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Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.
Makkar, Raj R; Thourani, Vinod H; Mack, Michael J; Kodali, Susheel K; Kapadia, Samir; Webb, John G; Yoon, Sung-Han; Trento, Alfredo; Svensson, Lars G; Herrmann, Howard C; Szeto, Wilson Y; Miller, D Craig; Satler, Lowell; Cohen, David J; Dewey, Todd M; Babaliaros, Vasilis; Williams, Mathew R; Kereiakes, Dean J; Zajarias, Alan; Greason, Kevin L; Whisenant, Brian K; Hodson, Robert W; Brown, David L; Fearon, William F; Russo, Mark J; Pibarot, Philippe; Hahn, Rebecca T; Jaber, Wael A; Rogers, Erin; Xu, Ke; Wheeler, Jaime; Alu, Maria C; Smith, Craig R; Leon, Martin B.
Affiliation
  • Makkar RR; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Thourani VH; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Mack MJ; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Kodali SK; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Kapadia S; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Webb JG; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Yoon SH; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Trento A; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Svensson LG; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Herrmann HC; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Szeto WY; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Miller DC; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Satler L; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Cohen DJ; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Dewey TM; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Babaliaros V; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Williams MR; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Kereiakes DJ; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Zajarias A; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Greason KL; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Whisenant BK; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Hodson RW; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Brown DL; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Fearon WF; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Russo MJ; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Pibarot P; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Hahn RT; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Jaber WA; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Rogers E; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Xu K; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Wheeler J; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Alu MC; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Smith CR; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
  • Leon MB; From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - b
N Engl J Med ; 382(9): 799-809, 2020 02 27.
Article in En | MEDLINE | ID: mdl-31995682
ABSTRACT

BACKGROUND:

There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.

METHODS:

We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.

RESULTS:

At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.

CONCLUSIONS:

Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
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Full text: 1 Database: MEDLINE Main subject: Aortic Valve Stenosis / Heart Valve Prosthesis / Heart Valve Prosthesis Implantation / Transcatheter Aortic Valve Replacement Type of study: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Aged80 / Female / Humans / Male Language: En Journal: N Engl J Med Year: 2020 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Aortic Valve Stenosis / Heart Valve Prosthesis / Heart Valve Prosthesis Implantation / Transcatheter Aortic Valve Replacement Type of study: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Aged80 / Female / Humans / Male Language: En Journal: N Engl J Med Year: 2020 Type: Article