TY - JOUR
T1 - Expert Consensus on Sizing and Positioning of SAPIEN 3/Ultra in Bicuspid Aortic Valves
AU - Blackman, Daniel
AU - Gabbieri, Davide
AU - Del Blanco, Bruno García
AU - Kempfert, Jörg
AU - Laine, Mika
AU - Mascherbauer, Julia
AU - Parma, Radoslaw
AU - Tchétché, Didier
N1 - Funding Information:
The journal’s Rapid Service Fee was supported by Edwards Lifesciences. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. All authors contributed equally. In addition, Dr. Daniel Blackman designed the structure of the article, and proofread the manuscript. This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. Daniel Blackman, Davide Gabbieri, Bruno García Del Blanco, Jörg Kempfert, Mika Laine, Julia Mascherbauer, Radoslaw Parma and Didier Tchétché were part of an advisory panel at Edwards for which they got paid. Furthermore, Davide Gabbieri, Jörg Kempfert, and Radoslaw Parma are proctors for Edwards Lifesciences. Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.
Funding Information:
The journal’s Rapid Service Fee was supported by Edwards Lifesciences.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85107447622&partnerID=8YFLogxK
U2 - 10.1007/s40119-021-00223-9
DO - 10.1007/s40119-021-00223-9
M3 - Review article
C2 - 34081277
VL - 10
SP - 277
EP - 288
JO - Cardiology and Therapy
JF - Cardiology and Therapy
SN - 2193-8261
IS - 2
ER -