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BACKGROUND Implantable cardioverter/defibrillators (ICDs) have conventionally been implanted in the operating room by surgeons. However, technological developments have reduced size and increased simplicity, bringing the procedure into the realm of the electrophysiologist. The purpose of this study was to evaluate the safety and efficacy of implantation of the entire ICD system by electrophysiologists in an electrophysiology laboratory. METHODS AND RESULTS Between July 1993 and February 1994, 23 patients (21 men; age, 64 +/- 11 years) underwent transvenous ICD implantation by electrophysiologists working alone, entirely in the electrophysiology laboratory. Indications for ICD were sudden death in 10 patients, uncontrolled life-threatening ventricular tachycardia in 12, and syncope with cardiomyopathy and familial sudden death in 1. Seventeen patients had coronary artery disease and a past history of acute myocardial infarction. Four patients had idiopathic dilated cardiomyopathy, 1 had coronary ectasia and poor left ventricular function, and another had poor left ventricular function related to valvular dysfunction. The mean left ventricular ejection fraction was 34 +/- 10% (range, 20% to 50%). General anesthesia was administered in 22 cases, and deep sedation was used in 1 elderly patient. After positioning of transvenous leads and subcutaneous patch/array lead positioning, defibrillation testing was performed. After transvenous and subcutaneous lead tunneling, all generators were placed subcutaneously in an abdominal pocket. The mean total time in the electrophysiology laboratory was 254 +/- 68 minutes (range, 150 to 375 minutes), with 104 +/- 42 minutes for anesthetic and other preparation, 159 +/- 45 minutes for implantation, and 8.7 +/- 5 minutes (range, 3 to 25 minutes) of fluoroscopy required for positioning of transvenous and subcutaneous lead systems. Implant times showed a significant improvement when the first 10 cases (188 +/- 44 minutes) were compared with the last 10 in the series (124 +/- 44 minutes, P < .01). The mean defibrillation threshold was 17 +/- 5 J (range, 5 to 25 J). There were 5 complications (22%): 1 patch-site hematoma, 1 pneumothorax related to subclavian venous puncture, 1 pulmonary embolism, and 2 patients requiring overnight ventilation after hemodynamic deterioration following defibrillation testing. There were no deaths, and there were no infections. The mean time to hospital discharge after the implant was 5.1 +/- 3.5 days. After 11.6 +/- 9 weeks of follow-up, all devices were functioning satisfactorily, all patients had successfully defibrillated at postimplant predischarge checkup with 29 +/- 5 J, and there had been no late complications. CONCLUSIONS This is the first report to show that nonthoracotomy ICD implantation may be successfully carried out by electrophysiologists working alone in the electrophysiology laboratory, with a high rate of success and few complications, even in high-risk patients. This high rate of success and safety probably relates to the availability of high-quality fluoroscopy and familiarity with electrophysiology laboratory equipment and personnel.

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The Metrixtrade mark Atrioverter Expanded Indication Trial evaluates the safety and efficacy of an implantable atrial defibrillator in patients with symptomatic, recurrent and drug refractory atrial fibrillation who also have structural heart disease. In this ongoing multicenter study, all patients are anticoagulated and concomitant antiarrhythmic drug treatment is left to the preference of the physician. Holter monitoring is performed prior to enrollment in the study. Spontaneous episodes of atrial fibrillation (AF) are treated under physician observation and when patients are ambulatory, the device is programmed in a monitoring mode. The atrial defibrillation threshold is measured at implantation and at 3, 6 and 12 months thereafter. The performance of the AF detection and R-wave synchronization algorithm is assessed at implantation, at regular follow-up intervals, and each time the patient visits the hospital for treatment of a spontaneous episode of AF. An echocardiogram is performed prior to implantation, at 3 and 6 month follow-up and for patients with an implanted heart valve, after 20 and 50 atrial defibrillation shocks have been delivered. The study started on October 1997 and will end after the last patient enrolled completes his/her six-month post-implantation follow-up, unless a safety issue arises. As of September 1998, 6 patients (2 patients with tachycardia induced cardiomyopathy, 1 patient with a mitral valve prosthesis, 2 patients with hypertrophic cardiomyopathy and 1 patient with congenital heart disease) have been enrolled in the study. Over 350 shocks have been delivered for atrial defibrillation testing or termination of spontaneous AF episodes. There have been no reported cases of ventricular proarrhythmia or inaccurately synchronized shocks and no complications of device therapy in this population.