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

Danny Dvir; Didier Tchétché; Martin B Leon; Philippe Généreux; Benjamin Seguy; Raj Makkar; Philippe Pibarot; Hemal Gada; Tamim Nazif; David Hildick-Smith; Jörg Kempfert; Nicolas Dumonteil; Axel Unbehaun; Thomas Modine; Brian Whisenant; Christophe Caussin; Lenard Conradi; Thomas Waggoner; Jacob M Mishell; Stanley J Chetcuti; Saibal Kar; Michael J Rinaldi; Molly Szerlip; Ravi K Ramana; Daniel J Blackman; Itsik Ben-Dor; Ran Kornowski; Ron Waksman; Ulrich Gerckens; Paolo Denti; Marian Kukucka; Julien Ternacle; Sabah Skaf; Jan Kovac; Hasan Jilaihawi; Vivek Patel; Rami Jubeh; Mohamed Abdel-Wahab; Susheel Kodali

doi:10.1093/eurheartj/ehae303

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

Eur Heart J. 2024 May 15:ehae303. doi: 10.1093/eurheartj/ehae303. Online ahead of print.

Authors

Danny Dvir¹, Didier Tchétché², Martin B Leon³, Philippe Généreux⁴, Benjamin Seguy⁵, Raj Makkar⁶, Philippe Pibarot⁷, Hemal Gada⁸, Tamim Nazif⁹, David Hildick-Smith¹⁰, Jörg Kempfert¹¹, Nicolas Dumonteil², Axel Unbehaun¹¹, Thomas Modine⁵, Brian Whisenant¹², Christophe Caussin¹³, Lenard Conradi¹⁴, Thomas Waggoner¹⁵, Jacob M Mishell¹⁶, Stanley J Chetcuti¹⁷, Saibal Kar¹⁸, Michael J Rinaldi¹⁹, Molly Szerlip²⁰, Ravi K Ramana²¹, Daniel J Blackman²², Itsik Ben-Dor²³, Ran Kornowski²⁴, Ron Waksman²³, Ulrich Gerckens²⁵, Paolo Denti²⁶, Marian Kukucka¹¹, Julien Ternacle⁵, Sabah Skaf⁶, Jan Kovac²⁷, Hasan Jilaihawi⁶, Vivek Patel⁶, Rami Jubeh¹, Mohamed Abdel-Wahab²⁸, Susheel Kodali⁹

Affiliations

¹ Department of Cardiology, Shaare Zedek Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Israel.
² Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
³ Columbia University Medical Center, NewYork-Presbyterian Hospital, Cardiovascular Research Foundation, New York, New York, USA.
⁴ Gagnon Cardiovascular Institute at Morristown Medical Center, NJ, USA.
⁵ CHU de Bordeaux, Bordeaux, France.
⁶ Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁷ Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
⁸ UPMC Harrisburg/Pinnacle Health Cardiovascular Institute, Wormleysburg, Pennsylvania, USA.
⁹ Columbia University Medical Center, New York Presbyterian, New York, New York, USA.
¹⁰ University Hospital Sussex, Royal Sussex County Hospital, Brighton, UK.
¹¹ 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.
¹² Department of Cardiology, Intermountain Medical Center, Salt Lake City, Utah, USA.
¹³ Institut Mutualiste Montsouris, Paris, France.
¹⁴ University Heart & Vascular Center Hamburg, Germany.
¹⁵ US Heart & Vascular, Tucson Medical Center, Tucson, Arizona, USA.
¹⁶ Kaiser Permanente Northern California Structural Heart Program, San Francisco, CA, USA.
¹⁷ University of Michigan, Ann Arbor, Michigan, USA.
¹⁸ Los Robles Regional Medical Center, Thousand Oaks, California, USA.
¹⁹ Carolinas Medical Center, Charlotte, North Carolina, USA.
²⁰ Baylor Scott & White The Heart Hospital, Plano, Texas, USA.
²¹ Advocate Christ Medical Center Oak Lawn, Illinois, USA; Heart Care Centers of Illinois, Palos Park, IL, USA.
²² Leeds Teaching Hospitals, Leeds, UK.
²³ Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
²⁴ Rabin Medical Center, Petah Tikva & Faculty of Medicine, Tel Aviv University, Israel.
²⁵ Bonn, Germany.
²⁶ Cardiac Surgery Departement, San Raffaele University Hospital, Milan, Italy.
²⁷ University Hospital of Leicester, Leicester, UK.
²⁸ Heart Center Leipzig at University of Leipzig, Leipzig, Germany.

PMID: 38747561
DOI: 10.1093/eurheartj/ehae303

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.

Keywords: Transcatheter aortic valve implantation; Valve Academic Research Consortium; Valve in Valve; Virtual Transcatheter Heart Valve To Coronary Artery; Virtual Transcatheter Heart Valve To Sinotubular Junction.