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BARCELONA -- One in five cases of structural valve dysfunction after transcatheter aortic valve replacement (TAVR) were attributed to leaflet thrombosis in a registry study reported here.

Out of 5,691 TAVR-related adverse events from 2012 to 2014 captured by the FDA Manufacturer and User Facility Device Experience (MAUDE) database, structural valve dysfunction was evident in 129 cases of leaflet restriction and 27 of malcoaptation. Leaflet thrombosis was deemed responsible for 29 and one of those findings, respectively, according to data presented at the European Society of Cardiology meeting and published online in .

The 30 leaflet thrombosis cases were tied to three stroke/TIAs, two cardiogenic shocks, and nine deaths, Ankur Kalra, MBBS, of University Hospitals Harrington Heart & Vascular Institute in Cleveland, told the audience here at a late-breaking registry study session. Half the cases were subclinical.

Eighteen of the 30 leaflet thrombosis cases occurred in the first year after TAVR, the rest taking place in years 2-5. Aortic stenosis tended to be diagnosed at around 15.5 months, regurgitation a bit earlier at 10.1 months.

"Early diagnosis of leaflet thrombosis may be crucial for planning appropriate management and optimizing clinical outcome for patients," Kalra suggested. His group noted that operators found thrombosis in various ways: during echocardiography; from gradient increase, reduced leaflet motion, or hypoattenuated leaflet thickening seen on CT angiography; or during autopsy or surgery.

Leaflet thrombosis culminating in structural valve dysfunction presented as aortic stenosis in about half of cases; regurgitation was seen in 23.5%, a combination of the two in 13.3%, or as stroke/TIA in 10.0%.

Patients got a mix of interventions to address leaflet thrombosis, but most common was surgery (46.7%), followed by antithrombotics (26.7%), and valve-in-valve TAVR (10.0%).

MAUDE is a database of device-related events that operators report to the FDA. The events in Kalra's analysis notably occurred before the 2015 appearance of a study on that suggested it was more common after TAVR than previously thought.

"It's plausible that a different diagnosis other than leaflet thrombosis was considered in patients that had surgery (such as infective endocarditis)," according to the investigator, who said data were collected while "we were about leaflet thrombosis."

Other chief caveats of the study were its reliance on self-reported events and the "incomplete capture of all events due to lack of standard definitions during the study period, leading to missed diagnoses, and underreporting by manufacturers," Kalra said.

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