Preemptive transvalvular mechanical circulatory support is safe and feasible in high-risk cardiac surgery patients: Results of Impella-Protected Cardiac Surgery Trial
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Structured Abstract Objectives To assess the safety and feasibility of Impella 5.5-protected cardiac surgery in patients with severe left ventricular dysfunction. Methods IMPACT is a prospective, multicenter, single-arm study assessing the safety and feasibility of initiation of transvalvular left ventricular unloading prior to separation from cardiopulmonary bypass. Eligible patients had a reduced left ventricular ejection fraction with planned elective or urgent conventional cardiac surgery. Patients were supported with the Impella 5.5 for at least 24 hours post-operation. Key exclusion criteria included pre-operative inotropic or mechanical circulatory support. A clinical events committee adjudicated endpoint events. Results One hundred subjects were enrolled at 18 sites in the United States, all of whom successfully received the Impella 5.5. Baseline left ventricular ejection fraction was 25% (IQR: 21.6, 28.9%) and STS-PROM was 4.1% (IQR: 2.5, 7.1%). The index cardiac procedure was primarily isolated coronary artery bypass graft (56%) or coronary artery bypass graft+valve (35%). Post-cardiotomy cardiac failure through hospital discharge, the primary effectiveness endpoint, occurred in 6% of subjects. The composite of all-cause mortality, stroke and new requirement for renal replacement therapy through 90 days post-operation, primary safety endpoint, occurred in 12% of subjects. The 30- and 90-day mortality were 2% and 4%, respectively. Subjects had a favorable post-operative trajectory with low perioperative VIS (VIS max <10 within 24 hours post-operation), timely extubation (14.4 hours) and acceptable hospital length of stay (13.9 days). Conclusions Impella 5.5-protected cardiac surgery appears safe, feasible and is a promising device supported strategy for cardiac surgery patients with severe left ventricular dysfunction.
Authors: Daniel J. Goldstein, Edward G. Soltesz, George Batsides, Jay K. Bhama, Amit A. Pawale, David D'Alessandro, Timothy George, Akinobu Itoh, Mani A. Daneshmand, Masahiro Ono, Carly Lodewyks, Brian Solomon, Marisa Cevasco, Esther Vorovich, Jeffrey Teuteberg, Kevin W. Lobdell, Danny Ramzy, Alexandra May, Randi J. Parks, Sanjeev Aggarwal, Hermann Reichenspurner, Peter Kane, Koji Takeda, V. Seenu Reddy, Kevin Koomalsingh, Raymond C. Lee, Justin Reknor
Institutions: Albert Einstein College of Medicine, Cleveland Clinic, Hackensack University Medical Center, Hackensack Meridian School of Medicine, Washington University in St. Louis, Massachusetts General Hospital, Heart Hospital Baylor Plano, Brigham and Women's Hospital, Emory University, The University of Texas at Austin, Naples Community Hospital Healthcare System, Hospital of the University of Pennsylvania, Northwestern University, Stanford Medicine, Stanford University, Advocate Health Care, The University of Texas Health Science Center at Houston, Abiomed (United States), Universität Hamburg, University Medical Center Hamburg-Eppendorf
Language: English
Subfield: Biomedical Engineering
Field: Engineering
Domain: Physical Sciences
Open Access status: hybrid
Estimated APC paid: $4,500
Funders: Johnson and Johnson, Ethicon
OpenAlex ID: W7203993032