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Leaflet Thrombosis Following TAVR
Study Questions:
What is the clinical significance of leaflet thrombosis beyond peri–transcatheter aortic valve replacement (TAVR) stroke or transient ischemic attacks (TIAs)?
Methods:
The investigators searched the MAUDE database for all entries with the identifier code “NPT,” designed by the US Food and Drug Administration (FDA) to identify TAVR-related adverse events (AEs) between January 2012 and October 2015. Selected entries were searched further for the terms “leaflet,” “central aortic regurgitation,” and “aortic stenosis” to capture all events related to leaflet thrombosis causing structural valve dysfunction (SVD). Presentation of leaflet thrombosis (aortic stenosis or regurgitation or mixed valve lesion), mode of diagnosis (echocardiography, computed tomography, surgical explantation, or autopsy), and duration of onset after TAVR were recorded. For all AEs of SVD due to leaflet thrombosis, the following outcomes were recorded: stroke or TIA, cardiogenic shock, and death from any cause. Descriptive statistical methods were used to describe medians for continuous variables, and frequency for categorical variables.
Results:
A total of 5,691 TAVR-related AEs were reported in the MAUDE database. SVD due to leaflet thrombosis was reported in 30 cases. Most cases (n = 18/30, 60.0%; 95% confidence interval [CI], 0.41-0.77) occurred in the first year following TAVR. SVD manifested as aortic stenosis (n = 16/30, 53.3%; 95% CI, 0.34-0.72), or regurgitation (n = 7/30, 23.3%; 95% CI, 0.10-0.42), or both (n = 4/30, 13.3%; 95% CI, 0.04-0.31). Interventions to address leaflet thrombosis included either escalation of antiplatelet or anticoagulant therapy (n = 9/30, 30.0%; 95% CI, 0.15-0.49), valve-in-valve TAVR (n = 5/30, 16.7%; 95% CI, 0.06-0.35), or surgery (n = 14/30, 46.7%; 95% CI, 0.28-0.66), or their combination. Outcome following leaflet thrombosis included stroke/TIA (n = 3/30, 10.0%; 95% CI, 0.02-0.27), cardiogenic shock (n = 2/30, 6.7%; 95% CI, 0.01-0.22), and death (n = 9/30, 30.0%; 95% CI, 0.15-0.49).
Conclusions:
The authors concluded that clinically manifest leaflet thrombosis was associated with serious clinical manifestations that included stroke, cardiogenic shock, and death.
Perspective:
This study reports that while clinical or symptomatic leaflet thrombosis is uncommon, it is a serious adverse event following TAVR, with a grave prognosis. Most cases appear to occur in the first year following TAVR, presented as aortic stenosis or regurgitation, requiring surgery in 47% of cases. As indications for TAVR expand to include patients at intermediate and perhaps low risk for perioperative mortality following surgery, an early diagnosis of leaflet thrombosis would be critical for appropriate management including antithrombotic therapy to optimize clinical outcomes.
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Anticoagulants, Cardiac Surgical Procedures, Echocardiography, Fibrinolytic Agents, ESC Congress, ESC2017, Heart Valve Diseases, Ischemic Attack, Transient, Shock, Cardiogenic, Stroke, Thrombosis, Tomography, Transcatheter Aortic Valve Replacement
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