TAVI and Aortic Regurgitation: Are All Valves the Same?

Aortic regurgitation (AR) accounts for 0.5- 2.2% of all cases of valve disease in individuals over 65 years old.

According to current guidelines, surgery is the treatment of choice in this scenario. However, some patients are not surgical candidates due to advanced age or comorbidities.

Transcatheter aortic valve implantation (TAVI) is a viable alternative, but it is important to note that the valves used are primarily designed for calcified tricuspid aortic stenosis. This entails certain challenges in cases of AR, including different anatomy with a larger annulus, aortic root dilation, absence of calcium where to anchor the bioprosthesis, and the presence of a regurgitant jet that may destabilize the implant, thus increasing the risk of embolization or migration.

A meta-analysis of 34 studies (19 multicenter and 15 single-center studies) assessed patients with pure AR. Among them, 1193 (55.2%) received a dedicated valve (DV) designed for pure AR, while the rest received an off-label valve (OLV).

Read also: 1-Year Outcomes of US TAVR Registry with 5th Generation Balloon Expandable Valves.

The dedicated valve used was the Jena Valve/J-Valve.

Mean patient age was 75 years; 43% of subjects were women and the STS score was 5.6%.

Results

Device success was significantly higher with dedicated valves (95% vs. 82%, p<0.001).

At 30 days, patients who received dedicated valves had lower mortality rates (3% vs. 9%, p<0.001) and a lower incidence of moderate or severe post-implantation AR (4% vs. 10%, p=0.03). They also experienced reduced rates of reintervention (4% vs. 10%, p<0.001), permanent pacemaker implantation (11% vs. 20%, p<0.001), embolization or migration (2% vs. 8%, p<0.001), and less incidence of major bleeding (3% vs. 7%, p<0.001).

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At one year, mortality was significantly lower in patients with dedicated valves (13% vs. 24%, p<0.001).

There were no significant differences in the incidence of stroke or major vascular complications between the two groups.

Conclusion

TAVI-dedicated valves in patients with native aortic regurgitation showed clear superiority in terms of device success, reduced mortality, lower residual regurgitation, and decreased reintervention rates compared to off-label valves.

Original Title: Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation. 

Reference: Sahar Samimi, et al. ACC Cardiovasc Interv. 2024, Article in Press.