MYVAL, a TAVR Balloon-Expandable Valve with Promising Results

TAVR has been shown beneficial over time, and with the development of new generation of prosthetic valves and implantation techniques, outcomes have been improved, reducing the incidence of leaks y and the need for definite pacemaker. 

MYVAL, una válvula balón expandible para TAVI con resultados alentadores

This study looked at the evolution of 100 patients with symptomatic aortic stenosis treated with Myval THV from Meril Life Sciences Pvt. Ltd.  

Patient mean age was 74, and they were mostly men. 95 participants were hypertensive, 40 diabetic, and most were in functional class II-III; 24 had prior MI, 22 prior CABG, 8 prior stroke, 9 were in need of a pacemaker and 18 presented atrial fibrillation. 17 cases had bicuspid valve. Ejection fraction was 55%.

Mortality STS score was 4.8%.

99 cases were treated with a transfemoral approach and 97 received conscious sedation. 

Read also: EVOQUE: Transcatheter Tricuspid Valve Replacement, One-Year Outcomes.

Device implantation was successful in 99 patients. 

At 30 days, there was one death, one stroke, five major bleeding events, and six major vascular complications., three cases of kidney function deterioration and 28 patients needed a pacemaker.

After 12 months, there were seven cases of all-cause mortality, five strokes, two endocarditis, one valve dysfunction requiring surgery and one hospitalization for cardiac failure. All patients experienced functional class improvement. 

Read also: New Advances in Mitral Regurgitation Devices with Promising Results.

ECG analysis showed mean gradient 9.5 mmHg, with no significant differences between bicuspid and tricuspid valves. Left ventricular ejection fraction was 59%, and no patient presented moderate or severe leaks. 

Conclusion

TAVR with Myval showed excellent results at 30 days and one year, considering technical success, survival and valve related events. We should take into account the limitations of this analysis, based on retrospectively gathered data from one single center. 

Dr. Carlos Fava - Consejo Editorial SOLACI

Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.

Original Title: Single center experience with the balloon‐expandable Myval transcatheter aortic valve system with the first 100 patients: 30‐day and 1‐year follow‐up. 

Reference: Balázs Magyari, et al. Catheter Cardiovasc Interv. 2023;102:1317–1330. 


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