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

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Title: Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial
Authors: 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
Publisher Information: Oxford University Press
Publication Year: 2022
Collection: St George's University of London: Repository
Description: 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.
Document Type: article in journal/newspaper
File Description: application/pdf; application/vnd.openxmlformats-officedocument.wordprocessingml.document
Language: English
ISSN: 1522-9645
Relation: https://openaccess.sgul.ac.uk/id/eprint/114849/6/ehac496.pdf; https://openaccess.sgul.ac.uk/id/eprint/114849/11/ehac496_supplementary_data.docx; https://openaccess.sgul.ac.uk/id/eprint/114849/1/ehac496.pdf; Knops, RE; Pepplinkhuizen, S; Delnoy, PPHM; Boersma, LVA; Kuschyk, J; El-Chami, MF; Bonnemeier, H; Behr, ER; Brouwer, TF; Kaab, S; et al. 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. Eur Heart J, 43 (47). pp. 4872-4883. ISSN 1522-9645 https://doi.org/10.1093/eurheartj/ehac496 SGUL Authors: Behr, Elijah Raphael
DOI: 10.1093/eurheartj/ehac496
Availability: https://openaccess.sgul.ac.uk/id/eprint/114849/
https://openaccess.sgul.ac.uk/id/eprint/114849/6/ehac496.pdf
https://openaccess.sgul.ac.uk/id/eprint/114849/11/ehac496_supplementary_data.docx
https://openaccess.sgul.ac.uk/id/eprint/114849/1/ehac496.pdf
https://doi.org/10.1093/eurheartj/ehac496
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  Data: 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 &lt;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.
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  Data: https://openaccess.sgul.ac.uk/id/eprint/114849/6/ehac496.pdf; https://openaccess.sgul.ac.uk/id/eprint/114849/11/ehac496_supplementary_data.docx; https://openaccess.sgul.ac.uk/id/eprint/114849/1/ehac496.pdf; Knops, RE; Pepplinkhuizen, S; Delnoy, PPHM; Boersma, LVA; Kuschyk, J; El-Chami, MF; Bonnemeier, H; Behr, ER; Brouwer, TF; Kaab, S; et al. 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. Eur Heart J, 43 (47). pp. 4872-4883. ISSN 1522-9645 https://doi.org/10.1093/eurheartj/ehac496 SGUL Authors: Behr, Elijah Raphael
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      – PersonEntity:
          Name:
            NameFull: van Opstal, JM
      – PersonEntity:
          Name:
            NameFull: Chicos, AB
      – PersonEntity:
          Name:
            NameFull: Allaart, CP
      – PersonEntity:
          Name:
            NameFull: Borger van der Burg, AE
      – PersonEntity:
          Name:
            NameFull: Dizon, JM
      – PersonEntity:
          Name:
            NameFull: Miller, MA
      – PersonEntity:
          Name:
            NameFull: Nemirovsky, D
      – PersonEntity:
          Name:
            NameFull: Surber, R
      – PersonEntity:
          Name:
            NameFull: Upadhyay, GA
      – PersonEntity:
          Name:
            NameFull: Weiss, R
      – PersonEntity:
          Name:
            NameFull: de Weger, A
      – PersonEntity:
          Name:
            NameFull: Wilde, AAM
      – PersonEntity:
          Name:
            NameFull: Olde Nordkamp, LRA
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 01
              Type: published
              Y: 2022
          Identifiers:
            – Type: issn-print
              Value: 15229645
            – Type: issn-locals
              Value: edsbas
            – Type: issn-locals
              Value: edsbas.oa
ResultId 1