Evaluation of Patients with Severe Aortic Stenosis after TAVI with Self-Expandable vs. Balloon-Expandable Devices

Abstract

Background: The introduction of transcatheter aortic valve implantation (TAVI) for the treatment of severe aortic stenosis (SAS) has expanded the therapeutic possibilities for successfully managing SAS in cases with intermediate and high surgical risks. However, the complications and outcomes of new devices have not been studied enough. Hence, the purpose of this study is to evaluate the midterm results of the Core Valve and Evolute R self-expandable (SE) devices versus the Edwards SAPIEN balloon-expandable (BE) devices. Methods and Material: This was a quasi-experimental study conducted in Tehran, Iran, from May 2012 to June 2017. SAS patients who were not ideal candidates for surgery were randomly assigned to either SE or BE groups. For each patient, a questionnaire, including four sections comprised of Basic characteristics, echocardiographic, angiographic, and Computed Tomography (CT) scan data was filled. TAVI was followed by echocardiography a week later and after three months they were reevaluated by another questionnaire. Results: The total number of patients was 60. The mean ages of patients undergoing the procedure with SE or BE devices were 81.2 ± 8 and 79.8 ± 7, respectively. Mortality occurred in 20% of the patients (5 cases in the SE group and 7 cases in the BE); mortality causes were 66.6 % cardiac and 33% non-cardiac. Moderate to severe Paravalvular leakage in both groups did not differ significantly. The mortality rate was 5 (41.6%) in the SE group versus 7 (58.3%) in the BE group (P > 0.05). Conclusion: In conclusion, the BE group did not experience fewer paravalvular leaks in comparison with the SE. Morbidity and mortality between the BE and the SE groups did not differ significantly.