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. 2023 Mar 20;12(6):2398.
doi: 10.3390/jcm12062398.

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis-A Multicentre Real-World Experience

Ahmed Elkoumy  1   2 , John Jose  3 , Christian Juhl Terkelsen  4 , Henrik Nissen  5 , Sengottuvelu Gunasekaran  6 , Mahmoud Abdelshafy  1   7 , Ashok Seth  8 , Hesham Elzomor  1 , Sreenivas Kumar  9 , Francesco Bedogni  10 , Alfonso Ielasi  11 , Shahram Arsang-Jang  1   12 , Santosh Kumar Dora  13 , Sharad Chandra  14 , Keyur Parikh  15 , Daniel Unic  16 , Andreas Baumbach  17 , Patrick Serruys  1   11   18 , Osama Soliman  1   12
Affiliations

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis-A Multicentre Real-World Experience

Ahmed Elkoumy et al. J Clin Med. .

Abstract

Background: Bicuspid aortic valve (BAV) affects approximately 1.5% of the general population and is seen in nearly 50% of candidates for aortic valve replacement (AVR). Despite increasingly utilised transcatheter aortic valve implantation (TAVI) in aortic stenosis (AS) patients, its use among patients with severe bicuspid AS is limited as BAV is a heterogeneous disease associated with multiple and complex anatomical challenges.

Aim: To investigate the one-year outcomes of TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., Vapi, India) in patients with severe bicuspid AS.

Methods and results: We collected data from consecutive patients with bicuspid AS who underwent TAVI with the Myval THV and had at least one-year follow-up. Baseline characteristics, procedural, and 30-day echocardiographic and clinical outcomes were collected. Sixty-two patients were included in the study. The median age was 72 [66.3, 77.0] years, 45 (72.6%) were males, and the mean STS PROM score was 3.2 ± 2.2%. All TAVI procedures were performed via the transfemoral route. The median follow-up duration was 13.5 [12.2, 18.3] months; all-cause mortality was reported in 7 (11.3%) patients and cardiovascular hospitalisation in 6 (10.6%) patients. All-stroke was reported in 2 (3.2%), permanent pacemaker implantation 5 (8.3%), and myocardial infarction 1 (1.6%) patients. The echocardiographic assessment revealed a mean pressure gradient of 10 [8, 16.5] mmHg, effective orifice area 1.7 [1.4, 1.9] cm2, moderate AR in 1 (2%), mild AR in 14 (27%), and none/trace AR in 37 (71%). In total, 1 patient was diagnosed with valve thrombosis (2.1%), Stage II (moderate) haemodynamic deterioration was seen in 3 (6.4%), and stage III (severe) haemodynamic deterioration in 1 (2.1%) patient.

Conclusions: TAVI with the Myval THV in selected BAV anatomy is associated with favourable one-year hemodynamic and clinical outcomes.

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

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Conflict of interest statement

C.T. has received a proctor fee from Meril Life, Edwards, Boston and a lecture fee from Terumo and Bristol-Myers Squibb. S.G. is working as a proctor for Myval and received honoraria from Meril Life sciences. F.B. 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, and personal fees from KSH, outside the submitted work; P.S. reports personal fees from SMT, Philips/Volcano, Xeltis, Novartis, and Meril life. 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
Haemodynamic performance at 30-day and 1-year follow-up.
See this image and copyright information in PMC

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