Vicentini Alessandro, Bisignani Giovanni, De Vivo Stefano, Viani Stefano, Savarese Gianluca, Francia Pietro, Celentano Eduardo, Checchi Luca, Carreras Giovanni, Santini Luca, Lamberti Filippo, Ottaviano Luca, Scalone Antonio, Giorgi Davide, Lovecchio Mariolina, Valsecchi Sergio, Rordorf Roberto
Department of Arrhythmia and Electrophysiology and Experimental Cardiology, IRCCS Fondazione Policlinico 'S. Matteo', Pavia, Italy.
Division of Cardiology, Castrovillari Hospital, Cosenza, Italy.
J Cardiovasc Electrophysiol. 2022 Jan;33(1):81-89. doi: 10.1111/jce.15297. Epub 2021 Nov 28.
The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD. No study has yet compared S-ICD and transvenous ICD by assessing patient acceptance as a patient-centered outcome.
To evaluate the patient acceptance of the S-ICD and to investigate its association with clinical and implantation variables. In patients with symptomatic heart failure and reduced ejection fraction (HFrEF), the acceptance of the S-ICD was compared with a control group of patients who received a transvenous ICD.
Patient acceptance was calculated with the Florida Patient Acceptance Survey (FPAS) which measures four factors: return to function (RTF), device-related distress (DRD), positive appraisal (PA), and body image concerns (BIC). The survey was administered 12 months after implantation.
176 patients underwent S-ICD implantation. The total FPAS and the single factors did not differ according to gender, body habitus, or generator positioning. Patients with HFrEF had lower FPAS and RTF. Younger patients showed better RTF (75 [56-94] vs. 56 [50-81], p = .029). Patients who experienced device complications or device therapies showed higher DRD (40 [35-60] vs. 25 [10-50], p = .019). Patients with HFrEF receiving the S-ICD had comparable FPAS, RTF, DRD, and BIC to HFrEF patients implanted with the transvenous ICD while exhibited significantly better PA (88 [75-100] vs. 81 [63-94], p = .02).
Our analysis revealed positive patient acceptance of the S-ICD, even in groups at risk of more distress such as women or patients with thinner body habitus, and regardless of the generator positioning. Among patients receiving ICDs for HFrEF, S-ICD was associated with better PA versus transvenous ICD.
皮下植入式心律转复除颤器（S-ICD）是经静脉植入式心律转复除颤器的一种有效替代方案。尚无研究通过评估患者接受度这一以患者为中心的结局指标来比较S-ICD和经静脉植入式心律转复除颤器。
评估患者对S-ICD的接受度，并研究其与临床及植入变量的关联。在有症状的心力衰竭且射血分数降低（HFrEF）的患者中，将S-ICD的接受度与接受经静脉植入式心律转复除颤器的对照组患者进行比较。
采用佛罗里达患者接受度调查（FPAS）计算患者接受度，该调查衡量四个因素：功能恢复（RTF）、与设备相关的困扰（DRD）、积极评价（PA）和身体形象担忧（BIC）。调查在植入后12个月进行。
176例患者接受了S-ICD植入。总FPAS及各单一因素在性别、体型或发生器位置方面无差异。HFrEF患者的FPAS和RTF较低。年轻患者的RTF较好（75[56 - 94]对56[50 - 81]，p = 0.029）。经历过设备并发症或接受过设备治疗的患者DRD较高（40[35 - 60]对25[10 - 50]，p = 0.019）。接受S-ICD的HFrEF患者在FPAS、RTF、DRD和BIC方面与接受经静脉植入式心律转复除颤器的HFrEF患者相当，但PA显著更好（88[75 - 100]对81[63 - 94]，p = 差异有统计学意义。
我们的分析显示患者对S-ICD的接受度较高，即使在如女性或体型较瘦的患者等可能面临更多困扰风险的群体中，且与发生器位置无关。在因HFrEF接受植入式心律转复除颤器的患者中，与经静脉植入式心律转复除颤器相比，S-ICD与更好的PA相关。
