Key result
The presence of a calcified raphe > 4 mm independently predicted long-term major adverse cardiac and cerebral events (HR 6.76) in patients with bicuspid aortic stenosis undergoing TAVR.
Why the study?
Guidelines recommend TAVR for bicuspid AS only in selected patients, making it crucial to identify factors determining long-term outcomes.
Does TAVR with the newer-generation Sapien 3 valve improve long-term clinical outcomes compared to the Sapien XT valve, and what are the anatomical predictors of adverse outcomes in patients with bicuspid aortic stenosis?
Cohort (n=56)
No
Does TAVR with the newer-generation Sapien 3 valve improve long-term clinical outcomes compared to the Sapien XT valve, and what are the anatomical predictors of adverse outcomes in patients with bicuspid aortic stenosis?
Hazard Ratio: 6.76 (95% CI 1.21–37.67)
p-value: p=0.029
In patients with bicuspid aortic stenosis undergoing TAVR, the presence of a calcified raphe >4 mm is a strong independent predictor of long-term adverse clinical outcomes.
Calcified raphe >4 mm may flag higher long-term MACCE risk in bicuspid TAVR; hypothesis-generating and requires prospective validation before practice change.
Objective Current guidelines recommend that transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve (BAV) with aortic stenosis (AS) should only be performed in selected patients. However, we consider it even more crucial to identify what the really important factors are while determining long-term outcomes in patients with BAV undergoing TAVR, which is precisely the aim of this study. Methods We retrospectively evaluated consecutive patients who underwent TAVR with balloon-expandable Sapien XT or Sapien 3 valves (Edwards Lifesciences, Irvine, CA) for the treatment of severe bicuspid AS. The primary end points were major adverse cardiac and cerebral events (MACCE), that is, mortality, non-fatal myocardial infarction (MI), disabling stroke, valve failure needing reintervention, or clinically relevant valve thrombosis during follow-up. Results A total of 56 patients who underwent TAVR with Sapien XT (n = 20) or Sapien 3 (n = 36) were included. The device and procedural success rates were similar between the two TAVR valves; however, the newer-generation Sapien 3 yielded a trend toward better long-term clinical outcomes than the early-generation Sapien XT did (MACCE rates 35 vs. 11%, p = 0.071). In the multivariate Cox proportional hazards analyses, the presence of calcified raphe > 4 mm was the only independent predictor of long-term MACCE (hazard ratio: 6.76; 95% confidence interval: 1.21–37.67, p = 0.029). Conclusion TAVR performed by a skilled heart team, while using newer-generation balloon-expandable Sapien 3 valve, may yield better long-term clinical outcomes compared to TAVR using early-generation Sapien XT valve. Moreover, the presence of calcified raphe >4 mm is an independent determinant of adverse clinical outcomes.
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Lee et al. (2022) conducted a cohort in Bicuspid aortic valve with severe aortic stenosis (n=56). Calcified raphe > 4 mm vs. Absence of calcified raphe > 4 mm was evaluated on Major adverse cardiac and cerebral events (MACCE) (HR 6.76, 95% CI 1.21-37.67, p=0.029). The presence of a calcified raphe > 4 mm independently predicted long-term major adverse cardiac and cerebral events (HR 6.76) in patients with bicuspid aortic stenosis undergoing TAVR.
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