Quality of life with ablation or medical therapy for ventricular arrhythmias: A substudy of VANISH.

Abstract

We compared health-related quality of life (HRQoL) in patients randomized to escalated therapy and those randomized to ablation for ventricular tachycardia in the VANISH trial. HRQoL was assessed among VANISH patients at baseline and 3-, 6-, and 12-month follow-up visits. Four validated instruments were used: the SF-36, the implanted cardioverter defibrillator (ICD) Concerns questionnaire (ICDC), the Hospital Anxiety and Depression Scale (HADS), and the EuroQol five dimensions questionnaire (EQ-5D). Linear mixed-effects modeling was used for repeated measures with SF-36, HADS, ICDC, and EQ-5D as dependent variables. In a second model, treatment was subdivided by amiodarone use prior to enrollment. HRQoL did not differ significantly between those randomized to ablation or escalated therapy. On subgroup analysis, improvement in SF-36 measures was seen at 6months in the ablation group for social functioning (63.5-69.3, P=0.03) and energy/fatigue (43.0-47.9, P=0.01). ICDC measures showed a reduction in ICD concern in the ablation group at 6months (10.4-8.7, P=0.01) and a reduction in ICD concern in the escalated therapy group at 6months (10.9-9.4, P=0.04). EQ-5D measures showed a significant improvement in overall health in ablation patients at 6months (63.4-67.3, P=0.04). Patients in the VANISH study randomized to ablation did not have a significant change in quality of life outcomes compared to those randomized to escalated therapy. Some subgroup findings were significant, as those randomized to ablation showed persistent improvement in SF-36 energy/fatigue and ICD concern, and transient improvement in SF-36 social functioning and EQ-5D overall health.