TY - JOUR
T1 - Operator preference and determinants of size selection when additional intermediate-size aortic transcatheter heart valves are made available
AU - Kawashima, Hideyuki
AU - Serruys, Patrick W.
AU - Mylotte, Darren
AU - Rosseel, Liesbeth
AU - Amat-Santos, Ignacio J.
AU - Rao, Ravinder Singh
AU - Onuma, Yoshinobu
AU - Wijns, William
AU - Abdel-Wahab, Mohamed
AU - Baumbach, Andreas
AU - Soliman, Osama
N1 - Funding Information: We thank the European investigators of the PRE-LANDMARK registry who have contributed to the collection of the data (Dr. Dariusz Jagielak, Dr. Francesco Bedogni, Dr. Peter Den Heijer, Dr. Henrik Nissen, Dr. Christian Juhl Terkelsen, Dr. Franz-Josef Neumann, Dr. Frederico De Marco, Dr. Alfonso Ielasi, Dr. Matteo Montorfano, Dr. Boris Star?evi?, Dr. Kresimir Stambuk, Dr. Giuseppe Bruschi, Dr. Pedro Martin, Dr. Luigi Salemme, Dr. Elia Iorio, Dr. Attila Kert?sz, Dr. Erente Giovanna, Dr. B?la Merkely, Dr. Gennaro Sardella, Dr. Bruno Garc?a del Blanco, Dr. Matja? Bunc, Dr. Ivo Petrov, and Dr. Carlo Trani) for the support of this Research Correspondence article. Furthermore, we thank Meril Life Sciences considering the technology and for the support of the data collection and for providing the instructions for use of the Myval device. Publisher Copyright: © 2021 The Author(s)
PY - 2021/9/1
Y1 - 2021/9/1
N2 - Background: Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. Methods: In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extra-large THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. Results: A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. Conclusions: Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional- and intermediate-size THVs.
AB - Background: Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. Methods: In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extra-large THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. Results: A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. Conclusions: Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional- and intermediate-size THVs.
KW - Aortic stenosis
KW - Balloon-expandable valve
KW - Intermediate-size
KW - Transcatheter aortic valve implantation
KW - Transcatheter heart valve
UR - http://www.scopus.com/inward/record.url?scp=85108569971&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ijcard.2021.06.029
DO - https://doi.org/10.1016/j.ijcard.2021.06.029
M3 - Article
C2 - 34147554
SN - 0167-5273
VL - 338
SP - 168
EP - 173
JO - International journal of cardiology
JF - International journal of cardiology
ER -