Left Atrial Appendage Occluder Implantation Research Articles

THORACOSCOPIC LEFT ATRIAL APPENDAGE AMPUTATION CAN BE AN ALTERNATIVE TO ENDOVASCULAR OCCLUSION

HighlightsWe present a clinical case of a patient with atrial fibrillation and a high bleeding risk according to HAS-BLED bleeding risk score who underwent thoracoscopic left atrial appendage (LAA) occluder implantation due to lack of endovascular access. Thoracoscopic amputation of LAA also can be performed in cases where an endovascular access cannot be achieved due to occlusion of the inferior vena cava or thrombosis of LAA. However, it is necessary to monitor the condition of the stump when conducting thoracoscopic amputation of LAA, and stop anticoagulation therapy only in case of non-embologenic stump. AbstractAtrial fibrillation is the most common rhythm disorder that can be conservatively treated using antiarrhythmic therapy, and anticoagulants can be used to prevent thromboembolic complications. However, prolonged use of anticoagulants is complicated by the risk of bleeding. Left atrial appendage (LAA) occluder implantation is an alternative way of preventing of thromboembolic and hemorrhagic complications. The article presents a clinical case of thoracoscopic LAA amputation after unsuccessful endovascular LAA occluder implantation in the patient with the inferior vena cava occlusion.

Thoracoscopic ablation of persistent atrial fibrillation after left atrial appendage occluder implantation: a case report

A clinical case of successful radiofrequency thoracoscopic ablation of persistent atrial fibrillation after implantation of an occluder in the left atrium appendage is presented.

The use of distal femoral venous access for pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation: randomized study design and preliminary results

Aim. This study aims to compare the results of the distal femoral access with the classic approach in patients undergoing pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation.Methods. The primary results of the 1:1 randomized single-center study are presented. The study group recruited 47 patients who underwent the catheter-based procedure using ultrasound-assisted distal femoral access. 38 patients with traditional ultrasound-guided proximal femoral access were involved in the control group.Results. Total 85 patients were included: 47 in the study group and 38 in the control group. The median age was 61 years, and pulmonary vein cryo-ablation was performed in 84%. 95% of patients were taking direct oral anticoagulants. In the study group, the most frequent topographic and anatomical variant was the location of the superficial femoral vein on the lateral side from the artery (81%), whereas in the control group it was on the medial side (81%). The median access time was 30 s in the study group for the right leg and 35 s for the left leg. In the control group, access time was 33 s and 39 s for the right and left leg respectively. Unintentional arterial puncture occurred more frequently in both groups when the vein was fully overlapped by the artery for both right and left legs, but the differences were statistical unsignificant (p>0.05 and p=0.09 in the main group, p=0.24 and p=0.72 in the control group). In a correlation analysis, neither body mass index (p=0.19) nor femoral circumference (p=0.19 for right and p=0.06 for left legs) influenced the access time and did not increase the number of unintended arterial punctures. Two patients in the control group required additional manual hemostasis. There was no postprocedural venous thrombosis in both groups. Back pain was observed only in patients in the control group.Conclusion. The efficacy and safety of the distal femoral access approach are comparable to the traditional proximal approach. Earlier postprocedural activation of patients can help improve quality of life.

Using a single steerable sheath for simultaneous left atrial appendage occluder implantation and pulmonary vein isolation.

The left atrial appendage (LAA) occluder (LAAO) has become an alternative to anticoagulation in patients with atrial fibrillation (AF). AF catheter ablation using a steerable sheath has been reported to result in a significantly higher clinical success rate.1 Therefore, there also may be advantages to using a steerable sheath for LAAO implantation.

Bailout left atrial appendage occluder for pulmonary vein isolation and electrical cardioversion in patients with atrial fibrillation and left atrial appendage thrombus: a pilot study.

Cardioversion and catheter-based circumferential pulmonary vein isolation (CPVI) are established rhythm control treatment strategies for patients with atrial fibrillation (AF). However, these treatments are contraindicated for AF patients with a left atrial appendage (LAA) thrombus. We conducted the first-in-man case series study to evaluate the feasibility and safety of performing cardioversion or CPVI in AF patients with LAA thrombus immediately after implantation of LAA Occluder (LAAO) in a combined procedure. In our multi-center LAAO registry of 310 patients, 27 symptomatic and drug-refractory AF patients underwent a combined procedure of LAAO and CPVI, among whom 10 (mean age 68 ± 16years, 6 men) having anticoagulant-resistant LAA thrombus received a bailout procedure of LAAO implantation first then CPVI, and the other 17 patients without LAA thrombus received CPVI first then LAAO for comparison. The mean CHA2DS2-VASc score and HAS-BLED score were comparable between these two groups. In patients with LAA thrombus, we put carotid filters and did a no-touch technique, neither advancing the wire and sheath into the LAA nor performing LAA angiography. After LAAO implantation, the connecting cable was still connected to the occluder when cardioversion was performed. During CPVI, the occluder location was registered in the LA geometry by three-dimensional mapping to guide the catheter not to touch the LAAO. The procedure was successful in all the patients without intra-procedural complications. After a mean follow-up of 1.7 ± 0.7years, there was no device embolization, peri-device leak ≧ 5mm or stroke event in both groups. The AF recurrence rate was also similar between the two groups (P = 0.697). We demonstrated that cardioversion or CPVI is doable in symptomatic AF patients with LAA thrombus if LAA was occluded ahead as a bailout procedure.

A Novel Echocardiographic-Based Classification for the Prediction of Peri-Device Leakage following Left Atrial Appendage Occluder Implantation.

(1) Background: The assessment of residual peri-device leakages (PDL) after left atrial appendage occlusion (LAAO) remains crucial for post-procedural management. Our study aimed to verify a novel echocardiographic classification for the prediction of PDL. (2) Methods: Echocardiographic data of 72 patients who underwent percutaneous LAAO were evaluated. All echo images were analyzed by two independent investigators using standard analysis software (Image-Arena IA-4.6.4.44 by TomTec®, Munich, Germany). A total number of 127 studies was evaluated. Forty-four patients had baseline studies, at 45 days and at 6 months post-implantation. We propose a morphological classification of LAA devices based on the amount of echodensity inside the devices into three types: type A showing complete homogenous thrombosis, type B incompletely thrombosed device with inhomogeneous echo-free space <50% of device, and type C with partially thrombosed device in which the echo free space was >50% of device in various planes, which we called the “ice-cream cone” sign. Each type was matched to the degree of PDL and clinical outcome parameters. (3) Results: Patients with type C had the highest percentage of PDL at 45 days follow-up (type A: 24%, type B: 31%, type C 100% PDL, p < 0.001) and at 6 months follow-up (type A: 7%, type B: 33%, type C 100% PDL, p < 0.001). Notably, device size in patients with PDL was larger than that in patients without PDL at 6 months follow-up (25.6 ± 3.5 mm vs. 28.7 ± 3.4 mm, p = 0.004). Device size in patients with type C appearance was the largest of the three types (type A: 25.9 ± 3.6 mm, type B: 25.8 ± 3.4 mm, type C 29.8 ± 3.0 mm, type A vs. C; p = 0.019; type B vs. C, p = 0.007). (4) Conclusions: In conclusion, PDL are common post-LAAO, and their frequency is underestimated and under-recognized. PDL are much more common in patients with larger LAA ostial sizes and likely lower longitudinal compression. Type C appearance of the LAAO devices (“ice-cream cone sign”) has a high positive predictive value for PDL. Further studies are needed for better delineation of the clinical importance of this proposed classification.

Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Gender-related outcomes in the German LAARGE Registry.

Gender-based differences in atrial fibrillation have been identified, but limited data exist for patients undergoing left atrial appendage occluder (LAAO) implantation. This study reports gender-related periprocedural and 1-year outcomes of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). LAARGE enrolled 641 patients who were scheduled for LAAO implantation from July 2014 to January 2016 in 38 hospitals in Germany. The data collected included demographics, clinical characteristics, details of implantation, and outcome. Efficacy and safety at 1-year follow-up were assessed by the occurrence of thrombembolic and bleeding events, as well as mortality. Of 638 patients undergoing LAAO implantation 38.9% were female and 61.1% male. Females were older (76.4 ± 8.2 [females] vs. 75.6 ± 7.7 [males], p = .042) and had a higher stroke risk (CHA2 DS2 -VASc score: 4.9 ± 1.5 vs. 4.3 ± 1.5, p < .001). In contrast, males suffered more often from coronary artery (33.1% vs. 53.8%, p < .001) and vascular disease (18.5% vs. 31.0%, p < .001). Technical success was high and similar for both genders (98.4% vs. 97.2%, p = .33). Severe periprocedural complications (6.9% vs. 3.1%, p = .032) occurred more often in females. At 1-year follow-up the rates of all-cause stroke (0.5% vs. 1.3%, p = .65) and severe bleeding (0.0% and 1.0%, p = .29) were low and comparable between the genders. Also, one-year all-cause mortality (9.2% vs. 13.1%, p = .14) did not differ significantly. LAARGE documented in this elderly patient population undergoing LAAO implantation a higher rate of severe periprocedural complications in females. At 1-year follow-up similar efficacy and safety outcomes were observed for both genders.

Safety of reduced or absent antithrombotic therapy after left atrial appendage closure in patients affected by hereditary hemorrhagic telangiectasia and atrial fibrillation.

Left atrial appendage (LAA) closure represents a novel therapeutic chance for patients with contraindications to long-term anticoagulation therapy, such as those affected by hereditary hemorrhagic telangiectasia (HHT) and atrial fibrillation (AF). Nevertheless, current experts' indications suggest the postprocedural administration of antithrombotic therapies to minimize the residual thromboembolic risk due to AF and to the need for device endothelialization. The aim of our study was to investigate the safety and effectiveness of LAA closure in preventing arterial thromboembolism in a very high-bleeding risk group, such as HHT patients, who are at risk not to tolerate even the mild postprocedural antithrombotic therapy usually recommended. Eight HHT-affected patients with non-valvular AF, high-bleeding risk and/or known intolerance to antiplatelet and anticoagulant therapy were treated with interventional LAA occlusion with the Amplatzer™ Cardiac Plug™ and Amplatzer™ Amulet™ devices. Device implantation was successful in all patients. Postprocedural antiplatelet/anticoagulation therapy was attempted in seven patients: adherence to therapy exceeded 6 months only for one, while four patients suspended all antithrombotic medications within 30 days from the procedure due to an increase in bleeding frequency and/or severity and the other two discontinued treatment within 6 months; a single patient was not prescribed any antithrombotic therapy. At a medium follow-up of 22.4±14.3 months no thromboembolic episodes attributable to AF or device related thrombosis were reported. Two deaths were recorded 1231 and 783 days after the procedure which were classified as unrelated to any cerebral or cardiovascular accident. Our study suggests that the percutaneous LAA closure in HHT patients with AF could be safe and effective in preventing arterial systemic thromboembolism, also in the presence of reduced or absent postinterventional antithrombotic treatment. LAA occluder implantation can represent a valid and potentially life-saving alternative to lifelong anticoagulant therapy in HHT, as in other very high-bleeding risk patients.

Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Acute and long-term outcome of occluder implantation in the LAARGE Registry.

Left atrial appendage occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) patients who are not eligible for long-term oral anticoagulation. The present paper describes the acute and 1-year follow-up outcome data of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). LAARGE enrolled 641 patients who were scheduled for LAAO implantation. The data collected included demographics, clinical characteristics, procedure indication, details of implantation, and outcome; patients were followed at 1-year post-implant. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively. A total of 641 consecutive patients (mean age: 75.9 ± 8.0) were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Patient demographics represent a critically-ill population with a calculated mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively, with bleeding events as the main indication for LAAO implantation (79.4%). One-year all-cause mortality post-procedure was 11.5% with a non-fatal stroke/TIA rate of 1.3% (8 patients) and a rate of major bleeding of 1.6% (10 patients). The anticoagulation regimen after 1 year consisted of oral anticoagulation in 5.5% of patients and an antiplatelet therapy (APT) rate of 84.1% (majority single APT with ASS (74.5%), dual APT in 6.7%). LAARGE, a prospective multicenter real-world and all-comer registry, is unique in its concept, as it is non-manufacturer sponsored and includes all commercially available devices. LAAO implantation is mainly performed in elderly, critically-ill patients with a history of bleeding. LAARGE demonstrates a favorable outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%) while using a single APT in the vast majority of patients.

In silico Optimization of Left Atrial Appendage Occluder Implantation Using Interactive and Modeling Tools.

According to clinical studies, around one third of patients with atrial fibrillation (AF) will suffer a stroke during their lifetime. Between 70 and 90% of these strokes are caused by thrombus formed in the left atrial appendage. In patients with contraindications to oral anticoagulants, a left atrial appendage occluder (LAAO) is often implanted to prevent blood flow entering in the LAA. A limited range of LAAO devices is available, with different designs and sizes. Together with the heterogeneity of LAA morphology, these factors make LAAO success dependent on clinician's experience. A sub-optimal LAAO implantation can generate thrombi outside the device, eventually leading to stroke if not treated. The aim of this study was to develop clinician-friendly tools based on biophysical models to optimize LAAO device therapies. A web-based 3D interactive virtual implantation platform, so-called VIDAA, was created to select the most appropriate LAAO configurations (type of device, size, landing zone) for a given patient-specific LAA morphology. An initial LAAO configuration is proposed in VIDAA, automatically computed from LAA shape features (centreline, diameters). The most promising LAAO settings and LAA geometries were exported from VIDAA to build volumetric meshes and run Computational Fluid Dynamics (CFD) simulations to assess blood flow patterns after implantation. Risk of thrombus formation was estimated from the simulated hemodynamics with an index combining information from blood flow velocity and complexity. The combination of the VIDAA platform with in silico indices allowed to identify the LAAO configurations associated to a lower risk of thrombus formation; device positioning was key to the creation of regions with turbulent flows after implantation. Our results demonstrate the potential for optimizing LAAO therapy settings during pre-implant planning based on modeling tools and contribute to reduce the risk of thrombus formation after treatment.

Main pulmonary artery perforations after left atrial appendage occluder implantation.

Main pulmonary artery perforations after left atrial appendage occluder implantation.

P2897Impact of age &gt;75 years on one-year events in patients with atrial fibrillation and left atrial appendage occluder implantation. Results of the prospective LAARGE Registry

P2897Impact of age &gt;75 years on one-year events in patients with atrial fibrillation and left atrial appendage occluder implantation. Results of the prospective LAARGE Registry

P936Catheter based Left Atrial Appendage Occluder implantation using a novel LAmbre system vs. Amulet and Watchman Device in atrial fibrillation

P936Catheter based Left Atrial Appendage Occluder implantation using a novel LAmbre system vs. Amulet and Watchman Device in atrial fibrillation

Left atrial appendage occluder implantation in Europe: indications and anticoagulation post-implantation. Results of the European Heart Rhythm Association Survey.

The aim of this EP Wire survey was to assess the indications and anticoagulation strategies post-left atrial appendage occluder (LAAO) implantation for stroke prevention in patients with non-valvular atrial fibrillation in Europe. A total of 33 centres in 13 European countries completed the survey. All centres were members of the European Heart Rhythm Association Electrophysiology Research Network. Left atrial appendage occluder procedures were performed by electrophysiologists in 52% of the centres and by interventional cardiologists in the remaining centres. The EP Wire survey has revealed that the most common indications for LAAO are stroke prevention in patients at high thrombo-embolic risk and absolute contraindications to oral anticoagulation (OAC) therapy or a history of bleeding. Early- and long-term post-implantation anticoagulation strategies in patients with and without device thrombosis were very heterogeneous between centres with most strategies not being supported by the randomized trials. In patients without contraindications to OAC, 41% of the centres would prescribe no therapy at all after 6 months following LAAO implantation. In patients with LAA thrombus during follow-up and patients with absolute contraindications to OAC, management was highly heterogeneous and included aspirin, clopidogrel, non-vitamin K antagonist oral anticoagulants, low molecular weight heparin, surgery, unfractionated heparin, or no therapy.

Left atrial appendage occluder implantation for stroke prevention in elderly patients with atrial fibrillation: acute and long-term results.

Left atrial appendage occluder implantation for stroke prevention in elderly patients with atrial fibrillation: acute and long-term results.

Early Anterior Mitral Valve Leaflet Mechanical Erosion Following Left Atrial Appendage Occluder Implantation

An 84-year-old woman was referred to our center for a left atrial appendage occlusion (LAAO) procedure. Her medical history included alcoholic cirrhosis, permanent atrial fibrillation, and recent hemorrhagic shock related to gastrointestinal bleeding under oral anticoagulation. CHA2DS2-VASc (

Convexity Subarachnoid Hemorrhage, Pseudomonas Aeruginosa (PA) Infective Endocarditis and Left Atrial Appendage Occluder (LAAO) Device Infection. A Case Report.

An 83 year-old-man with left atrial appendage occluder (LAAO) developed Pseudomonas Aeruginosa (PA) infective endocarditis. MRI at day 3 of onset showed distal small infarcts in both middle cerebral arteries and left postero-inferior cerebellar artery territories. MRI at day 6 revealed two sites of convexity subarachnoid hemorrhage (cSAH). MRA and CTA failed to reveal a Mycotic aneurysm.The radiologic findings favor the assumption of necrosis of distal branches of mca or of pial arteries wall.This case present three unusual features: the presence of localized cSAH after initiation of antibiotherapy without mycotic aneurysm being individualized; the late occurrence of infective endocarditis after LAAO implantation; the very rare occurrence of PA in prosthetic infections.

Preprocedural and procedural transesophageal echocardiography in patients with left atrial appendage occluder implantation

Preprocedural and procedural transesophageal echocardiography in patients with left atrial appendage occluder implantation

Three-Dimensional Printing for Planning Occlusion Procedure for a Double-Lobed Left Atrial Appendage

A 78-year-old woman with atrial fibrillation and contraindication to oral anticoagulation because of high bleeding risk was referred for catheter-based left atrial appendage (LAA) occlusion. Preprocedural transesophageal echocardiography (TEE) using the biplane mode showed an LAA with double-lobed anatomy with a dominant posterior lobe (p) and an accessory anterior lobe (a; Figure [A]). It was thought that successful LAA occluder implantation may be made more challenging by this anatomy because it is necessary to occlude the ostia of both lobes with the device. For better planning, we decided to simulate the actual procedure using three-dimensional (3D) printing technology. A computer-based hollow cast of the LAA was created from the 3D TEE data set and then converted to a stereolithography file for 3D printing using dedicated software (Mimics, Materialize Software, Leuven, Belgium; …