WATCHMAN versus ACP or amulet for left atrial appendage closure. Results from the LAARGE registry

Abstract Background Several left atrial appendage (LAA) closure systems are available and due to differences in device design safety and efficacy of specific occluders derived from trials cannot be simply generalized to all devices. Purpose The present analysis sought to assess two contemporary LAA closure devices in clinical practice. Methods The present work represents a non-randomized sub-analysis of the prospective, multicenter, Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) registry. The WATCHMAN (group 1) and the Amplatzer Cardiac Plug (ACP) or Amulet occluder (group 2) were assessed regarding technical success and procedural safety. Results A total of 641 patients at 38 centers were enrolled. Of them, 278 (43%) and 340 (53%) patients received the WATCHMAN and ACP/Amulet occluder, respectively. High technical success was achieved with a slight difference between the groups (96% in group 1 vs. 99% in group 2; p=0.007). Procedural safety did not differ (98% in group 1 vs. 97% in group 2; p=0.55). Chicken wing morphology of the LAA seemed to trigger the use of the ACP/Amulet (chicken wing in 36% of the cases in group 1 vs. 55% in group 2; p<0.001). The Kaplan Meier estimated 1-year composite of death or stroke was 12.0% and 12.9%, respectively (Figure 1A). The respective rates for the composite endpoint of death, stroke or systemic embolism were 12.0% and 13.2% (Figure 1B). Conclusions Both the WATCHMAN and the ACP/Amulet occluder provide excellent procedural results with comparable implantation success and no differences regarding procedural safety and long-term effectiveness. Figure 1. Composite endpoints at 1-year Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Stiftung Institut für Herzinfarktforschung (IHF)

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Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN

European Heart Journal ◽

10.1093/ehjci/ehaa946.2660 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

J Ledwoch ◽

K Sievert ◽

L Boersma ◽

M Bergmann ◽

H Ince ◽

...

Keyword(s):

Antiplatelet Therapy ◽

Left Atrial ◽

Initial Phase ◽

Left Atrial Appendage ◽

Initial Period ◽

Atrial Appendage ◽

Funding Source ◽

Second Period ◽

Laa Closure

Abstract Background Evidence regarding post-procedural antithrombotic regimes other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. Purpose The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. Methods A total of 998 patients with successful WATCHMAN implantation at 47 centers were available for the present analysis. The composite ischemic endpoint of stroke, TIA, systemic embolism and device thrombus as well as the bleeding endpoint defined as at least major bleeding according to BARC were assessed during an initial period (from implant until first medication change) and long-term period (from first change until up to 2 years). Results The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7% and no medication in 6%. In the long-term phase SAPT was used in 65%, DAPT in 23%, no therapy in 8% and OAC in 4%. No significant differences were found between the groups regarding the ischemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy; p=0.97) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy; p=0.36). With respect to bleeding events the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy (1.0% for DAPT vs. 0.8% for OAC vs. 7.4% for SAPT or no therapy; p=0.01). No differences in bleeding complications were observed during the second period (2.6% for SAPT vs. 2.9% for DAPT vs. 2.2% for no therapy; p=0.88). Conclusions Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischemic complications after LAA closure. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boston Scientific

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Predictors of spontaneous echo contrast and left atrial appendage thrombosis in nonvalvular atrial fibrillation

Russian Journal of Cardiology ◽

10.15829/1560-4071-2020-3765 ◽

2020 ◽

Vol 25 (7) ◽

pp. 3765

Author(s):

N. Yu. Khorkova ◽

T. P. Gizatulina ◽

A. V. Belokurova ◽

E. A. Gorbatenko

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Left Ventricular ◽

Atrial Appendage ◽

Nonvalvular Atrial Fibrillation ◽

Spontaneous Echo Contrast ◽

Obese Class ◽

Group 2 ◽

Group 1

Aim. To identify predictors of spontaneous echo contrast (SEC) and/or left atrial appendage (LAA) thrombosis in patients with nonvalvular atrial fibrillation (AF) who are referred for elective cardioversion or catheter ablation (CA).Material and methods. A retrospective analysis of data from 638 patients with nonvalvular AF who were hospitalized from 2014 to 2017 for cardioversion or CA was performed. All patients underwent diagnostic tests, including transthoracic and transesophageal echocardiography (TEE).Results. According to the TEE results, two groups of patients were formed: group 1 — 95 patients (14,9%) with signs of SEC and/or thrombosis in LAA; group 2 — 543 patients (85,1%) without SEC or thrombosis in LAA. Patients with the phenomenon of SEC and/or LAA thrombosis were older, had a higher risk on the CHA2DS2-VASc score. These patients were more likely to have coronary heart disease (CAD), hypertension, stage IIA chronic heart failure, obese class >II, persistent or permanent AF Patients in both groups did not differ in anticoagulant therapy. Patients in group 1 had a larger size of the left and right atria, right ventricle, left ventricular (LV) end-systolic and end-diastolic diameters, higher LV mass index, lower values of LV ejection fraction and blood flow velocity in LAA. Logistic regression revealed following independent predictors of SEC and/or LAA thrombosis: CAD (odds ratio (OR) 2,289; 95% confidence interval (CI) 1,313-3,990; p=0,003), persistent or permanent AF (OR 2,071; 95% CI 1,222-3,510; p=0,007), LA diameter >43 mm (OR 3,569; 95% CI 2,0822-6,117; p<0,001), concentric or eccentric LV hypertrophy (OR 2,230; 95% CI 1,302-3,819; p=0,003).Conclusion. As the result, all patients referring for CA or cardioversion, regardless of the CHA2DS2-VASc score, should underwent LAA. According to this study, the presence of CAD, persistent or permanent AF, LA diameter >43 mm, concentric or eccentric LV hypertrophy are independent predictors of SEC and/or LAA thrombosis.

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Safety and effects of volume loading during transesophageal echocardiography in the pre-procedural work-up for left atrial appendage closure

Cardiovascular Ultrasound ◽

10.1186/s12947-020-00230-1 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Afonso B. Freitas-Ferraz ◽

Mathieu Bernier ◽

Kim O’Connor ◽

Jonathan Beaudoin ◽

Jean Champagne ◽

...

Keyword(s):

Transesophageal Echocardiography ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Maximum Diameter ◽

Volume Loading ◽

Fluid Bolus ◽

Work Up ◽

Device Size ◽

Laa Closure

Abstract Background In patients undergoing left atrial appendage (LAA) closure, an accurate sizing of the LAA is key to optimize device sizing, procedural success and reduce complications. Previous studies have shown that intraprocedural volume loading increases LAA dimensions and improves device sizing. However, the safety and effects on LAA and device sizing of administering a fluid bolus during pre-procedural transesophageal echocardiography (TEE) are unknown. The aim of this study was to determine the safety and impact on LAA dimensions and device sizing of an intravenous (IV) fluid bolus administered during TEE in the setting of the pre-procedural work-up for LAA closure. Methods The study included a total of 72 patients who underwent TEE to assess suitability for LAAC and received a 500 ml IV bolus of normal saline. The LAA landing zone (LZ) and depth were measured by TEE before and after volume loading, and these measurements were used to predict the device size implanted during a subsequent percutaneous LAAC procedure. Results There were no complications associated with volume loading. The baseline mean LZ was 19.6 ± 3.6 mm at 90o, and 20.2 ± 4.1 mm at 135o. Following fluid bolus, the maximum diameter increased 1.5 ± 1.0 mm at 90o (p<0.001), and 1.3 ± 1.0 mm at 135o (p<0.001). The baseline mean depth of the LAA was 26.5 ± 5.5 mm at 90o, and 23.9 ± 5.8 mm at 135o. After fluid bolus, the mean depth increased by 1.5 ± 1.8 mm (p<0.001) and 1.6 ± 2.0 (p<0.001), at 90o and 135o, respectively. Sizing based on post-bolus measurements of the LZ significantly improved the agreement with the final device size selection during the procedure in 71.0% of cases (vs. 42.0% with pre-bolus measurements). Conclusions Volume loading during ambulatory TEE as part of the pre-procedural work-up of LAAC is safe and significantly increases LAA dimensions. This strategy may become the new standard, particularly in centers performing LAAC with no TEE guidance, as it improves LAA sizing and more accurately predicts the final device size.

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Does left atrial appendage occlusion influence left atrial hemodynamics? Pilot results of invasive intra-cardiac measurements

10.22541/au.161256726.66514930/v1 ◽

2021 ◽

Author(s):

Samuel Heuts ◽

John Heijmans ◽

Mark La Meir ◽

Bart Maesen

Keyword(s):

Pilot Study ◽

Left Atrial ◽

Left Atrial Appendage ◽

Systemic Arterial Pressure ◽

Left Ventricular ◽

Hemodynamic Effect ◽

Atrial Appendage ◽

Central Venous ◽

Left Atrial Appendage Occlusion ◽

Laa Closure

Introduction Although left atrial appendage (LAA) obliteration is the cornerstone of stroke prevention in surgical treatment of atrial fibrillation (AF), little is known about its direct impact on hemodynamics. In the current pilot study, we evaluated the hemodynamic effect of LAA closure by clipping in patients undergoing hybrid AF ablation. Methods Seven patients with paroxysmal or persistent AF were included. Hemodynamic and intracardiac pressure measurements such as systemic, pulmonary artery (PA), central venous and LA pressure, cardiac output and indexed left ventricular stroke volume (LVSVi) were measured directly before (T0) and after (T1), and 10 minutes after (T2) LAA closure. Results Of the 7 patients (median 66 yrs), 5 were in AF at the time of incision. There were no differences between T0 and T1, T1 and T2 and T0 and T2 for LA pressure, mean PA pressure, LVSVi and other hemodynamic parameters such as central venous oxygenation and pressure, or systemic arterial pressure. Conclusion In this pilot study, the direct hemodynamic effect of LAA closure is evaluated for the first time. Clipping of the LAA is safe and does not directly affect hemodynamic and intracardiac pressures.

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P4731Procedure-related acute thrombosis after surgical left atrial appendage occlusion for atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehz745.1107 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

T Inoue ◽

T Shimizu ◽

A Yoshimoto ◽

Y Suematsu

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Cardiac Ct ◽

Left Atrial Appendage ◽

Thrombus Formation ◽

Atrial Appendage ◽

Full Cohort ◽

Exact Test ◽

Acute Thrombosis ◽

Laa Closure

Abstract Background/Introduction Left atrial appendage (LAA) occlusion is an effective strategy for thromboembolism prevention in patients with atrial fibrillation (AF), and the novel methods of occlusion is various. The acute thrombosis after percutaneous LAA occlusion devices has been recently reported, but thrombus formation after surgical LAA occlusion is still unclear. Purpose This study aimed to analyse the incidence and prognosis of thrombus formation on closure stump line in patients with AF who underwent surgical LAA occlusion. Methods This study retrospectively analised the data from patients treated with two methods of surgical LAA closure, resection or clipping, from January 2014 to November 2018. Results A total of 187 consecutive patients with AF underwent surgical LAA closure (31 clipping and 156 stapler resection). 170 patients (91%) underwent cardiac CT for LAA imaging on postoperative day 2. The incidence of acute procedure-related thrombus formation in full cohort was 19% (35 cases). The incidence of acute thrombus in patients with clipping and resection was 19% and 16%, respectively (Fisher's exact test, p=0.8). All of 35 patients who had thrombus on LAA closure stump line underwent cardiac CT again 3 months after the primary CT. In all patients with secondary cardiac CT, thrombus on LAA closure stump line disappeared. No symptomatic thromboembolism occurred during the follow-up from operation to secondary CT scan. Conclusion(s) Thrombus formation on stump after surgical LAA closure may often occur on acute phase. The optimal LAA imaging and anti-coagulation therapy after surgical LAA occlusion will prevent patients with acute thrombus from thromboembolism.

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Image fusion of integrating fluoroscopy into 3D computed tomography in guidance of left atrial appendage closure

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jez286 ◽

2019 ◽

Vol 22 (1) ◽

pp. 92-101 ◽

Cited By ~ 1

Author(s):

Bin-Feng Mo ◽

Yi Wan ◽

Abudushalamu Alimu ◽

Jian Sun ◽

Peng-Pai Zhang ◽

...

Keyword(s):

Computed Tomography ◽

Image Fusion ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Control Group ◽

Closure Device ◽

Transseptal Puncture ◽

3D Computed Tomography ◽

Laa Closure

Abstract Aims We evaluated the feasibility of left atrial appendage (LAA) closure guided by the image fusion of integrating fluoroscopy into 3D computed tomography (CT). Methods and results A total of 117 consecutive patients who underwent LAA closure with or without the image fusion were matched (1:2). Each LAA closure step of the Image fusion group was guided by the preprocedure CT and image fusion, especially in the plan of LAA measurement and transseptal puncture. All patients were successfully implanted with a WATCHMAN closure device. Comparing the two groups, the mean number of recapture times and the number of devices per patient of the Image fusion group were significantly lower (0.4 ± 0.5 vs. 0.7 ± 0.8, P = 0.031 and 1.0 ± 0.2 vs. 1.1 ± 0.3, P = 0.027, respectively). The one-time successful deployment rate by the support of the image fusion was higher than in the control group (66.7% vs. 44.9%, P = 0.026). Each case of the Image fusion group was completely occluded with one transseptal puncture, while five of the Non-image fusion group required redo transseptal punctures. During the 45-day follow-up, both group cases presented occlusion efficiency and no major adverse cardiac events were observed. Conclusion Image fusion technique integrating fluoroscopy into the 3D CT is safe and feasible which can be easily incorporated into the procedural work-flow of percutaneous LAA closure. The fusion image can play an important alternative role in the plan of LAA measurement and transseptal puncture site for improving the LAA closure procedure.

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Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Postsurgical and Postlariat Leaks or Anatomies Unsuitable for Conventional Percutaneous Occlusion

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.120.009227 ◽

2020 ◽

Vol 13 (10) ◽

Author(s):

Domenico G. Della Rocca ◽

Rodney P. Horton ◽

Nicola Tarantino ◽

Christoffel Johannes Van Niekerk ◽

Chintan Trivedi ◽

...

Keyword(s):

Transesophageal Echocardiography ◽

Oral Anticoagulation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Systemic Circulation ◽

Atrial Appendage ◽

Landing Zone ◽

Septal Occluder Device ◽

Occluder Device ◽

Laa Closure

Background: Interventional therapies aiming at excluding the left atrial appendage (LAA) from systemic circulation have been established as a valid alternative to oral anticoagulation in patients at high thromboembolic risk. However, their efficacy on stroke prophylaxis may be compromised owing to incomplete LAA closure. Additionally, the need for an alternative thromboembolic prevention may remain unmet in patients with contraindications to oral anticoagulation whose appendage anatomy is unsuitable for some conventional devices commercially available. We aimed at evaluating the feasibility of LAA closure with the novel Gore Cardioform Septal Occluder in patients with incomplete appendage ligation or anatomic features which do not meet the manufacturer’s requirements for Watchman deployment. Methods: Twenty-one consecutive patients (mean age: 72±6 years; 85.7% males; CHA 2 DS 2 -VASc: 4.5±1.4; HAS-BLED: 3.6±1.0) were included. Transesophageal echocardiography was performed within 2 months to assess for residual LAA patency. Results: Fourteen patients had incomplete LAA closure following surgical (n=6) or Lariat ligation (n=8). In 7 patients with an appendage anatomy unsuitable for Watchman deployment, the mean maximal landing zone size and LAA depth were 14.4±1.3 and 18.6±2.8 mm. Successful Cardioform Septal Occluder deployment was achieved in all patients. No peri-procedural complications were documented. Procedure and fluoroscopy times were 46±13 and 14±5 minutes. Follow-up transesophageal echocardiography after 58±9 days revealed complete LAA closure in all patients. Conclusions: Transcatheter LAA closure via a Cardioform Septal Occluder device might be a valid alternative in patients with residual leaks following failed appendage ligation or whose LAA anatomy does not meet the minimal anatomic criteria to accommodate a Watchman device. Graphic Abstract: A graphic abstract is available for this article.

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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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Left atrial appendage perforation during appendage angiography treated by percutaneous left atrial appendage closure: a case report

European Heart Journal - Case Reports ◽

10.1093/ehjcr/ytab187 ◽

2021 ◽

Vol 5 (5) ◽

Author(s):

Catherine Champagne ◽

Nicolas Dognin ◽

Josep Rodés-Cabau ◽

Jean Champagne

Keyword(s):

Case Report ◽

Pericardial Effusion ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Closure Device ◽

Left Atrial Appendage Closure ◽

Case Summary ◽

Device Deployment ◽

Laa Closure

Abstract Background Pericardial effusion is a common complication of percutaneous left atrial appendage (LAA) closure. Acute management is the cornerstone of pericardial effusion treatment and interrupting the intervention is often required. Case summary A 65-year-old man presented an acute 10 mm pericardial effusion following pigtail contrast appendage injection. A rapid Watchman Flex 24 mm (Boston Scientific) deployment permitted bleeding interruption. A needle pericardiocentesis was achieved in order to prevent any haemodynamical instability. Discussion This case report describes an atypical cause of pericardial effusion and a technique for bleeding control with LAA closure device deployment.

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Closure of Residual Left Atrial Appendage Communications After a Prior Exclusion Attempt

10.22541/au.162224674.41334043/v1 ◽

2021 ◽

Author(s):

William Hucker ◽

Aneesh Bapat ◽

Alan Hanley ◽

Samuel Bernard ◽

Phillippe Bertrand ◽

...

Keyword(s):

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Imaging Data ◽

Maximal Diameter ◽

Amplatzer Occluder ◽

Preprocedural Imaging ◽

Watchman Device ◽

Laa Closure

Background: Surgical or percutaneous occlusion of the left atrial appendage (LAA) is increasingly used for thromboembolic protection in atrial fibrillation. Incomplete LAA closure may increase risk of thrombosis and thromboembolism, and therefore approaches to address residual communications are needed. Objective: To analyze the technique of closing an incompletely occluded LAA and subsequent patient outcomes. Methods: We performed a retrospective analysis of 5 consecutive patients who presented for completion of LAA closure. Results: Four patients were male, mean age 75, average CHA2DS2-VASc score 5.4, and four had prior surgical LAA ligation. One patient had previously had a WATCHMAN device placed for whom a 3D printed model was created from preprocedural imaging data to guide Amplatzer occluder device selection for closure. The residual LAA communication maximal diameter averaged 6.2 mm (range 5-8mm). In 4 of 5 cases, an ablation catheter was used to enter the LAA. The residual LAA communication was closed with either an Amplatzer occluder (n=3) or a WATCHMAN device (n=2). No procedural complications occurred, and no residual leak remained afterwards. No neurologic events occurred during follow up (average 603 days, range 155-1177 days). Anticoagulation or dual antiplatelet therapy was stopped following a transesophageal echo (TEE) ³ 6 weeks after the procedure demonstrated no residual communication in 4 of 5 patients, and after 20 weeks in the fifth patient without a follow up TEE. Conclusion: Large residual LAA communications after LAA occlusion attempts can be successfully and safely closed percutaneously using either Amplatzer occluder devices or WATCHMAN devices.

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