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One-year outcomes after rapid-deployment aortic valve replacement.

Authors
  • Young, Christopher1
  • Laufer, Günther2
  • Kocher, Alfred2
  • Solinas, Marco3
  • Alamanni, Francesco4
  • Polvani, Gianluca4
  • Podesser, Bruno K5
  • Aramendi, Jose Ignacio6
  • Arribas, Jose7
  • Bouchot, Olivier8
  • Livi, Ugolino9
  • Massetti, Massimo10
  • Terp, Kim11
  • Giot, Christophe12
  • Glauber, Mattia13
  • 1 St Thomas' Hospital, Cardiac Surgery Department, London, United Kingdom. Electronic address: [email protected] , (United Kingdom)
  • 2 Allgemeines Krankenhaus Wien, Cardiac Surgery Department, Vienna, Austria. , (Austria)
  • 3 Ospedale Del Cuore "G. Pasquinucci," Cardiac Surgery Department, Massa, Italy. , (Italy)
  • 4 Centro Cardiologico Monzino, Cardiac Surgery Department, Milan, Italy. , (Italy)
  • 5 Landesklinikum St Pölten, Cardiac Surgery Department, St Pölten, Austria. , (Austria)
  • 6 Centro Sanitario Hospital Universitario Cruces, Cardiac Surgery Department, Barakaldo, Spain. , (Spain)
  • 7 Hospital Universitario Virgen de La Arrixaca, Cardiac Surgery Department, Murcia, Spain. , (Spain)
  • 8 CHU du Bocage, Cardiac Surgery Department, Dijon, France. , (France)
  • 9 Santa Maria della Misericordia, Cardiac Surgery Department, Udine, Italy. , (Italy)
  • 10 Policlinico Universitario Agostino Gemelli, Cardiac Surgery Department, Rome, Italy. , (Italy)
  • 11 Aarhus University Hospital Skejby, Cardiac Surgery Department, Aarhus, Denmark. , (Denmark)
  • 12 Edwards Lifesciences SA, Nyon, Switzerland. , (Switzerland)
  • 13 Istituto Clinico San Ambrogio, Cardiac Surgery Department, Milan, Italy. , (Italy)
Type
Published Article
Journal
The Journal of thoracic and cardiovascular surgery
Publication Date
Feb 01, 2018
Volume
155
Issue
2
Pages
575–585
Identifiers
DOI: 10.1016/j.jtcvs.2017.09.133
PMID: 29415382
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The 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). Assessing 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. Between 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. These results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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