Evaluation of Balloon Expandable Transcatheter Heart Valve in the Treatment of Severe Symptomatic Native Aortic Stenosis: The First-in-human MyVal-1 Study

Rao, Ravinder Singh; Sharma, Samin K.; Chandra, Praveen; Sengottovelu, Gunasekaran; Bharadwaj, Prashant; Goel, Pravin K.; Joseph, George; Jose, John; Rath, Pratap Chandra; Abhaichand, Rajpal K.; Nair, Rajiv; S, Ajit Mullasari; Kumar, Vijay; Sasidharan, Bijulal; Manjunath, Cholenahally Nanjappa; Srinivas, Budanur Chikkaswamy; Raghu, T.R.; Mahajan, Ajaykumar U; Kumar, Ganesh; Arneja, Jaspal; Parikh, Keyur; Jain, Rajendra K.; Sharma, Sudhanshu; Chanana, Bharat Bhushan; Hiremath, M.S.; Parikh, Jagdish; Chopra, Manik; Boopathy, Senguttuvan Nagendra; Jain, Rashmi; Kadavil, Rony Mathew; Sethi, Rishi; Mehrotra, Sanjay; Murlidharan, T. R.; Kler, T.S.; Trehan, Vijay; Seth, Ashok

doi:10.1080/24748706.2020.1713659

Cited by 1 publication

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“…Ltd) is a new-generation balloon-expandable device that has been granted CE mark approval in 2020 after demonstrating safety and efficacy for treatment of severe symptomatic native aortic stenosis in intermediate and high-risk patients. 7 To address the concern of size limitation of the currently available THV portfolio, a wide range of sizes of the device has been developed including extralarge sized Myval THV (30.5 mm and 32 mm). To the best of our knowledge, the 32 mm Myval THV is the largest available aortic THV as it covers annular areas of 700-840 mm 2 .…”

Section: The Myval Transcatheter Heart Valve (Thv) (Meril Life Sciencesmentioning

confidence: 99%

“…The Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd) is a new‐generation balloon‐expandable device that has been granted CE mark approval in 2020 after demonstrating safety and efficacy for treatment of severe symptomatic native aortic stenosis in intermediate and high‐risk patients 7 . To address the concern of size limitation of the currently available THV portfolio, a wide range of sizes of the device has been developed including extra‐large sized Myval THV (30.5 mm and 32 mm).…”

Section: Introductionmentioning

confidence: 99%

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Performance of the 32 mm Myval transcatheter heart valve for treatment of aortic stenosis in patients with extremely large aortic annuli in real‐world scenario: First global, multicenter experience

Holzamer,

Bedogni,

van Wyk

et al. 2023

Cathet Cardio Intervent

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BackgroundExtremely large aortic valve anatomy is one of the remaining limitations leading to exclusion of patients for transcatheter aortic valve replacement (TAVR).AimsThe newly approved Myval 32 mm device is designed for use in aortic annulus areas up to 840 mm2. Here we want to share the initial worldwide experience with the device.Methods and ResultsRetrospective data were collected from 10 patients with aortic stenosis and very large annular anatomy (mean area 765.5 mm2), who underwent implantation with 32 mm Myval transcatheter heart valve at eight centers. Valve Academic Research Consortium‐2 device success was achieved in all cases. Mild paravalvular leak was observed in three patients and two patients required new pacemaker implantation. One patient experienced retroperitoneal hemorrhage caused by the contralateral 6 F sheath and required surgical revision. No device‐related complications, stroke, or death from any cause occurred within the 30‐day follow‐up period. In a studied cohort of 2219 consecutive TAVR‐screened patients from a central European site, only 0.27% of patients showed larger anatomy than covered by the 32 mm Myval device by instructions for use without off‐label use of overexpansion. This rate was significantly higher for the 34 mm Evolut Pro (1.8%) and 29 mm Sapien 3 (2.1%) devices.ConclusionsThe Myval 32 mm prosthesis showed promising initial results in a cohort of patients who previously had to be excluded from TAVR. It is desirable that all future TAVR systems accommodate larger anatomy to allow optimal treatment of all patients.

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Section: The Myval Transcatheter Heart Valve (Thv) (Meril Life Sciencesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Performance of the 32 mm Myval transcatheter heart valve for treatment of aortic stenosis in patients with extremely large aortic annuli in real‐world scenario: First global, multicenter experience

Holzamer,

Bedogni,

van Wyk

et al. 2023

Cathet Cardio Intervent

View full text Add to dashboard Cite

show abstract

Evaluation of Balloon Expandable Transcatheter Heart Valve in the Treatment of Severe Symptomatic Native Aortic Stenosis: The First-in-human MyVal-1 Study

Cited by 1 publication

References 0 publications

Performance of the 32 mm Myval transcatheter heart valve for treatment of aortic stenosis in patients with extremely large aortic annuli in real‐world scenario: First global, multicenter experience

Performance of the 32 mm Myval transcatheter heart valve for treatment of aortic stenosis in patients with extremely large aortic annuli in real‐world scenario: First global, multicenter experience

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