Transcatheter aortic valve replacement in small aortic annuli: Results from the FRANCE-TAVI registry

Reported from TCT 2022

Mirvat Alasnag provides her take on the outcomes of small annuli sub-study from the FRANCE-TAVI Registry which included 1,195 patients. This trial was presented by Walid Ben-Ali at TCT 2022.

The FRANCE-TAVI Registry was previously published and an updated report of trends and evolution of transcatheter aortic valve replacement (TAVR) in the French cohort was reported¹. Approximately 85,000 patients were enrolled with a median age of 83 years. The median EuroSCORE 1 surgical risk score was 12.8 which appeared to decrease during the course of the registry. There was a linear increase in the number of procedures from 1556 in 2010 to 14,114 in 2021. There was a signal to a lower in-hospital, 30-day and 1-year mortality per year after 2015 irrespective of the surgical risk score. The hospital length of stay also decreased from 8 days in 2010 to 4 days in 2021.

The registry also delineated the types of transcatheter heart valves (THV) implanted and the reported outcomes confirmed efficacy in all-comers. However, as TAVR is extended to different populations, other complications such as pacemaker implantation, valve durability and paravalvular regurgitation need to be closely monitored². This is particularly important in women and other populations with small annuli.

Pivato et al reported one-year outcomes of small size THV in the Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI Registry)³. 934 women were stratified into small (≤23 mm), accounting for 41.5% of the total, and nonsmall (>23 mm) THV. The primary efficacy endpoint was the Valve Academic Research Consortium-2 (VARC-2) composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year.

Women with a small valve size tended to have smaller body mass index, lower surgical risk score, less likely to have atrial fibrillation, less likely to require postdilation and had a less residual aortic regurgitation grade ≥2. The occurrence of the VARC-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881).

The France-TAVI Registry included 47,494 patients of whom 19,204 had small annuli. Walid Ben-Ali presented the outcomes of small annuli sub-study from the FRANCE-TAVI Registry at TCT 2022 which included 1,195 patients.

A small aortic annulus was defined as < 23 mm diameter or indexed diameter <12 mm/m2. At one year the effective orifice area (EOA) measurement of the self-expanding Evolut R/Pro valve, Medtronic (SEV) or balloon expandable Sapien 3 valve, Edwards Lifesciences (BEV). This was the first large all-comer real-world data comparing SEV and BEV THV in patients with small aortic valve annuli. The hemodynamic performance and impact on clinical outcomes was reported. Supra-annular SEV had superior hemodynamic performance at one-year which is consistent with contemporary data. Propensity-matched (BEV = 696; SEV = 232) and inverse probability of treatment weighting (IPTW; BEV = 895; SEV = 300) analyses were conducted. At 1 year, those with BEV had a higher mean gradient (13.74 mmHg) than those with a SEV (8.62 mmHg, p<0.001). The BEV group had smaller indexed EOA (0.9 cm²/m²) compared with the SEV group (1.11 cm²/m², p<0.001).

The results of the propensity-matched analysis persisted at 1 year at which time the mean gradient was 13.81 mmHg for BEV and 8.5 mmHg for SEV, p<0.001) and the indexed EOA was 0.9 cm²/m² for BEV compared with 1.1 cm²/m² for SEV, p<0.001. Those receiving a SEV had significantly lower rates of severe PPM (3.0%) compared to BEV patients (8.5%, p<0.001) at 1 year. The significance also held in the matched population (SEV 3.5% vs. BEV 8.0%, p<0.001). In both the matched and IPTW populations, implantation of a BEV was an independent predictor of moderate to severe patient-prosthesis mismatch (PPM) at 1 year compared with a SEV (matched: HR 2.94, 95% CI 1.79-4.76, p=0.01; IPTW: HR 2.86, 95% CI 1.92-4.35, p=0.01). Severe PPM at 1 year was an independent predictor of 3-year all-cause mortality in both the matched (HR 2.01, 95% CI 1.02-3.95; p=0.04) and IPTW (HR 2.41; 95% CI 1.31-4.44; p=0.004) analyses. Overall, BEV was an independent predictor of moderate or severe PPM. Severe PPM was particularly concerning with a nearly two-fold increase in all-cause mortality.

How these results apply to women is less understood. Given the limited availability of small THV platforms, it is imperative to reconsider THV in patients with small annuli. The durability of THV in small annuli is less well studied. This is particularly important when determining lifetime management and future options. The role of the heart team in addressing the initial strategy has a direct impact on future options. Root expansion or even a Ross procedure in expert centres should be considered at the outset.

References

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