Bioprosthetic Aortic Valves: The risk for Leaflet Thrombosis
Reporters: Aviva Lev-Ari, PhD, RN
Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves
Raj R. Makkar, M.D., Gregory Fontana, M.D., Hasan Jilaihawi, M.D., Tarun Chakravarty, M.D., Klaus F. Kofoed, M.D., D.M.Sc., Ole de Backer, M.D., Ph.D., Federico M. Asch, M.D., Carlos E. Ruiz, M.D., Niels T. Olsen, M.D., Ph.D., Alfredo Trento, M.D., John Friedman, M.D., Daniel Berman, M.D., Wen Cheng, M.D., Mohammad Kashif, M.D., Vladimir Jelnin, M.D., Chad A. Kliger, M.D., Hongfei Guo, Ph.D., Augusto D. Pichard, M.D., Neil J. Weissman, M.D., Samir Kapadia, M.D., Eric Manasse, M.D., Deepak L. Bhatt, M.D., M.P.H., Martin B. Leon, M.D., and Lars Søndergaard, M.D.
October 5, 2015DOI: 10.1056/NEJMoa1509233
https://clinicaltrials.gov/ct2/show/NCT02426307
Video
Leaflet Thrombosis in Bioprosthetic Valves?
Video
Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves.
Transcatheter aortic-valve replacement (TAVR) is a recent innovation in the management of aortic stenosis. The efficacy and safety of this therapeutic intervention have been studied in several randomized clinical trials.1-6 The Portico Re-sheathable Transcatheter Aortic Valve System U.S. Investigational Device Exemption (PORTICO IDE) study is an ongoing, prospective clinical trial to evaluate TAVR with either a Portico valve (St. Jude Medical) or a commercially available valve.
As specified in the PORTICO IDE protocol, computed tomography (CT) was performed in a subgroup of patients to assess the stent frame of the implanted valve. A finding of reduced leaflet motion on CT in a patient who had had a stroke after TAVR and similar findings in an asymptomatic patient at one clinical site led to closer scrutiny of this observation. Additional CT review by the core laboratory revealed that this finding was not isolated, which prompted a more extensive investigation that involved analysis of all available CT and echocardiographic data.
These events also led to the establishment of two physician-initiated registries to evaluate bioprosthetic leaflet function after TAVR or surgical aortic-valve replacement: the Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and Its Treatment with Anticoagulation (RESOLVE) registry and the Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed with Four-Dimensional Computed Tomography (SAVORY) registry. We report the findings of these investigations from the randomized, controlled PORTICO IDE study as well as from the two registries. The major objective of our analyses was to examine the prevalence of reduced leaflet motion in bioprosthetic aortic valves, as assessed on four-dimensional, volume-rendered CT; the association between reduced leaflet motion and strokes and transient ischemic attacks (TIAs); and the influence of anticoagulation on reduced leaflet motion.
Methods
Study Populations, Funding, and Oversight
This study was conducted in patients who were enrolled in the PORTICO IDE randomized trial and in the RESOLVE and SAVORY registries. The PORTICO IDE trial, which is sponsored by St. Jude Medical, has a target enrollment of 1206 patients. The trial protocol is available with the full text of this article at NEJM.org.
The RESOLVE and SAVORY registries are also ongoing. RESOLVE is a single-center registry study that is being conducted at Cedars–Sinai Medical Center in Los Angeles and that includes patients with previously implanted valves (retrospective enrollment) with a target enrollment of 200 patients; it is funded by the Cedars–Sinai Heart Institute. SAVORY is a single-center registry study that is being conducted at Rigshospitalet in Copenhagen and that includes patients with newly implanted valves (prospective enrollment) with a target enrollment of 75 patients; it is funded by St. Jude Medical.
For the PORTICO IDE trial, the sponsor contributed to the study design, supervised data collection and analysis, and reviewed the manuscript to verify the accuracy of data with respect to the PORTICO IDE patients. For the two registries, study design and data collection were conducted by the respective institutions. For the trial and the two registries, approval by the institutional review board at each participating site was obtained before study initiation, and all patients provided written informed consent. The coprincipal investigators had unrestricted access to the data from all three data sets for the purpose of this analysis. They also made the decision to submit the manuscript for publication, prepared all drafts of the manuscript, and attest to the completeness and accuracy of the reported data and for the fidelity of the study to the protocol.
SOURCE
NEJM
DOI: 10.1056/NEJMoa1509233
Leave a Reply