Long-Term Survival and Complications in Patients With Malignant Ventricular Tachyarrhythmias: Treatment With a Nonthoracotomy Implantable Cardioverter Defibrillator With or Without a Subcutaneous Patch

The Endotak lead system and ICD has been used to treat patients with malignant ventricular arrhythmias. We analyzed The clinical characteristics of 1,053 patients who underwent implantation of The Endotak lead system with or without a subcutaneous patch. Group A consisted of 567 patients receiving The Endotak lead with a subcutaneous patch: group B consisted of 486 patients receiving The Endotak lead alone. The 2-year survivals from sudden death, cardiac death, and total death in groups A and B were 97.6%/98.2% (P = 0.38), 88.6%/92.7% (P = 0.09), and 84.7%/86.8% (P = 0.06). respectively. Minimum tested effective defibrillation energy at implantation was 17.2 ± 5.2 J for group A and 15.8 ±5.1 J for group B (P < 0.01). The operative mortality was 1.8% in group A and 0.6% in group B (P = 0.09). The incidence of lead dislodgment, malfunction, and infection was 6,7% for group A and 3.5% for group B (P < 0,01), Sudden death survival was excellent in both groups with less lead complications in group B. The Endotak lead alone may be The preferred choice of lead configuration in those patients who have adequate defibrillation thresholds at implant. (PACE 1997: 20[Pt. I]:1305-1311)     

Italian Multicenter Clinical Experience with Endocardial Defibrillation: Acute and Long-Term Results in 307 Patients

This study presents the acute and long-term results of 307 patients (267 men, mean age 57.5 years, 205 suffering from coronary artery disease, mean left ventricular ejection fraction 33.3%) with malignant ventricular tachyarrhythmias who underwent attempted transvenous ICD implantation with the CPI Endotak lead system in 37 Italian centers. Transvenous ICD implantation was ultimately accomplished in 306 (99.7%) patients. These included 19 subjects with high (< 10 J below output energy of implanted device) defibrillation threshold (DFT) at implant. One hundred sixty-four patients (53%) were implanted with the endocardial lead alone, while 142 also received an SQ patch or SQ array. The mean DFT (not always step-down DFT) at implant was 16.9 ± 5.7 joules; 15.3 ± 5.2 joules with biphasic shock and 19.6 ± 5.4 joules with monophasic shock; P < 0.0001. A significantly higher percentage of patients tested with a biphasic shock could be implanted with adequate safety margin and without an additional SQ patch or SQ array (98% and 81 %, respectively). No perioperative deaths occurred. During the mean follow-up of 14.5 ± 10.2 months, 140 patients (52%) received at least one appropriate shock. An inappropriate shock was observed in 26% of episodes. The 1- and 3-year actuarial incidence of sudden death was 2% and 4%, respectively, and that of total death was 10% and 20%, respectively. A pocket infection requiring ICD explantation occurred in 4 patients (1.4%) and an endocardial lead dislodgment in 11 patients (3.6%). Two patients (0.3%) showed a sensing pin disconnection and six patients (2.3%) had a lead insulation break. The results of this Italian multicenter trial indicate that the GPl Endotak lead system is a simple, safe, and reliable system for endocardial defibrillation. When compared to epicardial leads, it clearly reduces the perioperative mortality and morbidity, while maintaining a similar efficacy in preventing sudden death and terminating ventricular arrhythmias.     

Implantation of an Automatic Defibrillator Using a New Nonthoracotomy Approach

Most current nonthoracotomy systems for defibrillator implantation use monophasic devices. To determine the safety and efficacy of a new nonthoracotomy lead configuration when used in conjunction with a device that used biphasic waveforms, 38 consecutive patients were taken to the operating room for implantation of a Cadence tiered therapy defibrillator system. The lead system consisted of a transvenous coil electrode positioned at the right atrial-superior vena caval junction, a bipolar endocardial right ventricular lead, and a large patch placed subcutaneously near the cardiac apex. Of the 38 nontboracotomy defibrillator implantations attempted, 36 (95%) were completed with adequate defibriliation thresholds. The mean defibriliation threshold in these 36 patients was ± 563 ± 10 V (± 20 ± 1 J). There was no perioperative mortality. Complications included coil lead migration (5). sensing lead migration (1), infection (3), pneumothorax (2), arterial embolism (1), and folding of the subcutaneous patch with an increase in defibriliation threshold (1). No patient died during a median follow-up period of 22 weeks. Fourteen patients (39%) had spontaneous sustained ventricular tachyarrhythmias, which were all successfully terminated by the implanted device. Shocks for nonsustained arrhythmias were aborted in eight patients (22%). Spurious discharges for sinus tachycardia or atrial fibrillation occurred in six patients (17%) and were readily diagnosed by examination of the stored electrograms. Thus, implantation of a biphasic tiered therapy defibrillator system using this nonthoracotomy approach is feasible in the majority of patients. The major complication associated with this procedure is lead dislodgment. The clinical course of these patients compares favorably with that of patients who have undergone defibrillator implantation via an epicardial approach.     

Defibrillation Thresholds and Perioperative Mortality Associated with Endocardial and Epicardial Defihrillation Lead Systems

Defibrillation thresholds (DFT) and perioperative mortality were evaluated in 123 patients who had endocardial defibrillation leads implanted in conjunction with the Medtronic model 7216A/7217 (Medtronic, Inc.) cardioverter-defibrillator (ICD). Clinical variables, implant DFTs, and 30-day perioperative mortality were compared with 266 patients who had the ICD implanted with epicardial defibrillation leads. The two groups were comparable in age, gender, and incidence of coronary artery disease. New York Heart Association Class I and II were more frequent in patients with endocardial leads (87.7%) as compared to those with epicardial leads (78.8%; P < 0.001). Mean left ventricular ejection fraction was significantly higher in patients with the endocardial lead system (37% vs 33%; P < 0.05). A significant proportion of patients with epicardial lead systems underwent another cardiac surgical procedure at the time of ICD implantation (13.9%) as compared to none in those who had endocardial leads implanted (P < 0.001). All patients with endocardial leads had implantation of triple lead systems as compared to 53.4% with epicardial leads (P < 0.001). The mean DFT at implant was lower in epicardial lead recipients (8.9 J) as compared to endocardial lead recipients (13.3 J; P < 0.001). Perioperative mortality had a significant trend to lower risk for endocardial lead systems (0.8%) as compared to epicardial systems (4.2%; P = 0.07). We conclude that this endocardial lead system has additional electrode and higher defibrillation energy requirements than the epicardial lead systems used with the Medtronic pacemaker ICD. However, the use of endocardial nonthoracotomy defibrillation leads is associated with a markedly reduced perioperative risk of ICD implantation. This could be due to patient characteristics, a less invasive implant procedure, and absence of concomitant cardiac surgery.     

Early Postoperative Increase in Defibrillation Threshold with Nonthoracotomy System in Humans

The stability of the defibrillation threshold (DFT) early after implantation of an implantable cardioverter defibrillator was evaluated in 15 patients. All but one patient had a three lead nonthoracotomy system using a subcutaneous patch, a right ventricular endocardial lead, and a lead in coronary sinus (n = 5) or superior vena cava (n = 9). Shocks were delivered using simultaneous in nine, sequential in three, and single pathway (coronary sinus not used) in one patient. DFTs were measured at implant (n = 15), 2–8 days postoperation (postop, n = 15), and 4–6 weeks later (n = 8). The DFT was defined as the lowest energy shock that resulted in successful defibrillation. The DFT was assessed with output beginning at 18 joules or 2–4 joules above the implant DFT. All shocks were delivered in 2- to 4-joule increments or decrements. DFTs were significantly higher postoperatively than DFTs at implant (22.7 ± 7.0 J vs 16.9 ± 3.9 J; P < 0.05), Eight of 15 patients had DFT determined at all three study periods. In these patients, DFT increased at postop (22.8 ± 8.3 J vs 16.4 ± 3.9 J at implant: P < 0.05) and returned to baseline at 4–6 weeks (16 ± 7.1) vs 16.4 ± 3.9 J at implant; P = N.S.). Thus, in patients with a multilead nonthoracotomy system, a DFT rise was observed early after implant. The DFT appears to return to baseline in 4–6 weeks. These results have important implications for programming energy output after implantable cardioverter defibrillator implantation.     

Nonthoracotomy Implantation of Cardioverter Defibrillators: Preliminary Experience with a Defibrillation Lead Placed at the Right Ventricular Outflow Tract

Although morbidity and mortality associated with defibrillator implantation using a nonthoracotomy approach have decreased as compared with a thoracotomy approach, dfifihrillation thresholds have been higher and fewer patients satisfied implan t criteria. It may be possible to improve on the success of nonthoracotomy defibrillator implantation by the placement of a right ventricular (HV) outflow defibrillation lead. Implnntable car-dioverter defibrillator implantation data of 30 consecutive patients with clinical VT or VF were reviewed. Three defibrillation leads were routinely used. When either pacing threshold at the RV apex ivas inadequate (n - 2) or 18-J shocks were not successful in terminating VF in 3 of 4 trials (n = 8). the RV apex lead was positioned to the HV outflow tract attaching to the septum. Defibrillation testing was first performed with the RV apex lead in combination with CS, SVC. and/or subcutaneous leads. Twenty patients satisfied implant criteria with a defibrillation threshold of 13.5 ± 3.6 J. In 7 of the 10 patients, whose RV lead was repositioned to the RV outflow tract, this lead in combination with SVC, CS, or subcutaneous leads produced successful defibrillation at < 18 J or in 3 of 4 trials. This approach improved the overall success of nonthoracotomy implantation of defibrillators from 69% to 90%, After a follow-up of 27 ± 6 months, there was no dislodgment of the HV outflow tract defibrillation leads. Conclusions: This article reports the preliminary observation that placement of defibrillation leads to the RV outflow tract in humans was possible and without dislodgment. RV outflow tract offers an alternative for placement of defibrillation leads, which may improve on the success of nonthoracotomy defibrillator implantation.     

Epicardial and Nonthoracotomy Defibrillation Lead Systems Combined with a Cardioverter Defibrillator

The intraoperative and long-term results were reviewed in 67 patients who underwent implantation of the Ventritex Cadence defibrillator with either epicardial patch (EPI, 25 patients) or nonthoracotomy CPI Endotak (ENDO, 42 patients) defibrillation lead systems. In the ENDO group, 35 patients (83 %) had a defibrillation threshold (DFT) of ≤ 20 joules and did not require a subcutaneous patch. Intraoperatively, the DFT was 13 ± 9 joules (mean ± SD) for EPI and 15 ± 8 joules for ENDO (P = NS). There was no perioperative death in either group. During a mean follow-up of 12 ± 8 months, there was no sudden death, and four patients died from congestive heart failure (3 EPI, 1 ENDO). During follow-up, 875 spontaneous arrhythmia episodes (AE) occurred in 15 of 25 EPI patients (60%). versus 652 in 28 of 42 ENDO patients (67%; P = NS). Ventricular tachycardia at a rate ≥ 222 beats/min or ventricular fibrillation represented 167 AE for EPI (19%) and 182 AE for ENDO (28%), and was terminated by the first shock in 76% and 75% of attempts, respectively. Ventricular tachycardia at a rate ≥ 222 beats/min represented a total of 1,178 AE and antitachycardia pacing was successful in 660 of 708 AE (93%) with EPI and 414 of 470 AE (88%) with ENDO lead systems (P= NS). Therefore, a nonthoracotomy approach using the Cadence V-100 is safe and effective and has clinical results that are not significantly different from epicardial defibrillation lead systems.     

A Prospective, Randomized Evaluation of a Nonthoracotomy Implantable Cardioverter Defibrillator Lead System

Nonthoracotomy lead systems for ICDs have been developed that obviate the need for a thoracotomy and reduce the morbidity and mortality associated with implantation. However, an adequate DFT cannot be achieved in some patients using transvenous electrodes alone. Thus, a new subcutaneous "array" electrode was designed and tested in a prospective, randomized trial that compared the DFT obtained using monophasic shock waveforms with a single transvenous lead alone that has two defibrillating electrodes, the transvenous lead linked to a subcutaneous/submuscular patch electrode, and the transvenous lead linked to the investigational array electrode. There were 267 patients randomized to one of the three nonthoracotomy ICD lead systems. All had DFTs that met the implantation criterion of ≤ 25 J. The resultant study population was 82% male and 18% female, mean age of 63 ± 11 years. The indication for ICD implantation was monomorphic VT in 70%, VF in 19%, monomorphic VT/VF in 6%, and polymorphic VT in 4% of the patients, respectively. The mean LVEF was 0.33 ± 0.13. The mean DFT obtained with the transvenous lead alone was 17.5 ± 4.9 J as compared to 16.9 ± 5.5 J with the lead linked to a patch electrode (P = NS), and 14.9 ± 5.6 with the lead linked to the array electrode (array versus lead alone, P = 0.0001; array versus lead/patch, P = 0.007). The results of this investigation suggest that the subcutaneous array may be superior to the standard patch as a subcutaneous electrode to lower the DFT and increase the margin of safety for successful nonthoracotomy defibrillation.     

Acute Efficacy and Chronic Follow-Up of Patients with Non-Thoracotomy Third Generation Implantahle Defibrillators

Non-thoracotomy implantation of implantable cardioverter defibrillators (ICDs) has simplified the process of device inserfion, promising to decrease associated procedural coniplications while providing sudden death protection at least equal to epicardial systems. This study presents the acute and chronic results of 110 patients who underwent attempted non-thoracotomy ICD impiuntation wiih the Medtronic Transvene lead system and PCD model 7217 or 7219. Of the 110 patients attempted, 100 (91%) had the system successfully implanted without the need for an epicar-dial patch. One patient died 1 week postoperatively of septic shock related to the implantation (0.9% perioperative mortality). During folloiv-up of 16 ± 11 months, 45% of the patients had an event detected as ventricular tachycardia; 26% of these detections were felt clinically to be due to supraventricular rhythms. Of the remainder, 87% were successfully treated with the first VT therapy, and 98% were terminated by the final therapy; 66% of the patients had at least one episode of ventricular fibrillation, of which 5% were felt to be inappropriate detections; 65% of the appropriate episodes were successfully treated with the first VF therapy, and all were converted by the final therapy. Total mortality at 6, 12, and 24 months was 3%, 11%, and 19% respectively. Only one patient had sudden cardiac death, occurring at 13 months postimplant. Overall, the non-thoracotomy lead system for this ICD displayed infrequent implant complications and proved to be reliable ai terminating arrhythmias and maintaining a low rate of sudden cardiac death in this high risk popuiation.     

The Effect of Polarity of the Initial Phase of a Biphasic Shock Waveform on the Defibrillation Threshold of Pectorally Implanted Defibrillators

The effect of initial phase polarity on the DFT of two pectorally implanted biphasic ICDs was tested in a randomized, prospective manner at the time of implantation. Twenty-two consecutive patients with VT or VF who received either the Medtronic PCD 7219C fewel device (10 patients) or PCD 7219D fewel device (12 patients) were studied. DFT testing was performed in a standard step-down manner. Both initial phase polarities—initial defibrillation current flowing from active can/SVC coil (± subcutaneous patch) to the RV coil (RV-) or from RV coil to active can/SVC coil (RV+)—were tested in random order. The mean DFT achieved with RV+ compared with RV- was lower for the 7219C patient group (6.6 ±3.1 vs 10.8 ± 5.5 J; P = 0.007). A similar trend was observed forthe 7219D group, though the difference did not reach statistical significance (12.0 ± 4.0 vs 16.3 ± 7.3 J; P = 0.07). Seven of the 10 patients in the 7219C group had a lower DFT with RV+, while the initial phase polarity made no difference in 3. In the 7219D group, 7 patients had a lower DFT using RV+, 2 patients had a lower DFT using RV-, and the initial phase polarity made no difference in 3. In conclusion, this study demonstrates that changing the polarity of the initial phase of a biphasic shock wave form can have a significant impact on the DFT achieved at the time of ICD implantation.     

Cost and Length of Hospital Stay: Comparisons Between Nonthoracotomy and Epicardial Techniques in Patients Receiving Implantable Cardioverter Defibrillators

Twenty-five patients with implantable Cardioverter defibrillators (ICDs) implanted intrathoracically (group I) were compared with 25 patients who underwent implant using the nonthoracotomy approach (group II). AH systems were implanted by the same medical team, in the same high volume implanting center. Indications for implantation were comparable in both groups. Patient characteristics were not statistically different with the exception of age fee-group I vs 71-group II; P < 0.05). Although left ventricular ejection fractions appeared to differ (32% vs 37%, respectively), this difference was not statistically significant (P = 0.06). ICD models used in group I were: Ventritex Cadence (16), Telectronics Guardian 4211 (2), Medtronic PCD (7); in group II they were: Ventritex Cadence (15), Guardian 4211 (2), and CPI 1600 (1). Total length of hospital stay was 16 ± 6 days for group I versus 12 ± 5 for group II (P < 0.05). Number of postoperative days in an intensive care unit was 3.2 ± 2.8 for group I versus 0.5 ± 0.6 for group II (P < 0.0001). Postoperative length of stay was 8.2 ± 3.1 for group I versus 5.7 ± 4.4 for group II (P < 0.001). Mean total hospital charges for the entire length of stay were $72,918 ±$26,770 in group I versus $55,031 ±$42,870 in group II, representing a mean reduction of 21 % in global costs for group II patients. These data confirm that nonthoracotomy ICD implantation in an experienced center is associated with significantly shorter hospital stays, a virtual elimination of the need for postoperative intensive care, and globally lower total hospital costs. In addition, the presence of a statistically older population in group II does not negate these beneficial effects.     

Interactions Between Transvenous Nonthoracotomy Cardioverter Defibrillator Systems and Permanent Transvenous Endocardial Pacemakers

Limited information is available regardIng potential adverse Interactions between transvenous nonthoracotomy cardioverter defibrillators and pacemakers. We describe our experience with 37 patients who have undergone successful Implantation of both a transvenous defibrillator and pacemaker. The patients’mean age was 64 ± 12,9 years. Thirty-three were male and four were female. The mean LVEF wos 30.8%±11.8%, The indications for pacemaker implantation included sick sinus syndrome in 13 patients, complete heart block in 15 patients, sinus brady-cardia secondary to medications In 8 patients, and neurocardlogenlc syncope In 1 patient. The Indications for Insertion of a defibrillator Included medically refractory VT in 27 patients and sudden cardiac death in 10 patients. Twenty-three patients received an Endotak lead and 14 patients received o Transvene lead. Eighteen patients had a pacemaker prior to an ICD, 14 patients had an ICD prior to a pacemaker, and 4 patients had both devices placed simultaneously. Interaction was evaluated at Implant of the second device and 1–3 days after both devices were placed. Detection of VF/VT was analyzed during asynchronous pacing (DOO/VOO) with maximum pacing output. In addition, in six patients, DFT was determined before and after pacemaker implantation. In 14 patients (38%), device interactions that could not always be optimally corrected were observed. In five patients, the pacemaker was reset to the “noise reversion” mode after high energy ICD discharge, Oversensing of atrial pacemaker stimuli resulted in inappropriate ICD firings in four patients. This wos observed only with a specific device ond could not be prevented by atriol leod repositioning in two of them, but required reprogramming of the pacemaker to the VVImode. An increase in DFT was observed in five patients who had a pacemaker implanted after on ICD. Compared with previously published studies, a greater frequency of tronsvenous ICD and pacemaker Interactions were observed. Considering that almost 50% of the patients already have o pacemaker ot the time of ICD Implant, the ovalloblllty of deflbrlllotors with dual chamber pocing capability will not eliminate the potential for this problem.     

Infections with Nonthoracotomy Implantable Cardioverter Defibrillators: Can These Be Prevented?

Nonthoracotomy ICDs are believed to be the best therapeutic modality for treatment of life-threatening ventricular arrhythmias. Little is known about the risk of infection with initial implantation of these devices. We studied the incidence, clinical characteristics, and risk factors associated with infections in 1,831 patients with nonthoracotomy ICD from the Endotak-C nonthoracotomy lead registry of Cardiac Pacemakers, Inc. A transvenous lead was implanted in 950 patients (51.9%) and a combination transvenous plus subcutaneous patch was used in 881 patients (48.1%). Nine preselected data variables were studied, and all investigators identified as having patients with infections were personally contacted. Infections occurred in 22 (1.2%) of 1,831 patients receiving this nonthoracotomy ICD system. The mean time to infection was 5.7 ± 6.5 months (range 1–25 months). Staphylococci were isolated in 58% of patients with reported infection. The presence of a subcutaneous defibrillator patch system was associated with the development of infection. Six of 950 patients (0.63%) with a totally transvenous lead system developed infection versus 16 of 838 (1.9%) patients with a transvenous lead plus subcutaneous patch system configuration (P = 0.015, Chi-square test), with an unadjusted estimated odds ratio of 3.06 (CI 1.19–7.86). The risk of infection encountered with the nonthoracotomy ICD is low, estimated from our data to be 1.2%. Placement of a subcutaneous defibrillator patch appears to be an independent risk factor for development of infection.     

Comparison of Simultaneous Versus Sequential Defibrillation Pulsing Techniques Using a Nonthoracotomy System

The defibrillation threshold (DFT) using simultaneous (SIML) versus sequential (SEQ) pathways for shock delivery was compared in 16 patients with an implanted cardioverter defibrillator. All patients had three-lead nonthoracotomy systems (NTL) using a left chest subcutaneous patch, a right ventricular endocardial lead, and a lead in the coronary sinus (n = 5) or superior vena cava (n = 11). The DFT were determined 2–44 days (17 ± 17 days) after implantation. The DFT was defined as the lowest energy shock that resulted in successful defibrillation. The first pathway tested was SIML in 12 and SEQ in 4 patients with output beginning at or above the intraoperative DFT, routinely 18 J. The second pathway was tested beginning 2–4 J above the DFT of the first tested pathway. All shocks were delivered in 2–4 J decrement or increment steps. The SEQ pathway shocks resulted in a significantly lower DFT than SIML pathway shocks (14 ± 6 vs 18 ± 6 J; I < 0.01). There was no difference in the time delay after ventricular fibrillation initiation before shock delivery for the successful defibrillation between SIML versus SEQ pathways (7 ± 2 secs for both pathways). In 7 of 16 patients, defibrillation using SEQ pathway resulted in a > 5 J lowering of DFT, while only one patient had > 5 J lowering of DFT using SIML shocks (P <0.05). These results have important implications for selecting the optimal pathway for implantable cardioverter defibrillator therapy with a multilead NTL system.     

Fate of Explanted ICD Patients

Of 56 consecutive patients who underwent an initial AICD implantation at our center, we analyzed eight patients who subsequently had their units explanted and not replaced by other antitachycardia devices. The mean age was 57.8 years, mean ejection fraction was 28.4%; six patients had coronary disease and two had cardiomyopathy. The presenting arrhythmia was sudden death in four patients and sustained ventricular tachycardia in four others. Mean follow-up from implant to explant was 25 ± 22 months, and 22 ± 10 months from explant to end of follow-up. Reasons for explantation were: infection in five patients, lead fracture in one patient, battery depletion in one patient, and one patient underwent cardiac transplantation. Devices were not reimplanted because of: patient refusal in three patients, physician discretion in two patients (one recurrent infection, one received no shocks over 24 months), cardiac transplantation in one patient, ablation of VT focus in one patient, and one patient died while being treated for infection. Three patients died 2, 21, and 26 months after device explantation of nonsudden cardiac, sudden cardiac and noncardiac causes, respectively. Conclusions: Preoperative clinical parameters were not indicative of a lower risk of arrhythmic events in these patients as compared to the general population of AICD implantees. Of eight patients, two received alternate nonmedical therapy, one died while receiving treatment for a device-related infection; of the five remaining patients none died of cardiac causes. Termination of AICD therapy for malignant ventricular arrhythmias does not imply imminent sudden cardiac death for most patients treated by alternate modes of therapy.     

Influence of Anodal Electrode Position on Transvenous Defibrillation Efficacy in Humans: A Prospective Randomized Comparison

Nonthoracotomy lead systems for implantable cardioverter defibrillators (ICDs) have reduced operative mortality and morbidity as compared to epicardial lead systems but are usually associated with higher defibrillation thresholds (DFTs). The purpose of this prospective randomized trial was to investigate if the second defibrillation electrode in the left subclavian vein can increase defibrillation efficacy and decrease DFT as compared to the superior vena cava (SVC) position in nonthoracotomy lead systems for ICDs. Seventeen patients (mean age; 49.9 ± 11.3 years, mean ejection fraction; 46.1%± 15.8%) were implanted with an investigational unipolar electrode (Medtronic 13001) used as the defibrillation anode. DFT testing was started in the SVC (n = 10, group A) or the left subclavian vein (n = 7, group B), and repeated in the alternative position starting at the DFT of the initial position. Fifteen patients were eligible for analysis (group A: n = 9, group B: n = 6). With the electrode in the SVC, ventricular fibrillation could be successfully terminated in 9 out of 15 patients (60%). In the left subclavian vein the success rate was 100% (P < 0.01). Mean DFT in the SVC was 13.0 ± 5.2 J and in the left subclavian vein 10.2 ± 4.9 J. DFTs in the left subclavian vein were either lower (group A: n = 5/9, group B: n = 5/6) or equal to the results in the SVC position (P < 0.001). Thus, the left subclavian vein appears to be a superior alternative for positioning of the defibrillation anode as compared to the SVC for nonthoracotomy lead systems using two separate leads.     

Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients

BACKGROUND: Although more than 150,000 implantable cardioverter defibrillators (ICDs) are implanted yearly worldwide, only few studies systematically examined complications of ICD therapy in large patient cohorts. METHODS: We prospectively analyzed ICD-related complications in 440 consecutive patients who underwent first implantation of an ICD system for primary or secondary prevention of sudden cardiac death within the last 10 years at our institution. All study patients received pectoral nonthoracotomy ICD lead systems with the exception of one patient who had an artificial tricuspid valve. RESULTS: During 46 +/- 37 months follow-up, 136 of 440 patients (31%) experienced at least one complication including implant procedure-related complications in 43 patients (10%), ICD generator-related complications in 28 patients (6%), lead-related complications in 52 patients (12%), and inappropriate shocks in 54 patients (12%). The most serious complications included one perioperative death due to heart failure (0.2%), two ICD system infections necessitating device removal (0.5%) and two perioperative cerebrovascular strokes (0.5%). CONCLUSIONS: We conclude that more than one quarter of ICD patients experience complications during a mean follow-up of almost 4 years, although serious complications such as intraoperative death or ICD system infections are rare in patients with nonthoracotomy ICD systems. Recognition of these complications is the prerequisite for advances in ICD technology and management strategies to avoid their recurrence.     

Does An SVC Electrode Further Reduce DFT In A Hot-Can ICD System?

Pectorally implanted ICDs that defibrillate with the RV electrode and the ICD housing have gained clinical acceptance. However, it is still debatable whether adding an SVC electrode connected to the housing will further reduce the threshold of defibrillation (DFT). This study utilized eight pigs. DFTs were measured with a 50 V step-down protocol starting at 650 V (20 J). Shock strength for 50% success (E50) was estimated with the average of three reversals. In addition to a dummy device, Lead I (Pacesetter Models 1558 and 1538) or Lead II (Endotak 72) were used. Leads I are active fixation, true bipolar sensing with 5-cm shocking coils. Lead II has an integrated bipolar sensing with a 4.7-cm RV and 6.9-cm SVC shocking coils. A 95 μF defibrillation system was used to deliver a 44% tilt tuned biphasic 1.6/2.5 ms waveform, and to measure lead impedance. The RV electrode was the anode during phase I. With Lead I RV → CAN the DFT was 531 ± 75 V (13.6 ± 3.8 J) and the E50 was 496 ± 89 (12 ± 4.3 J). These were not significantly (NS) different than the DFT for RV → CAN and SVC which was 518 ± 84 V (13 ± 4.2 J) or the E50 which was 476 ± 84 V (11 ± 3.9 J). Similar results were obtained with Lead II. Despite a decrease in lead impedance there was no apparent benefit from the addition of the SVC electrode. Lead I provided equivalent DFT performance to Lead II.     

Preliminary Clinical Results of a Biphasic Waveform and an RV Lead System

Biphasic defibrillation waveforms have provided a reduction in defibrillation thresholds in transvenous ICD systems. Although a variety of biphasic waveforms have been tested, the optimal pulse durations and tilts have yet to be identified. A multicenter clinical study was conducted to evaluate the performance of a new ICD biphasic waveform and new RV active fixation steroid eluting lead system. Fifty-three patients were entered into the study. Mean age was 63 years with a mean ejection fraction of 36.8%. Primary indication for implantation was monomorphic ventricular tachycardia alone (54.7%). Forty-eight patients (90.6%) were implanted with an RV shocking lead and active can alone as the anodal contact. The ICD can was the cathode. In four cases (7.5%), an additional SVC or CS had was used due to a high DFT with the RV lead alone. In an additional case, a chronic SVC lead was used although the RV-Can DFT was acceptable. DFT for all cases at implant was 9.8 ± 3.7 J. Repeat testing at 3 months for a subset of patients showed a reduction in DFT (7.4 ± 3.0 J), P value = 0.03. Sensing and pacing characteristics of the RV lead system remained excellent during the study period (acute 0.047 ± 0.005 ms at 5.4 V and 9.9 ± 6.2 mV R wave; chronic 0.067 ± 0.11 ms at 5.4 V and 9.3 ± 5.4 mV R wave). It is concluded that this lead system provides good acute and chronic sensing and pacing characteristics with good DFT values in combination with this waveform.     

Initial Single-Center Experience with an Advanced Third-Generation Investigational Defibrillator

The CPI PRxII is a recently approved, multitiered implantable cardioverter defibrillator (ICD) that delivers high and low energy biphasic shocks, antitachycardia (ATP) and bradycardia pacing, and stores 2.5 minutes of electrograms from the widely spaced shocking electrodes. The PRxII was implanted in 58 patients at Yale-New Haven Hospital between December 1993 and January 1995. At implant, mean biphasic defibrillation threshold (DFT) in patients with testing to failure was 10 J (1–20). All 36 patients who were candidates for a new transvenous system underwent successful nonthoracotomy implantation. Based on noninvasive predischarge EPS results, 30 patients had ≥ 1VT zone: 21 patients had ATP, 9 others had first shock ≤ 5 J. During follow-up, 13 patients had been treated for 379 events (range, 1–127). Of 340 events in a zone with ATP, 97% responded to ATP, 3% required shock. First programmed shock converted all events in a VF zone. Details, including RR intervals, were available for ail events in 15 of 17 patients receiving appropriate or inappropriate therapy or diverted shocks. One hundred eleven of 148 available electrograms confirmed VT by morphology, rate, and/or presence of AV dissociation. In nine patients, electrogram data altered therapy through diagnosis of inappropriate or diverted therapy, guidance of detection enhancements, or diagnosis of previously unrecognized VTs. We conclude the PRxII achieves low DFTs that obviate the need for thoracotomy and effectively treats ventricular arrhythmias with ATP and shock, with programming guided by noninvasive electrophysiology. Multiple stored electrograms from widely spaced shocking electrodes greatly enhance diagnostic capabilities, facilitating effective treatment.