TAVR for Bicuspid vs. Tricuspid Aortic Valve Stenosis

Study Questions:

What are the outcomes in patients with bicuspid aortic valves (BAVs) treated with transcatheter aortic valve replacement (TAVR)?

Methods:

This study compared patients enrolled in a multicenter registry of consecutive BAV patients treated with TAVR at 33 sites to patients with tricuspid aortic valve (TAV) treated with TAVR at 12 sites. Propensity analysis was used to compare procedural characteristics and outcomes between patients with BAV versus TAV valves, and between subsets of patients with BAV treated with TAVR.

Results:

Propensity analysis was used to match a total of 576 patients with BAV and 5,900 patients with TAV treated with TAVR. After propensity matching, 546 BAV and 546 TAV patients were compared, with no significant differences in measured patient characteristics between groups. BAV morphology included Type 0 (12.8%), Type 1 (85.6%), and Type 2 (1.7%). Patients with BAV had increased conversion to surgery (2.0% vs. 0.2%; p = 0.006) and lower procedural success (85.3% vs. 91.4%; p = 0.002). Among patients treated with early-generation devices, BAV patients had increased aortic root injury (4.5% vs. 0.0%; p = 0.02) when receiving the Sapien XT device, and increased moderate-to-severe paravalvular regurgitation (19.4% vs. 10.5%; p = 0.02) when receiving the CoreValve device. For patients with newer-generation devices, procedural results were not different between groups. The cumulative all-cause mortality rates at 2 years were similar between BAV and TAV patients treated with TAVR (17.2% vs. 19.4%; p = 0.28).

Conclusions:

In patients with severe aortic stenosis and BAV (predominantly Type 1), there was a decrease in procedural success and an increase in procedural complications, with no difference in 2-year mortality.

Perspective:

This study observes a decrease in procedural success and an increase in procedural complications among patients with BAV and severe aortic stenosis treated with TAVR, particularly using earlier generations of devices. While the propensity matching resulted in comparable patient characteristics between groups, it cannot account for unmeasured variables or possible biases inherent in selecting patients with BAV for this procedure, which may be different from site selection of patients with a TAV. Further, comparison groups are from different site combinations, which may impact the results. Most patients had a type 1 BAV, and comparisons of procedural outcomes between different types of BAV are not provided. These results are hypothesis-generating, and emphasize the need for randomized trials of patients with BAV and aortic stenosis to directly compare TAVR and surgical valve replacement.

Keywords: Aortic Valve Stenosis, Bicuspid, Cardiac Surgical Procedures, Heart Valve Diseases, Transcatheter Aortic Valve Replacement, Treatment Outcome, Tricuspid Valve Stenosis


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