Myval Transcatheter Heart Valve System in the Treatment of Severe Symptomatic Aortic Stenosis

Sharma, Samin K.; Rao, Ravinder Singh; Chopra, Manik; Sonawane, Anmol; Jose, John; Sengottuvelu, G.

doi:10.2217/fca-2020-0020

Cited by 20 publications

(15 citation statements)

References 26 publications

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“…Myval THV has been introduced for the treatment of native aortic valve stenosis where the clinical need is larger than dysfunctional RVOT. [ 6 ] Implantation of Myval THV ensures restoration of normal hemodynamics and optimal effective orifice area owing to its firm anchoring at orthotopic position of the annulus. The entire Myval THV system is designed so perfectly that precise positioning of the THV can be achieved with minimal efforts.…”

Section: Discussionmentioning

confidence: 99%

“…Myval THV is structured on a nickel-cobalt alloy frame with a unique honey-comb design comprising of hexagonal elements. [ 6 ] The valve consists of decellularized bovine pericardial tissue crafted into a tri-leaflet valve on the metal frame that has a skirt of polyethylene terephthalate to retard deposition of calcium and minimize paravalvular regurgitation [ Figure 1 ]. The valve is crimped on a unique hi-flex, over the wire Navigator balloon (Meril Life Sciences Pvt Ltd, India) using a mechanical crimping tool, Val-de-Crimp™ (Meril Life Sciences Pvt Ltd, India), prior to insertion into the systemic circulation.…”

Section: Methodsmentioning

confidence: 99%

“…Myval™ THV (Meril Life Sciences Pvt Ltd, Vapi, Gujarat, India) is a newer-generation balloon-expandable bioprosthetic valve, developed as a transcatheter alternative to surgical valve replacement for severe symptomatic native aortic stenosis. [ 6 7 ] Based on promising clinical and hemodynamic outcomes after transcatheter aortic valve replacement, the device has been approved by the Central Drugs Standard Control Organization and also received the Conformité Européenne certificate. However, there is a paucity of literature related to its safety and efficacy for treating dysfunctional RVOT conduits.…”

Section: Introductionmentioning

confidence: 99%

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Early multicenter experience of a new balloon expandable MyVal transcatheter heart valve in dysfunctional stenosed right ventricular outflow tract conduits

Sivaprakasam

Reddy

Gunasekaran

et al. 2021

Annals of Pediatric Cardiology

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Background : Transcatheter pulmonary valve implantation (TPVI) is a surgical alternative for correcting dysfunctional right ventricular outflow tract conduits in previously operated patients. MyVal transcatheter heart valve (THV) (Meril Life Sciences, India), a new transcatheter valve designed for aortic position has not been used for TPVI. Methods : Patients with stenosed dysfunctional conduits from the right ventricle to pulmonary artery (RV-PA) were prestented after initial computed tomography and balloon interrogation before the implantation of MyVal. Size of MyVal was chosen based on the final diameter of the prestent. Procedural details and post-TPVI follow-up were analyzed. Results : Seven patients aged 17–60 years (median 26 years) had stenosed RV-PA conduits implanted 5–17 years (median 9 years) ago for tetralogy of Fallot in three, following Ross procedure in two, repair of pulmonary stenosis, and following PA debanding in one patient each. Prestenting improved the conduit diameter from 9.3 ± 2.8 mm to 20.8 ± 1.1 mm and relieved the gradient from 87.3 ± 31.7 mmHg (50–137 mmHg) to 12.7 ± 6.4 mmHg (5–20 mmHg). A 23 mm MyVal was implanted in all the seven patients successfully; one patient needed an additional 24.5 mm MyVal valve in valve implantation for residual regurgitation. The mean fluoroscopic time and dose area product were 38.7 ± 25.3 min and 66.917 ± 39.211Gray. cm2, respectively. At a median follow-up duration of 16 months (10–22 months), all patients were asymptomatic receiving dual antiplatelet therapy with no PR and the gradient was 12.5 ± 5.8 mmHg on echocardiography. Although one patient needed an additional valve-in-valve implantation, there were no valve-related adverse events. Conclusions : Early experience of TPVI with MyVal THV in prestented conduits is encouraging with procedural success in all patients and acceptable mid-term outcomes.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Early multicenter experience of a new balloon expandable MyVal transcatheter heart valve in dysfunctional stenosed right ventricular outflow tract conduits

Sivaprakasam

Reddy

Gunasekaran

et al. 2021

Annals of Pediatric Cardiology

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“…1 ) is similar to the SAPIEN 3, but with some differences. The THVs were available in different sizes: conventional (20, 23, 26, and 29 mm), medium (21.5, 24.5, and 27.5 mm) and extra-large (30.5 and 32 mm; extra-large sizes) [ 17 ]. All Myval sizes are compatible with 14-Fr expandable sheaths, which are smaller than the SAPIEN-XT or SAPIEN‑3 inlet system.…”

Section: Discussionmentioning

confidence: 99%

“…According to a recently published article, Myval could be retrievable in some cases through the sheath if the valve is not implanted [ 17 ]. We had to retrieve the valve in three cases.…”

Section: Discussionmentioning

confidence: 99%

First experiences with a new balloon-expandable Myval transcatheter aortic valve: a preliminary study

Akyüz

Konuş

Çırakoğlu

et al. 2021

Herz

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Background In the present article, we present our first experiences with a new type of balloon-expandable Myval valve (Meril Life Sciences, Gujarat, India). Materials and methods A total of 25 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) from June 2020 to November 2020 were included in the study. Results The mean age of the study population was 83 (75–87) years; 17 (68%) were female, and 20 (80%) had hypertension. The Society of Thoracic Surgeons (STS) score of the group was 5.4% ± 3.5%. TAVI was performed via the transfemoral route on all patients. In 19 (76%) cases, we started the procedure without predilation. In two (10.5%) cases performed without predilation, the prosthesis did not pass the native valve. We had to implant the valve from the descending aorta in one (4%) patient. We used Prostar XL (Abbott Vascular, Santa Clara, CA, USA) for six (24%) patients and ProGlide (Abbott Vascular) for 19 (76%) patients for vascular closure. Two (8%) in-hospital deaths occurred in our study but there were no deaths in the 30-day and 90-day follow-up. Vascular complications were observed in one (4%) patient. None of the patients in our study had severe paravalvular leak (PVL), while two (8%) patients had moderate PVL. A permanent pacemaker (PPM) was required in two (8%) patients for the indication of complete atrioventricular block. The mean hospital stay for the whole group was 4 (3–7) days. Conclusion Based on our experiences, the new balloon-expandable valve Myval is easy to use, efficient, and has only a few negligible drawbacks such as the need for predilation of the sheath. While shaft flexibility may have advantages in some situations including in very tortuous arteries, it may cause some difficulties in alignment of the valves. Video online The online version of this article contains a video. The article and the video are available online (10.1007/s00059-021-05069-4). The video can be found in the article back matter as “Electronic Supplementary Material”.

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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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Myval Transcatheter Heart Valve System in the Treatment of Severe Symptomatic Aortic Stenosis

Cited by 20 publications

References 26 publications

Early multicenter experience of a new balloon expandable MyVal transcatheter heart valve in dysfunctional stenosed right ventricular outflow tract conduits

Early multicenter experience of a new balloon expandable MyVal transcatheter heart valve in dysfunctional stenosed right ventricular outflow tract conduits

First experiences with a new balloon-expandable Myval transcatheter aortic valve: a preliminary study

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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