Left Atrial Appendage Closure Registry Research Articles

Pericardial Effusion After Left Atrial Appendage Closure: Timing, Predictors, and Clinical Impact

BackgroundPericardial effusion (PE) is the most common serious left atrial appendage closure (LAAC) complication, but its mechanisms, time course, and prognostic impact are poorly understood. ObjectivesThis study sought to assess the frequency, timing, predictors and clinical impact of PE after LAAC. MethodsData on consecutive patients undergoing percutaneous LAAC between 2009 and 2022 were prospectively collected including the 1-year follow-up. Both single (Watchman 2.5/FLX, Boston Scientific) and double (Amplatzer Cardiac Plug or Amulet, St. Jude Medical/Abbott) LAAC devices were used. An imaging core laboratory adjudicated the PEs and categorized them as early (≤7 days) and late (8-365 days). Logistic regression analysis was used to identify predictors of early and overall PE. ResultsOf 1,023 attempted LAAC procedures, PE was observed in 44 (4.3%) patients; PE was categorized as early in 34 (3.3%) and late in 10 (0.9%) patients. The majority of PEs occurred within 6 hours after LAAC (n = 25, 56.8%) and were clinically relevant (n = 28, 63.6%). Independent predictors of early PE were double-closure left atrial appendage devices (adjusted OR: 8.20; 95% CI: 1.09-61.69), female sex (adjusted OR: 3.41; 95% CI: 1.50-7.73), the use of oral anticoagulation (OAC) at baseline (adjusted OR: 2.60; 95% CI: 1.11-6.09), and advanced age (adjusted OR: 1.07; 95% CI: 1.01-1.23), whereas female sex and OAC at baseline remained independent predictors of overall PE. ConclusionsIn this large LAAC registry, PE was observed in <1 in 20 patients and usually occurred within 6 hours after procedure. The majority of early PEs were clinically relevant and occurred in the Amplatzer Cardiac Plug/Amulet procedures. Independent predictors included the use of double-closure devices, female sex, OAC at baseline, and advanced age. (LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure; NCT04628078)

Steerable Delivery Sheath for Left Atrial Appendage Closure in Patients With Severely Enlarged Left Atria

BackgroundEnlarged left atrium (LA) is frequently identified in patients who undergo left atrial appendage closure (LAAC) and negatively affects the device’s final position and intervention results. Steerable delivery sheath (SDS) could represent an option to overcome these difficulties. We aimed to assess the feasibility of SDS-assisted procedures and compare their efficacy to the standard sheath strategy. MethodsThis study analyzed patients from our institution’s LAAC registry who had severe LA enlargement on CT scan (index LA volume >90 mL/m2) and underwent AMULET device implantation between January 2019 and March 2023. The patients underwent postprocedural CT scan to assess the device’s position, residual LAA filling, and peridevice leaks. ResultsA total of 195 consecutive patients were screened and 47 (24%) met the inclusion criteria (n = 22 SDS group; n = 25 standard group). There was no difference in baseline clinical, anatomical, or procedural characteristics. The procedural technical success (96%) and complication rates (9% vs 4%; P = .59) were comparable in both groups. Post-LAAC CT scans were obtained in 19 SDS group and 22 standard group patients. We observed significantly lower incidences of residual patent LAA (26% vs 72%; P = .005), peridevice leaks (16% vs 64%; P = .004), and off-axis device position (0% vs 27%; P = .02) in SDS compared to the standard group, suggesting a better LAA sealing. ConclusionsSevere LA enlargement was frequent among LAAC candidates. In this situation, the use of SDS appears feasible and safe, leading to more efficient closures on follow-up imaging without a higher risk of periprocedural complications.

Watchman device migration and embolization: A report from the NCDR LAAO Registry.

Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization (DME) requiring percutaneous or surgical retrieval. We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and postdischarge events were assessed among patients with 45-day follow-up. Of 120 278 Watchman procedures, the in-hospital DME rate was 0.07% (n = 84) and surgery was commonly performed (n = 39). In-hospital mortality rate was 14% among patients with DME and 20.5% among patients who underwent surgery. In-hospital DME was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p < .0001), with Watchman 2.5 versus Watchman FLX devices (0.08% vs. 0.04%, p = .0048), with larger LAA ostia (median 23 vs. 21 mm, p = .004), and with a smaller difference between device and LAA ostial size (median difference 4 vs. 5 mm, p = .04). Of 98 147 patients with 45-day follow-up, postdischarge DME occurred in 0.06% (n = 54) patients and cardiac surgery was performed in 7.4% (n = 4) of cases. The 45-day mortality rate was 3.7% (n = 2) among patients with postdischarge DME. Postdischarge DME was more common among men (79.7% of events but 58.9% of all procedures, p = .0019), taller patients (177.9 vs. 172 cm, p = .0005), and those with greater body mass (99.9 vs. 85.5 kg, p = .0055). The rhythm at implant was less frequently AF among patients with DME compared to those without (38.9% vs. 46.9%, p = .0098). While Watchman DME is rare, it is associated with high mortality and frequently requires surgical retrieval, and a substantial proportion of events occur after discharge. Due to the severity of DME events, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance.

Watchman device migration and embolization: a report from the NCDR LAAO registry

Abstract Background Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization requiring percutaneous or surgical retrieval. Purpose To report rates and characteristics of in-hospital and post-discharge Watchman device migration and embolization events in the United States. Methods We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and post-discharge events were assessed among patients with 45-day follow-up. Results Of 120,278 Watchman procedures, device migration or embolization occurred in 0.07% of patients (n=84) during the index hospitalization and surgery was performed in 39 patients. The in-hospital mortality rate was 14% among patients with device migration or embolization and 20.5% among patients who underwent surgery. In-hospital migration or embolization was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p&amp;lt;0.0001), with first-generation Watchman versus next-generation Watchman FLX devices (0.08% vs. 0.04%, p=0.0048), with larger LAA ostia (median 23 mm vs. 21 mm, p=0.004), and with a smaller difference between device and LAA ostial size (median difference 4 mm vs. 5 mm, p=0.04). There were no differences by age, sex, hospital type, hospital size, or teaching versus non-teaching status. Of 98,147 patients with 45-day follow-up, device migration or embolization after discharge occurred in 0.06% (n=54) patients and cardiac surgery was performed in 7.4% (n=4) of cases. The 45-day mortality rate was 3.7% (n=2) among patients with post-discharge device migration or embolization. Post-discharge migration or embolization was more common among men (79.7% of events but 58.9% of all procedures, p=0.0019), taller patients (177.9 cm vs. 172 cm, p=0.0005), and those with greater body mass (99.9 kg vs. 85.5 kg, p=0.0055); in contrast to in-hospital events, there were no differences in hospital volume, device characteristics, or LAA characteristics. Conclusions Watchman device migration or embolization is rare but associated with high mortality (Figure 1) and frequently requires surgical retrieval. A substantial proportion of all device migration or embolization cases occur after discharge and different patient and procedure characteristics are associated with in-hospital versus post-discharge cases. Given the morbidity and mortality associated with device migration or embolization, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health

Clinical benefit of left atrial appendage closure in octogenarians.

OBJECTIVESWhether left atrial appendage closure (LAAC) in octogenarians yield similar net clinical benefit compared to younger patients, was the purpose of the present study.METHODSTwo real-world LAAC registries, enrolling 744 consecutive Amplatzer and Watchman patients from 2009 to 2018, were retrospectively analyzed.RESULTSAll events are reported per 100 patient-years. Two hundred and sixty one octogenarians and 483 non-octogenarians with a mean follow-up of 1.7 ± 1.3 and 2.3 ± 1.6 years, and a total of 1,502 patient-years were included. Octogenarians had a higher risk for stroke (CHA2DS2-VASc score: 5.2 ± 1.2 vs. 4.3 ± 1.7, P < 0.0001) and bleeding (HAS-BLED score: 3.3 ± 0.8 vs. 3.1 ± 1.1, P = 0.001). The combined safety endpoint of major periprocedural complications and major bleeding events at follow-up was comparable (30/446, 6.7% vs. 47/1056, 4.4%; hazard ratio [HR] = 1.2; 95% confidence interval [CI]: 0.73−1.98;P = 0.48) between the groups. The efficacy endpoint of all-cause stroke, systemic embolism, and cardiovascular/unexplained death occurred more often in octogenarians (61/446, 13.7% vs. 80/1056, 7.6%; HR = 7.0; 95% CI: 4.53−10.93;P < 0.0001). Overall, octogenarians had a lower net clinical benefit, i.e., the composite of all above mentioned hazards, from LAAC compared to younger patients (82/446, 18.4% vs. 116/1056, 11.0%; HR = 4.6; 95% CI: 3.11−7.0;P < 0.0001). Compared to the anticipated stroke rate, the observed rate decreased by 41% in octogenarians and 53% in non-octogenarians. The observed bleeding rate was reduced by 10% octogenarians and 41% non-octogenarians. CONCLUSIONSLAAC can be performed with similar safety in octogenarians as compared to younger patients. On the long-term, it both reduces stroke and bleeding events, although to a lesser extent than in non-octogenarians.

Low haemoglobin is associated with increased risk of complications in left atrial appendage closure patients

Abstract Introduction Left atrial appendage closure is associated with a relevant procedural complication rate. Baseline risk factors, such as pre-procedural lab results, may identify patients that develop acute complications. Methods We performed a retrospective analysis of the impact of baseline characteristics and preprocedural lab results on the acute procedural outcome in patients undergoing left atrial appendage closure from the Austrian Left Atrial Appendage Closure Registry between 2010 and 2019. The endpoint for procedural complications was defined as death, stroke, major bleeding, necessity for intensive care, other complications requiring invasive interventions or failure to implant the device. We also evaluated a modified endpoint with the exclusion of bleeding events. Logistic regression was performed using stepwise approach (backward method with p_out = 0.1) and forced inclusion of age, left-ventricular function and kidney function. Results A total of 320 consecutive patients from 9 centres with a median age of 75 years (36.6% female) were included. Seventy-eight percent had a history of bleeding and 35% had a history of stroke. Median CHA2DS2-VASc score was 5 (interquartile range, 3–5) and median HAS-BLED score was 3 (2–4). Procedural complications occurred in 15.3% of cases. Low haemoglobin and low activated partial thromboplastin time were associated with an increased complication rate. Other significant baseline factors were liver disease, absence of intracranial haemorrhage and severe aortic stenosis. In multivariate analysis, low haemoglobin remained a significant predictor, even after adjustment for age, left-ventricular function and kidney function (Table). In the modified procedural complication endpoint excluding major bleeding events (14.1%), low haemoglobin remained a significant predictor (haemoglobin 11.9±2.0 vs. 12.8±2.0 g/dL in patients with vs. without modified endpoint, p=0.013). A baseline haemoglobin lower than 12 g/dL was present in 39.4% and it increased relative risk of procedural complications by 89% (21.4 vs. 11.3% in patients with reduced vs. normal haemoglobin), and risk of complications without bleeding by 92% (19.8 vs. 10.3%). Conclusion Low baseline haemoglobin is independently associated with a higher complication rate after left appendage closure compared to patients with normal haemoglobin levels, even in a modified endpoint excluding bleeding and requirement for transfusion. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Boston Scientific - unrestricted grant Table 1

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.

Atrial fibrillation evolution and rhythm control strategy following left appendage closure: new insights from the prospective FLAAC registry

BackgroundPercutaneous left atrial appendage (LAA) closure is an alternative to oral anticoagulation (OAC) for atrial fibrillation (AF) patients with high thromboembolism risk, particularly with contraindications to OAC. The LAA itself could possess proarrhythmogenic properties. As patients undergoing LAA closure could be candidates for cardioversion or ablation, we aimed to evaluate AF disease progression following LAA closure and the outcome of patients undergoing a rhythm control strategy after the procedure.MethodsThe prospective multicenter French Nationwide Observational LAA Closure Registry (FLAAC) comprises 33 French interventional cardiology departments. Patients were included if they fulfilled the following criteria: history of non-valvular AF, successful LAA closure and long-term ECG follow-up.ResultsA total of 331 patients with successful LAA closure were enrolled in the study. Patients mean age was 75.4 ± 0.5 years. The study population was characterized by a high thromboembolic risk (CHA2DS2-VASc score: 4.5 ± 0.1) and frequent comorbidities. The median follow-up was 11.9 months. One hundred and nineteen (36.0%) patients were in sinus rhythm (SR) at baseline. Among SR patients, documented AF was observed in 16 (13.4%) patients whereas 15 (7.1%) patients in AF at baseline restored SR, at the end of follow up. Finally, only 13 patients (4%) underwent procedures to restore SR without complications during the follow-up.ConclusionsThe vast majority of patients undergoing LAA closure have the same AF status at baseline and one year after the index procedure. During the follow-up, a very small proportion (4%) of our population underwent procedures to restore SR without complications whatever the post-procedural antithrombotic strategy was.

Indications and Outcome in Patients Undergoing Left Atrial Appendage Closure—The Austrian LAAC Registry

Background: Complete real-world data on the indications and outcomes of left atrial appendage closure (LAAC) outside of clinical trials are rare. In this study, we stratified patients undergoing LAAC by indication groups. Methods: This analysis of the national multicentre Austrian LAAC Registry comprised all patients that underwent LAAC up until 2018 at the currently active centres in Austria. The baseline characteristics, procedural details and outcomes between the following indication groups were compared: bleeding as an indication for LAAC (“bleeding” group) vs. thromboembolism despite oral anticoagulation (OAC; “thromboembolism” group) vs. an intolerance to OAC for reasons other than the above (“other” group). Results: The analysis included 186 patients, with 59.7% in the “bleeding” group, 8.1% in the “thromboembolism” group and 32.2% in the “other” group. The CHADS2 score was the highest in the “thromboembolism” group and the HAS-BLED score was the highest in the “bleeding” group. The procedural outcomes were similar between groups (implantation success, 97.3%), with major complications occurring in 7.0% of patients. One-year survival free from stroke, bleeding or LAAC-associated hospitalisation was 83.9%, 90.0% and 81.4% in the “bleeding”, “thromboembolism” and “other” groups, respectively (p = 0.891). Conclusions: In routine clinical practice, LAAC was used in a heterogeneous patient population with atrial fibrillation (AF) and contraindication, inefficacy or intolerance to OAC. The long-term outcome was favourable in all groups.

Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries

BackgroundLong-term data on the safety and efficacy of left atrial appendage closure (LAAC) for stroke prevention in patients with nonvalvular atrial fibrillation remain limited. ObjectivesThe purpose of this study was to evaluate 4.5- to 5-year data in 2 U.S. Food and Drug Association LAAC mandated registries (CAP [Continued Access to PROTECT-AF] and CAP2 [Continued Access to PREVAIL]) for safety and efficacy. MethodsTwo registries of patients implanted with LAAC devices provide the largest source of follow-up data. Both accompanied their respective randomized clinical trials, PROTECT-AF (Watchman Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device In Patients with Atrial Fibrillation versus Long Term Warfarin Therapy), which used the same endpoints (primary efficacy of composite of stroke, systemic embolism, cardiovascular/unexplained death, and safety). ResultsCAP included 566 patients with an average follow-up of 50.1 months (2,293 patient-years), and CAP2 included 578 patients with an average follow-up of 50.3 months (2,227 patient-years). CAP2 patients were significantly older and had higher CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) scores (4.51 vs. 3.88; p < 0.001). Procedural success was similar in both (94%). The primary composite endpoint occurred at a rate of 3.05 per 100 patient-years in CAP and 4.80 per 100 patient-years in CAP2; events contributing to this endpoint were most commonly cardiovascular/unexplained death (1.69 per 100 patient-years for CAP and 2.92 per 100 patient-years for CAP2). Hemorrhagic stroke was significantly less than ischemic stroke (0.17 per 100 patient-years in CAP and 0.09 per 100 patient-years in CAP2), and total stroke rates were significantly less than predicted by CHA2DS2-VASc score (78% reduction with CAP, 69% reduction with CAP2). ConclusionsThese registries, which contain the longest and largest follow-up data of patients with the Watchman device, support LAAC as a safe and effective therapy for long-term anticoagulation in patients with nonvalvular atrial fibrillation, and document the lowest rate of hemorrhagic stroke identified in this population.

Combining left atrial appendage closure and catheter ablation for atrial fibrillation: 2-year outcomes from a multinational registry.

Clinical practice guidelines do not recommend discontinuation of long-term oral anticoagulation in patients with a high stroke risk after catheter ablation for atrial fibrillation (AF). Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the long-term outcomes of combining catheter ablation procedures for AF and LAAC from multicentre registries. Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 142 subjects at 11 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful LAAC was achieved in 99.3% of patients. The 30-day device and/or procedure-related serious adverse event rate was 2.1%. After a mean follow-up time of 726 ± 91 days, 92% of patients remained off oral anticoagulation. The rates of the composite endpoint of ischaemic stroke/transient ischaemic attack/systemic thromboembolism were 1.09 per 100 patient-years (100-PY); and for non-procedural major bleeding were 1.09 per 100-PY. These represent relative reductions of 84% and 70% vs. expected rates per risk scores. The long-term outcomes from these international, multicentre registries show efficacy for all-cause stroke prevention and a significant reduction in late bleeding events in a population of high stroke risk post-ablation patients who have been withdrawn from oral anticoagulation.

P3724Impact of chronic kidney disease on efficacy and safety of interventional left atrial appendage closure – results from the prospective multicenter LAARGE registry

Abstract Background The interventional left atrial appendage closure (LAAC) is an effective and safe alternative to standard oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) patients with contraindications for long-term OAC. Chronic kidney disease (CKD) has a high prevalence among AF patients, and was shown to increase the number of peri-procedural complications in cardiac interventions. Purpose This subanalysis of the LAARGE registry aimed to investigate CKD's impact on outcomes after LAAC. Methods This prospective, real-world LAAC registry included 625 patients with documented renal function from 37 German centers between April 2014 and January 2016. CKD was defined by an eGFR &lt;60 mL/min/1.73 m2. Procedure was conducted with different LAAC devices considering the relevant recommendations. Baseline characteristics, procedural data, intra-hospital and one-year follow-up outcome were registered for CKD and non-CKD patients stratified by the different CKD stages. Results CKD patients (n=300; 48.0%) had a more pronounced cardiovascular risk profile, a higher stroke (CHA2DS2-VASc score 4.9±1.5 vs. 4.2±1.5; p&lt;0.001) and bleeding risk (HAS-BLED score 4.3±1.0 vs. 3.5±1.0; p&lt;0.001), and had experienced more prior bleedings (83.7 vs. 76.3%; p=0.022). Implantation success was similarly high between both groups (97.9%; p=n.s.). In CKD patients, MACCE during one-year follow-up was more frequent (18.1 vs. 6.8%; p&lt;0.001) mainly being triggered by all-cause deaths, but in-hospital MACCE was not (0.3 vs. 0.3%; p=n.s.). Kaplan-Meier estimation showed a lower one-year survival among CKD patients (82.4 vs. 94.4%; p&lt;0.001) without significant accentuation in patients with advanced CKD (i.e., &lt;30 mL/min/1.73 m2; p=n.s. to other CKD patients). While annual rate of device associated complications (2.6 vs. 2.8%; p=n.s.) and strokes (0 vs. 1.0%; p=n.s.) was comparable during follow-up, annual severe bleeding rate was higher in CKD patients (2.6 vs. 0.3%; p=0.027) which was 71.4 and 94.4% less than expected from the HAS-BLED score (p&lt;0.01 for the comparison to the estimated risks, but no significant interaction between groups). Conclusions Despite an increased cardiovascular risk profile of CKD patients, device implantation was safe, and annual stroke rate was statistically indifferent to non-CKD patients across all CKD stages after LAAC. Moreover, a substantial reduction of annual stroke and major bleeding risk was observed, as compared to the estimated annual risk. Acknowledgement/Funding Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany

P3727Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the prospective multicenter German LAARGE registry

Abstract Background and purpose Atrial fibrillation (AF) patients with increased thromboembolic risk and contraindications for standard oral anticoagulation (OAC) can profit from an interventional left atrial appendage closure (LAAC). While impaired left ventricular ejection fraction (LVEF) is associated with an increased thromboembolic risk in AF patients, cardiac interventions are often associated with an increase in complications in this patient population, and, therefore, the LAAC procedure's success and benefit has yet to be investigated in this subgroup. Methods This prospective, observational LAAC registry included 622 patients with documented LVEF from 37 German centers between April 2014 and January 2016. Patients were categorized into one of three groups: LVEF &gt;55% (preserved; p), LVEF 35–55% (mid-range; mr) and LVEF &lt;35% (reduced; r). Procedure was conducted in a standard fashion, and baseline characteristics, imaging as well as procedural data, intra-hospital and one-year follow-up outcome were registered for each group. Results 55.3% of patients had a pLVEF, 38.7% a mrLVEF and 5.9% a rLVEF. Patients with rLVEF were more often affected by coronary artery disease (p&lt;0.001 for trend), and had an elevated CHA2DS2-VASc (4.3±1.5 vs. 4.8±1.5 vs. 5.3±1.6; p&lt;0.001) and HAS-BLED score (3.7±1.1 vs. 4.1±1.2 vs. 4.3±0.9; p&lt;0.001). Percentage of prior cerebrovascular events and major bleedings was comparable at baseline (each p=n.s.). Procedural success was high (97.9%), while rates of intra-hospital MACCE (0.5%) and other major complications (4.2%) were low, with no significant difference between the groups (each p=n.s.). MACCE during follow-up was more frequent in rLVEF patients (11.0 vs. 11.3 vs. 27.8%; p=0.013), which was mainly driven by myocardial infarctions and all-cause deaths in this high risk collective. Likewise, Kaplan-Meier estimation showed a lower overall survival in this group (89.7 vs. 89.3 vs. 74.6%; p&lt;0.01). On the contrary, rates of stroke were extremely low across all groups and statistically similar (0.3 vs. 1.0 vs. 0%; p=n.s.). This was 93.4, 82.7 and 100.0% less in comparison to the estimated risk calculated from the CHA2DS2-VASc score Conclusions The LVEF had no influence on the procedural success as well as the intra-hospital complications after LAAC. Annual rate of stroke was low across all groups, and risk reduction was substantial especially in this high risk collective, as compared to the estimated risk. Acknowledgement/Funding Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany

Safety and efficacy of left atrial appendage closure in routine practice in France: Results of the French Nationwide Left Atrial Appendage Closure Registry

Left atrial appendage closure is an emerging option for the prevention of thromboembolic events in patients with atrial fibrillation and contraindication to anticoagulant agents. However, data in this field are scarce, and large registries are required to help physicians assess the risk/benefit ratio of left atrial appendage closure in such patients. The aim of the prospective, observational multicenter, FLAAC (French nationwide Left Atrial Appendage Closure) registry was to assess the clinical outcome of patients after left atrial appendage closure in routine practice in France. This study was conducted in 37 French interventional cardiology departments. The primary outcome was defined as the proportion of patients with thromboembolic events during the first year after left atrial appendage closure. Between April 2013 and September 2015, a total of 838 patients were prospectively included. The mean age of these patients was 75.4 ± 8.9 years and 63% were men. The device was successfully implanted in 98.6% of the patients. The rate of thromboembolic events one year after left atrial appendage closure was 2.5%. The all cause one-year mortality rate was 8.0%. Nine (1.1%) deaths were considered as related or possibly related to the procedure. Most of the patients died from the underlying cardiovascular disease (2.4%) or known comorbidities (3.0%), reflecting the high-risk nature of patients treated by left atrial appendage closure in routine practice. Finally, 11 (1.3%) patients died from a major bleeding event during the follow-up period. Percutaneous left atrial appendage closure is a reasonable option to decrease the thromboembolic event rate in patients with atrial fibrillation and no other option for thromboembolic risk reduction. Patients considered for left atrial appendage closure should undergo a comprehensive preprocedural assessment of frailty and comorbidities.

Combined atrial fibrillation ablation and left atrial appendage closure: long-term follow-up from a large multicentre registry.

Long-term freedom from atrial fibrillation (AF) after catheter ablation (CA) and consequently the potential for stroke reduction remain unpredictable. Percutaneous left atrial appendage closure (LAAC) is an effective mechanical alternative to oral anticoagulation (OAC) for stroke prevention in AF patients. This study aims to evaluate long-term clinical results of combined CA and LAAC in one single procedure. Patients with non-valvular AF who underwent combined CA and LAAC procedure were included in the retrospective compilation of independent prospective general LAAC registries at the individual centres. Transoesophageal echocardiography (TOE) was used to evaluate device position and LAA sealing. Between 2009 and 2015, 349 patients with AF (58% male, age 63.1 ± 8.2 years; score for stroke prediction in AF patients (CHA2DS2-VASc) 3.0; score for major bleeding in patients on anticoagulation (HAS-BLED) 3.0; 56% paroxysmal AF) were included. Indications for LAAC included previous stroke (38%), history of bleeding (22%), and physician/patient preference (29%). Periprocedural complications up to 30 days included pericardial effusion (1.5%) and one minor stroke (0.3%) but no death. After 6 weeks, TOE showed successful sealing of the LAA in 98.9%. After 35 months of follow-up, 51% of patients had AF recurrence. A total of nine ischaemic strokes were recorded, resulting in an annualized stroke rate of 0.9% compared to an expected stroke rate of 3.2% without anticoagulation and combined treatment. This large pooled multicentre analysis of five prospective registries shows that combining CA and LAAC is feasible, safe, and successful. Long-term follow-up shows greatly reduced stroke and bleeding rates despite recurrence of AF in more than half of the patients.

Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up.

AimsLong-term results from catheter ablation therapy for atrial fibrillation (AF) remain uncertain and clinical practice guidelines recommend continuation of long-term oral anticoagulation in patients with a high stroke risk. Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the initial results of combining catheter ablation procedures for AF and LAAC in a multicentre registry.Methods and resultsData were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 139 subjects at 10 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful Watchman implantation was achieved in 100% of patients. The overall 30-day serious adverse event (SAE) rate was 8.7%, with the device and/or procedure-related SAE rate of 1.4%. One pericardial effusion required percutaneous drainage, but there were no strokes, device embolization, or deaths at 30 days. The 30-day bleeding SAE rate was 2.9% with 55% of patients prescribed NOAC and 38% taking warfarin post-procedure.ConclusionThe outcomes from these international, multicentre registries support the feasibility and safety of performing combined procedures of ablation and Watchman LAAC for patients with non-valvular AF and high stroke risk. Further data are needed on long-term outcomes for the hybrid technique on all-cause stroke and mortality.