scholarly journals Short dual antiplatelet strategy following left atrial appendage closure with Watchman and Watchman FLX: 1-year outcomes

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Briosa E Gala ◽  
MTB Pope ◽  
C Monteiro ◽  
M Leo ◽  
TR Betts
Keyword(s):  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Transoesophageal Echocardiography ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Bleeding Events ◽  
Major Bleed ◽  
One Year

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left atrial appendage occlusion (LAAO) is an effective stroke prevention strategy in patients with non-valvular atrial fibrillation and high bleeding risk. Oral anticoagulation or dual antiplatelet (DAPT) therapy is recommended for the period of device endothelisation but confers an increased bleeding risk. Purpose This study sought to examine the one-year outcomes of a short DAPT strategy following LAA occlusion in a large UK tertiary centre. Methods This retrospective study included all patients discharged on a short DAPT strategy (6-8 weeks) following a LAAO device implantation from January 2010 and December 2020 in our institution. Medical notes, procedural, and imaging reports were reviewed and adverse event rates were calculated at one year. Yearly bleeding risk was extrapolated from the Swedish National Cohort study according to CHA2DS2-VASc and HASBLED score. Results A total of 140 patients (106 Watchman and 36 Watchman-FLX) were discharged on a planned short DAPT strategy (age 74 ± 9 years, 70% male, 71% had previous bleeding on OAC, 95% previous major or life-threatening bleeding episodes, 52% previous ischaemic stroke, CHA2DS2-VASc score 4.5 ± 1.2, HASBLED score 3.2 ± 0.7). The median time to switching to either single antiplatelet (APT) or no ATP was 62 days. After first follow-up, 90% were either on SAPT (46.3% aspirin and 39.3% clopidogrel) or no ATP (6.4%). Seven (5%) patients had device-related thrombus on transoesophageal echocardiography and were started on anticoagulation and 4 (3.5%) patients remained on DAPT. At one year, of the 129 patients on a short DAPT strategy the composite of death, ischaemic stroke and non-procedural bleeding occurred in 11 patients (KM 8.9%; 95% CI, 3.7% -13.8%).  Four patients (3.1/100 patient-years) suffered a major bleed and 3 (2.3/100 patient-years) had an ischaemic stroke on SAPT (mean time of 315 days). Compared to estimated annual stroke and bleeding risk adjusted for CHA2DS2-VASc and HASBLED score, this represents a 65% and 38% relative risk reduction in ischaemic stroke and major bleeding, respectively. Conclusion In our cohort, a short DAPT strategy following LAAO device appears safe with reduction of both thromboembolic and major bleeding events at 1-year. Abstract Figure 1

Long-term outcomes in patients with non-valvular atrial fibrillation and left atrial appendage closure in a large UK tertiary centre: 10-year experience

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Briosa E Gala ◽  
MTB Pope ◽  
C Monteiro ◽  
M Leo ◽  
TR Betts
Keyword(s):  
High Risk ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Tertiary Centre ◽  
Left Atrial Appendage Occlusion

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left atrial appendage occlusion (LAAO) is a well-established stroke prevention strategy in patients with non-valvular atrial fibrillation (AF) and high risk of bleeding or contra-indication to oral anticoagulation (OAC). Despite encouraging randomised control trial and international registry safety and efficacy data, long-term outcome data remains sparce. Purpose This study sought to evaluate the long-term outcomes in ‘real-world’ AF patients undergoing left atrial appendage occlusion in a large UK tertiary centre. Methods This retrospective study included all patients that had a LAAO device implanted in our institution from January 2010 to December 2020. Medical notes, electronic patient records, procedural and imaging reports were reviewed. Annual bleeding risk was extrapolated from the Swedish National Cohort study according to CHA2DS2-VASc and HASBLED score. Results During the study period a total of 225 patients underwent LAAO device implant. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 life-threatening bleeding episodes). Three different LAAO devices were used: 136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac plugs. Three patients (1.3%) had fatal complications related to the procedure. At discharge, 10% were taking single antiplatelet (ATP), 79% dual-antiplatelet (DAPT), 1.4% OAC, 3.6% ATP and OAC, 3.1% DAPT and OAC, 1.3% were not taking any anti-thrombotic. Nine (4%) patients had device-related thrombus on follow-up transoesophageal echocardiography with no significant difference between devices (5.0%, 2.8% and 6.7% p = 0.8, respectively) and anticoagulation strategy (p = 0.7). Over a total follow-up of 889 patient-years (mean follow-up 3.9 ± 3.7 years), 24 (10.4%) patients died, 55 patients (6.2/100 patient-years) suffered an adverse event, 15 ischaemic strokes (1.7/100 patient-years) and 20 non-procedural major bleeding episodes (2.3/100 patient-years) occurred. Compared to estimated annual stroke and bleeding risk adjusted for CHA2DS2-VASc and HASBLED score, our cohort had a 79% and 65% relative risk reduction in ischaemic stroke and major bleeding, respectively. Conclusion In this cohort of "real-world" high-risk patients, major bleeding and thromboembolic rate remained low on long-term follow-up. Abstract Figure 1

scholarly journals Addressing Stroke Risk in a Patient with CREST Syndrome and Atrial Fibrillation with Left Atrial appendage Occluder Device (WATCHMAN)

2021 ◽  
Vol 4 (1) ◽  
pp. 01-04
Author(s):  
Ali Alkhayru
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrial ◽  
Stroke Risk ◽  
Left Atrial Appendage ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Crest Syndrome ◽  
Increased Risk ◽  
Occluder Device ◽  
One Year

CREST syndrome is rare autoimmune disease causing calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly and telangiectasias. We present a case of an eighty-two year old female with CREST syndrome who presented to our clinic with atrial fibrillation and prohibitive bleeding risk. Managing stroke risk in atrial fibrillation is essential to minimize the morbidity and mortality of the condition. Those with CREST syndrome presenting with recurrent gastrointestinal bleeding may require alternatives to anticoagulation. Recently, the left atrial appendage occluder device became widely used to manage patients at increased risk for bleeding. The device provides a safe and efficacious alternative in lowering atrial fibrillation associated stroke risk. Our patient underwent uncomplicated implantation of the left atrial appendage occluder device. She was closely monitored for one year where she remained stroke free and had one minor episode of gastrointestinal hemorrhage.

P3726Percutaneous left atrial appendage closure and conservative antithrombotic treatment in patients with atrial fibrillation and contraindication to oral anticoagulation: a 5-year follow-up study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J P Pouru ◽  
S Jaakkola ◽  
J Lund ◽  
F Biancari ◽  
A Saraste ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Bleeding Risk ◽  
Left Atrial Appendage Closure ◽  
Bleeding Events ◽  
Device Embolization ◽  
High Bleeding Risk

Abstract Background Patients with atrial fibrillation (AF) having high thromboembolic risk and either a history of major bleeding or very high bleeding risk form a treatment challenge. Percutaneous left atrial appendage closure (LAAC) offers a feasible option for stroke prevention in these patients. However, the optimal treatment strategy for AF patients with contraindications to oral anticoagulation (OAC) remains unclear. Purpose To study periprocedural and late events after LAAC in AF patients with contraindications to OAC therapy. Methods Data were collected into a prospective registry from all consenting AF patients who underwent LAAC from February 2009 to August 2018. Follow-up data was gathered during scheduled clinical visits, annual phone calls and by reviewing electronic patient records. Only AF patients with contraindications to OAC were considered for the present analysis. Results LAAC using mainly Amplatzer Cardiac Plugs (98.2%) was attempted in a total of 172 patients (mean age 74 years; 60 women). The mean CHA2DS2-VASc score was 3.8±1.5 and HAS-BLED score 4.0±1.0. Contraindications to OAC were prior intracranial bleeding in 112 (65.1%), other major bleeding in 33 (19.2%) and high bleeding risk in 27 patients (15.7%). Procedure was technically successful in 166 (96.5%) patients. Clinically significant in-hospital complications were as follows: two patients (1.2%) had cardiac tamponade, which was fatal in one case, one (0.6%) had device embolization and eight (4.7%) had major access site-related bleeding events. None of the patients had in-hospital thromboembolic complications. After successful implantation, 152 patients (91.6%) were discharged on aspirin. Single antiplatelet therapy was more common than dual or triple antiplatelet therapy (74.7% vs. 18.1% vs. 1.8%, respectively), while 8 patients (4.8%) received no antiplatelet therapy. The length of initial antiplatelet therapy ranged from 0.5 to 12 months and long-term antiplatelet therapy was prescribed in 53 patients (31.9%). After a median follow-up of 33 months (interquartile range 12–49) there were 29 deaths (17.5%), 16 thromboembolic events (9.6%), consisting of 11 strokes (6.6%) and 5 transient ischemic attacks (3.0%). At the time of thromboembolic event, 10 patients (62.5%) were on antithrombotic therapy. Eighteen patients (10.8%) had at least one major bleeding event after the index hospitalization. Intracranial bleeding occurred in 7 patients (4.2%) and 6 of them (85.7%) were on antithrombotic therapy when the event occurred. Most thromboembolic events (68.8%) and intracranial bleedings (57.1%) occurred after one year of follow-up. One patient (0.6%) had an asymptomatic device embolization detected at 3-month control visit. No predictive factors for thromboembolic or major bleeding events were identified. Conclusion The early outcome of this challenging patient group is good after LAAC, but thromboembolic and major bleeding events are not uncommon during later follow-up.

scholarly journals Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study

2020 ◽  
Vol 41 (30) ◽  
pp. 2894-2901 ◽  
Author(s):  
David Hildick-Smith ◽  
Ulf Landmesser ◽  
A John Camm ◽  
Hans-Christoph Diener ◽  
Vince Paul ◽  
...  
Keyword(s):  
Adverse Events ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Cardiovascular Death ◽  
Atrial Appendage ◽  
Stroke Rate ◽  
Left Atrial Appendage Occlusion

Abstract Aims To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. Methods and results Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1–3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year—a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). Conclusion Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.

scholarly journals 479 Safety and effectiveness of left atrial appendage occlusion in patients with chronic kidney disease

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Michele Magnocavallo ◽  
Domenico Giovanni Della Rocca ◽  
Carlo Lavalle ◽  
Cristina Chimenti ◽  
Gianni Carola ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Risk Of Bleeding ◽  
Left Atrial Appendage Occlusion ◽  
Group 2 ◽  
Group 1

Abstract Aims Left atrial appendage occlusion (LAAO) might be particularly attractive in chronic kidney disease (CKD) patients, owing to a high thromboembolic risk and an even higher risk of bleeding. We sought to evaluate the safety and effectiveness of LAAO in CKD patients. Methods and results A total of 1238 patients undergoing LAAO at six centres were enrolled. On the basis of kidney function, as assessed via the CKD-EPI formula, patients were classified in two groups. Group1 had a GFR value ≤60 ml/min/1.73 m2 (CKD stages 3a-b, 4, and 5), whereas Group2 had a function >60 ml/min/1.73 m2 (CKD stages 1 and 2). Predicted annual rates of TE or major bleeding events were compared to the annualized observed risk of the two populations. Compared to Group 2 (n = 720, 47.5% males), patients in Group 1 (n = 518, 86.5% males) were older (mean age: 78 ± 8 vs. 75 ± 8, P < 0.001), and were at higher risk (CHA2DS2-VASc: 4.7 ± 1.4 vs. 4.4 ± 1.4; HAS-BLED: 3.8 ± 1.1 vs. 3.2 ± 1.0; P < 0.001 for both). Procedural complications (within 7 days) were observed in 3.1% of patients in Group1 and 4.6% of those in Group2 (P = 0.18); of them, major procedural adverse events occurred in 10 patients of Group1 [1.9%; four gastrointestinal (GI) bleedings, four tamponades, one myocardial infarction, one retroperitoneal hematoma] and in 15 (2.1%; seven pericardial tamponades, five retroperitoneal hematomas, two strokes, and one GI bleeding) of Group2 (P = 0.84). During a mean follow-up of 11.5 ± 7 months (1183 pt/years), 10 stroke/TIA (1.9%) and 25 major bleeding events (4.8%; 18 GI and 7 intracranial) were observed in Group1. Rate of TE events was not statistically different between groups (1.9% vs. 2.6%; P = 0.41); major bleedings had a significantly higher incidence in Group 1 (4.8% vs. 2.4%, P = 0.02). Based on the estimated annual TE risk according to the CHA2DS2-VASc score (4.76% in Group1 and 4.51% in Group 2), the % risk reduction after LAAO was 57.5% and 38.8%, respectively. Based on the estimated annual major bleeding risk based on the HAS-BLED score (7.31% in Group1 and 5.39% in Group2), the % bleeding risk reduction was 30.9% and 54.2%. Conclusions LAAO is a safe and effective approach in CKD patients. Given the increased risk of bleeding and contraindications to oral anticoagulation, CKD patients might be good candidates for LAA occlusion.

P1438Predictors and clinical impact of bleeding events after left atrial appendage closure in patients with high risk or a history of bleeding

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Sano ◽  
T Fink ◽  
V Sciacca ◽  
J Vogler ◽  
M Saad ◽  
...  
Keyword(s):  
High Risk ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Bleeding Events ◽  
History Of ◽  
Or History

Abstract Background Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation and may be especially attractive in patients with high risk or a history of bleeding. However, data of clinical benefit and incidence of post-procedural bleeding in patients with both high risk of bleeding and ischemic cerebral stroke after LAAC are lacking. Objectives This study sought to identify predictors and the prognostic impact of post-LAAC bleeding in patients at high risk and/or history of bleeding in the direct oral anticoagulant therapy (DOAC) era. Methods and results We retrospectively enrolled a total of 195 patients (75 ± 8.7 years, 38% female, 47% with previous major bleeding, mean CHA2DS2-VASc score 4.3 ± 1.6 and mean HAS-BLED score 2.7 ± 1.1) undergoing endocardial (91%) or epicardial (9%) LAAC during a mean follow-up of 339 ± 319 days. Twenty-three (11.9%) patients developed procedure-unrelated bleeding events after a median of 147 (43, 362) days after LAAC, in 12/23 (52%) patients under single antiplatelet therapy (SAPT), 6/23 (26%) dual antiplatelet therapy (DAPT), 1/23 (4%)  DOAC, 1/23 (4%) VKA, 2/23 (9%) dual therapy (SAPT and DOAC/VKA) and 1/23 (4%) triple therapy (DAPT and DOAC/VKA). (Figure) Diabetes mellitus and previous major bleeding were identified as the independent predictors of post-LAAC bleeding (Odds ratio 2.65 [95% CI:1.04-6.73], p = 0.041, and 5.50 [95% confidence interval:1.72-17.5], p = 0.004). Post-LAAC bleeding was associated with all-cause death (9/23 [39%] vs 18/171 [11%], p = 0.001), but not ischemic stroke/TIA (1/23 [4%] vs 6/171 [4%], p = 0.593) nor device thrombus (2/23 [9%] vs 3/171 [2%], p = 0.108). Kaplan-Meier curve estimated that patients with post-LAAC bleeding had a worse mortality than those without post-LAAC bleeding (3-year mortality; 35.6% [95%CI; 11.6-61.0%] vs 68.7% [45.0-83.8], p = 0.029) Conclusions In AF patients with high bleeding risk or history of bleeding undergoing LAAC, bleeding events are common and may occur even after long-term duration after LAAC. Previous major bleeding history strongly predicts subsequent bleeding events following LAAC and is associated with unfavorable mortality. Further investigations are required to identify optimal post-procedural antithrombotic strategies for patients undergoing LAAC with previous major bleeding. Abstract Figure. The association between time to bleeding

scholarly journals 240 Left atrial appendage occlusion: safety, efficacy, and antiplatelet therapy in a single-centre experience

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Luigi Vignali ◽  
Federico Barocelli ◽  
Filippo Luca Gurgoglione ◽  
Maria Alberta Cattabiani ◽  
Arianna Maini ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Bleeding Events ◽  
Left Atrial Appendage Occlusion ◽  
Clinical Events

Abstract Aims Oral anticoagulation (OAC) is the cornerstone therapy for stroke prevention in patients with atrial fibrillation (AF). However, a not negligible proportion of AF patients experiences major bleeding events or is affected by concomitant disorders that represent a contraindication for OAC. Left atrial appendage occlusion (LAAO) has emerged as an effective strategy to minimize the risk of thromboembolism in AF patients (without moderate/severe mitral stenosis or mechanical prosthetic heart valves) that are poor candidates for OAC. After the procedure variable regimens of antithrombotic therapy are prescribed, in order to provide protection and prevent device-related thrombus (DRT). The optimal post-procedural antithrombotic strategy remains to be assessed. Therefore, we aim to evaluate the safety and efficacy of LAAO procedure and the relationship between antiplatelet therapy and outcomes at long-term follow-up. Methods and results We conducted a retrospective observational study including consecutive AF patients who underwent LAAO at Azienda Ospedaliero-Universitaria of Parma from October 2010 to June 2021. The incidence of major ischaemic events [DRT, ischaemic stroke, transient ischaemic attack (TIA) and systemic embolism], Bleeding Academic Research Consortium major bleeding events and net adverse clinical events (major ischaemic + bleeding events) were assessed at follow-up. We enrolled 130 patients [median age 77 years (73; 81)] characterized by both high ischaemic (mean CHA2DS2-VASc 4.48) and bleeding risk (mean HAS-BLED 3.24). Technical procedure success was achieved in 123 (94.6%). Thirty-nine (31.7%) patients were discharged on short (≤1 month)-dual antiplatelet therapy (DAPT); 35 (28.5%) on long-DAPT (1–12 months) and 49 (39.8%) on single antiplatelet therapy (SAPT). Antiplatelet therapy was chosen after multidisciplinary discussion on the basis on the hemorrhagic risk [mean HAS-BLED 3.55; 3.11; 2.97 (P = 0.038) in SAPT, short-DAPT and long-DAPT groups respectively], while no differences were observed in ischaemic risk between the three groups. Clinical follow-up was completed in 119 (98.2%) of successfully implanted patients. After a median follow-up of 31 ± 16 months, 24 (20.2%) patients had a major adverse event: 11 (9.2%) ischaemic events [8 (6.7%) strokes and 3 (2.5%) TIA] and 13 (10.9%) major bleedings. Patients on short-DAPT had a significantly lower occurrence of major bleedings [0 vs. 4 (11.4%) on long-DAPT vs. 9 (18.4%) on SAPT; P = 0.033] and net adverse clinical events [3 (7.7%) vs. 7 (20.0%) on long-DAPT vs. 14 (28.6%) on SAPT; P = 0.005] compared to the other two groups, while no difference was observed in the incidence of major ischaemic events [3 (7.7%) on short-DAPT vs. 3 (8.6%) on long-DAPT vs. 5 (10.2%) on SAPT; P = 0.340]. Conclusions In our cohort of AF patients with a contraindication for OAC therapy, LAAO showed high procedural success; however, long-term major ischaemic and bleeding events were not negligible. Short-DAPT therapy turned out to be the best antiplatelet regimen regarding net ischaemic-hemorrhagic balance. Evidence from well-designed randomized trials would be desirable to guide a tailored approach in the selection of post-procedural antithrombotic regimens.

scholarly journals Major Bleeding Predictors in Patients with Left Atrial Appendage Closure: The Iberian Registry II

2020 ◽  
Vol 9 (7) ◽  
pp. 2295
Author(s):  
José Ramón López-Mínguez ◽  
Juan Manuel Nogales-Asensio ◽  
Eduardo Infante De Oliveira ◽  
Lino Santos ◽  
Rafael Ruiz-Salmerón ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
High Risk Population ◽  
Left Atrial Appendage Closure ◽  
Bleeding Events ◽  
Cox Regression Analysis ◽  
Major Bleeding Events

Introduction and objective: Major bleeding events in patients undergoing left atrial appendage closure (LAAC) range from 2.2 to 10.3 per 100 patient-years in different series. This study aimed to clarify the bleeding predictive factors that could influence these differences. Methods: LAAC was performed in 598 patients from the Iberian Registry II (1093 patient-years; median, 75.4 years). We conducted a multivariate analysis to identify predictive risk factors for major bleeding events. The occurrence of thromboembolic and bleeding events was compared to rates expected from CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes, stroke history, vascular disease, sex) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile INR, elderly, drugs or alcohol) scores. Results: Cox regression analysis revealed that age ≥75 years (HR: 2.5; 95% CI: 1.3 to 4.8; p = 0.004) and a history of gastrointestinal bleeding (GIB) (HR: 2.1; 95% CI: 1.1 to 3.9; p = 0.020) were two factors independently associated with major bleeding during follow-up. Patients aged <75 or ≥75 years had median CHA2DS2-VASc scores of 4 (IQR: 2) and 5 (IQR: 2), respectively (p < 0.001) and HAS-BLED scores were 3 (IQR: 1) and 3 (IQR: 1) for each group (p = 0.007). Events presented as follow-up adjusted rates according to age groups were stroke (1.2% vs. 2.9%; HR: 2.4, p = 0.12) and major bleeding (3.7 vs. 9.0 per 100 patient-years; HR: 2.4, p = 0.002). Expected major bleedings according to HAS-BLED scores were 6.2% vs. 6.6%, respectively. In patients with GIB history, major bleeding events were 6.1% patient-years (HAS-BLED score was 3.8 ± 1.1) compared to 2.7% patients-year in patients with no previous GIB history (HAS-BLED score was 3.4 ± 1.2; p = 0.029). Conclusions: In this high-risk population, GIB history and age ≥75 years are the main predictors of major bleeding events after LAAC, especially during the first year. Age seems to have a greater influence on major bleeding events than on thromboembolic risk in these patients.

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