To determine the incidence of complications of third-generation implantable cardioverter defibrillator (ICD) therapy, 144 patients were prospectively studied who underwent first implant of third-generation devices (i.e., ICD systems with biphasic shocks, ECG storage capability, and nonthoracotomy lead systems). During 21 +/- 15 months of follow-up, 41 (28%) patients had one or more complications. No patient died perioperatively (30 days) and no ICD infection was observed during follow-up. Complications included bleeding or pocket hematoma (hemoglobin drop > 2 g/dL) in 5 (3%) patients, prolonged reversible ischemic neurological deficit in 1 (1%) patient, postoperative deep venous thrombosis of leg in 1 (1%) patient, pneumothorax in 2 (1%) patients, difficulty to defibrillate ventricular fibrillation intraoperatively in 2 (1%) patients, generator malfunction in 1 (1%) patient, arthritis of the shoulder in 3 (2%) patients, and allergic reaction to prophylactic antibiotics in 2 (1%) patients. A total of seven lead related complications were observed in six (4%) patients including endocardial lead migration in four (3%) patients. Twenty-three (16%) patients received inappropriate shocks for supraventricular tachyarrhythmias (n = 13), non-sustained ventricular tachycardia (VT) (n = 7), or myopotential oversensing (n = 3). We conclude that serious complications such as perioperative death or ICD infection are rare in patients with third-generation ICDs. Lead-related problems and inappropriate shocks during follow-up are the most frequent complications of third-generation ICD therapy. Recognition of these complications should promote advances in ICD technology and management strategies to avoid their recurrence.

Between December 1992 and March 1997, 3rd generation automatic cardioverter-defibrillators (ICD) were implanted in 107 patients at the University of Marburg. Ali implantable ICDs had biphasic shock delivery and automatic ECG storage for arrhythmias triggering device therapy Thoracotomy at the time of implant had to be performed only in one patient with an artificial tricuspid valve. In the remaining 106 patients, ICD implantation was performed exclusively without thoracotomy with pure transvenous electrode systems (n = 101) or with transvenous electrodes in combination with a left pectoral subcutaneous patch electrode (n = 5). in the last 80 patients, only ICDs with electrically active housing were used. All ICDs with electrically active housing could be implanted successfully with pure transvenous electrode systems.After ICD implantation, ail patients were followed until September 1997 for 22 +/- 12 months. lip to now none of the 107 patients showed an ICD infection and no patient died during or within 4 weeks after ICD implantation. Analysis of stored ECGs by the ICD showed in 37 of 107 patients (35%) one or more sustained ventricular tachyarrhythmia, all of which were terminated by antitachycardia pacing or ICD shocks. In 23 patients (21%), at least 1 spontaneous ventricular tachycardia with a rate greater than or equal to 240/min was terminated successfully by an ICD shock. Altogether 76 patients [15%] died during 22 +/- 12 months follow-up after ICD implantation. Cause of death was terminal heart failure in 12 patients, sudden death in 2 patients and carcinoma or sepsis in 1 patient each.In summary implantation of 3rd generation ICDs is highly effective to prevent sudden cardiac death in patients with ventricular tachyarrhythmias. Serious complications such as perioperative death or ICD infection after implantation of 3rd generation ICDs should rarely occur any more.

Device-based testing of single-lead pectoral defibrillators (defibrillation efficacy testing without an external defibrillation system after complete implantation of the device) resulted in an adequate defibrillation threshold (< or = 20 J) in 45 of 50 study patients (90%). Mean surgical implantation time (skin to skin) was 62 +/- 29 minutes without perioperative mortality and without implantable cardioverter defibrillator infection during follow-up. Thus, device-based testing appears to be a simple and safe method to test defibrillation efficacy of single-lead pectoral defibrillators.

In order to evaluate the safety of implantation of a third generation automatic cardioverter-defibrillator (ICD) in patients with amiodarone therapy, we retrospectively analyzed implantation results and perioperative complications in 17 consecutive patients with continued amiodarone therapy and 38 patients without antiarrhythmics at first ICD implantation.ICD implantation could be performed successfully in all 55 patients using a transvenous electrode system. In one of 17 patients with amiodarone (6%) versus three of 38 patients without antiarrhythmics (8%), additional implantation of a subcutaneous patch electrode was necessary to achieve a defibrillation threshold </=24 Joules (p=n.s.). Intraoperatively tested defibrillation threshold was 13+/-5 Joules in the amiodarone group versus 12+/-5 Joules in patients without antiarrhythmics (p=n.s.). The incidence of perioperative complications was not different between patients with amiodarone and patients without antiarrhythmics.In summary, patients with amiodarone did not have higher defibrillation thresholds or a higher incidence of perioperative complications than patients without antiarrhythmics. The occasionally postulated discontinuation of amiodarone with subsequent waiting for the elimination of this antiarrhythmic drug is unnecessary. For final clarification of the influence of amiodarone-therapy on the defibrillation threshold in patients with third generation ICDs, a prospective randomized study in a large patiente cohort with standardized study conditions would be required.

Um die Sicherheit der Implantation eines automatischen Kardioverter-Defibrillators (ICD) der 3. Generation bei Patienten mit Amiodaron-Therapie zu überprüfen, analysierten wir retrospektiv Implantationsergebnisse und perioperative Komplikationen bei 17 Patienten mit fortgesetzter Amiodaron-Therapie sowie 38 Patienten ohne Antiarrhythmika bei ICD-Erst-implantation.