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
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...
May 15, 2024: European Heart Journal