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.

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

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 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

scholarly journals Comparison of Left Atrial Appendage Occlusion versus Non-Vitamin-K Antagonist Oral Anticoagulation in High-Risk Atrial Fibrillation: An Update

2021 ◽  
Vol 8 (6) ◽  
pp. 69
Author(s):  
Shaojie Chen ◽  
K. R. Julian Chun ◽  
Zhiyu Ling ◽  
Shaowen Liu ◽  
Lin Zhu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
High Risk ◽  
Vitamin K ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Vitamin K Antagonists ◽  
Left Atrial Appendage Occlusion ◽  
The Mean

Transcatheter left atrial appendage occlusion (LAAO) is non-inferior to vitamin K antagonists (VKAs) in preventing thromboembolic events in atrial fibrillation (AF). Non-vitamin K antagonists (NOACs) have an improved safety profile over VKAs; however, evidence regarding their effect on cardiovascular and neurological outcomes relative to LAAO is limited. Up-to-date randomized trials or propensity-score-matched data comparing LAAO vs. NOACs in high-risk patients with AF were pooled in our study. A total of 2849 AF patients (LAAO: 1368, NOACs: 1481, mean age: 75 ± 7.5 yrs, 63.5% male) were enrolled. The mean CHA2DS2-VASc score was 4.3 ± 1.7, and the mean HAS-BLED score was 3.4 ± 1.2. The baseline characteristics were comparable between the two groups. In the LAAO group, the success rate of device implantation was 98.8%. During a mean follow-up of 2 years, as compared with NOACs, LAAO was associated with a significant reduction of ISTH major bleeding (p = 0.0002). There were no significant differences in terms of ischemic stroke (p = 0.61), ischemic stroke/thromboembolism (p = 0.63), ISTH major and clinically relevant minor bleeding (p = 0.73), cardiovascular death (p = 0.63), and all-cause mortality (p = 0.71). There was a trend toward reduction of combined major cardiovascular and neurological endpoints in the LAAO group (OR: 0.84, 95% CI: 0.64–1.11, p = 0.12). In conclusion, for high-risk AF patients, LAAO is associated with a significant reduction of ISTH major bleeding without increased ischemic events, as compared to “contemporary NOACs”. The present data show the superior role of LAAO over NOACs among high-risk AF patients in terms of reduction of major bleeding; however, more randomized controlled trials are warranted.

Pericardial Patch Exclusion Technique for Left Atrial Appendage Closure

2018 ◽  
Vol 13 (2) ◽  
pp. 144-146
Author(s):  
Olivia K. Ginty ◽  
Ferns H. Khaliel ◽  
Corey Adams ◽  
Michael W. A. Chu
Keyword(s):  
Left Atrium ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Pericardial Patch ◽  
Left Atrial Appendage Closure ◽  
Risk Of Bleeding ◽  
Left Atrial Appendage Occlusion ◽  
Autologous Pericardial Patch ◽  
Patch Closure

We describe a technique of left atrial appendage occlusion that consists of autologous pericardial patch closure of the left atrial appendage orifice from within the left atrium. This pericardial patch exclusion technique has little added risk of bleeding, can be performed through sternotomy or right minithoracotomy, and can be used in re-operative situations.

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 >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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