Electrophysiological laboratory, electrophysiologist-implanted, nonthoracotomy-implantable cardioverter/defibrillators.

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.