Heart Rhythm Service, University Hospital, Western University, London, Ontario, Canada.
Department of Medicine, QEII Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada.
J Cardiovasc Electrophysiol. 2018 Mar;29(3):421-434. doi: 10.1111/jce.13419. Epub 2018 Jan 30.
BACKGROUND/OBJECTIVE: 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 6 months 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 6 months (10.4-8.7, P = 0.01) and a reduction in ICD concern in the escalated therapy group at 6 months (10.9-9.4, P = 0.04). EQ-5D measures showed a significant improvement in overall health in ablation patients at 6 months (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.
背景/目的：我们比较了 VANISH 试验中接受升级治疗和消融治疗的室性心动过速患者的健康相关生活质量（HRQoL）。
在 VANISH 患者中，基线和 3、6、12 个月随访时评估 HRQoL。使用了 4 种经过验证的工具：SF-36、植入式心脏复律除颤器（ICD）关注问卷（ICDC）、医院焦虑和抑郁量表（HADS）和 EuroQol 五维问卷（EQ-5D）。使用线性混合效应模型对 SF-36、HADS、ICDC 和 EQ-5D 作为因变量进行重复测量。在第二个模型中，根据入组前是否使用胺碘酮将治疗分为亚组。
接受消融或升级治疗的患者之间的 HRQoL 没有显著差异。亚组分析显示，消融组患者在 6 个月时 SF-36 测量的社会功能（63.5-69.3，P=0.03）和能量/疲劳（43.0-47.9，P=0.01）有所改善。ICDC 测量显示，消融组在 6 个月时 ICD 关注减少（10.4-8.7，P=0.01），升级治疗组在 6 个月时 ICD 关注减少（10.9-9.4，P=0.04）。EQ-5D 测量显示，在 6 个月时，消融患者的整体健康状况显著改善（63.4-67.3，P=0.04）。
与接受升级治疗的患者相比，VANISH 研究中随机接受消融治疗的患者生活质量没有显著变化。一些亚组结果具有统计学意义，随机接受消融治疗的患者在 SF-36 能量/疲劳和 ICD 关注方面持续改善，SF-36 社会功能和 EQ-5D 整体健康方面短暂改善。
