Safety and effectiveness of balloon-expandable Myval transcatheter aortic valve implantation: a single-center, real-world evidence from Kazakhstan

Abstract Background Untreated aortic stenosis (AS) leads to significant mortality and morbidity. Balloon-expandable Myval transcatheter heart valve (THV) has demonstrated safety and effectiveness for treating severe AS in patients at intermediate or high risk for surgery. This retrospective observational study aimed to analyze the safety and efficacy of Myval THV in AS patients who underwent transcatheter aortic valve implantation (TAVI) at a single-center. Methods Data from 100 consecutive patients who underwent transfemoral TAVI for severe symptomatic AS with Myval THV were analyzed. Baseline characteristics including medical history, clinical features, procedural data, laboratory and echocardiographic data, and outcome data at discharge and 30 days were collected retrospectively. Outcomes as defined according to the consensus document of the Valve Academic Research Consortium-3 were determined. Results Baseline characteristics of 100 patients were: 64% males, mean age: 70.87 ± 7.85 years, mean body mass index: 27.97 ± 4.30 Kg/m 2 , Society of Thoracic Surgeons risk score: 2.88 ± 2.18% and log EuroSCORE: 3.34 ± 2.82% respectively. Following transfemoral TAVI, mean and peak gradients were reduced ( p < 0.001). There was a significant improvement in Vmax 2.50 ± 1.52 m/s ( p < 0.0001), left ventricular ejection fraction 50.5 ± 10.64% ( p = 0.0003), aortic valve area 1.76 ± 0.52 ( p = 0.0013), and indexed aortic valve area 0.92 ± 0.28 ( p = 0.0034) at discharge which continued at 30-day follow-up. Nearly 94% of patients were asymptomatic and in the New York Heart Association class I–II, with 22% of patients reduced the degree of mitral regurgitation at 30 days. At discharge, only 4.12% had moderate aortic regurgitation while 73.2% had none. Two patients had stroke while 15 patients had conduction disturbances, which led to the implantation of permanent pacemakers. No death or hospitalization were reported. Life-threatening bleeding and access-related complications did not occur in any patient. The rates of the device and technical success were 95%. Conclusion Real-world data on the use of technologically advanced Myval THV leads to safe and precise orthotopic positioning in TAVI patients, ensuring optimal, large effective orifice area, and normal hemodynamic status.