Self-expanding and balloon-expandable valves in low risk TAVR patients. 

 -  2024 
<br/><br/> BACKGROUND: Recent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse.  CLINICAL TRIAL REGISTRY: LRT 1.0: NCT02628899 LRT 2.0: NCT03557242. Copyright © 2023 Elsevier B.V. All rights reserved.  CONCLUSION: In this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated.  METHODS: The current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves.  RESULTS: A total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (>=moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 +/- 0.43 mm2 vs. 1.69 +/- 0.45 mm2, p < 0.001) and lower mean gradient (8.93 +/- 3.53 mmHg vs. 13.41 +/- 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038). 
<br/><br/><br/>English 
<br/><br/><label>ISSN: </label>0167-5273 
<br/><br/><label>Standard No.: </label>10.1016/j.ijcard.2023.131431 [doi] S0167-5273(23)01461-4 [pii] 
<br/><br/><label>Subjects--Topical Terms: </label><br/>*Aortic Valve Stenosis<br/>*Heart Valve Prosthesis<br/>*Stroke<br/>*Thrombosis<br/>*Transcatheter Aortic Valve Replacement<br/>Aortic Valve Stenosis/di [Diagnosis]<br/>Aortic Valve Stenosis/et [Etiology]<br/>Aortic Valve Stenosis/su [Surgery]<br/>Aortic Valve/dg [Diagnostic Imaging]<br/>Aortic Valve/su [Surgery]<br/>Humans<br/>Prosthesis Design<br/>Risk Factors<br/>Stroke/et [Etiology]<br/>Thrombosis/et [Etiology]<br/>Transcatheter Aortic Valve Replacement/ae [Adverse Effects]<br/>Treatment Outcome
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Health Research Institute<br/>MedStar Heart & Vascular Institute<br/>MedStar Washington Hospital Center
<br/><br/><label>Index Terms--Occupation: </label><br/>Interventional Cardiology Fellowship
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article