Longitudinal changes in quality of life following ICD implant and the impact of age, gender, and ICD shocks: observations from the INTRINSIC RV trial.

PURPOSE: ICDs can improve survival in at-risk patients but no consensus exists with respect to their impact on health-related quality of life (QOL). Moreover, the data are unclear on QOL benefits in specific patient subgroups. We sought to analyze, in the INTRINSIC RV ICD trial population, health-related QOL longitudinally following ICD implant and consider impact of age, gender, and ICD shocks on QOL by employing a global measure of health-related QOL.
METHODS: One thousand five hundred thirty patients had an ICD implanted. One week after implant (n = 1461), 988 patients were randomized to DDDR with AV search hysteresis (n = 502) or VVI (n = 486) programming. QOL data, using the SF-36 short form, were obtained for the 1461 patient cohort, irrespective of randomization status, at baseline and prospectively for 1 year following ICD implant.
RESULTS: Longitudinal mixed-effect analyses revealed significant improvements from baseline across all SF-36 subscales and component scores for the overall study cohort. Women had a substantially lower QOL at baseline, although their improvement after implant was similar to men. Patients <50 years scored consistently worse at baseline but experienced the greatest QOL improvement versus other age groups. Patients with higher NYHA class, angina, and diabetes had greater QOL improvements. There was no significant difference in QOL between patients with and without ICD shocks.
CONCLUSIONS: Our findings indicate that QOL was reportedly better post-implant and suggest that benefits associated with ICD implantation go beyond the direct treatment of arrhythmias, with benefits seen across genders and different age groups. These results further highlight that ICD implantation, in and of itself, does not reduce QOL.

RCT Entities:   Population Interventions Outcomes