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.
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.
Authors: Marco Di Eusanio; Kevin Phan; Denis Bouchard; Thierry P Carrel; Otto E Dapunt; Roberto Di Bartolomeo; Harald C Eichstaedt; Theodor Fischlein; Thierry Folliguet; Borut Gersak; Mattia Glauber; Axel Haverich; Martin Misfeld; Peter J Oberwalder; Giuseppe Santarpino; Malakh Lal Shrestha; Marco Solinas; Marco Vola; Francesco Alamanni; Alberto Albertini; Gopal Bhatnagar; Michel Carrier; Stephen Clark; Federic Collart; Utz Kappert; Alfred Kocher; Bart Meuris; Carmelo Mignosa; Ahmed Ouda; Marc Pelletier; Parwis Baradaran Rahmanian; David Reineke; Kevin Teoh; Giovanni Troise; Emmanuel Villa; Thorsten Wahlers; Tristan D Yan Journal: Ann Cardiothorac Surg Date: 2015-03
Authors: Kevin Phan; Yi-Chin Tsai; Nithya Niranjan; Denis Bouchard; Thierry P Carrel; Otto E Dapunt; Harald C Eichstaedt; Theodor Fischlein; Borut Gersak; Mattia Glauber; Axel Haverich; Martin Misfeld; Peter J Oberwalder; Giuseppe Santarpino; Malakh Lal Shrestha; Marco Solinas; Marco Vola; Tristan D Yan; Marco Di Eusanio Journal: Ann Cardiothorac Surg Date: 2015-03
Authors: Vahid Sadri; Charles H Bloodworth; Immanuel David Madukauwa-David; Prem A Midha; Vrishank Raghav; Ajit P Yoganathan Journal: Gen Thorac Cardiovasc Surg Date: 2019-06-27
Authors: Martin Andreas; Stephanie Wallner; Andreas Habertheuer; Claus Rath; Martin Schauperl; Thomas Binder; Dietrich Beitzke; Raphael Rosenhek; Christian Loewe; Dominik Wiedemann; Alfred Kocher; Guenther Laufer Journal: Interact Cardiovasc Thorac Surg Date: 2016-03-13