Preoperative Risk Assessment and Shared Decision-Making in Older Patients Eligible for Cardiac Surgery: Protocol for a Non-Randomized Prospective Study

Background: The number of older patients undergoing cardiac surgery is increasing, and a substantial proportion of these patients are frail. Frailty is associated with increased mortality, psychological complications, functional decline, and reduced health-related quality of life, complicating treatment decision-making. Currently, treatment recommendations are formulated by the multidisciplinary Heart Team and are mainly based on disease-related parameters. To better integrate patient preferences, geriatric assessment, and shared decision-making into routine cardiothoracic practice, a nurse-led preoperative outpatient pathway was developed: the Preoperative RIsk assessment and shared decision-Making in patients Eligible for cardiac surgery (PRIME) clinic. This study aims to evaluate whether the implementation of PRIME consultation influences Heart Team treatment recommendations and to assess its cost-effectiveness. Methods: This single-center, non-randomized prospective study is conducted in the Netherlands. Patients aged ≥70 years who are eligible for cardiac surgery and have two or more risk factors for adverse postoperative outcomes are included. All patients are initially discussed in the Heart Team, resulting in a treatment recommendation. Patients in the intervention group subsequently visit the PRIME clinic, where a comprehensive geriatric assessment and a shared decision-making consultation are performed. Following this visit, patients are re-evaluated by the Heart Team. The primary outcome is the comparison between the initial and subsequent Heart Team treatment recommendations. Secondary outcomes include health-related quality of life and cost-effectiveness. Discussion: This prospective exploratory study evaluates the implementation of a novel, patient-centered preoperative care model integrating geriatric assessment and shared decision-making into routine cardiac surgical practice. By focusing on outcomes meaningful to older patients and their relatives, the study contributes to the development of value-based, individualized surgical care. Trial registration: The PRIME study was registered in ClinicalTrials.gov (trial registration number: NCT06616129).