Concept: Left atrial appendage occlusion
Left atrial appendage closure (LAAC) using the Watchman device was FDA-approved as a stroke prevention alternative to warfarin for patients with non-valvular atrial fibrillation. However, clinical decision-making is confounded by the fact that while LAAC avoids the anticoagulant-related lifetime risk of bleeding, implantation is associated with up-front complications. Thus, enthusiasm for LAAC as a treatment option has been appropriately tempered, particularly as the therapy is introduced beyond the clinical trial sites into general clinical practice.
OBJECTIVES: The purpose of the study was to determine the efficacy and safety of left atrial appendage (LAA) closure via a percutaneous LAA ligation approach. BACKGROUND: Embolic stroke is the most devastating consequence of atrial fibrillation. Exclusion of the LAA is believed to decrease the risk of embolic stroke. METHODS: Eighty-nine patients with atrial fibrillation were enrolled to undergo percutaneous ligation of the LAA with the LARIAT device. The catheter-based LARIAT device consists of a snare with a pre-tied suture that is guided epicardially over the LAA. LAA closure was confirmed with transesophageal echocardiography (TEE) and contrast fluoroscopy immediately, then with TEE at 1 day, 30 days, 90 days, and 1 year post-LAA ligation. RESULTS: Eighty-five (96%) of 89 patients underwent successful LAA ligation. Eighty-one of 85 patients had complete closure immediately. Three of 85 patients had a ≤2-mm residual LAA leak by TEE color Doppler evaluation. One of 85 patients had a ≤3-mm jet by TEE. There were no complications due to the device. There were 3 access-related complications (during pericardial access, n = 2; and transseptal catheterization, n = 1). Adverse events included severe pericarditis post-operatively (n = 2), late pericardial effusion (n = 1), unexplained sudden death (n = 2), and late strokes thought to be non-embolic (n = 2). At 1 month (81 of 85) and 3 months (77 of 81) post-ligation, 95% of the patients had complete LAA closure by TEE. Of the patients undergoing 1-year TEE (n = 65), there was 98% complete LAA closure, including the patients with previous leaks. CONCLUSIONS: LAA closure with the LARIAT device can be performed effectively with acceptably low access complications and periprocedural adverse events in this observational study.
The purpose of this study was to investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients undergoing percutaneous LAA closure with the Watchman device (Atritech, Inc., Plymouth, Minnesota).
Routine left atrial appendage ligation during cardiac surgery may prevent postoperative atrial fibrillation-related cerebrovascular accident
- The Journal of thoracic and cardiovascular surgery
- Published over 6 years ago
The aim of the study was to determine whether routine left atrial appendage ligation in cardiac surgery would reduce the risk of postoperative atrial fibrillation-related cerebrovascular accident.
BACKGROUND: The multicenter PROTECT AF study was conducted to determine whether percutaneous left atrial appendage (LAA) closure with a filter device (Watchman) was noninferior to warfarin for stroke prevention in atrial fibrillation (AF). METHODS AND RESULTS: Patients (n = 707) with nonvalvular AF and at least one risk factor (age > 75, hypertension, heart failure, diabetes or prior stroke/TIA) were randomized to either the Watchman device (n = 463) or continued warfarin (n = 244) in a 2:1 ratio. After device implantation, warfarin was continued for ~45 days, followed by clopidogrel for 4.5 months and lifelong aspirin. Study discontinuation rates were 15.3% (71/463) and 22.5% (55/244) for the Watchman and warfarin groups respectively. The time in therapeutic range for the warfarin group was 66%. The composite primary efficacy endpoint included stroke, systemic embolism and cardiovascular death, and the primary analysis was by intention-to-treat. After 1,588 patient-years of follow-up (mean 2.3±1.1 years), the primary efficacy event rates were 3.0% and 4.3% (percent per 100-patient years) in the Watchman and warfarin groups, respectively (RR = 0.71, 95% CI 0.44-1.30%/y), meeting the criteria for non-inferiority (probability of non-inferiority > 0.999). There were more primary safety events in the Watchman group (5.5%/y, 95% CI 4.2-7.1%/y) than in the control group (3.6%/y; 95% CI 2.2-5.3%/y; RR 1.53, 95% CI 0.95-2.70). CONCLUSIONS: The “local” strategy of LAA closure is noninferior to “systemic” anticoagulation with Warfarin. PROTECT AF has, for the first time, implicated the LAA in the pathogenesis of stroke in AF. CLINICAL TRIAL REGISTRATION INFORMATION: Clinicaltrials.gov; Unique Identifier: NCT00129545.
We sought to develop and validate an intracardiac echocardiography (ICE) imaging strategy for evaluation of left atrial (LA) appendage (LAA) anatomy and function to clarify equivocal findings of LAA thrombus with transesophageal echocardiography (TEE).
The classic cut and sew maze is thought to reduce stroke, in part because of left atrial appendage (LAA) elimination. Multiple LAA elimination techniques have evolved with the introduction of new surgical treatment options for atrial fibrillation (AF), but the impact on stroke remains unknown. We studied the rate of late neurologic event (LNE) in the era of contemporary AF surgery.
BACKGROUND: The aims of this study were to evaluate the relationship of the CHA(2)DS(2)-VASc score and risk categories with transesophageal echocardiographic (TEE) risk factors for thromboembolism and to compare the CHA(2)DS(2)-VASc and CHADS(2) risk stratification schemes with respect to their ability to predict these risk factors in a multiethnic US population with nonvalvular atrial fibrillation. METHODS: Transesophageal echocardiograms of 167 patients (mean age, 66.3 ± 11.6 years; 146 men [87%]; 100 whites [60%]; 40 Hispanics [24%]; 27 blacks [16%]) with nonvalvular atrial fibrillation were retrospectively reviewed for smoke, sludge, thrombus, and left atrial appendage (LAA) emptying velocity ≤20 cm/sec. The patients' CHA(2)DS(2)-VASc and CHADS(2) risk scores and categories were also calculated. RESULTS: Any LAA abnormality, smoke, sludge, thrombus, and abnormal LAA emptying velocity were present in 45%, 38%, 13%, 3%, and 22% of patients, respectively. Heart failure (P < .001), age (P < .001 for age ≥75 vs ≤64 years, P = .013 for age 65-74 vs ≤64 years), and diabetes (P = .019) were independent predictors of LAA abnormalities, while ethnicity was not. The prevalence of TEE risk factors for thromboembolism increased with increasing CHA(2)DS(2)-VASc score and risk category. The CHADS(2) risk categories of 35 patients (21%) were upgraded by the CHA(2)DS(2)-VASc scheme. Using the latter scheme, fewer patients were classified as at intermediate risk compared with the CHADS(2) system (21 [13%] vs 46 [28%]). Patients classified as at low risk by either scheme had almost no TEE risk factors. Of 30 intermediate-risk patients by CHADS(2) score upgraded to high risk using CHA(2)DS(2)-VASc score, eight (27%) had at least one TEE risk factor for thromboembolism. C-statistics, sensitivity, and specificity for predicting any LAA abnormality were 0.607 (95% confidence interval, 0.549-0.665), 92.0%, and 28.9% for CHA(2)DS(2)-VASc score and 0.685 (95% confidence interval, 0.615-0.755), 81.3%, and 54.2% for CHADS(2) score. CONCLUSIONS: CHA(2)DS(2)-VASc score is associated with TEE risk factors for thromboembolism in a multiethnic US population. Compared with CHADS(2) score, it has increased sensitivity, decreased specificity, and lower ability for predicting TEE risk factors in this population.
Although the initial results of patients who have had left atrial appendage (LAA) occlusion devices implanted have been promising, there have been associated complications requiring surgical intervention. We report a case of a LAA occlusion device migrating into the left ventricle requiring cardiac surgery to retrieve it.
With its high prevalence and well-known thromboembolic risk, atrial fibrillation (AF) is a crucial component of the 2010-2014 actions plan, ongoing in France to reduce the annual incidence of stroke. The stroke risk is stratified well with the CHA(2)DS(2)-VASc score. With the current guidelines, most patients with AF should be on oral anticoagulant regimen, a treatment recognized as effective but whose bleeding risks limit its use. In clinical practice, warfarin is often not prescribed in patients with high risk of stroke. Thus, the exploration of new ways in preventing thromboembolic events in patients with AF is needed. Beside new more convenient anticoagulant agents, the exclusion of the left atrial appendage recognized as main source of thrombi, may be an alternative in patients with both high risk of thrombotic and haemorrhagic events. Surgical experience showed that the results depend on the quality of the exclusion. For over the past 10years, several percutaneous exclusion systems of the left atrial appendage have been developed. A randomized study (PROTECT AF) demonstrated the non-inferiority of the percutaneous exclusion in comparison with the warfarin. However, the place of this interventional therapy remains to be clarified, particularly the definition of the target population. This often multidisciplinary approach will have to be accompanied by a reduction of periprocedural complications, increase in rate of complete occlusion, and enough long clinical follow-up to assess the efficiency of this strategy.