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Multicenter Study
. 2022 Jan;33(1):81-89.
doi: 10.1111/jce.15297. Epub 2021 Nov 28.

Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi-center experience

Alessandro Vicentini  1 , Giovanni Bisignani  2 , Stefano De Vivo  3 , Stefano Viani  4 , Gianluca Savarese  5 , Pietro Francia  6 , Eduardo Celentano  7 , Luca Checchi  8 , Giovanni Carreras  9 , Luca Santini  10 , Filippo Lamberti  11 , Luca Ottaviano  12 , Antonio Scalone  13 , Davide Giorgi  14 , Mariolina Lovecchio  15 , Sergio Valsecchi  15 , Roberto Rordorf  1 ; “S-ICD Rhythm Detect” Investigators
Affiliations
Multicenter Study

Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi-center experience

Alessandro Vicentini et al. J Cardiovasc Electrophysiol. 2022 Jan.

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT02275637.

Keywords: distressundefined; implantable defibrillatorundefined; patient acceptanceundefined; subcutaneousundefined.

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References

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