Perioperative interdisciplinary optimisation of patients with heart failure undergoing non-cardiac surgery with intermediate or high surgical risk: the rationale and study protocol for the multicentre, randomised interventional PeriOP-CARE HF trial.

Abstract

Aim: Chronic heart failure (HF) is a frequent comorbidity in elderly patients undergoing major non-cardiac surgery with increasing prevalence. This trial aims to evaluate a new interdisciplinary, multimodal and individually optimised treatment strategy in patients with established or at risk for HF throughout the entire perioperative period.

Methods: The PeriOP-CARE HF trial is a prospective, multicentre, randomised, controlled and interventional trial. The primary hypothesis is that an interdisciplinary, intersectoral and standardised approach to the preoperative evaluation, optimisation and perioperative management of patients aged ≥ 65 years undergoing non-cardiac surgery with intermediate or high surgical risk and preoperative N-terminal pro-brain natriuretic peptide levels ≥ 450 pg/mL, will reduce postoperative morbidity. The preoperative evaluation includes clinical evaluations by anaesthesiologists and cardiologists, electrocardiography and echocardiography, as well as a discussion of these findings by a perioperative management team, where all involved specialities, including the speciality surgeon, will decide the perioperative treatment strategy for each patient. Intraoperative strategies include individualised haemodynamic optimisation. The interdisciplinary team and specialised HF nurses will screen patients for HF-related postoperative complications. The primary end point will be a composite morbidity end point, comprising any rehospitalisation, acute kidney injury, suspected or proven bacterial infection requiring treatment and acute decompensated HF at postoperative day 90.

Conclusion: The new treatment form can potentially reduce the morbidity burden after major non-cardiac surgery in patients with known or unknown HF. If the PeriOP-CARE HF trial yields positive results, the treatment of patients with HF undergoing major non-cardiac surgery could be considerably improved.

Trial registration: clinicaltrials.gov: NCT06381427, registered April 24, 2024.