Key result
Supra-annular Evolut PRO linked to ~49 percentage points less PPM than SAPIEN 3 in small annuli.
Why the study?
Smaller THVs in TAVI can result in suboptimal haemodynamics and affect valve durability in patients with smaller aortic annuli, motivating an assessment of the predictive value of annulus size and valve selection on haemodynamics in contemporary TAVI.
Does the supra-annular CoreValve Evolut PRO THV improve 30-day valve haemodynamics and reduce patient-prosthesis mismatch compared to the intra-annular SAPIEN 3 THV in patients with small aortic annuli (<430mm2) undergoing TAVI?
Cohort (n=857)
No
Does the supra-annular CoreValve Evolut PRO THV improve 30-day valve haemodynamics and reduce patient-prosthesis mismatch compared to the intra-annular SAPIEN 3 THV in patients with small aortic annuli (<430mm2) undergoing TAVI?
In patients with small aortic annuli (<430mm2), predominantly women, selecting a supra-annular Evolut PRO valve over an intra-annular SAPIEN 3 valve significantly lowers 30-day transvalvular gradients and moderate-to-severe patient-prosthesis mismatch without affecting 1-year mortality.
Answers are grounded in this paper and cite their sources.
May favor supra-annular THVs to reduce PPM in small annuli; hypothesis-generating and requires RCTs before practice change.
Background/Introduction The use of smaller THVs in transcatheter aortic valve implantation (TAVI) can result in suboptimal haemodynamics with long-term implications on valve durability in patients with smaller aortic annuli. Purpose The objective of this study was to examine the predictive value of aortic annulus size on THV haemodynamics in patients with small annuli undergoing contemporary TAVI. Methods This was a retrospective, observational study of 857 patients who underwent TAVR using either the intra-annular SAPIEN 3 THV or the supra-annular CoreValve Evolut PRO THV at our institution between 2015–2020. Patients were dichotomized based on a native aortic annulus size above or below 430mm2. We then examined 30-day hemodynamics and outcomes in each subgroup and based on THV selection. Results The majority of patients with an annular area <430mm2 were females (82.5%). Of the 857 patients screened, 542 had an annular area >430mm2 and the remaining 315 had an annular area <430mm2. In patients with small aortic annuli, mean gradients were lower at 30 days if they received a supra-annular THV (8.1mmHg vs. 13.8mmHg; p<0.001) which led to lower rates of moderate or severe patient prosthesis mismatch (36.7% vs. 85.4%; p<0.001) (Table 1). All-cause mortality was similar in small annuli between THV groups at 1 year (Table 2). Conclusions The majority of patients with small aortic annuli (<430mm2) undergoing TAVI with contemporary THVs were females. Those that received a supra-annular THV saw superior haemodynamics at 30-days with similar mortality at 1 year.
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Medranda et al. (2021) conducted a cohort in Aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) (n=857). Supra-annular CoreValve Evolut PRO THV vs. Intra-annular SAPIEN 3 THV was evaluated on 30-day moderate or severe patient prosthesis mismatch (and mean transvalvular gradient) in patients with small aortic annuli (<430mm2) (p=<0.001). Supra-annular CoreValve Evolut PRO THVs resulted in lower 30-day mean gradients (8.1 vs 13.8 mmHg; p<0.001) and moderate/severe PPM (36.7% vs 85.4%; p<0.001) than intra-annular SAPIEN 3 in small annuli.
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