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Circ Arrhythm Electrophysiol · Oct 2012
Multicenter StudyShock efficacy of subcutaneous implantable cardioverter-defibrillator for prevention of sudden cardiac death: initial multicenter experience.
- Ali Aydin, Friederike Hartel, Michael Schlüter, Christian Butter, Julia Köbe, Martin Seifert, Nils Gosau, Boris Hoffmann, Matthias Hoffmann, Eik Vettorazzi, Iris Wilke, Karl Wegscheider, Hermann Reichenspurner, Lars Eckardt, Daniel Steven, and Stephan Willems.
- Department of Electrophysiology, University Heart Center, Hamburg, Germany. aydin@uke.de
- Circ Arrhythm Electrophysiol. 2012 Oct 1; 5 (5): 913-9.
BackgroundRecently, subcutaneous implantable cardioverter-defibrillator (S-ICD) has become available. The aim of our study was to assess the efficacy of S-ICD in a clinical setting.Methods And ResultsBetween June 2010 and July 2011, 40 consecutive patients (42 ± 15 years; body mass index, 27 ± 6 kg/m(2); left ventricular ejection fraction, 47 ± 15%; 28 men) received an S-ICD for primary (n=17) or secondary prevention (n=23 [58%]) at 3 institutions in Germany. Intraoperative defibrillation efficacy testing failed in 1 patient with severely reduced left ventricular ejection fraction; testing was effective in all other patients. All episodes stored in the S-ICD were analyzed for appropriate and inappropriate detection, as well as effective shock delivery to convert ventricular tachyarrhythmia into sinus rhythm. During a median follow-up of 229 (interquartile range, 116-305) days, 4 patients experienced 21 episodes, with correct detection of ventricular tachyarrhythmia and subsequent shock therapy. A total of 28 shocks were delivered in these 4 patients. Mixed logistic regression modeling revealed a shock efficacy of 96.4% (95% CI, 12.8%-100%). The efficacy of first shocks, however, was only 57.9% (95% CI, 35.6%-77.4%). Four episodes were incorrectly classified as ventricular tachyarrhythmia, which led to inappropriate shock delivery in 2 patients.ConclusionsIneffective shock delivery may occur in patients with S-ICD, even after successful intraoperative testing. Multicenter trials are required with close monitoring of safety and efficacy end points to identify patients who may be at risk for shock failure.
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