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3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

Publication ,  Journal Article
Forrest, JK; Deeb, GM; Yakubov, SJ; Gada, H; Mumtaz, MA; Ramlawi, B; Bajwa, T; Teirstein, PS; DeFrain, M; Muppala, M; Rutkin, BJ; Chawla, A ...
Published in: J Am Coll Cardiol
May 2, 2023

BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

May 2, 2023

Volume

81

Issue

17

Start / End Page

1663 / 1674

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transcatheter Aortic Valve Replacement
  • Stroke
  • Risk Factors
  • Prospective Studies
  • Male
  • Humans
  • Heart Valve Prosthesis
  • Female
  • Cardiovascular System & Hematology
 

Citation

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Forrest, J. K., Deeb, G. M., Yakubov, S. J., Gada, H., Mumtaz, M. A., Ramlawi, B., … Low Risk Trial Investigators, . (2023). 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol, 81(17), 1663–1674. https://doi.org/10.1016/j.jacc.2023.02.017
Forrest, John K., G Michael Deeb, Steven J. Yakubov, Hemal Gada, Mubashir A. Mumtaz, Basel Ramlawi, Tanvir Bajwa, et al. “3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.J Am Coll Cardiol 81, no. 17 (May 2, 2023): 1663–74. https://doi.org/10.1016/j.jacc.2023.02.017.
Forrest JK, Deeb GM, Yakubov SJ, Gada H, Mumtaz MA, Ramlawi B, et al. 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2023 May 2;81(17):1663–74.
Forrest, John K., et al. “3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.J Am Coll Cardiol, vol. 81, no. 17, May 2023, pp. 1663–74. Pubmed, doi:10.1016/j.jacc.2023.02.017.
Forrest JK, Deeb GM, Yakubov SJ, Gada H, Mumtaz MA, Ramlawi B, Bajwa T, Teirstein PS, DeFrain M, Muppala M, Rutkin BJ, Chawla A, Jenson B, Chetcuti SJ, Stoler RC, Poulin M-F, Khabbaz K, Levack M, Goel K, Tchétché D, Lam KY, Tonino PAL, Ito S, Oh JK, Huang J, Popma JJ, Kleiman N, Reardon MJ, Low Risk Trial Investigators. 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2023 May 2;81(17):1663–1674.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

May 2, 2023

Volume

81

Issue

17

Start / End Page

1663 / 1674

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transcatheter Aortic Valve Replacement
  • Stroke
  • Risk Factors
  • Prospective Studies
  • Male
  • Humans
  • Heart Valve Prosthesis
  • Female
  • Cardiovascular System & Hematology