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

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Stand-Alone Thoracoscopic Left Atrial Appendage Closure in Nonvalvular Atrial Fibrillation Patients at High Bleeding Risk

Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery ◽

10.1177/1556984520960116 ◽

2020 ◽

Vol 15 (6) ◽

pp. 541-546

Author(s):

Marco Franciulli ◽

Giuseppe De Martino ◽

Mariateresa Librera ◽

Ahmed Desoky ◽

Antonio Mariniello ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Oral Anticoagulants ◽

Bleeding Risk ◽

Atrial Appendage ◽

Nonvalvular Atrial Fibrillation ◽

High Bleeding Risk ◽

Laa Closure

Objective In nonvalvular atrial fibrillation (AF) patients at high bleeding risk, oral anticoagulants (OAC) may be contraindicated, and percutaneous left atrial appendage (LAA) closure has been advocated. However, following percutaneous procedure, either OAC or dual antiplatelet treatment is required. In this study, we present our experience in treating nonvalvular AF patients at high bleeding risk with thoracoscopic LAA closure with no subsequent antithrombotic therapy. Methods From April 2019 to January 2020, 20 consecutive AF patients, mean age 75.1 years, 16 (80%) males, underwent thoracoscopic LAA closure as a stand-alone procedure, using an epicardial clip device. OAC and antiplatelet therapy were contraindicated. Mean CHA2DS2-VASc score was 3.61, and the mean HAS-BLED score was 4.42. Successful LAA closure was assessed by transesophageal echocardiography. Primary endpoints were complete LAA closure (no residual LAA flow), operative complications, and all-cause mortality; secondary endpoints were 30-day and 6-month complications (death, ischemic stroke, hemorrhagic stroke, transient ischemic attack, any bleeding). Mean follow-up was 6 ± 4 months. Results Complete LAA closure was achieved in all patients. No operative clip-related complications or deaths occurred. At follow-up, freedom from postoperative complications was 95% and from any cerebrovascular events was 100%. Overall survival rate was 100%. Conclusions In nonvalvular AF patients at high bleeding risk (HAS-BLED score >3), thoracoscopic LAA closure appears to be a valid alternative to percutaneous techniques not requiring dual antiplatelet or OAC treatment. Apparently, external LAA clipping minimizes the risk of thromboembolic events as compared with percutaneous procedures.

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Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience.

10.21203/rs.3.rs-412824/v1 ◽

2021 ◽

Author(s):

Mohammed Saad ◽

Osama Risha ◽

Makoto Sano ◽

Thomas Fink ◽

Christian-Hendrik Heeger ◽

...

Keyword(s):

Major Bleeding ◽

Left Atrial ◽

Left Atrial Appendage ◽

Pericardial Tamponade ◽

Atrial Appendage ◽

Bleeding Complications ◽

Comparable Efficacy ◽

Hospital Death ◽

Left Atrial Appendage Closure

Abstract Objectives To compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry. Background Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. Methods Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during 2-year-follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death). Results After matching the patients for age (± 5 years), gender, CHA2DS2Vasc score (± 1) and HASBLED score (± 1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During 2-year follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively). Conclusion Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On 2-year follow-up, both devices showed comparable efficacy and safety.

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

European Heart Journal ◽

10.1093/eurheartj/ehz745.0585 ◽

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.

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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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Acute Device-Related Thrombus after Watchman Device Implant

Case Reports in Cardiology ◽

10.1155/2019/8397561 ◽

2019 ◽

Vol 2019 ◽

pp. 1-4

Author(s):

Muhammad Ajmal ◽

Vijendra Swarup

Keyword(s):

Left Atrial ◽

Left Atrial Appendage ◽

Blood Clot ◽

Heart Rhythm ◽

Bleeding Risk ◽

Atrial Appendage ◽

Acute Thrombosis ◽

Increased Risk ◽

Watchman Device ◽

Laa Closure

Atrial fibrillation is characterized by irregularly irregular heart rhythm with an increased morbidity and mortality. It is associated with an increased risk of thromboembolism due to formation of blood clot in the left atrium. Most of these blood clots are formed in the left atrial appendage. The risk of blood clot formation is reduced with the use of anticoagulants. The patients who cannot take anticoagulants due to an increased bleeding risk can undergo percutaneous left atrial appendage (LAA) closure. A Watchman device is used for this purpose. LAA closure with the Watchman device is associated with some adverse effects, and one of them is device-related thrombus. Currently, there are no specific guidelines for the management of device-related thrombus. We present a case of Watchman device-related thrombus which developed 16 hours after the device placement. We will also discuss various options for the management of acute thrombosis.

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