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Observational Study
. 2024 May 2;26(5):euae115.
doi: 10.1093/europace/euae115.

Sex differences among subcutaneous implantable cardioverter-defibrillator recipients: a propensity-matched, multicentre, international analysis from the i-SUSI project

Marco Schiavone  1 , Alessio Gasperetti  2 , Julia Vogler  3 , Paolo Compagnucci  4 , Mikael Laredo  5 , Alexander Breitenstein  6 , Simone Gulletta  7 , Martin Martinek  8 , Lukas Kaiser  9 , Fabrizio Tundo  1 , Pietro Palmisano  10 , Giovanni Rovaris  11 , Antonio Curnis  12 , Jürgen Kuschyk  13 , Mauro Biffi  14 , Roland Tilz  3 , Luigi Di Biase  15 , Claudio Tondo  1   16 , Giovanni B Forleo  17 ; i-SUSI investigators
Collaborators, Affiliations
Observational Study

Sex differences among subcutaneous implantable cardioverter-defibrillator recipients: a propensity-matched, multicentre, international analysis from the i-SUSI project

Marco Schiavone et al. Europace. .

Abstract

Aims: Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients.

Methods and results: Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications.

Conclusion: In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT0473876.

Trial registration: ClinicalTrials.gov NCT00473876.

Keywords: Appropriate shocks; Gender differences; S-ICD; Sex differences; Sudden cardiac death.

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Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
By covariate bias reduction with propensity matching.
Figure 2
Figure 2
Kaplan–Meier curves showing overall freedom from appropriate device intervention in the female (blue) and male (red) cohort.
Figure 3
Figure 3
Kaplan–Meier curves showing overall freedom from inappropriate device intervention in the female (blue) and male (red) cohort.
Figure 4
Figure 4
Kaplan–Meier curves showing overall freedom from device-related intervention in the female (blue) and male (red) cohort.
See this image and copyright information in PMC

References

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