The Clinical Times
The Front Page of Medicine

Cardiology · 1980

Implantable cardioverter-defibrillator first human implantation (Mirowski)

Automatic implantable cardioverter-defibrillator (ICD)

An implantable cardioverter-defibrillator device
n28ive1 on Flickr / CC BY 2.0 (Wikimedia Commons)

Sudden cardiac death from ventricular fibrillation killed an estimated 400,000 Americans per year in the late 1970s, most of them outside hospitals before any resuscitation was possible. Antiarrhythmic drugs could suppress some ectopic activity but did not reliably prevent fibrillation, and their own proarrhythmic effects sometimes made outcomes worse. Michel Mirowski, a cardiologist who had watched a close colleague die of recurrent ventricular fibrillation, became convinced that an implanted device capable of sensing and terminating the arrhythmia was the only solution that could reach patients before death.

Mirowski began device development in the late 1960s at Sinai Hospital in Baltimore with Morton Mower, his primary collaborator. The work faced sustained skepticism from prominent figures in electrophysiology, including Bernard Lown, who argued in print that the concept was technically implausible and clinically premature. Mirowski and Mower continued anyway, demonstrating feasibility in animal models and gradually miniaturizing the sensing and capacitor components. Medrad Inc., later reorganized as Intec Systems, provided industry support to bring the device toward clinical use.

The first human implantation was performed on February 4, 1980, at Johns Hopkins Hospital. The surgical team was led by Levi Watkins Jr., a cardiac surgeon who had been following the device's development. The patient was a woman with recurrent ventricular fibrillation who had survived multiple cardiac arrests despite antiarrhythmic therapy. The device required a thoracotomy to place epicardial patch electrodes directly on the heart surface; early models weighed approximately 250 grams. The initial clinical series of three patients was reported in the New England Journal of Medicine in 1980.

FDA approval followed in 1985 after a formal clinical trial documented reliable arrhythmia termination in a larger patient series. For the first decade, implantation required thoracotomy, limiting the procedure to patients robust enough for open-chest surgery. Transvenous lead systems, approved in the early 1990s, allowed subclavian or cephalic vein lead placement and made the procedure far less invasive. Device size fell from over 200 grams to under 30 grams as capacitor and battery technology improved.

The scope of benefit expanded as randomized trial data accumulated. MADIT in 1996 and MADIT-II in 2002 showed that prophylactic ICD implantation reduced mortality in patients with prior myocardial infarction and reduced ejection fraction, even without a history of sustained arrhythmia. SCD-HeFT in 2005 extended that finding to nonischemic cardiomyopathy. Current guidelines recommend ICD implantation in patients with an ejection fraction below 35 percent on optimal medical therapy who have reasonable expected survival, a population of millions worldwide.

Key People

Read the original — PubMed

New England Journal of Medicine, 1980

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