Incidence, risk factors, and clinical impact of peridevice leak following left atrial appendage closure with the LAmbre device-Data from a prospective multicenter clinical study.

BACKGROUND: In the present study, we sought to explore the incidence, risk factors, and clinical impact of peridevice leaks (PDLs), following LAmbre-assisted left atrial appendage closure (LAAC). METHODS: We performed transesophageal echocardiography (TEE) on patients participating in the LAmbre multicenter study, at Day 1 postimplantation, then at 3 and 12 months to assess PDL, device-related thrombus, left atrial appendage (LAA) thrombus, and left atrial thrombus. Clinical events were recorded during follow-up. RESULT: A total of 152 patients with atrial fibrillation successfully completed LAAC. At 3 months follow-up, 123 patients underwent TEE, with 21 (17%) of them presenting PDL. Among the 121 patients who underwent TEE at 12 months follow-up, 19 (15.7%) presented PDL. Patients with PDL exhibited larger LAA orifice diameters and larger device sizes compared to those in the no leak group. In addition, we found no significant differences in thromboembolic events between patients in the PDL and no leak groups. CONCLUSION: LAmbre-assisted LAA closure resulted in a relatively low PDL occurrence, and its rate decreased over time. In addition, PDL was more prominent in patients with larger LAA orifice diameter and larger device size. However, the condition was not associated with an increased risk for thromboembolic events.

3D printing for left atrial appendage closure: A meta-analysis and systematic review.

BACKGROUND: Three-dimensional printing (3D) has emerged as an alternative to imaging to guide left atrial appendage closure (LAAC) device sizing. AIMS: We assessed the usefulness of 3D printing compared to a standard imaging-only approach for LAAC. METHODS: We identified studies comparing an imaging-only with a 3D printing approach in LAAC. A fixed-effects meta-analysis was performed targeting a co-primary endpoint of disagreement in device sizing and leaks. RESULTS: Eight studies that assigned 283 participants to an imaging-only approach and 3D printing approach (145 patients) were included. 3D printing significantly reduced the risk of the co-primary endpoint (risk raio (RR) = 0.19; 95% confidence interval (CI) 0.09-0.37), with consistency across the studies (I2 = 0%). Individually, both device size disagreements [RR 0.13 (95% CI 0.06-0.29), P < 0.001] and leaks [RR 0.24 (95% CI 0.09-0.64) P = 0.004] were reduced under a 3D printing modeling strategy. CONCLUSION: Compared with an imaging-only strategy, 3D printing is associated with reduction in device size disagreements and leaks.

Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure.

BACKGROUND: In the U.S. Food and Drug Administration (FDA) clinical trials of left atrial appendage (LAA) closure, a postimplantation peridevice leak (PDL) of ≤5 mm (PDL≤5) was accepted as sufficient LAA "closure." However, the clinical consequences of these PDLs on subsequent thromboembolism are poorly characterized. OBJECTIVES: We sought to assess the impact of PDL≤5 on clinical outcomes after implantation of the Watchman device. METHODS: Using combined data from the FDA studies PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy), and CAP2 (Continued Access to PREVAIL), we assessed patients with successful device implantation for PDL by means of protocol-mandated transesophageal echocardiograms (TEEs) at 45 days and 1 year. Five-year outcomes were assessed as a function of the absence or presence of PDL≤5. RESULTS: The cohort included 1,054 patients: mean age 74 ± 8.3 years, 65% male, and CHA2DS2-VASc 4.1 ± 1.4. TEE imaging at 45 days revealed 634 patients (60.2%) without and 404 (38.3%) with PDL≤5, and 1-year TEE revealed 704 patients (71.6%) without and 272 (27.7%) with PDL≤5. The presence of PDL≤5 at 1 year, but not at 45 days, was associated with an increased 5-year risk of ischemic stroke or systemic embolism (adjusted HR: 1.94; 95% CI: 1.15-3.29; P = 0.014), largely driven by an increase in nondisabling stroke (HR: 1.97; 95% CI: 1.03-3.78; P = 0.04), while disabling or fatal stroke rates were similar (HR: 0.69; 95% CI: 0.19-2.46; P = 0.56). PDL≤5 was not associated with an increased risk of cardiovascular or unexplained death (HR: 1.20; P = 0.45) or all-cause death (HR: 0.87; P = 0.42). CONCLUSIONS: PDL≤5 at 1 year after percutaneous LAA closure with the Watchman device are associated with increased thromboembolism, driven by increased nondisabling stroke, but similar mortality. (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [PROTECT-AF; NCT00129545]; Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy [PREVAIL; NCT01182441]; Continued Access to PREVAIL [CAP2; NCT01760291]).

Evaluation of Multimodality LAA Leak Closure Methods Following Incomplete Occlusion: The LAA Leak Study.

BACKGROUND: Incomplete left atrial appendage (LAA) closure is an evolving topic of clinical significance and thromboembolic potential, with recent long-term studies suggesting lower cutoffs for relevant leak size. OBJECTIVES: The aim of this prospective observational study was to assess 3 different closure techniques for persistent peridevice leaks after incomplete LAA closure and compare their efficacy and safety outcomes. METHODS: We studied 160 patients (mean age 72 ± 9 years; 71% men) who underwent 1 of the 3 available modalities (detachable embolization coils, vascular plugs or septal occluders, and radiofrequency ablation) for residual central or eccentric leak closure. Both acute postprocedural success (closure or <1-mm leak at the end of the procedure) and closure at 1-year follow-up transesophageal echocardiography imaging were evaluated. RESULTS: Of 160 patients, 0.6%, 41.3%, and 58.1% had mild (1-2 mm), moderate (3-5 mm), and severe (≥5 mm) leaks, respectively. Baseline LAA closure type was 72.5% Watchman FLX, 16.3% Lariat, 5.6% surgical ligation, 1.9% AtriClip, and 1.9% Amulet. Successful closure (0- or <1-mm leak) was seen in 100% of patients in all cohorts following intervention, with overall complete closure (0-1 mm) or mild or minimal leaks (1-2 mm) on 1-year follow-up transesophageal echocardiography seen in 100% of the atrial septal occluder or vascular plug cohort, 85.9% of the coil cohort, and 83.3% of the radiofrequency ablation cohort (P < 0.001). Two patients (1.3%) experienced cardiac tamponade, and there were no deaths or other complications. CONCLUSIONS: Peridevice leaks can safely and effectively be closed using 3 different modalities depending on size and location.

Cardiac Computed Tomography for Left Atrial Appendage Occlusion: Acquisition, Analysis, Advantages, and Limitations.

Transcatheter left atrial appendage occlusion is increasingly used for stroke prevention in atrial fibrillation. The technique has proven effective and safe in randomized trials and multiple observational studies. The procedure is challenging due to the complex anatomy of the left atrial appendage; accurate cardiac imaging is essential for procedural guidance. Transesophageal echocardiography is the gold standard, but cardiac computed tomography (CT) has gained increasing interest within recent years. Cardiac CT offers high-resolution imaging allowing for preprocedural anatomic evaluation and device sizing, but may also be useful for exclusion of left atrial appendage thrombus, and follow-up assessment of residual peri-device leaks.