Evolut PRO and Fewer Paravalvular Leaks Following TAVI for Aortic Stenosis

The Evolut PRO is associated with a significantly lower rate of paravalvular leaks (PVL) and a trend toward a lower rate of life-threatening or major bleeding in patients receiving transcatheter aortic valve implantation (TAVI), according to a study in the International Journal of Environmental Research and Public Health.

The systematic review and meta-analysis compared short-term results (up to 30 days) of TAVI with the Evolut PRO (Medtronic) and Evolut R (Medtronic) valves in patients with symptomatic severe aortic valve stenosis. Outco.mes included PVL and major vascular complications (MVC), including serious bleeding.

Investigators searched PubMed, Google Scholar, ClinicalKey, and the Web of Science databases through November 2022 for human studies that directly compared strategies for transcatheter aortic valve replacement with the Evolut R and Evolut PRO.

A total of 11 observational studies (7 multicenter registries) with 12,363 patients were included. The studies had a moderate risk of bias.

Participants who received the Evolut PRO (n=3439) and Evolut R (n=8924) substantially differed in age (P <.001), sex (P <.001), and Society of Thoracic Surgeons Predicted Risk of Mortality risk profile (P <.001). Evolut PRO patients, compared with Evolut R patients, were older (80.13±7.65 years vs 77.58±8.79 years) and more were women (62.92% vs 54.71%) but they had a lower risk profile (6.79±6.4 vs 7.34±5.6).

The need for use of more than 1 prosthesis during initial implantation was low in the Evolut PRO (0.87%, 26 of 2973 cases) and Evolut R groups (1.18%, 94 of 7972 cases), with statistical significance in favor of the Evolut PRO (risk ratio [RR], 0.52; 95% CI, 0.30-0.89; P =.02; I²=8%). No difference was observed in the pooled estimate of other TAVI-related complications between the groups, which was 0.45% (13 of 2900 cases) for the Evolut PRO patients vs 0.49% (37 of 7526 cases) for the Evolut R patients.

The analysis of moderate-to-severe and mild PVL included 11 (n=12,363) and 7 (n=10,862) studies, respectively. The researchers found a decrease of about 35% in risk for moderate-to-severe PVL in patients with the Evolut PRO valve (RR, 0.66; 95% CI, 0.52-0.86; P =.002; I²=0%). There were corresponding event rates of 2.41% (83 of 3439) for the Evolut PRO and 3.03% (270 of 8924) for the Evolut R. No difference was observed for mild PVL between devices.

Analysis of serious bleeding and MVC included 9 studies. The Evolut PRO group had a decrease of over 35% in risk for serious bleeding compared with the Evolut R group (RR, 0.63; 95% CI, 0.41-0.96; P =.03; I²=39%). No differences in MVC were found between the 2 devices (RR, 0.77; 95% CI, 0.54-1.08; P =.13; I²=7%).

The risk for other clinical endpoints was similar between the devices, including 30-day mortality (RR, 0.93; 95% CI, 0.69-1.25; P =.63; I²=0%), periprocedural myocardial infarction (RR, 1.31; 95% CI, 0.42-4.05; P =.64; I²=40%), and cerebrovascular accident (RR, 0.81; 95% CI, 0.61-1.08; P =.15; I²=0%).

Among several study limitations, only observational studies are included, and those that have compared the Evolut PRO and Evolut R have reported only short-term outcomes thus far. Furthermore, 2 studies accounted for over 70% of the study population.

“The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in the clinical and procedural endpoints,” wrote the study authors. “Implantation of the Evolut PRO was associated with a statistically significantly lower rate of moderate-to-severe PVL. These benefits might, in consequence, further translate into improved long-term clinical outcomes.”