Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study

Danny Dvir, Department of Cardiology, Shaare Zedek Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Israel.
Didier Tchétché, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
Martin B. Leon, Columbia University Medical Center, NewYork-Presbyterian Hospital, Cardiovascular Research Foundation, New York, New York, USA.
Philippe Généreux, Gagnon Cardiovascular Institute at Morristown Medical Center, NJ, USA.
Benjamin Seguy, CHU de Bordeaux, Bordeaux, France.
Raj Makkar, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Philippe Pibarot, Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
Hemal Gada, UPMC Harrisburg/Pinnacle Health Cardiovascular Institute, Wormleysburg, Pennsylvania, USA.
Tamim Nazif, Columbia University Medical Center, New York Presbyterian, New York, New York, USA.
David Hildick-Smith, University Hospital Sussex, Royal Sussex County Hospital, Brighton, UK.
Jörg Kempfert, Deutsches Herzzentrum der Charité, Department of Cardiothoracic and Vascular Surgery, Berlin, Germany Charité-Universitätsmedizin Berlin, Germany DZHK (German Center for Cardiovascular Research), Partner Site Berlin, Germany.
Nicolas Dumonteil, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
Axel Unbehaun, Deutsches Herzzentrum der Charité, Department of Cardiothoracic and Vascular Surgery, Berlin, Germany Charité-Universitätsmedizin Berlin, Germany DZHK (German Center for Cardiovascular Research), Partner Site Berlin, Germany.
Thomas Modine, CHU de Bordeaux, Bordeaux, France.
Brian Whisenant, Department of Cardiology, Intermountain Medical Center, Salt Lake City, Utah, USA.
Christophe Caussin, Institut Mutualiste Montsouris, Paris, France.
Lenard Conradi, University Heart & Vascular Center Hamburg, Germany.
Thomas Waggoner, US Heart & Vascular, Tucson Medical Center, Tucson, Arizona, USA.
Jacob M. Mishell, Kaiser Permanente Northern California Structural Heart Program, San Francisco, CA, USA.
Stanley J. Chetcuti, University of Michigan, Ann Arbor, Michigan, USA.
Saibal Kar, Los Robles Regional Medical Center, Thousand Oaks, California, USA.
Michael J. Rinaldi, Carolinas Medical Center, Charlotte, North Carolina, USA.
Molly Szerlip, Baylor Scott & White The Heart Hospital, Plano, Texas, USA.
Ravi K. Ramana, Advocate Health - MidwestFollow
Daniel J. Blackman, Leeds Teaching Hospitals, Leeds, UK.
Itsik Ben-Dor, Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
Ran Kornowski, Rabin Medical Center, Petah Tikva & Faculty of Medicine, Tel Aviv University, Israel.
Ron Waksman, Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
Ulrich Gerckens, Bonn, Germany.
Paolo Denti, Cardiac Surgery Departement, San Raffaele University Hospital, Milan, Italy.
et al

Affiliations

Advocate Christ Medical Center

Abstract

Background and aims:This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction.

Methods:This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board.

Results:Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths.

Conclusions:Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Document Type

Article

PubMed ID

38747561

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