The use of intra-annular valves is associated with higher risk for prosthesis-patient mismatch (PPM) in patients with aortic stenosis and small aortic annuli undergoing transcatheter self-expandable valve (SEVs) implantation, with severe PPM an independent factor in all-cause mortality risk, a new analysis of registry data finds.
The study, published online Monday ahead of the June 14 issue of JACC: Cardiovascular Interventions, set out to define predictors of PPM and its impact on mortality after transcatheter aortic valve replacement (TAVR) SEVs in patients with small annuli using data from the TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) registry.
Led by first author Pier Pasquale Leone from Humanitas University and IRCCS Humanitas Research Hospital, Italy, the team reported that severe PPM was independently associated with all-cause mortality – adding that among patients with aortic stenosis and small aortic annuli undergoing transcatheter SEV implantation, use of intra-annular valves yielded higher risk for PPM.
Conversely, they reported that post-dilation and valve oversizing protected against PPM occurrence.
“In this additional analysis of the registry, intra-annular valves were found to confer an augmented risk for PPM, while post-dilation and valve oversizing protect against PPM occurrence,” said the team – adding that patients with severe PPM had higher 1-year all-cause mortality compared with those without PPM, and severe PPM was an independent predictor of all-cause mortality.
Leone and colleagues analyzed predictors of PPM and all-cause mortality using multivariable logistic regression analysis from the cohort of the TAVI-SMALL registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter SEVs: 445 patients with (n = 129) and without (n = 316) PPM were enrolled.
They reported that intra-annular valves conferred increased risk for PPM (odds ratio [OR]: 2.36; 95% confidence interval [CI]: 1.16 to 4.81), while post-dilation (OR: 0.46; 95% CI: 0.25–0.84) and valve oversizing (OR: 0.53; 95% CI: 0.28–1.00) seemed to protect against PPM occurrence.
At a median follow-up of 354 days, patients with severe PPMhad a higher all-cause mortality rate compared with those without PPM (log-rank p = 0.008), the authors reported. However, patients with moderate PPM had a similar all-cause mortality rate to those without PPM.
Incidence of severe PPM was 9% and was independently associated with use of an intra-annular prosthesis (adjusted OR: 2.36; 95% CI: 1.16–4.81), they added, noting that multivariable Cox regression confirmed severe PPM as an independent predictor of all-cause mortality (hazard ratio [HR]: 4.27; 95% CI: 1.34 to 13.6).
In a separate editorial, Howard C. Herrmann, MD, of the Perelman School of Medicine at the University of Pennsylvania, noted that the current findings contrast with those of a recent registry analysis of supra-annular self-expanding prostheses in which the incidence of severe PPM was also low (5.3%) but was not associated with 1-year mortality.
He noted that in the first decade of TAVR, landmark randomized trials have demonstrated that this novel treatment could equal and, in some cases, surpass the results of surgery in medium-term follow-up.
“However, we want to know that long-term outcomes are also as good as those we have come to expect following surgical aortic valve replacement,” said Herrmann. “In the next decade of TAVR, operators will need to refine our approach to reduce short-term complications, maximize long-term durability, and further improve TAVR outcomes.”
Leone PP, Regazzoli D, Pagnesi M, et al. Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli. JACC Cardiovasc Interv 2021;14:1218–28.
Herrmann HC. Small Annulus, Hemodynamic Status, and TAVR. JACC Cardiovasc Interv 2021;14:1229-30.