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

Abstract

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”.

Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study

“…Myval, a newer-generation balloon-expandable (BE) transcatheter heart valve (THV) system, is designed on a nickel-cobalt alloy (MP35N) frame – which enables optimal radial strength and radiopacity – and decellularized bovine pericardium tissue, crafted into a tri-leaflet valve [ 4 ]. The valve consists of a novel hybrid honeycomb scaffold design.…”

“…The upper part of the frame is composed of a single row of tall, large, and open-cell configuration to ensure unjailing of the coronary ostia that preserves coronary flow; the lower part of the frame is composed of two short rows of tightly packed, close-cell hexagonal configuration providing high radial strength required at the annular base. This unique pattern of Myval helps the operator in planning the precise placement of the valve and ensures its orthotopic deployment [ 4 – 6 ]. The lower closed cells of the Myval THV are covered externally with a sealing cuff, made of polyethylene terephthalate, to form an external buffing that minimizes or eliminates paravalvular leak (PVL).…”

“…The Navigator balloon-expandable THV delivery system has a unique design featuring a proximal deep flexion handle and a distal balloon with two counter-opposing soft stoppers within that create a superficial low-profile crimping zone and thus a comfortable fit that prevents any unwanted movement of the Myval THV during crossover through the sheath or thereafter. The delivery system allows for flexion of the distal catheter system that ensures trauma-free negotiation across the aortic arch and minimizes or eliminates the risk of a periprocedural stroke during arch navigation [ 4 – 6 ]. Compared to old generation BE THV systems, the Myval has several advantages: First, the Myval THV has its own intermediate and extra-large sizes and all sizes can be used through a 14F Python sheath.…”

“…Second, the valve is directly mounted on a balloon (similar to a stent) and can be inserted into the introducer sheath with a “just deliver and implant” approach. Third, the valve can be taken out through the introducer sheath and can be both reinserted and reimplanted [ 4 – 6 ].…”