Subcutaneous or Transvenous Defibrillator Therapy

Reinoud E. Knops; Louise R. A. Olde Nordkamp; Peter-Paul H. M. Delnoy; Lucas V. A. Boersma; Juergen Kuschyk; Mikhael F. El-Chami; Hendrik Bonnemeier; Elijah R. Behr; Tom F. Brouwer; Stefan Kaab; Suneet Mittal; Anne-Floor B. E. Quast; Lonneke Smeding; Willeke van der Stuijt; Anouk de Weger; Koen C. de Wilde; Nick R. Bijsterveld; Sergio Richter; Marc A. Brouwer; Joris R. de Groot; Kirsten M. Kooiman; Pier D. Lambiase; Petr Neuzil; Kevin Vernooy; Marco Alings; Tim R. Betts; Frank A. L. E. Bracke; Martin C. Burke; Jonas S. S. G. de Jong; David J. Wright; Jan G. P. Tijssen; Arthur A. M. Wilde; PRAETORIAN Investigators

doi:10.1056/NEJMoa1915932

Subcutaneous or Transvenous Defibrillator Therapy

Reinoud E. Knops^*, Louise R. A. Olde Nordkamp, Peter-Paul H. M. Delnoy, Lucas V. A. Boersma, Juergen Kuschyk, Mikhael F. El-Chami, Hendrik Bonnemeier, Elijah R. Behr, Tom F. Brouwer, Stefan Kaab, Suneet Mittal, Anne-Floor B. E. Quast, Lonneke Smeding, Willeke van der Stuijt, Anouk de Weger, Koen C. de Wilde, Nick R. Bijsterveld, Sergio Richter, Marc A. Brouwer, Joris R. de GrootKirsten M. Kooiman, Pier D. Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Tim R. Betts, Frank A. L. E. Bracke, Martin C. Burke, Jonas S. S. G. de Jong, David J. Wright, Jan G. P. Tijssen, Arthur A. M. Wilde, PRAETORIAN Investigators

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	526-536
Number of pages	11
Journal	New England Journal of Medicine
Volume	383
Issue number	6
DOIs	https://doi.org/10.1056/NEJMoa1915932
Publication status	Published - 6 Aug 2020

Keywords

EFFICACY
OUTCOMES
PREVENTION
SAFETY
SHOCKS
IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR

Access to Document

10.1056/NEJMoa1915932

Cite this

Knops, R. E., Nordkamp, L. R. A. O., Delnoy, P.-P. H. M., Boersma, L. V. A., Kuschyk, J., El-Chami, M. F., Bonnemeier, H., Behr, E. R., Brouwer, T. F., Kaab, S., Mittal, S., Quast, A.-F. B. E., Smeding, L., van der Stuijt, W., de Weger, A., de Wilde, K. C., Bijsterveld, N. R., Richter, S., Brouwer, M. A., ... PRAETORIAN Investigators (2020). Subcutaneous or Transvenous Defibrillator Therapy. New England Journal of Medicine, 383(6), 526-536. https://doi.org/10.1056/NEJMoa1915932

@article{d0a2a9f0830d45d092fab8a6cb624688,

title = "Subcutaneous or Transvenous Defibrillator Therapy",

abstract = "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.",

keywords = "EFFICACY, OUTCOMES, PREVENTION, SAFETY, SHOCKS, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR",

author = "Knops, {Reinoud E.} and Nordkamp, {Louise R. A. Olde} and Delnoy, {Peter-Paul H. M.} and Boersma, {Lucas V. A.} and Juergen Kuschyk and El-Chami, {Mikhael F.} and Hendrik Bonnemeier and Behr, {Elijah R.} and Brouwer, {Tom F.} and Stefan Kaab and Suneet Mittal and Quast, {Anne-Floor B. E.} and Lonneke Smeding and {van der Stuijt}, Willeke and {de Weger}, Anouk and {de Wilde}, {Koen C.} and Bijsterveld, {Nick R.} and Sergio Richter and Brouwer, {Marc A.} and {de Groot}, {Joris R.} and Kooiman, {Kirsten M.} and Lambiase, {Pier D.} and Petr Neuzil and Kevin Vernooy and Marco Alings and Betts, {Tim R.} and Bracke, {Frank A. L. E.} and Burke, {Martin C.} and {de Jong}, {Jonas S. S. G.} and Wright, {David J.} and Tijssen, {Jan G. P.} and Wilde, {Arthur A. M.} and {PRAETORIAN Investigators}",

note = "Publisher Copyright: Copyright {\textcopyright} 2020 Massachusetts Medical Society.",

year = "2020",

month = aug,

day = "6",

doi = "10.1056/NEJMoa1915932",

language = "English",

volume = "383",

pages = "526--536",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOCIETY",

number = "6",

}

Knops, RE, Nordkamp, LRAO, Delnoy, P-PHM, Boersma, LVA, Kuschyk, J, El-Chami, MF, Bonnemeier, H, Behr, ER, Brouwer, TF, Kaab, S, Mittal, S, Quast, A-FBE, 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 & PRAETORIAN Investigators 2020, 'Subcutaneous or Transvenous Defibrillator Therapy', New England Journal of Medicine, vol. 383, no. 6, pp. 526-536. https://doi.org/10.1056/NEJMoa1915932

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

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 -