Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial

Reinoud E. Knops; Shari Pepplinkhuizen; 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; Willeke Van Der Stuijt; Lonneke Smeding; Jolien A. De Veld; Jan G.P. Tijssen; Nick R. Bijsterveld; Sergio Richter; Marc A. Brouwer; Joris R. De Groot; Kirsten M. Kooiman; Pier D. Lambiase; Petr Neuzil; Kevin Vernooy; Marco Alings; Timothy R. Betts; Frank A.L.E. Bracke; Martin C. Burke; Jonas S.S.G. De Jong; David J. Wright; Ward P.J. Jansen; Zachary I. Whinnett; Peter Nordbeck; Michael Knaut; Berit T. Philbert; Jurren M. Van Opstal; Alexandru B. Chicos; Cornelis P. Allaart; Alida E.Borger Van Der Burg; Jose M. Dizon; Marc A. Miller; Dmitry Nemirovsky; Ralf Surber; Gaurav A. Upadhyay; Raul Weiss; Anouk de Weger; Arthur A.M. Wilde

doi:10.1093/eurheartj/ehac496

Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial

Reinoud E. Knops^*, Shari Pepplinkhuizen, 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, Willeke Van Der Stuijt, Lonneke Smeding, Jolien A. De Veld, Jan G.P. Tijssen, Nick R. Bijsterveld, Sergio Richter, Marc A. Brouwer, Joris R. De GrootKirsten M. Kooiman, Pier D. Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Timothy R. Betts, Frank A.L.E. Bracke, Martin C. Burke, Jonas S.S.G. De Jong, David J. Wright, Ward P.J. Jansen, Zachary I. Whinnett, Peter Nordbeck, Michael Knaut, Berit T. Philbert, Jurren M. Van Opstal, Alexandru B. Chicos, Cornelis P. Allaart, Alida E.Borger Van Der Burg, Jose M. Dizon, Marc A. Miller, Dmitry Nemirovsky, Ralf Surber, Gaurav A. Upadhyay, Raul Weiss, Anouk de Weger, Arthur A.M. Wilde

^*Corresponding author for this work

Medicine, Cardiology Division

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

33 Scopus citations

Abstract

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. Methods and results: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). Conclusion: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

Original language	English (US)
Pages (from-to)	4872-4883
Number of pages	12
Journal	European heart journal
Volume	43
Issue number	47
DOIs	https://doi.org/10.1093/eurheartj/ehac496
State	Published - Dec 14 2022

Funding

Conflict of interest: R.E.K reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical Inc. S.M. reports consultancy fees from Boston Scientific. K.V. reports consultancy fees from Medtronic and Abbott. M.C.B. is a consultant and receives honoraria, as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. D.J.W. has consultancy arrangements with Boston Scientific and Medtronic and a research grant from Boston Scientific. P.N. reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. M.A.M. reports consultancy fees from Boston Scientific. Z.I.W. is an advisor for Boston Scientific and on the advisory board for Medtronic and Abbot and reports speaker fees from Medtronic. The other authors report no conflicts. The PRAETORIAN trial was funded by Boston Scientific, which had no role in the design of the trial, analysis of the data, or the drafting and submission of the manuscript (grant number ISROTH20076).

Keywords

Complications
Infections
Invasive interventions
Lead-related complications
Subcutaneous ICD
Transvenous ICD

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1093/eurheartj/ehac496

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Knops, R. E., Pepplinkhuizen, S., 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., Van Der Stuijt, W., Smeding, L., De Veld, J. A., Tijssen, J. G. P., Bijsterveld, N. R., Richter, S., Brouwer, M. A., ... Wilde, A. A. M. (2022). Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial. European heart journal, 43(47), 4872-4883. https://doi.org/10.1093/eurheartj/ehac496

@article{ed4e53843a6045d1878c19aab7d48c5b,

title = "Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial",

abstract = "Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. Methods and results: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). Conclusion: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.",

keywords = "Complications, Infections, Invasive interventions, Lead-related complications, Subcutaneous ICD, Transvenous ICD",

author = "Knops, {Reinoud E.} and Shari Pepplinkhuizen 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 {Van Der Stuijt}, Willeke and Lonneke Smeding and {De Veld}, {Jolien A.} and Tijssen, {Jan G.P.} 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, {Timothy R.} and Bracke, {Frank A.L.E.} and Burke, {Martin C.} and {De Jong}, {Jonas S.S.G.} and Wright, {David J.} and Jansen, {Ward P.J.} and Whinnett, {Zachary I.} and Peter Nordbeck and Michael Knaut and Philbert, {Berit T.} and {Van Opstal}, {Jurren M.} and Chicos, {Alexandru B.} and Allaart, {Cornelis P.} and {Van Der Burg}, {Alida E.Borger} and Dizon, {Jose M.} and Miller, {Marc A.} and Dmitry Nemirovsky and Ralf Surber and Upadhyay, {Gaurav A.} and Raul Weiss and {de Weger}, Anouk and Wilde, {Arthur A.M.}",

note = "Publisher Copyright: {\textcopyright} 2022 The Author(s). Published by Oxford University Press on behalf of European Society of Cardiology.",

year = "2022",

month = dec,

day = "14",

doi = "10.1093/eurheartj/ehac496",

language = "English (US)",

volume = "43",

pages = "4872--4883",

journal = "European heart journal",

issn = "0195-668X",

publisher = "Oxford University Press",

number = "47",

}

Knops, RE, Pepplinkhuizen, S, Delnoy, PPHM, Boersma, LVA, Kuschyk, J, El-Chami, MF, Bonnemeier, H, Behr, ER, Brouwer, TF, Kaab, S, Mittal, S, Quast, AFBE, Van Der Stuijt, W, Smeding, L, De Veld, JA, Tijssen, JGP, 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, Jansen, WPJ, Whinnett, ZI, Nordbeck, P, Knaut, M, Philbert, BT, Van Opstal, JM, Chicos, AB, Allaart, CP, Van Der Burg, AEB, Dizon, JM, Miller, MA, Nemirovsky, D, Surber, R, Upadhyay, GA, Weiss, R, de Weger, A & Wilde, AAM 2022, 'Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial', European heart journal, vol. 43, no. 47, pp. 4872-4883. https://doi.org/10.1093/eurheartj/ehac496

TY - JOUR

T1 - Device-related complications in subcutaneous versus transvenous ICD

T2 - a secondary analysis of the PRAETORIAN trial

AU - Knops, Reinoud E.

AU - Pepplinkhuizen, Shari

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 - Van Der Stuijt, Willeke

AU - Smeding, Lonneke

AU - De Veld, Jolien A.

AU - Tijssen, Jan G.P.

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, Timothy R.

AU - Bracke, Frank A.L.E.

AU - Burke, Martin C.

AU - De Jong, Jonas S.S.G.

AU - Wright, David J.

AU - Jansen, Ward P.J.

AU - Whinnett, Zachary I.

AU - Nordbeck, Peter

AU - Knaut, Michael

AU - Philbert, Berit T.

AU - Van Opstal, Jurren M.

AU - Chicos, Alexandru B.

AU - Allaart, Cornelis P.

AU - Van Der Burg, Alida E.Borger

AU - Dizon, Jose M.

AU - Miller, Marc A.

AU - Nemirovsky, Dmitry

AU - Surber, Ralf

AU - Upadhyay, Gaurav A.

AU - Weiss, Raul

AU - de Weger, Anouk

AU - Wilde, Arthur A.M.

PY - 2022/12/14

Y1 - 2022/12/14

N2 - Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. Methods and results: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). Conclusion: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

AB - Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. Methods and results: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). Conclusion: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

KW - Complications

KW - Infections

KW - Invasive interventions

KW - Lead-related complications

KW - Subcutaneous ICD

KW - Transvenous ICD

UR - http://www.scopus.com/inward/record.url?scp=85148361336&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85148361336&partnerID=8YFLogxK

U2 - 10.1093/eurheartj/ehac496

DO - 10.1093/eurheartj/ehac496

M3 - Article

C2 - 36030464

AN - SCOPUS:85148361336

SN - 0195-668X

VL - 43

SP - 4872

EP - 4883

JO - European heart journal

JF - European heart journal

IS - 47

ER -

Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial

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