Didier Tchétché1, Bernard Chevalier2, David Holzhey3, Axel Harnath4, Ulrich Schäfer5, Emmanuel Teiger6, Thibaut Manigold7, Thomas Modine8, Geraud Souteyrand9, Didier Champagnac10, Jae K Oh11, Shuzhen Li12, Jean-Philippe Verhoye13, Ran Kornowski14. 1. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France. Electronic address: d.tchetche@clinique-pasteur.com. 2. Ramsay Générale de Santé, Institut Cardio-vasculaire Paris-Sud, Massy, France. 3. Department of Cardiac Surgery, Leipzig Heart Institute, Leipzig, Germany. 4. Department of Cardiology, Sana-Herzzentrum Cottbus, Cottbus, Germany. 5. Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 6. Interventional Cardiology Unit, CHU Mondor, Créteil, France. 7. Cardiology Service, CHU de Nantes, Nantes, France. 8. Department of Cardiovascular Surgery, CHU Lille, Lille, France. 9. Cardiology Department, CHU Clermont, Clermont-Ferrand, France. 10. Department of Cardiology, Tonkin Clinic, Villeurbane, France. 11. Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. 12. Coronary and Structural Heart Clinical Department, Medtronic, Mounds View, Minnesota. 13. Department of Cardiovascular Surgery, CHU Rennes, Rennes, France. 14. Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
Abstract
OBJECTIVES: The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation. BACKGROUND: Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery. METHODS: VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve. RESULTS: Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later. CONCLUSIONS: Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298).
OBJECTIVES: The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation. BACKGROUND: Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery. METHODS: VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve. RESULTS:Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later. CONCLUSIONS: Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298).
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