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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 (MACE) in patients scheduled for elective cardiac surgery. METHODS: In a multicentre 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 MACE, (i.e., 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 one 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% confidence interval (CI) 0.7 to 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 odds ratio 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. CLINICALTRIALS: gov (NCT04393636).
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OBJECTIVES: Prehabilitation through a digital platform could preoperatively improve the physical and mental fitness of patients undergoing cardiothoracic surgery, thereby improving treatment outcomes. This study aimed to describe the reasons and predictors of non-participation in a personalized digital prehabilitation care trial (Digital Cardiac Counseling randomized controlled trial) for patients undergoing elective cardiothoracic surgery. METHODS: Adult patients scheduled for elective cardiothoracic surgery at the Maastricht University Medical Center+ were approached to participate in a digital prehabilitation care trial, in which patients were informed about their care pathway, monitored for symptom progression and screened for preoperative modifiable risk factors. Baseline characteristics of all eligible patients and reasons of non-participation were registered prospectively. Predictors of non-participation were determined using logistic regression. RESULTS: Between May 2020 and August 2022, 815 patients were eligible for participation; 421 (52%) did not participate in the personalized digital prehabilitation care trial. Reasons for non-participation were 'lack of internet access or insufficient digital skills' (32%), 'wishing no participation' (39%) and 'other reasons' (30%; e.g. vision or hearing impairments, analphabetism, language barriers). Independent predictors of non-participation were age [odds ratio (OR) 1.024 (1.003-1.046), P = 0.024], socioeconomic status [OR 0.267 (0.133-0.536), P < 0.001], current smoker [OR 1.823 (1.124-2.954), P = 0.015] and EuroSCORE II [OR 1.160 (1.042-1.292), P = 0.007]. CONCLUSIONS: Half of the eligible patients did not participate in a personalized digital prehabilitation care trial. Non-participants were vulnerable patients, with a more unfavourable risk profile and more modifiable risk factors, who could potentially benefit the most from prehabilitation.