1. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator
- Author
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Paul, Friedman, Francis, Murgatroyd, Lucas V A, Boersma, Jaimie, Manlucu, David, O'Donnell, Bradley P, Knight, Nicolas, Clémenty, Christophe, Leclercq, Anish, Amin, Béla P, Merkely, Ulrika M, Birgersdotter-Green, Joseph Y S, Chan, Mauro, Biffi, Reinoud E, Knops, Greg, Engel, Ignacio, Muñoz Carvajal, Laurence M, Epstein, Venkata, Sagi, Jens B, Johansen, Maciej, Sterliński, Clemens, Steinwender, Troy, Hounshell, Richard, Abben, Amy E, Thompson, Christopher, Wiggenhorn, Sarah, Willey, Ian, Crozier, Sergio, Thal, Cardiology, and ACS - Heart failure & arrhythmias
- Subjects
Treatment Outcome ,Electric Countershock ,Humans ,Arrhythmias, Cardiac ,General Medicine ,Prospective Studies ,Defibrillators, Implantable - Abstract
BACKGROUND: The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODS: We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. RESULTS: A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P
- Published
- 2022