TY - JOUR
T1 - Subcutaneous or Transvenous Defibrillator Therapy
AU - Knops, Reinoud E.
AU - Nordkamp, Louise R. A. Olde
AU - Delnoy, Peter-Paul H. M.
AU - Boersma, Lucas V. A.
AU - Kuschyk, Juergen
AU - El-Chami, Mikhael F.
AU - Bonnemeier, Hendrik
AU - Behr, Elijah R.
AU - Brouwer, Tom F.
AU - Kaab, Stefan
AU - Mittal, Suneet
AU - Quast, Anne-Floor B. E.
AU - Smeding, Lonneke
AU - van der Stuijt, Willeke
AU - de Weger, Anouk
AU - de Wilde, Koen C.
AU - Bijsterveld, Nick R.
AU - Richter, Sergio
AU - Brouwer, Marc A.
AU - de Groot, Joris R.
AU - Kooiman, Kirsten M.
AU - Lambiase, Pier D.
AU - Neuzil, Petr
AU - Vernooy, Kevin
AU - Alings, Marco
AU - Betts, Tim R.
AU - Bracke, Frank A. L. E.
AU - Burke, Martin C.
AU - de Jong, Jonas S. S. G.
AU - Wright, David J.
AU - Tijssen, Jan G. P.
AU - Wilde, Arthur A. M.
AU - PRAETORIAN Investigators
N1 - Publisher Copyright:
Copyright © 2020 Massachusetts Medical Society.
PY - 2020/8/6
Y1 - 2020/8/6
N2 - BACKGROUNDThe subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.METHODSWe conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.RESULTSA total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P=0.01 for noninferiority; P=0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).CONCLUSIONSIn patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks.
AB - BACKGROUNDThe subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.METHODSWe conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.RESULTSA total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P=0.01 for noninferiority; P=0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).CONCLUSIONSIn patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks.
KW - EFFICACY
KW - OUTCOMES
KW - PREVENTION
KW - SAFETY
KW - SHOCKS
KW - IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR
U2 - 10.1056/NEJMoa1915932
DO - 10.1056/NEJMoa1915932
M3 - Article
C2 - 32757521
SN - 0028-4793
VL - 383
SP - 526
EP - 536
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 6
ER -