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

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.

Abstract 16527: Peri-Procedural and 45-Day Outcomes in the Roll-In Cohort of the Amplatzer Amulet Ide Trial of Left Atrial Appendage Occlusion

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Rakesh Gopinathannair ◽  
Scott M Koerber ◽  
Krishna Akella ◽  
Dhanunjaya Lakkireddy
Keyword(s):  
Ischemic Stroke ◽  
High Risk ◽  
Adverse Events ◽  
Hospital Discharge ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Watchman Device ◽  
Major Adverse Events

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.

scholarly journals Acute Device-Related Thrombus after Watchman Device Implant

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.

scholarly journals Incidence and characteristics of left atrial appendage stumps after device-enabled epicardial closure

2019 ◽  
Vol 29 (5) ◽  
pp. 663-669 ◽  
Author(s):  
Etem Caliskan ◽  
Matthias Eberhard ◽  
Volkmar Falk ◽  
Hatem Alkadhi ◽  
Maximilian Y Emmert
Keyword(s):  
Computed Tomography ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Success Rates ◽  
Imaging Data ◽  
Long Term Follow Up ◽  
Short And Long Term

Abstract OBJECTIVES High success rates for left atrial appendage (LAA) exclusion with the AtriClip (Atricure, USA) device have been reported in the literature. This study evaluated the presence and characteristics of residual LAA stumps after AtriClip LAA exclusion using postoperative short- and long-term computed tomography angiography (CTA). METHODS In this retrospective analysis, 43 of 291 consecutive patients undergoing cardiac surgery with concomitant LAA occlusion using the AtriClip device were identified with available postoperative short- and long-term follow-up by CTA. LAA patency and the absence or the size of a present residual LAA stump were assessed on 2-dimensional multiplanar reconstructions, on maximum intensity projection images and on volume-rendered 3-dimensional computed tomography reconstructions. Based on current recommendations, the threshold for a significant LAA stump length was defined <10 mm. RESULTS The LAA was successfully occluded in all 43 patients (100%) as confirmed by intraoperative transoesophageal echocardiography and CTA imaging with a mean follow-up duration of 7.1 ± 0.8 years post-implant. The absence of blood flow in the excluded LAA was confirmed in all cases. In 31 of 43 patients (72%), no residual stump (0 mm) was observed creating a smooth endocardial surface, CTA revealed residual LAA stumps in 11/43 patients (26%) with a length <10 mm and a significant residual stump with a depth of >10 mm (12 mm) in 1 patient (2%). The mean length, width and depth of the residual stumps were 5.8 ± 2.1, 4.4 ± 1.2 and 7.3 ± 2.3 mm, respectively. CONCLUSIONS This study investigated the incidence of residual stump formation (>10 mm) after LAA closure with the AtriClip device based on CTA imaging data obtained during short- and long-term follow-up. While no LAA stump was detectable in the majority of patients, a non-significant LAA stump (<10 mm) was present in 26% of cases, indicating a favourable LAA occlusion profile for the AtriClip device. However, although a LAA stump length <10 mm is currently considered clinically safe, this definition needs further attention in future studies with regards to its potential clinical implications.

Abstract 16076: Cost-effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF vs. PREVAIL

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
James V Freeman ◽  
David W Hutton ◽  
Geoffrey D Barnes ◽  
Ruo P Zhu ◽  
Douglas K Owens ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Intracranial Hemorrhage ◽  
Left Atrial ◽  
Randomized Trials ◽  
Left Atrial Appendage ◽  
Cost Effective ◽  
Atrial Appendage ◽  
Watchman Device ◽  
Using Data ◽  
Laa Closure

Introduction: Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown disparate results, and its cost-effectiveness compared to anticoagulation has not been evaluated using contemporary data. Methods: We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost-effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of PROTECT AF and PREVAIL randomized trials. Results: Using data from PROTECT AF, the incremental cost-effectiveness ratios (ICER) compared to warfarin and dabigatran were $20,140 and $24,400 per quality adjusted life year (QALY), respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (9.46, 9.59, and 9.64 QALYs, respectively) and more costly. At a willingness-to-pay-threshold of $50,000 per QALY, LAA closure was cost-effective 62% and 35% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation. Conclusion: The cost-effectiveness of LAA closure with the Watchman device depends largely on the clinical trial used for assigning event rates. Using data from PROTECT AF, Watchman was cost-effective; using PREVAIL data, Watchman was more costly and less effective than warfarin and dabigatran. Results were highly sensitive to the rates of stroke and intracranial hemorrhage in both treatment groups. Post-marketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice.

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

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.

scholarly journals Late left atrial appendage closure device displacement and massive thrombus formation: a case report

2020 ◽  
Vol 4 (2) ◽  
pp. 1-5 ◽  
Author(s):  
Benjamin Sasko ◽  
Oliver Ritter ◽  
Peter Bramlage ◽  
Fabian Riediger
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Thrombus Formation ◽  
Anticoagulation Therapy ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Closure Device ◽  
Watchman Device ◽  
High Bleeding Risk ◽  
Laa Closure

Abstract Background  Left atrial appendage (LAA) closure with the WATCHMAN device is an alternative to anticoagulation therapy for the prevention of stroke in selected patients with atrial fibrillation (AF). Infrequently, left atrial (LA) device-related thrombus formation occurs and it is poorly understood. Thrombus formation due to incomplete covering of the LAA is even rarer and may occur within the first few months after device implantation. Case summary  Here, we present a case of a 68-year-old male patient with permanent AF, drug- and hepatitis induced liver cirrhosis (CILD Score B), and prior aortic valve replacement. The patient had a history of percutaneous LAA closure using a WATCHMAN device. He developed massive peri-device leak and thrombus arising from the space between the device and appendage cleft 2 years after implantation. Because of the high bleeding risk with a HAS-BLED score of 5 points, surgery was chosen as the therapy of choice instead of long-term anticoagulation. The patient was discharged in good clinical condition and has been scheduled for a yearly follow-up. Discussion  This case emphasizes the importance of choosing appropriately sized LAA occluder devices and planning for regular post-interventional follow-ups to minimize the risk of per-device leaks and thrombi.

Abstract 17421: Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Post-Surgical and Post-Lariat Leaks or Anatomies Unsuitable for Conventional Percutaneous Occlusion

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Domenico G Della Rocca ◽  
Rodney Horton ◽  
Nicola Tarantino ◽  
Luigi Di Biase ◽  
Carola Gianni ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Systemic Circulation ◽  
Atrial Appendage ◽  
Landing Zone ◽  
Septal Occluder Device ◽  
Watchman Device ◽  
Occluder Device ◽  
Procedural Complications ◽  
Laa Closure

Introduction: Interventional therapies aiming at excluding the left atrial appendage (LAA) from systemic circulation have been established as a valid alternative to oral anticoagulation (OAC) in patients at high thromboembolic (TE) risk. However, their efficacy on stroke prophylaxis may be compromised owing to incomplete LAA closure. Additionally, the need for an alternative TE prevention may remain unmet in patients with contraindications to OAC whose appendage anatomy is unsuitable for some conventional devices commercially available. Hypothesis: We aimed at evaluating the feasibility of LAA closure with the novel Gore® Cardioform Septal Occluder (CSO) in patients with incomplete appendage ligation or anatomical 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. Trans-esophageal echocardiography (TEE) 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±1.3mm and 18.6±2.8mm. Successful CSO deployment was achieved in all patients. No peri-procedural complications were documented.Procedure and fluoroscopy times were 46±13min and 14±5min. Follow-up TEE after 58±9 days revealed complete LAA closure in all patients. Conclusions: Transcatheter LAA closure via a CSO device might be a valid alternative in patients with residual leaks following failed appendage ligation or whose LAA anatomy does not meet the minimal anatomical criteria to accommodate a Watchman device.

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.

A collective European experience with left atrial appendage suture ligation using the LARIAT+ device

EP Europace ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. 924-931
Author(s):  
Roland Richard Tilz ◽  
Thomas Fink ◽  
Krzysztof Bartus ◽  
Tom Wong ◽  
Julia Vogler ◽  
...  
Keyword(s):  
Adverse Events ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Transoesophageal Echocardiography ◽  
Atrial Appendage ◽  
Suture Ligation ◽  
Ventricular Tachycardia Ablation ◽  
European Experience ◽  
Laa Closure

Abstract Aims We report the collective European experience of percutaneous left atrial appendage (LAA) suture ligation using the recent generation LARIAT+ suture delivery device. Methods and results A total of 141 patients with non-valvular atrial fibrillation and contraindication to oral anticoagulation (OAC), thrombo-embolic events despite OAC or electrical LAA isolation were enrolled at seven European hospitals to undergo LAA ligation. Patients were followed up by clinical visits and transoesophageal echocardiography (TOE) following LAA closure. Left atrial appendage ligation was completed in 138/141 patients (97.8%). Three patients did not undergo attempted deployment of the LARIAT device due to pericardial adhesion after previous epicardial ventricular tachycardia ablation (n = 1), a pericardial access-related complication (n = 1), and multiple posterior LAA lobes (n = 1). Serious 30-day procedural adverse events occurred in 4/141 patients (2.8%). There were two device-related LAA perforations (1.4%) not resulting in any corrective intervention as the LAA was completely sealed with the LARIAT. Minor adverse events occurred in 19 patients (13.5%), including two pericardial effusions due to procedure-related pericarditis requiring pericardiocentesis. Transoesophageal echocardiography was performed after LAA ligation in 103/138 patients (74.6%) after a mean of 181 ± 72 days. Complete LAA closure was documented in 100 patients (97.1%). Two patients (1.8% of patients with follow-up) experienced a transient ischaemic attack at 4 and 7 months follow-up, although there was no leak observed with TOE. There were two deaths during long-term follow-up which were both not device related. Conclusion Initial experience with the LARIAT+ device demonstrates feasibility of LAA exclusion. Further larger prospective studies with longer follow-up are warranted.

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