Risk factors, clinical implications, and management of peridevice leak following left atrial appendage closure: A systematic review

Background: Left atrial appendage closure (LAAC) is a treatment modality for stroke prevention in patients with atrial fibrillation (AF). One of the potential complications of LAAC is a peri-device leak (PDL), which could potentially increase the risk of thromboembolism formation.

Methods: This systematic review was done according to PRISMA guidelines. Using four databases, all primary studies through April 2022 that met selection criteria were included. Outcomes of interest were studies reporting on PDL characteristics, risk factors and management.

Results: A total of 116 studies met selection criteria (97 original studies and 19 case reports/series). In the original studies (n = 30,133 patients), the weighted mean age was 72.0 ± 7.4 years (57% females) with a HAS-BLED and CHA2DS2-VASc weighted means of 2.8 ± 1.1 and 3.8 ± 1.3, respectively. The most common definition of PDL was based on size; 5 mm: major, 3-5 mm: moderate, < 1 mm minor, or trivial. Follow up time for PDL detection was 7.15 ± 9.0 months. 33% had PDL, irrespective of PDL severity/size, and only 0.9% had PDL of greater than 5 mm. The main risk factors for PDL development included lower degree of over-sizing, lower left ventricular ejection fraction, device/LAA shape mismatch, previous radiofrequency ablation, and male sex. The most common methods to screen for PDL included transesophageal echocardiogram and cardiac CT. PDL Management approaches include Amplatzer Patent Foramen Ovale occluder, Hookless ACP, Amplatzer vascular plug II, embolic coils, and detachable vascular coils; removal or replacement of the device; and left atriotomy.

Conclusion: Following LAAC, the emergence of a PDL is a significant complication to be aware of. Current evidence suggests possible risk factors that are worth assessing in-depth. Additional research is required to assess suitable candidates, timing, and strategies to managing patients with PDL.