TAVR in Pure Native Aortic Regurgitation: Are Dedicated Devices Truly Superior?

This systematic meta-analysis assessed the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation. The emergence of second-generation transcatheter devices, in particular scaffolds specifically dedicated to this condition, has made it possible to offer a viable therapeutic alternative for this subgroup of patients, who were historically excluded from randomized clinical trials.

This review included 19 observational studies with a minimum of 20 patients, encompassing a total of 1804 subjects treated from the beginning of the available literature through April 2024. The mean age was 75.3 years, with an average STS-PROM score of 6.5%. Researchers compared outcomes obtained with first-generation devices, second-generation devices, and valves specifically designed for pure native aortic regurgitation (JenaValve and J-Valve). This analysis took into account the specific anatomical characteristics of this condition—such as the absence of calcification, annular dilation, and increased stroke volume—which hinder device anchoring and increase the risk of valve migration.

The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included device success, the incidence of valve migration, one-year mortality, and the occurrence of relevant periprocedural events, such as coronary obstruction, annular rupture, need for bailout surgery, reintervention, and vascular or bleeding complications.

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Among the 1804 patients analyzed, the overall 30-day mortality was 8.7% (95% confidence interval [CI]: 5.8–10.7%), with a marked reduction according to device generation: 16.9% with first-generation valves, 7.2% with second-generation devices, and 4.7% with dedicated platforms (p <0.0001). Implantation success was 84.1% (95% CI: 78.0–88.9%), showing a progressive improvement from first-generation devices (63.1%) to second-generation devices (86.3%) and dedicated devices (93.0%) (p <0.00001). Valve migration occurred in 7.8% of cases but was significantly reduced with advancing technology: 19.0% with first-generation devices, 6.9% with second-generation devices, and only 3.0% with dedicated valves (p <0.00001).

One-year mortality was 14% (95% CI: 10.1–19.9%), again lower with dedicated devices (8.7%) compared with second-generation (12.7%) and first-generation devices (27.2%) (p <0.0001). Other periprocedural events, with low incidence, included crossover to surgery (2.8%), coronary obstruction (1.0%), annular rupture (0.7%), reintervention (3.6%), stroke (3.3%), and major vascular complications (5.1%), with no significant differences between generations. Moderate or greater paravalvular regurgitation was present in 5.8% of cases, with clear superiority of dedicated devices (1.1%).

Conclusion

This meta-analysis demonstrates that transcatheter aortic valve replacement for pure native aortic regurgitation achieves significantly better outcomes with the use of dedicated devices, which entail higher implantation success rates, lower valve migration, and meaningful reductions in 30-day and one-year mortality. While the available evidence is observational in nature, these findings support TAVR as a valid alternative in patients at high surgical risk and position scaffolds specifically designed for this anatomy as the main step towards safely expanding this indication.

Original Title: Dedicated versus conventional devices in patients with pure native aortic regurgitation: a systematic review and meta-analysis.

Reference: Elena Bacigalupi, et al. Journal of the American Heart Association, 2025.