Key result
New-generation TAVR is linked to ~32% higher device success than early-generation devices in pure AR.
Why the study?
Limited data exist regarding the safety and efficacy of TAVR in patients with pure native aortic regurgitation.
Does TAVR with new-generation devices improve procedural and clinical outcomes compared to early-generation devices in symptomatic patients with pure native aortic regurgitation?
Observational (n=331)
Yes
Does TAVR with new-generation devices improve procedural and clinical outcomes compared to early-generation devices in symptomatic patients with pure native aortic regurgitation?
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.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The off-label use of first-generation THVs in patients with severe pure native AR was associated with poor device success and clinical outcomes. Since the introduction of newer generation THVs, a few multicenter registries have demonstrated improved outcomes with these devices compared with their older generation counterparts for the treatment of patients with pure native AR.”
“In 2013, the first multicenter registry evaluating off-label use of a self-expanding THV (CoreValve, Medtronic) for TAVR in pure AR confirmed general feasibility with a procedural success rate of 74.4%, but it also highlighted technical limitations, as a second valve had to be implanted in 18.6% of cases. These limitations were persistently observed in subsequent reports of off-label AR treatment with several self-expanding and balloon-expandable devices, emphasizing an inferior efficacy profile compared to TAVR in AS.”
“PAR poses unique challenges in valve intervention, notably high-velocity diastolic flow, aortic root enlargement, and the absence of calcification for valve anchorage. Despite these challenges, the 2021 ESC/EACTS guidelines cautiously consider TAVI for select PAR patients, ineligible for surgical aortic valve replacement.”
May support TAVR in pure native AR; hypothesis-generating and requires randomized confirmation before practice change.
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.
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Yoon et al. (2017) conducted an 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).
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