TY - JOUR
T1 - TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device
T2 - 1-Year Results From the Prospective VIVA Postmarket Study
AU - VIVA Investigators
AU - Tchétché, Didier
AU - Chevalier, Bernard
AU - Holzhey, David
AU - Harnath, Axel
AU - Schäfer, Ulrich
AU - Teiger, Emmanuel
AU - Manigold, Thibaut
AU - Modine, Thomas
AU - Souteyrand, Geraud
AU - Champagnac, Didier
AU - Oh, Jae K.
AU - Li, Shuzhen
AU - Verhoye, Jean Philippe
AU - Kornowski, Ran
AU - Gilard, Martine
AU - Verhoye, Jean Philippe
AU - Leroux, Lionel
AU - Casassus, Frédéric
AU - Grisoli, Dominique
AU - Dambrin, Gregoire
AU - Marcheix, Bertrand
AU - Scholtz, Werner
AU - Kim, Won Keun
AU - Guetta, Victor
AU - Ettori, Federica
AU - Petronio, Anna Sonia
AU - Bedogni, Francesco
N1 - Funding Information:
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.
Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/5/27
Y1 - 2019/5/27
N2 - 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)
AB - 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)
KW - TAVR
KW - aortic stenosis
KW - self-expanding
KW - valve-in-valve
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U2 - 10.1016/j.jcin.2019.02.029
DO - 10.1016/j.jcin.2019.02.029
M3 - Article
C2 - 31122349
AN - SCOPUS:85065409470
VL - 12
SP - 923
EP - 932
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 10
ER -