Self-expanding and balloon-expandable valves in low risk TAVR patients.
Citation: International Journal of Cardiology. 395:131431, 2024 Jan 15.PMID: 37832606Institution: MedStar Health Research Institute | MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment: Interventional Cardiology FellowshipForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aortic Valve Stenosis | *Heart Valve Prosthesis | *Stroke | *Thrombosis | *Transcatheter Aortic Valve Replacement | Aortic Valve Stenosis/di [Diagnosis] | Aortic Valve Stenosis/et [Etiology] | Aortic Valve Stenosis/su [Surgery] | Aortic Valve/dg [Diagnostic Imaging] | Aortic Valve/su [Surgery] | Humans | Prosthesis Design | Risk Factors | Stroke/et [Etiology] | Thrombosis/et [Etiology] | Transcatheter Aortic Valve Replacement/ae [Adverse Effects] | Treatment OutcomeYear: 2024ISSN:- 0167-5273
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Journal Article | MedStar Authors Catalog | Article | 37832606 | Available | 37832606 |
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).
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