Peridevice leak and device-related thrombus in the OPTION randomized trial

Left atrial appendage closure (LAAC) has been shown to be a safe and effective alternative to oral anticoagulation (OAC) for stroke prevention in patients with AF.

The OPTION trial compared LAAC to OAC for reducing the risk of thromboembolism in patients who had a catheter ablation for atrial fibrillation (AF). This analysis aims to assess the rate of peri-device leak (PDL) and device-related thrombus (DRT) in the ablation+LAAC arm of the trial.

OPTION was a randomized controlled trial enrolling patients undergoing catheter ablation for AF. The ablation procedure was performed 90 to 180 days prior to or sequ concomitant with LAAC. Groups were randomized 1:1 to either ablation+LAAC or ablation+OAC. Imaging with transesophageal (TEE) or CT was performed at 3 and 12 months and analyzed by an independent core laboratory.

In OPTION, 803 patients were randomized to ablation + LAAC; 753 patients received LAAC after catheter ablation and are the focus of this subanalysis. The procedure was guided by TEE (97.9%) or intracardiac echocardiography (2.1%).; Complete seal and PDL over time are shown in the Table. The rate of complete seal was 81.0% and 79.7% at 3 and 12 months, respectively Most PDL were small (≤3mm). DRT was found in 1.1% and 1.9% of patients at 3 and 12 months, respectively. Most DRT had a laminar morphology and were non-mobile. No patient with DRT experienced a stroke or systemic embolism during follow-up and none of the patients with PDL had a DRT. No patient had a stroke or systemic embolism related to the LAAC device. No patient experienced a pericardial effusion related to the procedure. There was 1 device migration and 1 device embolization which led to removal of the LAAC devices. Additional details will be available at the time of the presentation.

Among patients who underwent catheter ablation for AF, LAAC can be safely performed with a small rates of DRT and PDL.