MAUDE: Leaflet Thrombosis Following TAVR is Associated With Stroke, Cardiogenic Shock, Death

Leaflet thrombosis is a serious adverse event following transcatheter aortic valve replacement (TAVR) and is associated with serious clinical manifestations, including stroke, cardiogenic shock and death, according to the MAUDE Trial presented by Ankur Kalra, MD, FACC, on Aug. 29 at ESC Congress 2017 in Barcelona and simultaneously published in Structural Heart: Journal of the Heart Team.

Investigators searched for data on TAVR-related adverse events in the Manufacturer and User Facility Device Experience (MAUDE) database between January 2012 and October 2015. Selected entries were searched further for the terms, “leaflet,” “central aortic regurgitation (AR)” and “aortic stenosis.” Cases of structural valve dysfunction (SVD) due to procedure-related factors or not classified were excluded. Presentation of leaflet thrombosis, mode of diagnosis and timing of onset after TAVR were recorded.

A total of 5,691 TAVR-related adverse events were reported in the database. There were 546 adverse events based on the pre-specified search terms and 156 adverse events of SVD due to leaflet restriction (n = 129) or leaflet malcoaptation (n = 27). SVD caused by leaflet thrombosis was documented in 30 cases. Of these, 60 percent occurred in the first year following TAVR and 40 percent occurred within 13 to 60 months. SVD presented as aortic stenosis in 53.3 percent of patients, regurgitation in 23.3 percent or both in 13.3 percent of patients. Three of the 30 patients had a stroke or transient ischemic attack (TIA). Aortic stenosis occurred within 15.5 ± 12.2 months and regurgitation occurred within 10.1 ± 10.9 months of TAVR.

Leaflet thrombosis was treated with escalation of antiplatelet or anticoagulant therapy in 26.7 percent, valve-in-valve TAVR in 10.0 percent or surgery in 46.7 percent of patients. Other interventions included diuretics (n = 1), balloon aortic valvuloplasty (n = 2) and no intervention (n = 2). Outcomes after leaflet thrombosis were stroke or TIA (10.0 percent), cardiogenic shock (6.7 percent) and death (30.0 percent).

This study demonstrated that leaflet thrombosis is a serious adverse event following TAVR. Leaflet thrombosis was associated with the serious clinical manifestations of stroke, cardiogenic stroke and death. The investigators concluded that early diagnosis of leaflet thrombosis may be crucial for planning appropriate management and optimizing clinical outcomes for patients.

Limitations of the study included ascertainment bias and lack of independent verification of reports obtained from the database. Additionally, time lapse and interim management decisions between adverse event occurrence and final interventions were not available. The authors noted that a different diagnosis other than leaflet thrombosis, such as infective endocarditis, may have been considered in the patients who had surgery. Further, incomplete capture of all events because of lack of standard definitions during the study period might have resulted in missed diagnoses and underreporting by manufacturers. The search terms also did not include the term ‘stroke/TIA.’


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