Why the study?
Severe aortic stenosis patients with bicuspid anatomy were excluded from major TAVI randomized clinical trials, leaving no official recommendations for bicuspid TAVI.
Provides expert consensus and a step-by-step guide for sizing and positioning SAPIEN 3/Ultra TAVI valves in patients with severe bicuspid aortic stenosis, a population excluded from major randomized trials.
Supports individualized TAVI planning in bicuspid aortic stenosis; extends expert consensus to a population excluded from randomized trials.
Severe aortic stenosis patients with bicuspid anatomy have been excluded from the major transcatheter aortic valve replacement (TAVI) randomized clinical trials. As a result, there is no official recommendation on bicuspid TAVI. A panel of bicuspid experts was created to fill this gap. In this consensus statement, an algorithm is proposed to guide the choice of surgery or TAVI within this complex patient population, depending on aortic dilatation, age, surgical risk score, and anatomy. A step-by-step guide for sizing and positioning of the SAPIEN 3/Ultra TAVI bioprostheses is presented. Annular sizing remains the primary strategy in most bicuspid patients. However, some anatomies may require sizing at the supra-annular level, for which patients the panel recommends the circle method, a dedicated sizing and positioning approach for SAPIEN 3/Ultra. The consensus provides valuable pre-operative insights on the interactions between SAPIEN 3/Ultra and the bicuspid anatomy; understanding the valve-anatomy relationship is critical to avoid complications and to optimize outcomes for patients.
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Blackman et al. (2021) studied this question.
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