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心脏再同步治疗对轻度心力衰竭的长期影响:来自左心室收缩功能障碍再同步治疗逆转重构(REVERSE)研究的 5 年结果。

Long-term impact of cardiac resynchronization therapy in mild heart failure: 5-year results from the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study.

机构信息

Department of Cardiology, Karolinska University Hospital, S- 17176, Stockholm, Sweden.

出版信息

Eur Heart J. 2013 Sep;34(33):2592-9. doi: 10.1093/eurheartj/eht160. Epub 2013 May 2.

Abstract

BACKGROUND

The benefit of cardiac resynchronization therapy (CRT) among patients with mild heart failure (HF), reduced left ventricular (LV) function and wide QRS is well established. We studied the long-term stability of CRT.

METHODS

REVERSE was a randomized, double-blind study on CRT in NYHA Class I and II HF patients with QRS ≥120 ms and left ventricular ejection fraction (LVEF) ≤40%. After the randomized phase, all were programmed to CRT ON and prospectively followed through 5 years for functional capacity, echocardiography, HF hospitalizations, mortality, and adverse events. We report the results of the 419 patients initially assigned to CRT ON.

FINDINGS

The mean follow-up time was 54.8 ± 13.0 months. After 2 years, the functional and LV remodelling improvements were maximal. The 6-min hall walk increased by 18.8 ± 102.3 m and the Minnesota and Kansas City scores improved by 8.2 ± 17.8 and 8.2 ± 17.2 units, respectively. The mean decrease in left ventricular end-systolic volume index and left ventricular end-diastolic volume index was 23.5 ± 34.1 mL/m(2) (P < 0.0001) and 25.4 ± 37.0 mL/m2 (P < 0.0001) and the mean increase in LVEF 6.0 ± 10.8% (P < 0.0001) with sustained improvement thereafter. The annualized and 5-year mortality was 2.9 and 13.5% and the annualized and 5-year rate of death or first HF hospitalization 6.4, and 28.1%. The 5-year LV lead-related complication rate was 12.5%.

CONCLUSION

In patients with mild HF, CRT produced reverse LV remodelling accompanied by very low mortality and need for heart failure hospitalization. These effects were sustained over 5 years. Cardiac resynchronization therapy in addition to optimal medical therapy produces long-standing clinical benefits in mild heart failure.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov identifier NCT00271154.

摘要

背景

心脏再同步治疗(CRT)在轻度心力衰竭(HF)、左心室(LV)功能降低和宽 QRS 患者中的益处已得到充分证实。我们研究了 CRT 的长期稳定性。

方法

REVERSE 是一项在 NYHA Ⅰ级和Ⅱ级 HF 患者中进行的 CRT 随机、双盲研究,QRS≥120 ms,左心室射血分数(LVEF)≤40%。随机阶段后,所有患者均程控为 CRT ON,并前瞻性随访 5 年,以评估心功能、超声心动图、HF 住院、死亡率和不良事件。我们报告了最初分配到 CRT ON 的 419 例患者的结果。

结果

平均随访时间为 54.8±13.0 个月。2 年后,心功能和 LV 重构改善达到最大。6 分钟步行距离增加了 18.8±102.3 m,明尼苏达和堪萨斯城评分分别改善了 8.2±17.8 和 8.2±17.2 单位。左心室收缩末期容积指数和左心室舒张末期容积指数的平均降低分别为 23.5±34.1 mL/m2(P<0.0001)和 25.4±37.0 mL/m2(P<0.0001),LVEF 平均增加 6.0±10.8%(P<0.0001),此后持续改善。年死亡率和 5 年死亡率分别为 2.9%和 13.5%,年死亡率和 5 年死亡率或首次 HF 住院率分别为 6.4%和 28.1%。5 年 LV 导联相关并发症发生率为 12.5%。

结论

在轻度 HF 患者中,CRT 产生了相反的 LV 重构,同时死亡率和心力衰竭住院率非常低。这些效果在 5 年内持续存在。心脏再同步治疗加上最佳药物治疗可在轻度心力衰竭中产生长期的临床获益。

临床试验注册

Clinicaltrials.gov 标识符 NCT00271154。

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