Operator preference and determinants of size selection when additional intermediate-size aortic transcatheter heart valves are made available

Hideyuki Kawashima,Patrick W Serruys,Darren Mylotte,Liesbeth Rosseel,Ignacio J Amat-Santos,Ravinder Singh Rao,Yoshinobu Onuma,William Wijns,Mohamed Abdel-Wahab,Andreas Baumbach,Osama Soliman

doi:10.1016/j.ijcard.2021.06.029

Abstract

BackgroundAppropriate 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. MethodsIn 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. ResultsA 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. ConclusionsIntermediate-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.

Highlights

Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture
Ltd., India) for TAVI in a real-world dataset. 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 extralarge THVs
Appropriate size selection of the transcatheter heart valves (THVs) is critical to reduce the incidence of paravalvular aortic regurgitation (PVR), conduction disturbance requiring new permanent pacemaker implantation (PPI), and the risk of life-threatening complications, such as valve embolization or annular rupture [1]

Summary

Introduction

Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. 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 extralarge THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions.

Results

Conclusion