ERAS protocol reduced 1-year cardiac-related in-hospital stay by 29% (adjusted ratio 0.71, p<0.01) with similar physical performance at discharge in minimally invasive valve surgery patients.
Does an Enhanced Recovery After Surgery (ERAS) protocol reduce in-hospital stay and maintain physical performance compared to standard of care in patients undergoing minimally invasive heart valve surgery?
An ERAS protocol in minimally invasive heart valve surgery is safe and feasible, and while it did not significantly reduce the primary endpoint of in-hospital stay at 1 year in the main analysis, it maintained physical performance at discharge.
Absolute Event Rate: 0% vs 0%
Abstract Background Enhanced recovery after surgery (ERAS) protocols are patient-centered and interprofessional perioperative care models, aiming to reduce hospital stay, complications, and to improve patient satisfaction. However, in cardiac surgery, the evidence for ERAS is low. Purpose The INCREASE trial aims to evaluate the efficacy and the safety of ERAS-based intervention in cardiac surgery. Methods The INCREASE trial is a randomized, parallel, two-arm trial designed to compare the ERAS protocol with standard of care in minimally invasive heart valve surgery. The trial was conducted in an interprofessional consortium consisting of 2 university hospitals, 7 referring hospitals, 8 rehabilitation centers, a health insurance company and a patient organization. The intervention group (IG) received treatment according to the standardized ERAS protocol, which included prehabilitation, early extubation, and modifications in the postoperative care e.g., physiotherapy beginning at 3hours postoperatively. The control group (CG) received treatment as usual. Two co-primary endpoints were considered: a) in-hospital stay (days) within 1 year after surgery due to cardiac causes (superiority hypothesis), b) physical performance measured by 6-minute walk test (6MWT) at hospital discharge (non-inferiority hypothesis). Primary outcome analysis included only surgically treated patients (modified intention to treat (mITT) population). Results 201 patients (mean age 57±13 years, 72% male) scheduled for minimally invasive valve surgery were randomized into IG (n=101) and CG (n=100) between 09/2021 and 05/2023. 190 patients (93 IG vs. 97 CG) served as mITT population. Total weighted in-hospital stay (weights= individual study duration) within 1 year after surgery due to cardiac causes was 9.0±11.6 days in the IG and 11.7±13.1 days in the CG (adjusted mean difference -2.7, 95%CI (-6.3, 0.9), p=0.07). Sensitivity analyses using the negative binomial model revealed an adjusted ratio of 0.71, 95% CI (0.6, 0.85), p0.01) in favor of IG. The 6MWT measured 380.0±117.5 m in the IG vs 382.8±106.0 m in the CG in the per-protocol (PP) population. After adjustment for baseline 6MWT, the mean difference between the groups was -14%, 95%CI (-43%, 15%) with the lower limit of the confidence interval exceeding the non-inferiority margin of -15% (one-sided p=0.48). Without adjustment for baseline, a mean difference in 6MWT values between the groups was -1%, 95%CI (-10%, 8%), reaching non-inferiority in the IG (one-sided p=0.001). Conclusions The ERAS protocol is feasible and safe in minimally invasive heart valve surgery. Despite the fact that the primary endpoint was not achieved, ERAS treated patients had shorter in-hospital stay within 1 year after surgery due to cardiac reasons compared to the control group. Despite earlier hospital discharge, ERAS patients had similar physical performance to the control group when the difference in the baseline 6MWT was disregarded.INCREASE flow chart INCREASE study flow diagram
Girdauskas et al. (Sat,) reported a other. ERAS protocol reduced 1-year cardiac-related in-hospital stay by 29% (adjusted ratio 0.71, p<0.01) with similar physical performance at discharge in minimally invasive valve surgery patients.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: