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Objectives: Our purpose was to demonstrate that strategically chosen implantable cardioverter-defibrillator (ICD) ventricular tachycardia (VT) or ventricular fibrillation (VF) detection and therapy parameters can reduce the combined incidence of device-delivered shocks, arrhythmic syncope, and untreated sustained symptomatic VT/VF (morbidity index)., Background: Strategically chosen ICD VT/VF detection and therapy parameters have been shown in previous studies to reduce the number of shocked episodes. In the PREPARE (Primary Prevention Parameters Evaluation) study, these prior strategies were combined with additional strategies specific to primary prevention patients., Methods: The PREPARE study was a prospective, cohort-controlled study that analyzed 700 patients (biventricular [Bi-V] ICD and non-Bi-V ICD) with primary prevention indications for an ICD from 38 centers followed for 1 year. VT/VF was detected for rates > or =182 beats/min that were maintained for at least 30 of 40 beats. Antitachycardia pacing was programmed as the first therapy for regular rhythms with rates of 182 to 250 beats/min, and supraventricular tachycardia discriminators were used for rhythms < or =200 beats/min. The control cohort consisted of 689 primary prevention patients from the EMPIRIC (Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter Defibrillators Trial) (non-Bi-V ICD, physician arm only) and MIRACLE ICD (Multicenter InSync Implantable Cardioversion Defibrillation Randomized Clinical Evaluation) (Bi-V ICD) trials for whom VT/VF detection and therapy programming were not controlled., Results: The PREPARE programming significantly reduced the morbidity index incidence density (0.26 events/patient-year for PREPARE study patients vs. 0.69 control cohort, p = 0.003). The PREPARE study patients were less likely to receive a shock in the first year compared with control patients (9% vs. 17%, p < 0.01). The incidence of untreated VT and arrhythmic syncope was similar between the PREPARE study patients and the control cohort., Conclusions: Strategically chosen VT/VF detection and therapy parameters can safely reduce shocks and other morbidities associated with ICD therapy in patients receiving an ICD for primary prevention indications. (PREPARE-Primary Prevention Parameters Evaluation; NCT00279279).

Implantable cardioverter-defibrillators (ICDs) with nonthoracotomy lead systems are widely available, and are implanted either in the electrophysiology laboratory or the operating room. The purpose of this study was to prospectively evaluate the safety and efficacy of nonthoracotomy ICD implantation in an electrophysiology laboratory versus an operating room. During a 7-month period, 62 consecutive ICDs with nonthoracotomy lead systems were implanted in patients in an electrophysiology laboratory. During the next 10 months, 110 consecutive ICDs were implanted in patients in a surgical operating room. All ICD implantations were performed under general anesthesia by electrophysiologists. There were no differences in age (58 +/- 14 vs 62 +/- 12 years, p = 0.06), gender distribution (p = 0.3), frequency of structural heart disease (97% vs 97%, p = 0.9), ejection fraction (0.31 +/- 0.15 vs 0.29 +/- 0.13, p = 0.3), or presentation with cardiac arrest (65% vs 53%, p = 0.2) between patients undergoing ICD implantation in the electrophysiology laboratory and operating room, respectively. The rate of successful implantation and of complications for systems implanted in the electrophysiology laboratory (95% and 13%, respectively) and in the operating room (98% and 14%, respectively) were similar (p = 0.4 and p = 0.8, respectively). Specifically, the rate of infection (0% vs 4%, p = 0.3) and hematoma formation (2% vs 4%, p = 0.8) were not statistically significantly different. Three patients who had undergone ICD implantation in an operating room died within 30 days. ICDs with nonthoracotomy lead systems can be implanted with a similarly high rate of success and acceptable complication rate in the electrophysiology laboratory and in the operating room.

The purpose of this study was to compare implant charges and convalescence for transvenous and epicardial defibrillation systems. Hospital stay, intensive care utilization, professional fees, and hospital bills were compared in 44 patients who underwent implantation of a cardiac defibrillator between September 1991 and May 1993. Twenty-five consecutive patients received an epicardial lead system, while 19 consecutive patients underwent implantation of the entire transvenous defibrillation system in the electrophysiology laboratory. There were no significant differences between the two groups in mean age or left ventricular ejection fraction. There was a significant reduction in postoperative hospital convalescence from 7.2 +/- 2.0 days with epicardial systems to 3.1 +/- 1.5 days with transvenous systems (P < 0.001). Postoperative intensive care unit stay was significantly reduced with transvenous systems compared with epicardial systems (0.1 +/- 0.2 vs 1.5 +/- 0.9 days; P < 0.001). Hospital charges were also significantly reduced with the transvenous lead system implants. Mean implant charges were lower with transvenous systems: $32,090 +/- $2,620 vs $38,307 +/- $2,701 (P < 0.001); convalescence charges were lower: $5,861 +/- $5,010 $12,447 +/- $4,969 (P < 0.001); the total hospital bill was also significantly lower with transvenous systems: $53,459 +/- $12,588 vs $71,981 +/- $16,172 (P < 0.001). Professional fees for implantation ($4,131 +/- $1,724 vs $6,100 +/- 0, P < 0.001), convalescence care ($1,258 +/- $960 vs $2,846 +/- $1,770; P < 0.001), and total professional fees ($12,925 +/- $4,772 vs $15,731 +/- $4,055, P < 0.05) were lower in the transvenous defibrillation group.(ABSTRACT TRUNCATED AT 250 WORDS)

Objectives: The purpose of this study was to determine whether the polarity of a monophasic shock used with a transvenous lead system affects the defibrillation threshold., Background: The ability to implant an automatic defibrillator depends on achieving an adequate defibrillation threshold., Methods: A transvenous defibrillation lead with distal and proximal shocking electrodes was used in this study. In 29 consecutive patients, the defibrillation threshold, using a stepdown protocol was determined twice in random order: 1) with the distal coil as the anode, and 2) with the polarity reversed. Only the 20 patients in whom an adequate defibrillation threshold could be obtained with the transvenous lead alone were included in this study. These patients were 61 +/- 14 years old (mean +/- SD) and had a mean ejection fraction of 28 +/- 12%., Results: The mean defibrillation threshold was 11.5 +/- 5.0 J with the distal coil as the anode versus 16.9 +/- 7.7 J with the distal coil as the cathode (p = 0.04). The defibrillation threshold was lower by a mean of 9 +/- 7 J with the former configuration in 14 patients and was lower by a mean of 7 +/- 6 J with the latter configuration in 3 patients; in 3 patients it was the same with both configurations. Use of a subcutaneous patch was avoided in five patients by utilizing the distal electrode as the anode., Conclusions: Defibrillation thresholds with monophasic shocks are approximately 30% lower with the distal electrode as the anode. The use of anodal shocks may obviate the need for a subcutaneous patch and allow more frequent implantation of a transvenous lead system.

Background: Traditional lead systems for implantable cardioverter defibrillators (ICDs) require a thoracotomy for placement. Nonthoracotomy lead systems are available and are usually implanted by an electrophysiologist and a surgeon. The purpose of this study was to prospectively evaluate the safety and efficacy of ICD implantation with a nonthoracotomy lead system by electrophysiologists., Methods and Results: A consecutive series of 100 patients (mean age, 61 +/- 13 years, +/- SD) underwent ICD implantation with a nonthoracotomy lead system while intubated and under general anesthesia. Seventy-seven patients had coronary artery disease, 15 had idiopathic cardiomyopathy, 6 had miscellaneous heart disease, and 2 had structurally normal hearts. The mean ejection fraction was 0.29 +/- 0.13. Sixty-eight patients had suffered a cardiac arrest, and 32 had had ventricular tachycardia or syncope. All patients except 9 underwent electrophysiological testing and had failed 1 +/- 1 drug trials before ICD implantation. Three types of nonthoracotomy lead systems were used. The nonthoracotomy lead with an ICD was successfully implanted in 96 patients (96%). Of the unsuccessful implants, 1 patient did not have venous access, the passive fixation lead in 1 would not remain lodged, 1 had elevated defibrillation thresholds, and 1 developed a hemopneumothorax while venous access was being obtained. The mean defibrillation threshold was 17 +/- 6 J. The mean procedure duration was 161 +/- 57 minutes. When a subcutaneous patch was used (n = 58), the procedure duration was 189 +/- 5 minutes, and when a subcutaneous patch was not required (n = 40), the procedure lasted 123 +/- 37 minutes (P < .0001). Patients remained in the hospital 4.5 +/- 4.1 days after implantation, with no procedure-related deaths. Acute complications occurred in 10 patients; 2 had lead dislodgments, 1 with previous abdominal surgery had his abdominal cavity entered (without other complications) while the ICD pocket was being made, 1 had postoperative heart failure, 1 developed a large hematoma when anticoagulation therapy was initiated, 3 required reintubation because of excessive anesthesia, 1 developed superficial cellulitis, and 1 developed a hemopneumothorax secondary to a lacerated subclavian vein. During 6 +/- 3 months of follow-up, 2 patients developed lead fractures., Conclusions: (1) Electrophysiologists can implant an ICD with a nonthoracotomy lead system safely and with a high success rate; (2) use of a subcutaneous patch correlates with longer procedure durations; and (3) special precautions should be taken in patients with previous abdominal surgery.