Rise of India's TAVI as a Global Trend: MyVal
Status of TAVI in India
An 80-year-old female patient with severe AS who was refused surgery because of high comorbidities had the first clinical experience with TAVI in India in 2011. She received the first TAVI in India with a 26-mm Medtronic CoreValve and was released from the hospital in good health.
TAVI is being performed at about 30 centers across India, with about seven centers managing most of the TAVI workload. One such renowned place in Mumbai, India is The Valve Clinic (TVC) where they determine your suitability to undergo a TAVI procedure. All patients are referred to them through a diagnosis of aortic stenosis, and patients can get complete cardiovascular care at TVC with their team of experts trained in heart valve surgery and care.
Smaller aorta and peripheral vessel diameter, high prevalence of rheumatic heart disease, low coronary Ostia, high prevalence of bicuspid aortic valve (BAV), and heavy calcification of aortic valve leaflets are anatomic peculiarities of the Indian population that require special attention. These characteristics have a substantial impact on the economic viability, prosthesis durability, procedural complications, and long-term outcomes1.
the CoreValve® Revalving system and the Edwards Sapien system are the two types of valves that are currently approved by the U.S. FDA for TAVI. However, indigenous valve development is a new trend in India now. One domestic valve, known as MyVal, has had a considerable impact on the Indian market thanks to its innovative distribution mechanism, affordable price, and attractive design.
What is MyVal?
The MyVal valve is a newly developed balloon-expandable heart valve comprised of leaflets of the bovine pericardium and a nickel-cobalt alloy frame. The valve has a special hybrid honeycomb cell design with closed cells on the lower half for strong radial strength and open cells on the upper half to ensure the unfailing of the coronary Ostia. This design, when compressed, creates a special “dark and light” band pattern that can be seen during fluoroscopy and ensures precise valve location and orthotopic implantation2. A protective sealing cuff made of polyethylene terephthalate externally reduces or almost eliminates paravalvular leak (PVL). Depending on the diameter of the natural annulus, MyVal comes in a variety of sizes: 20, 21.5, 23, 24.5, 26, 27.5, 29, or 32 mm.
A specially created hi-flex, over-the-wire balloon catheter system (NavigatorTM, Meril Life Sciences Pvt. Ltd., India) is used to deliver the THV (Transcatheter Heart Valve) system. MyVal THV’s direct crimping over its Navigator delivery system eliminates the need for the device to be maneuvered in the descending aorta, as was the case with first-generation balloon-expandable THV. The Navigator delivery system’s flexibility while crossing over the arch prevents severe damage to the arch’s anatomy. The Navigator balloon’s dual nose cone guarantees perfect crimping, optimal placement, and predictable release of MyVal THV.
When it comes to the studies done related to MyVal, The MyVal-1 research proved the Myval THV’s primary efficacy and safety without the need for a new PPM up to a 12-month follow-up. Future trials including more patients and long-term follow-up are needed to determine the device’s safety and effectiveness, though3. Since this THV system is less expensive than comparable western technologies, more patients can now access the therapy thanks to the popularity of this THV system among interventional cardiologists.
MyVal is indeed a breakthrough in the field of TAVI due to its efficient design and effectiveness as mentioned above. It is already going global showing that it would be further developed in the future.
- Gupta P, Arora S, Qamar A, Gupta M, Seth A. Current status of transcatheter aortic valve replacement in India. Cardiovasc Diagn Ther. 2020;10(1):83. doi:10.21037/CDT.2019.05.
- 04Myval: India’s TAVI technology is now going global – Cardiovascular News. Accessed June 28, 2022. https://cardiovascularnews.com/myval-indias-tavi-technology-is-now-going-global/
- Sharma SK, Rao RS, Chandra P, et al. First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study. EuroIntervention. 2020;16(5):421-429. doi:10.4244/EIJ-D-19-00413