Subcutaneous or Transvenous Defibrillator Therapy.

(The New England journal of medicine, v383.6:526-536)

Background

The 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.

Methods

We 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.

Results

A 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).

Conclusions

In 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. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).

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Overview publication

Title	Subcutaneous or Transvenous Defibrillator Therapy.
Date	2020-08-06
Issue name	The New England journal of medicine
Issue number	v383.6:526-536
DOI	10.1056/NEJMoa1915932
PubMed	32757521
Authors	Knops RE, Olde Nordkamp LRA, Delnoy PHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kääb S, Mittal S, Quast ABE, Smeding L, van der Stuijt W, de Weger A, de Wilde KC, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Tijssen JGP & Wilde AAM
Info	PRAETORIAN Investigators, Knops RE, Wilde AAM, Nordkamp LRO, Tijssen JGP, Delnoy PPH, Boersma LVA, Kääb S, Mittal S, Behr ER, Petersen HH, Wilde AAM, Kooiman KM, Smeding L, Brouwer TF, Quast ABE, de Wilde KC, van der Stujit W, Weger A, Vertelman LV, Go IK, Olde Nordkamp LRA, Bijsterveld NR, Jansen WPJ, Kuschyk J, Richter S, Bonnemeier H, Vernooy K, Brouwer MA, El-Chami MF, Bracke FALE, Alings M, Betts TR, de Jong JSSG, Wright DJ, Knaut M, Neuzil P, Philbert BT, Nordbeck P, van Opstal J, Whinnett ZI, Lambiase PD, Allaart CP, Chicos AB, Miller MA, Upadhyay GA, Surber R, Borger van der Burg AE, Nemirovsky D, Dizon JM, Clancy JF, Germans T, Weiss R, Cheung JW, Leyva F, Burke MC, Theuns DAMJ, de Groot JR, Wilkoff BL, Driessen AHG, Sperzel J, Videbaek R, Maass AH, van Dessel PHFM
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