Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).
Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands (A.G.).
Circ Cardiovasc Qual Outcomes. 2024 Nov;17(11):e010822. doi: 10.1161/CIRCOUTCOMES.124.010822. Epub 2024 Nov 19.
The 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.
The 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 tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time.
Patients 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 (=0.008) and role limitations due to emotional problems (=0.001) than patients without a shock, but this effect did not differ between treatment arms.
In 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.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
皮下植入式心律转复除颤器（S-ICD）的研发旨在克服与经静脉植入式心律转复除颤器（TV-ICD）相关的导线相关并发症的风险。与 TV-ICD 不同，S-ICD 是一种完全胸外设备。因此，这两种植入式心律转复除颤器之间的并发症不同，这可能会影响患者对治疗的看法。这项预先设定的 PRAETORIAN 试验的二次分析评估了生活质量的差异。
PRAETORIAN 试验（皮下与经静脉植入式心律转复除颤器治疗的前瞻性随机比较）将有植入式心律转复除颤器适应证的患者随机分为 S-ICD 或 TV-ICD 治疗组，无需起搏。在基线、出院时、12 个月和 30 个月时收集了两份问卷。杜克活动状态指数（Duke Activity Status Index）衡量心脏特异性身体功能，36 项简短健康调查问卷（36-Item Short Form Health Survey）衡量身体和精神健康，本分析中关注躯体疼痛和心理健康子量表。采用 Mann-Whitney U 检验比较研究组，采用混合模型描述问卷结果随时间的变化。
患者被随机分配到 S-ICD 组（n=426）和 TV-ICD 组（n=423）。在 S-ICD 组中，20%为女性，而 TV-ICD 组为 19%。S-ICD 组的中位年龄为 63（四分位间距，54-69）岁，而 TV-ICD 组为 64（四分位间距，56-69）岁。在任何时间点，两组间杜克活动状态指数和 36 项简短健康调查问卷的躯体疼痛和心理健康子量表均无显著差异。在过去 90 天内发生过电击的患者，其社会功能（=0.008）和情绪问题导致的角色限制（=0.001）评分显著低于未发生电击的患者，但这种影响在治疗组之间无差异。
在接受 S-ICD 或 TV-ICD 治疗的大型随机队列中，未观察到整体生活质量的差异。然而，植入式心律转复除颤器电击会导致生活质量下降，而与设备类型或适用性无关。
