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TAVR or SAVR in Severe Aortic Stenosis and Small Aortic Annulus
Quick Takes
- In a prospective, randomized, multicenter trial comparing TAVR and SAVR among 151 patients ≥65 years old with severe aortic stenosis and small aortic annulus, there were no differences in the incidence of severe prosthesis-patient mismatch or mean transvalvular gradient observed at 60 days.
- SAVR compared to TAVR was associated with higher rates of major/life-threatening bleeding and new-onset AF at 30 days; but there were no differences between groups in mortality or stroke at 30 days or in mortality, stroke, or cardiac hospitalization at a median follow-up of 2 years.
Study Questions:
What are the hemodynamic and clinical outcomes after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis (AS) and a small aortic annulus?
Methods:
The VIVA trial was a prospective, randomized trial conducted in 15 centers in Canada, Europe, and Brazil that included 151 patients ≥65 years old with severe AS and small aortic annulus (mean aortic diameter <23 mm and minimal diameter <21.5 mm on computed tomography) randomized 1:1 to TAVR (n = 77) versus SAVR (n = 74). TAVR was restricted to newer-generation devices (SAPIEN 3/Ultra, Evolut R/PRO/PRO+/FX, Acurate neo/neo2); all approved surgical valves were allowed. The primary outcome was impaired valve hemodynamics (severe prosthesis-patient mismatch [PPM; effective orifice area index ≤0.65 cm2/m2] or moderate-severe aortic regurgitation [AR]) at 60 days on Doppler echocardiography. Secondary outcomes included mean transvalvular gradient at 60 days and clinical events (death, stroke, major or life-threatening bleeding, new-onset atrial fibrillation [AF], permanent pacemaker implantation, cardiac rehospitalization) at 30 days and later follow-up.
Results:
Mean age was 75.5 ± 5.1 years, 140 (93%) patients were women, the median Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) was 2.50% (interquartile range [IQR] 1.67%-3.28%), and median annulus diameter was 21.1 mm (IQR 20.4-22.0 mm). A self-expanding valve was used in 59.2% of patients in the TAVR group; a bioprosthesis (Magna Ease, Inspiris Resilia, Percival, Braile Biomedica, Trifecta, Avalus, Mitroflow, Intuity Elite) was used in all but one patient in the SAVR group, and 7% of SAVR patients underwent concomitant root-enlarging procedure.
There were no statistically significant differences between groups in the rates of severe PPM (4 [5.6%] TAVR vs. 7 [10.3%] SAVR, p = 0.30) and moderate-severe AR (none in either group). Mean aortic gradient at 60 days was 11 ± 5 mm Hg in both groups (p = 0.70). At 30 days, SAVR was associated with a higher incidence compared to TAVR of major/life-threatening bleeding (21.6% vs. 9.1%, p = 0.03) and new-onset AF (27.0% vs. 6.5%); no significant differences were found between groups in 30-day mortality (1 [1.3%] TAVR vs. 1 [1.4%] SAVR, p = 1.00) and stroke (0 TAVR vs. 2 [2.7%] SAVR, p = 0.24). After a median follow-up of 2 years (IQR 1-4 years), there were no differences between groups in mortality (7 [9.1%] TAVR vs. 6 [8.1%] SAVR, p = 0.89), stroke (3 [3.9%] TAVR vs. 3 [4.1%] SAVR, p = 0.95), and cardiac hospitalization (15 [19.5%] TAVR vs. 15 [20.3%] SAVR, p = 0.80).
Conclusions:
There was no evidence of hemodynamic superiority of contemporary TAVR versus SAVR among patients with severe AS and small aortic annulus; and after a median follow-up of 2 years, there were no differences in clinical outcomes between groups except for a higher rate of new-onset AF after SAVR. The authors conclude that these findings suggest that the two therapies are valid alternatives for treating patients with severe AS and small aortic annulus and that treatment likely should be individualized, but that the results of the study should be interpreted with caution because of the limited sample size leading to an underpowered study with a need for confirmation in future larger studies.
Perspective:
Data from past observational studies and randomized trial substudies have suggested superior hemodynamics associated with TAVR versus SAVR among patients with severe AS and small aortic annulus. This study found equivalent hemodynamic outcomes at 60 days, albeit in a select population that was predominantly (93%) women; and (except for higher rates of bleeding and new-onset AF) equivalent clinical outcomes through 2 years, albeit in a population at low surgical risk (median STS PROM 2.5%). However, this small study had trends that did not reach statistical significance toward larger body size in the SAVR group; more PPM and higher mean gradient after SAVR; and a higher rate of disabling stroke after SAVR. Although this study adds additional data for comparison of hemodynamic and clinical outcomes after TAVR versus SAVR among patients with severe AS and small aortic annulus, the small sample size and specific characteristics of the population and the valves used limit the ability to draw definitive conclusions.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Transcatheter Aortic Valve Replacement
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