Device specific quality of life in subcutaneous versus transvenous implantable cardioverter defibrillator implantations: results from the ATLAS multi-centre randomized controlled trial

Abstract

Abstract Background Newer innovative subcutaneous implantable cardioverter defibrillators (S-ICDs) offer an alternative to transverse ICDs (TV-ICDs), placing leads outside of the heart thereby potentially reducing lead-related complications. The ATLAS trial, a multi-centre randomized controlled trial, showed a significant reduction in perioperative complications in TV-ICD versus S-ICD patients. The following results report device-related quality-of-life (QoL) measured in the trial. QoL measures are recognized as key patient-reported outcome measures (PROMs). Purpose To compare TV-ICD and S-ICD post implantation device-related QoL in the ATLAS trial. Methods Sample included all randomized ATLAS trial patients. The Florida Patient Acceptance Survey (FPAS) was completed at 1- and 6-months post implantation. The FPAS includes a total score and 4 subscale scores; 1) return to function, 2) device-related distress, 3) positive appraisal, and 4) body image concerns. Scores are scaled from 0-100, with total scores below 63 suggesting poor device acceptance. The primary analysis was based on complete cases and used analysis of covariance (ANCOVA) with 6-month scores as the dependent variable, group as the independent variable, and 1-month FPAS scores as the covariate. Change in FPAS total score over time within each group was explored using paired t-tests. Results There were 252 TV-ICD and 251 S-ICD patients enrolled in the main ATLAS trial, and of these, in the present analysis, 404 patients (197 TV-ICD; 207 S-ICD) had complete FPAS data. Sample mean age (SD) was 49.31 (11.54) years, males (74.3%) and Caucasian (83.7%). There were no substantive differences in patient characteristics between groups. The primary analyses found no differences between TV-ICD and S-ICD groups for FPAS total score (Mean Difference=-0.75; 95% CI, -3.15, 1.66; p=0.510) or FPAS subscale scores. Mean FPAS total scores increased from 74.43 (15.35) to 78.25 (15.88) and 73.73 (16.09) to 77.05 (16.13) between 1-month and 6-months in the TV-ICD and S-ICD groups respectively. The increase from 1-month to 6-months was statistically significant in both groups (p< 0.001). These findings suggest that regardless of ICD type, there is device acceptance in both groups from implantation and over time. Conclusion Analysis of the FPAS measure, a device-specific QoL measure, found both TV-ICD and S-ICD patients reported good acceptance of their devices, with no significant differences between groups for up to 6 months post implantation. These findings provide an important piece to the TV-ICD versus S-ICD line of inquiry in ICD patient populations particularly for this newer S-ICD innovation and can be included in decision making between health professionals and patients.