3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement

• Published in: Journal of the American College of Cardiology Vol. 67; no. 22; pp. 2565 - 2574
• Main Authors: Deeb, G. Michael, Reardon, Michael J., Chetcuti, Stan, Patel, Himanshu J., Grossman, P. Michael, Yakubov, Steven J., Kleiman, Neal S., Coselli, Joseph S., Gleason, Thomas G., Lee, Joon Sup, Hermiller, James B., Heiser, John, Merhi, William, Zorn, George L., Tadros, Peter, Robinson, Newell, Petrossian, George, Hughes, G. Chad, Harrison, J. Kevin, Maini, Brijeshwar, Mumtaz, Mubashir, Conte, John, Resar, Jon, Aharonian, Vicken, Pfeffer, Thomas, Oh, Jae K., Qiao, Hongyan, Adams, David H., Popma, Jeffrey J.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 07.06.2016; Elsevier Limited
• Subjects: Acute Kidney Injury - etiology; Aged, 80 and over; aortic stenosis; Aortic Valve - diagnostic imaging; Aortic Valve - surgery; Aortic Valve Insufficiency - epidemiology; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - surgery; Cardiology; Cardiovascular; Clinical outcomes; Echocardiography; Endocarditis - etiology; Female; Follow-Up Studies; Heart attacks; Hemodynamics; Hospitalization - statistics & numerical data; Humans; Kidneys; Male; Mortality; outcomes; Pacemaker, Artificial - statistics & numerical data; Prospective Studies; Reoperation; Stents; Stroke; Stroke - epidemiology; Studies; Surgery; surgical aortic valve replacement; Surgical outcomes; Transcatheter Aortic Valve Replacement; United States - epidemiology; NYHA; aortic stenosis; outcomes; transcatheter aortic valve replacement; MACCE; surgical aortic valve replacement; AVA; MDCT; SAVR; TAVR; major adverse cardiovascular and cerebrovascular events; New York Heart Association; multidetector computed tomography; aortic valve area
• DOI: 10.1016/j.jacc.2016.03.506
• ISSN: 0735-1097; 1558-3597

In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery. This study sought to determine whether this clinical benefit was sustained over time. Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure. A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group. Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)