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射血分数降低的心力衰竭患者且QRS时限为120 - 149毫秒时的心脏收缩力调制:降低心力衰竭住院率并改善功能结局。

Cardiac contractility modulation in heart failure with reduced ejection fraction patients with QRS duration 120-149 ms: Reduction in heart failure hospitalizations and improvement in functional outcome.

作者信息

Fastner Christian, Varma Niraj, Rao Ishu, Falk Peter, Remppis Bjoern Andrew, Najarian Kevin, Burkhoff Daniel, Akin Ibrahim, Kuschyk Juergen

机构信息

Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Centre Mannheim (UMM), Medical Faculty Mannheim, Heidelberg University, European Center for AngioScience (ECAS), and German Center for Cardiovascular Research (DZHK) Partner Site Heidelberg/Mannheim, Mannheim, Germany.

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.

出版信息

Heart Rhythm. 2024 Sep 19. doi: 10.1016/j.hrthm.2024.09.038.

Abstract

BACKGROUND

A subset of heart failure with reduced ejection fraction (HFrEF) patients qualifies for cardiac resynchronization therapy (CRT). However, a 30% CRT nonresponder rate persists, with patients having narrower QRS durations (ie, QRSd 120-149 ms) receiving less or inconsistent benefit. Cardiac contractility modulation (CCM) may be an important alternative therapy option but has largely been evaluated only in HFrEF patients with QRSd <120 ms.

OBJECTIVES

The purpose of this study was to evaluate the impact of CCM on HF-related hospitalizations and on left ventricular ejection fraction (LVEF) as well as quality of life in HFrEF patients with QRSd 120-149 ms compared to QRSd <120 ms.

METHODS

The CCM-REG Registry enrolled a total of 503 HFrEF patients with follow-up up to 2 years. Hospitalization rates were available for 1 year preimplant. Safety was assessed by comparison of actual vs Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) risk score- or Seattle Heart Failure Model (SHFM)-predicted mortality.

RESULTS

Among 111 of 455 patients with QRSd 120-149 ms (mean QRSd 130 ± 9 ms; 20% female; age 68 ± 11 years; LVEF 29% ± 9%; 82% New York Heart Association [NYHA] class III), CCM diminished HF-related hospitalization rate by 72% (pre- vs postimplant 0.90 vs 0.25 events per patient-year over 2 years; P <.001). LVEF improved by 7% ± 9% (P = .014 vs baseline), Minnesota Living with Heart Failure Questionnaire score by 10 ± 23 points (P = .010 vs baseline), and NYHA class by 0.5 ± 0.7 classes (<0.001 vs baseline). The effect sizes were similar to those in QRSd <120 ms patients. Mortality within the first year was 19% in QRSd 120-149 ms patients (ie, not significantly different from the MAGGIC risk score or SHFM prediction).

CONCLUSIONS

CCM significantly improved HF control in NYHA class III HFrEF with reduced ejection fraction patients with moderately prolonged QRSd of 120-149 ms. The effect was comparable to that in patients with QRSd <120 ms.

摘要

背景

射血分数降低的心力衰竭(HFrEF)患者中有一部分符合心脏再同步治疗(CRT)的条件。然而,CRT无反应率仍为30%,QRS波时限较窄(即QRSd为120 - 149毫秒)的患者获益较少或获益不一致。心脏收缩力调制(CCM)可能是一种重要的替代治疗选择,但主要仅在QRSd<120毫秒的HFrEF患者中进行了评估。

目的

本研究的目的是评估与QRSd<120毫秒的HFrEF患者相比,CCM对QRSd为120 - 149毫秒的HFrEF患者心力衰竭相关住院、左心室射血分数(LVEF)以及生活质量的影响。

方法

CCM-REG注册研究共纳入503例HFrEF患者,随访时间长达2年。可获得植入前1年的住院率。通过比较实际死亡率与慢性心力衰竭荟萃分析全球组(MAGGIC)风险评分或西雅图心力衰竭模型(SHFM)预测的死亡率来评估安全性。

结果

在455例QRSd为120 - 149毫秒的患者中,有111例(平均QRSd为130±9毫秒;20%为女性;年龄68±11岁;LVEF为29%±9%;82%为纽约心脏协会[NYHA] III级),CCM使心力衰竭相关住院率降低了72%(植入前与植入后2年期间每位患者每年的事件数分别为0.90和0.25;P<.001)。LVEF提高了7%±9%(与基线相比,P =.014),明尼苏达心力衰竭生活问卷评分提高了10±23分(与基线相比,P =.010),NYHA分级降低了0.5±0.7级(与基线相比,<0.001)。效应大小与QRSd<120毫秒的患者相似。QRSd为120 - 149毫秒的患者第一年死亡率为19%(即与MAGGIC风险评分或SHFM预测无显著差异)。

结论

CCM显著改善了NYHA III级射血分数降低且QRSd适度延长至120 - 149毫秒的HFrEF患者的心力衰竭控制情况。其效果与QRSd<120毫秒的患者相当。

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