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

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          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.

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          Most cited references15

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          2017 ESC/EACTS Guidelines for the management of valvular heart disease.

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            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

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              A classification system for the bicuspid aortic valve from 304 surgical specimens.

              In general, classification of a disease has proven to be advantageous for disease management. This may also be valid for the bicuspid aortic valve, because the term "bicuspid aortic valve" stands for a common congenital aortic valve malformation with heterogeneous morphologic phenotypes and function resulting in different treatment strategies. We attempted to establish a classification system based on a 5-year data collection of surgical specimens. Between 1999 and 2003 a precise description of valve pathology was obtained from operative reports of 304 patients with a diseased bicuspid aortic valve. Several different characteristics of bicuspid aortic valves were tested to generate a pithy and easily applicable classification system. Three characteristics for a systematic classification were found appropriate: (1) number of raphes, (2) spatial position of cusps or raphes, and (3) functional status of the valve. The first characteristic was found to be the most significant and therefore termed "type." Three major types were identified: type 0 (no raphe), type 1 (one raphe), and type 2 (two raphes), followed by two supplementary characteristics, spatial position and function. These characteristics served to classify and codify the bicuspid aortic valves into three categories. Most frequently, a bicuspid aortic valve with one raphe was identified (type 1, n = 269). This raphe was positioned between the left (L) and right (R) coronary sinuses in 216 (type 1, L/R) with a hemodynamic predominant stenosis (S) in 119 (type 1, L/R, S). Only 21 patients had a "purely" bicuspid aortic valve with no raphe (type 0). A classification system for the bicuspid aortic valve with one major category ("type") and two supplementary categories is presented. This classification, even if used in the major category (type) alone, might be advantageous to better define bicuspid aortic valve disease, facilitate scientific communication, and improve treatment.
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                Author and article information

                Contributors
                daniel.blackman1@nhs.net
                dgabbieri@yahoo.it
                brunogb51@gmail.com
                kempfert@dhzb.de
                mika.laine@hus.fi
                julia.mascherbauer@meduniwien.ac.at
                radoslaw.parma@gmail.com
                dtchetche@clinique-pasteur.com
                Journal
                Cardiol Ther
                Cardiol Ther
                Cardiology and Therapy
                Springer Healthcare (Cheshire )
                2193-8261
                2193-6544
                3 June 2021
                3 June 2021
                December 2021
                : 10
                : 2
                : 277-288
                Affiliations
                [1 ]GRID grid.415967.8, ISNI 0000 0000 9965 1030, Leeds Teaching Hospitals NHS Trust, ; Leeds, UK
                [2 ]GRID grid.414062.5, ISNI 0000 0004 1760 2091, Hesperia Hospital, ; Modena, Italy
                [3 ]GRID grid.411083.f, ISNI 0000 0001 0675 8654, Hospital Vall D’hebron, ; Barcelona, Spain
                [4 ]GRID grid.418209.6, ISNI 0000 0001 0000 0404, German Heart Center Berlin, ; Berlin, Germany
                [5 ]GRID grid.15485.3d, ISNI 0000 0000 9950 5666, Helsinki University Central Hospital, ; Helsinki, Finland
                [6 ]GRID grid.10420.37, ISNI 0000 0001 2286 1424, University of Vienna, ; Vienna, Austria
                [7 ]GRID grid.459693.4, Karl Landsteiner University of Health Sciences, ; Krems, Austria
                [8 ]GRID grid.411728.9, ISNI 0000 0001 2198 0923, Department of Cardiology and Structural Heart Diseases, , Medical University of Silesia, ; Katowice, Poland
                [9 ]GRID grid.464538.8, ISNI 0000 0004 0638 3698, Clinique Pasteur, ; Toulouse, France
                Article
                223
                10.1007/s40119-021-00223-9
                8555019
                34081277
                cf4eb002-71b3-40ff-b4e4-78a37b7fb8ca
                © The Author(s) 2021

                Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 6 April 2021
                Funding
                Funded by: Edwards Lifesciences
                Categories
                Review
                Custom metadata
                © The Author(s) 2021

                bicuspid aortic valve,tavi,bicuspid sizing,bicuspid positioning,sapien 3/ultra

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