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

被引：6

作者：

Elkoumy, Ahmed ^{[1
,2
]}

Jose, John ^{[3
]}

Terkelsen, Christian Juhl ^{[4
]}

Nissen, Henrik ^{[5
]}

Gunasekaran, Sengottuvelu ^{[6
]}

Abdelshafy, Mahmoud ^{[1
,7
]}

Seth, Ashok ^{[8
]}

Elzomor, Hesham ^{[1
]}

Kumar, Sreenivas ^{[9
]}

Bedogni, Francesco ^{[10
]}

Ielasi, Alfonso ^{[11
]}

Arsang-Jang, Shahram ^{[1
,12
]}

Dora, Santosh Kumar ^{[13
]}

Chandra, Sharad ^{[14
]}

Parikh, Keyur ^{[15
]}

Unic, Daniel ^{[16
]}

Baumbach, Andreas ^{[17
]}

Serruys, Patrick ^{[1
,11
,18
]}

Soliman, Osama ^{[1
,12
]}

机构：

[1] Univ Galway, Galway Univ Hosp, Saolta Grp, Hlth Serv Execut & CORRIB Core Lab,Discipline Card, Galway H91 V4AY, Ireland

[2] Al Azhar Univ, Islamic Ctr Cardiol, Cairo 11651, Egypt

[3] Christian Med Coll & Hosp, Vellore 632004, India

[4] Aarhus Univ Hosp, Dept Cardiol, DK-8200 Aarhus, Denmark

[5] Odense Univ Hosp, Dept Cardiol, DK-5000 Odense, Denmark

[6] Apollo Main Hosp, Dept Cardiol, Greams Rd, Chennai 600006, India

[7] Al Azhar Univ, Dept Cardiol, Cairo 11311, Egypt

[8] Fortis Escorts Heart Inst, New Delhi 110025, India

[9] Apollo Hosp, Dept Cardiol, Apollo Hlth City, Jubilee Hills, Hyderabad 500050, India

[10] IRCCS Policlin San Donato, Dept Cardiol, I-20097 Milan, Italy

[11] Ist Clin St Ambrogio, Clin & Intervent Cardiol Unit, I-20149 Milan, Italy

[12] CURAM SFI Res Ctr Med Devices, Galway H91 TK33, Ireland

[13] Asian Heart Inst, Mumbai 400051, India

[14] King Georges Med Univ, Dept Cardiol, Lucknow 226003, India

[15] Care Inst Med Sci, Ahmadabad 380060, India

[16] Univ Hosp Dubrava, Dept Cardiac & Transplant Surg, Zagreb 10000, Croatia

[17] Queen Mary Univ London, William Harvey Res Inst, Barts Heart Ctr, London EC1M 6BQ, England

[18] Imperial Coll London, Natl Heart & Lung Inst NHLI, London SW7 2AZ, England

来源：

JOURNAL OF CLINICAL MEDICINE | 2023年 / 12卷 / 06期

基金：

英国科研创新办公室;

关键词：

aortic stenosis; bicuspid aortic valve; BAV; transcatheter aortic valve implantation; Myval; END-POINT DEFINITIONS; AMERICAN SOCIETY; TRANSCATHETER; REPLACEMENT; ECHOCARDIOGRAPHY; RECOMMENDATIONS; INTERVENTIONS; ASSOCIATION; MANAGEMENT; DISEASE;

D O I：

10.3390/jcm12062398

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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] cm(2), 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.

引用

页数：10

共 31 条

[1] Surgery Versus TAVR for Bicuspid Aortic Valve Disease The Time Has Come for a Randomized Study [J].

Colombo, Antonio ;

Mangieri, Antonio .

JACC-CARDIOVASCULAR INTERVENTIONS, 2020, 13 (09) :1028-1029

[2] Early clinical and haemodynamic matched comparison of balloon-expandable valves [J].

Delgado-Arana, Jose R. ;

Gordillo-Monge, Maria X. ;

Halim, Jonathan ;

De Marco, Federico ;

Trani, Carlo ;

Martin, Pedro ;

Infusino, Fabio ;

Ancona, Marco ;

den Heijer, Peter ;

Bedogni, Francesco ;

Franco, Luis Nombela ;

Moreno, Raul ;

Sargella, Gennaro ;

Montorfano, Matteo ;

Aristizabal-Duque, Cristhian ;

Romero-Delgado, Teresa ;

Santos, Sandra ;

Barrero, Alejandro ;

Gomez Salvador, Itziar ;

IJsselmuiden, Sander ;

Redondo Dieguez, Alfredo ;

San Roman Calvar, Jose Alberto ;

Amat-Santos, Ignacio J. .

HEART, 2022, 108 (09) :725-732

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

Elkoumy, Ahmed ;

Jose, John ;

Terkelsen, Christian J. ;

Nissen, Henrik ;

Gunasekaran, Sengottuvelu ;

Abdelshafy, Mahmoud ;

Seth, Ashok ;

Elzomor, Hesham ;

Kumar, Sreenivas ;

Bedogni, Francesco ;

Ielasi, Alfonso ;

Dora, Santosh K. ;

Chandra, Sharad ;

Parikh, Keyur ;

Unic, Daniel ;

Wijns, William ;

Baumbach, Andreas ;

Mylotte, Darren ;

Serruys, Patrick ;

Soliman, Osama .

JOURNAL OF CLINICAL MEDICINE, 2022, 11 (02)

[4] Performance of high conformability vs. high radial force devices in the virtual treatment of TAVI patients with bicuspid aortic valve [J].

Finotello, Alice ;

Romarowski, Rodrigo M. ;

Gorla, Riccardo ;

Bianchi, Giovanni ;

Bedogni, Francesco ;

Auricchio, Ferdinando ;

Morganti, Simone .

MEDICAL ENGINEERING & PHYSICS, 2021, 89 :42-50

[5] Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients [J].

Garcia-Gomez, Mario ;

Raul Delgado-Arana, Jose ;

Halim, Jonathan ;

De Marco, Federico ;

Trani, Carlo ;

Martin, Pedro ;

Won-Keun, Kim ;

Montorfano, Matteo ;

den Heijer, Peter ;

Bedogni, Francesco ;

Sardella, Gennaro ;

IJsselmuiden, Alexander J. J. ;

Teles, Rui Campante ;

Aristizabal-Duque, Christian H. ;

Gordillo, Ximena ;

Santos-Martinez, Sandra ;

Barrero, Alejandro ;

Gomez-Salvador, Itziar ;

Ancona, Marco ;

Redondo, Alfredo ;

Alberto San Roman, J. ;

Amat-Santos, Ignacio J. .

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2022, 99 (03) :889-895

[6]

Généreux P, 2021, EUR HEART J, V42, P1825, DOI [10.1093/eurheartj/ehaa799, 10.1016/j.jacc.2021.02.038]

[7]

Kappetein AP, 2012, J AM COLL CARDIOL, V60, P1438, DOI [10.1016/j.jacc.2012.09.001, 10.1093/ejcts/ezs533]

[8] Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves [J].

Kawashima, Hideyuki ;

Wang, Rutao ;

Mylotte, Darren ;

Jagielak, Dariusz ;

De Marco, Frederico ;

Ielasi, Alfonso ;

Onuma, Yoshinobu ;

den Heijer, Peter ;

Terkelsen, Christian Juhl ;

Wijns, William ;

Serruys, Patrick W. ;

Soliman, Osama .

GLOBAL HEART, 2021, 16 (01)

[9] Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography, and the Brazilian Department of Cardiovascular Imaging [J].

Lancellotti, Patrizio ;

Pibarot, Philippe ;

Chambers, John ;

Edvardsen, Thor ;

Delgado, Victoria ;

Dulgheru, Raluca ;

Pepi, Mauro ;

Cosyns, Bernard ;

Dweck, Mark R. ;

Garbi, Madalina ;

Magne, Julien ;

Nieman, Koen ;

Rosenhek, Raphael ;

Bernard, Anne ;

Lowenstein, Jorge ;

Campos Vieira, Marcelo Luiz ;

Rabischoffsky, Arnaldo ;

Vyhmeister, Rodrigo Hernandez ;

Zhou, Xiao ;

Zhang, Yun ;

Zamorano, Jose-Luis ;

Habib, Gilbert .

EUROPEAN HEART JOURNAL-CARDIOVASCULAR IMAGING, 2016, 17 (06) :589-595

[10] The Presence of Calcified Raphe Is an Independent Predictor of Adverse Long-Term Clinical Outcomes in Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement [J].

Lee, Yung-Tsai ;

Yin, Wei-Hsian ;

Tsao, Tien-Ping ;

Lee, Kuo-Chen ;

Hsiung, Ming-Chon ;

Tzeng, Yun-Hsuan ;

Wei, Jeng .

FRONTIERS IN CARDIOVASCULAR MEDICINE, 2022, 9

← 1 2 3 4 →