Author + information
- Received November 6, 2018
- Revision received February 15, 2019
- Accepted February 19, 2019
- Published online May 20, 2019.
- Didier Tchétché, MDa,∗ (, )
- Bernard Chevalier, MDb,
- David Holzhey, MDc,
- Axel Harnath, MDd,
- Ulrich Schäfer, MDe,
- Emmanuel Teiger, MD, PhDf,
- Thibaut Manigold, MDg,
- Thomas Modine, MDh,
- Geraud Souteyrand, MDi,
- Didier Champagnac, MDj,
- Jae K. Oh, MDk,
- Shuzhen Li, PhDl,
- Jean-Philippe Verhoye, MDm,
- Ran Kornowski, MDn,
- on behalf of the VIVA Investigators
- aGroupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France
- bRamsay Générale de Santé, Institut Cardio-vasculaire Paris-Sud, Massy, France
- cDepartment of Cardiac Surgery, Leipzig Heart Institute, Leipzig, Germany
- dDepartment of Cardiology, Sana-Herzzentrum Cottbus, Cottbus, Germany
- eDepartment of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
- fInterventional Cardiology Unit, CHU Mondor, Créteil, France
- gCardiology Service, CHU de Nantes, Nantes, France
- hDepartment of Cardiovascular Surgery, CHU Lille, Lille, France
- iCardiology Department, CHU Clermont, Clermont-Ferrand, France
- jDepartment of Cardiology, Tonkin Clinic, Villeurbane, France
- kDepartment of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- lCoronary and Structural Heart Clinical Department, Medtronic, Mounds View, Minnesota
- mDepartment of Cardiovascular Surgery, CHU Rennes, Rennes, France
- nDepartment of Cardiology, Rabin Medical Center, Petah Tikva, Israel
- ↵∗Address for correspondence:
Dr. Didier Tchétché, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, 45 avenue de Lombez, 31076, Toulouse cedex 03, France.
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)
This work was funded by Medtronic. Dr. Tchétché is a consultant for Medtronic. Dr. Souteyrand has received personal fees from Medtronic, Abbott, Terumo, and AstraZeneca, all outside the submitted work. Dr. Kornowski is a clinical investigator and proctor for Medtronic. Dr. Holzhey is a proctor for Abbott and Medtronic; and is an adviser for Edwards Lifesciences. Dr. Teiger has received personal fees from Medtronic during conduct of the study. Dr. Li is an employee of and shareholder in Medtronic. Dr. Harnath has received payments for clinical study involvement from Medtronic; has received traveling compensation from Medtronic; and is a proctor and consultant for Medtronic. Dr. Manigold is a consultant and proctor for Medtronic. Dr. Oh has a consulting contract with Medtronic; and has received grants paid to his institution. Dr. Schäfer has received proctor speaking honoraria, travel support, and grant support from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 6, 2018.
- Revision received February 15, 2019.
- Accepted February 19, 2019.
- 2019 American College of Cardiology Foundation
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