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May 15, 2010

An Entirely Subcutaneous Implantable Cardioverter–Defibrillator

www.nejm.org May 12, 2010 (10.1056/NEJMoa0909545)

ABSTRACT

Background Implantable cardioverter–defibrillators (ICDs) prevent sudden death from cardiac causes in selected patients but require the use of transvenous lead systems. To eliminate the need for venous access, we designed and tested an entirely subcutaneous ICD system.


Methods First, we conducted two short-term clinical trials to identify a suitable device configuration and assess energy requirements. We evaluated four subcutaneous ICD configurations in 78 patients who were candidates for ICD implantation and subsequently tested the best configuration in 49 additional patients to determine the subcutaneous defibrillation threshold in comparison with that of the standard transvenous ICD. Then we evaluated the long-term use of subcutaneous ICDs in a pilot study, involving 6 patients, which was followed by a trial involving 55 patients.

Results The best device configuration consisted of a parasternal electrode and a left lateral thoracic pulse generator. This configuration was as effective as a transvenous ICD for terminating induced ventricular fibrillation, albeit with a significantly higher mean (±SD) energy requirement (36.6±19.8 J vs. 11.1±8.5 J). Among patients who received a permanent subcutaneous ICD, ventricular fibrillation was successfully detected in 100% of 137 induced episodes. Induced ventricular fibrillation was converted twice in 58 of 59 patients (98%) with the delivery of 65-J shocks in two consecutive tests. Clinically significant adverse events included two pocket infections and four lead revisions. After a mean of 10±1 months, the device had successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia.

Conclusions In small, nonrandomized studies, an entirely subcutaneous ICD consistently detected and converted ventricular fibrillation induced during electrophysiological testing. The device also successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia.

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Dr Greg Szto - 0438 231 165
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Peninsula Private Hospital
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MORNINGTON

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ROSEBUD

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Peninsula Medical Suites
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03 9789 0088

Dr Greg Szto - 0438 231 165
Dr Vivek Gupta - 0431 025 021

FRANKSTON

Suite11, Peninsula Private Hospital
525 McClelland Drive

MORNINGTON

Consulting Suites, Beleura Private Hospital
925 Nepean Highway

ROSEBUD

Suite 8, Peninsula Medical Suites
1533 Pt Nepean Road

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