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Randomized Controlled Trial
. 2022 Dec 14;43(47):4872-4883.
doi: 10.1093/eurheartj/ehac496.

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

Reinoud E Knops  1 , Shari Pepplinkhuizen  1 , Peter Paul H M Delnoy  2 , Lucas V A Boersma  1   3 , Juergen Kuschyk  4   5 , Mikhael F El-Chami  6 , Hendrik Bonnemeier  7 , Elijah R Behr  8   9 , Tom F Brouwer  1 , Stefan Kaab  10   11   12 , Suneet Mittal  13 , Anne-Floor B E Quast  1 , Willeke van der Stuijt  1 , Lonneke Smeding  1 , Jolien A de Veld  1 , Jan G P Tijssen  1 , Nick R Bijsterveld  14 , Sergio Richter  15   16 , Marc A Brouwer  17 , Joris R de Groot  1 , Kirsten M Kooiman  1 , Pier D Lambiase  18 , Petr Neuzil  19 , Kevin Vernooy  20 , Marco Alings  21   22 , Timothy R Betts  23 , Frank A L E Bracke  24 , Martin C Burke  25 , Jonas S S G de Jong  26 , David J Wright  27 , Ward P J Jansen  28 , Zachary I Whinnett  29 , Peter Nordbeck  30 , Michael Knaut  16 , Berit T Philbert  31 , Jurren M van Opstal  32 , Alexandru B Chicos  33 , Cornelis P Allaart  34 , Alida E Borger van der Burg  35 , Jose M Dizon  36 , Marc A Miller  37 , Dmitry Nemirovsky  38 , Ralf Surber  39 , Gaurav A Upadhyay  40 , Raul Weiss  41 , Anouk de Weger  1 , Arthur A M Wilde  1   12 , Louise R A Olde Nordkamp  1
Affiliations
Randomized Controlled Trial

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

Reinoud E Knops et al. Eur Heart J. .

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.

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Conflict of interest statement

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.

Figures

Structured Graphical Abstract
Structured Graphical Abstract
Shown is the summary of the main endpoints of the manuscript: device-related complications in the subcutaneous and transvenous ICD: a secondary analysis of the PRAETORIAN trial. ICD, implantable cardioverter-defibrillator.
Figure 1
Figure 1
Time-to-first-event curves for total device-related complications, device-related complications requiring invasive intervention and lead-related complications. Shown are the cumulative event rates of the first occurrence of device-related complications (A), device-related complication requiring invasive intervention (B), and lead-related complications (C). Hazard ratios are derived from Cox regressions and indicate the relative risk (subcutaneous ICD vs. transvenous ICD) of the endpoint. P-values were not adjusted for multiple comparisons. ICD, implantable cardioverter-defibrillator; S-ICD, subcutaneous ICD; TV-ICD, transvenous ICD.
Figure 2
Figure 2
Type of intervention after device-related complications. Shown are the different interventions after a specific device-related complication in the S-ICD group (A) and the different interventions after a specific device-related complication in the TV-ICD group (B). Details on type of non-invasive interventions are presented in Table 5. DFT, defibrillator threshold testing, ICD, implantable cardioverter-defibrillator, S-ICD, subcutaneous ICD, TV-ICD, transvenous ICD.
Figure 3
Figure 3
Burden of device-related complications on the healthcare system. Shown is the burden of device-related complications on new hospitalizations, prolonged hospitalizations and visits to the outpatient clinic. ICD, implantable cardioverter-defibrillator, S-ICD, subcutaneous ICD, TV-ICD, transvenous ICD.
See this image and copyright information in PMC

Comment in

References

    1. Tarakji KG, Wazni OM, Harb S, et al. . Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. Europace 2014;16:1490–1495. - PubMed
    1. Sohail MR, Uslan DZ, Khan AH, et al. . Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol 2007;49:1851–1859. - PubMed
    1. Moss AJ, Zareba W, Hall WJ, et al. . Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877–883. - PubMed
    1. Bardy GH, Lee KL, Mark DB, et al. . Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225–237. - PubMed
    1. Koneru JN, Jones PW, Hammill EF, et al. . Risk factors and temporal trends of complications associated with transvenous implantable cardiac defibrillator leads. J Am Heart Assoc 2018;7:e007691. - PMC - PubMed

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