ESC Focus on Interventions & PC - 10

Late-Breaking Registry Results

Leaflet Thrombosis Following
TAVR Is Associated With Serious
Adverse Events
Written by Toni Rizzo

October 2017

Figure 1. Cases and Timing of Leaflet Thrombosis, Aortic Stenosis, and
Aortic Regurgitation
Number of Cases of Leaflet
Thrombosis Post TAVR

Number of Cases

9
6
3
0

Leaflet Thrombosis Post TAVR

12
9
6
3
0

0-5 7-12 13-18 19-24 25-30 31-36 37-42 43-48 49-54 55-60

Time

Time (Months)

Aortic Stenosis Post TAVR

Number of Cases

Leaflet thrombosis is a complication of transcatheter
aortic valve replacement (TAVR) that can lead to
transcatheter valve failure, but the clinical consequences
of leaflet thrombosis are not clear. The purpose of
this study, presented by Ankur Kalra, MD, University
Hospitals Cleveland Medical Center, Cleveland, Ohio, USA,
was to determine whether leaflet thrombosis has clinical
significance beyond peri-TAVR stroke and transient
ischaemic attack (TIA).
The Manufacturer and User Facility Device
Experience (MAUDE) database was searched for the
identifier code, "NPT," designated by the US Food and
Drug Administration to identify TAVR-related adverse
events (AEs) occurring between the dates January 2012
and October 2015. Selected entries were searched further for the terms, "leaflet," "central aortic regurgitation (AR)," and "aortic stenosis." All reports that did
not have the term "leaflet" were excluded. Cases of
structural valve dysfunction (SVD) due to procedurerelated factors or not classified were also excluded.
Presentation of leaflet thrombosis, mode of diagnosis,
and timing of onset after TAVR were recorded.
A total of 5,691 TAVR-related AEs were reported in the
database. There were 546 AEs based on the prespecified
search terms and 156 AEs of SVD due to leaflet restriction
(n = 129) or leaflet malcoaptation (n = 27). SVD caused
by leaflet thrombosis was documented in 30 cases,
20 with the Edwards-Sapien valve and 10 with the
CoreValve (Figure 1). Of these, 60% occurred in the first
year following TAVR and 40% occurred within 13 to 60
months. SVD presented as aortic stenosis in 53.3% of
patients, regurgitation in 23.3% of patients, or both in
13.3% of patients. Aortic stenosis occurred within 15.5
± 12.2 months and regurgitation occurred within 10.1 ±
10.9 months of TAVR. Three of the 30 patients had a
stroke or TIA.
Leaflet thrombosis was treated with escalation of antiplatelet or anticoagulant therapy in 26.7% of patients,
valve-in-valve TAVR in 10.0% of patients, or surgery in
46.7% of patients. Other interventions included diuretics
(n = 1), thrombus aspiration (n = 1), and balloon aortic valvuloplasty (n = 2). Two patients received no intervention.
Outcomes after leaflet thrombosis were stroke or TIA in
10.0% of patients, cardiogenic shock in 6.7% of patients,
and death in 30.0% of patients.

9
6

Aortic Regurgitation Post TAVR
Acute: 0 - 3d
Subacute: 3d - 3mo
Late: 3mo - 1yr
Very late: > 1yr

9
6
3

Time

TAVR, transaortic valve replacement.
Reproduced with permission from A Kalra, MD.

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 AE 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."
In summary, this study demonstrated that leaflet
thrombosis is a serious AE following TAVR. Most cases
occurred in the first year following TAVR. Leaflet thrombosis was associated with the serious clinical manifestations of stroke, cardiogenic stroke, and death. The authors
concluded that early diagnosis of leaflet thrombosis may
be crucial for planning appropriate management and
optimising clinical outcomes for patients.
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