scholarly journals P923 Ultrasound follow-up of left atrial appendage occlusion devices

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
D Molinero ◽  
P Cabeza ◽  
N Hernandez ◽  
W Delgado ◽  
E Silva

Abstract Background Left atrial appendage (LAA) occlusion devices represent an important alternative to anticoagulation in patients with atrial fibrillation (AF) with high risk of bleeding and who have suffered any hemorrhagic event. At first, a transesophageal ultrasound is performed to examine cardiac cavities, take measures of LAA and discharge the presence of thrombi. We redo a new transesophageal ultrasound as a control three months later after having installed the device. The purpose of this article is to show our experience in ultrasound follow up of LAA occlusion. Methodology All measures of LAA were taken with the transoesophageal ultrasound device by the same operator. According to the size acquired from the appendage of each patient, they were divided into a first group with the implementation of the Watchman device (23 patients) and Amplatzer (6 patients). A transthoracic echocardiography control was performed on each patient to rule out the presence of complications after the intervention, before to be discharged from hospital. After three months, a new transoesophageal study was repeated to assess the correct position of the device and to rule out the presence of any disfunctions or clot formation. Results A total of 29 patients with AF (CHADSVASC 4.09 HASBLED 2.96) with a high risk of bleeding and after having suffered any complications (41% brain bleeding, 31% major gastrointestinal bleeding, 27% advanced chronic kidney disease) were presented for the implantation of a LAA closure device. Firstly, LAA size was confirm and the presence of a thrombi was rule out. No patient suffered complications during the procedure that was confirmed with transthoracic echocardiography (discharging the presence of perforation, pericardial effusion or tamponade). At three months later, we performed a new transoesophageal as a control for the assessment of the place and presence of GAPs, if any (80% correct-placed, 15% placed with a gap of 2-4 mm with passage of flow throughout). In a 10-month follow-up, it was found that practically 93% of patients were still without anticoagulation, except two patients, one of them (CHADSVASC 4 HASBLED 2) had to reintroduce oral anticoagulation due to the fact of the clot formation on the device. The second one (CHADSVASC 4 HASBLED 2) had to reintroduce temporarily fractionated heparin due to stent thrombosis in the femoral artery. None of them presented any ischemic complications or new haemorrhagic events. Conclusions LAA occlusion devices are an effective and safe alternative to anticoagulation in patients with atrial fibrillation with predisposition to bleeding where ultrasound techniques play an essential role in all stages of procedure (prior to implantation of the device, during and at the follow-up).

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

Abstract Aims Left atrial appendage occlusion (LAAO) is a therapeutic option for patients with non-valvular atrial fibrillation (NVAF) and high risk of bleeding. This study reports outcomes of patients enrolled in the prospective multicentre, investigator initiated real life registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure). Methods and results Data of all consecutive 521 patients (64.7% adult males, 35.3% adult females, mean age: 75.1 (SD 7.9) years with non-valvular atrial fibrillation undergoing interventional left atrial appendage occlusion procedure in the ORIGINAL prospective registry were analysed. The CHA2DS2-VASc and HAS-BLED scores were 4.3 (SD 1.5) and 3.7 (SD 1.1), respectively. 78.9% of the patients had a history of bleeding. 89.3% of the patients were considered as non-eligible for long term oral anticoagulation. A left atrial appendage occlusion device was successfully implanted in 97.5% of cases. A mean follow-up of 463 days could be reached in 386 patients. Among these, the distribution of the follow-up length reached was as follows: 1 year 205, 2 years 118, 3 years 65 and 4 years 17 patients. In the follow-up the annual frequency of stroke was very low (0.4%), which resulted in the 4.98% absolute risk reduction in the amount of thromboembolic strokes, which would have been expected according to the calculated CHA2DS2-VASc score in the hypothetic group not receiving any anticoagulant therapy. The occurrence of major and minor bleeding in the follow-up was 1.55% and 3.37% respectively. Conclusions In this prospective multicentre study we included the patients who are at high risk of stroke and bleeding. The annual ischemic stroke rate was 0.4%, the LAA could be sealed in 97.5%. Six months after the LAA closure only 3.63% of all patients were further on treated using oral anticoagulation. Considering the stroke reduction rates, the implantation of an LAAO device proves to be effective and safe in the clinical routine in the studied population. Acknowledgement/Funding None


2020 ◽  
Vol 33 (2) ◽  
pp. 115-121
Author(s):  
Cristiano Pisani ◽  
Muhieddine Chokr ◽  
Carina Hardy ◽  
Sissy Lara ◽  
Mauricio Scanavacca

A 57 year-old patient with dilated cardiomyopathy, long-standing persistent atrial fibrillation, heart failure and episodes of gastrointestinal bleeding underwent AF ablation with pulmonary vein isolation, homogeneization of septal scar, posterior wall isolation and also left atrial appendage isolation. Additionally, because of the high risk of embolism, underwent left atrial appendage occlusion.


Author(s):  
Alexander Sedaghat ◽  
Vivian Vij ◽  
Baravan Al-Kassou ◽  
Steffen Gloekler ◽  
Roberto Galea ◽  
...  

Background: Left atrial appendage closure is an established therapy in patients with atrial fibrillation. Although device-related thrombosis (DRT) is relatively rare, it is potentially linked to adverse events. As data on DRT characteristics, outcome, and treatment regimen are scarce, we aimed to assess these questions in a multicenter approach. Methods: One hundred fifty-six patients with the diagnosis of DRT after left atrial appendage closure were included in the multinational EUROC-DRT registry. Baseline characteristics included clinical and echocardiographic data. After inclusion, all patients underwent further clinical and echocardiographic follow-up to assess DRT dynamics, treatment success, and outcome. Results: DRT was detected after a median of 93 days (interquartile range, 54–161 days) with 17.9% being detected >6 months after left atrial appendage closure. Patients with DRT were at high ischemic and bleeding risk (CHA 2 DS 2 -VASc 4.5±1.7, HAS-BLED 3.3±1.2) and had nonparoxysmal atrial fibrillation (67.3%), previous stroke (53.8%), and spontaneous echo contrast (50.6%). The initial treatment regimens showed comparable resolution rates (antiplatelet monotherapy: 57.1%, dual antiplatelet therapy: 85.7%, vitamin K antagonists: 80.0%, novel oral anticoagulants: 75.0%, and heparin: 68.6%). After intensification or switch of treatment, complete DRT resolution was achieved in 79.5% of patients. Two-year follow-up revealed a high risk of mortality (20.0%) and ischemic stroke (13.8%) in patients with DRT. Patients with incomplete DRT resolution showed numerically higher stroke rates and increased mortality rates (stroke: 17.6% versus 12.3%, P =0.29; mortality: 31.3% versus 13.1%, P =0.05). Conclusions: A substantial proportion of DRT is detected >6 months after left atrial appendage closure, highlighting the need for imaging follow-up. Patients with DRT appear to be at a high risk for stroke and mortality. While DRT resolution was achieved in most patients, incomplete DRT resolution appeared to identify patients at even higher risk. Optimal DRT diagnostic criteria and treatment regimens are warranted.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Briosa E Gala ◽  
MTB Pope ◽  
C Monteiro ◽  
M Leo ◽  
TR Betts

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


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Rakesh Gopinathannair ◽  
Scott M Koerber ◽  
Krishna Akella ◽  
Dhanunjaya Lakkireddy

Background: The Amulet IDE trial is an ongoing, randomized, worldwide trial, enrolled but following patients with non-valvular atrial fibrillation (AF) at high risk of stroke. The study is comparing the safety and effectiveness of the Amplatzer™ Amulet™ left atrial appendage (LAA) Occluder to the Watchman device. At US sites, the implanting physicians only had experience with the Watchman device; therefore, up to three roll-in subjects with Amplatzer Amulet device implantation were permitted prior to randomization. The purpose of this analysis is to describe the peri-procedural outcomes for the roll-in cohort. Methods: Roll-in subjects met the same eligibility criteria and have the same data collection requirements as randomized subjects. Adverse events were adjudicated by an independent clinical events committee and LAA occlusion was assessed by an independent core laboratory based on the 45-day TEE. Major adverse events included all cause death, ischemic stroke, systemic embolism or device-/procedure-related events requiring open cardiac surgery or major endovascular intervention within 7 days post implant or hospital discharge, whichever is later. Results: From August 2016 to November 2018, 201 patients with non-valvular AF at high risk of stroke and bleeding were enrolled at 82 sites as roll-in subjects. Mean age was 74.2 ± 7.5 years and 62% of subjects were male. The Amplatzer Amulet device was successfully deployed in 99% of subjects. Major adverse events within 7 days or hospital discharge occurred in 2.5% of patients and included death (n=3), ischemic stroke (n=1) and vascular access site bleeding (n=1). The majority (79%) of patients were discharged on antiplatelet therapy only or no anti-thrombotic medication. TEE follow-up at the 45-day visit revealed adequate (≤ 5 mm jet) occlusion of the appendage in 98.9% (178/180) of patients. Device-related thrombus (DRT) was identified by the core laboratory in 6 patients (3%); no patient experienced a thrombo-embolic event. Conclusions: In the roll-in cohort, with implanting physicians having no prior experience using the Amplatzer™ Amulet™ device, there was a low rate of procedural complications and high rates of both implant success and adequate LAA sealing at follow up.


TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e351-e353
Author(s):  
Wern Yew Ding ◽  
Gregory Y.H. Lip ◽  
Timothy Fairbairn ◽  
Sukumaran Binukrishnan ◽  
Afshin Khalatbari ◽  
...  

2020 ◽  
Vol 4 (2) ◽  
pp. 1-4
Author(s):  
Andreas Bugge Tinggaard ◽  
Kasper Korsholm ◽  
Jesper Møller Jensen ◽  
Jens Erik Nielsen-Kudsk

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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