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重新定义心脏再同步治疗反应的分类:REVERSE 研究结果。

Redefining the Classifications of Response to Cardiac Resynchronization Therapy: Results From the REVERSE Study.

机构信息

Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland Ohio, USA.

出版信息

JACC Clin Electrophysiol. 2021 Jul;7(7):871-880. doi: 10.1016/j.jacep.2020.11.010. Epub 2021 Feb 24.

DOI:10.1016/j.jacep.2020.11.010
PMID:33640347
Abstract

OBJECTIVES

This study sought to assess the impact of a more detailed classification of response on survival.

BACKGROUND

Cardiac resynchronization therapy (CRT) improves functional status and outcomes in selected populations with heart failure (HF). However, approximately 30% of patients do not improve with CRT by various metrics, and they are traditionally classified as nonresponders.

METHODS

REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) was a randomized trial of CRT among patients with mild HF. Patients were classified as Improved, Stabilized, or Worsened using prespecified criteria based on the clinical composite score (CCS) and change in left ventricular end-systolic volume index (LVESVi). All-cause mortality across CRT ON subgroups at 5 years was compared.

RESULTS

Of the 406 subjects surviving 1 year, 5-year survival differed between CCS subgroups (p = 0.03), with increased mortality in the Worsened response group. Of the 353 subjects with adequate echocardiograms, survival differed significantly between response groups (p < 0.001), also due to increased mortality in the Worsened group. When combining CCS and LVESVi results, the lowest survival was observed among subjects who worsened for both measures, whereas the highest survival occurred in subjects who did not worsen by either endpoint. Multivariate analysis showed that LVESVi worsening with CRT at 6 months, baseline LVESVi, and gender were independent predictors of survival.

CONCLUSIONS

For both CCS and reverse remodeling, patients who worsen with CRT have a high mortality, although remodeling was the more important endpoint. Patients who stabilize early with CRT have a much better prognosis than previously recognized, suggesting that the current convention of nonresponder classification should be modified. (REVERSE [Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction]; NCT00271154).

摘要

目的

本研究旨在评估更详细的反应分类对生存的影响。

背景

心脏再同步治疗(CRT)可改善心力衰竭(HF)特定人群的功能状态和结局。然而,约 30%的患者在各种指标上并未因 CRT 而改善,传统上他们被归类为无反应者。

方法

REVERSE(心脏再同步治疗逆转收缩性左心室功能障碍的重构)是一项 CRT 治疗轻度 HF 患者的随机试验。根据临床综合评分(CCS)和左心室收缩末期容积指数(LVESVi)变化,采用预设标准将患者分为改善、稳定或恶化。比较 CRT ON 亚组 5 年的全因死亡率。

结果

在 406 例存活 1 年的患者中,CCS 亚组之间 5 年生存率存在差异(p=0.03),恶化反应组死亡率增加。在 353 例有足够超声心动图的患者中,反应组之间的生存率存在显著差异(p<0.001),也因恶化组死亡率增加。当结合 CCS 和 LVESVi 结果时,两个指标均恶化的患者生存率最低,而未恶化的患者生存率最高。多变量分析显示,CRT 治疗 6 个月时 LVESVi 恶化、基线 LVESVi 和性别是生存的独立预测因素。

结论

对于 CCS 和反向重塑,CRT 恶化的患者死亡率较高,尽管重塑是更重要的终点。CRT 早期稳定的患者预后明显优于以往认识,提示目前的无反应者分类标准应加以修改。(REVERSE [心脏再同步治疗逆转收缩性左心室功能障碍的重构];NCT00271154)。

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