Key result
Oral anticoagulation is linked to ~99% lower risk of subclinical leaflet thrombosis progression versus antiplatelet therapy.
Why the study?
Four-dimensional volume-rendered CT has demonstrated HALT and HAM after TAVI and SAVR, but the temporal pattern of evolution of these phenomena is uncertain.
Does oral anticoagulation prevent the progression of subclinical leaflet thrombosis in patients with bioprosthetic aortic valves compared to antiplatelet therapy?
Observational (n=84)
Does oral anticoagulation prevent the progression of subclinical leaflet thrombosis in patients with bioprosthetic aortic valves compared to antiplatelet therapy?
Subclinical leaflet thrombosis is a dynamic phenomenon after TAVI and SAVR, and oral anticoagulation may protect against its progression compared to antiplatelet therapy.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Since its initial description in 2015, the issue of imaging-defined leaflet thrombosis after aortic bioprostheses has represented a problem of uncertain extent and significance. The wide variability in incidence reported in prior studies has, on its own, flummoxed attempts to characterize its effects.”
“In most cases, patients with HALT or reduced leaflet motion were clinically asymptomatic, and the findings were categorized as subclinical.”
“Ten years ago, the first studies on subclinical leaflet thrombosis following transcatheter aortic valve implantation were reported. It was detected as hypoattenuated leaflet thickening with or without reduced leaflet mobility on post-TAVI cardiac computed tomography scans. A decade and multiple studies later, SLT remains a clinical conundrum due to its high incidence, dynamic clinical course, uncertain prognostic impact and challenging treatment strategies.”
OAC was associated with less progression of subclinical leaflet thrombosis post-TAVI/SAVR; hypothesis-generating observation that leaves open need for RCTs.
AIMS: Four-dimensional volume-rendered computed tomography (4DCT) has demonstrated instances of hypo-attenuating leaflet thickening (HALT) with or without hypo-attenuation affecting motion (HAM) after transcatheter and surgical aortic valve implantation (TAVI, SAVR). The temporal pattern of evolution of these phenomena is uncertain. METHODS AND RESULTS: The SAVORY registry enrolled patients treated by TAVI (n = 75) or SAVR (n = 30) with two 4DCT scans fully interpretable for HALT and HAM as well as unchanged anti-thrombotic medication between the scans. Logistic regression analysis was performed to examine the evolution of HALT and HAM while accounting for demographic and baseline variables, timing of both CT scans, valve type and antithrombotic therapy. The analysis population consisted of 84 patients, in whom first and second CT scans were performed at 140 ± 152 days and 298 ± 141 days after valve implantation, respectively. Hypo-attenuating leaflet thickening was noted in 32 patients (38.1%), with HAM in 17 (20.2%). Both findings were dynamic, showing progression in 13 (15.5%) and regression and 9 (10.7%) patients. Compared with antiplatelet therapy, progression was less likely among patients on oral anticoagulation with vitamin-K antagonists or non-VKA oral anticoagulants (odds ratio: 0.014, P = 0.036). Maintenance on chronic oral anticoagulation was not a significant predictor of regression. These findings were similar for both transcatheter and surgical bioprosthetic aortic valves. No patients developed symptoms of valve dysfunction and leaflet thickening was not clearly associated with any clinical events. CONCLUSIONS: Subclinical leaflet thrombosis is a common finding after TAVI and SAVR, and may progress from normal leaflet over HALT to the more severe HAM. The phenomenon can develop and regress at variable intervals after valve implantation. Anticoagulants may have a protective effect against the development of HALT, but HALT can also regress without anticoagulation therapy. REGISTERED AT CLINICALTRIALS.GOV: NCT02426307.
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Søndergaard et al. (2017) conducted an observational in Subclinical leaflet thrombosis after TAVI and SAVR (n=84). Oral anticoagulation (VKA or NOAC) vs. Antiplatelet therapy was evaluated on Progression of subclinical leaflet thrombosis (HALT/HAM) (OR 0.014, p=0.036). Compared with antiplatelet therapy, oral anticoagulation was associated with a lower likelihood of progression of subclinical leaflet thrombosis (OR 0.014, P=0.036).
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