One-year outcomes after rapid-deployment aortic valve replacement

Christopher Young, Günther Laufer, Alfred Kocher, Marco Solinas, Francesco Alamanni, Gianluca Polvani, Bruno K Podesser, Jose Ignacio Aramendi, Jose Arribas, Olivier Bouchot, Ugolino Livi, Massimo Massetti, Kim Terp, Christophe Giot, Mattia Glauber

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: 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).

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: These results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting.

Original languageEnglish
Pages (from-to)575-585
Number of pages11
JournalJournal of Thoracic and Cardiovascular Surgery
Volume155
Issue number2
DOIs
Publication statusPublished - Feb 2018

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Young, C., Laufer, G., Kocher, A., Solinas, M., Alamanni, F., Polvani, G., Podesser, B. K., Aramendi, J. I., Arribas, J., Bouchot, O., Livi, U., Massetti, M., Terp, K., Giot, C., & Glauber, M. (2018). One-year outcomes after rapid-deployment aortic valve replacement. Journal of Thoracic and Cardiovascular Surgery, 155(2), 575-585. https://doi.org/10.1016/j.jtcvs.2017.09.133