Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study
Recommended Citation
Dvir D, Tchétché D, Leon MB, Généreux P, Seguy B, Makkar R, Pibarot P, Gada H, Nazif T, Hildick-Smith D, Kempfert J, Dumonteil N, Unbehaun A, Modine T, Whisenant B, Caussin C, Conradi L, Waggoner T, Mishell JM, Chetcuti SJ, Kar S, Rinaldi MJ, Szerlip M, Ramana RK, Blackman DJ, Ben-Dor I, Kornowski R, Waksman R, Gerckens U, Denti P, Kukucka M, Ternacle J, Skaf S, Kovac J, Jilaihawi H, Patel V, Jubeh R, Abdel-Wahab M, Kodali S. Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study. Eur Heart J. 2024 Sep 1;45(33):3031-3041. doi: 10.1093/eurheartj/ehae303. PMID: 38747561; PMCID: PMC11365606.
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
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
Affiliations
Advocate Christ Medical Center