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Thrombus formation on LAA closure device is not unusual

Between 5% and 9% of patients with atrial fibrillation (AF) who undergo percutaneous closure of the left atrial appendage (LAA) experience subsequent thrombus formation on the device, results from a late-breaking registry presented at the Congress yesterday shows.

Arrhythmias


Principal investigator Professor Laurent Fauchier (Trousseau Regional University Hospital, Tours, France), who presented the findings, said: “Thrombus formation is not a benign finding and should be actively investigated, as it is strongly associated with a higher risk of ischaemic stroke during follow-up. Optimal strategies at the time of implantation and for postoperative antithrombotic management should be considered to reduce the risk of thrombus formation. Good knowledge of technical aspects at the time of LAA device implantation is probably needed to reduce this risk.”

Percutaneous left atrial appendage (LAA) closure is an alternative strategy for stroke prevention in atrial fibrillation (AF) patients. Thrombus formation on the device is a possible finding during follow-up, but its clinical significance is still debated and poorly understood. In the absence of consensus about appropriate antithrombotic regimens after implantation in patients with high bleeding risk, or those that cannot receive anticoagulation, this study aimed to evaluate incidence, predictors, and prognosis of thrombus formation on devices in a relatively large series of patients with AF treated with LAA closure (using different devices currently available).

The seven-centre French study assessed 377 consecutive AF patients (229 males, 74.8 ± 8.9 years old, mean CHA2DS2¬VASc score 4.5 ± 1.4, HASBLED score 3.7 ± 1.0) who received LAA closure from March 2012 to September 2016. The rate of successful implantations was 96.0%; a variety of devices were used in the study. At discharge, 36.1% of the patients were treated with a single antiplatelet therapy, 21.1% received dual antiplatelet therapy, 28.9% received oral anticoagulation (OAC) and no antiplatelet therapy, 5.8% received OAC plus APT, and 8.1% received no antithrombotic therapy, antithrombotic therapy being decided on an individual basis. Mean follow-up was 11 ± 11 months during which 22 thrombi on device (6.1%), 10 ischaemic strokes (2.8%), 18 major haemorrhages (5.0%), and 25 deaths (6.9%) were recorded in 69 patients (19.2%).

Thrombus formation was seen in 10 patients (8.6%) with one device and 12 patients (4.9%) with another device. Older age and history of previous ischaemic stroke were the only independent predictors of thrombus formation on a device. Use of antiplatelet therapy and OAC tended to be associated with a lower risk of thrombus formation in a multivariate analysis, but this did not reach statistical significance. Patients with device thrombosis had a higher risk of ischaemic stroke during subsequent follow-up. This result was similar after adjustment for age, sex, CHA2DS2-VASc score, HASBLED score, and treatment at discharge, and thrombus on a device was the only independent predictor of ischaemic stroke during follow-up.

The researchers concluded that thrombus formation on the device is not uncommon in AF patients treated by LAA closure.

Prof. Fauchier said: “We were not able to find an antithrombotic strategy clearly associated with a lower risk of thrombus formation, but a strategy with no antithrombotic at all is, at the moment, probably not a satisfying option—particularly in the initial phase in the first weeks or months after implantation of the device. Large randomised trials comparing different devices and, more importantly, different antithrombotic strategies are urgently needed. We need to know which type of antithrombotic therapy, whether it be antiplatelet therapy and/or anticoagulation, is the best option in the initial phase. Also, we need to know which dosing and for how long. Other large observational analyses, with long follow-up and relevant adjustment, would also be interesting, as they would help in the design of these randomised trials.”

Late Breaking Trial Session: Left atrial appendage occlusion

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