Abstract
Case Summary
This clinical vignette describes successful transcatheter aortic valve implantation (TAVI) in the largest reported annulus (1,040 mm2) using a novel 35-mm balloon-expandable valve. TAVI can be performed off-label in selected patients with a massive aortic annulus using commercially available 29-mm transcatheter aortic valves by adding additional volume; however, this risks paravalvular leak, valve embolism, and damage to bioprosthetic leaflets.
Take-Home Message
TAVI is feasible in patients with a massive aortic annulus measuring >1,000 mm2 using Myval 35-mm balloon-expandable valve with balloon overfilling.
Key words: aortic valve, reduced ejection fraction, valve replacement
Graphical Abstract
Clinical Vignette
A 75-year-old man had recurrent hospitalizations with decompensated heart failure. Echocardiography revealed mixed aortic valve disease with moderate aortic stenosis and severe aortic regurgitation, along with a severely dilated left ventricle with an ejection fraction of 25%. Past history included metastatic prostate cancer. Medical therapy was limited by persistent hypotension; coronary angiography demonstrated no significant disease. Computed tomography revealed a massive aortic annulus with an area of 1,040 mm2, perimeter of 117 mm, mean diameter of 37 mm, left ventricular outflow tract 38 mm, with a mean sinus of Valsalva diameter of 43 mm, ascending aorta of 40 mm, and moderate leaflet calcification (Figures 1A to 1C). These dimensions exceeded manufacturer's instructions for use for all commercially available transcatheter aortic valves. After Heart Team review, the patient was accepted for transcatheter aortic valve implantation (TAVI) with a Myval 35-mm balloon-expandable valve (BEV) (Meril Life Sciences) on a compassionate use basis.
Take-Home Messages
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Transcatheter aortic valve implantation can be performed off-label in selected patients with large aortic annulus using commercially available 29-mm valves by adding additional volume; however, this risks paravalvular leak, valve embolism, and damage to bioprosthetic leaflets.
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Transcatheter aortic valve implantation is feasible in patients with a massive aortic annulus measuring >1,000 mm2 using a Myval 35-mm balloon-expandable valve with balloon overfilling.
Figure 1.
Transcatheter Aortic Valve Implantation With a Myval 35-mm Balloon-Expandable Valve
(A) Aortic annulus on computed tomography (CT) measuring 10.4 cm2. (B) Aortic valve leaflets on CT. (C) Coronal view of aorta, aortic valve, and left ventricle. (D and E) Valve deployment. (F) Final result.
TAVI was performed under conscious sedation via right femoral arterial access. The valve was implanted under rapid ventricular pacing with slow inflation, with an additional 10 cc added to the nominal inflation volume (total 60 cc) at the time of deployment to achieve adequate oversizing. Postdeployment angiography demonstrated excellent valve positioning with no paravalvular leak, patent coronary arteries, and no new conduction abnormalities (Figures 1D to 1F, Video 1). Echocardiography showed a mean transvalvular gradient of 1 mm Hg with no aortic regurgitation.
Discussion
TAVI in patients with very large annuli beyond device instructions for use has been shown to be feasible, with comparable short-term outcomes and valve performance by valve academic research consortium-3 criteria, although with higher rates of paravalvular leak, valve embolism, and need for a second valve.1 Recent reports have described successful TAVI with a Myval 35-mm BEV for annuli of 722 mm2 and 883 mm2.2,3 To the best of our knowledge, this case represents the largest annular area successfully treated with TAVI. Larger prospective studies are needed to determine the efficacy and safety of this novel BEV.
Funding Support and Author Disclosures
Dr Fam is a consultant to Edwards Lifesciences, Abbott, Cardiovalve, Medtronic, Tricares, inQB8, and Jenscare. Dr Alnasser is a consultant to Abbott, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Footnotes
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.
Appendix
For a supplemental video, please see the online version of this paper.
Appendix
Valve Deployment and Final Result
References
- 1.Hof A., Wienemann H., Veulemans V., et al. Feasibility and outcome of third-generation transcatheter aortic valve implantation in patients with extra-large aortic annulus. Clin Res Cardiol. 2024;113(1):107–115. doi: 10.1007/s00392-023-02278-1. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Jose J., George P.V., Riyaz Mirza S.U., Mathen P.G., Selvaraj S., Raja H. Novel 35-mm balloon-expandable transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2024;17:1057–1059. doi: 10.1016/j.jcin.2024.01.309. [DOI] [PubMed] [Google Scholar]
- 3.Bhaskaran J., Amat Santos I.J., Manzil A.S., Mandalay A. Transcatheter aortic valve replacement in pure native valve aortic regurgitation using a 35-mm balloon-expandable myval XXL valve and a 24-French python BZ smart introducer sheath. Catheter Cardiovasc Interv. 2025;106(2):863–868. doi: 10.1002/ccd.31632. [DOI] [PubMed] [Google Scholar]
Associated Data
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Supplementary Materials
Valve Deployment and Final Result