Physician`s Manual
Contents
1. 25 Percutaneous Implant Technique 25 Venous Cut Down Technique 25 Abdominal Implants Models 0139 and 0159 only 27 Tunneling the Lead to the Abdominal Pocket 27 Connection to a Pulse Generator 28 Post implant Evaluation 29 Explantations u a uu a us at sluku 29 References 2 6 8 020k ahi de ae cen aes 30 SPECIFICATIONS Nominal aaa 31 DEVICE DESCRIPTION 1 DEVICE DESCRIPTION The ENDOTAK RELIANCE lead Models 0157 0158 0159 and the ENDOTAK RELIANCE S lead Models 0137 0138 0139 are active fixation endocardial cardioversion defibrillation and pace sense leads with an extendable retractable helix and a steroid eluting collar The silicone lead body has a lubricious coating The ENDOTAK RELIANCE dual coil leads and the ENDOTAK RELIANCE S single coil leads are for use as an integral part of an AICD automatic implantable cardioverter defibrillator system with DF 11 and IS 12 ports Instructions in this manual should be used in conjunction with other resource material including the applicable AICD physician s manual the applicable VENTAK External Cardioverter Defibrillator ECD user s manual the ENDOTAK SQ Array lead physician s manual and the AICD Y Connector product data sheet Indications fo2. 3 Potential Adverse Events 4 Warranty uu a uu aaa e 5 Lead F at r 8s uu uuu cae ed 6 Lead Evaluation u 8 Implant Information 8 Opening Instructions 9 Sterilizatioltu a S uhaq usss a awu s 9 Surgical Preparation 9 ACCOSSONOS Eege us dE 10 Suture Sleeves 10 Fixation Tool uuu un deeg eeh 10 EE u nn ee a Ree SR Ras 10 Stylet Ge s u un unahan 11 Vulle n un ee es 11 Ree 11 Handling the Lead 12 Implantati n EE 12 Inserting the Stylet 12 Handling the Fixation Helix 13 Inserting the Lead 14 Positioning the Lead 16 Lead Fixatl ft r ua a a aoe 17 Checking for Lead Stability 19 Repositioning the Lead 19 Evaluating Lead Position a 20 Minimizing Pacemaker Interaction 20 Taking Baseline Measurements 20 Electrical Performance 21 Evaluating with the Pulse Generator 22 Evaluating with the ECD 22 Conversion Testing a 23 Securing the Lead
3. CARDIAC RHYTHM MANAGEMENT GUIDANT Physician s Manual ENDOTAK RELIANCE Models 0157 0158 0159 ENDOTAK RELIANCE S Models 0137 0138 0139 Steroid Eluting Extendable Retractable Helix Defibrillation mae RESTRICTED DEVICE Federal law USA restricts the sale distribution or use of this device to by or on the lawful order of a physician Alo SONVI E VLON Ge epoue jeur pono l Duneiuguep EWIXUg 6 Ieuluuu 1 pono l su s 5ed elsIp pue ELDO 9 t Se EA epouleo Sue epo josje Buye uqyep Ee Z poub l 109 BulTe quep aor 9 map epoue poxno l 109 su s 5ed EURO luo 6S LO pue BELO SI8polN 9A9 9 S anng puo59S poule5 pono l su s oed Bunnj pio1 ls Eis 6S10 8S10 ZS10 SI PON Do 3ONVIT3td MVLOGNA 6 L0 8 L0 ZE LO SIS DON pee7 S 3ONVIT3ti MVLOGNA CONTENTS Device Description u 1 Indications for Use A 1 CGontraindications a 1 WarmnihgS EE 1 AICD Lead Compatibility 2 Implantati fi u uu u uum uum ia dies 2 Electrical Performance 2 Conversion Testing eeeeeeeeeeeeeeeeeeererereeeeeeeeeeee 3 Securing and Tunneling 3 Preca tioniS2 u unas eaa pa aia ides 3 Observed Adverse Events
4. Adverse event data is derived from 30 patients followed for 30 days Patients and leads may have multiple adverse events c Complications are defined as adverse events requiring invasive mea sures to correct eg surgical intervention d Observations are defined as adverse events which are correctable by noninvasive measures eg reprogramming gp 4 DEVICE DESCRIPTION Potential Adverse Events Based on the literature and lead implant experience the possible physical effects from implantation of an ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead are listed below in alphabetical order Air embolism Lead fracture insulation break Allergic reaction Lead tip deformation and or Bleeding breakage Cardiac perforation e Local tissue reaction tamponade Low amplitude VF signals Chronic nerve damage Myocardial injury Death Myocardial irritability Elevated pacing thresholds Oversensing undersensing Erosion extrusion Pneumothorax Excessive fibrotic tissue Post shock rhythm growth disturbances Formation of hematomas or e Random component failures cysts e Shunting current or insulating Inappropriate therapy shocks myocardium during e Incomplete connection with defibrillation with internal or pulse generator external paddles Infection Threshold elevation Keloid formation Thrombosis thromboemboli e Lead abrasion Venous occlusion Lead displacement
5. S lead supplementary implantation of an ENDOTAK SQ Array lead or an alternate lead system will require additional conversion testing Refer to the ENDOTAK SQ Array lead physician s manual for instructions concerning auxiliary use of this lead with the ENDOTAK RELIANCE and ENDOTAK RELIANCE S lead CAUTION An ENDOTAK SQ Array lead may increase the energy required to cardiovert defibrillate the heart with transthoracic paddles Care should be taken not to place the external defibrillator paddles directly over the ENDOTAK SQ Array lead WARNING Use of any component of the ENDOTAK lead system to assist in delivery of external source rescue shocks could cause extensive tissue damage The decision to implant any AICD lead system in any configuration should be based on demonstration of adequate safety margins at the programmed shock energy as determined by DFT and cardioversion energy requirement CER testing Refer to the applicable AICD physician s manual for DFT and CER testing requirements Clinical study indicates that a programmed safety margin of 9 10 J above the patients DFT was used in the majority of patients If a 9 10 J safety margin cannot be obtained by other less invasive means consider placing an additional defibrillation lead Note If after prolonged and repeated inductions of VF a tho racotomy is to be performed consider performing it at a later date If using an ECD turn off the ECD after arrhythmia testing
6. This will help Shape Sr ihe strain reli f minimize flexing at the suture loop Models 0139 and sleeve and interaction with the 0159 only clavicle first rib region Tunneling the Lead to the Abdominal Pocket A short terminal leg STL tunneling tool is recommended for use with this lead if the AICD pulse generator is implanted in the abdomen Tunnel the lead subcutaneously from the chest area to the abdominal AICD implant pocket If the tunneling procedure must be delayed cap the lead terminal pin and form a temporary pocket for the coiled lead Capping the terminal pin protects it and prevents body fluids from entering the lumen of the lead Note When using a Guidant lead tunneler do not cap the leads CAUTIONS e Tunnel the lead from the chest area to the pulse generator implant site Never tunnel the lead from the pulse generator implant site to the chest area This can damage the electrodes or lead body or both by permanently stretching the lead e When tunneling the lead take precautions not to place excessive tension on the lead This can cause either structural weakness or conductor discontinuity or both 28 IMPLANTATION e After tunneling re evaluate the lead to verify that no significant change in signals or damage to the lead has occurred during the tunneling procedure Reattach the lead terminals to the AICD pulse generator or ECD cables If the measurements are unacceptable check the electrical c
7. component of the ENDOTAK lead system to assist in delivery of external source rescue shocks could cause extensive tissue damage Page 24 Securing and Tunneling Do not kink twist or braid the lead terminals as doing so could cause lead insulation abrasion damage Page 26 Precautions e The lead and its accessories are intended only for one time use Do not reuse thas not been determined whether the warnings precautions or complications usually associated with injectable dexamethasone acetate apply to the use of the low concentration highly localized controlled release device For a listing of potentially adverse effects refer to the Physician s Desk Reference Refer to the Implant Information Implantation and Post implant Evaluation sections of this manual for cautions specific to handling implanting and testing the ENDOTAK RELIANCE lead family Failure to observe these cautions could result in incorrect lead implantation lead damage and or harm to the patient Adverse Events Observed Adverse Events A confirmatory clinical investigation was conducted on the ENDOTAK RELIANCE lead Models 0157 0158 0159 The complications and observations are reported in Table 1 Table 1 ENDOTAK RELIANCE Lead Ventricular Morbidity Adverse ofpts of pts of Events per n 30 95 Cl Leads ead Month Complications total 0 0 0 Observations total 0 0 0
8. established e Lead fracture dislodgment abrasion and or an incomplete connection can cause a periodic or continual loss of rate sensing possibly resulting in arrhythmia nondetection or over sensing of rate possibly resulting in inappropriate delivery of a pulse generator shock or inadequate delivery of converting energy Although pliable the lead is not designed to tolerate excessive flexing bending or tension This could cause structural weakness conductor discontinuity and or lead dislodgment Page 12 Take care to obtain appropriate electrode position Failure to do so may result in higher defibrillation thresholds or may render the lead unable to defibrillate a patient whose tachyarrhythmia s might otherwise be convertible by an AICD system Page 17 In order to deliver defibrillation therapy the single coil ENDOTAK RELIANCE S lead must be implanted with a separate defibrillation electrode Guidant recommends using the ENDOTAK RELIANCE S lead with a pectorally implanted device that uses the metallic housing as a defibrillation electrode Page 17 Electrical Performance e When connecting the lead to ECD cables and or later to the AICD pulse generator it is very important that proper connections are made Damage to the heart could result if a high voltage defibrillating pulse were to be delivered through the pace sense tip electrode Page 21 DEVICE DESCRIPTION 3 Conversion Testing Use of any
9. has been completed and disconnect the ECD cables per instructions in the ECD user s manual IMPLANTATION 25 Securing the Lead After the electrodes are satisfactorily positioned and conversion testing has been performed secure the lead to the vein to achieve permanent hemostasis and lead stabilization Suture sleeve tie down techniques can vary with the lead insertion technique used Securing the lead will provide permanent hemostasis and lead stabilization Percutaneous Implant Technique 1 Peel back the introducer sheath and slide the suture sleeve deep into the tissue Figure 14 2 Using both grooves ligate the suture sleeve to the lead 3 Next secure the sleeve and lead to the fascia First pass Second pass Secure sleeve to lead Secure sleeve and lead to fascia Use both grooves Figure 14 Using the sleeve with the percutaneous implant technique 4 Check the suture sleeve after tie down to demonstrate stability and lack of slippage by grasping the suture sleeve with fingers and trying to move the lead in either direction Venous Cut Down Technique 1 Slide the suture sleeve into the vein past the distal pre formed groove Ligate the vein around the suture sleeve to obtain hemostasis Next using the same groove secure the lead and vein to the adjacent fascia Figure 15 26 IMPLANTATION Distal Groove First pass secure vein to lead Second pass secure vein and lead to fasci
10. helix is extended outside the distal fluoroscopy markers Figure 13 Refer to the Specifications section on Page 31 for the expected number of turns to extend or retract the helix FULLY RETRACTED FULLY EXTENDED Visual Visual Fluoroscopic Fluoroscopic Figure 13 Possible views of the helix electrode CAUTION Do not rotate the terminal pin clockwise more than the maximum number of turns indicated for each model number in the Specification section on Page 31 Continu ing to rotate the terminal pin once the helix is fully extended or retracted as indicated by fluoroscopy can damage the lead cause lead dislodgment and or cause acute pacing threshold to rise IMPLANTATION 19 Note Stylet curvature extended implant time and reposition ing the lead multiple times may increase the number of turns to extend or retract the helix 3 Loosely hold the proximal end of the lead and release the fixation tool Note After Step 3 minimal counterrotation in the termi nal pin may be observed 4 Remove the fixation tool from the terminal pin by pressing the handles of the tool together If the helix mechanism fails to function properly during repositioning the following caution must be carefully observed to avoid possible tissue snagging when removing the lead CAUTION Do not use the lead if the helix cannot be retracted during implant Continuous counterclockwise rotation of the lead body during lead removal
11. may straighten as it passes through the lumen of the terminal pin A gentle curve is less likely to Figure 7 Curve the stylet straighten CAUTION Do not bend the lead with a stylet in place Bend ing the lead could damage the conductor and insulation material Syringe Note To optimize insertion into the lead do not allow body fluids to come in contact with the stylet Handling the Fixation Helix Before implanting the lead verify the mechanical functioning of the lead by rotating the terminal pin and visually observing the helix extending and retracting The helix can be extended or retracted by rotating the terminal pin clockwise to extend the helix or counterclockwise to retract it Note Refer to the Lead Fixation section on Page 17 for adai tional information on how to fixate the helix and to the Specifi cations section on Page 31 for the expected and maximum number of turns to extend or retract the helix CAUTIONS Do not overextend or overretract the helix Continuing to rotate the terminal pin once the helix is fully extended or retracted can damage the lead Ifthe helix cannot be extended or retracted do not use the lead Do not alter the electrodes or use a lead with a deformed helix or damaged helix fixation mechanism Do not attempt to straighten or realign the fixation helix Notes Do not insert a lead into the vein when the helix is extended Rotate the terminal pin countercl
12. the pacemaker electrodes to avoid cross sensing between the AICD and the pacemaker Lead Fixation The ENDOTAK RELIANCE and ENDOTAK RELIANCE S active fixation lead s helix is electrically conductive to allow mapping of potential electrode positions Mapping means pacing and sensing thresholds can be measured without extending the helix into the tissue Rather the distal tip of the lead can be placed against the tissue and measurements can be taken If data is acceptable proceed with lead fixation Mapping of the ventricle prior to lead fixation is recommended as it can reduce the potential need for multiple lead positionings 18 IMPLANTATION Note The stylet must be fully inserted during fixation or repo sitioning 1 When the correct position has been achieved attach the fixation tool to the ter minal pin Press the han dles together and place the pin in the preformed groove Release the ten sion on the handles to Figure 12 Attaching and secure the terminal pinin rotating the fixation tool the fixation tool Figure 12 Apply forward pressure to the lead body to position the distal electrode against the desired fixation site and rotate the fixation tool clockwise to affix the distal electrode helix into the heart wall View the radiopaque markers under fluoroscopy to identify when the fixation helix is fully extended Full extension is achieved when the radio paque markers are joined and the fixation
13. 014 in 0 36 mm diameter b White knobs 0 016 in 0 41 mm diameter Opening Instructions The outer package and sterile tray may be opened by authorized personnel under clean conditions To ensure sterility the sealed inner sterile tray must be opened using accepted aseptic technique by scrubbed masked sterile gowned personnel The sterile tray is opened by peeling back the cover Sterilization Guidant sterilizes the lead and accessories with ethylene oxide gas EtO before final packaging When they are received they are sterile and ready for use If the container is wet damaged punctured or if the seal is broken return the lead to the nearest Guidant representative Never attempt to resterilize the lead Surgical Preparation Instrumentation for cardiac monitoring imaging fluoroscopy defibrillation and lead signal measurements must be available during implant When using electrical instrumentation electrically isolate the patient from potentially hazardous current leakage Guidant also recommends availability of 10 LEAD EVALUATION sterile duplicates of all implantable items in case of accidental damage or contamination Accessories Suture Sleeves Suture sleeves are an CHI 9 adjustable tubular Figure 2 The long tapered reinforcement positioned over end of the suture sleeve the outer lead insulation Figure faces toward the vein 2 They are designed to secure and protect the lead afte
14. AICD pulse generator into the AICD implant pocket as indicated in the AICD physician s manual Also refer to Connection to a Pulse Generator Page 28 for more information Evaluate the lead signals by viewing the real time EGM The signal from the implanted lead should be continuous and without artifact similar to a body surface ECG A discontinuous signal may indicate a lead fracture or an otherwise damaged lead or an insulation break that would necessitate lead replacement Inadequate signals may result either in a failure of the AICD system to detect an arrhythmia or in an unnecessary delivery of therapy Evaluating with the ECD Connect the pace sense lead terminal pin to the sterile bipolar cable Connect the defibrillation lead terminal pin s to the high voltage cable Then connect the bipolar and high voltage cables to the respective connectors on the Guidant ECD Evaluate the lead signals using the Programmer Recorder Monitor PRM programming system or an external strip chart recorder As seen on the strip chart recorder the signal from the implanted lead should be continuous and without artifact similar to a body surface ECG A discontinuous signal may indicate a lead fracture or otherwise damaged lead or an insulation break that would necessitate lead replacement Inadequate signals may result in failure of the AICD system to detect an arrhythmia or in unnecessary delivery of therapy CAUTIONS e Guidant ECDs a
15. D lead ports identified as defibrillation maintaining the polarity and electrode configuration determined during DFT testing POST IMPLANT EVALUATION 29 Giving consideration to patient anatomy and pulse generator size and motion gently coil any excess lead and place adjacent to the pulse generator It is important to place the lead into the pocket in a manner that minimizes lead tension twisting sharp angles and or pressure POST IMPLANT EVALUATION Perform follow up evaluation as recommended in the applicable AICD pulse generator physician s manual CAUTION For some patients lead performance at implant may not predict performance in the chronic state There fore Guidant strongly recommends that post implant follow up EP testing be performed before the patient is discharged from the hospital This testing should include at least one arrhythmia induction conversion test of ventricular fibrillation In addition to the pulse generator follow up instructions use beeping tones to evaluate pacing sensing integrity If programmed accordingly placing and holding a magnet over an active implanted pulse generator elicits tones synchronously with the R wave of the pace sense electrodes If a problem exists with the pace sense electrodes or their interface with the pulse generator it may be revealed by evaluating the beeping tones of the device Refer to the applicable AICD system manual for specific instructions Chronic repositi
16. ING Although pliable the lead is not designed to toler ate excessive flexing bending or tension This could cause structural weakness conductor discontinuity and or lead dislodgment CAUTIONS e Avoid holding or handling the distal tip of the lead Do not wipe or immerse the electrode in fluid Such treatment will reduce the amount of steroid available when the lead is implanted e Chronic repositioning may adversely affect the lead s low threshold performance because the steroid may be depleted Do not attempt to alter the electrodes Do not apply pressure to the tip of the electrode e The conductor insulation is silicone rubber which can attract particulate matter and must always be protected from surface contamination Note Guidant suggests using sterile water if a lubricant is needed when coupling the lead with the ECD cables AICD pulse generator or the AICD Y connector IMPLANTATION Inserting the Stylet Choose a stylet according to the function and to the firmness desired Remove the preinserted stylet before inserting a different one Make sure the stylet is fully inserted in the lead prior to inserting the lead into the vein IMPLANTATION 13 Gently curve the preferred straight stylet with any sterile smooth surfaced instrument eg 70 90 10 or 12 cc syringe barrel Figure 7 and carefully insert the stylet through the lumen of the 6 cm conductor A sharp bend in the gt stylet
17. K lead system configurations A major consideration in choosing the ENDOTAK RELIANCE lead family is that it does not require a thoracotomy The physician should weigh its advantages against the patient s ability to withstand additional electrophysiology EP testing arrhythmia induction and conversion testing and a possible thoracotomy should the lead system prove ineffective Various factors such as cardiomegaly or drug therapy may necessitate repositioning of the defibrillation leads or substitution of one lead system for another in order to facilitate arrhythmia conversion In some cases reliable arrhythmia conversion may not be obtained with any leads at the available AICD energy levels Bipolar pacemakers may be used with the ENDOTAK RELIANCE lead family and AICD pulse generator as long as the pacemaker and AICD pulse generator do not interact LEAD EVALUATION 9 causing AICD pulse generator nondetection or false detection Refer to the section Minimizing Pacemaker Interaction on Page 20 for more information The lead is not designed sold or intended for use except as indicated The following items are packaged with the ENDOTAK RELIANCE and ENDOTAK RELIANCE S active fixation lead Straight stylets softa Straight stylets firmb Fixation tools Stylet guide Vein pick Lead caps 2 DF 1 and 1 IS 1 DF 1 port plugs ENDOTAK RELIANCE S lead only Literature packet a Green knobs 0
18. Retractable Fixation Helix The extendable retractable helix design anchors the distal tip electrode to the endocardial surface without support of trabecular structures offering various lead placement possibilities for the tip electrode The extendable retractable helix serves as the cathode for intracardiac right ventricular electrogram rate sensing and pacing The helix is extended retracted using a terminal pin mechanism Fluoroscopic Markers The lead has radiopaque markers near the distal tip that can be seen under fluoroscopy These markers show when the helix is fully retracted or fully extended Coil Electrodes The distal coil electrode is intended to serve as an anode for rate sensing and pacing and as an anode or cathode for cardioversion defibrillation shocks The proximal coil electrode on the ENDOTAK RELIANCE lead is intended to serve as an anode or cathode for cardioversion defibrillation shocks The ENDOTAK RELIANCE lead family uses the implanted device metallic housing as an additional defibrillation electrode Lead Body The isodiametric lead body contains one conductor for pacing sensing The ENDOTAK RELIANCE lead has two conductors for defibrillation and the ENDOTAK RELIANCE S lead has one conductor for defibrillation The conductors are coated with PTFE and LEAD FEATURES 7 insulated in separate lumens within the silicone rubber lead body A second layer of silicone covers the lead body providing additional insula
19. Venous perforation erosion dislodgment Clinical Investigation Clinical data supporting this lead came from the ENDOTAK RELIANCE lead Models 0157 0158 0159 confirmatory clini cal investigation The confirmatory clinical investigation was an evaluation of the ENDOTAK RELIANCE lead Models 0157 0158 0159 in 30 patients The confirmatory clinical investigation provided reasonable assurance of the safety and effectiveness of the ENDOTAK RELIANCE lead system Lead safety was sup ported by a review of lead related complications In 30 implanted leads there were no lead related complications Patient population characteristics and electrical performance are summarized in the tables below DEVICE DESCRIPTION 5 Table 2 Patient Population Characteristics N 30 patients ENDOTAK RELIANCE lead Category Models 0157 0158 0159 Number of Patients Attempted N 0 Number of Patients Implanted N 30 Age at Implant years N 30 Minimum 55 7 Maximum 86 5 Mean 68 5 Standard Deviation 9 1 Gender Male 23 76 7 Female 7 23 3 Left Ventricular Ejection Fraction LVEF N 30 Minimum 15 0 Maximum 55 0 Mean 29 4 up Period N 30 patients Table 3 Mean Ventricular Voltage Threshold at 0 5 ms by Follow ENDOTAK RELIANCE lead Models 0157 0158 0159 Follow up Number of Patients Mean V Standard Deviation Pre discharge 29 0 5 0 2 1 month 29 0 8 0 3 Table 4 Ve
20. a Proximal Groove First pass secure sleeve to lead Second pass secure sleeve and lead to fascia Figure 15 Using the sleeve with the venous cutdown technique 2 Using the proximal pre formed groove secure the sleeve to the lead Using the same groove secure the sleeve and lead to the adjacent fascia 3 Check the suture sleeve after tie down to demonstrate stability and lack of slippage by grasping the suture sleeve with fingers and trying to move the lead in either direction WARNING Do not kink twist or braid the lead terminal with other leads as doing so could cause lead insulation abra sion damage CAUTIONS e When ligating the vein avoid too tight a stricture A tight stricture might damage the silicone rubber insulation or sever the vein Avoid dislodging the electrode tip during the anchoring procedure Do not remove or cut the suture sleeves from the lead as it may cause lead damage IMPLANTATION 27 Abdominal Implants Models 0139 and 0159 only Allow slack on the lead for strain relief on the lateral side of the suture sleeve near the venous entry site when securing the leads to body tissue Figure 16 This will prevent lead dislodgment caused by the weight of the pulse generator or upper extremity movement Note When implanting the lead via a subclavian puncture allow slack in the lead between the distal suture sleeve and the Figure 16 Position and venous entry site
21. art for ENDOTAK RELIANCE leads that the proximal coil electrode ENDOTAK RELIANCE lead models only is situated in the superior vena cava and high right atrium Correct functioning of the lead depends on appropriate placement of the electrodes IMPLANTATION 17 Notes When the lead is used with an AICD with ya pacing capability position the distal tip in healthy myocardium in the apex of the heart WARNINGS Distal coil electrode e Use fluoroscopy to verify that the lead tip is directed toward Figure 11 Suggested electrode h h position within the heart for the apex when ENDOTAK RELIANCE S leads implanted Other positions may result in lead movement which could affect defibrillation efficacy e Take care to obtain appropriate electrode position Failure to do so may result in higher defibrillation thresholds or may render the lead unable to defibrillate a patient whose tachyarrhythmia s might otherwise be convertible by an AICD system e In order to deliver defibrillation therapy the single coil ENDOTAK RELIANCE S lead must be implanted with a separate defibrillation electrode Guidant recommends using the ENDOTAK RELIANCE S lead with a pectorally implanted device that uses the metallic housing as a defibrillation electrode CAUTION For patients with bipolar cardiac pacemakers the lead pace sense electrode the tip electrode and distal coil electrode should be placed as far as possible from
22. d its interelectrode spacing must be no greater than 1 2 cm because greater separation may cause the signal from the leads to exceed the refractory period of the AICD pulse generator resulting in oversens ing in normal rhythm or undersensing in polymorphic rhythm In addition a wide pace sense electrode separation may contribute to oversensing by introducing a large repolar ization signal T wave thereby causing false fulfillment of the rate criteria Reliable conversion of VF should be demonstrated at an energy level less than the maximum energy setting of the pulse generator Guidant recommends that multiple induction conversion tests of VF be performed to determine conversion reliability and the patient s defibrillation threshold DFT Itis a matter of clinical judgment as to what constitutes a demonstration of reliable conversion Since the result of any single test is subject to statistical variation a one time conversion of a rhythm disturbance at a particular energy level 24 IMPLANTATION does not necessarily predict future conversion energy levels Refer to the applicable AICD physician s manual for conversion testing guidelines Weigh the probability of reliable conversion in the ambulatory state against the availability of AICD energy settings and the patient s ability to tolerate multiple arrhythmia inductions If a patient s arrhythmia s cannot be reliably converted with an ENDOTAK RELIANCE or ENDOTAK RELIANCE
23. defibrillators JACC 1990 16 666 673 SPECIFICATIONS Nominal 31 SPECIFICATIONS Nominal Expected number of rotations to fully extend retract the helixa 0137 0138 8 turns 0139 10 turns ENDOTAK ENDOTAK RELIANCE S RELIANCE 0137 59 cm 0157 59 cm Models and Length 0138 64 cm 0158 64 cm 0139 90 cm 0159 90 cm 0157 0158 8 turns 0159 10 turns Maximum number of rotations allowed to extend retract the helix 0137 0138 20 turns 0139 25 turns 0157 0158 20 turns 0159 25 turns Terminal sizes 1 IS 1 bipolar 1 IS 1 bipolar 1 DF 1 2 DF 1 Recommended lead 9 Fr 9 Fr introducer size Tip to proximal coil electrode length NA teem Diameter Isodiametric lead 27mm 27mm body Coil electrode 2 7mm 2 7 mm Fixation Helix 1 3 mm 1 3 mm Active surface area Distal coil electrode 450 mm2 450 mm2 Proximal electrode NA 660 mm2 Active tip electrode 5 7 mm2 5 7 mm2 Material External insulation DF 1 terminal pin IS 1 terminal pin Pace sense conductor Shocking conductor Tip electrode helix Silicone rubber Titanium Stainless steel MPS35N nickel cobalt alloy PTFE coated Drawn brazed strand cable PTFE coated Platinum iridium Compatibility Guidant AICD pulse generators ENDOTAK SQ Array leads and AICD Y connector Steroid Approximately 1 0 mg dexamethasone acetate a Use fluoroscopy markers for verification of full extension retraction o
24. e chronic state 2 the maximum sensitivity and 3 the minimum cardiac rate acceptable for the patient Also consider using pacemaker leads with close interelectrode spacing eg 1 2 cm Taking Baseline Measurements Connect the terminal pins to a pacing system analyzer PSA and evaluate the placement by determining the following R wave amplitude Pacing threshold Pacing lead impedance IMPLANTATION 21 Note that the pulse generator measurements may not exactly correlate to the PSA measurements due to signal filtering Baseline measurements should fall within the recommended values listed in Table 7 Table 7 Recommended Lead Signal Parametersa Signal Amplitude Duration Pacing Type a b c abe Threshold mPedance Pacing 300 Sensing gt 5 mV lt 100 ms lt 1 5 V 1200 Q Gg simv lt 150ms NA 20 80 Q a Measured approximately 10 minutes after placement b This measurement is not inclusive of current injury c In normal sinus rhythm d Pulse width setting at 0 5 ms Lower intrinsic potentials longer durations and higher pacing thresholds may indicate lead placement in ischemic or scarred tissue Because signal quality may deteriorate reposition the lead if necessary to obtain a signal with the largest possible amplitude shortest duration and lowest pacing threshold CAUTION R wave amplitudes of less than the recom mended value can cause inaccurate rate counting in the c
25. erve these implant precautions in order to avoid clavicle first rib damage to the lead It has been established in the literature that lead fracture can be caused by lead entrapment in such soft tissue structures as the subclavius muscle costocoracoid ligament or the costoclavicular ligament Leads placed by percutaneous subclavian venipuncture should enter the subclavian vein where it passes over the first rib rather than more medially to avoid entrapment by the subclavius muscle or ligamentous structures associated with the narrow costoclavicular region 4 Guidant recommends introducing the lead into the subclavian vein near the lateral border of the first rib The syringe should be positioned directly above and parallel to the axillary vein to reduce the chance that the needle will contact the axillary or subclavian arteries or the brachial IMPLANTATION 15 plexus Use of fluoroscopy is helpful in locating the first rib and in guiding the needle The steps below explain how to identify the skin entry point and define the course of the needle toward the subclavian vein where it crosses the first rib 1 Referring to Figure 8 identify points St sternal angle and Cp coracoid process 2 Visually draw a line between St and Cp and divide the segment into thirds The needle should pierce the skin at the junction of the middle and lateral thirds directly above the axillary vein point Ax 3 Place an index finger on the clavic
26. f helix b Implants using the retained guide wire technique may require a 10 5 Fr introducer LUA DNN O T DTT GUIDANT Guidant Corporation 24 Hour Consultation Cardiac Rhythm Management 1 800 CARDIAC 227 3422 4100 Hamline Avenue North Worldwide 651 582 4000 St Paul MN 55112 5798 USA www guidant com 2002 Guidant Corporation All rights reserved 355458 002 A 3 02
27. hronic state possibly resulting in failure to sense a tach yarrhythmia or misdiagnosis of a normal rhythm as abnor mal Signal durations that exceed the programmed refractory period of the AICD pulse generator can cause inaccurate cardiac rate determination or inappropriate high voltage shock delivery or both If the measurements do not conform to these values reinsert the stylet and reposition the lead using the procedures previously discussed Verify that measurements fall within the recommended values If testing results are unsatisfactory further lead system repositioning or replacement may be required Electrical Performance Make the lead connections and evaluate the lead signals using either the pulse generator or a Guidant ECD WARNING When connecting the lead to ECD cables and or the AICD pulse generator it is very important that proper connections are made Damage to the heart could 22 IMPLANTATION result if a high voltage defibrillating pulse were to be delivered through the pace sense tip electrode Note Prior to connecting the cardioversion defibrillation leads to the ECD ensure the ECD s output circuitry is dis abled and any electrocautery equipment is turned off and unplugged Consult the ECD user s manual for directions con cerning connecting the ECD cables to the ECD and the ECD to a chart recorder Evaluating with the Pulse Generator Connect the terminal pins to the pulse generator and place the
28. is neces sary to avoid inadvertent tissue trauma Counterclock wise lead rotation helps to prevent accidental fixation and releases the electrode helix if tissue snagging has occurred Checking for Lead Stability After fixation partially withdraw the stylet 8 to 10 cm Check the stability of the lead using fluoroscopy If possible have the patient cough or take several deep breaths When electrode position is satisfactory completely withdraw the stylet CAUTION Should dislodgment occur immediate medical care is required to resolve the electrode position and min imize endocardial trauma Repositioning the Lead If the lead needs repositioning verify the stylet is fully inserted in the lead reconnect the fixation tool and rotate the tool counterclockwise to retract the helix Use fluoroscopy to verify that the helix is retracted and disengaged completely from the heart wall before attempting to reposition the lead Reaffix the electrode using the procedures previously discussed in the Positioning the Lead Lead Fixation and Checking for Lead Stability sections Do not rotate the fixation tool more than the maximum number of turns indicated in the Specifications Page 31 Continuing to rotate the terminal pin once the helix is fully extended or retracted as indicated by fluoroscopy can damage the lead 20 IMPLANTATION Evaluating Lead Position Verify electrical performance of the lead before attaching the lead to the pu
29. le at the junction of the medial and middle thirds point V beneath which point the subclavian vein should be located Costoclavicular lig Figure 8 Landmarks identify the entry point for a percutaneous subclavian venipuncture 4 Press a thumb against the index finger and project one or two centimeters below the clavicle to shield the sub clavius muscle from the needle when hypertrophy of the pectoralis muscle is apparent the thumb should project about two centimeters below the clavicle because the subclavius muscle should be hypertrophied as well Fig ure 9 5 Feel with the thumb the pressure from the passage of the needle through the superficial fascia direct the needle deep into the tissues toward the subclavian vein and the underlying first rib Fluoroscopic guidance will reduce the chance that the needle would pass below the first rib and into the lung 16 IMPLANTATION Figure 9 Location of thumb and needle entry Positioning the Lead Under fluoroscopy and with the helix retracted and a stylet in the lead advance the lead as far as possible so the tip electrode is in the apex of the right ventricle Figure 10 and Figure 11 Also verify under fluoroscopy that the distal coil electrode is situated in the right ventricle below the tricuspid valve and Proximal coil electrode Distal coil electrode Figure 10 Suggested electrode position within the he
30. lse generator or a Guidant ECD and after allowing sufficient time for the effect of local tissue trauma to subside The use of radiography or fluoroscopy during the operation may help ensure lead position and integrity If testing results are unsatisfactory lead system repositioning or replacement may be required Minimizing Pacemaker Interaction To minimize potential interaction between a permanent pacemaker and an AICD pulse generator consider the following S 6 After implanting the pacing leads examine the signals from the pace sense electrodes to ensure that minimal pacemaker artifacts are present Use a recording system that has a bandwidth of at least 2000 Hz to ensure that minimal pacemaker artifacts are present All of the patient s ventricular tachyarrhythmias and ventricular fibrillation should be induced while the AICD pulse generator is activated and the pacemaker is programmed to an asynchronous mode at maximum output This should provide the greatest opportunity for inhibition of arrhythmia detection due to pacemaker artifacts The pacing leads may have to be repositioned to eliminate artifacts e Since it is difficult to predict the relative magnitudes of pacemaker artifacts and various tachyarrhythmia electrograms that may occur chronically or during EP testing it is important to reduce artifacts to the minimum e Consider programming the pacemaker to 1 the lowest amplitude allowable for safe capture in th
31. n Pick The vein pick is a sterile disposable nontoxic nonpyrogenic plastic device designed to assist the physician during entry of the lead s electrode tip into the vein To use the vein pick during a cutdown procedure isolate and open the selected vein using an appropriate scalpel or scissors Introduce the point of the vein pick via this incision into the lumen of the vein Figure 5 Using the vein pick Figure 5 With the point of the vein pick facing in the direction of the desired lead passage gently raise and tilt the pick Pass the lead under the vein pick and into the vein CAUTION The vein pick is not intended either for puncturing the vein or for dissecting tissue during a cutdown proce dure Be sure that the vein pick does not puncture the sil icone rubber insulation of the lead This could prevent proper lead function Lead Caps The silicone rubber lead LL Li 2 p caps should be used to IS 1 DF 1 protect the lead terminals Figure 6 Use IS 1 lead caps on during the procedure Lead 1IS 1 terminals and DF 1 lead caps may also be used to caps on DF 1 terminals isolate or cap any lead terminal not inserted into the AICD pulse generator or AICD Y connector if used Placing a suture in the lead cap groove will secure the lead cap to the lead terminal 12 IMPLANTATION Handling the Lead Observe the following when handling the lead WARN
32. ntricular Lead Pacing Impedance by Follow up Period ENDOTAK RELIANCE lead Models 0157 0158 0159 Follow up Number of Patients Mean Q Standard Deviation Pre discharge 30 568 98 2 1 month 29 530 66 2 Table 5 R wave Sensing Amplitudes by Follow up Period ENDOTAK RELIANCE lead Models 0157 0158 0159 Follow up Number of Patients Mean mV Standard Deviation Pre discharge 30 14 3 5 9 1 month 29 16 2 6 4 Warranty See the enclosed Lead Information card for warranty information For additional copies please contact Guidant Corporation at the address on the back cover 6 LEAD FEATURES Refer to the Contraindications Warnings Precautions and Adverse Events sections of this manual for information concerning the performance of this device LEAD FEATURES Features of the ENDOTAK RELIANCE and ENDOTAK RELIANCE S active fixation lead include the following components Steroid Distal Tip The tip electrode contains a nominal dose of 1 0 mg dexamethasone acetate within a silicone collar Upon exposure to body fluids the steroid elutes from the external collar Steroid suppresses the inflammatory response believed to cause threshold rises typically associated with implanted pacing electrodes Lower thresholds are desirable because they can increase pacing safety margins and reduce pacing energy requirements potentially increasing pulse generator longevity Extendable
33. ockwise to retract the helix into the distal lead tip prior to insertion into the vein 14 IMPLANTATION Any curves introduced into the stylet could increase the number of turns needed to extend or retract the helix Inserting the Lead The lead may be inserted using one of the following methods Via cutdown through the left or right cephalic vein Only one incision below the clavicle is required to insert the lead through the cephalic vein The endocardial lead is inserted into the right or left cephalic vein in the del topectoral groove The vein pick packaged with this lead can be used during a cutdown procedure to aid insertion of the lead into the vein Before inserting the lead refer to the Accessories section for instructions on using the vein pick Percutaneously or via cutdown through the subclavian vein or internal jugular vein typically the left subclavian or right internal jugular vein A 9F subclavian introducer set is available from Guidant for use during percutaneous lead insertion CAUTION When attempting to implant the lead via a subcla vian puncture do not insert the lead under the medial one third region of the clavicle Damage to the lead is possible if the lead is implanted in this manner If implan tation via the subclavian vein is desired the lead must enter the subclavian vein near the lateral border of the first rib and must avoid penetrating the subclavius mus cle It is important to obs
34. oning of the lead may be difficult because of body fluid or fibrotic tissue intrusion into the helix mechanism Explantation Return all explanted leads to Guidant Examination of explanted leads may provide information for continued improvement in system reliability Use a Guidant Returned Product Kit to properly package the lead and complete an Observation Complication Out of Service Report form Send the form and kit to Guidant at the address on the back of this manual Note Disposal of explanted devices is subject to local state and federal regulations Contact your Guidant representative or call Guidant at 1 800 CARDIAC for a Returned Product Kit 30 REFERENCES REFERENCES 1 DF 1 refers to the international standard ISO 11318 1993 IS 1 refers to the international standard ISO 5841 3 1992 Magney JE et al Anatomical mechanisms explaining damage to pacemaker leads defibrillator leads and fail ure of central venous catheters adjacent to the sterno clavicular joint PACE 1993 16 445 457 Magney JE et al A new approach to percutaneous sub clavian venipuncture to avoid lead fracture or central venous catheter occlusion PACE 1993 16 2133 2141 Epstein AE et al Combined automatic implantable car dioverter defibrillator and pacemaker systems implanta tion techniques and follow up JACC 1989 13 121 131 Calkins H et al Clinical interactions between pacemak ers and automatic implantable cardioverter
35. onnections A discontinuous or abnormal signal may indicate dislodgment a loose connection or lead damage If necessary reposition the lead electrodes until acceptable values are obtained To reposition the lead carefully withdraw the tunneled portion back to the venous entry site Release the permanent ligatures and reposition the lead using procedures previously discussed Connection to a Pulse Generator Consult the AICD physician s manual for directions concerning connecting the lead terminals to the pulse generator Verify the stylet is removed prior to connecting the lead to the pulse generator CAUTION Insert the IS 1 lead terminal straight into the lead port Do not bend the lead near the lead header interface Improper insertion can cause insulation damage near the terminal ring that could result in lead damage Notes If necessary lubricate the lead terminal sparingly with ster ile water to make insertion easier If the lead terminal pin will not be connected to an AICD pulse generator at the time of lead implantation the lead connector must be capped before closing the pocket inci sion Place a suture around the lead cap to keep it in place Plug any unused DF 1 lead port on the pulse generator with the DF 1 port plug ENDOTAK RELIANCE S lead only The pace sense terminal is inserted into the AICD lead port identified as the pacing sensing port The defibrillation terminals are inserted into the AIC
36. r Use The ENDOTAK RELIANCE lead Models 0157 0158 0159 and the ENDOTAK RELIANCE S lead Models 0137 0138 0139 provide pacing and rate sensing and deliver cardioversion and defibrillation shocks for AICD automatic implantable cardioverter defibrillator systems Contraindications Use of the ENDOTAK RELIANCE and ENDOTAK RELIANCE S active fixation lead is contraindicated for the following patients Patients who have a unipolar pacemaker Patients with a hypersensitivity to a nominal single dose of 1 0 mg dexamethasone acetate Patients with tricuspid valvular disease Patients with mechanical tricuspid heart valves Warnings In the following list of warnings page numbers are indicated for those warnings that are specific to other areas of the manual Refer to the indicated pages for information relevant to the warning 2 DEVICE DESCRIPTION AICD Lead Compatibility Do not attempt to use the ENDOTAK lead system with any device other than a commercially available implantable defibrillator system with which it has been tested and demonstrated to be safe and effective The potential adverse consequences of using a combination that has not been tested and demonstrated to be safe and effective may include but are not limited to undersensing cardiac activity and failure to deliver necessary therapy Implantation The safety and efficacy of the tip electrode placement above midseptum has not been clinically
37. r distal electrode fixation Using suture sleeves optimizes lead longevity and reduces the possibility of structural damage caused by suturing directly over the lead body To move a suture sleeve gently twist and pull it over the lead until it is in the desired position CAUTION Do not suture directly over the lead body as this may cause structural damage Use the suture sleeves to secure the lead lateral to the venous entry site The following items are packaged with the lead and are also available from Guidant as accessory items Fixation Tool The fixation tool can be attached to the terminal pin and rotated clockwise or counterclockwise for extending or retracting the helix Figure 3 Stylets Firm and soft positioning stylets are packaged with each lead A stylet inserted in the lead aids in positioning the lead tip in the heart The stylet length is imprinted on the color coded cap of the knob Table 6 Also refer to Inserting the Stylet Page 12 for more information Table 6 Stylets Figure 3 The fixation tool Stylet Length cm Knob Color Cap Color 59 Green Soft Yellow Straight 64 or Green 90 White Firm Orange LEAD EVALUATION 11 Stylet Guide A stylet guide is packaged with the lead and is intended to ease insertion of a stylet into the pace sense terminal of the lead Figure 4 a j Figure 4 Using the stylet guide Vei
38. re synchronized external cardioverter defibrillators capable of delivering high energy pulses up to 40 J to the patient If using an ECD be thoroughly familiar with ECD operation prior to connecting the lead to the IMPLANTATION 23 ECD Never use the ECD without a standard external defibrillator immediately available as a backup Remove the stylet from the lead before connecting the lead to the ECD bipolar cable A stylet left in the lead could 1 cause false electrical readings 2 cause lead perforation or 3 prevent use of a new stylet should relocation of the lead be necessary Conversion Testing After obtaining acceptable signals use the AICD pulse generator or ECD to demonstrate ability to reliably convert ventricular fibrillation VF and when appropriate to the patient ventricular tachycardias The ECD can substitute for an AICD pulse generator during conversion testing This testing involves inducing arrhythmias and shocking the patient with high voltage pulses delivered from the AICD pulse generator or ECD through the defibrillation electrodes of the lead to the heart CAUTION Following an unsuccessful high energy shock miscounting of cardiac rate delayed detection or nonde tection due to low amplitude VF signals it may be neces sary to reposition the lead or use a separate rate counting electrode system If a separate pace sense electrode system such as Guidant Model 4055 Sweet Picotip Rx is use
39. tion and a uniform body diameter The terminal yoke suture sleeves and terminal moldings are fabricated from molded silicone rubber The entire lead body fits through a 9Fr lead introducer when not retaining a guide wire A color coded mark on the terminal end of the lead allows for a quick visual reference of the lead length The lead color matches the same length stylet cap color Lubricious Coating The ENDOTAK RELIANCE lead family is the first to introduce a proprietary coating that makes the silicone lead surface more lubricious The lubricious coating reduces both the static and dynamic coefficients of friction making the lead surface feel and handle like polyurethane while providing the time tested reliability of silicone Terminals The ENDOTAK RELIANCE lead has three terminals two DF 1 shock and one bipolar IS 1 pace sense The ENDOTAK RELIANCE S lead has two terminals one DF 1 shock and one bipolar IS 1 pace sense The pace sense terminal is tubular and is fitted with a stylet guide to facilitate the insertion of a stylet The lead is intended for chronic implantation within the superior vena cava right atrium and right ventricle The extendable retractable helix design provides various lead placement possibilities for the tip electrode in the right ventricle Refer to Figure 10 and Figure 11 for suggested lead positioning When connected to the AICD pulse generator the implanted lead will perform the following f
40. unctions Provide rate sensing and shocking electrode electrograms Deliver cardioverting defibrillating electrical shocks from the pulse generator to the heart Provide pacing capabilities Nominal overall lengths of the active fixation leads are as follows ENDOTAK RELIANCE 0157 0158 0159 59cm 64 cm 90 cm ENDOTAK RELIANCE S 0137 0138 0139 59 cm 64 cm 90 cm 8 LEAD EVALUATION The nominal electrode spacing measured from the distal tip base to the distal end of the proximal coil electrode of the ENDOTAK RELIANCE lead is 18 cm Figure 1 18 cm aL HUDD DR Figure 1 Electrode spacing for the ENDOTAK RELIANCE lead is measured from the distal tip base to the distal end of the proximal coil electrode LEAD EVALUATION Implant Information Proper surgical procedures and techniques are the responsibility of the medical professional The described implant procedures are furnished only for informational purposes Each physician must apply the information in these instructions according to professional medical training and experience Use of the lead alone is the least invasive approach to AICD lead system implantation In some cases a lead from the ENDOTAK SQ Array family may be implanted in conjunction with the ENDOTAK RELIANCE and ENDOTAK RELIANCE S lead in an attempt to convert a patient s tachyarrhythmia s Refer to the ENDOTAK SQ Array physician s manual for alternative ENDOTA
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