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September 7, 2026Journal of the American College of CardiologyOpen Access

Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis

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Why the study?

Few studies have evaluated clinical outcomes of TAVR in bicuspid aortic valve stenosis, with limited data comparing new-generation versus early-generation devices.

Population

301 consecutive patients with bicuspid AS undergoing TAVR

Comparison

Early-generation devices vs new-generation devices

Design

International multicenter registry study

Follow-up

1 year

Key result

TAVR with new-generation devices in bicuspid aortic stenosis was associated with less moderate or severe paravalvular leak (0.0% vs 8.5%, p=0.002) and higher device success than early devices.

Authors

SYSung-Han YoonTLThierry LefèvreJAJung-Ming Ahn

Discussion

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Overview

Observational study reveals improved device success with new-generation prostheses in bicuspid aortic valve stenosis, indicating enhanced safety.

Key Points

  • To evaluate the procedural safety, efficacy, and clinical outcomes of transcatheter aortic valve replacement comparing early-generation and new-generation devices in patients with bicuspid aortic valve stenosis.
  • International multicenter registry evaluating patients with severe bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
  • Comparison of procedural and clinical outcomes between early-generation devices (e.g., Sapien XT, CoreValve) and new-generation devices (e.g., Sapien 3, Evolut R, Lotus).
  • Assessment of device success, significant paravalvular regurgitation, aortic root injury, and mortality at 30 days and 1 year.
  • New-generation transcatheter heart valves achieved significantly higher device success compared to early-generation devices.
  • Use of new-generation devices resulted in significantly reduced rates of moderate-to-severe paravalvular regurgitation and lower rates of aortic root injury.

Study Design

Type

Cohort (n=301)

Multicenter

Yes

PICO

P
Population
301 consecutive patients with bicuspid aortic valve stenosis undergoing TAVR, evaluated for clinical outcomes and device success.
E
Exposure / Comparator
TAVR with new-generation devices vs TAVR with early-generation devices
O
Primary Outcome
Moderate or severe paravalvular leak, p=0.002

Main Result

Absolute Event Rate: 0% vs 8.5%

p-value: p=0.002

Cite This Study

Yoon et al. (2016) conducted a cohort in bicuspid aortic valve stenosis (n=301). TAVR with new-generation devices vs. TAVR with early-generation devices was evaluated on Moderate or severe paravalvular leak (p=0.002). TAVR with new-generation devices in bicuspid aortic stenosis was associated with less moderate or severe paravalvular leak (0.0% vs 8.5%, p=0.002) and higher device success than early devices.

synapsesocial.com/papers/6a9ed5ddae051fe680bc566fhttps://doi.org/10.1016/j.jacc.2016.06.041
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