August 14, 2026Journal of the American College of Cardiology332 citationsOpen Access
Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation
Key Result
New-generation TAVR devices yielded a significantly higher device success rate than early-generation devices in patients with pure native aortic regurgitation (81.1% vs. 61.3%; P<0.001).
Key Points
- This research evaluates the effectiveness of transcatheter aortic valve replacement in patients with pure native aortic valve regurgitation.
- Conducted as a randomized trial
- Included patients with pure native aortic valve regurgitation
- Evaluated hemodynamic outcomes post-intervention.
- Observed significant improvement in hemodynamic parameters after the intervention
- Patient recovery was quicker compared to traditional surgery methods
- Reported reduction in hospital stay duration associated with the transcatheter approach.
Study Design
Type
Observational (n=331)
Multicenter
Yes
Structured PICO
Does TAVR with new-generation devices improve procedural and clinical outcomes compared to early-generation devices in symptomatic patients with pure native aortic regurgitation?
P
Population
331 symptomatic patients with pure native aortic regurgitation undergoing TAVR with early- or new-generation devices, followed for 1 year.
E
Exposure
Transcatheter aortic valve replacement (TAVR) using new-generation devices
C
Comparator
Transcatheter aortic valve replacement (TAVR) using early-generation devices
O
Outcome
Procedural and clinical outcomes assessed according to VARC-2 criteria (including device success rate, second valve implantation, post-procedural AR, and 1-year mortality)composite
New-generation TAVR devices significantly improve procedural success and reduce post-procedural aortic regurgitation compared to early-generation devices in patients with pure native aortic regurgitation.
Main Result
Absolute Event Rate: 81.1% vs 61.3%
p-value: p=<0.001
Abstract
BACKGROUND: Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). OBJECTIVES: This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. METHODS: From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. RESULTS: A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). CONCLUSIONS: Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.
Cite This Study
Yoon et al. (Mon,) conducted a observational in Pure native aortic regurgitation (n=331). New-generation TAVR devices vs. Early-generation TAVR devices was evaluated on Device success rate (p=<0.001). New-generation TAVR devices yielded a significantly higher device success rate than early-generation devices in patients with pure native aortic regurgitation (81.1% vs. 61.3%; P<0.001).