Temporal changes and clinical significance of peridevice leak following left atrial appendage occlusion with Amplatzer devices

Abstract

Background: The natural history of peridevice leak (PDL) following left atrial appendage occlusion (LAAO) is unknown. This study sought to investigate changes of PDL from 2 until 12 months after LAAO, using cardiac computed tomography (CT), and to assess the potential association between persistent PDL and clinical outcomes Methods: Single-center observational study of Amplatzer LAAO implants between 2010 and 2017 (n = 206). Patients with 2 and 12 months cardiac CT were included in the study (n = 153). Images were blindly analyzed. PDL was characterized by frequency and size at the device disc, lobe, and left atrial appendage contrast patency. Patients were followed for the composite outcome of ischemic stroke, transient ischemic attack, systemic embolism, or all-cause death. Median follow up from LAAO was 3.1 (2.3-4.3) years.Results: Contrast patency was present in 101 (66%) and 72 (47%) (p < 0.001) at 2 and 12 months, respectively. PDL was identified at the disc in 103 (67%) patients at 2 months versus 93 (61%) at 12 months (p = 0.08), and at the lobe in 29 (19%) at both time points. PDL area at the disc did not change significantly over time, ∆ area: −8.95 mm (95% confidence interval [CI]: −18.9; 1.01) p = 0.08. Permanent atrial fibrillation was independently associated with persistent PDL. Persistent versus no PDL was associated with a 62% worse clinical outcome, however not statistically significant, hazard ratio (HR): 1.62 (95% CI: 0.9-2.93), p = 0.11. Conclusion:Persistent PDL was frequently observed following LAAO with Amplatzer devices. The PDL frequency and size appeared unchanged between 2 and 12 months. Persistent PDL was not significantly associated with worse clinical outcomes, yet this needs further delineation in future studies.

Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device

“…The cut-off for clinically acceptable PDL size has been arbitrarily defined and the significance remains debatable (5,19,23). The natural history of PDL is unclear, but smaller PDL (< 3 mm) adjacent to Watchman 2.5 devices may reduce in size over time (24), while a cardiac CT and TEE study revealed no significant PDL size reduction over time with Amplatzer devices (25). Nevertheless, contrast patency at 1 year is common and likely represents incomplete endothelialization with contrast passing through the device membrane.…”

The Effect of Peri-Device Leaks on Ischaemic Stroke/Transient Ischaemic Attack/Systemic Embolism after Left Atrial Appendage Closure: A Systematic Review and Meta-Analysis

“…1). After reviewing and assessing the inclusion and exclusion criteria, only thirteen articles [16–28] met the criteria and were included in the meta-analysis. These articles, which included a total of 54,405 patients, were all observational trials.…”

Left atrial appendage occlusion

“…In the PROTECT AF trial, any PDL was detected in 40.9% of patients during follow-up TOE imaging at 45 days but decreased to 32.1% at 1 year. Large PDL (>3 mm in diameter) were present in 13.3% patients at 45 days and in 11.8% at 1 year 90 . In a large nationwide cohort of >50,000 patients enrolled in the NCDR-LAAO Registry, small leaks (1-5 mm) were present in ~25% of patients, while large (>5 mm) leaks were rare (<1%) 92 (Figure 19).…”

“…The pivotal PROTECT AF and PREVAIL follow-up included 45-day, 6-and 12-month imaging which has been extrapolated to clinical practice 89 . Changes in post-procedural anticoagulation regimen 71,88 and studies demonstrating persistent PDL or signs of incomplete device endothelialisation at 1 year raise questions about the optimal timing of follow-up 89,90 . Early imaging follow-up is, however, generally recommended, while longer-term imaging follow-up of patients with DRT or HAT and those with large PDL may warrant sequential follow-up imaging.…”