Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN-LAAC Registry

Abstract

BACKGROUND: The impact of peridevice leak (PDL) at device implantation on clinical outcomes after percutaneous left a-trial appendage closure (LAAC) is unknown. This study aimed to investigate the association between PDL and clinical outcomes after LAAC. METHODS: Using data from the OCEAN-LAAC (Optimized Catheter Valvular Intervention-Left Atrial Appendage Closure) Japanese multicenter registry, we examined 1397 patients who underwent LAAC between September 2019 and December 2022. The primary outcome was transient ischemic attack, ischemic stroke, or systemic embolism within 2 years of LAAC. Clinical outcomes were compared between patients with and without PDL at device implantation using Fine and Gray multivariable regression analyses and propensity score matching. Additional analyses were performed by categorizing PDL into 2 groups: ≤3 mm and >3 mm but ≤5 mm. RESULTS: Of 1397 patients who underwent LAAC, 84 (6.0%) had PDL, of whom 73 (86.9%) had ≤3 mm PDL. Patients with PDL had a larger left atrium and higher CHADS2 scores than those without PDL. Multivariable analyses showed that PDL was significantly associated with a higher risk of transient ischemic attack, ischemic stroke, or systemic embolism (adjusted sub-distribution hazard ratio [sHR], 4.25 [95% CI, 1.91–9.44]; P<0.001). Even PDL ≤3 mm was independently associated with an increased risk compared with no PDL (adjusted sHR, 3.53 [95% CI, 1.37–9.04]; P=0.016). Propensity score matching analyses revealed consistent findings. CONCLUSIONS: PDL was associated with a higher risk of transient ischemic attack, ischemic stroke, or systemic embolism, even PDL ≤3 mm. Therefore, it may be necessary to aim for no PDL as much as possible.