Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study.
This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement.



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.



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.



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 cm2to 1.9 ± 0.5 cm2(p < 0.001). Moderate residual paravalvular leak was identified in 5.3% of patients.



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).
Departments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery), Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: jpopma@bidmc.harvard.edu.
Jeffrey J
JJ
Popma
Department of Cardiovascular Surgery, Methodist DeBakey Heart and Vascular Institute, Houston, Texas.
Michael J
MJ
Reardon
Departments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery), Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Kamal
K
Khabbaz
Cardiology Division in the Duke Department of Medicine, Duke University Medical Center, Durham, North Carolina.
J Kevin
JK
Harrison
Cardiology Division in the Duke Department of Medicine, Duke University Medical Center, Durham, North Carolina.
G Chad
GC
Hughes
Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital, New York, New York.
Susheel
S
Kodali
Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital, New York, New York.
Isaac
I
George
Department of Cardiac Surgery, University of Michigan Health Systems, Ann Arbor, Michigan.
G Michael
GM
Deeb
Department of Cardiac Surgery, University of Michigan Health Systems, Ann Arbor, Michigan.
Stan
S
Chetcuti
Department of Cardiology, Morristown Memorial Hospital, Morristown, New Jersey.
Robert
R
Kipperman
Department of Cardiology, Morristown Memorial Hospital, Morristown, New Jersey.
John
J
Brown
Statistical Services, Medtronic, Minneapolis, Minnesota.
Hongyan
H
Qiao
Departments of Medicine (Cardiology) and Cardiothoracic Surgery, New York University Langone Medical Center, New York, New York.
James
J
Slater
Departments of Medicine (Cardiology) and Cardiothoracic Surgery, New York University Langone Medical Center, New York, New York.
Mathew R
MR
Williams
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D018618:Echocardiography, Doppler, Color; D018619:Echocardiography, Doppler, Pulsed; D005260:Female; D006350:Heart Valve Prosthesis; D006439:Hemodynamics; D006801:Humans; D008297:Male; D018579:Patient Selection; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016896:Treatment Outcome; D014481:United States
aortic stenosis; congestive heart failure; transcatheter therapy