Clinica Mediterranea, Naples, Italy.
Ospedale Carlo Poma, Mantua, Italy.
Heart Rhythm. 2018 Nov;15(11):1675-1682. doi: 10.1016/j.hrthm.2018.04.011. Epub 2018 Apr 14.
Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials.
The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines.
We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization.
Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39-0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055).
In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.
专业指南基于现有最佳证据。然而,在临床实践中治疗的患者可能与参考试验中纳入的患者不同。
本研究旨在评估根据 2016 年欧洲心力衰竭(HF)指南对接受心脏再同步治疗(CRT)的大量 CRT 设备植入患者进行分层的 CRT 治疗效果。
我们从心脏再同步治疗模块注册中收集了 930 例连续患者的数据。主要终点是死亡和 HF 住院的复合终点。
563 例(60.5%)患者符合 I 类适应证,145 例(15.6%)为 IIa 类,108 例(11.6%)为 IIb 类,114 例(12.3%)为 III 类。中位随访 1001 天后,120 例(14.7%)有 CRT 适应证的患者死亡,71 例(8.7%)因 HF 住院。I 类适应证患者的终点时间更长(风险比 0.55;95%置信区间 0.39-0.76;P =.0001)。12 个月后,520 例患者中有 61.5%(320 例)的左心室(LV)收缩末期容积减少≥15%,而 676 例患者中有 57.5%(389 例)的 LV 射血分数绝对改善≥5%。I 类适应证的依从性也与 LV 射血分数增加>5%(P =.0142)和 LV 收缩末期容积减少≥15%(P =.0055)相关。
在我们的人群中,约 60%的患者根据 2016 年欧洲 HF 指南的 I 类适应证接受了植入。I 类适应证的依从性与较低的死亡率和 HF 住院率以及更好的 LV 逆向重构相关。