What is the clinical evidence from this study?

Study design: Observational. Population: Bicuspid and tricuspid aortic stenosis (n=1597). Intervention: Bailout valve-in-valve (ViV) TAVR vs. Standard TAVR without bailout ViV. Primary outcome: 30-day all-cause mortality (HR 3.09, p=0.019).

What does this research mean for the field?

Bailout valve-in-valve TAVR is associated with significantly higher 30-day all-cause mortality compared to standard TAVR, but shows no significant difference in mid-term survival. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

May 20, 2026Open Access

Bailout valve-in-valve therapy during transcatheter aortic valve replacement in bicuspid and tricuspid aortic stenosis: an observational single-centre study in China

Key Result

Bailout valve-in-valve TAVR was associated with significantly higher 30-day all-cause mortality (HR 3.09, p=0.019) compared to standard TAVR, with no significant difference in mid-term survival.

Key Points

The research aims to evaluate the outcomes of bailout valve-in-valve therapy during transcatheter aortic valve replacement in patients with different aortic valve anatomies.
Retrospective analysis of 1597 patients undergoing transcatheter aortic valve replacement (TAVR) with 48.3% having bicuspid aortic valve.
Patients were stratified by bailout valve-in-valve requirement due to significant residual aortic regurgitation or valve embolisation.
Predictors identified using multivariate logistic regression and early/mid-term survival outcomes compared using Inverse Probability of Treatment Weighting (IPTW).
Bailout valve-in-valve was needed in 6.20% of patients (6.87% for bicuspid, 5.57% for tricuspid).
Higher early mortality observed in the bailout group: all-cause mortality HR 3.09 (p=0.019) and cardiovascular mortality HR 3.49 (p=0.021) at 30 days.
No significant differences in mid-term mortality were found between groups.

Study Design

Type

Observational (n=1,597)

Multicenter

Structured PICO

Does bailout valve-in-valve therapy during TAVR affect mortality in patients with bicuspid and tricuspid aortic stenosis?

Population

1597 patients undergoing transcatheter aortic valve replacement (48.3% bicuspid aortic valve) at a single centre in China

Intervention

Bailout valve-in-valve (ViV) transcatheter aortic valve replacement for significant residual aortic regurgitation or valve embolisation

Comparator

Standard transcatheter aortic valve replacement without bailout valve-in-valve

Outcome

30-day and mid-term all-cause and cardiovascular mortalityhard clinical

Bailout valve-in-valve during TAVR is associated with increased 30-day mortality but similar mid-term survival compared to standard TAVR, with specific anatomical and procedural predictors identified.

Main Result

Effect estimate: HR 3.09

p-value: p=0.019

Abstract

Background Bailout valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) is a critical rescue strategy for procedural failure, yet evidence regarding its outcomes in bicuspid aortic valve (BAV) anatomy remains limited. Methods This retrospective, single-centre study analysed 1597 patients (48.3% BAV) undergoing TAVR. Patients were stratified by the requirement for bailout ViV, which was conducted for significant residual aortic regurgitation (AR) or valve embolisation. Predictors were identified via multivariate logistic regression. Early- and mid-term survival outcomes were compared using Inverse Probability of Treatment Weighting (IPTW) via entropy balancing. Results Bailout ViV was required in 6.20% of patients (BAV: 6.87%; tricuspid aortic valve (TAV): 5.57%). Larger annulus perimeter and significant residual AR after initial deployment were identified as consistent independent predictors of bailout ViV across all cohorts. Additionally, lower annulus calcification volume, non-repositionable self-expanding valves and the learning phase were predictors in the overall cohort. Significant mitral regurgitation and lower calcification volume in BAV and male sex in TAV cohorts were independent risk factors. IPTW-adjusted analysis revealed significantly higher 30-day all-cause (HR 3.09, p=0.019) and cardiovascular mortality (HR 3.49, p=0.021) in the bailout ViV group. However, no significant differences were observed in mid-term all-cause or cardiovascular mortality between groups. Conclusions Bailout ViV was associated with elevated early mortality but offered satisfactory mid-term survival. Key predictors include anatomical challenges (large annulus and insufficient calcification) and procedural factors (non-repositionable self-expanding valve, learning phase TAVR and significant residual AR after the first prosthesis).