Transcatheter aortic valve implantation with Vitaflow prosthesis in Latin America

Juan G. Chiabrando, Department of Interventional Cardiology, Sanatorio Anchorena, Buenos Aires; Department of Interventional Cardiology Department, Sanatorio Finochietto, Buenos Aires. Argentina
Verónica González, Department of Interventional Cardiology, Sanatorio Anchorena, Buenos Aires; Department of Interventional Cardiology Department, Sanatorio Finochietto, Buenos Aires. Argentina
Alfredo Rodríguez, Department of Interventional Cardiology, Sanatorio Otamendi, Buenos Aires, Argentina
Germán Cafaro, Department of Interventional Cardiology, Sanatorio Mendez, Buenos Aires, Argentina
Marcelo Menéndez, Department of Interventional Cardiology, Sanatorio Plaza, Rosario Santa Fe, Argentina
José Lazarte, Department of Interventional Cardiology, Sanatorio Boratti, Misiones, Argentina
Agustín Hauqui, Department of Interventional Cardiology, Hospital San Juan de Dios, Buenos Aires; Department of Interventional Cardiology, Instituto de Diagnóstico de La Plata, Buenos Aires; Argentina
Oscar Mendiz, Department of Interventional Cardiology, Fundación Favaloro, Buenos Aires, Argentina
Pablo Lamelas, Department of Interventional Cardiology, Instituto Cardiovascular de Buenos Aires. Argentina
Matías Sztejfman, Department of Interventional Cardiology, Sanatorio Anchorena, Buenos Aires; Department of Interventional Cardiology Department, Sanatorio Finochietto, Buenos Aires. Argentina

Background: Robust long-term data on the performance and durability of novel transcatheter aortic valve implantation (TAVI) valve designs, especially in Latin America, are lacking and warrant further investigation. Objectives: To provide a 1 year follow-up data regarding a novel TAVI device. Methods: A retrospective, multicenter cohort study was conducted in Latin America of patients with severe symptomatic aortic stenosis treated with the Vitaflow prosthesis from June 2022 to June 2023. The clinical endpoints were all-cause death, cardiovascular death, myocardial infarction, stroke, vascular and bleeding complications, permanent pacemaker implantation (PPM), and heart failure admission. Echocardiographic outcomes were the transvalvular gradient and paravalvular leak at 1 year of follow-up. Results: A total of 46 consecutive patients were included. The mean age of the patients was 80.9 ± 6.13 years; 50% were men, the mean STS score was 4.64 ± 2.67, and 60.8% were in NYHA class III/IV. The most used valve size was the 27 mm (47.1%). All-cause death at 1-year follow-up occurred in 4 patients (8.7%), of which 3 were cardiovascular (6.5%). There were 2 strokes, 1 vascular event, 2 major bleeding events, 4 new PPMs, and no myocardial infarctions or heart failure admissions. The 1-year mean transvalvular gradient was 7 ± 4 mmHg, and 3 patients (6.4%) had moderate paravalvular leak, with no severe leaks. Conclusions: In a Latin American population, the Vitaflow TAVI valve has proved good safety and efficacy outcomes at 12 months of follow-up in the treatment of patients with severe aortic stenosis.

Keywords: Transcatheter aortic valve implantation. Transcatheter aortic valve replacement. Vitaflow. LATAM. Aortic valve.