TAVR vs. SAVR Durability at 6 Years

Feb 05, 2019
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Authors:
Søndergaard L, Ihlemann N, Capodanno D, et al.
Citation:
Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk. J Am Coll Cardiol 2018;73:546-553.
Summary By:
David S. Bach, MD, FACC

Study Questions:

What are the comparative durabilities of transcatheter (TAVR) and surgical bioprosthetic aortic valve replacement (SAVR)?

Methods:

In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients >70 years of age with severe aortic stenosis and lower surgical risk for mortality (mean Society of Thoracic Surgeons [STS] score 3.0 ± 1.0, most <10%) were randomized 1:1 to TAVR (n = 139 [100% first-generation CoreValve]) or SAVR (n = 135 [27% Mosaic, 29% Epic, 24% Trifecta, 10% Perimount, 10% Mitroflow]). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months, or moderate/severe paravalvular AR. Bioprosthetic valve failure (BVF) was defined as valve-related death, aortic valve re-intervention, or severe hemodynamic SVD.

Results:

At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%, p < 0.001), whereas there were no significant differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%, p = 0.89).

Conclusions:

In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. The authors concluded that longer-term follow-up of randomized clinical trials will be necessary to confirm these findings.

Perspective:

Comparisons between interventions ideally should come from randomized trials, and findings from this trial therefore are important. The unexpected and somewhat surprising finding that the incidence of SVD was lower following TAVR than SAVR might be explained by the specific surgical prostheses implanted, notably including one with known poor durability. Although truly long-term data for TAVR are not yet available, data from this study and an accompanying study in this issue of the journal (Blackman DJ, et al., J Am Coll Cardiol 2019;73:537-45) suggest that freedom from SVD through about 6 years remains fairly good.

Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Endocarditis, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Transcatheter Aortic Valve Replacement


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