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

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Fastner ◽  
J Brachmann ◽  
T Lewalter ◽  
U Zeymer ◽  
H Sievert ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Cardiovascular Risk ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Bleeding Risk ◽  
Risk Profile ◽  
Cardiovascular Risk Profile ◽  
Left Atrial Appendage Closure ◽  
One Year

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 <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<0.001) and bleeding risk (HAS-BLED score 4.3±1.0 vs. 3.5±1.0; p<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<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<0.001) without significant accentuation in patients with advanced CKD (i.e., <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<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

scholarly journals Impact of atrial fibrillation pattern on left atrial appendage closure: insights from the prospective LAARGE registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
S Kany ◽  
J Brachmann ◽  
T Lewalter ◽  
I Akin ◽  
H Sievert ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Systemic Embolism ◽  
Long Term Outcomes ◽  
Left Atrial Appendage Closure ◽  
History Of ◽  
One Year

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Stiftung für Herzinfarkforschung Background  Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death compared with paroxysmal AF (PAF). This study investigates the procedural safety and long-term outcomes of left atrial appendage closure (LAAC) in patients with different forms of AF. Methods  Comparison of procedural details and long-term outcomes in patients (pts) with PAF against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC in Germany (LAARGE).  Results  A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. NPAF consisted of 31.6% patients with persistent AF and 68.4% with longstanding persistent AF or permanent AF. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The PAF group had significantly less history of heart failure (19.0% vs 33.0%, p &lt; 0.001) while the current median LVEF was similar (60% vs 60%, p = 0.26). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), but no difference in the HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was observed. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77) in both groups. In the three-month echo follow-up, device-related thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak &gt;5 mm (0.0% vs 7.1%, p= 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95%-CI: 1.02-2.72). Conclusion  Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE of patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality and combined outcome of death, stroke and systemic embolism.

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.

Abstract 17230: Transcatheter Leak Occlusion With Endovascular Coils Following Left Atrial Appendage Closure

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Domenico G Della Rocca ◽  
Rodney Horton ◽  
Luigi Di Biase ◽  
Nicola Tarantino ◽  
Jorge Romero ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Bleeding Risk ◽  
Pericardial Tamponade ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Iodinated Contrast ◽  
Endovascular Coils ◽  
Laa Closure

Introduction: The Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures (TREASURE) is a prospective, nonrandomized, single-center study. This study was undertaken to investigate the efficacy of transcatheter leak closure with endovascular coils in patient with incomplete percutaneous/epicardial left atrial appendage (LAA) closure procedures and high thromboembolic (TE)- and bleeding-risk. Hypothesis: We report the efficacy of transcatheter leak closure with endovascular coils in patients with incomplete LAA closure. Methods: Sixty-five consecutive patients with a clinically relevant residual leak (mean age: 72±8 years; 73.8% males; CHA 2 DS 2 -VASc: 4.7±1.1; HAS-BLED: 3.7±0.7) underwent percutaneous closure of the LAA patency via embolization coils. Trans-esophageal echocardiography (TEE) was performed at 60±15 days post-procedure. Results: LAA closure had been previously attempted with a Watchman device in 62 patients, and a LARIAT in 3. Baseline TEE documented a moderate or severe leak in 14 (21.5%) and 51 (78.5%) patients, respectively. Procedure and fluoroscopy times were 69±37min and 22±15min, respectively; the mean volume of iodinated contrast medium used was 82±43mL. Coil deployment was successful in all cases [median n. of coils attempted: 3 (IQR:2-5); median n. of coils deployed: 3 (IQR: 2-4)]. The overall complication rate was 3.1% (1 pericardial tamponade, 1 pericardial effusion). Peri-procedural angiographic and TEE outcomes demonstrated complete obliteration or a negligible residual opacification with a trivial residual jet in 62 cases (95.4%), and a partial occlusion with moderate residual jet in 3 (6.4%). Follow-up TEE after 67±12 days revealed complete LAA sealing or a negligible residual leak in 63 cases (96.9%). Coil deployment led to an average reduction of 90.1% in leak size (p<0.001). After an overall follow-up of 17±4 months, no TE events were documented; 3 patients died from non-cardiovascular and one from cardiovascular causes (heart failure). Conclusions: Transcatheter LAA leak occlusion via endovascular coils appears to be a safe, effective, and promising approach in high TE-risk patients with incomplete LAA closure.

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

2020 ◽  
Vol 109 (11) ◽  
pp. 1333-1341
Author(s):  
Christian Fastner ◽  
Johannes Brachmann ◽  
Thorsten Lewalter ◽  
Uwe Zeymer ◽  
Horst Sievert ◽  
...  
Keyword(s):  
Left Ventricular Ejection Fraction ◽  
Ejection Fraction ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Left Atrial Appendage Closure ◽  
Ventricular Ejection Fraction ◽  
One Year

Abstract Background Interventional left atrial appendage closure (LAAC) effectively prevents thromboembolic events in atrial fibrillation patients. Impaired left ventricular ejection fraction (LVEF) increases not only the thromboembolic risk but also the complication rates of cardiac interventions. The LAAC procedure’s benefit in patients with an impaired LVEF, therefore, has yet to be investigated. Methods LAARGE is a prospective, non-randomized registry depicting the clinical reality of LAAC in Germany. Procedure was conducted with different standard commercial devices, and follow-up period was one year. In the sense of an as-treated analysis, patients with started procedure and documented LVEF were selected from the whole database. Results 619 patients from 37 centers were categorized into one of three groups: LVEF > 55% (56%), 36–55% (36%), and ≤ 35% (8%). Prevalence of cardiovascular comorbidity increased with LVEF reduction (p < 0.001 for trend). CHA2DS2-VASc score was 4.3, 4.8, and 5.1 (p < 0.001), and HAS-BLED score was 3.7, 4.1, and 4.2 (p < 0.001). Implantation success was consistently high (97.9%), rates of intra-hospital MACCE (0.5%), and other major complications (4.2%) were low (each p = NS). Kaplan–Meier estimation showed a decrease in survival free of stroke with LVEF reduction during one-year follow-up (89.3 vs. 87.0 vs. 79.8%; p = 0.067), a trend which was no longer evident after adjustment for relevant confounding factors. Rates of non-fatal strokes (0.4 vs. 1.1 vs. 0%) and severe bleedings (0.7 vs. 0.0 vs. 3.1%) were consistently low across all groups (each p = NS). Conclusions LVEF reduction neither influenced the procedural success nor the effectiveness and safety of stroke prevention by LAAC. Trial Registration ClinicalTrials.gov Identifier: NCT02230748 Graphic abstract

P3731The improvement in left atrial strain among patients undergoing percutaneous left atrial appendage closure

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Ijuin ◽  
A Hamadanchi ◽  
F Haertel ◽  
L Baez ◽  
C Schulze ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Sinus Rhythm ◽  
Transesophageal Echocardiography ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Lateral Wall ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Left Atrial Strain

Abstract Background Percutaneous left atrial appendage closure (LAAC) is being established as an alternative option for atrial fibrillation (AF) patients with high bleeding risk. Few studies reported the influence of percutaneous LAAC on left atrial (LA) performance, but most of the studies demonstrated no remarkable changes in their parameters after the procedure. Method The study included 95 patients (age: 75±6.7 years, 67% male) whom underwent percutaneous LAAC in a single center between September 2012 and November 2018. LA strain was evaluated at three different time intervals by transesophageal echocardiography (baseline, 45 days and 180 days after procedure). All data were analyzed using a dedicated. 70 patients had atrial fibrillation whereas 25 were in sinus rhythm. Analysis was performed for peak atrial longitudinal strain (PALS) and peak atrial contraction strain (PACS) from segment of lateral wall in mid-esophageal 4 chamber view. The validity of lateral wall left atrial analysis was recently shown by our group. PACS was obtained in patients with sinus rhythm during exams. Results Compared to baseline, PALS was significantly increased after 45 days (12.4±8.4% vs 16.0±10.7%, p=0.001) and remained stable after 180 days (13.8±9.0% vs 17.0±12.4%, p=0.098). Even in only patients with atrial fibrillation during exams, it was increased (10.8±7.7% vs 13.4±7.1%, p=0.012 and 8.5±5.1% vs 13.9±8.1%, p=0.014). Similarly, compared with the baseline, PACS was significantly increased after 45 days and 180 days (5.8±3.9% vs 10.6±7.6%, p=0.001 and 4.5±2.6% vs 7.9±3.1%, p=0.036). The Changes in PALS and PACS Conclusion Our study has demonstrated for the first time the improvement in LA strain following LAAC within 45 days of implantation by transesophageal echocardiography and these values were maintained at least for 6 months. Further appraisal is warranted for confirmation of these preliminary findings.

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

scholarly journals Left atrial appendage closure devices for cardiovascular risk reduction in atrial fibrillation patients

2015 ◽  
pp. 47
Author(s):  
Ignacio Cruz-Gonzalez ◽  
Juan Carlos Rama-Merchan ◽  
Javier Rodriguez-Collado ◽  
Javier Martin-Moreiras ◽  
Alejandro Diego-Nieto ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiovascular Risk ◽  
Risk Reduction ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Cardiovascular Risk Reduction
Sign in / Sign up

Export Citation Format

Share Document