criteria To support the objectives of this investigation the exclusion criteria at the time of patient enrollment included the following Previously implanted CRT device ACC AHA NASPE indication for bradycardia pacing sinus node dysfunction Six minute walk test distance greater than 450 meters Chronic atrial tachyarrhythmias refractory to cardioversion shock therapy Receiving intermittent unstable intravenous inotropic drug therapy patients on stable doses of positive inotropic outpatient therapy for at least one month are pe
115. ng Off On Stratos LV LV T Technical Manual 155 Rate Fading Rate Increase 0 5 1 2 1 6 ppm cycle Rate Fading Rate Decrease 0 25 0 5 0 25 1 25 ppm cycle Lead Configuration Pacing for the Stratos LV LV T UNIP BIPL 3 separate channels Sensing for the Stratos LV LV T UNIP BIPL 2 separate channels 3 IEGM channels Lead check Off On 3 separate channels Rate Adaptation Off On Sensor Accelerometer Sensor Gain Auto 1 40 in 32 steps Automatic Sensor Gain Off On Sensor Threshold Very low low medium high very high Rate Increase 0 5 1 1 6 ppm cycle Rate Decrease 0 25 0 25 1 25 ppm cycle Maximum Sensor Rate 90 5 120 5 180 ppm 156 Stratos LV LV T Technical Manual 11 3 Diagnostic Memory Functions IEGM Recoding AF OFF 3 1 31 count AF Detection Rate 100 10 300 20 400 ppm AF End Rate 100 10 300 20 400 ppm Mode Switching Recording Off 3 1 31 count High Ventricular Rate Recording OFF 3 1 31 count Ventricular Sense Rate 100 10 250 ppm Patient Activated Recording OFF 1 1 31 count Pre trigger Recording 0 10 80 Recording when Switching off Off On 11 4 Home Monitoring Stratos LV T Mean Ventricular Heart Rate at Rest Start Time 00 00 00 10 23 50 Event Messages ON OFF Home Monitoring ON OFF Stratos LV LV T Technical Manual 157 Patient Trigge
116. ng a device containing such a tag within close proximity to the CRT P i e inside a shirt pocket 1 5 8 Cellular Phones Recent studies have indicated there may be a potential interaction between cellular phones and pacemaker operation Potential effects may be due to either the radio frequency signal or the magnet within the phone and could include inhibition or asynchronous pacing when the phone is within close proximity within 6 inches 15 cm to the CRT P Stratos LV LV T Technical Manual 15 Based on testing to date effects resulting from an interaction between cellular phones and the implanted pacemakers have been temporary Simply moving the phone away from the implanted device will return it to its previous state of operation Because of the great variety of cellular phones and the wide variance in patient physiology an absolute recommendation to cover all patients cannot be made Patients having an implanted CRT P who operate a cellular phone should e Maintain a minimum separation of 6 inches 15 cm between a hand held personal cellular phone and the implanted device Portable and mobile cellular phones generally transmit at higher power levels compared to hand held models For phones transmitting above 3 watts maintain a minimum separation of 12 inches 30 cm between the antenna and the implanted device e Patients should hold the phone to the ear opposite the side of the implanted device Patients should not carry
117. nical Manual Complications and observations for the Stratos LV study groups are summarized in Table 5 and Table 6 The total number of patients may not equal the sum of the number of patients listed in each category as an individual patient may have experienced more than one complication or observation Stratos LV LV T Technical Manual 33 Table 5 Summary of Complications Stratos LV Number Complications of Number of Category of s N per patient Patients Patients Complications year Device Related Pocket Infection or Pain Total High Threshold No Capture Diaphragmatic Stimulation O02 Dislodgement a 0 03 0 02 Total 0 06 High Threshold 0 06 No Capture Total 0 06 Pneumothorax 0 02 User error 0 02 Hematoma 0 02 Total 0 05 Total Lead and 11 14 7 14 0 22 Procedure Related Worsening CHF 0 03 Non CHF cardiac 5 6 7 5 0 08 symptoms 34 Stratos LV LV T Technical Manual Table 5 Summary of Complications Stratos LV Number Complications of Number of Category of i a per patient Patisnts Patients Complications year Repeated ablation Lead addition 0 02 Other medical 0 05 Total 0 22 Total All Patients and 20 26 7 28 0 43 Categories Number of Patients 75 Number of Patient Years 64 4 Table 6 Summary of Observations Stratos LV Number of R Observations Category of 7 eat per patient 3 Patients C
118. ninnnnnnnns 5 1 Threshold Test Testing the Pacing Function 5 2 P R Measurement Testing the Sensing Function 5 3 Testing for Retrograde Conduction ooooonncccinnnncccn 5 4 Non Invasive Programmed Stimulation NIPS 541 Descriptores 5 4 2 Burst Stimulation 0 eee EE 5 4 3 Programmed Stimulation ccceeeeeeeeeees 5 4 4 Back UP PacidQ ocoocnnnnnnocinnnncocnconoconcnnncnnnncnnnanos 5 4 5 NIPS Safety Features eeeeeeeeteeeeeeees 6 Other Functions Features cccsssccccssseeressseeeeessseeees 6 1 Temporary PrograMmMinQ cooococcccnnnonccicnnoncccnnnnnncccnnnn 6 2 Patient Data Memory oooonccccnnnocccccononccccnnoncccninannnncnnnn 6 3 Safe Program Settings ooooonnicicnnnnnnccccnnonccccnnannnccinn 6 4 Magnet Efecto nos cscneiiiessaoes tasthotessasenednisenocegssseeteee 6 5 Position Indicato oneer OR 6 6 Pacing When Exposed to Interference 7 Product Storage and HandliNQ cccoononncconnnnnconnssnnnnos 7 1 Sterilization and Storage ooonnccccnnnnniccnnnancccnnnancccnnn 7 2 Opening the Sterile ContainerF ooonnnccccnnnnnicnnnnnnccccnn 7 3 Pulse Generator Orientation oooonnnncccnnnnnicccnnnccccnnns 8 Lead Connection ccccocccccnnnnnnccnnancccnnancnnnananononanarnnanarona 8 1 Lead Configurati0N ooononcccnnnnnncccnnnncccccnnonncccnnnnnccnnnn 8 2 Lead Connection oooocccnnnonococcccncnccncnnonnnncnnnnnnnnannnnnnnos 9 Elective Replacemen
119. nt manufacturers There were no adverse events reported attributable to lead generator incompatibility e The cumulative implant duration is 1240 4 months with a mean duration of 9 6 months for the study group The cumulative implant duration is 596 5 months with a mean duration of 9 3 months for the control group e The overall protocol compliance rate is 79 2 in the study group and 85 9 in the control group The overall follow up compliance rate is 99 4 in the study group and 98 3 in the control group e There have been 10 patient deaths reported in the study group and 4 patient deaths reported in the control group The clinical investigators have determined that no deaths were related to the study device Primary Endpoint 1 Six Minute Walk Test amp QOL Effectiveness The purpose of Primary Endpoint 1 is to evaluate the effectiveness of the Tupos LV ATx system in providing CRT as measured by the average composite rate of improvement in six minute walk test and QOL Table 15 presents the average composite rate of improvement in six minute walk test distance and QOL score the average 6 minute walk test distance and the average QOL score at Baseline and at the Six Month follow up as well as the average difference in 6 minute walk test distance and QOL score between Baseline and the Six Month follow up for the Study and Control Groups for those patients with six minute walk test data and complete QOL data at both Baseline and t
120. omplications Patients year LV Lead Related High Threshold A No Capture nos Diaphragmatic 43 17 3 13 0 20 Stimulation Total 18 7 0 22 Device Related Pocket Infection or pain 0 08 Total 0 08 Pneumothorax 0 02 Atrial edema 0 02 User error 0 02 Total 0 05 Total Lead pevce ang 19 25 3 22 0 34 Procedure Related Stratos LV LV T Technical Manual 35 Table 6 Summary of Observations Stratos LV Number of Number of Observations Category of e e per patient z Patients Complications Patients year Other Medical Dizziness 0 05 Other Medical 32 0 0 53 Worsening as eal 10 7 A 0 12 Ventricular 2 7 0 03 arrhythmias Shortness of Stroke TIA E 0 02 Non CHF cardiac 1 1 3 1 0 02 symptoms Total 35 46 7 54 0 84 Total All Patients and 45 60 0 76 1 18 Categories Number of Patients 75 Number of Patient Years 64 4 There have been 3 patient deaths reported for the Stratos LV groups out of 75 Stratos LV patients None of the deaths were related to the implanted CRT P system Table 7 provides a summary of reported patient deaths Table 7 Summary of Patient Deaths Stratos LV Patients N 75 Sudden Cardiac IC Non Cardiac II All Causes gt 36 Stratos LV LV T Technical Manual Primary Endpoint Six Minute Walk Test amp QOL Effectiveness The purpose of Primary Endpoint 1 was to evaluate the effectiveness o
121. oo closely 14 Stratos LV LV T Technical Manual Home Appliances Home appliances normally do not affect CRT P operation if the appliances are in proper condition and correctly grounded and encased There are reports of CRT P disturbances caused by electrical tools and by electric razors that have touched the skin directly over the CRT P Communication Equipment Communication equipment such as microwave transmitters linear power amplifiers or high power amateur transmitters may generate enough EMI to interfere with CRT P operation if approached too closely Commercial Electrical Equipment Commercial electrical equipment such as arc welders induction furnaces or resistance welders may generate enough EMI to interfere with CRT P operation if approached too closely Electrical Appliances Electric hand tools and electric razors used over the skin directly above the CRT P have been reported to cause pacemaker disturbances Home appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with implanted device operation Electronic Article Surveillance EAS Equipment such as retail theft prevention systems may interact with the CRT Ps Patients should be advised to walk directly through and not to remain near an EAS system longer than necessary Radio Frequency Identification RFID RFID tags may interact with the CRT Ps Patients should be advised to avoid leavi
122. ooccccocococccccccnccconcononccnncnnnnannnonnnos 92 2 12 Preventive Overdrive Pacing Overdrive Mode 92 2 13 AES Detection and Pacing 94 213 1 AES Detection oda 94 2 13 2 Post AES Stimulation oooooinnninnnnocicnnnncociccnnnnnos 95 2 14 Parameters for Rate Adaptive Pacing occcononcccc 95 2 14 1 Rate Adaptation c ccceceeeeeseeetceeeeeeeeeeeeees 95 2 14 2 Sensor Calida ias 96 2 14 3 Automatic Sensor Gain ooonncccocnnncocicccnncanccnnnnnnn 96 2 14 4 Sensor Threshold c ooooonnnccccnnnccoccnnnocannnonanancnnnnnnns 97 2145 Rate Increase tia adds 97 had Stratos LV LV T Technical Manual iii 2 14 6 Maximum Activity Rate ooooooiinnnnnccnnnnnicinnncconco 98 2 14 7 Rate DeCay coococococcccccciconononcnncnnncnonnnnonnnnnnnnnanannnns 98 2 15 Sensor Stimulation 0 cccecceeeeceeeeeceeeeeeeeeeseneeeeeees 98 2 16 Rate Fading mida and taaan sta 99 2 17 Home Monitoring Stratos LV ooinnnninnnnnnnnnnncconco 100 2 17 1 Transmission of Information cccee 102 2 17 2 Patient Device ooooocconnnncocccccoccnccncnncononcnnnnnnnns 103 2 17 3 Transmitting Data ooononnccinnnnnicnnnnnciccnnnanncrnnnnnnos 103 2 17 4 Types of Report Transmissions oo mmcnnncno 105 2 17 5 Description of Transmitted Data 107 Z 18 SUAUSUCS uc aia Be 109 2 18 11 TIMING O 109 218 2 An A estne 109 2 183 O TN 109 251624 Ses istmo 109 281629 PACING e ee a a A
123. or If a pulse amplitude of 7 2 V or higher is programmed and high pacing rates are reached output amplitudes may differ from programmed values Programming Modifications Extreme programming changes should only be made after careful clinical assessment Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm 2 4 2 Sensitivity The parameter sensitivity is used to set the pulse generator s threshold for detecting intracardiac signals The lower the programmed sensitivity values the higher the device s sensitivity If intracardiac signals are of low amplitude a change to a higher sensitivity lower value may be indicated Conversely if the sensing amplifier is responding to extraneous signals such as artifacts or interference a change to a lower sensitivity higher value may resolve the difficulty In dual chamber sensing modes the sensitivity values for the atrial and ventricular channels are independently programmable With Unipolar programming the highest possible sensitivity setting is 1 0 mV 2 4 3 Lead Polarity The programmed lead polarity determines whether the CRT P senses or paces in a unipolar or bipolar configuration Lead polarity can be programmed separately for sensing and pacing in all three chambers CAUTION Atrial Sensitivity In dual chamber systems the atrial sensitivity of 0 1mV should only be programmed in conjunction with a bipolar lead
124. otocol and all of the clinical centers used the same methods to collect and report the clinical data In order to justify pooling of the data from multiple centers several analyses were completed All of the centers were divided into two groups based on implant volume Comparisons were then made between the patient populations based on the results of each of the endpoints Additionally analyses were performed on the data collected in the OPTION CRT ATx clinical investigation in order to compare results between males and females The first type of analysis compared enrollment by patient gender in each of the study and control groups The second type of analysis compared effectiveness outcomes in each gender The results of these analyses demonstrate poolability of the data between sites There were no significant differences in the second primary endpoint or any of the secondary endpoints between high and low volume implant centers The gender distribution in this clinical investigation is consistent within the study groups and includes a representative proportion of enrolled female participants 28 0 versus 72 0 male There were no significant differences in any of the primary or secondary endpoints between the male and female population Stratos LV LV T Technical Manual 61 1 7 5 Conclusions Drawn from Studies The clinical study results support the safety and effectiveness of the Stratos LV CRT P device The OPTION CRT ATx clinical
125. oxide Due to the double packing the outside of the inner container is sterile and can be removed using standard aseptic technique and placed on the sterile field Stratos LV LV T Technical Manual 137 Peel off the sealing paper of the outer container as indicated by the arrow Take out the inner sterile container by the gripping tab and open it by peeling the sealing paper as indicated by the arrow 138 Stratos LV LV T Technical Manual CAUTION Muscle or Nerve Stimulation Inappropriate muscle or nerve stimulation may occur with unipolar pacing when using a non coated Stratos CRT P Myopotential Sensing The filter characteristics of BIOTRONIK implantable devices have been optimized to sense electrical potentials generated by cardiac activity and to reduce the possibility of sensing skeletal myopotentials However the risk of pulse generator operation being affected by myopotentials cannot be eliminated particularly in unipolar systems Myopotentials may resemble cardiac activity resulting in inhibition of pacing triggering and or emission of asynchronous pacing pulses depending on the pacing mode and the interference pattern Certain follow up procedures such as monitoring pulse generator performance while the patient is doing exercises involving the use of pectoral muscles as well as Holter monitoring have been recommended to check for interference caused by myopotentials If sensing of myopotentials is encountered
126. pulse and mark the sensed event and its timing on the ECG Especially with unipolar sensing functions the selected sensitivity level should be checked for possible interference from skeletal myopotentials If oversensing is observed the programming of a lower sensitivity higher value or bipolar sensing function if the implanted lead is bipolar should be evaluated Stratos LV LV T Technical Manual 125 5 3 Testing for Retrograde Conduction Retrograde conduction from the ventricle to the atrium can be assumed when a 1 1 relationship between the ventricular stimulation and atrial depolarization has been obtained with a constant coupling interval during ventricular stimulation The Stratos CRT Ps feature a test for measuring retrograde conduction time During operation of this test the patient is paced at an increased ventricular rate over several cycles while the retrograde conduction time is measured Both the programmer display and printout provide measured retrograde conduction times minimum mean and maximum The duration of time that the test is conducted may be selected To prevent retrograde P waves from triggering ventricular pulses thereby mediating a re entry tachycardia pacemaker mediated tachycardia PMT the programmed post ventricular atrial refractory period must be longer than the retrograde conduction time 5 4 Non invasive Programmed Stimulation NIPS WARNING NIPS Life threatening ventricular a
127. pulses in response to sensed events this may result in unnecessary pacing during the absolute refractory period of the myocardium inappropriate pacing in response to oversensing of cardiac or extracardiac signals The risks associated with triggered pacing include excessive pacing arrhythmias due to the R on T phenomenon and early battery depletion Therefore it is important that the triggered modes are not used for long term therapy and that the CRT P is always returned to a non triggered permanent program 1 5 5 Home Monitoring Patient s Ability Use of the Home Monitoring system requires the patient and or caregiver to follow the system instructions and cooperate fully when transmitting data 12 Stratos LV LV T Technical Manual If the patient cannot understand or follow the instructions because of physical or mental challenges another adult who can follow the instructions will be necessary for proper transmission Electromagnetic Interference EMI Precautions for EMI interference with the Stratos CRT Ps are provided in Section 1 5 6 Sources of EMI including cellular telephones electronic article surveillance systems and others are discussed therein Use in Cellular Phone Restricted Areas The mobile patient device transmitter receiver should not be utilized in areas where cellular phones are restricted or prohibited i e commercial aircraft Event Triggered Report A timely receipt of the event report canno
128. red Messages ON OFF Time of Trend Message 00 00 00 10 23 50 11 5 Additional Functions NOTE Availability of the following functions is dependent upon pulse generator configuration Permanent IEGM transmission with comprehensive marker annotation Storing of comprehensive patient data Comprehensive statistics with AES and VES classification Histogram and event counters and Tachy episode trend Guided follow up Retrograde conduction test NIPS 158 Stratos LV LV T Technical Manual NIPS Specifications Burst Mode Burst stimulation Programmed Stimulation Back up Pacing Burst Chamber Coupling Interval ms Burst Type Burst Range ppm 1 S1 Cycles Pause ms No of intervals Decrement ms Modes Rate ppm Amplitude V Pulse width ms Pace Polarity Atrium Ventricle None 2000 Pushbutton Ramp 30 800 1 S2 S2 S3 3 S4 S4 S5 0 10 Stop 50 4 0 100 VOO VVI SOO SSI OSO 000 OVO 30 180 0 1 8 4 0 1 0 2 0 3 0 4 0 5 0 75 1 0 1 5 Bipolar Unipolar 11 6 Programmers ICS 3000 Implant Control System Stratos LV LV T Technical Manual 159 11 7 Default Programs Stratos LV LV T Parameter Factory settings Safe Program Function Standard Program SO bl Synchronization AV delay 120ms at 130 ppm First Chamber Paced VV delay after 5 ms pace VV delay after 5 ms sense Pulse 3 6 V A 3 6 V 4 8 V
129. rial extrasystoles AES events An atrial event is classified as an atrial extra systole AES if it falls in the AES window This AES window begins after the absolute atrial refractory period and ends at a programmable Atrial Prematurity percentage of the average of the last four P P intervals AT AES Classification The Stratos CRT Ps classify AES events that occur according to their complexity The following information is available when AES statistics are enabled Class Corresponding to Additional Criteria AF Atrial Fibrillation unstable rate and x out of 8 criteria AFI Atrial Flutter stable rate AT Atrial Tachycardia Sudden onset Additionally the following accelerations between zones are reported AFI to AF AT to AFI AT to AF SR to AT The AES events are classified according to their complexity in one of the following classes Class Event Sequence Single AES A AES Couplets A AES AES Triplets A AES AES AES The average number of AES per hour and the shortest AES AES interval are also reported Stratos LV LV T Technical Manual 115 AES vs Atrial Rate Information about the number of AES events as a function of the atrial rate can be found in the AES vs Atrial Rate Histograms For Stratos CRT Ps single AES bar chart displays the percentage of specific AES in 17 different rate ranges lt 40 ppm to gt 180 ppm The atrial rate of the last interval before the AES serves to classify the AES Two sequential AES ar
130. rive pacing and guarantees that pacing occurs at a rate slightly above the intrinsic sinus rate Atrial overdrive pacing thereby minimizes the number of atrial sensed events The overdrive mode is available in modes DDD R DDT A R AAI R and AAT R Stratos LV LV T Technical Manual 93 The features of Atrial Overdrive pacing include After every atrial sensed event non AES the pacing rate is increased by a programmable rate increase above the last P P interval 2 2 10 ppm If the intrinsic rate does not continue to rise after the programmable number of cycles overdrive pacing plateau the overdrive pacing rate is reduced in steps of 1 ppm In each instance the rate drop occurs after the programmed number of cycles has been completed Values between 1 and 32 cycles can be assigned to the overdrive pacing plateau The pacing rate is reduced until an atrial event is again sensed Afterwards the overdrive pacing cycle begins again at an increased rate Protection Function of the Algorithm Preventive overdrive pacing Overdrive Mode consists of different functions that become effective at high atrial rates e When the programmed maximum overdrive rate MOR standard setting 120 ppm 90 5 160 ppm is exceeded as with atrial tachycardias the algorithm is automatically deactivated If the rate falls below the MOR the overdrive algorithm is reactivated e The function is deactivated when the mean of the atrial rat
131. rmitted Enrolled in another cardiovascular or pharmacological clinical investigation Expected to receive a heart transplant within 6 months Life expectancy less than 6 months Presence of another life threatening underlying illness separate from their cardiac disorder Acute myocardial infarction unstable angina or cardiac revascularization within the last 30 days prior to enrollment Conditions that prohibit placement of any of the lead systems 52 Stratos LV LV T Technical Manual Follow Up Schedule After successful enrollment all patients were randomly assigned to either the study group or the control group The specific procedures of this study were e Pre enrollment screening e Randomization e System implantation e Pre discharge follow up e Baseline evaluation CRT activation e One Month follow up e Three Month follow up e Six Month follow up e Subsequent routine follow ups every three months Clinical Endpoints Primary Endpoint 1 Six Minute Walk Test amp QOL Effectiveness The purpose of Primary Endpoint 1 is to evaluate the effectiveness of the Tupos LV ATx system in providing CRT as measured by the average composite rate of improvement in six minute walk test and QOL Secondary Endpoint Results 1 The purpose of this secondary endpoint is to evaluate improvement in functional capacity as measured by the six minute walk test The six minute walk test is a well accepted measure of functional capac
132. ronization Therapy in CHF patients as well as those for bradycardia therapy as exhibited in a wide variety of patients The Stratos family is comprised of two CRT Ps that are designed to handle a multitude of situations Triple chamber rate adaptive Stratos EY unipolar bipolar pacing CRT P Triple chamber rate adaptive Stratos LV T unipolar bipolar pacing CRT P with Home Monitoring Throughout this manual specific feature and function descriptions may only be applicable to the Stratos LV T and those features will be referenced as such Otherwise reference to Stratos CRT Ps refers to both devices 1 2 Indications The Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers CRT Ps are indicated for patients who have moderate to severe heart failure NYHA Class III IV including left ventricular dysfunction EF lt 35 and QRS 2 120 ms and remain symptomatic despite stable optimal heart failure drug therapy Stratos LV LV T Technical Manual 3 13 Contraindications Use of Stratos LV and Stratos LV T CRT Ps are contraindicated for the following patients e Unipolar pacing is contraindicated for patients with an implanted cardioverter defibrillator ICD because it may cause unwanted delivery or inhibition of ICD therapy e Single chamber atrial pacing is contraindicated for patients with impaired AV nodal conduction e Dual chamber and single chamber atrial pacing is contraindicated for p
133. rrhythmias can be induced by stimulation in the ventricle Ensure that an external cardiac defibrillator is accessible during tachycardia testing Only physicians trained and experienced in tachycardia induction and reversion protocols should use non invasive programmed stimulation NIPS 5 4 1 Description The implanted CRT P lead system may be used in conjunction with the programmer to generate externally controlled pacing pulses Burst Stimulation or Programmed Stimulation may be selected with up to four extra stimuli at pacing rates to 800 ppm 126 Stratos LV LV T Technical Manual 5 4 2 Burst Stimulation Burst Stimulation offers a burst of pacing pulses to either atrium or ventricle when the programming wand is placed directly over the CRT P The duration of the burst is as long as the burst key on the programmer is touched When the burst key is no longer touched the program reverts to the backup program Should the wand be removed the pulse generator reverts to the permanent program Burst Stimulation may be stepped up or down from the nominal value to user defined high or low limits as long as the selection is touched on the touch screen When the Step Up or Step Down key is touched NIPS is invoked starting at the nominal burst rate and then steps up or down respectively in 25 ppm steps As soon as the step up or step down key is released NIPS terminates Subsequent inductions resume at the initially programmed burst rat
134. rts with either an atrial sense event a ventricular extrasystole or after expiration of the preceding basic interval 68 Stratos LV LV T Technical Manual 2 1 6 AAI and VVI The pacing modes AAI and VVI provide atrial and ventricular demand pacing The lower rate timer is started by a sense or pace event A sense event outside of the refractory period inhibits pacing and resets the lower rate timer in the absence of a sense event a pulse generator pulse will be emitted at the end of the lower rate interval 2 1 7 AAI VVI The AAI and VVI single chamber pacing modes are used in atrial and demand pacing In each case pacing and sensing only occur in the atrium AAI or the ventricle VVI The basic interval is started by a sense or pace event If the sense event occurs before the basic interval has expired pacing is inhibited Otherwise pacing occurs at the end of the basic interval 2 1 8 AOO VOO In these modes atrial ventricular and AV sequential pulses respectively are emitted asynchronously These modes primarily serve diagnostic purposes during follow up When programming to the VOO or VOO mode the risks associated with asynchronous ventricular pacing should be considered 2 1 9 DOO Asynchronous AV sequential pacing pulses are emitted in this pacing mode When programming DOO mode the risks of asynchronous ventricular pacing should be considered 2 1 10 VDI The VDI mode corresponds to the VVI mode with the
135. sing function of the pulse generator using surface ECG However real time telemetry of marker channels and or intracardiac electrogram via the programmer and programming wand is recommended over the use of a triggered pacing mode in the clinical setting A triggered pacing mode may be preferred in situations where positioning the programming head over the pulse generator would be impossible or impractical i e during exercise testing or extended Holter monitoring Another possible application of triggered modes is to ensure pacing as a short term solution during a period of inhibition of pacing by extracardiac interference mechanical noise signals or other sensing abnormalities Because triggered modes emit pacing pulses in response to sensed events this may result in unnecessary pacing during the absolute refractory period of the myocardium inappropriate pacing in response to oversensing of cardiac or extracardiac signals The risks associated with triggered pacing include excessive pacing arrhythmias due to the R on T phenomenon and early battery depletion Therefore it is important that the triggered modes are not used for long term therapy and that the CRT P is always returned to a non triggered permanent program Stratos LV LV T Technical Manual 67 2 1 3 DDI In contrast to DDD mode the basic interval in the DDI mode is not restarted by sensed P waves but by ventricular sensed or paced events The VA delay is started toge
136. sitivity In dual chamber systems the atrial sensitivity of 0 1 mV should only be programmed in conjunction with a bipolar lead configuration Programmed to Triggered Modes When programmed to triggered modes pacing rates up to the programmed upper limit may occur in the presence of either muscle or external interference Triggered Modes While the triggered modes DDT DVT DDTR A DDTR V DDI T VDT VVT and AAT can be programmed permanently these modes are intended for use as temporary programming for diagnostic purposes In triggered pacing modes pacing pulses are emitted in response to sensed signals and therefore the pacing pulse can be used as an indicator or marker of sensed events for evaluating the sensing function of the pulse generator using surface ECG However real time telemetry of marker channels and or intracardiac electrogram via the programmer and programming wand is recommended over the use of a triggered pacing mode in the Clinical setting A triggered pacing mode may be preferred in situations where positioning the programming head over the pulse generator would be impossible or impractical i e during exercise testing or extended Holter monitoring Another possible application of triggered modes is to ensure pacing as a short term solution during a period of inhibition of pacing by extracardiac interference mechanical noise signals or other sensing abnormalities Because triggered modes emit pacing
137. ss than the lower rate A conflict symbol gt gt will appear and transmission will be prohibited for Hysteresis rates which are less than 30 bpm The ability to decrease the effective lower rate through Hysteresis is intended to preserve intrinsic rhythm The Stratos CRT Ps operate by waiting for a sensed event throughout the effective lower rate interval Hysteresis interval If no sensed event occurs a pacing pulse is emitted following the Hysteresis interval In DDD R DDT R A DDT R VDD R VDT R AAT R and AAI R pacing modes the hysteresis interval starts with an atrial sense event In DDI R VVI R VVT R and VDI R pacing modes the hysteresis interval starts with a ventricular sense event In DDD R DDT R A DDT R VDD R and VDT R pacing modes the hysteresis interval also starts with ventricular extrasystoles NOTE If rate adaptation is active the Hysteresis rate is based on the current sensor indicated rate and the value of the programmable parameter 72 Stratos LV LV T Technical Manual The rate hysteresis is deactivated in the standard setting but can be programmed from 5 5 90 If Hysteresis is used in the DDI mode the AV delay must be programmed shorter than the spontaneous AV conduction time Otherwise stimulation in the absence of spontaneous activity occurs at the hysteresis rate instead of the lower rate Hysteresis is suspended during the Night Mode activated time Programming con
138. study completed and reviewed under PO50023 provided a reasonable assurance that bi ventricular pacing is effective in NYHA class III IV heart failure patients with a prolonged QRS and a left ventricular ejection fraction lt 35 The addition of ICD back up therapy does not affect the biventricular pacing performance of the device The AVAIL CLS CRT and Corox OVID clinical studies demonstrated the safety of the Stratos LV CRT P in NYHA class III IV heart failure patients with a prolonged QRS and a left ventricular ejection fraction lt 35 OVID 62 Stratos LV LV T Technical Manual Stratos LV LV T Technical Manual 63 2 Programmable Parameters For a complete list of programmable parameters and the available settings for the Stratos CRT Ps see Section 11 2 1 Pacing Modes For a complete list of pacing modes available in each Stratos CRT P configuration see Section 11 1 2 1 1 Rate adaptive Modes The rate adaptive modes are designated with an R in the fourth position of the NBG pacemaker code on the programmer screen The rate adaptive modes function identically to the corresponding non rate adaptive modes except that the basic rate increases when physical activity is detected by the motion sensor In demand modes i e DDDR DDIR DVIR VDDR VVIR AAIR it is possible that the atrial and or ventricular refractory period can comprise a major portion of the basic interval at high sensor modulated rates This may l
139. t indication is reached e Mode switching e PMT detection and termination e Biventricular synchronization NOTE The statistics are frozen when ERI is reached WARNING High Output Settings High output settings combined with extremely low lead impedance may reduce the life expectancy of the Stratos CRT Ps Programming of pulse amplitudes higher than 4 8 V in combination with long pulse widths and or high pacing rates may lead to premature activation of the replacement indicator Table 31 shows the expected longevity in months from BOS to ERI at standard program for Stratos CRT Ps The Stratos programmer software provides an estimated time to ERI in months and years that is updated each time the device is reprogrammed This estimation allows the physician to understand the longevity effects of modifying programmed parameters The data is based on the referenced lead impedance for each chamber 100 biventricular pacing and the data supplied by the battery manufacturer Table 31 Nominal pulse generator longevity Standard Pulse Generator BOS ERI in Months Stratos LV LV T 5000hms 51 51 Stratos LV LV T 1000 ohms 60 Standard 60 ppm 3 6 V 0 4 ms 148 Stratos LV LV T Technical Manual Table 32 shows the mean expected time intervals in months from ERI to EOS at standard program for Stratos CRT Ps All service intervals including the above cited nominal longevity are based on the bat
140. t Indication ER oomm AAA sehe nnn innnan E enisi d niian inaana 11 Technical Data ooooconcccccnnccannnnnoncccncnnnnnnnnnnnnnnnnnnnnnnnannonnns 11 1 Available Pacing Modes 11 2 Pulse and Control ParameterS cesses 11 3 Diagnostic Memory Functions 11 4 Home Monitoring Stratos LV T cc eeeeeteeeeeees 11 5 Additional FUNCtIONS sienien TEG Programmers accordance 11 7 Default Programs cecccinoccstrii e NEA 11 8 Materials in Contact with Human Tissue 11 9 Electrical Data Battery ooooooooonnnnccnnnnncicinnnanacnininnccnns 11 10 Mechanical Dala resina Stratos LV LV T Technical Manual v 12 Order Information cccoocnoccncnnnccnnnaniconnnarononanaronananonanana 161 PAPDOMGIXGA EET T ii 163 vi Stratos LV LV T Technical Manual Stratos LV LV T Technical Manual 1 1 General 1 1 Device Description The Stratos LV and Stratos LV T CRT Ps are rate adaptive pacemakers designed to provide Cardiac Resynchronization Therapy CRT The Stratos CRT Ps provide all standard bradycardia pacemaker therapy with the additional capabilities of biventricular pacing for CRT Biventricular pacing in the Stratos CRT Ps can be programmed to initially pace in either the right or left ventricular chambers with separately programmable outputs for both left and right channels Sensing of cardiac signals only occurs in the right ventricular chamber The Stratos CRT Ps can also provide singl
141. t be guaranteed The receipt is also dependent on whether the patient was physically situated in the required coverage range of the patient device at the time the event information was sent Patient Activated Report The magnet effect must be programmed synchronous if the Patient Report function is activated Not for Conclusive Diagnosis Because not all information available in the implant is being transmitted the data transmitted by Home Monitoring should be evaluated in conjunction with other clinical indicators i e in office follow up patient symptoms etc in order to make a proper diagnosis Frequency of Office Follow Ups When Using Home Monitoring The use of Home Monitoring does not replace regular follow up examinations When using Home Monitoring the time period between follow up visits may not be extended Stratos LV LV T Technical Manual 13 1 5 6 Electromagnetic Interference EMI The operation of any implanted device may be affected by certain environmental sources generating signals that resemble cardiac activity This may result in inhibition of pacing and or triggering or in asynchronous pacing depending on the pacing mode and the interference pattern In some cases i e diagnostic or therapeutic medical procedures the interference sources may couple sufficient energy into a pacing system to damage the device and or cardiac tissue adjacent to the leads BIOTRONIK CRT Ps have been designed to signifi
142. ted There is no influence on mode switching As occurs during The event influences mode switching the Atrial Refractory Period ARP As occurs in the The AUI atrial upper interval starts The PMT protection AV delay is not restarted Post AES window pacing is started if the atrial sense is classified as an AES 2 3 6 1 Atrial Refractory Period In all modes in which atrial depolarization can be sensed the Stratos CRT Ps will start an atrial refractory period upon each atrial depolarization programmable AUTO 225 25 775 In standard Auto setting the atrial refractory period ARP is automatically preset to a minimum value of 225ms and is automatically extended if the AV delay is longer Stratos LV LV T Technical Manual 77 In the case an atrial sense event falls within the PMT protection window the Stratos CRT Ps start a minimal ARP 2 3 6 2 Atrial Far Field Protection In all dual chamber modes with atrial sensing the Stratos CRT Ps start an atrial FFP window upon each ventricular event to prevent sensing of far field potentials in the ventricle The atrial far field protection window is separately programmable for ventricular sensed events at 30 10 100 1 200 ms and for ventricular paced events at 30 10 100 and 100 10 220 ms If an atrial event occurs during the FFP window the atrial event is classified as an invalid FFP event and has no influence on the timing of the CRT
143. tery discharge behavior and the hybrid circuit properties including current consumption and replacement indicator The statistical calculations are based on 500 ohm lead impedances 100 pacing and data supplied by the battery manufacturer Table 32 Remaining Expected Service time ERI to EOS Pacing Program Stratos LV months Standard Mean Program with high pulse energy 50 of all pacemakers reach or exceed the given value t Standard DDDR 60 ppm 3 6 V 0 4 ms High DDDR 90 ppm 4 8 V 1 0 ms Stratos LV LV T Technical Manual 149 10 Explantation Explanted devices and accessories may not be reused Explanted CRT Ps can be delivered to the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal If possible the explanted devices should be cleaned with a sodium hyperchlorine solution of at least 1 chlorine and thereafter washed with water prior to shipping All implantable electronic devices should be explanted before cremation of a deceased patient CAUTION Device Incineration Never incinerate a CRT P Be sure the CRT P is explanted before a patient who has died is cremated see Section 10 Explanted Devices Return all explanted devices to BIOTRONIK 150 Stratos LV LV T Technical Manual Stratos LV LV T Technical Manual 151 11 Technical Data 11 1 Available Pacing Modes DDDR DDTRA DDTR DDIR DDITR DVIR DVTR DOOR VDDR VDTR VDIR
144. the lead connector until it is firmly placed in the setscrew Insert the lead connector pin into the connector receptacle of the CRT P without bending the lead until the connector pin becomes visible behind the setscrew Hold the connector in this position Securely tighten the setscrew of the connector clockwise with the torque wrench until torque transmission is limited by the wrench After retracting the torque wrench the perforation will self seal The proximal electrode of bipolar leads is automatically connected Connect the second lead as described above Attach the other ventricular lead to the right ventricular port RV and the atrial lead to the right atrial port RA in the same manner 144 Stratos LV LV T Technical Manual 6 Pass non absorbable ligature through the hole in the connector receptacle to Y secure the CRT P in the pocket CAUTION Tightening Setscrew s Do not overtighten the setscrew s Use only the BIOTRONIK supplied torque wrench Sealing System Be sure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle Failure to do so may result in damage to the plug and its self sealing properties NOTE Do not lubricate the grommets Stratos LV LV T Technical Manual 145 9 Elective Replacement Indication ERI Service times for the Stratos CRT Ps vary based on several factors including battery properties storage time le
145. the phone in a breast pocket or on a belt over or within 6 inches 15cm of the implanted device as some phones emit signals when they are turned ON but not in use i e in the listen or standby mode Store the phone in a location opposite the side of implant 1 5 9 Hospital and Medical Environments Refer to Section 1 5 1 for information regarding CRT P interaction with the following medical procedures environments e Electrosurgical Cautery e Lithotripsy e External Defibrillation e High Radiation Sources 1 5 10 Device Explant and Disposal Device Incineration Never incinerate a CRT P Be sure the CRT P is explanted before a patient who has died is cremated see Section 10 Explanted Devices Return all explanted devices to BIOTRONIK 16 Stratos LV LV T Technical Manual 1 6 Potential Effects of the Device on Health The following possible adverse events may occur with this type of CRT P based on implant experience including Potential Adverse Events Air embolism Allergic reactions to contrast media Arrhythmias Bleeding Body rejection phenomena Cardiac tamponade Chronic nerve damage Damage to heart valves Elevated pacing thresholds Extrusion Fluid accumulation Infection Keloid formation Lead dislodgment Lead fracture insulation damage Lead related thrombosis Local tissue reaction fibrotic tissue formation Muscle or nerve stimulation Myocardial damage Myopotential sensing Pacemaker m
146. ther with the basic interval If atrial or ventricular sensing does not occur during the VA delay the atrial pacing occurs at the end of the VA delay Atrial pacing starts the AV delay If atrial sensing occurs outside of the atrial refractory period ARP a PMT safety interval or the FFP far field protection window atrial pacing is inhibited However the AV delay does not start with a sense event but at the end of the VA interval Therefore P waves in the DDI mode do not trigger ventricular events NOTE For additional information on far field protection window see Section 2 3 Timing Functions An atrial sensed event that occurs during the PMT protection window starts the atrial upper basic rate to avoid pacing during the vulnerable phase of the atrium If the interval of the atrial upper rate is longer than the basic interval the AV delay is shortened by that same amount after atrial pacing but only until the end of the safety interval 2 1 4 DVI The DVI mode is derived from the DDI mode In contrast to the latter atrial sensing does occur Therefore atrial pacing is delivered at the end of the AV delay Ventricular sensing within the AV delay inhibits atrial and ventricular pacing Ventricular sensing within the AV delay inhibits ventricular pacing 2 1 5 VDD The VDD mode corresponds to the DDD mode with the exception that it does not provide atrial pacing In the absence of a sense event the basic interval sta
147. tient data the AVAIL CLS CRT study alone was insufficient to support CRT pacing effectiveness or an ablate and pace indication e The cumulative enrollment duration was 416 7 months with a mean duration of 9 7 months for Group 1 522 4 months with a mean duration of 10 4 months for Group 2 and 261 1 months with a mean duration of 10 4 months for Group 3 73 61 9 of the study patients had enrollment durations greater than 6 months e There were 158 adverse events 115 observations in 68 patients and 43 complications in 34 patients There were no unanticipated adverse device effects reported e The overall protocol violation non compliance rate is 0 4 in Group 1 0 5 in Group 2 and 0 4 in Group 3 The overall follow up compliance rate is 99 8 in all groups e There were 3 patient deaths reported two in Group 2 and one in Group 3 The clinical investigators and clinical events committee determined that none of these deaths were related to the study devices e Both the CRT pacing and the RV pacing only groups showed improvements in the primary composite endpoint of quality of life and six minute walk distance between the baseline evaluation and the six month follow up In addition there was a trend towards improvement between the combined CRT pacing groups compared to the RV pacing only group at six months Stratos LV LV T Technical Manual 29 Primary Endpoint Complication free Rate Safety The safety of the Stratos LV
148. ting at BIOTRONIK All of the clinical centers followed the requirements of an identical clinical protocol and all of the clinical centers used the same methods to collect and report the clinical data including New York Heart Association evaluation six minute walk test Minnesota Living with Heart Failure questionnaire and echocardiographic measurements In order to justify pooling of the data from multiple centers several analyses were completed All of the centers were divided into two groups Small and Large sites based on implant volume Comparisons were then made between the patient populations based on the results of the safety and effectiveness endpoints Additionally analyses were performed on the data collected in the AVAIL clinical investigation in order to compare results between males and females The first type of analysis compared enrollment by patient gender in each of the study groups The second type of analysis compared effectiveness and safety outcomes in each gender The results of these analyses demonstrated poolability of the data between sites There were no significant differences in the primary safety or effectiveness endpoints between high and low volume implant centers Stratos LV LV T Technical Manual 39 The gender distribution in this clinical investigation was consistent within the study groups and included a representative proportion of enrolled female participants 57 2 versus 42 7 male There were no si
149. tomatic lead check cannot be programmed ON if left ventricular paces are programmed to occur before right ventricular paces 86 Stratos LV LV T Technical Manual 2 6 Antitachycardia Functions The antitachycardia functions include e Upper basic rate e Tachycardia mode e Tachycardia behavior e Mode Switching e PMT Management e Preventive Overdrive Pacing e Post AES Pacing 2 6 1 Upper Rate and UTR Response In atrial controlled dual chamber modes the upper tracking interval UTI along with the atrial refractory period or PMT protection window limits the ventricular pacing rate such that it will never exceed the programmed upper rate regardless of the patient s atrial rate In all triggered modes the upper tracking interval limits the pacing rate that is triggered by sensing NOTE Select the upper rate based upon the patient s tolerance for the rate The upper rate limit determines the minimal interval between a sense or pace event and the subsequent atrial or ventricular pacing event A shortening of the pacing interval to the upper rate interval may also be initiated at rest e g by detection of muscle potentials Therefore for patients with increased vulnerability a lower programmed upper rate is recommended 2 7 Wenckebach 2 1 Wenckebach behavior or 2 1 behavior is available depending on the programming of the atrial refractory period the PMT protection window and the upper tracking interval in the modes D
150. tos LV F Number of Number of Complications ategory of Patients Complications pen patient Patients year Other Medical Worsenin CHF j 0 03 Repeat Ablation pee Non CHF cardiac 0 05 symptoms Other Medical 0 05 Total 0 17 Total All Patients and 0 37 Categories Number of Patients 75 Number of Patient Years 64 4 The freedom from Stratos LV system related and procedure related complications was 85 33 with a one sided lower 95 confidence bound of 76 89 Therefore the procedure lead and device related complication free rate at 6 months met the pre specified acceptance criterion of equivalence non inferiority within 10 of 85 p 0 0196 Observed Adverse Events Adverse events are classified as either observations or complications Observations are defined as clinical events that do not require additional invasive intervention to resolve Complications are defined as clinical events that require additional invasive intervention to resolve Of the 104 adverse events reported in the Stratos LV study groups there have been 76 observations in 45 patients and 28 complications in 20 patients with a cumulative enrollment duration of 64 4 patient years 26 7 of the enrolled Stratos LV patients have experienced a complication The rate of complications per patient year is 0 43 60 0 of the enrolled study patients have a reported observation The rate of observations per patient year is 1 18 32 Stratos LV LV T Tech
151. ts in the temporary program or in the magnet asynchronous mode recordings are not made in the trend there are gaps 118 Stratos LV LV T Technical Manual R Wave Trend This is the sensitivity of the ventricles displayed over time The R wave trend is displayed in the form of a line chart The R wave trend is a rolling long term trend with a fixed resolution of 36 hours Therefore the 240 time windows with 36 hour recording periods result in actual recordings of approximately one year The R wave trend can record amplitudes from 0 0 to 20 mV In the Stratos LV the specific RV and LV amplitudes are shown in trends of different colors The R wave trend is available in all modes that sense in the ventricle except triggered modes DDI R T DVT R VDT R and VVT R 2 24 Pacing Statistics Impedance Trend The atrial and ventricular impedances are measured in the Stratos CRT Ps and both values are displayed in the impedance trend in the form of a line chart The impedance trend is a long term trend with a fixed resolution of 36 hours per window Therefore the 240 possible windows each with 36 hour recording periods result in an actual recording time of approximately one year This recording only occurs in paced events After approximately one year of recording the impedance trend begins to roll The impedance can also be recorded in the left atrial and left ventricular channel The values of the impedance trend lie between
152. was evaluated based on complications adverse events that require additional invasive intervention to resolve related to the implanted CRT system which includes the Stratos LV the right ventricular the left ventricular lead lead ventricular lead adapters if used and the implant procedure The target complication free rate at six months is 85 13 complications in these categories were seen in 11 patients with cumulative enrollment duration of 783 5 months 64 4 patient years 14 7 of the patients had a reported complication in these categories The rate of complications per patient year is 0 20 Details of the Stratos LV complications in the AVAIL CLS CRT study are listed in Table 4 30 Stratos LV LV T Technical Manual Table 4 AVAIL CLS CRT Complication Free Rate at 6 months Stratos LV of Number of Patients Complications Device Related Category Pocket Infection Pain Total High Threshold No Capture Diaphragmatic Stimulation Dislodgement Total High Threshold No Capture Total Pneumothorax User error Hematoma Total Total Lead and Procedure Related Number of Patients RV Lead Related Procedure 14 7 13 Complications per patient year 0 03 0 03 0 02 0 02 0 03 0 06 0 06 0 06 0 02 0 02 0 02 0 05 0 20 Stratos LV LV T Technical Manual 31 Table 4 AVAIL CLS CRT Complication Free Rate at 6 months Stra

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