TAVR for Native Valve and Surgical AVR Pure Aortic Regurgitation

May 15, 2017
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Authors:
Sawaya FJ, Deutsch MA, Seiffert, M, et al.
Citation:
Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study. JACC Cardiovasc Interv 2017;10:1048-1056.
Summary By:
David S. Bach, MD, FACC

Study Questions:

What are the outcomes associated with the use of transcatheter aortic valve replacement (TAVR) for the treatment of pure aortic regurgitation (AR) among patients with a noncalcific native aortic valve (AV) or a surgical bioprosthesis with structural valve deterioration (SVD)?

Methods:

The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints, assessed at each site, were device success, and early (30-day) safety and clinical efficacy, as defined by Valve Academic Research Consortium 2 (VARC 2) criteria.

Results:

The study cohort consisted of 146 patients, including 78 patients with a native noncalcified AV and 68 patients with SVD following surgical AVR. In the native AV group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer-generation TAVRs (Evolut R, SAPIEN S3, Lotus Valve System, Direct Flow, JenaValve) compared with old-generation (CoreValve, SAPIENT XT) devices (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); mainly due to less second TAVR implantations (10% vs. 24%, p = 0.16) and a lower rate of moderate to severe post-procedure paravalvular regurgitation (2% vs. 29%, p = 0.004). Independent predictors of 30-day mortality were body mass index <20 kg/m2, major vascular or access complication, and moderate to severe AR. In the patients with SVD following surgical AVR (30-day), device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively.

Conclusions:

TAVR for pure, native AV, noncalcified AR remains a challenging condition. The authors concluded that older-generation TAVRs were associated with higher rates of device embolization and migration, and significant paravalvular regurgitation; but that newer-generation devices appeared to have more promising outcomes. For patients with severe AR due to a surgical bioprosthesis with SVD, TAVR was a valuable therapeutic option.

Perspective:

The use of valve-in-valve TAVR for treatment of a surgical bioprosthetic valve with structural valve deterioration is increasing accepted as an attractive alternative to re-do open surgical valve replacement. This study adds additional data supporting this use of TAVR. Importantly, this multicenter registry also addresses the use of TAVR among patients with noncalcified native valve AR, and suggests that newer-generation devices (Evolut R, SAPIEN S3, Lotus Valve System, Direct Flow, JenaValve) might provide reasonable early outcomes.

Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Bioprosthesis, Body Mass Index, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement, Treatment Outcome


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