Expert Consensus on Sizing and Positioning of SAPIEN 3/Ultra in Bicuspid Aortic Valves

Abstract

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

Clinical outcomes and the impact of valve morphology for transcatheter aortic valve replacement in bicuspid aortic valves: A systematic review and meta‐analysis

“…Systematic search through June 2022 resulted in 50 eligible studies for the analysis, 3,8–56 including 203,288 cases (184,716 TAV and 18,572 BAV, Figure 1 and Supporting Information: Table ). Both groups had relatively the same age (81.7 years in BAV vs. 81.0 years in TAV), and 56% of each group was male.…”

The Presence of Calcified Raphe Is an Independent Predictor of Adverse Long-Term Clinical Outcomes in Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

“…Some experts have proposed various supra-annular sizing methods, algorithms, balloon sizing, or even computer simulation to improve valve sizing and device selection, hoping to reduce complications ( 12 , 16 – 26 ). Whether supra-annular sizing can truly provide additional benefits in terms of improving device and procedural success and/or clinical outcomes remains controversial ( 27 – 29 ) because the supra-annular sizing is less reproducible than annular sizing, and its techniques of measurements not yet standardized ( 17 – 26 ).…”

“…Some experts have proposed various supra-annular sizing methods, algorithms, balloon sizing, or even computer simulation to improve valve sizing and device selection, hoping to reduce complications ( 12 , 16 – 26 ). Whether supra-annular sizing can truly provide additional benefits in terms of improving device and procedural success and/or clinical outcomes remains controversial ( 27 – 29 ) because the supra-annular sizing is less reproducible than annular sizing, and its techniques of measurements not yet standardized ( 17 – 26 ). However, as shown in this study, although there was no clinically significant difference between annular and supra-annular sizings, supra-annular sizing, which selects a smaller THV than suggested by annular sizing and thus avoids the oversizing-related risks for the minority of patients with tapered or funnel anatomy, appeared to be of incremental value.…”

“…Suchlike cases as discussed here consisted of four out of the 56 (7%) of the patients in our series. Compared to the use of the circle method for supra-annular sizing, advocated in BAV cases by a Bicuspid Expert Panel of interventional cardiologists and cardiac surgeons ( 26 ), moreover, our method is much easier to apply and time-saving, and the diameter of THV derived is more precise and may guarantee safer implantation.…”

“…However, complications, such as moderate or severe paravalvular leakage (PVL) and aortic root dissection are more commonly seen in patients with BAV compared with those in patients with tricuspid aortic valve ( 9 – 15 ). Hence, certain experts proposed new BAV imaging classification for the patients who underwent TAVR and, to reduce complications, various supra-annular sizing methods, algorithms, balloon sizing, or even computer simulation to improve valve sizing and device selection ( 12 , 16 – 26 ). However, whether these approaches can truly provide additional benefits in terms of improving either device or procedural success, or even clinical outcomes, remain controversial ( 26 – 29 ).…”