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Review
. 2021 Dec;10(2):277-288.
doi: 10.1007/s40119-021-00223-9. Epub 2021 Jun 3.

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

Affiliations
Review

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

Daniel Blackman et al. Cardiol Ther. 2021 Dec.

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 complications and to optimize outcomes for patients.

Keywords: Bicuspid aortic valve; Bicuspid positioning; Bicuspid sizing; SAPIEN 3/Ultra; TAVI.

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Figures

Fig. 1
Fig. 1
Decision tree: SAVR or TAVI for bicuspid severe aortic stenosis patients? This algorithm was created based on the consensus reached by the Bicuspid Expert Panel, including both interventional cardiologists and cardiac surgeons. CT computed tomography, HT Heart Team, SAVR surgical aortic valve replacement, TAVI transcatheter aortic valve replacement, MED RX standard medical therapy
Fig. 2
Fig. 2
Aortic root configurations. The orifice is the perimeter created by the free edge of the leaflets, whereas the annulus is the virtual ring formed by linking the basal attachments of the aortic leaflets. As defined in the BAVARD Registry [8], bicuspid landing zone may present with three different configurations: tubular (both annulus and orifice have the same size), flared (annulus smaller than the orifice), or tapered (annulus larger than the orifice)
Fig. 3
Fig. 3
The circle method. SAPIEN 3 visual simulation to provide pre-operative insights into the interaction between SAPIEN 3 and bicuspid anatomy. Circles are drawn at 0–3-6–9 mm from the annulus to understand sealing zone at the commissures to determine size and position. Coronary take-off and above levels are checked for left main/right coronary artery clearance
Fig. 4
Fig. 4
How to position the valve before opening

References

    1. Baumgartner H, De Backer J. The ESC clinical practice guidelines for the management of adult congenital heart disease 2020. Eur Heart J. 2020;41(43):4153–4154. doi: 10.1093/eurheartj/ehaa701. - DOI - PubMed
    1. Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL, Group ESCSD 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739–2791. doi: 10.1093/eurheartj/ehx391. - DOI - PubMed
    1. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM, III, Thompson A, Toly C. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2020;2:3. doi: 10.1161/CIR.0000000000000923. - DOI - PubMed
    1. Head SJ, Celik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017;38(28):2183–2191. doi: 10.1093/eurheartj/ehx141. - DOI - PubMed
    1. Pollari F, Hitzl W, Vogt F, Cuomo M, Schwab J, Sohn C, Kalisnik JM, Langhammer C, Bertsch T, Fischlein T, Pfeiffer S. Aortic valve calcification as a risk factor for major complications and reduced survival after transcatheter replacement. J Cardiovasc Comput Tomogr. 2020;14(4):307–313. doi: 10.1016/j.jcct.2019.12.001. - DOI - PubMed