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

Ahmed Elkoumy; John Jose; Christian J. Terkelsen; Henrik Nissen; Sengottuvelu Gunasekaran; Mahmoud Abdelshafy; Ashok Seth; Hesham Elzomor; Sreenivas Kumar; Francesco Bedogni; Alfonso Ielasi; Santosh K. Dora; Sharad Chandra; Keyur Parikh; Daniel Unic; William Wijns; Andreas Baumbach; Darren Mylotte; Patrick Serruys; Osama Soliman

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, John Jose, Christian J. Terkelsen, Henrik Nissen, Sengottuvelu Gunasekaran, Mahmoud Abdelshafy, Ashok Seth, Hesham Elzomor, Sreenivas Kumar, Francesco Bedogni, Alfonso Ielasi, Santosh K. Dora, Sharad Chandra, Keyur Parikh, Daniel Unic, William Wijns, Andreas Baumbach, Darren Mylotte, Patrick Serruys^*, Osama Soliman

^*Kontaktforfatter

KI, OUH, Forskningsenhed for Kardiologi (Odense)

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

50 Downloads (Pure)

Abstract

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is appar-ent 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. Proce-dures 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.

Originalsprog	Engelsk
Artikelnummer	443
Tidsskrift	Journal of Clinical Medicine
Vol/bind	11
Udgave nummer	2
Antal sider	11
ISSN	2077-0383
DOI	https://doi.org/10.3390/jcm11020443
Status	Udgivet - 15. jan. 2022

Bibliografisk note

Funding Information:
Conflicts of Interest: 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.

Dokumenter og links

10.3390/jcm11020443Licens: CC BY

Open Access VersionForlagets udgivne version, 1,03 MBLicens: CC BY

SDU link

Tjek adgangen til materialet i Syddansk Universitetsbiblioteks søgemaskine

Citationsformater

Elkoumy, A., Jose, J., Terkelsen, C. J., Nissen, H., Gunasekaran, S., Abdelshafy, M., Seth, A., Elzomor, H., Kumar, S., Bedogni, F., Ielasi, A., Dora, S. K., Chandra, S., Parikh, K., Unic, D., Wijns, W., Baumbach, A., Mylotte, D., Serruys, P., & Soliman, O. (2022). Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis—A Multicenter Real-World Experience. Journal of Clinical Medicine, 11(2), Artikel 443. https://doi.org/10.3390/jcm11020443

@article{2d1b2de45d094564ac7d0c993a469e97,

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

abstract = "Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is appar-ent 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{\textquoteright}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. Proce-dures 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",

author = "Ahmed Elkoumy and John Jose and Terkelsen, {Christian J.} 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 Dora, {Santosh K.} and Sharad Chandra and Keyur Parikh and Daniel Unic and William Wijns and Andreas Baumbach and Darren Mylotte and Patrick Serruys and Osama Soliman",

note = "Publisher Copyright: {\textcopyright} 2022 by the authors. Licensee MDPI, Basel, Switzerland.",

year = "2022",

month = jan,

day = "15",

doi = "10.3390/jcm11020443",

language = "English",

volume = "11",

journal = "Journal of Clinical Medicine",

issn = "2077-0383",

publisher = "MDPI",

number = "2",

}

Elkoumy, A, Jose, J, Terkelsen, CJ, Nissen, H, Gunasekaran, S, Abdelshafy, M, Seth, A, Elzomor, H, Kumar, S, Bedogni, F, Ielasi, A, Dora, SK, Chandra, S, Parikh, K, Unic, D, Wijns, W, Baumbach, A, Mylotte, D, Serruys, P & Soliman, O 2022, 'Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis—A Multicenter Real-World Experience', Journal of Clinical Medicine, bind 11, nr. 2, 443. https://doi.org/10.3390/jcm11020443

TY - JOUR

T1 - Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis—A Multicenter Real-World Experience

AU - Elkoumy, Ahmed

AU - Jose, John

AU - Terkelsen, Christian J.

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 - Dora, Santosh K.

AU - Chandra, Sharad

AU - Parikh, Keyur

AU - Unic, Daniel

AU - Wijns, William

AU - Baumbach, Andreas

AU - Mylotte, Darren

AU - Serruys, Patrick

AU - Soliman, Osama

PY - 2022/1/15

Y1 - 2022/1/15

N2 - Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is appar-ent 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. Proce-dures 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.

AB - Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is appar-ent 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. Proce-dures 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.

KW - Aortic stenosis

KW - Bicuspid aortic valve

KW - Transcatheter aortic valve implantation

U2 - 10.3390/jcm11020443

DO - 10.3390/jcm11020443

M3 - Journal article

C2 - 35054137

AN - SCOPUS:85122857198

SN - 2077-0383

VL - 11

JO - Journal of Clinical Medicine

JF - Journal of Clinical Medicine

IS - 2

M1 - 443

ER -

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

Abstract

Bibliografisk note

Dokumenter og links

SDU link

Fingeraftryk

Citationsformater