One-year outcomes after rapid-deployment aortic valve replacement

The Journal of Thoracic and Cardiovascular Surgery

Ugolino Livi¹  Günther Laufer²  Jose Ignacio Aramendi³  Marco Solinas⁴  Gianluca Polvani⁵  Massimo Massetti⁶  Bruno K. Podesser⁷  Kim Terp⁸  Francesco Alamanni⁹  Alfred Kocher^1,10  Olivier Bouchot^1,11  Jose Arribas^1,12  Christopher Young^1,13 

[1] Aarhus University Hospital Skejby, Cardiac Surgery Department, Aarhus, Denmark;Allgemeines Krankenhaus Wien, Cardiac Surgery Department, Vienna, Austria;CHU du Bocage, Cardiac Surgery Department, Dijon, France;Centro Cardiologico Monzino, Cardiac Surgery Department, Milan, Italy;Centro Sanitario Hospital Universitario Cruces, Cardiac Surgery Department, Barakaldo, Spain;Edwards Lifesciences SA, Nyon, Switzerland;Hospital Universitario Virgen de La Arrixaca, Cardiac Surgery Department, Murcia, Spain;Istituto Clinico San Ambrogio, Cardiac Surgery Department, Milan, Italy;Landesklinikum St Pölten, Cardiac Surgery Department, St Pölten, Austria;Ospedale Del Cuore “G. Pasquinucci,” Cardiac Surgery Department, Massa, Italy;Policlinico Universitario Agostino Gemelli, Cardiac Surgery Department, Rome, Italy;Santa Maria della Misericordia, Cardiac Surgery Department, Udine, Italy;St Thomas' Hospital, Cardiac Surgery Department, London, United Kingdom

关键词: aortic valve replacement;    bioprosthesis;    heart valve;    hemodynamics;   

DOI  :  10.1016/j.jtcvs.2017.09.133

学科分类：心脏病和心血管学

来源: Mosby, Inc.

【 摘 要 】

ObjectiveThe goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif).MethodsAssessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system. During rapid-deployment aortic valve replacement, device technical success and crossclamp time were assessed. Procedural outcomes, hemodynamic performance, and various adverse events and clinical outcomes were evaluated up to 2 years.ResultsBetween 2012 and 2014, 493 of 517 enrolled patients successfully received implants with the study valve (95.4% technical success). Mean crossclamp times for 163 full sternotomies, 128 mini-upper sternotomies, and 36 right anterior thoracotomies isolated aortic valve replacements were 47.3, 52.0, and 73.3 minutes, respectively. Mean follow-up was 1.8 years, with 870 total patient-years of follow-up. Mean effective orifice area increased from 0.72 (baseline) to 1.88 cm2, and mean pressure gradient decreased from 47.6 to 9.6 mm Hg (1 year). Mean effective orifice area index increased (0.39-1.01 cm2/m2), and 28 of 287 patients (9.8%) exhibited severe prosthesis–patient mismatch at 1 year. After 1 year, 68.1% and 21.7% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major perivalvular leak, reoperation, and device explant at 1 year were 0.935, 0.939, 0.976, 0.975, and 0.983, respectively.ConclusionsThese results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting.

【 授权许可】

Unknown