Temporal Changes and Clinical Implications of Delayed Peridevice LeakFollowing Left Atrial AppendageClosure.

Abstract

The aim of this study was to assess temporal changes and clinical implications of peridevice leak (PDL) after left atrial appendage closure. Endocardial left atrial appendage closure devices are alternatives to long-term oral anticoagulation (OAC) for patients with atrial fibrillation. PDL >5mm may prohibit discontinuation of OAC. Patients included in the study had: 1) successful Watchman device implantation without immediate PDL; 2) new PDL identified at 45 to 90days using transesophageal echocardiography; 3) eligibility for OAC; and 4) 1 follow-up transesophageal echocardiographic study for PDL surveillance. Relevant clinical and imaging data were collected by chart review. The combined primary outcome included failure to stop OAC after 45 to 90days, transient ischemic attack or stroke, device-related thrombi, and need for PDL closure. Relevant data were reviewed for 1,039 successful Watchman device implantations. One hundred eight patients (10.5%) met the inclusion criteria. The average PDL at 45 to 90days was 3.2 ± 1.6mm. On the basis of a median PDL of 3mm, patients were separated into≤3mm (n=73) and >3mm (n=35) groups. In the≤3mm group, PDL regressed significantly (2.2 ± 0.8mm vs 1.6 ± 1.4mm; P=0.002) after 275 ± 125days. In the >3mm group, there was no significant change in PDL (4.9 ± 1.4mm vs 4.0 ± 3.0mm; P=0.12) after 208 ± 137days. The primary outcome occurred more frequently (69% vs 34%; P=0.002) in the >3mm group. The incidence of transient ischemic attack or stroke in patients with PDL was significantly higher compared with patients without PDL, irrespective of PDL size. New PDL detected by transesophageal echocardiography at 45 to 90days occurred in a significant percentage of patients and was associated with worse clinical outcomes. PDL≤3mm tended to regress over time.