TY - JOUR
T1 - One-year outcomes after rapid-deployment aortic valve replacement
AU - Young, Christopher
AU - Laufer, Günther
AU - Kocher, Alfred
AU - Solinas, Marco
AU - Alamanni, Francesco
AU - Polvani, Gianluca
AU - Podesser, Bruno K
AU - Aramendi, Jose Ignacio
AU - Arribas, Jose
AU - Bouchot, Olivier
AU - Livi, Ugolino
AU - Massetti, Massimo
AU - Terp, Kim
AU - Giot, Christophe
AU - Glauber, Mattia
N1 - Publisher Copyright:
© 2017 The American Association for Thoracic Surgery
PY - 2018/2
Y1 - 2018/2
N2 - 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.
AB - 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.
KW - Aged
KW - Aged, 80 and over
KW - Aorta/surgery
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Insufficiency/diagnostic imaging
KW - Aortic Valve Stenosis/diagnostic imaging
KW - Constriction
KW - Europe
KW - Female
KW - Heart Valve Prosthesis
KW - Heart Valve Prosthesis Implantation/adverse effects
KW - Hemodynamics
KW - Humans
KW - Male
KW - Middle Aged
KW - Operative Time
KW - Postoperative Complications/surgery
KW - Product Surveillance, Postmarketing
KW - Prospective Studies
KW - Recovery of Function
KW - Registries
KW - Reoperation
KW - Risk Factors
KW - Sternotomy
KW - Thoracotomy
KW - Time Factors
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85044320146&partnerID=8YFLogxK
U2 - 10.1016/j.jtcvs.2017.09.133
DO - 10.1016/j.jtcvs.2017.09.133
M3 - Journal article
C2 - 29415382
SN - 0022-5223
VL - 155
SP - 575
EP - 585
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 2
ER -