Angiographic quantification of aortic regurgitation following myval octacor implantation; independent core lab adjudication
Ahmed Elkoumy, John Jose, Sengottuvelu Gunasekaran, Asish Kumar, B C Srinivas, Cholenahally Nanjappa Manjunath, K.S. Ravindranath, Maulik Parekh, Praveen Chandra, Rajneesh Kapoor, Mahmoud Abdelshafy, Ashok Seth, Praveer Agrawal, A. Mathur, Ravindra Singh Rao, Hesham Elzomor, K S Sadanada, Vijay Kumar, Shahram Arsang-Jang, Sanjay Mehrotra, Bagirath Raghuraman, Uday B. Khanolkar, Rajendra Kumar Premchand, Manik Chopra, Prem Krishna, Haresh Mehta, Rahul Gupta, Viveka Kumar, Nagendra Boopathy Senguttuvan, Andreas Baumbach, Patrick W. Serruys, Osama Soliman
Abstract
BACKGROUND: The balloon expandable Myval transcatheter heart valve (THV) showed encouraging results regarding residual aortic regurgitation (AR) from multiple observational studies. The newly designed Myval Octacor has been introduced recently, aiming for a reduction in AR and improved performance. OBJECTIVES: The focus of this study is to report the incidence of AR using the validated quantitative Videodensitometry angiography technology (qLVOT-AR%) in the first in human use of the Myval Octacor THV system. METHODOLOGY: We report on the first in human use of the Myval Octacor THV system in 125 patients in 18 Indian centres. Independent retrospective analysis of the final aortograms following implantation of the Myval Octacor was performed using the CAAS-A-Valve software. AR is reported as a regurgitation fraction. The previously validated cutoff values have been used to identify ≥moderate AR (RF% >17%), mild (6% < RF% ≤17%), and none or trace AR (RF% ≤ 6%). RESULTS: Final aortogram was analysable for 103 patients (84.4%) among the 122 available aortograms. 64 (62%) patients, had tricuspid aortic valve (TAV), 38 (37%) with bicuspid AV (BAV), and one with unicuspid AV. The median absolute RF% was 2% [1, 6], moderate or more AR incidence was 1.9%, mild AR in 20.4%, and none or trace AR in 77.7%. The two cases with RF% >17% were in the BAV group. CONCLUSION: The initial results of Myval Octacor using quantitative angiography-derived regurgitation fraction demonstrated a favourable outcome regarding residual AR, possibly due to improved device design. Results must be confirmed in a larger randomised study, including other imaging modalities.