Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Dec 1;9(12):1106-1114.
doi: 10.1001/jamacardio.2024.3241.

Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial

Didier Tchétché  1 , Roxana Mehran  2 , Daniel J Blackman  3 , Ramzi F Khalil  4 , Helge Möllmann  5 , Mohamed Abdel-Wahab  6 , Walid Ben Ali  7 , Paul D Mahoney  8 , Hendrik Ruge  9 , Sabine Bleiziffer  10 , Lang Lin  11 , Molly Szerlip  12 , Kendra J Grubb  13 , Isida Byku  14 , Mayra Guerrero  15 , Linda D Gillam  16 , Anna Sonia Petronio  17 , Guilherme F Attizzani  18 , Wayne B Batchelor  19 , Hemal Gada  20 , Toby Rogers  21 , Joshua D Rovin  22 , Brian Whisenant  23 , Stewart Benton  24 , Blake Gardner  25 , Ratnasari Padang  26 , Andrew D Althouse  27 , Howard C Herrmann  28
Affiliations
Randomized Controlled Trial

Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial

Didier Tchétché et al. JAMA Cardiol. .

Abstract

Importance: Historically, women with aortic stenosis have experienced worse outcomes and inadequate recognition compared to men, being both underdiagnosed and undertreated, while also facing underrepresentation in clinical trials.

Objective: To determine whether women with small aortic annuli undergoing transcatheter aortic valve replacement have better clinical and hemodynamic outcomes with a self-expanding valve (SEV) or balloon-expandable valve (BEV).

Design, setting, participants: The Small Annuli Randomized to Evolut or SAPIEN Trial (SMART) was a large-scale randomized clinical trial focusing on patients with small aortic annuli undergoing transcatheter aortic valve replacement, randomized to receive SEVs or BEVs and included 716 patients treated at 83 centers in Canada, Europe, Israel, and the US from April 2021 to October 2022. This prespecified secondary analysis reports clinical and hemodynamic findings for all 621 women enrolled in SMART. Data for this report were analyzed from February to April 2024.

Interventions: Transcatheter aortic valve replacement with an SEV or a BEV.

Main outcomes and measures: The composite coprimary clinical end point comprised death, disabling stroke, or heart failure-related rehospitalization. The coprimary valve function end point was the incidence of bioprosthetic valve dysfunction, both assessed through 12 months. Secondary end points included the incidence of moderate or severe prosthesis-patient mismatch.

Results: A total of 621 women (mean [SD] age, 80.2 [6.2] years; 312 randomized to the SEV group and 309 to the BEV group) were included in the present analysis. At 12 months, there were no significant differences in the coprimary clinical end point between the SEV and BEV groups (9.4% vs 11.8%, absolute risk difference -2.3%; 95% CI -7.2 to 2.5, P = .35). However, SEV implantation was associated with less bioprosthetic valve dysfunction (8.4% vs 41.8%; absolute risk difference, -33.4%; 95% CI, -40.4 to -26.4; P < .001). SEV implantation resulted in lower aortic valve gradients and larger effective orifice areas at 30 days and 12 months and less mild or greater aortic regurgitation at 12 months compared to BEV implantation. Prosthesis-patient mismatch was significantly lower with SEVs, regardless of the definition used and adjustment for body mass index. Use of SEVs was associated with better quality of life outcomes as assessed by the Valve Academic Research Consortium-3 ordinal quality of life measure.

Conclusions and relevance: Among women with severe symptomatic aortic stenosis and small aortic annuli undergoing transcatheter aortic valve replacement, the use of SEVs, compared to BEVs, resulted in similar clinical outcomes and a markedly reduced incidence of bioprosthetic valve dysfunction through 12 months, including a lower risk of prosthesis-patient mismatch and better 12-month quality of life.

Trial registration: ClinicalTrials.gov Identifier: NCT04722250.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Tchétché has received honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mehran reported grants from Medtronic during the conduct of the study and grants from Abbott, Abiomed, Affluent Medical, Alleviant Medical, Amgen, AM-Pharma, Arena, AstraZeneca, AtriCure, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CeloNova, European Cardiovascular Research Center, Chiesi, Cleerly Health, Concept Medical, Cytosorbents, Daiichi Sankyo, Duke University, Element Science, Essential Medical, Faraday, Humacyte, Idorsia, Janssen, MedAlliance, Medscape, Mediasphere, Medtelligence, MJH Healthcare, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Population Health Research Institute, Protembis, ReCor Medical, RenalPro, RM Global, Sanofi, Shockwave, Vivasure, and Zoll; personal fees from Affluent Medical, Boehringer Ingelheim, Cardiovascular Research Foundation, Cordis, Daiichi Sankyo Brasil, E.R. Squibb & Sons, Esperion Science, Boston Scientific, Europa Group, Innovative Biopharma, Gaffney Events, Educational Trust, Global Clinical Trial Partners, Henry Ford Health Cardiology, Ionis Pharmaceuticals, Eli Lilly and Company, MedCon International, Novartis, Novo Nordisk, PeerView Institute for Medical Education, Terumo Europe, Vectura, VoxMedia, IQVIA, Radcliffe, Tarsus Cardiology, and WebMD; and other from Elixir Medical (equity <1%), Stel (equity <1%), ControlRad (equity <1% [spouse]), JAMA Cardiology (honorarium), and American College of Cardiology (honorarium) outside the submitted work. Dr Blackman reported personal fees from Medtronic and Abbott Vascular outside the submitted work. Dr Khalil reported served as a proctor for Medtronic. Dr Möllmann reported personal fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work. Dr Abdel-Wahab reported personal fees (paid to institution) from Medtronic and Boston Scientific outside the submitted work. Dr Ben Ali reported grants from Medtronic and Edwards Lifesciences outside the submitted work. Dr Mahoney reported personal fees (for serving as consultant and proctor) from Medtronic, Edwards, Abbott, and Boston Scientific during the conduct of the study. Dr Ruge reported personal fees from Edwards LifeSciences outside the submitted work. Dr Bleiziffer reported speaker fees from Medtronic, Edwards, Abbott, and Boston Scientific outside the submitted work. Dr Szerlip reported personal fees from Edwards Lifesciences (honoraria), Abbott (advisory committee), and Boston Scientific (advisory committee) outside the submitted work. Dr Grubb reported personal fees from Medtronic during the conduct of the study and grants from Edwards Lifesciences and personal fees from Abbott, Boston Scientific, Ancora, 4C Medical, and OpSens outside the submitted work. Dr Byku reported nonfinancial support from Edwards Lifescience; personal fees from Shockwave Medical; and institutional grant support from Edwards Lifesciences, Medtronic, and Abbott outside the submitted work. Dr Guerrero reported grants from Edwards Lifesicences outside the submitted work. Dr Gillam reported personal fees from Medtronic (executive committee participation) during the conduct of the study and fees from Medtronic (advisory board) outside the submitted work. Dr Petronio reported grants from Medtronic during the conduct of the study and personal fees from Medtronic, Edwards Lifesciences, and Abbott outside the submitted work. Dr Attizzani reported grants and personal fees from Medtronic and personal fees from Boston Scientific during the conduct of the study. Dr Batchelor reported consulting fees from Medtronic during the conduct of the study and from Edwards, Boston Scientific, and Abbott outside the submitted work. Dr Gada reported personal fees from Medtronic, Abbott Vascular, Boston Scientific Corp, Edwards Lifesciences, and Innovative Cardiovascular Solutions outside the submitted work. Dr Rogers reported personal fees from Medtronic during the conduct of the stud and from Boston Scientific, Abbott, Anteris, Edwards Lifesciences, and Transmural Systems outside the submitted work. Dr Rovin reported personal fees (proctor and consultant) from Medtronic and Abbott outside the submitted work. Dr Whisenant reported personal fees from Medtonic and Edwards Lifesciences outside the submitted work. Dr Benton reported personal fees from Medtronic (time compensation for teaching and education committee participation) during the conduct of the study. Dr Gardner reported personal fees from Medtronic and nonfinancial support from Edwards Lifesciences outside the submitted work. Dr Althouse reported being a full-time employee of Medtronic. Dr Herrmann reported grants from Abbott, Edwards Lifesciences, and Medtronic (institutional research funding) and personal fees from Abbott, Edwards Lifesciences, and Medtronic during the conduct of the study as well as grants from Boston Scientific, Innovalve, Shockwave, and Vivasure and personal fees from Holistick Medical, Prolifagen, Wells Fargo, and Truffle Capital outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Death, Disabling Stroke, or Rehospitalization for Heart Failure (HF) in Women Through 12 Months
Kaplan-Meier curve for the clinical primary end point, a composite of death from any cause, disabling stroke, or HF rehospitalization through 12 months. Absolute difference in rates and 95% CIs are reported. BEV indicates balloon-expandable valve; SEV, self-expanding valve.
Figure 2.
Figure 2.. Hemodynamics Through 12 Months
A, Aortic valve mean gradient (MG) and effective orifice area (EOA) for the self-expanding valve (SEV) and balloon-expandable valve (BEV) at baseline and at different time points after valve implantation. B, Total aortic regurgitation at 30 days and 12 months.
See this image and copyright information in PMC

References

    1. Adams DH, Popma JJ, Reardon MJ, et al. ; U.S. CoreValve Clinical Investigators . Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370(19):1790-1798. doi: 10.1056/NEJMoa1400590 - DOI - PubMed
    1. Mack MJ, Leon MB, Thourani VH, et al. ; PARTNER 3 Investigators . Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705. doi: 10.1056/NEJMoa1814052 - DOI - PubMed
    1. Popma JJ, Deeb GM, Yakubov SJ, et al. ; Evolut Low Risk Trial Investigators . Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380(18):1706-1715. doi: 10.1056/NEJMoa1816885 - DOI - PubMed
    1. Reardon MJ, Van Mieghem NM, Popma JJ, et al. ; SURTAVI Investigators . Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376(14):1321-1331. doi: 10.1056/NEJMoa1700456 - DOI - PubMed
    1. Clavel MA, Iung B, Pibarot P. A nationwide contemporary epidemiological portrait of valvular heart diseases. Heart. 2017;103(21):1660-1662. doi: 10.1136/heartjnl-2017-311472 - DOI - PubMed

Publication types

Associated data