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左心室收缩功能障碍的心脏收缩力调节:一项前瞻性注册研究的初步研究和设计中的一年经验。

Cardiac contractility modulation in left ventricular systolic dysfunction: one-year experience in a pilot study and design of a prospective registry.

机构信息

Division of Cardiology, Sant'Andrea Hospital, Vercelli, Italy -

Division of Cardiology, Sant'Andrea Hospital, Vercelli, Italy.

出版信息

Minerva Cardiol Angiol. 2021 Feb;69(1):15-24. doi: 10.23736/S2724-5683.20.05219-6. Epub 2020 Jul 10.

DOI:10.23736/S2724-5683.20.05219-6
PMID:32657553
Abstract

BACKGROUND

Cardiac contractility modulation (CCM) is a treatment option for patients suffering symptomatic chronic heart failure (CHF) with reduced left ventricular ejection fraction (LVEF) who are not eligible for cardiac resynchronization. Data on mid-term follow-up are limited to small observational studies. The aim of this study was to assess the impact of CCM on quality of life, symptoms, exercise tolerance and left ventricular function in patients with CHF and moderate-to-severe left ventricular systolic dysfunction.

METHODS

Patients suffering CHF with LVEF <45% and NYHA class >II despite optimal medical therapy, underwent CCM implantation. Enrolled patients underwent baseline and 3, 6 and 12-months evaluation with ECG, echocardiogram, clinical assessment, 6-minute walking test and Minnesota Living with Heart Failure Questionnaire (MLWHFQ).

RESULTS

Ten patients underwent CCM implantation. All patients were actively treated with the optimal pharmacological therapy as tolerated and had at least one hospitalization for worsening heart failure during the previous year. After a mean follow-up of 15 months, 9 patients were alive, while one patient died for worsening heart failure precipitated by pneumonia. Among the remaining 9 patients, LVEF improved non-significantly from 29.4±8% to 32.2±10% (P=0.092), 6-minute walking test distance improved from 179±73 m to 304±99 m (P<0.001), NYHA class reduced from 3.0±0.4 to 1.6±0.5 (P=0.003) and MLWHFQ score improved from 59.6±49 to 34.2±32 (P=0.037). Only 2 patients have been hospitalized during the 12 months. Overall, a net clinical benefit was detected in 6 out of 9 patients.

CONCLUSIONS

CCM could be effective in improving quality of life, symptoms and exercise tolerance, and reduces hospitalizations in patients with symptomatic CHF on top of optimal medical and electrical therapy. A prospective registry has been designed to identify the subsets of patients gaining more benefit, and to assess the long-term effect of CCM on those clinical endpoints.

摘要

背景

心脏收缩力调节(CCM)是一种治疗选择,适用于患有症状性慢性心力衰竭(CHF)且射血分数(LVEF)降低、不符合心脏再同步治疗条件的患者。关于中期随访的数据仅限于小型观察性研究。本研究旨在评估 CCM 对 CHF 合并中重度左心室收缩功能障碍患者生活质量、症状、运动耐量和左心室功能的影响。

方法

患有 LVEF<45%和 NYHA 分级>II 级的 CHF 患者,尽管接受了最佳药物治疗,但仍接受了 CCM 植入。入组患者接受基线和 3、6 和 12 个月的心电图、超声心动图、临床评估、6 分钟步行试验和明尼苏达州心力衰竭生活质量问卷(MLWHFQ)评估。

结果

10 例患者接受了 CCM 植入。所有患者均接受了最佳药物治疗,同时根据耐受情况接受了积极治疗,且在过去一年中至少有一次因心力衰竭恶化而住院。平均随访 15 个月后,9 例患者存活,1 例患者因肺炎加重导致心力衰竭而死亡。在其余 9 例患者中,LVEF 从 29.4±8%非显著改善至 32.2±10%(P=0.092),6 分钟步行试验距离从 179±73 m 显著改善至 304±99 m(P<0.001),NYHA 分级从 3.0±0.4 显著改善至 1.6±0.5(P=0.003),MLWHFQ 评分从 59.6±49 显著改善至 34.2±32(P=0.037)。仅 2 例患者在 12 个月内住院。总体而言,在最佳药物和电治疗的基础上,6 例患者中有 6 例患者的临床获益明显。

结论

CCM 可有效改善症状性 CHF 患者的生活质量、症状和运动耐量,并减少住院次数。目前已设计前瞻性登记研究以确定获益更多的患者亚组,并评估 CCM 对这些临床终点的长期影响。

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