Key result
Self-expandable devices demonstrated a 97% device success rate compared to 100% for balloon-expandable devices in patients with severe aortic stenosis, with no significant difference in 90-day mortality (17% vs 21%, p=0.184).
Why the study?
Complications and outcomes of new TAVI devices have not been studied enough, motivating an evaluation of midterm results between self-expandable and balloon-expandable devices.
Does self-expandable TAVI improve device success and reduce complications compared to balloon-expandable TAVI in high-risk patients with severe aortic stenosis?
Observational (n=60)
Open-label
None
Yes
Does self-expandable TAVI improve device success and reduce complications compared to balloon-expandable TAVI in high-risk patients with severe aortic stenosis?
In high-risk patients with severe aortic stenosis, self-expandable and balloon-expandable TAVI devices demonstrated comparable midterm morbidity, mortality, and paravalvular leakage rates.
Answers are grounded in this paper and cite their sources.
Comparable outcomes support either device in high-risk aortic stenosis; leaves open whether randomized trials confirm equivalence.
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.
No takes yet. Share an insight, caveat, or question.
Nourizadeh et al. (2023) conducted an observational in Severe Aortic Stenosis (n=60). Self-expandable devices (Core Valve, Evolute R) vs. Balloon-expandable devices (Edwards SAPIEN) was evaluated on Device success. Self-expandable devices demonstrated a 97% device success rate compared to 100% for balloon-expandable devices in patients with severe aortic stenosis, with no significant difference in 90-day mortality (17% vs 21%, p=0.184).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: