P998Left atrial appendage closure device thrombosis is associated with systemic embolization

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Hala ◽  
V Lekesova ◽  
T Mraz ◽  
M Prokopova ◽  
J Petru ◽  
...  

Abstract Introduction Atrial fibrillation, in one of its forms, is the most frequent sustained tachyarrhythmia and increases the risk of stroke more than 5 times. Cardioembolic stroke and systemic embolism (CS/SE) represents the most severe complication of this arrhythmia. Approximately 92% of intracardiac thrombosis originates from the left atrial appendage (LAA) and, although its mechanical occlusion is proved method to prevent cardioembolism, thrombosis of all types of LAA occlusion devices and their associations with CS/SE were observed. The purpose of this study is to evaluate the rate of LAA occlusion device thrombosis, its predictors and the risk for cardioembolism. Methods We analyzed a group of 359 patients (65% male, mean age 72 years) with high risk for thromboembolism (mean CHADSVASc = 4.0) after LAA catheter occlusion using any of 9 different occluder types since 2005. During clinical follow-up 819 patientyears were collected and an intracardiac thrombus was found on 22 devices. Total of 17 patients suffered CS/SE. Results Thrombosis was found in 11 men and 11 women, mean age 76 years, average CHADSVASc = 4.5 and HASBLED = 2.0. The thrombus was discovered on average 4.0 months after the LAA occlusion. In that time patients were receiving dual antiplatelet therapy (11x), acetysalicic acid (4x), or interrupted anticoagulation (6x). In 3 cases the thrombosis was associated with CS/SE which represented risk of 6.6% per year. In patients with no thrombosis annual risk of CS/SE was only 1.7% (P<0.001). Figure 1 Conclusion In our single center register thrombosis was found in total of 6.3% patients after LAA device implantation. In these patients, risk of CS/SE is 3.9-fold higher compared to patients without thrombus formation. Elderly patients and patients with more risk factors in general were affected more frequently.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Kretzler ◽  
C Wunderlich ◽  
M Christoph ◽  
A Langbein ◽  
S G Spitzer ◽  
...  

Abstract Background Oral anticoagulation for prophylaxis of central and peripheral embolisation is limited in its use in patients with atrial fibrillation (AF) and bleeding events. As an alternative to anticoagulation, the interventional closure of the left atrial appendage (LAAO) is available. A common clinical dilemma is the treatment of patients with potential peri-device leakage following LAA occlusion. The specific definition of the severity of the leak and the long-term clinical implications have not yet been sufficiently investigated. Methods The multi-centre ORIGINAL registry was initiated 2014. The aim of this registry is to analyze the safety and efficacy of the procedure in patients with a high risk of bleeding in everyday clinical practice and to evaluate hemorrhagic and thromboemb. events in the long term follow-up. Patients with an indication for LAA occl. were included in the registry after informed consent. The impl., follow-up and anticoagulation regimens are performed according to the standard of the participating centers. 521 patients with AF underwent an implantation of an LAA closure device between Jul. 2014 and Nov. 2018. A mean follow-up of 463 days could be reached in 386 patients. Results The periprocedural complication rate was 3.8% of which 5 patients experienced pericardial effusion (successful treatment with pericardial puncture or surgical), 2 patients had periprocedural stroke and 1 patient suffered from air embolism. In 27 patients a peri-device flow due to incomplete occlusion was detected by TEE (5.4% of the implantations). The size ranged between 1 and 8 mm (mean 2.28 mm (SD=2.11)). The eccentricity index (EI) of the LAA in these patients was 1.22 (SD 0.17), and thus the LAA rather oval, while those LAA without leakage tend to be more circular (EI 1.08 with SD=0.17). 2 of the patients with leakage (7.4%) experienced stroke or peripheral embolism, respectively. The annual risk for stroke/TIA/peripheral embolism of these patients was 5.84%, the annual risk of the patients without leakage was 2.04%. Patients with a leakage >6 mm were treated with rivaroxaban in full therapeutic dosage. One patient underwent an additional procedure. Conclusion The evaluation and management of para-device leakage after an interventional LAA occlusion represents a challenge. Currently, limited data are available on the optimal strategy. Those data indicate that residual peri-device flow into the LAA after percutaneous closure with the Watchman device represents no cause for alarm. However, our data suggest, that patients with peridevice leak might be at a higher risk of thromboembolic events. Furthermore, it could be shown, that these patients had rather oval ostium of the LAA, while those LAA without leakage tend to be more circular. This implicates the importance of advanced imaging methods, such as 3D-TEE, which are capable to precisely determine the size of the LAA and the degree of its circularity. Acknowledgement/Funding None


2021 ◽  
Vol 5 (3) ◽  
Author(s):  
Stefano Albani ◽  
Nicola Berlier ◽  
Francesco Pisano ◽  
Paolo Scacciatella

Abstract Background Late-onset complications of left atrial appendage occlusion (LAAO) device procedure are anecdotal and there are no such complications reported in literature using Cardia Ultraseal (Cardia, Inc., Eagan, MN, USA). Case summary We report the case of a 74-year-old Caucasian man affected by paroxysmal atrial fibrillation with significant bleeding risk (familiar thrombocytopenia, macroscopic haematuria episodes during therapy with direct oral anticoagulants, HAS-BLED risk score: 4) and ischaemic risk as well (CHADSVASC score: 3). The patient was treated with LAAO device implantation for high bleeding risk. Subsequently, after 26 days from LAAO procedure, he was admitted to the emergency department for haematic cardiac tamponade. The patient was successfully treated with subxyphoidal pericardiocentesis in the acute phase, unfortunately cardiac arrest occurred during the transfer to the referral hospital for urgent cardiac surgery. Permanent neurological damage was reported and the patient died on day 28. Discussion LAAO late-onset complications are very rare and the case presented is the first case described of late-onset pericardial effusion and tamponade secondary to the Cardia Ultraseal LAAO device implantation. We present a revision of the literature regarding the occurrence of similar adverse events and discuss the hypothetical mechanism of this major complication.


Heart Rhythm ◽  
2020 ◽  
Vol 17 (1) ◽  
pp. 27-32 ◽  
Author(s):  
Erika Hutt ◽  
Oussama M. Wazni ◽  
Simrat Kaur ◽  
Walid I. Saliba ◽  
Khaldoun G. Tarakji ◽  
...  

2018 ◽  
Vol 19 (2) ◽  
pp. 147032031878262 ◽  
Author(s):  
Ya Suo ◽  
Zhiwei Zhang ◽  
Huaying Fu ◽  
Yue Zhang ◽  
Meng Yuan ◽  
...  

Aims: We examined whether the use of a renin-angiotensin-aldosterone system (RAS) inhibitor plays a role in protecting against left atrial appendage thrombus (LAAT) in patients with hypertension complicated by atrial fibrillation (AF). Methods: Two observational studies were conducted on patients with diagnoses of hypertension and AF, who were categorized into RAS inhibitor user or nonuser groups. Demographic characteristics, clinical characteristics, echocardiographic parameters and hemostatic markers were examined and the occurrence of LAAT during follow-up were recorded. Results: In the first study ( n = 131), LA peak systolic strain and LAA emptying flow velocity (LAA eV) were significantly increased in patients on RAS inhibitors compared with the nonuser group ( p < 0.05). Lower D-dimer and fibrinogen levels were observed in patients on RAS inhibitors ( p < 0.05). In the second study ( n = 99), 25.9% ( n = 11) of patients on RAS inhibitors developed LAAT, compared with 46.7% ( n = 21) in the nonuser group ( p < 0.05). After controlling for risk factors related to LAAT, use of RAS inhibitors remained associated with a significantly lower risk of developing LAAT (HR, 0.406; 95% CI, 0.191–0.862; p = 0.019). Conclusions: RAS inhibitors use was associated with a significant reduction in the risk of LAAT in patients with hypertension and AF.


2018 ◽  
Vol 7 (3) ◽  
pp. 6-11
Author(s):  
J. А. Reiss ◽  
D. A. Evans

The study demonstrates the safety, feasibility and effectiveness of a comprehensive approach to minimize fluoroscopy and contrast use during Watchman left atrial closure device implantation.Background. The introduction of Watchman left atrial appendage occlusion device (WM) has provided an effective alternative to anticoagulation for patients with a high risk of cerebrovascular accidents (CVA) and high risk of bleeding and who are unable to take long-term anticoagulation therapy. Since its introduction, WM has been implanted more than 50,000 times worldwide. While the implant procedure is relatively safe, it involves the use of fluoroscopy and contrast and, as such, poses some associated risk to patient safety. The adoption of procedural techniques which reduce fluoroscopy exposure and contrast use have the potential to provide clinical patient benefit without compromising safety or efficacy. Aim To demonstrate that WM implant can be performed with minimal exposure to both ionizing radiation and IV contrast without compromising safety or efficacy.Methods. A retrospective chart review of all 75 consecutive Watchman implantations by a single operator at a single center between December 2015 and December 2017. Every effort to optimize the WM implant procedure and minimize radiation and contrast exposure was incorporated as implant techniques evolved. Contrast and radiation exposure data were collected and analyzed year-over-year.Results. Charts from 75 consecutive cases were reviewed with all cases at index procedure (100%), and included the majority of patients presenting in paroxysmal AF (63%). Baseline patient characteristics were consistent across years. Procedural characteristics also were consistent over time. The median absorbed radiation dose was low (75 mGy in 2015) and did not change significantly over time. Similarly, the median fluoroscopy time used after the initial case was low (2.8 minutes) and did not vary. 73 of 75 (97%) of procedures resulted in successful implantation. There were no procedural complications; notably, no cases resulted in stroke, death, pericardial effusion, vascular accidents or device embolization.Conclusion.The current generation of WM can be successfully implanted using low fluoroscopy and contrast without compromising safety or efficacy using the techniques described.


EP Europace ◽  
2020 ◽  
Vol 22 (9) ◽  
pp. 1358-1366
Author(s):  
Thomas Fink ◽  
Feifan Ouyang ◽  
Christian-Hendrik Heeger ◽  
Vanessa Sciacca ◽  
Bruno Reissmann ◽  
...  

Abstract Aims Left atrial appendage (LAA) electrical isolation (LAAEI) in addition to pulmonary vein isolation is an emerging catheter-based therapy to treat symptomatic atrial fibrillation. Previous studies found high incidences of LAA thrombus formation after LAAEI. This study sought to analyse therapeutic strategies aiming at the resolution of LAA thrombi and prevention of thromboembolism. Methods and results Left atrial appendage electrical isolation was conducted via creation of left atrial linear lesions or cryoballoon ablation. Follow-up including transoesophageal echocardiography was conducted. In patients with LAA thrombus, oral anticoagulation (OAC) was adjusted until thrombus resolution was documented. Percutaneous LAA closure (LAAC) under use of a cerebral protection device was conducted in case of medically refractory LAA thrombi. Left atrial appendage thrombus was documented in 54 of 239 analysed patients who had undergone LAAEI. Thrombus resolution was documented in 39/51 patients (72.2%) with available follow-up after adjustment of OAC. Twenty-nine patients underwent LAAC and 10 patients were kept on OAC after LAAEI. No thromboembolic events or further LAA thrombi were documented after 553 ± 443 days of follow-up in these patients. Persistent LAA thrombi despite adaption of OAC was documented in 12/51 patients. One patient remained on OAC until the end of follow-up, while LAAC with a cerebral protection device was performed in 11 patients in the presence of LAA thrombus without complications. Conclusion Left atrial appendage thrombus formation is common after LAAEI. Adjustment of OAC leads to LAA thrombus resolution in most patients. Left atrial appendage closure in the presence of LAA thrombi might be a feasible option in case of failed medical treatment.


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