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

Ahmed Elkoumy; John Jose; Christian Juhl Terkelsen; Henrik Nissen; Sengottuvelu Gunasekaran; Mahmoud Abdelshafy; Ashok Seth; Hesham Elzomor; Sreenivas Kumar; Francesco Bedogni; Alfonso Ielasi; Shahram Arsang-Jang; Santosh Kumar Dora; Sharad Chandra; Keyur Parikh; Daniel Unic; Andreas Baumbach; Patrick Serruys; Osama Soliman

doi:10.3390/jcm12062398

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

Ahmed Elkoumy, John Jose, Christian Juhl Terkelsen, Henrik Nissen, Sengottuvelu Gunasekaran, Mahmoud Abdelshafy, Ashok Seth, Hesham Elzomor, Sreenivas Kumar, Francesco Bedogni, Alfonso Ielasi, Shahram Arsang-Jang, Santosh Kumar Dora, Sharad Chandra, Keyur Parikh, Daniel Unic, Andreas Baumbach, Patrick Serruys^*, Osama Soliman^*

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin - Hjertesygdomme

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

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.

Originalsprog	Engelsk
Artikelnummer	2398
Tidsskrift	Journal of Clinical Medicine
Vol/bind	12
Nummer	6
ISSN	2077-0383
DOI	https://doi.org/10.3390/jcm12062398
Status	Udgivet - mar. 2023

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10.3390/jcm12062398Licens: CC BY

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Elkoumy, A., Jose, J., Terkelsen, C. J., Nissen, H., Gunasekaran, S., Abdelshafy, M., Seth, A., Elzomor, H., Kumar, S., Bedogni, F., Ielasi, A., Arsang-Jang, S., Dora, S. K., Chandra, S., Parikh, K., Unic, D., Baumbach, A., Serruys, P., & Soliman, O. (2023). One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience. Journal of Clinical Medicine, 12(6), Artikel 2398. https://doi.org/10.3390/jcm12062398

@article{23f6e687c33c4f8899c8ca8b865ed746,

title = "One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience",

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 = "aortic stenosis, BAV, bicuspid aortic valve, Myval, transcatheter aortic valve implantation",

author = "Ahmed Elkoumy and John Jose and Terkelsen, {Christian Juhl} and Henrik Nissen and Sengottuvelu Gunasekaran and Mahmoud Abdelshafy and Ashok Seth and Hesham Elzomor and Sreenivas Kumar and Francesco Bedogni and Alfonso Ielasi and Shahram Arsang-Jang and Dora, {Santosh Kumar} and Sharad Chandra and Keyur Parikh and Daniel Unic and Andreas Baumbach and Patrick Serruys and Osama Soliman",

note = "Publisher Copyright: {\textcopyright} 2023 by the authors.",

year = "2023",

month = mar,

doi = "10.3390/jcm12062398",

language = "English",

volume = "12",

journal = "Journal of Clinical Medicine",

issn = "2077-0383",

publisher = "MDPI AG",

number = "6",

}

Elkoumy, A, Jose, J, Terkelsen, CJ, Nissen, H, Gunasekaran, S, Abdelshafy, M, Seth, A, Elzomor, H, Kumar, S, Bedogni, F, Ielasi, A, Arsang-Jang, S, Dora, SK, Chandra, S, Parikh, K, Unic, D, Baumbach, A, Serruys, P & Soliman, O 2023, 'One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience', Journal of Clinical Medicine, bind 12, nr. 6, 2398. https://doi.org/10.3390/jcm12062398

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience. / Elkoumy, Ahmed; Jose, John; Terkelsen, Christian Juhl et al.
I: Journal of Clinical Medicine, Bind 12, Nr. 6, 2398, 03.2023.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience

AU - Elkoumy, Ahmed

AU - Jose, John

AU - Terkelsen, Christian Juhl

AU - Nissen, Henrik

AU - Gunasekaran, Sengottuvelu

AU - Abdelshafy, Mahmoud

AU - Seth, Ashok

AU - Elzomor, Hesham

AU - Kumar, Sreenivas

AU - Bedogni, Francesco

AU - Ielasi, Alfonso

AU - Arsang-Jang, Shahram

AU - Dora, Santosh Kumar

AU - Chandra, Sharad

AU - Parikh, Keyur

AU - Unic, Daniel

AU - Baumbach, Andreas

AU - Serruys, Patrick

AU - Soliman, Osama

PY - 2023/3

Y1 - 2023/3

N2 - 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.

AB - 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.

KW - aortic stenosis

KW - BAV

KW - bicuspid aortic valve

KW - Myval

KW - transcatheter aortic valve implantation

UR - http://www.scopus.com/inward/record.url?scp=85151632517&partnerID=8YFLogxK

U2 - 10.3390/jcm12062398

DO - 10.3390/jcm12062398

M3 - Journal article

C2 - 36983397

AN - SCOPUS:85151632517

SN - 2077-0383

VL - 12

JO - Journal of Clinical Medicine

JF - Journal of Clinical Medicine

IS - 6

M1 - 2398

ER -

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

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