The Feasibility And Safety Of The Next Generation Balloon Expandable Indian Trans Catheter Heart Valve: Myval
ETERNAL HOSPITAL, JAIPUR, India.
OBJECTIVE: To demonstrate the feasibility and safety of MyVal in patients at intermediate or high-risk with severe symptomatic aortic stenosis, with the next-generation balloon-expandable Indian Trans catheter heart valve (THV).METHODS: We enrolled 100 consecutive patients >18 years with degenerative aortic valve stenosis, having co-morbidities such that the heart team concur that the predicted risk of operative mortality was ≥15% and/or a minimum Society of Thoracic Surgeons (STS) score of ≥ 4. All patients were symptomatic from aortic valve stenosis as demonstrated by New York Heart Association (NYHA) Functional Class ≥II. The echo-cardiographically derived criteria included mean gradient > 40mmHg or jet velocity greater than 4.0 m/s or an aortic valve area (AVA) of < 0.8 cm2. The six-minute walk test and Kansas City Cardiomyopathy Questionnaire (KCCQ) score were recorded. After successful implantation of MyVal THV, 96.6% and 100% were in NYHA functional class I/II at 30-day and one year follow-up, respectively.RESULTS: In 100 Intermediate and High-risk patients of MyVal-1 study, MyVal THV system demonstrated excellent clinical and hemodynamic outcomes at 30 days shows 96% Survival & Low incidence of Stroke (1%), Low 2%* rate of New permanent pacemaker implantation post-procedure, high procedural success due to Precise orthotropic valve positioning and significant improvement in quality of life of patients at 30 days.One-year follow-up results of initial 30 MyVal-1 study reported: high procedural success & no device-related mortality, no new pacemaker implantation, strokes or Para valvular leaks. The Echo parameters were maintained from post-procedure up to one year follow up. Four all-cause mortality were reported through one year.CONCLUSIONS: The MyVal-1 study demonstrated the feasibility primary safety and efficacy of MyVal THV with no new PPM requirement through one year follow-up. However, future trials with larger number of patients and long-term follow-up are warranted to establish the safety and efficacy.
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