Background

Interventional occlusion of the left atrial appendage (LAA-O) is an established therapeutic option in atrial fibrillation (AF) patients, which are not suitable for oral anticoagulation (OAC) therapy. Very recently, results from the National Cardiovascular Data Registry (NCDR) LAA-O Registry have been published demonstrating that women undergoing LAA-O using exclusively the Watchman device have a significant higher risk for in-hospital adverse events (AE). However, less is known about incidence and characteristics of gender-stratified procedural and device-related AE comparing different LAA-O devices.

Methods and Results

Between 2015 and 2021 in 339 AF patients LAA-O was performed at University Medical Center Ulm. Procedural AE was defined as periprocedural death, stroke, pericardial tamponade, bleeding acquiring transfusion, whereas device-related AE was defined as failed device implantation, device dislocation, residual jet around the device >5 mm or thrombotic formation on LAA-O device. LAA occlusion was performed by different generations of Watchman (45.9%) or Amplatzer (54.1%) devices.

125/339 (37%) patients were female with a mean age of 77 ±7 years compared to a mean age of 75 ±7 years in male patients (219/339(63%)). Further baseline characteristics differ significantly between both study groups resulting in a significant higher CHA²DS²-VaSc-Score in female patients (female: 6 ±1 vs. male: 4 ±1; p<0.01). Procedural AE tend to be higher in female patients (8.0%) compared to male patients (3.7%; p=0.08). Most common procedural AE was pericardial tamponade (female: 4.0% vs. male 2.3%, p=0.28). Remarkably, rate of device-related AE was significantly higher in female patients (female: 11.2% vs. male: 5.0%; p=0.03). Most common device-related AE was thrombotic formation on LAA-O device (female: 8.0% vs. male: 3.0%; p=0.07). Type of implanted LAA-O device was not an independent predictor for procedural or device-related AE.

Conclusion

Procedural AE as well as device-related AE were higher in female patients undergoing LAA-O irrespective of used LAA-O device. Hence, female patients that are referred for LAA-O should be under intensified monitoring during and after implantation with the aim to prevent adverse events, mainly pericardial effusion and thrombotic formation on LAA-O device.