作者
Gust H Bardy, Warren M Smith, Margaret A Hood, Ian G Crozier, Iain C Melton, Luc Jordaens, Dominic Theuns, Robert E Park, David J Wright, Derek T Connelly, Simon P Fynn, Francis D Murgatroyd, Johannes Sperzel, Jörg Neuzner, Stefan G Spitzer, Andrey V Ardashev, Amo Oduro, Lucas Boersma, Alexander H Maass, Isabelle C Van Gelder, Arthur A Wilde, Pascal F Van Dessel, Reinoud E Knops, Craig S Barr, Pierpaolo Lupo, Riccardo Cappato, Andrew A Grace
发表日期
2010/7/1
期刊
New England Journal of Medicine
卷号
363
期号
1
页码范围
36-44
出版商
Massachusetts Medical Society
简介
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 …
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GH Bardy, WM Smith, MA Hood, IG Crozier, IC Melton… - New England Journal of Medicine, 2010