Use of the impella system in high-risk patients undergoing non-cardiac surgery: a pilot study

Background: Patients with advanced heart failure are often deemed ineligible for non-cardiac surgery (NCS) due to poor hemodynamic reserve and increased perioperative risk. Mechanical circulatory support using the Impella device may stabilize cardiac function during surgery, enabling safe intervention in this population. This pilot study evaluates the feasibility, safety, and hemodynamic performance of SURGELLA, the perioperative use of Impella in high-risk patients undergoing NCS. Methods: This single-center, single-arm, retrospective pilot study (clinical trial number not applicable) included patients with heart failure and reduced left ventricular ejection fraction (≤ 35%) who underwent major NCS with perioperative Impella support between July 24, 2023, and February 17, 2025. Impella CP with SmartAssist was placed preoperatively. Primary endpoints were safety (30-day major adverse cardiac events) and efficacy (freedom from intraoperative hemodynamic compromise). Secondary endpoints included procedural complications, laboratory changes, and postoperative recovery. Hemodynamic and laboratory parameters were compared pre- and post-Impella support. Results: A total of 10 patients underwent Impella-supported NCS, including five gastrointestinal, four orthopedic, and one major vascular procedure. Mean duration of Impella support was 131.4 min. None of the patients experienced major adverse cardiac events, deaths from any cause, or Impella device malfunctions. Hemodynamic stability and organ function were maintained throughout the perioperative period, and only one patient experienced bleeding that required transfusion. The average time to hospital discharge following surgery was 8 ± 2 days, and median follow-up was 227 (interquartile range: 100-353) days. Conclusions: The results of this small pilot study demonstrate that Impella-supported NCS (SURGELLA) in high-risk heart failure patients appears feasible, safe, and effective in maintaining perioperative hemodynamic stability. These early data suggest that temporary mechanical support may expand surgical eligibility for patients with advanced cardiac dysfunction. Prospective studies are warranted to further assess the role of Impella compared to standard perioperative care in this high-risk population.