Circulation, Vol 89, 2503-2508, Copyright © 1994 by American Heart Association
AP Fitzpatrick, MD Lesh, LM Epstein, RJ Lee, A Siu, S Merrick, JC Griffin and MM Scheinman
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.
ARTICLES
Electrophysiological laboratory, electrophysiologist-implanted, nonthoracotomy-implantable cardioverter/defibrillators
University of California, Department of Medicine, San Francisco 94143.
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