Dataset Information

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.

SUBMITTER: Knops RE

PROVIDER: S-EPMC9748587 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Knops Reinoud E RE Pepplinkhuizen Shari S Delnoy Peter Paul H M PPHM Boersma Lucas V A LVA Kuschyk Juergen J El-Chami Mikhael F MF Bonnemeier Hendrik H Behr Elijah R ER Brouwer Tom F TF Kaab Stefan S Mittal Suneet S Quast Anne-Floor B E ABE van der Stuijt Willeke W Smeding Lonneke L de Veld Jolien A JA Tijssen Jan G P JGP Bijsterveld Nick R NR Richter Sergio S Brouwer Marc A MA de Groot Joris R JR Kooiman Kirsten M KM Lambiase Pier D PD Neuzil Petr P Vernooy Kevin K Alings Marco M Betts Timothy R TR Bracke Frank A L E FALE Burke Martin C MC de Jong Jonas S S G JSSG Wright David J DJ Jansen Ward P J WPJ Whinnett Zachary I ZI Nordbeck Peter P Knaut Michael M Philbert Berit T BT van Opstal Jurren M JM Chicos Alexandru B AB Allaart Cornelis P CP Borger van der Burg Alida E AE Dizon Jose M JM Miller Marc A MA Nemirovsky Dmitry D Surber Ralf R Upadhyay Gaurav A GA Weiss Raul R de Weger Anouk A Wilde Arthur A M AAM Olde Nordkamp Louise R A LRA

European heart journal 20221201 47

<h4>Background</h4>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.<h4>Methods and results</h4>The PRAETO ...[more]

PMID: 36030464

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Project description:BackgroundThe subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life.MethodsThe PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time.ResultsPatients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (P=0.008) and role limitations due to emotional problems (P=0.001) than patients without a shock, but this effect did not differ between treatment arms.ConclusionsIn a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Project description:IntroductionIn the context of randomized clinical trials, subcutaneous implantable cardiac defibrillators (S-ICDs) are non-inferior to transvenous ICDs (T-ICDs) concerning device-related complications or inappropriate shocks in patients with an indication for defibrillator therapy and not in need of pacing. We aimed at describing the clinical features of patients who underwent S-ICD implantation in our clinical practice, as well as the ICD-related complications and the inappropriate therapies among S-ICD vs. T-ICD recipients during a long-term follow-up.Materials and methodsAll patients undergoing ICD, both S-ICD and TV-ICD, at Monaldi Hospital from January 1, 2015 to January 1, 2019 and followed up at our institution were included in the present analysis. The clinical variables associated with S-ICD implantation were evaluated by logistic regression analyses. We collected the ICD inappropriate therapies, ICD-related complications (including both pulse generator and lead-related complications), ICD-related infections, appropriate ICD therapies, and overall mortality. Kaplan-Meier (KM) analyses were performed to assess the risk of clinical outcome events between the two subgroups. A time-dependent Cox regression analysis was performed to adjust the results.ResultsTotal 607 consecutive patients (mean age 53.8 ± 16.8, male 77.8%) with both TV-ICD (n: 290, 47.8%) and S-ICD (n: 317, 52.2%), implanted and followed at our center for a mean follow-up of 1614 ± 1018 days, were included in the study. At multivariate logistic regression analysis, an independent association between S-ICD implantation and ionic channel disease [OR: 6.01 (2.26-15.87); p < 0.0001] and ischemic cardiomyopathy [OR: 0.20 (0.12-0.35); p < 0.0001] was shown. The KM analysis did not show a significantly different risk of the inappropriate ICD therapies (log rank p = 0.64) between the two subgroups; conversely, a significant increase in the risk of ICD-related complications (log rank p = 0.02) and infections (log rank p = 0.02) in TV-ICD group was shown. The adjusted risk for ICD-related infections [OR: 0.07 (0.009-0.55), p = 0.01] and complications [0.31 (0.12-0.81), p = 0.01] was significantly lower among patients with S-ICD.ConclusionsThe choice to implant S-ICD was mainly driven by younger age and the presence of ionic channel disease; conversely ischemic cardiomyopathy reduces the probability to use this technology. No significant differences in inappropriate ICD therapies were shown among S-ICD vs. TV-ICD group; moreover, S-ICD is characterized by a lower rate of infectious and non-infectious complications leading to surgical revision or extraction.

Project description:The subcutaneous implantable cardioverter-defibrillator (S-ICD) system is an established therapy for prevention of sudden cardiac death (SCD) and an alternative to a transvenous implantable cardioverter-defibrillator (ICD) system in selected patients. Since introduction of S-ICD in 2010, the device has undergone further development. Based on the unique feature of an entirely extracardiac implantation, S-ICD is able to reduce the known common perioperative and long-term complications of conventional transvenous implanted ICD systems. Especially for patients with a complex anatomy and no option of an endovascular lead implantation, the S-ICD offers a potential alternative. Initial uncertainty existed, questioning whether this ICD approach would be reliable in detecting and terminating ventricular arrhythmias. Multiple clinical studies, however, provided evidence for an effective treatment. Based on obvious advantages compared to conventional ICD systems, the question arises whether the S-ICD should actually be the first choice in the majority of all primary prevention patients in the future. Recent data from large registries show that S-ICD indications are also expanding in secondary prevention patients. As a consequence, the S-ICD was listed in the 2015 ESC guidelines as an alternative therapeutic option with a class-IIa recommendation in patients with an ICD indication not requiring pacing for bradycardia, cardiac resynchronization therapy or anti-tachycardia pacing (ATP). In addition, the American Heart Association guidelines refer to class-I recommendation for patients with a complex anatomy and venous access problems or at a high risk for infections who need ICD therapy. Limitations with respect to the not available pacing option of S-ICD might be also overcome by a potential combination with a leadless pacemaker in the near future. This article provides an overview of recent developments of S-ICD and reviews the most recent literature and ongoing studies.

Dataset Information

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

Background

Methods and results

Conclusion

Publications

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

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