First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study

Sharma, Samin K.; Rao, Ravinder Singh; Chandra, Praveen; Goel, Pravin K.; Bharadwaj, Prashant; Joseph, George; Jose, John; Mahajan, Ajaykumar U; Mehrotra, Sanjay; Sengottovelu, Gunasekaran; Kumar, Vijay; Manjunath, Cholenahally Nanjappa; Abhaichand, Rajpal K.; Sethi, Rishi; Seth, Ashok

doi:10.4244/eij-d-19-00413

Cited by 60 publications

(57 citation statements)

References 28 publications

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“…Ltd., India) was granted the CE mark in April 2019. The safety and efficacy of the Myval THV was shown in the MyVal-1 first-in-human trial, with particularly low rates of AR [ 4 ].…”

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confidence: 99%

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

et al. 2021

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Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloonexpandable valves. Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). Conclusion: The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

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“…Ltd., India) was granted the CE mark in April 2019. The safety and efficacy of the Myval THV was shown in the MyVal-1 first-in-human trial, with particularly low rates of AR [ 4 ].…”

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confidence: 99%

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

et al. 2021

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“…27.5 mm) and two extra-large sizes (30.5 and 32 mm) [6]. This expanded size-matrix of the Myval THV has the potential to optimize THV sizing.…”

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confidence: 99%

Operator preference and determinants of size selection when additional intermediate-size aortic transcatheter heart valves are made available

Kawashima

Serruys

Mylotte

et al. 2021

International Journal of Cardiology

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Background: Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. Methods: In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extralarge THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. Results: A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. Conclusions: Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional-and intermediate-size THVs.

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“…6,7 The recent MyVal-1 study reported the primary safety and efficacy of the novel balloon-expandable Myval THV. 5 The honeycomb geometry of the stent is designed not only to increase radial force, but also to define a unique radiopaque marker pattern which alternates dark and light bands allowing, together with a well-designed deployment system, a more precise positioning: a useful tool in ViS cases, where the cumbersome sutureless stent could limit THV navigation.…”

Section: Commentmentioning

confidence: 99%

“…4 The Myval (Meril Life Sciences Pvt. Ltd.; Figure 1B) transcatheter heart valve (THV) is a new balloon-expandable prosthesis that has recently gained the CE mark, 5 with peculiar features allowing a precise positioning. 6,7 In this case report, we present the first Valve-in-Sutureless (ViS) case performed using the novel Myval prosthesis.…”

Section: Introductionmentioning

confidence: 99%

First‐in‐man Valve‐in‐Valve with the new balloon‐expandable Myval transcatheter heart valve in a failed sutureless Perceval bioprosthesis

Belluschi

Buzzatti

Denti

et al. 2021

Journal of Cardiac Surgery

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Sutureless aortic bioprostheses were introduced more than ten years ago, with the aim of decreasing cross-clamp time and thus becoming the first choice in older patients for many surgeons. However, published data are limited to a 5-year follow-up, and some cases of deterioration have already been described. High-risk patients who once have benefitted from a fast sutureless aortic replacement and now are experiencing a prosthesis dysfunction, could take advantage of a percutaneous Valve-in-Sutureless technique. Furthermore, thanks to technological improvement, new transcatheter prostheses have been designed, allowing a more precise positioning. In this report, we described the first Myval-in-Perceval case, which resulted in a safe and effective procedure.

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First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study

Cited by 60 publications

References 28 publications

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

Operator preference and determinants of size selection when additional intermediate-size aortic transcatheter heart valves are made available

First‐in‐man Valve‐in‐Valve with the new balloon‐expandable Myval transcatheter heart valve in a failed sutureless Perceval bioprosthesis

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