One-year outcomes of the Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve (TRITON) trial

A prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System

Alfred A. Kocher, Günther Laufer, Axel Haverich, Malakh Shrestha, Thomas Walther, Martin Misfeld, Joerg Kempfert, Linda Gillam, Christoph Schmitz, Thorsten C. Wahlers, Jens Wippermann, Friedrich W. Mohr, Matthias Roth, Adalbert Skwara, Parwis Rahmanian, Dominik Wiedemann, Michael A. Borger

Research output: Contribution to journalArticle

116 Citations (Scopus)

Abstract

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 cm2 and 8.8 ± 3.0 mm Hg at 3 months, and 1.7 ± 0.2 cm2 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.

Original languageEnglish (US)
Pages (from-to)110-116
Number of pages7
JournalJournal of Thoracic and Cardiovascular Surgery
Volume145
Issue number1
DOIs
StatePublished - Jan 1 2013
Externally publishedYes

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Aortic Valve Stenosis
Aortic Valve
Surgical Instruments
Multicenter Studies
Prospective Studies
Cardiopulmonary Bypass
Bioprosthesis
Minimally Invasive Surgical Procedures
Stents
Arterial Pressure
Hemodynamics
Survival
Mortality

All Science Journal Classification (ASJC) codes

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Kocher, Alfred A. ; Laufer, Günther ; Haverich, Axel ; Shrestha, Malakh ; Walther, Thomas ; Misfeld, Martin ; Kempfert, Joerg ; Gillam, Linda ; Schmitz, Christoph ; Wahlers, Thorsten C. ; Wippermann, Jens ; Mohr, Friedrich W. ; Roth, Matthias ; Skwara, Adalbert ; Rahmanian, Parwis ; Wiedemann, Dominik ; Borger, Michael A. / One-year outcomes of the Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve (TRITON) trial : A prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. In: Journal of Thoracic and Cardiovascular Surgery. 2013 ; Vol. 145, No. 1. pp. 110-116.
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title = "One-year outcomes of the Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve (TRITON) trial: A prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System",
abstract = "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 cm2 and 8.8 ± 3.0 mm Hg at 3 months, and 1.7 ± 0.2 cm2 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.",
author = "Kocher, {Alfred A.} and G{\"u}nther Laufer and Axel Haverich and Malakh Shrestha and Thomas Walther and Martin Misfeld and Joerg Kempfert and Linda Gillam and Christoph Schmitz and Wahlers, {Thorsten C.} and Jens Wippermann and Mohr, {Friedrich W.} and Matthias Roth and Adalbert Skwara and Parwis Rahmanian and Dominik Wiedemann and Borger, {Michael A.}",
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Kocher, AA, Laufer, G, Haverich, A, Shrestha, M, Walther, T, Misfeld, M, Kempfert, J, Gillam, L, Schmitz, C, Wahlers, TC, Wippermann, J, Mohr, FW, Roth, M, Skwara, A, Rahmanian, P, Wiedemann, D & Borger, MA 2013, 'One-year outcomes of the Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve (TRITON) trial: A prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System', Journal of Thoracic and Cardiovascular Surgery, vol. 145, no. 1, pp. 110-116. https://doi.org/10.1016/j.jtcvs.2012.07.108

One-year outcomes of the Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve (TRITON) trial : A prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. / Kocher, Alfred A.; Laufer, Günther; Haverich, Axel; Shrestha, Malakh; Walther, Thomas; Misfeld, Martin; Kempfert, Joerg; Gillam, Linda; Schmitz, Christoph; Wahlers, Thorsten C.; Wippermann, Jens; Mohr, Friedrich W.; Roth, Matthias; Skwara, Adalbert; Rahmanian, Parwis; Wiedemann, Dominik; Borger, Michael A.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 145, No. 1, 01.01.2013, p. 110-116.

Research output: Contribution to journalArticle

TY - JOUR

T1 - One-year outcomes of the Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve (TRITON) trial

T2 - A prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System

AU - Kocher, Alfred A.

AU - Laufer, Günther

AU - Haverich, Axel

AU - Shrestha, Malakh

AU - Walther, Thomas

AU - Misfeld, Martin

AU - Kempfert, Joerg

AU - Gillam, Linda

AU - Schmitz, Christoph

AU - Wahlers, Thorsten C.

AU - Wippermann, Jens

AU - Mohr, Friedrich W.

AU - Roth, Matthias

AU - Skwara, Adalbert

AU - Rahmanian, Parwis

AU - Wiedemann, Dominik

AU - Borger, Michael A.

PY - 2013/1/1

Y1 - 2013/1/1

N2 - 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 cm2 and 8.8 ± 3.0 mm Hg at 3 months, and 1.7 ± 0.2 cm2 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.

AB - 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 cm2 and 8.8 ± 3.0 mm Hg at 3 months, and 1.7 ± 0.2 cm2 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.

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