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; Louise R A Olde Nordkamp

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 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, Louise R A Olde Nordkamp

^*Corresponding author for this work

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

Abstract

BACKGROUND: The subcutaneous ICD (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: The PRAETORIAN trial is an international, multicenter, randomised trial in which 849 patients with an indication for ICD therapy were randomised to receive an SICD (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.

RESULTS: 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 to the TV-ICD group (P <0.001, P =0.03 respectively). Significantly more complications required invasive interventions in the TV-ICD group compared to the S-ICD group (8.3% vs. 4.3%, HR 0.59; P =0.047).

CONCLUSIONS: This secondary analysis shows that, lead-related complications and systemic infections are more prevalent in the TV-ICD group compared to 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
Pages (from-to)	4872-4883
Number of pages	12
Journal	European Heart Journal
Volume	43
Issue number	47
Early online date	28 Aug 2022
DOIs	https://doi.org/10.1093/eurheartj/ehac496
Publication status	Published - 14 Dec 2022

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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., ... Olde Nordkamp, L. R. A. (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{fbc8b11894c6442592f13a7f2d544992,

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

abstract = "BACKGROUND: The subcutaneous ICD (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: The PRAETORIAN trial is an international, multicenter, randomised trial in which 849 patients with an indication for ICD therapy were randomised to receive an SICD (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.RESULTS: 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 to the TV-ICD group (P <0.001, P =0.03 respectively). Significantly more complications required invasive interventions in the TV-ICD group compared to the S-ICD group (8.3\% vs. 4.3\%, HR 0.59; P =0.047).CONCLUSIONS: This secondary analysis shows that, lead-related complications and systemic infections are more prevalent in the TV-ICD group compared to 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.",

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 \{Borger van der Burg\}, \{Alida E\} 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\} and \{Olde Nordkamp\}, \{Louise R A\}",

note = "{\textcopyright} The Author(s) 2022. 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",

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, Borger van der Burg, AE, Dizon, JM, Miller, MA, Nemirovsky, D, Surber, R, Upadhyay, GA, Weiss, R, de Weger, A, Wilde, AAM & Olde Nordkamp, LRA 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 - Borger van der Burg, Alida E

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

AU - Olde Nordkamp, Louise R A

PY - 2022/12/14

Y1 - 2022/12/14

N2 - BACKGROUND: The subcutaneous ICD (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: The PRAETORIAN trial is an international, multicenter, randomised trial in which 849 patients with an indication for ICD therapy were randomised to receive an SICD (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.RESULTS: 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 to the TV-ICD group (P <0.001, P =0.03 respectively). Significantly more complications required invasive interventions in the TV-ICD group compared to the S-ICD group (8.3% vs. 4.3%, HR 0.59; P =0.047).CONCLUSIONS: This secondary analysis shows that, lead-related complications and systemic infections are more prevalent in the TV-ICD group compared to 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 ICD (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: The PRAETORIAN trial is an international, multicenter, randomised trial in which 849 patients with an indication for ICD therapy were randomised to receive an SICD (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.RESULTS: 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 to the TV-ICD group (P <0.001, P =0.03 respectively). Significantly more complications required invasive interventions in the TV-ICD group compared to the S-ICD group (8.3% vs. 4.3%, HR 0.59; P =0.047).CONCLUSIONS: This secondary analysis shows that, lead-related complications and systemic infections are more prevalent in the TV-ICD group compared to 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.

U2 - 10.1093/eurheartj/ehac496

DO - 10.1093/eurheartj/ehac496

M3 - Article

C2 - 36030464

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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