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

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 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.

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

Evaluating long-term outcomes of left atrial appendage occlusion: the results of a prospective single-center registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Maarse ◽  
L Wintgens ◽  
E Aarnink ◽  
M Huijboom ◽  
B Abeln ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Left Atrial Appendage Occlusion ◽  
Long Term Follow Up

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted grant from Boston Scientific. Boston Scientific was not involved in the design/conduct of the study, data collection/analysis and interpretation of the data and preparation of the manuscript. Background Percutaneous left atrial appendage occlusion is an emerging alternative to anticoagulation in the prevention for stroke in patients with atrial fibrillation, especially in patients with a contra-indication for oral anticoagulation therapy. Long-term results on the efficacy and safety of this treatment remain scarce. Methods In this single-center prospective registry, data of all consecutive patients that underwent percutaneous left atrial appendage closure between 2009 and 2019 were collected. Patients with successful left atrial appendage closure (peri-device leakage ≤5mm) and at least one year of follow-up data were analyzed. The occurrence of thrombo-embolic events (ischemic stroke, TIA and systemic embolism), major bleeding events (BARC &gt;2) and anticoagulation use during long-term follow-up were evaluated. Results A total of 192 patients after left atrial appendage occlusion were included (61 % male, age 69.0 ± 8.4 years, CHA2DS2-VASc 4.0[3.0-5.0], HAS-BLED 3.0[2.0-3.25]) with a mean follow-up duration of 5.7 ± 2.8 years (in total 1087 patient-years). During follow-up 36 patients (19%) died. 49 thrombo-embolic complications were observed in 38 patients. The ischemic stroke rate was 1.9 events per 100 patient-years, accounting for a 70% reduction compared to CHA2DS2-VASc predicted rate. Device-related thrombus (DRT) occurred in 5 patients (2.6%), 3 were observed during routine follow-up and were not associated with thrombo-embolic complications. The other 2 DRT were observed in patients presenting with ischemic stroke more than 3 years after device implantation. Furthermore, 38 non-procedural major bleeding complications occurred in 19 patients, resulting in 3.5 events per 100-patients years, accounting for a reduction of 43% compared to estimated bleeding rates under OAC use. At the end of the study 71% of all patients were on single antiplatelet or no antiplatelet/anticoagulation treatment at all. Conclusions During long-term follow-up thrombo-embolic event rates and non-procedural major bleeding rates were consistently low (ischemic stroke rate reduction 70% and non-procedural major bleeding rate reduction 40% compared to predicted rates). These results confirm the efficacy of left atrial appendage occlusion. Abstract Figure. Ischemic stroke rates

Left atrial appendage closure device implantation in patients at very high risk for stroke

Heart Rhythm ◽  
2020 ◽  
Vol 17 (1) ◽  
pp. 27-32 ◽  
Author(s):  
Erika Hutt ◽  
Oussama M. Wazni ◽  
Simrat Kaur ◽  
Walid I. Saliba ◽  
Khaldoun G. Tarakji ◽  
...  
Keyword(s):  
High Risk ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Closure Device ◽  
Left Atrial Appendage Closure ◽  
Device Implantation ◽  
Very High

scholarly journals Single Antiplatelet Therapy Following Left Atrial Appendage Closure in Patients With Contraindication to Anticoagulation

2016 ◽  
Vol 68 (17) ◽  
pp. 1920-1921 ◽  
Author(s):  
Tania Rodriguez-Gabella ◽  
Luis Nombela-Franco ◽  
Ander Regueiro ◽  
Pilar Jiménez-Quevedo ◽  
Jean Champagne ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure
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