Transvenous Defibrillation Leads: Is There an Ideal Position of the Defibrillation Anode?

A potential benefit of two-lead transvenous defibrillation systems is the ability to independently position the defibrillation electrodes, changing the vector field and possibly decreasing the DFT, Using the new two-lead transvenous TVL lead system, we studied whether DFT is influenced by SVC lead position and whether there is an optimal position. TVL leads and Cadence pulse generators were implanted in 24 patients. No intraoperative or perioperative complications were observed. In each patient, the DFTs were determined for three SVC electrode positions, which were tested in random order: the brachiocephalic vein, the mid-RA, and the RA-SVC junction. The mean DFTs in the three positions were not statistically different, nor was any single lead position consistently associated with lower DFTs. However, an optimal electrode position was identified in 83% of patients, and the DFT from the best lead position for each patient was significantly lower than for any one of the electrode positions (P < 0.01). The mean safety margin for the best SVC lead position was approximately 27 J. These results demonstrate the advantage of a two-lead system, as well as the importance of testing multiple SVC lead positions when the patient's condition permits. Both of these factors can decrease the DFT and maximize the defibrillation safety margin. This will become increasingly important as pulse generator capacitors become smaller (as part of the effort to decrease generator size) and the energy output of the generators consequently decreases.     

Initial Experience with Transvenous Implantable Cardioverter Defibrillator Lead Systems: Operative Morbidity and Mortality

Introduction of non-thoracotomy lead systems™ (Medtronic, Inc.) for the implantable cardioverter defibrillator (ICD) has expanded the indications for use of this mode of therapy. Patients previously considered "too ill" to undergo a thoracotomy as well as patients who are at a high risk for developing sudden death but without previous cardiac arrest, are now considered candidates. The initial experience with the non-thoracotomy lead system at our institution was analyzed for morbidity and mortality. Thirty-four patients underwent attempted intravascular lead implantation, with 30 having initial successful implantation (88.2%). There were 23 males; average ejection fraction (EF) was 38.6%. Three patients developed pulmonary edema and low output immediately after the procedure. Three patients developed electromechanical dissociation during defibrillation threshold testing. A prolonged testing time for the non-thoracotomy lead system was noted when compared to the thoracotomy system (57.39 vs 32.30 min; P < 0.0000). There were more intraoperative morbidities with the non-thoracotomy leads than with the thoracotomy system. There were no perioperative deaths. The potential consequences of prolonged anesthesia time and extensive defibrillation threshold testing should be considered when choosing the route of ICD implant, the type of anesthesia, and the intraoperative testing protocol for each patient.     

Comparison of a Unipolar Defibrillation System with a Dual Lead System Using an Enlarged Defibrillation Anode

The unipolar system for transvenous defibrillation, consisting of a single right ventricular lead as the cathode and the device shell as anode, has been shown to combine low de- fibrillation thresholds (DFTs) and simple implantation techniques. We compared the defibrillation efficacy of this system with the defibrillation efficacy of a dual lead system with a 12-cm long defibrillation anode placed in the left subclavian vein. The data of 38 consecutive patients were retrospectively analyzed. The implantation of an active can system was attempted in 20 patients (group 1), and of the dual lead system in 18 patients (group 2). Both groups had comparable demographic data, cardiac disease, ventricular function, or clinical arrhythmia. The criterion for successful implantation was a DFT of > 24 J. This criterion was met in all 18 patients of group 2, The active can system could not be inserted in 3 of the 20 group 1 patients because of a DFT > 24 J. In these patients, the implantation of one (n = 2) or two (n = 1) additional transvenous leads was necessary to achieve a DFT ≤ 24). The DFTs of the 17 successfully implanted group 1 patients were not significantly different from the 18 patients in group 2 (12.3 ± 5.7 f vs 10.8 ± 4.8 J). The defibrillation impedance was similar in both groups (50.1 ± 6.1 ± 48.9 ± 5.2 Ω). In group 1, both operation duration (66.8 ± 17 min vs 80.8 ± 11 min; P < 0.05) and fluoroscopy time (3.3 ± 2.1 min vs 5.7 ± 2.9 min; P < 0,05) were significantly shorter. Thus, the active can system allows reliable transvenous defibrillation and a marked reduction of operation duration and fluoroscopy time. The dual lead system, with an increased surface area defibrillation anode, seems to he a promising alternative for active can failures.     

Improved Sensing Signals After Endocardial Defibrillation with a Redesigned Integrated Sense Pace Defibrillation Lead

Adequate sensing is a basic requirement for appropriate therapy with ICDs. Integrated sense pace defibrillation leads, which facilitate ICD implantation, show a close proximity of sensing and defibrillation electrodes that might affect the sensing signal amplitude by the high currents of internal defibrillation. In 99 patients, we retrospectively examined two integrated sense pace defibrillation leads, eitherboth with a distance of 6 mm between the tip of the lead (sensing cathode) and the right ventricular defibrillation electrode (sensing anode) or one with a distance of 12 mm. Three seconds after a shock of 20 J, mean sensing signal amplitude during sinus rhythm (SR) decreased from 10.5 ± 4.3 mVto 5.1 ± 3.7 mV (P < 0.001) for the 6-mm lead, but showed no significant decrease for the 12-mm lead. The degree of signal reduction was inversely related to the time passed since defibrillation. Significant differences in reduction of sensing signal amplitude concerning monophasic and biphasic shocks could not be observed. Mean sensing signal amplitude of VF after shocks that failed to terminate it decreased in the same order as during SR (from 8.3 ± 4.1 mV to 4.1 ± 3.2 mV), but resulted in no failure of redetection during ongoing VF. DFTs did not differ for the 6-mm and the 12-mm lead. In conclusion, close proximity of the right ventricular defibrillation coil to the sensing tip of an integrated sense pace defibrillation lead causes energy and time related reductions in sensing signal amplitude after defibrillation, and might cause undersensing in the postshock period. A new lead design with a more proximal position of the right ventricular defibrillation coil avoids these problems without impairing DFTs.     

Effects of a Thin-Sized Lead Body of a Transvenous Single Coil Defibrillation Lead on ICD Implantation

SCHUCHERT, A., et al. : Effects of a Thin‐Sized Lead Body of a Transvenous Single Coil Defibrillation Lead on ICD Implantation. In the interest of patients receiving implantable cardioverter defibrillators (ICDs), the clinical benefits of newer and thinner transvenous defibrillation leads have to be determined. The aims of this study were to evaluate the ICD procedure duration and the frequency of lead dislocation at the 3‐month follow‐up of a new defibrillation lead with a thin‐sized lead body and its conventionalsized predecessor. The thin‐sized single coil defibrillation lead (Kainox RV, Biotronik; lead body 6.7 Fr) was implanted in 61 patients and the conventional‐sized defibrillation lead (SPS, Biotronik; lead body 7.8 Fr) in 60 patients. Both leads were connected to a left‐sided, prepectorally implanted Phylax ICD (Biotronik) with active housing. The lead implantation time and total procedure duration were determined. Lead implantation time was defined as the time from lead insertion to the end of the pacing measurements. The total procedure duration spanned skin incision to closure. The incidence of lead repositioning during the lead implantation time and during ventricular fibrillation conversion testing was also assessed. The frequency of lead dislocations was recorded at the 3‐month follow‐up. Mean lead implantation time and total procedure duration of the thin‐sized lead (23 ± 22 minutes 76 ± 37 minutes ) were not statistically different from the time needed for the conventional‐sized lead (22 ± 20 minutes 81 ± 34 minutes ). The number of lead repositionings during the lead implantation time was similar (thin‐sized lead: 1.4 ± 2.4 ; conventional‐sized lead: 1.1 ± 1.9 ). An additional lead repositioning was not necessary during ventricular fibrillation conversion testing in 93.4% of the patients with thin‐sized and in 94.4% with conventional‐sized leads (not significant). At the 3‐month follow‐up, there were four (6.6%) lead dislocations in the thin‐sized and four (6.7%) in the conventional‐sized lead group. In conclusion, the downsized lead body of the new defibrillation lead influenced neither ICD procedure duration nor the incidence of lead dislocation during follow‐up.     

Effect of Biphasic Waveform Pulse on Endocardial Defibrillation Efficacy in Humans

Several clinical studies have proved increased defibrillation efficacy for implantable cardioverter defibrillators with biphasic pulse waveforms compared to monophasic pulse waveforms. This difference in defibrillation efficacy depends on the type of defibrillation lead system used. The influence of biphasic defibrillation pulse waveforms on the defibrillation efficacy of purely endocardial defibrillation lead systems has not yet been sufficiently examined, we, therefore studied 30 consecutive patients with drug refractory ventricular tachyarrhythmias during the implantation of a cardioverter defibrillator. After implanting an endocardial "integrated" sensing/defibrillation lead we performed a prospective randomized comparison of the defibrillation efficacy of monophasic and biphasic defibrillation waveform pulses. For endocardial defibrillation with the biphasic waveform the mean defibrillation threshold was 12.5 ± 4.9 joules and for the monophasic waveform 22.2 ± 5.6 joules (P < 0.0001). There was a decrease in the required defibrillation energy of biphasic defibrillation in 29/30 patients. Thus considering purely endocardial defibrillation a statistically significant and clinically relevant increase in defibrillation efficacy can be demonstrated for biphasic defibrillation waveform pulses.     

Transseptal Defibrillation Is Superior for Transvenous Defibrillation

The conventional electrode configuration of current internal defibrillation systems most commonly use superior vena caval (SVC) or combined SVC and subcutaneous (SC) electrodes as anode, and right ventricular apex (HVA) electrode as cathode. We have demonstrated earlier that the septal mass is important for defibrillation. The purpose of the present study was to compare a transseptal to a conventional electrode arrangement in the canine model. Three endocardial electrodes, 5 French EnGuard™ were positioned in RVA, SVC, and the right ventricular outflow (RVO) in eight dogs. A 5 French SC electrode was positioned in the fifth left intercostal space. RVA-RVO^-/SC⁺ (configuration 2) was compared to SVC-SC⁺/RVA^-(configuration 1). Defibrillation threshold testing was performed using asymmetrical biphasic shock, 6 msec⁺/2 msec^-. Probit fit was used to compare the results at 40%, 50%, 60%, and 90% probabilities, and the logistic regression analysis to estimate the impact of variables. Electrode configuration had the strongest predictive value. Configuration 2 was superior to configuration 1 (P = 0.0016). At any voltage settings the probability of success for configuration 2 was greater, and current less (P < 0.00005). The energy requirements were reduced by approximately 33% for configuration 2. There were no significant differences in impedance between the two configurations. We conclude that transseptal defibrillation is more effective because of the improved lead geometry and voltage gradient.     

Ventricular and Atrial Defibrillation Using New Transvenous Tripolar and Bipolar Leads with 5 French Electrodes and 8 French Subcutaneous Catheters

This study evaluated the use of new small fransvenous atrial and ventricular leads for converting atrial fibrillation (AF) and ventricular fibrillation (VF) in 10 adult male mongrel dogs. Five dogs (group A) received a right atrial "J" (AJ) and right ventricular (RV) active fixation tripolar lead, each consisting of a platinized platinum pacing tip, anode band, and braided defibrillalion electrode. The remaining five dogs (group B) received one bipolar R V lead and one tripolar AJ lead. The RV leads were implanted in the right ventricular upex (RVA) and the AJ leads were placed in the atrial appendage. Additionally all dogs received two 8 French subcutaneous defibrillulion catheters in the fifth and seventh intercostal spaces. Twenty asymmetric biphasic shocks consisting of five randomized voltage levels were used to convert VF in groups A and B. The bipolar RV lead (group B) had a significantly higher probability of success in converting VF than the tripolar RV lend (group A). In group A defibrillation thresholds for converting AF were obtained using two electrode configurations. No significant difference was observed between the two electrode configurations used to convert AF. Pacing and sensing thresholds were satisfactory for bipolar and tripolar lead configuration.     

Defibrillation Efficacy of Different Electrode Placements in a Human Thorax Model

The objective of this study was to measure the defibrillation threshold (DFT) associated with different electrode placements using a three-dimensional anatomically realistic finite element model of the human thorax. Coil electrodes (Endotak DSP, model 125, Guidant/CPI) were placed in the RV apex along the lateral wall (RV), withdrawn 10 mm away from the RV apex along the lateral wall (RVprox), in the RV apex along the anterior septum (RVseptal), and in the SVC. An active pulse generator (can) was placed in the subcutaneous prepectoral space. Five electrode configurations were studied: RV → SVC, RV_prox→ SVC, RV_SEPTAL→SVC, RV →Can, and RV →SVC+Can. DFTs are defined as the energy required to produce a potential gradient of at least 5 V/cm in 95% of the ventricular myocardium. DFTs for RV → SVC, RV_PROX→ SVC, RV_septal→ SVC, RV → Can, and RV → SVC + Can were 10, 16, 7, 9, and 6 J, respectively. The DFTs measured at each configuration fell within one standard deviation of the mean DFTs reported in clinical studies using the Endotak leads. The relative changes in DFT among electrode configurations also compared favorably. This computer model allows measurements of DFT or other defibrillation parameters with several different electrode configurations saving time and cost of clinical studies.     

Safety of Pacemaker Implantation in Patients with Transvenous (Nonthoracotomy) Implantable Cardioverter Defibrillators

While several reports bave documented the safety of implantation of transvenous pacemakers in patients with epicardial patch-based impiantable cardioverter defibrillators (ICDs), the implantation of transvenous pacemakers in patients with transvenous (nonthoracotomy) ICDs has not been well-descrihed. We present three patients with transvenous ICDs who subsequently underwent implantation of transvenous pacemakers without complication. Technical considerations and a testing protocol for detection of pacemaker-ICD interactions are discussed.     

Influence of Malpositioned Transvenous Leads on Defibrillation Efficacy With and Without a Subcutaneous Array Electrode

Some patients cannot receive a transvenous lead system because of high defibrillation thresholds (DFTs). We hypothesized that a right ventricular (RV) catheter electrode not extending as far as possible into the RV apex could cause high DFTs, Recently, a subcutaneous array (SQA) electrode has been shown to lower DFTs substantially. We compared the influence of a malpositioned RV catheter electrode on defibrillation efficacy for endocardial lead systems with and without a SQA. In eight anesthetized pigs, defibrillation catheters were placed in the RV apex and near the junction of the superior vena cava (SVC) and right atrium. SQA, formed by three elements, each 20 cm in length, was placed in the left thorax. DFTs were determined for a biphasic waveform using an up/ down protocol with the RV catheter at the apex and with it repositioned 1-cm and 2-cm proximal to the apex. The mean DFT energies for the configurations with a SQA were less than those without a SQA for every catheter position. The placement of the RV catheter away from the apex caused an increase in defibrillation energy for the configurations without a SQA (apex: 17.1 ± 3.8 J [mean ± SD]; 1 cm: 20.1 ± 4.6 J; 2 cm: 27.6 ± 9.5 J; P ± 0.05), but not for the configurations with a SQA (apex: 12.2 ± 2.2 J; 1 cm: 12.3 ± 2.9 J; 2 cm: 12.1 ± 0.9 J: P= NS). These results suggest that a malpositioned RV catheter electrode, at the time of implantation or by late dislodgment, significantly elevates DFTs for a total endocardial system but not for a system that includes a SQA.     

Removal of Endocardial Defibrillation Leads

Two patients, each with an endocardial defibrillation lead system (Endotak O62), required lead removal; one because of chronic lead infection and the second because of spurious shocks caused by lead insulation damage. Neither lead could be removed by simple traction. The defective lead was removed by a combination of catheterization techniques including a steerable ablation catheter and traction, both under general anesthesia. The lead with the insulation defect was rapidly removed with a locking stylet, suggesting that endocardial lead defibrillating leads can be removed similarly to pacemaker leads, thus avoid thoracotomy.     

Effect of a Single Element Subcutaneous Array Electrode Added to a Transvenous Electrode Configuration on the Defibrillation Field and the Defibrillation Threshold

Even with the use of biphasic shocks, up to 5% of patients need an additional subcutaneous lead to obtain a defibrillation safety margin of at least 10 J. The number of patients requiring additional subcutaneous leads may even increase, because recent generation devices have a < 34 J maximum output in order to decrease their size. In 20 consecutive patients, a single element subcutaneous array lead was implanted in addition to a transvenous lead system consisting of a right ventricular (RV) and a vena cava superior lead using a single infraclavicular incision. The RV lead acted as the cathode; the subcutaneous lead and the lead in the subclavian vein acted as the anode. The biphasic defibrillation threshold was determined using a binary search protocol. Patients were randomized as to whether to start them with the transvenous lead configuration or the combination of the transvenous lead and the subcutaneous lead. In addition, a simplified assessment of the defibrillation field was performed by determining the interelectrode area for the transvenous lead only and the transvenous lead in combination with the subcutaneous lead from a biplane chest X ray. The intraoperative defibrillation threshold was reconfirmed after 1 week, after 3 months, and after 12 months. The mean defibrillation threshold with the additional subcutaneous lead was significantly (P = 0.0001) lower (5.7 ± 2.9 J) than for the transvenous lead system (9.5 ± 4.6 J). With the subcutaneous lead, the impedance of the high voltage circuit decreased from 48.9 ± 7.4 Ω to 39.2 ± 5.0 Ω. In the frontal plane, the interelectrode area increased by 11.3%± 5.5% (P < 0.0001) and in the lateral plane by 29.5%± 12.4% (P < 0.0001). The defibrillation threshold did not increase during follow-up. Complications with the subcutaneous electrode were not observed during a follow-up of 15.8 ± 2 months. The single finger array lead is useful in order to lower the defibrillation threshold and can be used in order to lower the defibrillation threshold.     

Implantable Defibrillation: Eight Years Clinical Experience

Implantation of the first automatic defibrillator occurred in February 1980. Incorporation of cardioversion capability in 1982 resulted in the AICD™ automatic implantable cardioverter defibrillator. Between April 1, 1982 and April 15, 1988, 3610 patients in 236 U.S. and 84 international centers received AICD pulse generators. Patient population consisted of 2904 males and 683 females with recurrent ventricular tachycardia and/or fibrillation, mean age 59 yrs. (range 9–96 yrs.). Primary diagnoses reported for the patient group were: coronary artery disease (63.5%), nonischemic cardiomyopathy (12.9%), other (6.4%) and unspecified (17.2%). Mean reported LV ejection fraction was 32.8%. Follow-up averaged 12.2 mo. (range 0–72 mo.). Of 385 deaths, 94 (24%) were sudden. Cumulative percentage survival (±S.E.) from sudden cardiac death (SCD) was 98.0 ± 0.3%, 96.5 ± 0.5%, 95.2 ± 0.7%, 93.7 ± 1.0%, 93.7 ± 1.0% and 89.7 ± 4.0% at 12, 24, 36, 48, 60 and 72 months, respectively. Operative mortality (30 days) was 2.5%. Reported side effects/complications were similar to those of pacemakers. To date, 33% of the patients received spontaneous device countershocks. AICD pulse generator survival from electrical and mechanical failures was 92.8 ± 0.5%, 88.4 ± 0.7%, 86.7 ± 0.8% and 86.4 ± 0.9% at 12, 18, 24 and 30 mos. Data analysis demonstrates that the AICD has had a significant impact on patient survival from SCD.     

Bipolar Transvenous Defibrillation: Efficacy of Two Different Positions of the Anode

For most nonthoracotomy defibrillotion lead systems, the transvenous anode can be positioned independently of the right ventricular (RV) cathode. Usually a vertical position in the superior vena cava (SVC) is chosen. However, it is unknown if this position yields the optimal defibrillation threshold (DFT). There-fort, in 15 patients undergoing defibrillator implantation the SVC position was compared in a crossover study design with a horizontal position in the left brachiocephalic vein (BCV). Mean DFT was not different for SVC and BCV (19.2 ± 9.6) vs 18.5 ± 9.1 J) but DFT of individual patients differed by up to 12 joules. A positive correlation between impedance and DFT in the BCV position (r = 0.6; P ≤ 0.05) indicated that the improved geometry of the defibrillation field with the BCV position is opposed by a higher impedance found for this position (63 ± 15 Ω vs 52 ± 7 Ω). Thus, defibrillation is not improved in general although individual patients might benefit.     

Effects of Internal Defibrillation on an Implanted Pacing System with Programmable Polarity

Management of multiple cardiac arrhythmias in some patients with both an implantable cardioverter defibrillator (ICD) and a pacemaker has demonstrated several advantages. In such circumstances, it is imperative that pacemaker function and its programmed parameters be preserved following a deftbrillation shock. This article describes the effects encountered by a specific programmable polarity pacemaker (Relay® 294–03) when subjected to electrical defibrillation in a canine model. Three pacemakers were repeatedly tested in three separate dog experiments. Each pacemaker, with its leads implanted in the right atrium and the right ventricle, was subjected to a minimum total number of 24 high energy biphasic and monophasic shocks (600–700 V) delivered by a coexisting ICD system using three different defibrillating lead configurations. None of the pacemaker systems showed any failure in function; all pacemakers continued to function within preshock specification and conversion to unipolar pacing and/ or backup mode was not observed in any of the tests. Intracardiac electrical potentials measured directly off the ICD and the pacemaker leads, during a defibrillation shock (mean 566.6 V; 23.7 J), showed that potentials measured in a bipolar configuration (tip-ring: mean 21.0 V in atrium, 12.0 V in ventricle) were significantly less than potentials measured in a unipolar configuration (tip-can: mean 387.9 V in atrium, 394.0 V in ventricle; ring-can: mean 405.6 V in atrium, 395.4 V in ventricle). Our compatibility tests demonstrate that use of this programmable-polarity pacemaker in concert with an ICD system appears to be safe. Testing similar to the present study should be conducted prior to complete clinical acceptance of combined ICD and pacemaker implantation.     

Resolution of High Initial Epicardial Patch Defibrillation Thresholds Following Chronic Implantation

To determine what effect chronic implantation of automatic implantable car-dioverter defibrillator epicardial patch electrodes had on initial high defibrillation thresholds at implant, six patients were studied. There were five men, one woman, mean age 61 years. Three had coronary artery disease and three had dilated cardiomyopathies. Mean ejection fraction was 20%. Two patients underwent concomitant coronary artery revascularization and one underwent mitral valve replacement. No patient was on antiarrhythmic drugs. At the time of initial implant, adequate defibrillating thresholds could not be obtained in any patch configuration despite the use of up to 40 joules. Further testing was precluded in each patient due to the development of profound hypotension ( 70 mmHg systolic) that was poorly responsive to pressors. The patch electrodes were then implanted in an arbitrary anterior-posterior position and the leads were tunneled to an abdominal pocket. After 10–15 days (mean 11), the lead ends were exposed and defibrillation testing was performed again. In all six patients, adequate defibrillation thresholds were obtained (mean 18 joules). We conclude that if adequate defibrillation thresholds cannot be obtained at implant and if further testing cannot be performed without jeopardizing the life of the patient, the patch electrodes should be implanted and retesting performed at 10–15 days.