Heart Team for Left Atrial Appendage Occlusion: A Patient-Tailored Approach

Background and Purpose: Left atrial appendage occlusion (LAAO) is an accepted therapeutic option for stroke prevention; however, the ideal technique and device have not yet been identified. In this study we evaluate the potential role of a heart team approach for patients contraindicated for oral anticoagulants and indicated for left atrial appendage closure, to minimize risk and optimize benefit in a patient-centered decision-making process. Methods: Forty patients were evaluated by the heart team for appendage occlusion. Variables considered were CHA2DS2VASc, HASBLED, documented blood transfusions, comorbidities, event forcing anticoagulant interruption, past medical history, anatomy of the left atrial appendage, and patient quality of life. Twenty patients had their appendage occluded percutaneously (65% male, mean age 72.3 ± 7.5, mean CHA2DS2VASc 4.2 ± 1.5, mean HASBLED 3.5 ± 1.1). The other twenty underwent thoracoscopic occlusion (65% male, mean age of 74.9 ± 8, mean CHA2DS2VASc 6.0 ± 1.5, HASBLED mean 5.4 ± 1.4). Percutaneous patients were on dual antiplatelet therapy for the first three months and aspirin thereafter, whereas the others received no anticoagulant/antiplatelet therapy from the day of surgery. Follow up included TEE, CT scan, and periodical clinical evaluation. Results: Mean duration of procedures and hospital stay were comparable. All patients had complete exclusion of the appendage; at a mean follow up of 33.1 ± 14.1 months, no neurological or hemorrhagic events were reported. Conclusions: A heart team approach may improve the decision-making process for stroke and hemorrhage prevention, where LAAO is a therapeutic option. Percutaneous and thoracoscopic appendage occlusion seem to be comparably safe and effective. An epicardial LAAO could be advisable in patients for whom the risk of bleeding is estimated as being too high for post-procedural antiplatelet therapy.

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

European Heart Journal Supplements ◽

10.1093/eurheartj/suab134.002 ◽

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.

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An heart team stroke prevention decision-making process comparing percutaneous endocardial and thoracoscopic epicardial left atrial appendage occlusion

European Heart Journal ◽

10.1093/eurheartj/ehab724.2233 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

S Branzoli ◽

M Marini ◽

F Guarracini ◽

G D'Onghia ◽

D Penzo ◽

...

Keyword(s):

Atrial Fibrillation ◽

Antiplatelet Therapy ◽

Left Atrial Appendage ◽

Therapeutic Option ◽

Bleeding Risk ◽

Low Molecular Weight ◽

Heart Team ◽

Risk Of Bleeding ◽

Left Atrial Appendage Occlusion

Abstract Introduction Left atrial appendage occlusion (LAAO) is a validated therapeutic option in patients with atrial fibrillation (AF) at high thrombo-embolic risk and contraindication to oral anticoagulation. Large clinical trials have demonstrated excellent efficacy of percutaneous LAAO, but also stand-alone thoracoscopic LAAO has shown promising results with the advantage of absence of antiplatelet therapy. No direct comparison of both strategies has been published yet. Purpose To evaluate an Atrial Fibrillation Heart Team guided approach to percutaneous or thoracoscopic left appendage exclusion in patients with non valvular atrial fibrillation (NVAF). Methods Forty patients with a contraindication to oral anticoagulation (OAC) were evaluated in the AF Heart Team for LAA exclusion. Contraindication for OAC was based upon a history of cerebral hemorrhages (n=17), non-cerebral life-threatening hemorrhages (n=9), repetitive bleeding (n=8) and having underlying diseases associated to high bleeding risk (n=6). The 20 patients included in the LAAO-Percutaneous group (LAAO-P) were on low molecular weight heparin pre-procedure, whereas in the LAAO-thoracoscopic group (LAAO-TT) none were on low molecular weight heparin nor antiplatelet therapy since the bleeding risk was estimated too high. The LAAO-P group were 70% male, with a mean age of 72.3±7.5 (range 57–82), mean CHA2DS2VASc 4.2 (range 1–6) and a mean HASBLED 3.5 (range 1–5) with an expected risk of bleeding between 3.7–8.7% per year. The LAAO-TT were 72.5% male, with a mean age of 74.9±8 (range 53–87 years), mean CHA2DS2-VASc 6.05 (range 4–8), HASBLED mean 5.4 (range3–8) expected risk of bleeding >12.5% per year. Variables considered were CHA2DS2VASc, HASBLED, documented blood transfusions, comorbidities related risk of bleeding, anatomy of the LAA, lung function, patient quality of life. LAAO-P patients were on dual antiplatelet therapy (DAT) at discharge for the first three months and aspirine 100mg/day thereafter, whereas the LAAO-TT patients were not. Follow up included TEE at 1 months and CT scan at 3 months. Results Mean duration of procedures for LAAO-P was 54.4 minutes, for LAAO-TT 52.01 minutes, mean post procedural ventilation time was respectively 11.2±6.4 and 15.8±16.4 minutes. No major complications occurred in both groups. One patient in the LAAO-P crossed over because of an unsuitable anatomy which became apparent intra-operatively. Mean hospital stay were comparable in both groups, 3.4±0.7 and 3.8±0.9 days respectively. At mean follow up of 24.3±10.1 months (range 5–36) all patients had complete exclusion of the appendage, no neurological events were reported. Conclusions The Heart Team can improve decision making in complex stroke prevention where LAAO is a therapeutic option, percutaneous and thoracoscopic occlusion seem to be comparably safe and effective. An epicardial LAAO could be advised in patients were the bleeding risk is estimated too high for AP therapy. FUNDunding Acknowledgement Type of funding sources: None. Appendage closure: CT scan view Appendage closure: surgical view

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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 ◽

10.1093/europace/euab116.283 ◽

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

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

EP Europace ◽

10.1093/europace/euab116.287 ◽

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 >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

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Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer™ Amulet™ Occluder Observational Study

EP Europace ◽

10.1093/europace/euaa262 ◽

2020 ◽

Author(s):

Xavier Freixa ◽

Boris Schmidt ◽

Patrizio Mazzone ◽

Sergio Berti ◽

Sven Fischer ◽

...

Keyword(s):

Observational Study ◽

Ischaemic Stroke ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Serious Adverse Events ◽

Left Atrial Appendage Occlusion ◽

Increased Risk ◽

The Impact

Abstract Aims Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up. Methods and results We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA). Serious adverse events (SAEs) were reported from implant through a 2-year post-LAAO visit and adjudicated by an independent clinical events committee. Overall, 1088 subjects were prospectively enrolled. There were 265 subjects (24.4%) <70 years old, 491 subjects (45.1%) ≥70 and <80 years old, and 332 subjects (30.5%) ≥80 years old, with the majority (≥80%) being contraindicated to anticoagulation. As expected, CHA2DS2-VASc and HAS-BLED Scores increased with age. Implant success was high (≥98.5%) across all groups, and the proportion of subjects with a procedure- or device-related SAE was similar between groups. At follow-up, the observed ischaemic stroke rate was not significantly different between groups, and corresponding risk reductions were 62, 56, and 85% when compared with predicted rates for subjects <70, ≥70 and <80, and ≥80 years old, respectively. Major bleeding and mortality rates increased with age, while the incidence of device-related thrombus tended to increase with age. Conclusions Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.

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Spontaneously occluded left atrial appendage in a patient with atrial fibrillation and stroke: a case report

European Heart Journal - Case Reports ◽

10.1093/ehjcr/ytaa027 ◽

2020 ◽

Vol 4 (2) ◽

pp. 1-4

Author(s):

Andreas Bugge Tinggaard ◽

Kasper Korsholm ◽

Jesper Møller Jensen ◽

Jens Erik Nielsen-Kudsk

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Transoesophageal Echocardiography ◽

Similar Efficacy ◽

Cardiovascular Death ◽

Atrial Appendage ◽

Left Atrial Appendage Occlusion ◽

All Cause Mortality

Abstract Background The left atrial appendage (LAA) is the main source of thromboembolism in atrial fibrillation (AF). Transcatheter closure is non-inferior to warfarin therapy in preventing stroke. Case summary A patient with two consecutive strokes associated with AF was referred for transcatheter LAA occlusion (LAAO). Preprocedural cardiac CT and transoesophageal echocardiography demonstrated a spontaneously occluded LAA with a smooth left atrial surface, with stationary results at 6- and 12-month imaging follow-up. Warfarin was discontinued, and life-long aspirin instigated. Discussion Left atrial appendage occlusion has shown non-inferiority to warfarin for prevention of stroke, cardiovascular death, and all-cause mortality. No benefits from anticoagulation have been demonstrated in patients with embolic stroke of undetermined source. In the present case, we observed that the LAA was occluded and, therefore, treated with aspirin monotherapy assuming similar efficacy as transcatheter LAAO.

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