Physician`s Manual
Contents
1. u u 16 Positioning the Lead u 18 Minimizing Pacemaker Interaction 19 Checking for Lead Stability 20 Evaluating Lead Position 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 in ain 24 Percutaneous Implant Technique 24 Venous Cut Down Technique 25 Tunneling the Lead to the Abdominal Pocket 26 Connection to a Pulse Generator 27 POST IMPLANT EVALUATION 28 Follow Up Testing 28 Explantatiori u u aise lie 28 REFERENCES u u n an nuan asua 29 SPECIFICATIONS Nominal aaa aasa 30 INFORMATION FOR USE 1 INFORMATION FOR USE Device Description The ENDOTAK RELIANCE lead Models 0147 0148 0149 and the ENDOTAK RELIANCE S lead Models 0127 0128 0129 are steroid eluting tined endocardial cardioversion defibrillation and pace sense2. Amplitude Duration Pacing Signal Type a b c a b c Threshold d impedance Pacing 450 Sensing gt 5 mV lt 100 ms lt 1 5V 1800 Q Defibrillation gt 1 mV lt 150 ms 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 chronic 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 positioning proce dures previously discussed Verify that measurements fall within the recommended values If testing results are unsatis factory further lead system repositioning or replacement may be required Electrical Performance M
3. 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 14 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 dis Figure 14 Position and tal suture sleeve and the venous shape of the strain relief entry site This will help minimize loop Models 0129 and flexing at the suture sleeve and 0149 only interaction with the clavicle first rib region 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 insu lation or sever the vein Avoid dislodging the elec trode tip during the stabilization procedure Do not remove or cut the suture sleeves from the lead as it may cause lead damage 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 IMPLANTATION 27 form a temporary pocket fo
4. Connect the pace sense lead terminal pin to the sterile bipolar cable Connect the defibrillation lead terminal pins 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 are synchronized external cardio verter defibrillators capable of delivering high energy pulses up to 40 J to the patient Be thoroughly familiar with ECD operation prior to connecting the lead to the ECD Never use the ECD without a standard external defibrillator immediately available as a backup e 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 IMPLANTATION 23 new stylet should relocation of the lead be neces sary Conversion Testing After obtaining acceptable signals us
5. GUIDANT Physician s Manual ENDOTAK RELIANCE Models 0147 0148 0149 ENDOTAK RELIANCE S Models 0127 0128 0129 Steroid Eluting Tined Endocardial Defibrillation Leads CARDIAC RHYTHM MANAGEMENT RESTRICTED DEVICE Federal law USA restricts the sale distribution or use of this device to by or on the lawful order of a physician A S AMNS v uo SONVITEY MVLOGNA pox 5 l Buds Buryeyjiuquep ewixdg poue euluuj9 po115 Bulyeyquep eWIXO1g JEUILWI9 po1199 9 su s 95eq pouleo peua poJ o l Bunelluqij p Ielsiq y luo GY 0 pue GZLO sjapon anaals anng puo5 s aposjoaje Buds Bureyuqyep Je sIp epoue apoujoaje Buds asuas eoed jewxold Z apoyyed aposjoaj9 su s 5ed Bunni pioj 91s e siq L l ONO 6VLO BVLO ZVLO SI PON speq 3ONVI Tati MVLOGNA 6z L0 8Z 10 22 10 SI pON spe 1 S 3ONVI Tad MVLOGNA CONTENTS INFORMATION FOR USE 1 Device Description 1 Indications uu uu uuu u us eaan aa eaaa aaia iaai 1 Contraindications a 1 Warnings 32 005 226s as dines canny See 1 AICD Lead Compatibility 2 mplanting a sic added cca TA 2 Electrical Performance 2 Conversio
6. 59 cm 64 cm 90 cm The electrode spacing measured from the distal tip to distal end of the proximal spring electrode of the ENDOTAK RELI ANCE lead is 18 cm Figure 2 LEAD EVALUATION 11 18 cm c C C C una Figure 2 Electrode spacing for the ENDOTAK RELIANCE lead is measured from the distal tip to the distal end of the proximal spring electrode LEAD EVALUATION Implant Information Proper surgical procedures and techniques are the responsi bility of the medical professional The described implant pro cedures are furnished for informational purposes only 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 or ENDOTAK RELIANCE S lead in an attempt to convert a patient s tachyarrhythmia s Refer to the ENDOTAK SQ physician s manuals for alternative ENDOTAK lead system configurations A major consideration in choosing the ENDOTAK RELIANCE lead family is that it does not require a thoracotomy The phy sician should weigh its advantages against the patient s ability to withstand additional electrophysiology EP testing arrhyth mia induction and conversion testing and a possible thorac otomy should the lead system prove in
7. Clinical Trial Given the similar design features including the porous tip electrode steroid elution and high pacing impedance the ENDOTAK ENDURANCE Rx clinical investigation was used to support the ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead The following is a summary of findings from the ENDOTAK ENDURANCE Rx Lead Clinical Investigation Clinical Investigation The study was a non randomized historical control study com paring the performance of the ENDOTAK ENDURANCE Rx lead to that of the ENDOTAK DSP lead The objectives of this investigation were to demonstrate higher pacing impedance and lower pacing threshold performance of the ENDOTAK ENDURANCE Rx lead compared to the historical control lead the ENDOTAK DSP Ninety eight patients were implanted with the ENDOTAK ENDURANCE Rx lead The mean implant duration of the study population was 4 9 months with a cumu lative implant duration of 478 6 months No statistical differ ences were found in the baseline variables between the study patient group and the historical control group with respect to demographic profiles except for age primary arrhythmia and antiarrhythmic drug therapy None of these factors are clini cally significant relative to meeting the study endpoints Addi tional demographic information is presented in Table 2 6 INFORMATION FOR USE Table 2 Description of the Study Population n 98 ENDOTAK ENDOTAK DSP Characteristic ENDURANCE
8. INFORMATION FOR USE ual Refer to the indicated pages for information relevant to the warning 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 dem onstrated 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 Implanting 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 conversion energy Although pliable the lead body is not designed to tolerate excessive flexing bending or tension This could cause structural weaknesses conductor discontinuity and or lead dislodgment Page 14 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 tach yarrhythmia s might otherwise be convertible by an AICD system Page 19 In order to deliver defibrillation therapy the single coil ENDOTAK RELIANCE S lead must be imp
9. Lead The lead may be inserted using one of the following methods e 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 see the Accessory Options 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 An 9 Fr 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 observe 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
10. 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 Ifnecessary lubricate the lead terminal sparingly with ster ile water to make insertion easier 28 POST IMPLANT EVALUATION 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 itin place The pace sense terminal is inserted into the AICD lead port identified as the ventricular pacing sensing port The defibril lating terminals are inserted into the AICD lead ports identi fied as defibrillating maintaining the polarity and electrode configuration determined during DFT testing Giving consideration to patient anatomy and pulse generator size and motion gently coil any excess lead and place adja cent to the pulse generator It is important to place the lead into the pocket in a manner that minimizes lead tension twist ing sharp angles and or pressure POST IMPLANT EVALUATION Follow Up Testing Perform follow up evaluation as recommended in the applica ble AICD pulse generator physician s manual CAUTION For some patients lead pe
11. 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 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 17 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 clavicle 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 v
12. 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 Mineral oil should never come in contact with a Guidant porous tipped lead electrode Mineral oil on the porous tip may inhibit tissue ingrowth and con duction Note Guidant suggests using sterile water if a lubricant is needed when coupling the lead with the VENTAK ECD cables AICD pulse generator or the AICD Y connector IMPLANTATION Inserting the Stylet Choose a stylet according 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 Gently curve the preferred stylet with any sterile smooth surfaced instrument eg 10 or 70 90 12 cc syringe barrel Figure 7 and carefully insert the stylet through the lumen of the con 6cm nector A sharp bend in the stylet can straighten as it Syringe passes through the lumen of the terminal pin A gentle curve is less likely to straighten CAUTION Do not bend the lead with a stylet in place Bend ing the lead could damage the conductor and insulation material Figure 7 Curve the Stylet 16 IMPLANTATION Note To optimize insertion into the lead do not allow body fluids to come in contact with the stylet Inserting the
13. 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 fam ily is the first to introduce a proprietary coating that makes the silicone lead surface more lubricious The 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 ter minals two DF 1 shock and one IS 1 bipolar pace sense The ENDOTAK RELIANCE S lead has one DF 1 shock terminal and one IS 1 terminal 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 supe rior vena cava right atrium and right ventricle When con nected to the AICD pulse generator the implanted lead will perform the following functions Provide rate sensing and shocking electrode electrograms Deliver cardioverting defibrillating electrical shocks from the pulse generator to the heart Provide pacing capabilities if available in the AICD pulse generator Nominal overall lengths of the leads are as follows ENDOTAK RELIANCE 0147 0148 0149 59 cm 64 cm 90 cm ENDOTAK RELIANCE S 0127 0128 0129
14. over the lead body as this may cause structural damage Use the suture sleeves to secure the lead lateral to the venous entry site Stylets Stylets of varying stiffness are packaged with each lead Stylets are also available as accessory items 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 5 Also refer to Inserting the Stylet Page 15 for more information Table 5 Stylets Stylet Length cm Knob Color Cap Color 59 Green Soft Yellow Straight 64 or Green 90 White Firm Orange 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 ee j Figure 4 Using the stylet guide 14 LEAD EVALUATION Vein 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 P cutdown procedure isolate and open the selected vein using an appropriate scalpel or scissors Introduce the point of the vein pick via this incision N a into the lumen of the vein Fig Figure 5 Using the vein pick ure 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 un
15. 4 1 1 a AE Adverse Event is de tions and observations ined as the total lead related complica b Complications are defined as adverse events requiring invasive mea sures to correct eg surgical intervention c Observations are defined as adverse events which are correctable by non invasive measures eg reprogramming Type 1 observations are related to the implanted device or a system component Potential Adverse Events Based on the literature and lead implant experience the pos sible physical effects from implantation of an ENDOTAK RELI ANCE or ENDOTAK RELIANCE S lead are listed below in alphabetical order Air embolism Allergic reaction Bleeding e Cardiac perforation Chronic nerve damage Displacement dislodgment Erosion extrusion Local tissue reaction Low amplitude VF signals Myocardial injury Lead fracture insulation break Lead tip deformation and or breakage Myocardial irritability Pneumothorax INFORMATION FOR USE 5 Fibrotic tissue formation Post shock rhythm disturbances Hematoma e Random component failures e Inappropriate therapy Shunting of current or insulation of myocardium during defibrillation with internal or external paddles Incomplete connection with e Transvenous lead related pulse generator thrombosis Infection Threshold elevation Keloid formation Venous occlusion Lead abrasion Venous perforation
16. DOTAK ENDUR ANCE Rx lead impedance is 67 above the nominal industry standard of 500 Q at 3 months Figure 1 shows a graphical comparison of ENDOTAK ENDURANCE Rx lead the control lead and the nominal industry standard in terms of lead impedance ENDOTAK ENDURANCE Control ENDOTAK DSP Industry Standard 1000 a _ 800 700 600 5002 er sto heel as aye eee Bose en eae Sr E Impedance Q 400 300 l l Implant 1 Month 3 Months Time Figure 1 ENDOTAK ENDURANCE Rx lead impedance by follow up period n 98 Pacing thresholds measured at implant predischarge 1 month and 3 month follow up visits were compared to the historical control to demonstrate lower pacing threshold performance Study results in Table 4 show that the ENDOTAK ENDUR ANCE Rx lead pacing threshold was 37 1 lower at implant and 42 9 lower at 3 months when compared to the control lead representing a statistically significant reduction in pacing thresholds throughout the chronic implant period Note The data in Table 4 was obtained using clinical leads that contained an average dose of 0 4 mg dexamethasone sodium phosphate which is less than the approximate dose of 1 0 mg used in the commercially available design R wave amplitudes were also measured at implant and were compared to the implant R wave amplitudes for the historical control to determine equivalency of sensing characteristics Result
17. LIANCE leads tricuspid valve and that the proximal spring elec trode ENDOTAK RELIANCE leads only is situated in the superior vena cava and high right atrium Correct function ing of the lead depends on appropriate placement of the electrodes IMPLANTATION 19 Note When the lead is ey used with an AICD pulse y re generator with pacing capa bility position the distal tip in healthy myocardium in the apex of the heart WARNINGS Distal spring electrode Take care to obtain appro priate electrode position Failure to do so may wee Ista Figure 11 Suggested electrode result in higher defibrilla position within the heart for tion thresholds or may ENDOTAK RELIANCE S leads render the lead unable to defibrillate a patient whose tachyarrhythmia s might other wise be convertible by an AICD system 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 AICD pulse generator that uses the metallic housing as a defibrillation electrode CAUTION For patients with bipolar cardiac pacemakers the lead pace sense electrode the porous tip and distal spring electrode should be placed as far as possible from the pacemaker electrodes to avoid cross sensing between the AICD pulse generator and the pacemaker Minimizing Pacemaker Intera
18. RELIANCE lead or approximately 20 to 25 cm on the ENDOTAK RELIANCE S lead Check the stability of the lead using fluoroscopy If possi ble have the patient cough or take several deep breaths When electrode position is satisfactory completely withdraw the stylet To provide temporary lead stabilization and hemostasis ligate the vein and lead proximally and the vein distally to the venous entry site Permanent lead stabilization and venous ligation will be performed following satisfactory electrogram evaluation and conversion testing Evaluating Lead Position Verify electrical performance of the lead before attaching the lead to the pulse generator or Guidant s ECD and after allow ing sufficient time for the effect of local tissue trauma to sub side The use of radiography or fluoroscopy during the operation may help ensure lead position and integrity If test ing results are unsatisfactory lead system repositioning or replacement may be required 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 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 6 IMPLANTATION 21 Table 6 Recommended Lead Signal Parametersa
19. Rx Lead Lead Population Population Number of Patients 98 78 Gender Male 78 60 Female 20 18 Age at Implant years Range 29 8 84 7 33 75 Mean Standard Deviation 66 11 4 60 9 9 7 Mean LVEF Standard Deviation 34 3 13 4 35 1 14 1 Primary Arrhythmia MVT 68 38 VF 17 27 PVT 8 5 Other 5 8 Primary Cardiac Disease Coronary artery disease 62 42 Cardiomyopathy 25 26 Other 11 10 Lead measurements were recorded at implant predischarge 1 month and 3 month follow up visits The results in Table 3 and Table 4 show a statistically significant difference in imped ance and threshold values when comparing the ENDOTAK ENDURANCE Rx lead and the control lead Table 3 Lead Pacing Impedance by Follow up Period n 98 ENDOTAK Statistical ENDOTAK DSP d ENDURANCE Rx Q Analysis Follow Change Mean t up SD N Mean SD N P Value Q test Implant 906 0 180 8 96 535 7 111 7 77 15 7 0 00012 69 1 Predis charge 815 5 1425 95 520 0 863 67 15 1 0 00014 56 8 1 month 830 1 118 7 88 604 2 111 5 58 11 5 0 00013 37 4 3 months 836 5 130 7 79 635 5 90 1 26 7 3 0 00014 31 6 a Extremely statistically significant p lt 0 001 INFORMATION FOR USE 7 The mean ENDOTAK ENDURANCE Rx lead impedance was 69 1 higher at implant and 31 6 higher at 3 months than the control lead Subsequently the mean EN
20. The decision to implant any AICD lead system in any configu ration 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 patient s DFT was used in the majority of patients If a 9 10 J safety margin cannot be obtained con sider 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 and after arrhythmia testing has been com pleted turn off the ECD and disconnect the ECD cables per instructions in the ECD user s manual Securing the Lead After the electrodes are satisfactorily positioned and conver sion 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 per manent hemostasis and lead stabilization Percutaneous Implant Technique 1 Peel back the introducer sheath and slide the suture sleeve deep into the tissue Figure 12 IMPLANTATION 25 2 Using both grooves ligate the suture sleeve to the lead 3 Next secure the sleeve and lead to the fa
21. ake 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 result if a high voltage defibrillating pulse were to be delivered through the rate sensing porous tip electrode Note Prior to connecting the cardioversion defibrillating leads to the ECD ensure the ECD s output circuitry is dis abled and any electrocautery equipment is turned off and 22 IMPLANTATION 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 AICD pulse generator into the AICD implant pocket as indicated in the AICD physician s manual Also refer to Con nection to a Pulse Generator Page 27 for more information Evaluate the lead signals by viewing the real time EGM The signal from the implanted lead should be continuous and with out 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 deliv ery of therapy Evaluating with the ECD
22. because they can increase pacing safety margins and reduce pacing energy requirements High Pacing Impedance The lead features a small active surface area of the distal tip electrode that is designed to increase pacing impedance The lead s high impedance performance and low pacing thresholds may combine to reduce pacing system energy requirements potentially increasing the pacing longevity of the pulse generator Spring Electrodes The distal spring electrode is intended to serve as an anode for rate sensing and pacing and as a cathode or anode for cardioversion defibrillation shocks The proximal spring electrode on the ENDOTAK RELI ANCE lead is intended to serve as an anode or cathode for cardioversion defibrillation shocks The ENDOTAK RELI ANCE S lead uses the implanted device s metallic housing as a defibrillation electrode Lead Body The isodiametric lead body contains one con ductor 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 insulated in separate lumens within the silicone rubber lead body A second layer of silicone coats the lead body providing additional insula tion and uniform body diameter Fixation tines a terminal 10 DEVICE FEATURES yoke suture sleeves and terminal moldings are fabricated from molded silicone rubber The entire lead body fits through a 9 Fr lead
23. ccessories 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 electri cally isolate the patient from potentially hazardous current leakage Guidant also recommends availability of sterile dupli cates of all implantable items in case of accidental damage or contamination LEAD EVALUATION 13 Accessory Options The following items are packaged with the lead and are also available from Guidant as accessory items Suture Sleeves Suture sleeves are an adjust C ID able tubular reinforcement posi Figure 3 The long tapered tioned over the outer lead end of the suture sleeve insulation Figure 3 They are faces toward the vein designed to secure and protect the lead at the venous entry site after 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
24. ce pacing sys tem energy requirements potentially improving pacing system longevity For specific pacing system longevity values refer to the applicable pulse generator physician s manual Warranty See the enclosed Lead Information card for warranty and guarantee information For additional copies please contact Guidant Corporation at the address on the back cover Refer to the Contraindications Warnings Precautions and Adverse Events sections of this manual for information con cerning the performance of this device DEVICE FEATURES 9 DEVICE FEATURES Detailed Device Description Features of the ENDOTAK RELIANCE or ENDOTAK RELI ANCE S lead include the following components Porous Tip Electrode The porous tip electrode serves as the cathode for intracardiac right ventricular electrogram rate sensing and pacing The lead uses a platinum iridium porous tip electrode design that increases the effective active area for sensing by allowing fibrotic tissue ingrowth and an increase in chronic lead tip stability while maintain ing a small surface area for pacing Steroid The tip electrode contains approximately 1 0 mg dexamethasone sodium phosphate contained in a silicone rubber binder Upon exposure to body fluids the steroid elutes from the electrode Steroid suppresses the inflam matory response believed to cause threshold rises typically associated with implanted pacing electrodes Lower thresh olds are desirable
25. ction To minimize potential interaction between a permanent pace maker and an AICD pulse generator consider the following gt 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 pace maker artifacts are present All of the patient s ventricular tachyarrhythmias and ventric ular 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 20 IMPLANTATION Since it is difficult to predict the relative magnitudes of pacemaker artifacts and various tachyarrhythmia electro grams 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 the 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 Checking for Lead Stability After positioning partially withdraw the stylet past the most proximal electrode on the ENDOTAK
26. der 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 might allow body fluids to seep into the lead and could prevent proper lead function Lead Caps The silicone rubber lead mimi D CIE caps should be used to pro IS 1 DF 1 tect the lead terminals dur Figure 6 Use IS 1 lead caps on ing the procedure Figure 6 IS 1 terminals and DF 1 lead Lead caps may also be used caps on DF 1 terminals to isolate or cap any lead ter minal 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 Handling the Lead Observe the following when handling the lead WARNING Although pliable the lead is not designed to toler ate excessive flexing bending or tension This could cause structural weaknesses conductor discontinuity and or lead dislodgment CAUTIONS Do not wipe or immerse the porous tipped elec trode in fluid Such treatment will reduce the IMPLANTATION 15 amount of steroid available when the lead is implanted Chronic repositioning may adversely affect the lead s low threshold performance because the steroid may be depleted Do not attempt to alter the
27. e the AICD pulse gener ator or ECD to demonstrate ability to reliably convert ventricu lar 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 defibrillating 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 use a separate rate counting electrode system If a separate pace sense electrode system such as Guidant Model 4055 Sweet Picotip Rx is used 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 oversensing 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 co
28. effective Various factors such as cardiomegaly or drug therapy may necessitate repositioning of the defibrillating leads or substitu tion 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 RELI ANCE lead family and AICD pulse generator as long as the pacemaker and AICD pulse generator do not interact causing AICD pulse generator nondetection or false detection Refer to Minimizing Pacemaker Interaction Page 19 for more information 12 LEAD EVALUATION The lead is not designed sold or intended for use except as indicated Included Items The following items are packaged with the ENDOTAK RELI ANCE or ENDOTAK RELIANCE S lead e Lead caps 2 DF 1 and 1 IS 1 Vein pick Stylet guide Soft stylets 0 014 in 0 36 mm diameter Firm stylets 0 016 in 0 41 mm diameter e Literature packet DF 1 port plugs ENDOTAK RELIANCE S lead only Opening Instructions The outer package and inner sterile tray may be opened by authorized personnel under clean conditions To ensure sterility the sealed inner ster ile 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 a
29. enipuncture 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 18 IMPLANTATION i Figure 9 Location of thumb and needle entry CAUTION When implanting the lead via a subclavian punc ture allow slack in the lead between the suture sleeve and the venous entry site This will help minimize flexing at the suture sleeve and interaction with the clavicle first rib region Positioning the Lead Under fluoroscopy and with the stylet in the lead advance the lead as far as possible to the apex of the proximal spring right ventricle where the electrode porous tip electrode should be firmly wedged i I into the trabeculae Figure spg 10 and Figure 11 Also verify under fluoroscopy that the distal spring elec L trode is situated in the Flaure 10 Suagested slectrode right ventricle below the ENDOTAK RE
30. ing 2 a electrode 450 mm 450 mm Proximal electrode NA 660 mm Active tip electrode 2 0 mm2 2 0 mm Material External insulation DF 1 terminal pin IS 1 terminal pin Pace Sense conductor Shocking conductor Tip electrode Steroid Silicone rubber Titanium Stainless steel MP35N nickel cobalt alloy PTFE coated Drawn brazed strand cable PTFE coated Platinum iridium Approximately 1 0 mg dexamethasone sodium phosphate introducer Implants using the retained guide wire technique may require a 10 5 Fr 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 2000 Guidant Corporation All rights reserved Printed USA 355456 002 A 10 00
31. lanted 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 19 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 porous tip electrode Page 21 INFORMATION FOR USE 3 Conversion Testing Use of any 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 General e The lead and its accessories are intended for one time use only Do not reuse lt has not been determined whether the warnings precau tions or complications usually associated with injectable dexamethasone sodium phosphate 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 cau tions specific to handling implanting and testi
32. leads The ENDOTAK RELI ANCE lead dual coil and the ENDOTAK RELIANCE S lead single coil are for use as an integral part of an AICD auto matic implantable cardioverter defibrillator system with DF 1 and IS 12 ports The lead features a small active surface area of the distal tip electrode that is designed to increase pacing impedance Instructions in this manual should be used in conjunction with other resource material including the applicable AICD device system manual and if used the applicable VENTAK External Cardioverter Defibrillator ECD user s manual the ENDOTAK SQ lead array family physician s manuals and the AICD Y Connector product data sheet Indications The ENDOTAK RELIANCE lead Models 0147 0148 0149 and the ENDOTAK RELIANCE S lead Models 0127 0128 0129 provide pacing and rate sensing and deliver cardiover sion and defibrillation shocks for AICD automatic implantable cardioverter defibrillator systems Contraindications Use ofthe ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead is contraindicated for the following patients Patients who have a unipolar pacemaker Patients with a hypersensitivity to a single dose of approxi mately 1 0 mg of dexamethasone sodium phosphate Patients with tricuspid valvular disease e 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 man 2
33. n Testing 3 Securing and Tunneling 3 Precau tions s u cc vicstiefisceeeeiedecesasshsdatasuasteuaivises istestes 3 General o Sau u maaa Sata qa qasapas eb 3 Adverse Event iinom onenen eea et 3 Observed Adverse Events 3 Potential Adverse Events ceecee 4 Clinical Trial smesan ies 5 Clinical Investigation 5 WarIra ty u u rera aapa aaaeeeaa naa a ia aao SaS aai 8 DEVICE FEATURES 9 Detailed Device Description 9 LEAD EVALUATION a 11 Implant Information 11 Included I ms aaaea aiaa aaan 12 Opening Instructions 12 Sterilization u L u nasua i 12 Surgical Preparation 12 Accessory Option Sirenin a eaaa 13 Suture Sleeves a u 13 Stylets iii sis i hited 13 Stylet GUIE senri R o 13 Veim Picku E E E 14 Lead Caps a su a amu iia qusa shuyu 14 Handling the Lead 14 IMPLANTATION a 15 Inserting the Stylet 15 Inserting the Lead
34. ng 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 Given the similar design features including the porous tip electrode steroid elution and high pacing impedance the ENDOTAK ENDURANCE Rx clinical investigation was used to support the ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead The following are the adverse events reported in that investigational study A total of two complications and six observations related to the implanted device or system components were reported during the clinical investigation of the ENDOTAK ENDUR ANCE Rx lead One hundred and one patients were enrolled in the investigation and ninety eight were implanted with 478 6 cumulative implant months Observed Adverse Events Table 1 reports lead or system related complications and observations for the ENDOTAK ENDURANCE Rx lead 4 INFORMATION FOR USE Table 1 ENDOTAK ENDURANCE Rx lead Study Complications and Observations of of of of pts pts leads AEsa n 98 95 CI n 98 Complications P 2 2 0 2 2 all types 0 0 4 8 1 0 Hematoma 1 0 0 3 0 1 1 1 0 Noncapture connector 1 0 0 3 0 1 1 Observations 6 6 0 6 6 Type I 1 3 10 7 Oversensing 2 0 2 0 0 4 8 2 2 Pen 2 0 Threshold difficulty 2 0 0 4 8 2 2 1 0 Tel t elemetry 1 0 0 3 0 1 1 Inappropriate therapy 1 io 5
35. nversion reliability and the patient s defibrillation threshold DFT It is a matter of clinical judgment as to what constitutes a demon stration 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 does not nec essarily 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 24 IMPLANTATION If a patient s arrhythmia s cannot be reliably converted with an ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead supplementary implantation of an ENDOTAK SQ lead array or an alternate lead system will require additional conversion testing Refer to the ENDOTAK SQ lead physician s manuals for instructions concerning auxiliary use of these leads with the ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead CAUTION An ENDOTAK lead system 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 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
36. onal standard ISO 11318 1993 2 1IS 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 4 Magney JE et al Anew approach to percutaneous sub clavian venipuncture to avoid lead fracture or central venous catheter occlusion PACE 1993 16 2133 2142 5 Epstein AE et al Combined automatic implantable car dioverter defibrillator and pacemaker systems implanta tion techniques and follow up JACC 1989 13 121 131 6 Calkins H et al Clinical interactions between pacemak ers and automatic implantable cardioverter defibrillators JACC 1990 16 666 673 30 SPECIFICATIONS Nominal SPECIFICATIONS Nominal ENDOTAK ENDOTAK RELIANCE S RELIANCE Models 0127 0128 0129 0147 0148 0149 0127 59 cm 0147 59 cm yellow yellow Length 0128 64 cm green 0148 64 cm green 0129 90 cm 0149 90 cm orange orange F A 1 IS 1 bipolar 1 IS 1 bipolar Terminal sizes 1 DF 1 2 DF 1 Guidant AICD pulse generators Compatibility ENDOTAK SQ array leads and AICD Y connector Recommended lead 9 Fr 9 Fr introducer size Tip to proximal spring NA 18 cm electrode length Diameter Isodiametric lead Fm 27mm body Coil electrode 2 7 mm 2 7 mm Porous tip base 2 0 mm 2 0 mm Active surface area Distal spr
37. r the coiled lead Capping the ter minal pin protects it and prevents body fluids from entering the lumen of the lead which may cause lead malfunction Note When using a Guidant lead tunneler do not cap the leads CAUTIONS e Tunnel the lead from the chest area to the pulse gen erator implant site Never tunnel the lead from the pulse generator implant site to the chest area This could damage the electrodes and or lead body by permanently stretching the lead e When tunneling the lead take precautions not to place excessive tension on the lead This can cause structural weaknesses and or conductor discontinuity After tunneling reevaluate the lead to verify that no significant change in lead 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 connections A discontinuous or abnormal signal may indicate dislodgment a loose connection or lead dam age If necessary reposition the lead electrodes until accept able 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
38. rformance 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 pro grammed accordingly placing and holding a magnet over an active implanted pulse generator elicits tones synchronous 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 sys tem manual for specific instructions 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 REFERENCES 29 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 REFERENCES 1 DF 1 refers to the internati
39. s demonstrate that the ENDOTAK ENDURANCE Rx lead s R wave amplitudes are equivalent to those for the ENDOTAK DSP lead 8 INFORMATION FOR USE Table 4 Mean Pacing Threshold V at 5 0 ms by Follow Up Period n 98 ENDOTAK Statistical Follow ENDURANCE Rx FNDOTAK DSP Analysis up Change Mean sp N Mean SD N t test P value Volts Implant 0 66 0 60 95 1 05 0 81 77 3 63 0 0004 37 1 Predis charge 0 63 0 29 95 1 27 1 08 67 5 51 0 00014 50 4 1 monii 0 76 0 48 88 1 52 0 93 58 6 48 0 00012 50 0 3 ine 0 88 0 74 79 1 54 0 77 25 3 85 0 00028 42 9 a Extremely statistically significant p lt 0 001 There was no statistical difference in the number of patient deaths between the ENDOTAK ENDURANCE Rx lead and the control lead There were two complications in the ENDOTAK ENDURANCE Rx lead study with one due to a header con nector issue that was resolved by tightening the set screws and the second due to a hematoma One complication was documented in the historical control group during a three month duration that was due to infection An actuarial analysis on the complications demonstrates no significant difference between the ENDOTAK ENDURANCE Rx lead and the Con trol lead with the p value 0 69 ENDOTAK ENDURANCE Rx lead s higher impedance values and low pacing thresholds may combine to redu
40. scia First pass Second pass Secure sleeve to lead Secure sleeve and lead to fascia Use both grooves Figure 12 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 13 Distal Groove First pass secure vein to lead Second pass secure vein and lead to fascia Proximal Groove First pass secure sleeve to lead Second pass secure sleeve and lead to fascia Figure 13 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 26 IMPLANTATION 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 Note If venous entry is made using a Guidant lead intro ducer ligate the lead to the adjacent fascia using the suture sleeve to prevent lead movement Models 0129 and 0149 Only Abdominal implants
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