Objectives: A new class of rapid-deployment aortic valves has emerged with the potential to simplify minimally invasive aortic surgery and reduce crossclamp and cardiopulmonary bypass times. We report the 1-year clinical outcomes of aortic valve replacement with the EDWARDS INTUITY Valve System (Edwards Lifesciences LLC, Irvine, Calif) in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial.
Methods: Seventeen surgeons from 6 European centers treated 152 consecutive patients with aortic stenosis requiring valve replacement in a prospective, single-arm trial. A stented trileaflet bovine pericardial bioprosthesis with a balloon-expandable, cloth-covered stent frame at the inflow aspect was implanted in 146 patients (mean age, 75.5 ± 6.7 years; 52.7% were female). Five valve sizes were evaluated (19-27 mm); 58.9% of cases had isolated aortic valve replacement, and 41.1% of cases involved concomitant procedures. Minimally invasive surgical approaches occurred in 48.8% of the isolated aortic valve replacements. Patients were followed at discharge, 3 months, and 1 year postoperatively.
Results: Implantation success was 96.1% (146/152), early valve-related mortality was 1.4% (2/146), and cumulative survival was 92.5% at a mean follow-up of 9.8 ± 5.1 months. Crossclamp time for isolated aortic valve replacement was 41.1 ± 10.6 minutes. Independent core laboratory-adjudicated mean effective orifice area and aortic valve pressure gradient were 1.7 ± 0.2 cm(2) and 8.8 ± 3.0 mm Hg at 3 months, and 1.7 ± 0.2 cm(2) and 8.4 ± 3.4 mm Hg at 1 year, respectively.
Conclusions: Implantation of the EDWARDS INTUITY Valve System is feasible, safe, and efficacious for aortic valve replacement. Aortic crossclamp and cardiopulmonary bypass times were reduced compared with those for conventional aortic valve replacement. Early hemodynamic performance was excellent and remained so up to 1 year.
Trial registration: ClinicalTrials.gov NCT01445171.
Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.