Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing

• Published in: JACC. Cardiovascular interventions Vol. 12; no. 21; pp. 2198 - 2206
• Main Authors: Rogers, Toby, Greenbaum, Adam B, Babaliaros, Vasilis C, Stine, Annette M, Khan, Jaffar M, Schenke, William H, Eng, Marvin H, Paone, Gaetano, Leshnower, Bradley G, Satler, Lowell F, Waksman, Ron, Chen, Marcus Y, Lederman, Robert J
• Format: Journal Article
• Language: English
• Published: United States 11.11.2019
• Subjects: Aged; Aged, 80 and over; Animals; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - surgery; Catheterization, Peripheral - adverse effects; Catheterization, Peripheral - instrumentation; Equipment Design; Feasibility Studies; Female; Femoral Artery - diagnostic imaging; Hemorrhage - etiology; Hemorrhage - prevention & control; Hemostatic Techniques - adverse effects; Hemostatic Techniques - instrumentation; Humans; Male; Models, Animal; Prospective Studies; Punctures; Risk Factors; Sus scrofa; Time Factors; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - instrumentation; Treatment Outcome; United States; Vascular Closure Devices; Venae Cavae - diagnostic imaging; United States; transcatheter aortic valve replacement; early feasibility study; first-in-human; transcaval access and closure

This study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD). Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol card...