Device-specific quality of life: Results from the ATLAS trial—Avoid Transvenous Leads in Appropriate Subjects

Abstract

Aim Patient reported outcomes (PROs) provide important insights into patients’ acceptance of their medical devices. ATLAS, a randomized, multi-center, open-label clinical trial, recently reported fewer perioperative complications in S-ICD compared to TV-ICD patients. This study reports PROs, including device-specific and generic quality of life (QOL) from the ATLAS trial. Methods and results Device-specific QOL was the primary PRO using the Florida Patient Acceptance Survey (FPAS) at 1-and 6-months post-implantation. Secondary outcomes included generic QOL using the Medical Outcomes Survey (SF-36) pre-implant and 6-months post-implantation. FPAS and SF-36 were analyzed using ANCOVA. Pain measured using a Numeric Rating Scale, at 1-and 6-months, anesthetic, BMI and within/between differences were analyzed using descriptive statistics and mixed-effects linear models (MLM). Of the 503 patients randomized in ATLAS, 404 had complete FPAS data to include in this analysis. Participant characteristics were balanced. There were no significant differences between S-ICD and TV-ICD for FPAS or SF-36, across timepoints. Mean total FPAS scores increased from 73.73 (16.09) to 77.05 (16.13) and 74.43 (15.35) to 78.25 (15.88) for S-ICD and TV-ICD, respectively, (p <0.001). PROs suggested that both devices were associated with good QOL. Conclusion Device-specific and generic QOL were similar between S-ICD and TV-ICD groups up to 6-months post-implantation indicating that regardless of device type, both groups reported good device specific QOL in ATLAS patients. S-ICD patients reported higher pain scores at implant, but pain decreased by 6 months. The findings offer evidence that can be included during shared decision-making. The inclusion of patient partners in ATLAS provided opportunity to measure PROs that were deemed important to patients. Registration ClinialTrials.gov # NCT02881255