ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Coronary Artery Disease
This article is part of the Research TopicCoronary Artery Disease in Young Adults: Epidemiology, Clinical Insights and ManagementView all 3 articles
Clinical Outcomes of Aortic Stenosis Patients Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention
Provisionally accepted
Poonam Velagapudi1
Lavanya Bellumkonda2
David J Cohen3Alexandra J Lansky2
Arsalan Abu-Much3Julia B Thompson3
Michael Schonning3*Björn Redfors3Zhipeng Zhou3Cindy L Grines4Aneel S Maini3Yanru Li3
Wayne Batchelor5
William O'Neill6*- 1University of Nebraska Medical Center, Omaha, United States
- 2Yale School of Medicine, New Haven, United States
- 3Cardiovascular Research Foundation, New York, United States
- 4Northside Hospital Heart Institute, Atlanta, United States
- 5Inova Heart and Vascular Institute, Falls Church, United States
- 6Henry Ford Hospital, Detroit, United States
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ABSTRACT Background: Severe aortic stenosis (AS) is associated with an increased risk of adverse outcomes in patients undergoing percutaneous coronary intervention (PCI). While Impella-supported high-risk PCI (HRPCI) has demonstrated improved outcomes, its safety in patients with AS is inadequately established. Objectives: We evaluated the effectiveness and safety of Impella support in patients with AS undergoing HRPCI. Methods: Patients in the PROTECT III study (NCT04136392), a single-arm, FDA-audited, multicenter study of patients undergoing Impella-supported HRPCI were assessed. AS severity was classified as: none/trivial, mild, moderate, or severe. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE: the composite of all-cause death, MI, stroke/transient ischemic attack (TIA), and revascularization). Secondary outcomes included in-hospital complications, stroke/TIA, and vascular complications requiring surgery. Results: Of the 594 patients with available echocardiographic data, 490 had none/trivial AS, and 34, 24, and 46 had mild, moderate, or severe AS, respectively. Patients with AS were older, had fewer incidences of diabetes, were more likely to have left main disease, and had higher left ventricular ejection fraction. Severely calcified lesions and atherectomy were more frequent among patients with moderate or severe AS. There were no differences in the rates of PCI-related complications, stroke/TIA, and 30-day or 90-day MACCE according to AS severity. However, transfusion rates were higher among patients with AS. Conclusion: In patients undergoing Impella-supported HRPCI, 90-day MACCE and PCI-related complications were similar across AS severity levels. These findings suggest the procedural safety in this complex, high-risk population.
Keywords: high-risk percutaneous coronary intervention, aortic stenosis, Mechanical circulatory support, Major adverse cardiovascular and cerebrovascular events, ProTECT III
Received: 30 May 2025; Accepted: 28 Nov 2025.
Copyright: © 2025 Velagapudi, Bellumkonda, Cohen, Lansky, Abu-Much, Thompson, Schonning, Redfors, Zhou, Grines, Maini, Li, Batchelor and O'Neill. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Michael Schonning
William O'Neill
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