Jeffrey J Popma1, Michael J Reardon2, Kamal Khabbaz3, J Kevin Harrison4, G Chad Hughes4, Susheel Kodali5, Isaac George5, G Michael Deeb6, Stan Chetcuti6, Robert Kipperman7, John Brown7, Hongyan Qiao8, James Slater9, Mathew R Williams9. 1. Departments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery), Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: jpopma@bidmc.harvard.edu. 2. Department of Cardiovascular Surgery, Methodist DeBakey Heart and Vascular Institute, Houston, Texas. 3. Departments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery), Beth Israel Deaconess Medical Center, Boston, Massachusetts. 4. Cardiology Division in the Duke Department of Medicine, Duke University Medical Center, Durham, North Carolina. 5. Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital, New York, New York. 6. Department of Cardiac Surgery, University of Michigan Health Systems, Ann Arbor, Michigan. 7. Department of Cardiology, Morristown Memorial Hospital, Morristown, New Jersey. 8. Statistical Services, Medtronic, Minneapolis, Minnesota. 9. Departments of Medicine (Cardiology) and Cardiothoracic Surgery, New York University Langone Medical Center, New York, New York.
Abstract
OBJECTIVES: This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement. BACKGROUND: A novel self-expandable TAV bioprosthesis was designed to provide a low-profile delivery system, conformable annular sealing, and the ability to resheath and reposition during deployment. METHODS: The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. An independent echocardiography laboratory was used to evaluate hemodynamic outcomes. RESULTS: Patients were elderly (83.3 ± 7.2 years of age) and had high surgical risk (Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4%). The majority of patients (89.5%) were treated by iliofemoral access. Resheathing or recapturing was performed in 22.6% of patients; more than 1 valve was required in 3 patients (1.3%). The 30-day outcomes included all-cause mortality (2.5%), disabling stroke (3.3%), major vascular complications (7.5%), life-threatening or disabling bleeding (7.1%), and new permanent pacemaker (16.4%). AV hemodynamics were markedly improved at 30 days: the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg (p < 0.001) and AV area increased from 0.6 ± 0.2 cm2 to 1.9 ± 0.5 cm2 (p < 0.001). Moderate residual paravalvular leak was identified in 5.3% of patients. CONCLUSIONS: We conclude that this novel self-expanding TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery. (Medtronic CoreValve Evolut R U.S. Clinical Study; NCT02207569).
OBJECTIVES: This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement. BACKGROUND: A novel self-expandable TAV bioprosthesis was designed to provide a low-profile delivery system, conformable annular sealing, and the ability to resheath and reposition during deployment. METHODS: The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. An independent echocardiography laboratory was used to evaluate hemodynamic outcomes. RESULTS:Patients were elderly (83.3 ± 7.2 years of age) and had high surgical risk (Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4%). The majority of patients (89.5%) were treated by iliofemoral access. Resheathing or recapturing was performed in 22.6% of patients; more than 1 valve was required in 3 patients (1.3%). The 30-day outcomes included all-cause mortality (2.5%), disabling stroke (3.3%), major vascular complications (7.5%), life-threatening or disabling bleeding (7.1%), and new permanent pacemaker (16.4%). AV hemodynamics were markedly improved at 30 days: the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg (p < 0.001) and AV area increased from 0.6 ± 0.2 cm2 to 1.9 ± 0.5 cm2 (p < 0.001). Moderate residual paravalvular leak was identified in 5.3% of patients. CONCLUSIONS: We conclude that this novel self-expanding TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery. (Medtronic CoreValve Evolut R U.S. Clinical Study; NCT02207569).
Authors: Giuseppe D'Ancona; Stephan Kische; Mohamed El-Mawardy; Martin Dißmann; Helmut Heinze; Dietlind Zohlnhöfer-Momm; Hakan Gürer; Hüseyin Ince Journal: Heart Vessels Date: 2019-05-27 Impact factor: 2.037
Authors: Ted E Feldman; Michael J Reardon; Vivek Rajagopal; Raj R Makkar; Tanvir K Bajwa; Neal S Kleiman; Axel Linke; Dean J Kereiakes; Ron Waksman; Vinod H Thourani; Robert C Stoler; Gregory J Mishkel; David G Rizik; Vijay S Iyer; Thomas G Gleason; Didier Tchétché; Joshua D Rovin; Maurice Buchbinder; Ian T Meredith; Matthias Götberg; Henrik Bjursten; Christopher Meduri; Michael H Salinger; Dominic J Allocco; Keith D Dawkins Journal: JAMA Date: 2018-01-02 Impact factor: 56.272
Authors: Sarah K L Moore; Katherine H Chau; Salma Chaudhary; Geoffrey Rubin; Joseph Bayne; Uma Mahesh R Avula; Daniel Y Wang; Carmine Sorbera; Jose Dizon; Angelo Biviano; Marc Waase; Vivek Iyer; Isaac George; Susheel K Kodali; Tamim M Nazif; Hasan Garan; Elaine Y Wan Journal: Pacing Clin Electrophysiol Date: 2019-03-18 Impact factor: 1.976
Authors: Dae Hyun Kim; Jonathan Afilalo; Sandra M Shi; Jeffrey J Popma; Kamal R Khabbaz; Roger J Laham; Francine Grodstein; Kimberly Guibone; Eliah Lux; Lewis A Lipsitz Journal: JAMA Intern Med Date: 2019-03-01 Impact factor: 21.873