Johannes Petersen, Sina Stock, Christian Brettschneider, Luisa Dolata, Christian Dumps, Bernd Löwe, Eric Nijman, Ann-Kathrin Ozga, Hermann Reichenspurner, Mona Elisabeth Schmid, Leonie Schulte-Uentrop, Eik Vettorazzi, Antonia Zapf, Inke Zastrow, Susanne G. R. Klotz, Evaldas Girdauskas
- Objectives: Enhanced recovery after surgery (ERAS) protocols are patient-centered, interprofessional perioperative care models aimed at reducing hospital stays, complications, healthcare costs, and improving patient satisfaction. Evidence for ERAS in cardiac surgery is scarce; therefore, we aimed to assess its efficacy and safety in minimally invasive heart valve surgery (MIHS).
Methods: INCREASE is a randomized-controlled trial that compares ERAS with standard care in MIHS. The intervention group (IG) received ERAS-based treatment; the control group (CG) standard care. Co-primary endpoints were in-hospital stay for cardiovascular reasons within one year postoperatively (superiority hypothesis) and physical performance (six-minute walk test (6MWT)) at discharge (non-inferiority hypothesis). Superiority hypothesis was tested primarily in surgically treated patients (modified intention to treat population), while non-inferiority hypothesis was tested in per protocolObjectives: Enhanced recovery after surgery (ERAS) protocols are patient-centered, interprofessional perioperative care models aimed at reducing hospital stays, complications, healthcare costs, and improving patient satisfaction. Evidence for ERAS in cardiac surgery is scarce; therefore, we aimed to assess its efficacy and safety in minimally invasive heart valve surgery (MIHS).
Methods: INCREASE is a randomized-controlled trial that compares ERAS with standard care in MIHS. The intervention group (IG) received ERAS-based treatment; the control group (CG) standard care. Co-primary endpoints were in-hospital stay for cardiovascular reasons within one year postoperatively (superiority hypothesis) and physical performance (six-minute walk test (6MWT)) at discharge (non-inferiority hypothesis). Superiority hypothesis was tested primarily in surgically treated patients (modified intention to treat population), while non-inferiority hypothesis was tested in per protocol population.
Results: In total, 201 patients scheduled for MIHS were randomized (IG: 101; CG: 100). Total weighted in-hospital stay within one year was non-significantly shorter in the IG (adjusted mean difference -2.7 days, 95% confidence interval (CI) (-6.3, 0.9), one-sided p = 0.07). Sensitivity analyses favoured the IG (adjusted ratio 0.71, 95%CI (0.6, 0.85)). For 6MWT, adjusted mean difference was -14%, 95%CI (-43%, 15%) exceeding the non-inferiority margin of -15% (one-sided p = 0.48). Without baseline adjustment, 6MWT values revealed a mean difference between groups of -1%, 95%CI (-10%, 8%), reaching non-inferiority of the IG. Safety outcomes were comparable with the exception of an unexpected higher rate of post-operative atrial fibrillation in patients randomized to ERAS.
Conclusions: ERAS is feasible and safe in MIHS. The trial did not demonstrate a reduction in length of hospital stay in the population studied. Exploratory analyses suggest that further evaluation of ERAS concepts is justified.…
