Meril announce Lancet publication for landmark RCT of MYVAL THV series

Meril Life Sciences announces the publication of the landmark trial study titled “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,” in The Lancet, showcasing its indigenously developed Myval Transcatheter Heart Valve (THV) series.

The research compares early outcomes of the new-generation Myval THV series with contemporary (Sapien and Evolut) THV series in real-world patients suffering from severe symptomatic native aortic stenosis (AS). The findings highlight that the Myval THV series is non-inferior to global giants. Occurrence of the primary composite endpoint which is a composite of deaths, stroke, major bleeding, acute kidney injury, major vascular complications, moderate or severe valve regurgitation, and the need for new permanent pacemaker implantation as per the third Valve Academic Research Consortium consensus) with no difference in the itemised components of the primary composite endpoints (24.7 per cent Myval THV series vs. 27.0 per cent Contemporary THV series, p<0.0001 statistically significant non-inferiority). 

Aortic stenosis is a condition where the aortic valve doesn’t open fully, restricting blood flow from the heart to the rest of the body. This can cause symptoms like chest pain, dizziness, and shortness of breath. Treatment of AS depends on the severity of the condition. In severe AS, the aortic valve needs to be replaced with an artificial one. This can be done via open-heart surgery or through a minimally invasive interventional procedure that uses a small tube called a catheter inserted into a common femoral artery of the leg. This procedure is called transcatheter aortic valve implantation (TAVI) and the valve used is called a transcatheter heart valve (THV).

The Myval THV series is a novel THV that comes in various size options compared to the currently available THVs, making it easier to find the right fit for different patients. It is available in a wide range of sizes, including traditional sizes (20 mm, 23 mm, 26 mm, and 29 mm), intermediate sizes (21.5 mm, 24.5 mm, and 27.5 mm), and larger sizes (30.5 mm and 32 mm). This extensive range ensures that more patients can receive a valve that closely matches their anatomical needs, potentially improving outcomes and making advanced heart valve treatment more accessible to a broader population.

As per Global Principal Investigator, Prof Andreas Baumbach, “The Landmark trial showed that the Myval THV series performed as safely and effectively as contemporary THV series. It is a valve made for everyday clinical practice and an all-comers population. The special feature of intermediate diameters allows for more accurate sizing, which has the potential to translate into improved long-term outcomes. Our patients will be followed up for 10 years and it will be interesting to see the long-term results in the three treatment arms.”

The team also enrolled patients with more complicated cases, such as those with small aortic valve sizes and bicuspid valves, which have only two leaflets instead of the usual three. The Myval THV series produced a greater valve opening (known as effective orifice area (EOA)) for blood flow into the aorta compared to the Sapien THV series in several diameters. However, the Myval THV series produced a similar valve opening to the Evolut THV series. Intermediate sizes of the Myval THV series allowed for better matching of the THV to each patient’s aortic valve size, with 48 per cent of all Myval THV series implants in the trial being intermediate-sized THVs. Further patient follow-up over ten years will provide more information about the long-term effects and durability of the THVs.