A study on a transcatheter heart valve (THV) used in patients with aortic stenosis, researched and developed in India has been published in the Lancet.
The study, Comparison of early outcomes of newer generation Myval transcatheter heart valve series with contemporary valves (sapien and evolut) THV series in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial, compared the early outcomes of new-generation Myval THV series with the contemporary THV series in patients with severe symptomatic native aortic stenosis (AS).
AS is a condition where the aortic valve does not open fully, restricting blood flow from the heart to the rest of the body. For severe conditions, artificial valves are used as replacements through minimally invasive procedure called transcatheter aortic valve implantation (TAVI) and the valve used is called a transcatheter heart valve (THV).
The randomised controlled trial for Myval THV series, done by Meril Life Sciences, was researched and developed in India. Andreas Baumbach, the global principal investigator, said the trial showed that Myval THV series performed as safely and effectively as the contemporary THV series.
“The special feature of intermediate diameters allows for more accurate sizing, which has the potential to translate into improved long-term outcomes,” he said, adding that the patients would be followed up for 10 years to see the long-term result.
Interventional cardiologist G. Sengottuvelu said being featured in Lancet underscored the significance and impact of the Myval THV series. It proved India’s capability to set new standards in cardiovascular care and revolutionised heart valve treatment the world over. “This trial also reiterates the success of the ‘Make in India’ initiative,” he said.
The multi-centre international study established comparable safety and effectiveness of the Myval THV with those manufactured in western countries, John Jose E., an interventional cardiologist in Christian Medical College, Vellore, said, adding: “The study findings align with our clinical experiences in a multinational randomised control trial environment. A considerable number of our Indian patients have surpassed the five-year follow up mark and the long-term outcomes appear promising.”
Thomas Alexander, consultant and interventional cardiologist and head of cardiology division at Kovai Medical Centre and Hospital, said the novel THV series came in various sizes, making it easier to find the right fit for patients.
