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Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves

Open access
Makkar, Raj R., Fontana, Gregory, Jilaihawi, Hasan, Chakravarty, Tarun, Kofoed, Klaus F., De Backer, Ole, Asch, Federico M., Ruiz, Carlos E., Olsen, Niels T., Trento, Alfredo, Friedman, John, Berman, Daniel, Cheng, Wen, Kashif, Mohammad, Jelnin, Vladimir, Kliger, Chad A., Guo, Hongfei, Pichard, Augusto D., Weissman, Neil J., Kapadia, Samir, Manasse, Eric, Bhatt, Deepak L., Leon, Martin B., Søndergaard, Lars·2015·New England Journal of Medicine

Abstract

BACKGROUND: A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. METHODS: We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]). RESULTS: Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P=0.01 in the clinical trial; and 0% and 29%, respectively, P=0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P=0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P=0.007). CONCLUSIONS: Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation. (Funded by St. Jude Medical and Cedars-Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.).

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Metadata

Authors
Makkar, R. R., Fontana, G., Jilaihawi, H., Chakravarty, T., Kofoed, K. F., De Backer, O., Asch, F. M., Ruiz, C. E., Olsen, N. T., Trento, A., Friedman, J., Berman, D., Cheng, W., Kashif, M., Jelnin, V., Kliger, C. A., Guo, H., Pichard, A. D., Weissman, N. J., Kapadia, S., Manasse, E., Bhatt, D. L., Leon, M. B., & Søndergaard, L.
Venue
New England Journal of Medicine
Published
2015-11-19
Volume
373
Issue
21
Pages
2015-2024
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2318441640
Cited by
1,051
References
14
FWCI
97.03
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. https://app.cochat.ai/papers/10.1056/nejmoa1509233
The paper
Makkar, R. R., Fontana, G., Jilaihawi, H., Chakravarty, T., Kofoed, K. F., De Backer, O., Asch, F. M., Ruiz, C. E., Olsen, N. T., Trento, A., Friedman, J., Berman, D., Cheng, W., Kashif, M., Jelnin, V., Kliger, C. A., Guo, H., Pichard, A. D., Weissman, N. J., . . . Søndergaard, L. (2015). Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1509233

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.