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. 2022 Jan 15;11(2):443.
doi: 10.3390/jcm11020443.

Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis-A Multicenter Real-World Experience

Ahmed Elkoumy  1 , John Jose  2 , Christian J Terkelsen  3 , Henrik Nissen  4 , Sengottuvelu Gunasekaran  5 , Mahmoud Abdelshafy  1 , Ashok Seth  6 , Hesham Elzomor  1 , Sreenivas Kumar  7 , Francesco Bedogni  8 , Alfonso Ielasi  9 , Santosh K Dora  10 , Sharad Chandra  11 , Keyur Parikh  12 , Daniel Unic  13 , William Wijns  1   14 , Andreas Baumbach  15 , Darren Mylotte  1 , Patrick Serruys  1   14   16 , Osama Soliman  1   14
Affiliations

Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis-A Multicenter Real-World Experience

Ahmed Elkoumy et al. J Clin Med. .

Abstract

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI's procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.

Keywords: aortic stenosis; bicuspid aortic valve; transcatheter aortic valve implantation.

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Conflict of interest statement

Christian Terkelsen has received a proctor fee from Meril Life, Edwards, Boston and a lecture fee from Terumo and Bristol-Myers Squibb. Francesco Bedogni reports a proctor fee from Meril life. A.S. serves as an Advisory Board Member/Speaker’s bureau/received consulting honoraria—Abbott Vascular, Medtronic, Boston Scientific and Meril Life sciences. A.B. reports grants from Abbott Vascular, personal fees from Microport, personal fees from Sinomed, personal fees from Medtronic, personal fees from KSH, outside the submitted work; P.S. reports personal fees from SMT, Philips/Volcano, Xeltis, Novartis, and Meril life. W.W. reports grants and personal fees from MicroPort, outside the submitted work, and is cofounder of Argonauts, an innovation facilitator. D.M. is a consultant for Medtronic and Boston Scientific, outside the submitted work. O.S. reports institutional research grants outside the submitted work. All other authors have no conflict of interest to declare.

Figures

Figure 1
Figure 1
Visual abstract of the Myval bicuspid registry summarizing the key findings of the registry; including the procedural details and outcome, 30-day echocardiographic and clinical outcomes. AR: Aortic regurgitation; iSV: indexed stroke volume; mPG: mean pressure gradient; PPM: patient prosthesis mismatch; DVI: dimensionless velocity index. EOA: Effecive orifice area; BAV: Bicuspid aortic valve STS: Society of Thoracic Surgeons; TAVI: Transcatheter aortic valve implanttaion.
Figure 2
Figure 2
Cumulative curve showing the age groups of the included patients in the registry. The figure shows the cut-off age recommended by the ACC/AHA, 2020 and ESC/EACTS 2021 guidelines.
Figure 3
Figure 3
The frequency of aortic regurgitation (AR) severity was assessed with echocardiography at 30 days.
See this image and copyright information in PMC

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