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远程预康复对择期心脏手术后不良事件的影响:一项随机对照试验。

The Effect of Teleprehabilitation on Adverse Events After Elective Cardiac Surgery: A Randomized Controlled Trial.

作者信息

Scheenstra Bart, van Susante Lieke, Bongers Bart C, Lenssen Ton, Knols Henriette, van Kuijk Sander, Nieman Maxime, Maessen Jos, Van't Hof Arnoud, Sardari Nia Peyman

机构信息

Department of Cardiothoracic Surgery, Heart and Vascular Center, Maastricht University Medical Center, Maastricht, the Netherlands; Department of Cardiothoracic Surgery, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, the Netherlands.

Department of Cardiothoracic Surgery, Heart and Vascular Center, Maastricht University Medical Center, Maastricht, the Netherlands.

出版信息

J Am Coll Cardiol. 2025 Mar 4;85(8):788-800. doi: 10.1016/j.jacc.2024.10.064. Epub 2024 Oct 11.

Abstract

BACKGROUND

Patients scheduled for cardiac surgery and procedures often present with modifiable risk factors for adverse perioperative outcomes. Prehabilitation has shown potential to enhance mental and physical fitness; however, its effect on clinical cardiovascular endpoints in this population has not been studied.

OBJECTIVES

The current trial was designed to evaluate the effect of a personalized multimodal teleprehabilitation on the incidence of composite endpoint on major adverse cardiovascular events in patients scheduled for elective cardiac surgery.

METHODS

In a multicenter randomized controlled trial, 394 patients awaiting elective cardiac surgery and procedures were enrolled. Of these, 197 patients were randomized to an online multimodal personalized teleprehabilitation program through shared decision-making by a multidisciplinary team, and 197 were assigned to a control group. The primary outcome was major adverse cardiovascular events (ie, cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure or other life-threatening cardiac events, and earlier or repeated intervention), as measured from the randomization until 1-year postoperatively. All events were adjudicated by a blinded event committee. Secondary outcomes included length of hospital stay, postoperative complications, quality of life, adherence to the program, and effect on the incidence of modifiable risk factors. Sensitivity analyses of the primary outcome were conducted adjusting for baseline characteristics to evaluate the consistency of treatment effects.

RESULTS

From randomization until 1 year postoperatively, the primary endpoint occurred in 33 patients (16.8%) in the teleprehabilitation group and 50 patients (25.5%) in the control group (difference 8.8%; 95% CI: 0.7%-16.8%; P = 0.032). This difference was primarily driven by a reduction in hospitalizations, and the sensitivity analyses showed that treatment effect was mainly in the patients undergoing a cardiac surgery rather than transcatheter procedures with adjusted OR of 0.54 (95% CI: 0.30-0.96; P = 0.035). Teleprehabilitation also reduced the incidence of active smokers, elevated pulmonary risk scores, and elevated depression scores. There was no significant difference in postoperative length of hospital stay, occurrence of postoperative complications, physical fitness, incidence of obesity, or malnutrition.

CONCLUSIONS

Multimodal personalized teleprehabilitation resulted in a clinically relevant and statistically significant reduction of the primary endpoint in patients undergoing cardiac surgery. (Digital Cardiac Counseling Trial: DCC Trial [DCC]; NCT04393636).

摘要

背景

计划进行心脏手术及相关操作的患者通常存在可改变的围手术期不良结局风险因素。术前康复已显示出增强心理和身体健康的潜力;然而,其对该人群临床心血管终点的影响尚未得到研究。

目的

本试验旨在评估个性化多模式远程术前康复对计划进行择期心脏手术患者主要不良心血管事件复合终点发生率的影响。

方法

在一项多中心随机对照试验中,纳入了394例等待择期心脏手术及相关操作的患者。其中,197例患者通过多学科团队的共同决策被随机分配至在线多模式个性化远程术前康复项目组,197例被分配至对照组。主要结局为主要不良心血管事件(即心血管死亡、心肌梗死、中风、因心力衰竭或其他危及生命的心脏事件住院,以及早期或重复干预),从随机分组至术后1年进行测量。所有事件均由一个盲法事件委员会判定。次要结局包括住院时间、术后并发症、生活质量、项目依从性以及对可改变风险因素发生率的影响。对主要结局进行敏感性分析,调整基线特征以评估治疗效果的一致性。

结果

从随机分组至术后1年,远程术前康复组有33例患者(16.8%)发生主要终点事件,对照组有50例患者(25.5%)发生(差异8.8%;95%置信区间:0.7%-16.8%;P = 0.032)。这种差异主要是由于住院次数减少所致,敏感性分析表明治疗效果主要体现在接受心脏手术的患者中,而非接受经导管操作的患者,调整后的比值比为0.54(95%置信区间:0.30-0.96;P = 0.035)。远程术前康复还降低了现吸烟者的发生率、升高的肺部风险评分以及升高的抑郁评分。术后住院时间、术后并发症发生率、身体健康状况、肥胖发生率或营养不良发生率方面无显著差异。

结论

多模式个性化远程术前康复使接受心脏手术的患者主要终点在临床和统计学上有显著降低。(数字心脏咨询试验:DCC试验[DCC];NCT04393636)

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