Efficacy Of Left Atrial Appendage Closure Research Articles

P463 LEFT ATRIAL APPENDAGE CLOSURE VERSUS TRIPLE ANTITHROMBOTIC THERAPY IN PATIENTS WITH LONG TIME INDICATION TO DUAL ANTIPLATELET THERAPY

Abstract Introduction Recent guidelines suggest a limited duration of triple antithrombotic therapy (TAT) in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) at elevated bleeding risk. Indeed, in patients who are also at elevated thrombotic risk and with indication to prolonged dual antiplatelet therapy, percutaneous left atrial appendage closure (LAAC) could be a possible safe and effective option to prevent both bleeding and thrombotic events. Methods retrospective single–center study enrolling all consecutive patients between September 2012 and February 2020, comparing patients deemed at increased thrombotic and bleeding risk who received LAA percutaneous closure to avoid TAT before or after PCI with patients who received TAT after PCI. The aim of the study was to establish the safety and efficacy of LAAC in comparison to TAT. Results A total of 168 patients were included in the study: 56 underwent percutaneous LAAC while 112 were discharged in TAT. Median age was 75 (69–79). TAT patients had a CHA2DS2–VASc score of 4 (3–5) and a mean HAS–BLED score of 3 (2–3), whereas in LAAC patients the mean CHA2DS2–VASc was 4.9 (±1.5) and the mean HAS–BLED was 3.9 (±0.9); the difference in Score Points was statistically significant (p=0.001). The population who underwent LAAC was characterized by a remarkable procedural PCI complexity with a mean DAPT score of 1.4 (±1.3), with respect to the population discharged in TAT which was 0 (0–2). At follow–up (mean follow–up period in days: 727 [489–1000]), four bleeding episodes were recorded in LAAC population in comparison to 16 bleeding episodes observed in TAT population (12.6% vs. 15.4%; p–value=0.142): two bleeding episodes were major in LAAC group and five in TAT group (3.6% vs. 4.8%; p–value=1). One case of stroke (1.8%) occurred in LAAC population and two cases (1.8%) in TAT population (p=1.000). Conclusions In a single–centre retrospective study no significant difference was observed in terms of bleeding between TAT and LAAC, in patients at high ischemic and thrombotic risk with indication to prolonged dual antiplatelet therapy after PCI and anticoagulation for AF. Nevertheless, the non statistical trend to reduction of bleeding events in LAAC group might be explored in a larger study population.

Left atrial appendage closure in end-stage renal disease and hemodialysis: Data from a German multicenter registry.

Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild-to-moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end-stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials. The objective of this study is to evaluate safety and efficacy of LAAC in patients with ESRD. Patients undergoing LAAC were collected in a German multicenter real-world observational registry. A composite endpoint consisting of the occurrence of ischemic stroke/transient ischemic attack, systemic embolism, and/or major clinical bleeding was assessed. Patients with ESRD were compared with propensity score-matched patients without severe CKD. ESRD was defined as a glomerular filtration rate < 15 ml/min/1.73 m2 or chronic hemodialysis treatment. A total of 604 patients were analyzed, including 57 with ESRD and 57 propensity-matched patients. Overall, 596 endocardial and 8 epicardial LAAC procedures were performed. Frequency of major complications was 7.0% (42/604 patients) in the overall cohort, 8.8% (5/57 patients) in patients with ESRD, and 10.5% (6/57 patients) in matched controls (p = 0.75). The estimated event-free survival of the combined endpoint after 500 days was 90.7 ± 4.5% in patients with ESRD and 90.2 ± 5.5% in matched controls (p = 0.33). LAAC had comparable procedural safety and clinical efficacy in patients with ESRD and patients without severe CKD.

Long-term safety and efficacy of left atrial appendage closure in patients with small appendage orifices measured with transesophageal echocardiography.

The Watchman device is the most widely used occluder but is indicated in atrial fibrillation (AF) patients with a maximal left atrial appendage (LAA) orifice diameter between 17 and 31 mm. We aimed to compare the long-term safety and efficacy of left atrial appendageclosure (LAAC) between patients with a small LAA (<17 mm) and those with an indicated LAA (17-31 mm) measured by transesophageal echocardiography (TEE). A total of 369 AFpatients treated with LAAC between March 2015 and February 2019 were included and divided into two groups based on the maximal LAA orifice diameter measured by TEE: small LAA group (n = 22) and indicated LAA group (n = 347). Periprocedural complications and long-term clinical outcomes were compared. The Watchman device was successfully implanted in all patients. Mean device compression was higher in the small LAA group. Four patients (1.2%) in the indicated LAA group experienced pericardial effusion, and none experienced pericardial effusion in the small LAA group. Device-related thrombus was detected in one (4.5%) patient in the small LAA group and five (1.4%) in the indicated LAA group (p = .310). After a mean follow-up period of 4.1 ± 1.6 years, one patient in the small LAA group (4.5%; 1.1/100 person-years) and four in the indicated LAA group (1.2%; 0.3/100 person-years) suffered an ischemic stroke (p = .266). The safety and efficacy of LAAC with the Watchman device were comparable between patients with small and indicated LAA orifice diameters measured by TEE.

Percutaneous Left Atrial Appendage Closure With a Novel LAA Occluder for Stroke Prevention in Atrial Fibrillation.

More than 90% of thromboses originate from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation (NVAF). This study was designed to investigate the safety and efficacy of LAA closure with the Leftear device (Pulse Scientific) in NVAF patients. A prospective, multicenter, registry-based study was conducted in 200 NVAF patients with CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes, previous stroke/transient ischemic attack, vascular disease, female sex) scores≥2. The primary safety endpoint was defined as any serious adverse events. Efficacy was assessed by a primary composite endpoint of hemorrhagic or ischemic stroke, systemic embolism, and cardiac or unexplained death at 1 year of follow-up. The device was implanted in 196 patients, with 1-stop LAA closure combined with atrial fibrillation ablation implemented in 133 patients. The immediate success rate was 100%. There were serious adverse events in 9 patients (4.5%; 95%CI: 1.6%-7.4%), which mainly occurred in 1-stop LAA closure. All pericardial tamponades occurred in 6patientswith 1-stop LAA closure. No patient experienced a major bleeding event or acute device-related thrombus. During the 12-month follow-up period, the risk of the primary composite endpoint was 1.6% (95%CI: 0.3%-4.5%), and statistical noninferiority was achieved (the upper bound of 95%CI: 4.5%< the prespecified maximum annual incidence of 8.0%). Ischemic stroke occurred in 1 patient, 3 patients had incomplete LAA sealing, and no delayed device-related thrombus was found. LAA closure with the novel disc-like occluder shows high procedural success, satisfactory safety, andencouraging efficacy for stroke prevention in patients with NVAF. Compared with 1-stop LAA closure, single LAAclosure may be more tolerable. (A multicenter, single-arm clinical trial to evaluate the efficacy and safety of left atrial appendage system for left atrial appendage occlusion in patients with non-valvular atrial fibrillation; ChiCTR1900023035).

Impact of Echocardiographic Guidance on Safety and Efficacy of Left Atrial Appendage Closure: An Observational Study.

The aim of this study was to evaluate the impact of echocardiographic guidance on the safety and efficacy of left atrial appendage closure (LAAC). Expert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography or intracardiac echocardiography to guide LAAC. However, no evidence exists that intraprocedural echocardiographic guidance in addition to fluoroscopy improves the safety and efficacy of LAAC. Consecutive LAAC procedures performed at a high-volume center between January 2009 and October 2020 were stratified on the basis of intraprocedural imaging modalities, including fluoroscopic guidance (FG) only or intraprocedural echocardiographic guidance (EG) in addition to fluoroscopy. The primary safety endpoint was the composite of procedure-related complications occurring within 7days after the procedure. Technical success at 7days and at follow-up were secondary endpoints. Among 811 LAAC procedures, 549 (67.7%) and 262 (32.3%) were assigned to the FG and EG groups, respectively. After adjusting for confounders, EG remained associated with a lower rate of the primary safety endpoint (3.4% vs 9.1%; P=0.004; adjusted odds ratio [OR]: 0.31; 95% CI: 0.11-0.90; P=0.030). Technical success trended higher at 7days (92.1% vs 87.2%; P=0.065; adjusted OR: 1.68; 95%CI: 0.95-3.01; P=0.079) and was significantly improved with EG compared with FG (87.6% vs 79.9%; P=0.018; OR: 4.06; 95%CI: 1.60-10.27; P=0.003) after a median follow-up period of 4.9months (interquartile range: 3.4 months-6.2months). In a large cohort of consecutive LAACs, the use of intraprocedural echocardiography to guide intervention in addition to standard fluoroscopy was associated with lower risks for procedural complications and highermid-term technical success rates.

Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry.

The French left atrial appendage (LAA) closure registry (FLAAC) aimed to assess the safety and efficacy of LAA closure in daily practice. LAA closure has emerged as an alternative for preventing thromboembolic events (TE) in patients with non-valvular atrial fibrillation (NVAF). Clinical data in this field remains limited and few investigator-initiated, real-world registries have been reported. This nationwide, prospective study was performed in 36 French centers. The primary endpoint was the TE rate after successful LAA closure. The FLAAC registry included 816 patients with a mean age of 75.5 ± 0.3 years, mean follow-up of 16.0 ± 0.3months, high TE (CHA2 DS2 -VASc score: 4.6 ± 0.1) and bleeding risks (HAS-BLED score: 3.2 ± 0.05) and common contraindications to long-term anticoagulation (95.7%). Procedure or device-related serious adverse events occurred in 49 (6.0%) patients. The annual rate of ischemic stroke/systemic embolism was 3.3% (2.4-4.6). This suggests a relative 57% reduction compared to the risk of stroke in historical NVAF populations without antithrombotic therapy. By multivariate analysis, history of TE was the only factor associated with stroke/systemic embolism during follow-up (HR, 3.3 [1.58-6.89], p=0.001). The annual mortality rate was 10.2% (8.4-12.3). Most of the deaths were due to comorbidities or underlying cardiovascular diseases and unrelated to the device or to TE. Our study suggests that LAA closure can be an option in patients with NVAF. Long-term follow-up mortality was high, mostly due to comorbidities and underlying cardiovascular diseases, highlighting the importance of multidisciplinary management after LAA closure. NCT02252861.

Impact of Left Atrial Appendage Closure on LAA Thrombus Formation and Thromboembolism After LAA Isolation.

This study sought to evaluate the safety and effectiveness of electrical isolation of the left atrial appendage (LAAEI) as well as the status of left atrial appendage closure (LAAC) in these patients. Catheter-based LAAEI is increasingly performed for treatment of symptomatic atrial fibrillation and pulmonary vein isolation nonresponders. Previous studies indicate an increased incidence of thromboembolic events after LAAEI despite effective oral anticoagulation. Interventional LAAC may prevent cardioembolic events after LAAEI but data regarding safety, feasibility, and efficacy of LAAC in this clinical setting are scarce. Consecutive patients who underwent LAAEI at 2 German tertiary care hospitals were analyzed. A total of 270 patients underwent LAAEI by radiofrequency ablation in 255 (94.4%), cryoballoon ablation in 12 (4.4%), and by a combination of both techniques in 3 cases (1.1%). Stroke or transient ischemic attack occurred in 24 of 244 (9.8%) individuals with available follow-up. LAA thrombus formation was found in 53 patients (19.6%). A total of 150 patients underwent LAAC after LAAEI. No LAA thrombus was documented in any patient who underwent LAAC. Of the patients who underwent LAAEI, 67.6% were in sinus rhythm after a mean of 682.7 ± 61.7days. LAA flow after LAAEI but not arrhythmia recurrence was identified as an independent predictor of stroke and/or transient ischemic attack or LAA thrombus (p<0.0001). Sinus rhythm was documented in about two-third of patients undergoing LAAEI as treatment of therapy refractory atrial arrhythmias. LAAC potentially prevents LAA thrombus formation and thromboembolism.

LEFT ATRIAL APPENDAGE CLOSURE IN VALVULAR ATRIAL FIBRILLATION: A SAFE OPTION?

Left atrial appendage closure (LAAC) devices have become a valuable treatment option in the management of atrial fibrillation(AF). The seminal studies analyzing these devices have largely been restricted to non-valvular AF (NVAF). In this study, we analyze the outcomes and efficacy of LAAC in the

Feasibility and Safety of Left Atrial Appendage Closure Using the LAmbre Device in Patients with Nonvalvular Atrial Fibrillation with or Without Prior Catheter Ablation.

Left atrial appendage (LAA) closure (LAAC) has emerged as an alternative therapeutic approach to medical therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, complex LAA anatomy may preclude its use. LAmbre is a new, self-expanding LAA occluder, and is highly adaptable to different LAA morphologies. We explored the feasibility, safety, and efficacy of LAAC using LAmbre device in NVAF patients with or without prior catheter ablation (CA). LAAC using LAmbre device was applied in NVAF patients with (group C) or without (group N) prior CA. Transesophageal echocardiography (TEE) was performed at 3, and 12 months post-LAAC. Among 17 LAAC patients (group C, 6 & group N, 11), 4 cases were implanted with special type devices, 5 were implanted with large devices. Besides one case of cardiac tamponade (N group), there were two minor peri-procedural complications only. Successful sealing of the LAA was documented in all the patients (100%) by TEE both post LAAC and at 3 months. At 3 months, no residual flow was achieved in 11 patients (64.7%); six patients (35.3%) had residual flow < 5 mm. There was no device dislocation or leakage during the mean of 30 months follow up. At 545 days after LAAC, one patient in group C experienced sudden death. Baseline, peri-procedural, and follow-up characteristics were similar between two groups (P > 0.05). LAAC with LAmbre device, subsequent to prior CA for AF, can be performed successfully and safely. The design and distinguishing features of this device could be of help in patients with complex anatomy of LAA.

Impact of chronic kidney disease on Watchman implantation: experience with 300 consecutive left atrial appendage closures at a single center

The prevalence of chronic kidney disease (CKD) is high in patients with atrial fibrillation (AF). Left atrial appendage closure (LAAC) has been recognized as an efficient alternative to oral anticoagulation for the prevention of thromboembolic events in patients with non-valvular AF (NVAF); however, the long-term safety and efficacy of LAAC in patients with CKD remain unclear. This study was designed to provide data regarding the safety and efficacy of LAAC in NVAF patients with CKD. A real-world analysis of the safety and efficacy of LAAC was performed on a cohort of 300 NVAF patients with or without CKD who underwent LAAC using the Watchman (WM) device at our center. The patients with CKD (n = 151) were significantly older (77.0 ± 7.2 vs. 73.2 ± 7.8 years, respectively, P < 0.0001) and had a higher CHA2DS2-VASc score (4.3 ± 1.5 vs. 3.4 ± 1.4, respectively, P < 0.0001) and HAS-BLED score (4.0 ± 1.0 vs. 3.0 ± 1.0, respectively, P < 0.0001) than the patients without CKD (n = 149). However, there were no differences between groups with respect to the device implant success rate (98.7 vs. 97.3%, respectively, P = 0.446) or severe periprocedural complications within 7 days. The patients were followed up for 637 ± 398 days, and all patients received repeat transesophageal echocardiography (TEE). Thirteen (4.3%) device-related thrombi, 3 (1.0%) ischemic strokes, and 19 (6.3%) non-procedural major bleeding cases were documented, and there were no differences in these complications between groups. The observed rate of all thromboembolic events by Kaplan–Meier analysis decreased by 68.8% (CKD) and 48.6% (non-CKD); moreover, the observed annual rate of bleeding was reduced by 57.5% (CKD) and 11.4% (non-CKD). Our results indicate that LAAC with the WM device is safe and effective in preventing stroke in NVAF patients with and without CKD.

Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia.

Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width<17mm has not been evaluated. The goal of this study was to determine the acute and short-term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width<17mm. Thirty-two consecutive patients with a maximal LAA ostial width<17mm as determined by a screening transesophageal echocardiogram (TEE) underwent LAA closure with the WATCHMAN device between March 2015 and November 2016 at five medical centers, and were included in this study. Mean age, body mass index (BMI), and CHA2 DS2 -VASC score were 70.8 ± 8.6 years, 29.3 ± 6.5kg/m2 , and 3.9 ±1.2, respectively. At the screening TEE, mean maximal LAA ostial width and depth were 15.6 ± 0.6mm (range 14-16) and 23.2 ± 4.5mm (range 13-31), respectively. Successful LAA closure with the WATCHMAN device was achieved in 31 of 32 patients (97%), with no major complications. TEE performed 45 days after LAA closure demonstrated no peridevice leak>5mm and no device related thrombi. Warfarin was discontinued in all 31 patients 45 days after LAA closure. LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width<17mm.

Left Atrial Appendage Closure in Patients with Atrial Fibrillation and Previous Intracerebral Hemorrhage

Percutaneous left atrial appendage closure (LAAC) may be considered in patients with atrial fibrillation and contraindication for long-term anticoagulation. This study aimed to assess the safety and efficacy of LAAC followed by single antiplatelet therapy in patients with atrial fibrillation and previous spontaneous intracerebral hemorrhage (ICH). In this explorative, prospective, single-center study, consecutive patients who underwent LAAC because of previous spontaneous ICH over a period of 4 years were analyzed. Risks of ischemic strokes and hemorrhagic complications were estimated using the CHA2DS2-VASc and HAS-BLED scores, respectively. Single antiplatelet therapy was given for at least 6 months post implantation. Clinical follow-up included cardiological evaluations at 1, 3, 6, and 12 months, and neurological evaluations at 3 and 12 months. A total of 46 patients underwent LAAC with a mean follow-up of 12 ± 7 months. The observed annual rate of ischemic stroke was 4.35% compared with an expected rate of 7.23% according to the mean risk of the population based on CHA2DS2-VASc score, which translated into a 40% risk reduction. The observed annual rate of major bleeding was 4.35% compared with an expected rate of 8.05% according to the mean risk of the population based on HAS-BLED score, which translated into a 46% risk reduction. LAAC followed by single antiplatelet therapy is feasible as an alternative to oral anticoagulation in high-risk patients with previous ICH, with an acceptable periprocedural risk. Longer follow-up in a larger number of patients will be needed to establish the effectiveness of LAAC relative to direct oral anticoagulants.

EXPERIENCE OF PERCUTANEOUS LEFT ATRIAL APPENDAGE SUTURE LIGATION: RESULTS FROM A UNITED STATES MULTICENTER EVALUATION

The limited data regarding epicardial ligation of left atrial appendage (LAA) has discordant results regarding the safety. To delineate the safety and efficacy of LAA closure with the LARIAT device for LAA ligation. This is a retrospective, multicenter registry of 712 consecutive patients (mean

Short and long-term outcomes of percutaneous left atrial appendage suture ligation: Results from a US multicenter evaluation

Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results. The purpose of this study was to delineate the safety and efficacy of LAA closure with the LARIAT device. This is a multicenter registry of 712 consecutive patients undergoing LAA ligation with LARIAT at 18 US hospitals. The primary end point was successful suture deployment, no leak by intraprocedural transesophageal echocardiography (TEE), and no major complication (death, stroke, cardiac perforation, and bleeding requiring transfusion) at discharge. A leak of 2-5 mm on follow-up TEE was the secondary end point. LARIAT was successfully deployed in 682 patients (95.5%). A complete closure was achieved in 669 patients (98%), while 13 patients (1.8%) had a trace leak (<2 mm). There was 1 death related to the procedure. Ten patients (1.44%) had cardiac perforation necessitating open heart surgery, while another 14 (2.01%) did not need surgery. The risk of cardiac perforation decreased significantly after the introduction of a micropuncture (MP) needle for pericardial access. Delayed complications (pericarditis requiring >2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge) occurred in 34 (4.78%) patients, and the risk decreased significantly with the periprocedural use of colchicine. Follow-up TEE (n = 480) showed a leak of 2-5 mm in 6.5% and a thrombus in 2.5%. One patient had a leak of >5 mm. LARIAT effectively closes the LAA and has acceptable procedural risks with the evolution of the use of the micropuncture needle for pericardial access and the use of colchicine for mitigating the postinflammatory response associated with LAA ligation and pericardial access.

Superiority of Closure Devices over Conventional Sutures in Left Atrial Appendage Closure (LAAC)

Background: Although the major source of thrombi in patients with atrial fibrillation is the left atrial appendage (LAA), closure during open heart surgery is not recommended any more - most probably due to the high number of insufficient closures. We present a prospective, echo-controlled study on the efficacy of LAAC during open heart procedures comparing conventional suture techniques and new closure devices.

Safety and efficacy of transcatheter left atrial appendage closure using the Watchman device in Egyptian patients with nonvalvular atrial fibrillation

Abstract Background Atrial fibrillation (AF) is considered the major cause of stroke in the elderly. Alternative therapies to the anticoagulant therapy are warranted, particularly in patients who are ineligible or at high risk of bleeding. The left atrial appendage (LAA) is a prominent source of thrombi in nonvalvular AF, accounting for 90% of thrombi. As a result, surgical and transcatheter techniques have been explored to reduce the risk of stroke in patients with AF by occluding the LAA. Objectives To assess the safety and efficacy of LAA closure in patients with nonvalvular atrial fibrillation (AF) ineligible for warfarin therapy. Methods A prospective study that evaluated LAA closure with the Watchman device (Boston Scientific, Natick, MA; group A) in fifteen patients with nonvalvular AF and CHADS2 (congestive heart failure, hypertension, age ⩾75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ⩾1, who were considered ineligible for warfarin therapy. The primary efficacy endpoint was the combined events of ischemic/hemorrhagic stroke, systemic embolism and cardiovascular/unexplained death during a period of six months follow-up. Results Successful closure of the LAA using the Watchman device was achieved in 15 patients (100%). The mean age was found to be 67.9 ± 9 years with 40% of them being males. No device or procedure related adverse events were detected. The mean CHADS2 score was 2.4 ± 0.8, while the mean CHA2DS2-VASC score was 4.4 ± 1.0. After a mean period of 8 ± 2 months of follow-up, no device dislodgement or device-related thrombi were documented. The all-cause stroke (ischemic and hemorrhagic) and systemic embolism were 0%. The device and procedure related mortality was found to be 0%. Only one patient died after 8 months of device implantation from pneumonia. Conclusion LAA closure with the Watchman device can be safely performed, and may be a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation or with high risk of bleeding.

0240: Percutaneous left atrial appendage closure for stroke patients with nonvalvular atrial fibrillation and contraindication for oral anticoagulation

The PROTECT AF trial previously demonstrated that left atrial appendage closure (LAAC) was non inferior to warfarin in patients with nonvalvular atrial fibrillation (NVAF). However, this trial included patients eligible for anticoagulation therapy who received warfarin for 6 weeks after device implantation. The purpose of the present study was to assess the safety and efficacy of LAAC for stroke patients with NVAF and contraindication for anticoagulation. Consecutive patients with a previous ischemic or hemorrhagic stroke, NVAF and contraindication for anticoagulation underwent LAAC with the Amplatzer Cardiac Plug device between July 2010 and July 2013 in a French university hospital. Follow-up included clinical evaluation at 3 and 12 months, and a cardiac computed tomography (CT) at 3 months. Single-antiplatelet therapy was prescribed after the procedure for a minimum of 3 months and stopped if the control cardiac CT demonstrated complete LAA exclusion. RESULTS: 26 patients (age 73±8 years) were included. The mean CHA 2 DS 2 -VASc and HAS-BLED scores were 4±1.5 and 4±0.8, respectively. The main contraindications for anticoagulation were: intracerebral hemorrhage while receiving anticoagulation (62%), ischemic stroke with large hemorrhagic transformation (15%) and probable cerebral amyloid angiopathy (8%). The procedure was successful in 100%. Procedure-related complications were serious pericardial effusion (3.8%) and femoral bleeding (7.7%). During a mean follow-up of 8.6 (3-16) months, ischemic stroke occurred in 2 patients (7.7%), after antiplatelet therapy was stopped for one of them. One patient died of an intracranial hemorrhage. LAAC followed by a single antiplatelet therapy could be a reasonable alternative for stroke patients with NVAF and contraindication for anticoagulation. Lifelong rather than short-term single antiplatelet therapy should be prescribed after the procedure for patients at high cardio-vascular risk.

Feasibility of closed-chest ligation of the left atrial appendage in humans

Atrial fibrillation is associated with an increased risk of embolic events. The left atrial appendage (LAA) is believed to be an incubator for thrombus formation. LAA exclusion has been advocated to potentially reduce embolic events arising from the LAA. The aim of the study was to determine the feasibility of a closed-chest surgical suture ligation of the LAA in man. Thirteen patients undergoing either mitral valve surgery (n = 2) or electrophysiological study and radiofrequency catheter ablation for atrial fibrillation (n = 11) underwent ligation of the LAA with the LARIAT snare device. In patients having an ablation procedure, pericardial access was obtained prior to the patients undergoing radiofrequency catheter ablation. After transseptal catheterization, endocardial and epicaridal magnet-tipped guide wires were positioned under fluoroscopic guidance to stabilize the LAA. Transesophageal echocardiography (TEE) was used as guidance for positioning a marker balloon at the ostium of the LAA. An over-the-wire approach was used to guide the LARIAT snare device over the LAA to allow closure and suture ligation of the LAA. TEE and contrast fluoroscopy were used to confirm acute closure of the LAA. Both mitral valve replacement (MVR) patients had complete closure of the LAA determined by visual inspection. Ten of 11 patients having ablation underwent a successful closed-chest LAA ligation procedure with TEE and contrast fluoroscopy verification of closure of the LAA. Only one of 11 procedures was terminated owing to the lack of echocardiography guidance of the snare over the marker balloon. One patient with pectus excavatum did have ligation of his LAA; however, a thorascopic procedure was required to remove the snare from the LAA owing to compression of the LARIAT by the concave sternum. There were no other significant complications. Catheter-based surgical suture ligation of the LAA is feasible in humans. This novel catheter approach may be appropriate for patients with atrial fibrillation who are ineligible for anticoagulation therapy. Further investigation is needed to demonstrate the long-term safety and efficacy of LAA closure.