Transseptal Removal of a Destabilized and Displaced Left Atrial Appendage Closure Device; to Touch or Not to Touch!

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Feasibility and clinical efficacy of left atrial ablation for the treatment of atrial tachyarrhythmias in patients with left atrial appendage closure devices.

The PROTECT AF and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage (LAA) closure device is a reasonable alternative to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the USA and Europe. We conducted the SALUTE trial to confirm the safety and efficacy of the LAA closure therapy for patients with NVAF in Japan. A total of 54 subjects (including 12 Roll-in) with NVAF who had a CHA2DS2-VASc score ≥2 were enrolled. All subjects were successfully implanted with the LAA closure device. No serious adverse events related to the primary procedure-safety endpoint occurred. The 2nd co-primary endpoint was a composite of all stroke, systemic embolism and cardiovascular/unexplained death. One ischemic stroke (1/42) occurred during the 6-month follow-up. The effective LAA closure rate defined as the 3rd co-primary endpoint was 100% (42/42) at both 45-day and 6-month follow-up. The procedural safety and 6-month results from the SALUTE trial demonstrated that the LAA closure device was safe and effective, similar to the results of large-scale randomized clinical trials, and provides a novel perspective of LAA closure for Japanese patients with NVAF in need of an alternative to long-term oral-anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134).

Percutaneous Retrieval of Left Atrial Appendage Closure Devices With an EndoscopicGraspingTool.

Blood clots (90%) originate from the left atrial appendage (LAA) in non-valvular atrial fibrillation patients and are a major cause of embolic stroke. Long-term anticoagulation therapy has been used to prevent thrombus formation, but its use is limited in patients at a high risk for bleeding complications. Thus, left atrial appendage closure (LAAC) devices for LAA occlusion are well-established as an alternative to the anticoagulation therapy. However, the anticoagulation therapy is still required for at least 45 days post-implantation to bridge the time until complete LAA occlusion by neoendocardium coverage of the device. In this study, we applied an endothelium-mimicking nanomatrix to the LAAC device membrane for delivery of nitric oxide (NO) to enhance endothelialization, with the goal of possibly being able to reduce the duration of the anticoagulation therapy. The nanomatrix was uniformly coated on the LAAC device membranes and provided sustained release of NO for up to 1 month in vitro. In addition, the nanomatrix coating promoted endothelial cell proliferation and reduced platelet adhesion compared to the uncoated device membranes in vitro. The nanomatrix-coated and uncoated LAAC devices were then deployed in a canine LAA model for 22 days as a pilot study. All LAAC devices were not completely covered by neoendocardium 22 days post-implantation. However, histology image analysis showed that the nanomatrix-coated LAAC device had thicker neoendocardium coverage compared to the uncoated device. Therefore, our in vitro and in vivo results indicate that the nanomatrix coating has the potential to enhance endothelialization on the LAAC device membrane, which could improve patient outcomes by shortening the need for extended anticoagulation treatment.

The "Left Atrial Appendage Closure (LAAC) Device" is specifically designed to address the problem of stroke prevention in patients with atrial fibrillation (AF). In individuals with AF, the heart's atria (upper chambers) do not beat effectively, allowing blood to pool and potentially form clots, particularly in the left atrial appendage (LAA). These clots can then travel to the brain, causing a stroke. The purpose of the Left Atrial Appendage Closure Device is to mechanically seal off the left atrial appendage, preventing blood clots from forming there and reducing the risk of stroke in patients with atrial fibrillation who are at high risk of stroke but cannot tolerate long-term anticoagulation therapy. Hence Patients with atrial fibrillation frequently develop thrombus in the Left Atrial Appendage (LAA), which significantly increases their risk of stroke. LAA closure devices block the appendage, providing a percutaneous method of lowering this risk. With an emphasis on current developments, this research article examines the history, development effectiveness, delivery & deployment and safety of LAA closure devices via in-vitro simulation testing with controlled conditions.

Percutaneous approaches for retrieval of an embolized or malpositioned left atrial appendage closure device: A multicenter experience

Background: Direct current cardioversion (DCCV) is a standard intervention for restoring sinus rhythm in atrial fibrillation (AF). Left atrial appendage closure (LAAC) devices provide an alternative to anticoagulation (AC) for stroke prevention in select AF patients, but their effectiveness in mitigating thromboembolic complications during and after DCCV remains uncertain. This study evaluates the outcomes of DCCV in patients with LAAC devices in those receiving AC and those who are not. Methods: This was a retrospective observational cohort study using de-identified electronic health records from the TriNetX Research Network, including 103 healthcare organizations across the United States. The study included patients who underwent DCCV at least 6 months after LAAC device implantation. Patients with prior stroke, transient ischemic attack (TIA), hypertrophic cardiomyopathy, deep vein thrombosis, or pulmonary embolism were excluded. The primary exposure was AC use from 1 day prior to 1 month post-DCCV. The primary thromboembolic outcome was a composite of stroke, TIA, and arterial thromboembolism. The primary bleeding outcome was a composite of gastrointestinal, intracranial, genitourinary, and other bleeding events. Follow-up time was 1 year. Propensity score matching (1:1) was used to control for confounders including age, sex, hypertension, heart failure, ischemic heart disease, and diabetes. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. Results: Of 1,295 patients identified, 925 received AC and 370 did not. After propensity score matching, 364 patients remained in each group. The mean age was 73.6 ± 8.1 years and 62% were male. At 1 year, the composite thromboembolic event rate was 3.3% in the AC group and 3.8% in the non-AC group (RR 0.86; 95% CI 0.40–1.83; p=0.690). Bleeding events occurred more frequently in the AC group (18.7%) than in the non-AC group (12.9%) (RR 1.45; 95% CI 1.03–2.04; p=0.033). Conclusions: In patients with LAAC devices undergoing DCCV, the omission of routine periprocedural AC did not increase thromboembolic risk but was associated with fewer bleeding complications. Selective use of AC may be appropriate, especially when a stable device seal is confirmed. Further prospective studies are warranted to define standardized management protocols.

Left atrial appendage and pulmonary artery anatomic relationship by cardiac-gated computed tomography: Implications for late pulmonary artery perforation by left atrial appendage closure devices

BackgroundAlthough left atrial appendage (LAA) anatomy and topographic relations are well understood, little is known about the impairment of neighboring structures (NBS) by an implanted left atrial appendage closure (LAAC) device. This prospective longitudinal observational study for the first time describes distances of implanted LAA closure (LAAC) devices to NBS using a standardized imaging protocol of cardiac computed tomography angiography (cCTA).HypothesiscCTA imaging is an eligible tool for post‐implantation evaluation of LAAC devices and their relation to neighboring structures.MethodscCTA data sets of consecutive patients 6 months after successful LAAC were acquired on a third generation dual‐source CT system and reconstructed with a slice thickness of 0.5 mm. The standardized multi‐planar reconstruction LAA occluder view for post‐implantation evaluation (LOVE) algorithm was used to measure the distances to NBS in relation to LAA morphology and implanted LAAC devices.ResultsA total of 48 patients (median age 80 years, 25% female) were included. Left upper pulmonary vein and circumflex artery were generally closest to occlusion devices (median 2.9 and 2.8 mm, respectively). AMPLATZER AMULET devices were closer to the mitral valve annulus than WATCHMAN devices (6.6 mm (inter quartile range [IQR] 4.9‐8.6) vs 10.9 mm (IQR 7.4‐14.0), P = 0.001). Distances to the left upper pulmonary vein were affected by LAA morphology, with cauliflower type having the closest proximity (1.7 mm [IQR 1.0‐3.4], P = 0.048).ConclusionA standardized cCTA imaging protocol is an eligible tool to accurately measure distances to NBS. Left upper pulmonary vein and circumflex artery are closest to LAAC devices and could thus be most prone to impairment.

Atrial fibrillation (AF) is the most common sustained heart rhythm disorder, with an estimated prevalence of 0.4% to 1% in the general population. In addition, AF is responsible for approximately 15% to 20% of ischemic strokes. Device interventions to prevent strokes in patients with AF are nonsurgical procedures to block blood clots (thrombus) from forming and traveling out of the heart. The “quivering” rather than normal contractions of the upper chambers of the heart (atria) from disorganized electric activity (AF) leads to blood stasis and thrombus formation. A small cul-de-sac called the left atrial appendage (LAA) is especially prone to thrombus formation (Figure 1). In AF patients without valvular heart disease, almost all thrombus originates from the LAA. The thrombus travels to and block major vessels in the body. Blocking blood vessels to the brain leads to strokes and transient ischemic attacks (mini-strokes). Figure 1. Transesophageal echocardiogram image of a thrombus in the left atrial appendage (dotted line). Patients with the following risk factors have a higher stroke risk: heart failure, hypertension, age of 75 years or greater, diabetes mellitus, and prior history of strokes or mini-strokes. These are often combined to form the CHADS2 score. The more risk factors you have, the higher your CHADS2 score and risk of stroke are. Blood-thinning medications (anticoagulants) such as warfarin, dabigatran, rivaroxaban, and apixaban are effective stroke prevention therapies. The risks of bleeding associated with long-term anticoagulation led to the development of permanent treatment options like surgery. Closures by sutures (ligation) and removal (amputation) of the LAA …

Introduction Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding. Areas covered This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized. Furthermore, the future perspectives of Watchman will be discussed. Expert opinion LAAC with Watchman appears a promising, safe, and effective alternative to OAC. Ongoing and future studies to consolidate the position of Watchman should focus on comparative safety and efficacy of different LAAC devices, patient selection, various post-procedural antithrombotic regimens, head-to-head comparisons with NOAC, better understanding of device-related thrombus, and the role of the LAA in the propagation of non-valvular AF. This research may attribute to a paradigm shift in which LAAC no longer serves as a ’last resort’ treatment for AF patients ineligible for OAC but may serve as a second-line or even first-line treatment option for AF patients.

Left atrial appendage (LAA) closure devices are alternative treatments recently approved for patients with atrial fibrillation. Due to the novelty of these devices, limited postapproval surveillance data on LAA closure devices have been published. Thus, we analyzed the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to report these findings. The primary endpoint was final event outcome, and secondary endpoints included management strategies of reported events.

Atrial fibrillation-related stroke is a leading cause of morbidity and mortality. The comparative effectiveness and safety of left atrial appendage closure (LAAC) devices, compared with one another and with anticoagulation, is unclear. We conducted a systematic review and network meta-analysis (NMA) of all clinical trials comparing the Watchman and Amplatzer Amulet LAAC devices with each other or with warfarin or direct oral anticoagulants (DOACs). The primary comparison was between LAAC devices with secondary comparisons to anticoagulation. The primary effectiveness outcomes were any stroke and all-cause death. Safety outcomes included any thromboembolism, device embolization, and pericardial effusion. There were 476 articles identified from the search and 6 eligible RCTs were included (n = 3666). There was no difference in the risk of stroke with Amulet versus Watchman (RR = 1.48, 95% CI: 0.64-3.46, I2 = 41.3%), nor in the risk of death (RR = 1.00, 95% CI: 0.59-1.70, I2 = 45.0%). Risk of thromboembolism was not significantly different with Amulet versus Watchman (RR = 0.73, 95% CI: 0.18-2.97, I2 = 0%), nor was risk of device embolization (RR = 2.29, 95% CI: 0.71, 7.43, I2 = 0%). Both devices exhibited increased risk of pericardial effusion compared with warfarin, with Amulet at highest relative risk (RR = 27.08, 95% CI: 3.53-207.98, I2 = 0%) followed by Watchman (RR = 12.79, 95% CI: 1.73-94.85, I2 = 0%). Amulet also carried higher relative risk of pericardial effusion than Watchman (RR = 2.12, 95% CI: 1.45-3.09). In this NMA, the Amulet and Watchman LAAC devices were associated with similar risks for stroke, mortality, thromboembolism, and device embolization. Pericardial effusion risk was higher with Amulet than Watchman.

A 72-year-old man who underwent a left atrial appendage (LAA) closure device 2 years ago presented with atrial flutter with rapid ventricular rate and was referred for cardioversion. Precardioversion transesophageal echocardiogram showed left atrial thrombus and therefore the procedure was aborted. Currently, there is no guideline on imaging surveillance or anticoagulation in patients with LAA closure device who develop intracardiac thrombus after the initial 6-month surveillance period.