Percutaneous Left Atrial Appendage Occlusion Research Articles

Percutaneous left atrial appendage closure, a safe alternative to anticoagulation for patients with nonvalvular atrial fibrillation and end-stage renal disease on hemodialysis: A single center experience.

The evidence about the effectiveness and safety of oral anticoagulation in patients on hemodialysis is conflicting and scarce. Percutaneous left atrial appendage occlusion (LAAO) has demonstrated to be a valid alternative therapeutic option for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). The aim of this study is to present the outcomes of percutaneous LAAO in patients with end-stage renal disease (ESRD) on hemodialysis and NVAF in our center. We conducteda retrospective review of clinical records, demographics, LAAO procedure, complications, and outcomes of patients with NVAF and ESRD on hemodialysis who underwent a percutaneous LAAO in our center between January 2017 and January 2019. In the period of the study, eight patients with ESRD on hemodialysis underwent a percutaneous LAAO in our center. The overall mean age was 67.5years (range 56-81; SD±7.2). All patients had permanent NVAF. The total mean dialysis duration was 8.49years (range 0.83-14.8; SD±6.2). The mean CHA2DS2-VASc and HAS-BLED scores were high (4.75 [SD±1.16] and 4.62 [SD±0.91], respectively). All patients had history of a major hemorrhagic event (BARC Score ≥3). Most patients (n=6) showed left ventricular hypertrophy, and the average LVEF was 54% (SD±6.5). All devices were implanted successfully. Postprocedural antithrombotic regimen prescribed was based on antiplatelet therapy. No deaths, cardioembolic events, or major bleeding (according to the BARC scale) were reported during a mean follow-up of 14.24months (SD±9.44). Percutaneous LAAO could be of particular interest in patients with NVAF and CKD in hemodialysis. Further studies will be necessary to confirm this hypothesis.

Long-term transesophageal echocardiography follow-up after percutaneous left atrial appendage closure

Peri-device leaks and device thrombi are assumed to lead to ischemic events after percutaneous left atrial appendage occlusion (LAAO). While these device-related complications are well assessed until 12 months after LAAO, no data are available beyond this period. The purpose of this study was to assess device-related complications beyond 12 months after LAAO. All patients who underwent successful percutaneous LAAO ≥12 months ago in the 2 participating centers were screened for eligibility. After inclusion, structured transesophageal echocardiography (TEE) was performed to assess peri-device leaks, device thrombus, and other device-related complications. A total of 63 patients were enrolled in the present prospective, 2-center, nonrandomized, single-arm trial. The median time from implantation until long-term TEE was 3.1 years (interquartile range 2.0-5.1 years), ranging from 1.0 to 7.5 years. The number of patients without a detectable leak increased significantly at long-term TEE compared with 6-week follow-up (P = .04). Major peri-device leaks (>5 mm) were detected in 2 patients (3%). Device thrombus was found in 8 patients (13%). Patients with device thrombus at long-term follow-up had larger peri-device leaks at 6-week follow-up than did those without thrombus formation (3.0 [interquartile range 2.7-3.5] vs 1.4 [interquartile range 0.0-2.6]; P = .04). Of those who suffered an ischemic stroke during long-term follow-up (n = 5), 1 patient showed a peri-device leak >5 mm. None of the patients with detected device thrombus had a stroke. Peri-device leaks and device thrombi continue to occur during long-term follow-up after LAAO. The clinical impact of these late occluder complications requires further evaluation in larger prospective trials.

Efficacy and safety of catheter ablation combined with left atrial appendage occlusion for nonvalvular atrial fibrillation: A systematic review and meta-analysis.

Atrial fibrillation (AF) is currently the most prevalent arrhythmia in clinical practice, with stroke being one of its major complications. Combining catheter ablation and percutaneous left atrial appendage occlusion (LAAO) into a "one-stop" intervention could reduce stroke incidence in selected high-risk patients and, at the same time, relieve AF symptoms in a single procedure. This meta-analysis analyzed the efficacy and safety of catheter ablation combined with LAAO for nonvalvular AF. PubMed, EMBASE, and the Cochrane Library were searched from inception to April 2019 to identify relevant citations. Efficacy indexes were procedural success, AF recurrence, stroke/transient ischemic attacks (TIA), and device-related thrombus (DRT). Safety indexes were all-cause death, major hemorrhagic complications, and pericardial effusion/cardiac tamponade. The incidence rate of events (ratio of events to patients) and 95% confidence interval (CI) were calculated as summary results. A forest plot was constructed to present pooled rates. Eighteen studies (two randomized controlled trials and 16 observational studies) were included. The results showed that one-stop intervention has significant efficacy and safety, with procedural success of .98 (95% CI, .97-1.00), AF recurrence of .24 (95% CI, .15-.35), stroke/TIA of .01 (95% CI, .00-.01), DRT of .00 (95% CI, .00-.01), all-cause mortality of .00 (95% CI, .00-.00), cardiac/neurological mortality of .00 (95% CI, .00-.00), major hemorrhagic complications of .01 (95% CI, .00-.02), and pericardial effusion/cardiac tamponade of .01 (95% CI, .00-.01). A single procedure with catheter ablation and LAAO in AF is a feasible strategy with significant efficacy and safety.

Incidence, Characteristics and Management of Persistent Peri-Device Flow after Percutaneous Left Atrial Appendage Occlusion

ABSTRACT Background : Severe peri-device leaks after left atrial appendage (LAA) occlusion requires continuation of life-long oral anticoagulation. However, the majority of patients referred for LAA occlusion are not suitable for anticoagulation. Data on the incidence, characteristics, and management of peri-device leak after LAA occlusion are scarce. Methods : We assessed the incidence of peri-device leak, its characteristics, and their management outcomes in 200 consecutive patients who underwent LAA occlusion between April 2016 and August 2018. Results : Severe persistent peri-device flow was present in 9/200 patients (4.5%) at 45 days. Baseline clinical characteristics were comparable between patients with or without severe leaks. However, patients with severe leaks had larger LAA diameter (24.5 ± 4.3 vs. 19.8 ± 3.7 mm, p < 0.001), and more sub-optimal deployments (100% vs. 26.7%, p < 0.001). Sub-optimal deployment parameters included: non-coaxial deployment, preferential single lobe deployment, incomplete coverage of a proximal side lobe, and shallow implantation. Among patients with severe leaks, 7 (78%) underwent percutaneous closure. Percutaneous closure with the Amplatzer Vascular Plug-II device had a 100% success rate and no short-term complications. Conclusions : Severe peri-device leak is present in ~5% of patients following LAA occlusion. Certain anatomical and procedural factors might contribute to the occurrence of peri-device leak. Severe leaks can be effectively closed with percutaneous techniques.

A case of a patient treated with percutaneous edge-to-edge mitral valve repair, percutaneous left atrial appendage occlusion and implantable cardioverter-defibrillator

The article presents the case of a 55-year-old woman who suffered from anterior myocardial infarction and chronic complications of the underlying disease, heart failure with reduced left ventricular ejection fraction, severe secondary mitral regurgitation, and paroxysmal atrial fibrillation. Due to the severity of symptoms, which persisted despite the optimal pharmacotherapy, after exclusion of reversible causes, the patient was qualified for different advanced percutaneous treatment methods. Within two years from the onset of the disease, three percutaneous procedures were performed: mitral valve correction with the MitraClip system, left atrial appendage occlusion using the Watchman system, and implantation of cardioverter-defibrillator.

ISCHEMIC STROKE IN A PATIENT WITH A WATCHMAN DEVICE: WHAT'S THE LEAK GOT TO DO WITH IT?

SESSION TITLE: Monday Medical Student/Resident Case Report Posters SESSION TYPE: Med Student/Res Case Rep Postr PRESENTED ON: 10/21/2019 02:30 PM - 03:15 PM INTRODUCTION: The prevention of stroke is a significant challenge in patients with atrial fibrillation. The advent of the WATCHMAN device has provided a much needed alternative for patients in whom long term anticoagulation is not appropriate. However, the efficacy and safety of this device has not been well studied. CASE PRESENTATION: 82-year-old man presented with visual disturbances and unsteady gait. He underwent MRI of the brain which revealed an acute right occipital infarction which appeared embolic in origin. He had a history of chronic atrial fibrillation requiring anticoagulation and had undergone successful left atrial appendage (LAA) closure via placement of WATCHMAN device 6 months prior. Anticoagulation was discontinued post-implant as per protocol. In the setting of an acute embolic stroke with a WATCHMAN device in place, further workup was advised. To ascertain the source of the embolic stroke, further imaging was undertaken. CT angiogram of the head, neck, and chest did not show any extracardiac source of thromboembolism. Transesophageal echocardiogram (TEE) was negative for intracardiac thrombus, however, a 5 mm residual leak was noted at the edge of the WATCHMAN implant. In the absence of any other source, the patient’s stroke was presumed to be cardioembolic and likely originating in the LAA, given the leak around the implant. Dual antiplatelet therapy was resumed with the intention of initiating anticoagulation once he recovered from his acute stroke. DISCUSSION: Left atrial appendage occlusion (LAAO) is a novel procedure that is becoming more commonplace. It is indicated for patients with atrial fibrillation at high risk for cardioembolic stroke but also have contraindications to anticoagulation. However, LAAO devices are not without complications. Currently, the WATCHMAN implant is the only FDA approved LAAO device on the market. Trial data suggests a higher risk of ischemic strokes in patients who have undergone WATCHMAN implant. However, there is limited awareness and understanding of this complication in clinical practice. Up to 14% of patients can develop device-related thrombi (DRT) and up to 3.7% of patients can have device embolization. Because the incidence of DRT is rare, it is difficult to identify risk factors that may predict individuals at risk of developing them. Current guidelines recommend screening TEE at 45 days, however, most DRT are detected after more than 45 days. This implies that current recommendations may be inadequate for preventing DRT in at-risk patients. CONCLUSIONS: As LAA closure devices become more prevalent, there is a growing need for re-assessing their efficacy and establishing guidelines for assessing device function. Furthermore, identification of sub-groups that are at higher risk for delayed complications will help with patient selection in the future. Reference #1: Moussa Pacha H, Al-Khadra Y, Soud M, Darmoch F, Moussa Pacha A, Alraies MC. Percutaneous devices for left atrial appendage occlusion: A contemporary review. World J Cardiol. 2019;11(2):57-70. Reference #2: Dukkipati S.R., Kar S., Holmes D.R., et al: Device-related thrombus after left atrial appendage closure: incidence, predictors, and outcomes. Circulation 2018; 138: pp. 874-885. Reference #3: Alkhouli M., Busu T., Shah K., Osman M., Alqahtani F., and Raybuck B.: Incidence and clinical impact of device-related thrombus following percutaneous left atrial appendage occlusion: a meta-analysis. J Am Coll Cardiol EP 2018; 4: pp. 1629-1637. DISCLOSURES: No relevant relationships by basma al-bast, source=Web Response No relevant relationships by Mirza Ali, source=Web Response No relevant relationships by Abdisamad Ibrahim, source=Web Response No relevant relationships by Abhishek Kalidas Kulkarni, source=Web Response No relevant relationships by Nitin Tandan, source=Web Response

P1002Echocardiographic assessment of optimal device position after percutaneous left atrial appendage occlusion - introduction of a novel classification and its impact on outcome

Abstract Background Left atrial appendage occlusion (LAAo) is an established therapy in patients with atrial fibrillation. However, criteria regarding optimal device position are not well defined making comparability of procedural results virtually impossible. We therefore sought to a) introduce a classification describing optimal vs. suboptimal device-position by assessing predefined parameters in transoesophageal echocardiography (TEE) and to b) analyze the impact of device-position on outcome in patients treated with different LAAo devices. Methods and results We retrospectively analyzed 120 patients who were treated by LAAo and had undergone follow-up TEEs after 3 or 6 months. Patients were at mean age: 76±8 years; female 40% and presented an increased CHADS-VASC- (4.6±1.4) and HAS-BLED-score (3.7±1). TEE-guidance was performed in all cases. In 62.5% (75/120) pacifier occluders (PO) (ACP/Amulet, Lambre, Ultraseal) were used, whereas 37.5% (45/120) were treated with non-pacifier occluders (NPO) (Watchman, Wavecrest, Occlutech). To assess device position, TEE images in a commissural view (60–90°) were analyzed and characterised by 1) implantation depth in the left atrial appendage, 2) peridevice flow (PF) and 3) the angle between occluder disc and pulmonal ridge (LUPV). For the purpose of this study, optimal device position was defined as a) ostial (LUPV length &lt;10mm) or slightly subostial position (LUPV length ≤15mm, angle ≥100°) with b) the absence of major PF (&gt;3mm). Overall, occluders were implanted at a depth of 12±7.8 mm with ostial positioning being achieved in 47.5% (57/120). Major PF was seen in 7.5% (9/120). NPOs were implanted deeper than POs (depth: 15.6±7.1 vs. 9.8±7.4 mm, p&lt;0.01; ostial position: 31.1% vs. 57.3%, p&lt;0.01) and were associated with a higher incidence of major PF (15.6% vs. 2.7%, p=0.01). Also, the depth/angle ratio was higher (i.e. “worse”) in NPOs (18.3±9 vs. 14.6±8, p&lt;0.04). As a result, optimal device position was achieved in 48.3% (58/120) of all patients, with lower rates in NPOs than in POs (26.7% vs. 61.3%, p&lt;0.01). Procedural aspects revealed slight differences in occluder size (optimal: 23.7±3.2 vs. suboptimal: 24.5±3.7 mm, p=0.3), need for repositioning (10.3% vs. 17.7%, p=0.25) and procedural duration (48±36 vs. 52±34 min, p=0.3). Of interest, device related thrombi (DRT) occurred less frequently in optimally implanted devices (3.4% vs. 12.9%, p=0.06). Hereby, implantation depth and depth/angle ratio were found to be predictors for DRT in ROC-analysis, respectively (AUC: 0.7, 95% Confidence interval [CI]: 0.56–0.84, p=0.05 and AUC: 0.72, 95% CI: 0.58–0.86, p=0.03). Optimal vs. suboptimal position Conclusion Echocardiographic classification of device-position is warranted to provide comparability and appears to be feasible. Based on the novel classification provided, optimal device-position is achieved in 50% and is found more often with the use of POs. DRT appeared to occur more often in suboptimal device-position.

Risk of thromboembolic events after percutaneous left atrial appendage ligation in patients with atrial fibrillation: Long-term results of a multicenter study

Percutaneous left atrial appendage (LAA) occlusion with Lariat has emerged as a viable alternative to oral anticoagulation (OAC) to prevent thromboembolic (TE) events in patients with atrial fibrillation. We evaluated the long-term TE risk in post-Lariat patients. Consecutive patients undergoing LAA ligation with the Lariat device at multiple centers with at least 1-year follow-up were included in the analysis. Transesophageal echocardiography (TEE) was performed at 4 weeks, 6 months, and 12 months to assess the completeness of LAA occlusion. OAC was discontinued if 4-week TEE revealed no device-related thrombus and complete closure of the appendage. Patients remained on 81 mg of aspirin per day after discontinuation of the blood thinner. A total of 306 patients were included in the study (mean age 68.8 ± 11.0 years; mean CHA2DS2-VASc score 3.6 ± 1.7). Four-week TEE revealed leaks in 81 patients (26.5%); all leaks were less than 5 mm in diameter. At 6-month TEE, spontaneous closure of the leak was demonstrated in 21 patients (25.9%), 26 patients (32%) underwent a successful leak closure procedure, and the remaining 34 (42%) patients were placed on OAC. At the median follow-up period of 15.9 ± 9.2 months, 9 TE events (2.9%) were reported: 7 with persistent leak and 2 without any detectable leaks on 2-dimensional TEE (P < .001). Complete occlusion of the LAA with the Lariat device was associated with the low rate of TE events at long-term follow-up. However, residual leaks were common after Lariat closure and the stroke rate was significantly higher in patients with incomplete occlusion, even with small leaks.

Percutaneous left atrial appendage closure in a patient with haemophilia and atrial fibrillation: a case report.

Background Atrial fibrillation (AF) is the most common cardiac arrhythmia and is a major cause of embolic stroke. In patients with hereditary bleeding disorders such as haemophilia, management of AF particularly anticoagulation can be quite challenging. Left atrial appendage (LAA) closure is an emerging option in AF patients who are not eligible for oral anticoagulation therapy because of contraindications or high bleeding risk.Case summary A 67-year-old man with permanent AF and haemophilia was referred for further evaluation of our cardiology clinic by his primary haematologist. The CHA2DS2-VASc score was estimated to be 3 and the HAS-BLED score was 3. Due to high risk of bleeding, we decided to perform percutaneous LAA closure instead of oral anticoagulation. Pre-procedural cardiac computerized tomography angiography and transoesophageal echocardiography were performed for measurements of LAA dimensions and exclude LAA thrombus. Percutaneous LAA occlusion was performed using a 28-mm AmplatzerTM AmuletTM device. The final result was excellent without significant residual leak, pericardial effusion, and embolic complication. Clopidogrel 75 mg/day and aspirin 81 mg/day for 1 month with adequate FVIII prophylaxis and then only aspirin 81 mg/day for 2 months were recommended. No antiplatelet was given after 3 months. The patient did not report any thrombotic or haemorrhagic adverse events and there were no complications related to implanted device after 1 year of follow-up.Discussion In patients with hereditary bleeding disorders such as haemophilia, management of AF particularly anticoagulation can be quite challenging. In this report, we present a case of percutaneous LAA occlusion using AmplatzerTM AmuletTM device in a patient who has haemophilia and permanent AF. LAA closure has the potential to be more cost effective as compared to oral anticoagulation therapy due to lesser necessity of clotting factor infusion.

Comparison of intracardiac and transoesophageal echocardiography for guidance of percutaneous left atrial appendage occlusion: A meta-analysis.

We performed a meta-analysis to compare the safety and efficacy of intracardiac echocardiography (ICE) vs transoesophageal echocardiography (TOE) for the guidance of percutaneous left atrial appendage occlusion (LAAO). A comprehensive search of the literature was performed, from inception to December 2018 using MEDLINE, Cochrane Library, and Google Scholar electronic databases, and references from articles. Publications comparing ICE and TOE for the guidance of percutaneous LAAO were included in the analysis. The co-primary endpoints were procedural success and procedure-related complications. Secondary endpoints included procedural and fluoroscopy times and the volume of contrast media used. Five studies were included in the analysis, providing a total of 1122 patients. Procedural success was similar with both techniques (pooled odd ratio [OR] 1.46, 95% confidence interval [CI] 0.77-2.75, P=0.24, I2 =0%), with a trend for less procedure-related complications in the ICE group (pooled OR 0.57, 95% CI 0.31-1.05, P=0.07, I2 =0%). Neither procedural (mean difference -1.64minutes, 95% CI -16.42 to 13.14, P=0.83, I2 =96%) nor fluoroscopy times (mean difference+1.29minutes, 95% CI -1.38 to 3.97, P=0.34, I2 =76%) varied significantly between groups. There was a reduction in the volume of contrast media used in the ICE group (mean difference -9.71mL, 95% CI -14.61 to -4.81, P>0.01, I2 =0%). Intracardiac echocardiography is a safe and effective alternative to TOE for guidance of percutaneous LAAO.

Left Atrial Occlusion Device Implantation: the Role of the Echocardiographer.

Atrial fibrillation is the most common arrhythmia worldwide and is a major risk factor for embolic stroke. For patients with atrial fibrillation who are unable to tolerate systemic anticoagulation, left atrial appendage (LAA) occlusion has been shown to mitigate stroke risk. In this article, we describe the vital role of the echocardiographer in intraprocedural guidance of percutaneous LAA occlusion procedures as well as in the pre- and post-procedure assessment of these patients. A few percutaneously delivered devices for LAA exclusion from the systemic circulation are available in contemporary practice. These devices employ an either exclusive endocardial LAA occlusion approach, such as the Watchman (Boston Scientific, Maple Grove, MN) and Amulet (St. Jude Medical, Minneapolis, MN), or both an endocardial and pericardial (epicardial) approach such as the Lariat procedure (SentreHEART, Palo Alto, CA). Two- and three-dimension transesophageal echocardiography is critical for patient selection, procedure planning, procedural guidance, and ensuring satisfactory immediate as well as long-term LAA occlusion/exclusion efficacy. This review will provide an overview of the role of the echocardiographer in all aspects of LAA occlusion/exclusion procedures for the most commonly used commercially available devices in current practice.

Cerebral amyloid angiopathy and atrial fibrillation: a dangerous union

Intracranial hemorrhage (ICH) is the major complication of oral anticoagulant therapy. Cerebral amyloid angiopathy (CAA) is an age-related disease characterized by the pathological deposition of β-amyloid protein in leptomeningeal and cortical cerebral vessels. Such vascular alterations expose to the risk of spontaneous vascular rupture. The main clinical manifestations are represented by ICH, cognitive decline and transient focal neurological episodes (TFNE). In the patient subgroup with TFNE, a misdiagnosis with transient ischemic attack may have catastrophic consequences, resulting in a significant increase in the risk of spontaneous ICH within weeks after clinical onset, with potentially devastating consequences if anticoagulant therapy is started.The prevention of bleeding complications related to CAA is based on disease knowledge. This is particularly relevant because non-pharmacological treatment options, including percutaneous left atrial appendage occlusion, are emerging as an alternative to traditional anticoagulant therapies in patients at high bleeding risk.

The value of the left atrial appendage orifice perimeter of 3D model based on 3D TEE data in the choice of device size of LAmbre™ occluder.

Preoperative optimal selection of the occluder size is crucial in percutaneous left atrial appendage (LAA) occlusion, and the maximal width of the LAA orifice is the main reference index, however it can not fully meet the practical operation requirements. We retrospectively analyzed three-dimensional (3D) transesophageal echocardiography (TEE) and computed tomography (CT) imaging dataset of the 41 patients who underwent LAA occlusion with LAmbre™ system. The LAA orifice parameters were overall evaluated to determine their role in device size selection. Eight LAA 3D models of the four cases who had been replaced their device during the procedure based on TEE and CT were printed out to verify the optimal parameter decision strategy. There was a significant concordance of the results between 3D TEE and CT in the LAA orifice evaluation. The correlations between the perimeter and maximal width measurements by 3D TEE and the closure disk of the device were stronger than that between the area measurements and the closure disk (r = 0.93, 0.95, 0.86, respectively and p < 0.001 all), and the result was similar to that by CT (r = 0.92, 0.93, 0.84, respectively and p < 0.001 all). The ratios of the maximal width to the minimal width of the four cases were all > 1.4, however the rest 37 cases were all ≤ 1.4. Based on the comprehensive assessment of the LAA orifice perimeter and maximal width of the 3D printed models, the experiments were all succeed just for one try. The LAA orifice perimeter of 3D printed model based on 3D TEE may help in choosing the optimal device size of LAmbre™, especially for the LAA with flater ostial shape.

Fatal Cardioembolic Syndrome Due to Late Device-Related Thrombus After Left Atrial Appendage Occlusion

A 75-year-old patient was referred to our center by the neurology department for the evaluation of multiple cardioembolic cerebral infarctions ([Figures 1A and 1B][1]). The clinical history of the patient included persistent atrial fibrillation and percutaneous left atrial appendage occlusion (LAAO

Kidney function stratified outcomes of percutaneous left atrial appendage occlusion in patients with atrial fibrillation and high bleeding risk

Background: Patients with chronic kidney disease (CKD) and atrial fibrillation have increased risks for stroke and bleeding under oral anticoagulation (OAC). We investigated an alternative therapy of percutaneous left atrial appendage occlusion (LAAO) in CKD patients in this study.Methods: Consecutive patients undergoing LAAO were included in a retrospective analysis and stratified for kidney function into CKD/Non-CKD groups (cutoff eGFR 60 ml/min). Procedural characteristics, in-hospital and follow-up events were analysed and compared between groups.Results: LAAO was performed in 146 patients (81 CKD; 65 Non-CKD), mean follow-up was 391 days. Groups differed in eGFR (40.1 (CKD) vs. 75.1 (Non-CKD) ml/min) and CHA2DS2VASc scores (4.65 ± 1.3 (CKD) vs. 4.06 ± 1.4 (Non-CKD)). Procedural success was 98.6%, contrast-induced acute kidney injury was significantly more frequent in CKD patients (11.1% vs. 0%; p = .004). Follow-up mortality was higher in CKD (10.5/100 PY vs. 4.2/100 PY; p = .156). Follow-up stroke rates were 2.3/100 (CKD) patient-years (PY) and 1.4/100 PY (Non-CKD) (p = 1.000), corresponding to a relative risk reduction (RRR) of 60% (all), 68% (CKD) and 71% (Non-CKD) compared to expected stroke rates. Follow-up major bleeding rates were 3.5/100 PY (CKD) and 4.2/100 PY (Non-CKD), corresponding to RRR of 57% (all), 61% (CKD) and 53% (Non-CKD) compared to OAC.Conclusions: Left atrial appendage occlusion shows comparable efficacy for stroke and bleeding prevention in CKD and Non-CKD patients. CKD patients experience more adverse events during follow-up and a significantly increased risk for periprocedural contrast-induced acute kidney injury.

Image-Based Flow Simulations of Pre- and Post-left Atrial Appendage Closure in the Left Atrium.

For patients with atrial fibrillation, the left atrial appendage (LAA) is often the site of thrombus formation due to low atrial ejection fraction that triggers strokes and other thromboembolic events. Recently introduced percutaneous LAA occlusion procedure is known to reduce LAA-induced strokes. Despite having the procedure, there are still 11% of the patients who continue to suffer from future strokes or transient ischemic attacks, not accounting for the procedural related complications. The high failure rate is largely due to the variabilities in LAA's shape, size, and contractility which may result in ineffectiveness of this procedure. To correctly identify the candidates and evaluate the effectiveness of the procedure, we rely on patient-specific CT scans which provides the exact LA and LAA geometries and predictive hemodynamic analysis to assist in evaluating quantitative flow parameters pre- and post-LAA occlusion procedures. Hemodynamic parameters are critical to predict adverse hemodynamic flow patterns in LAA as well as the effectiveness of LAA closure in individual patient. The aim of this paper is to establish an image-based patient-specific computational fluid dynamic (CFD) simulation framework specific to the prediction of treatment outcomes of LAA closure with atrial fibrillation. This framework utilizes automated LA/LAA image segmentation which yields significant reduction in image processing. One set of patient data with successful procedure outcome is used to illustrate the potential of the proposed framework. The proposed LAA occlusion simulation framework is composed of several components: (1) a novel image segmentation procedure, which is fully-automated to identify LA/LAA geometries from CT images, (2) a finite-element mesh generation procedure which transforms the surface geometry into a 3-D volume mesh and properly identified boundary planes, (3) performing CFD simulations with atrial fibrillation flow boundary conditions, and (4) analyzing flow characteristics (velocity, flow patterns, streamlines, vortices) within the LA for before and after LAA closure. Based on the LA/LAA segmentation of a 65 year old female patient with chronic atrial fibrillation, a CFD analysis was pursued to examine flow characteristics upon LAA closure. The results showed that the flow velocity magnitudes were significantly reduced by a maximum factor of 2.21, flow streamlines were greatly stabilized, and mitral outflow appeared to be more organized. Vortices were dramatically reduced in size, number, intensity, as well as duration. During diastole, the peak vortex diameter was reduced from 2.8 to 1.5 cm, while the vortex duration was reduced from 0.210 to 0.135 s. These flow characteristics all indicated a reduced risk in future thrombus formation and strokes based on the established relationship between flow and thrombus formation. For the patient case under study, the effectiveness of the procedure is predicted and found to be consistent with the actual procedural outcome. This framework successfully predicted patient-specific outcome of a LAA closure procedure for one patient with atrial fibrillation. It can be further developed into a useful tool for pre-procedural planning and candidate selection. More patient data are necessary for further validation studies.

Device Sizing Guided by Echocardiography-Based Three-Dimensional Printing Is Associated with Superior Outcome after Percutaneous Left Atrial Appendage Occlusion

Left atrial appendage (LAA) occlusion is an alternative to anticoagulation for stroke prevention in patients with atrial fibrillation. Accurate device sizing is crucial for optimal outcome. Patient-specific LAA models can be created using three-dimensional (3D) printing from 3D transesophageal echocardiographic (TEE) images, allowing invitro model testing for device selection. The aims of this study were to assess the association of model-based device selection with procedural safety and efficacy and to determine if preprocedural model testing leads to superior outcomes. In 72 patients who underwent imaging-guided LAA occlusion, 3D models of the LAA were created from 3D TEE data sets retrospectively (retrospective cohort). The optimal device determined by invitro model testing was compared with the actual device used. Associations of model-match and model-mismatch device sizing with outcomes were analyzed. In another 32 patients, device selection was prospectively guided by 3D models in adjunct to imaging (prospective cohort). The impact of model-based sizing on outcomes was assessed by comparing the two cohorts. Patients in the retrospective cohort with model-mismatch sizing had longer procedure times, more implantation failures, more devices used per procedure, more procedural complications, more peridevice leak, more device thrombus, and higher cumulative incidence rates of ischemic stroke and cardiovascular or unexplained death (P<.05 for all) over 3.0±2.3years after LAA occlusion. Compared with the retrospective imaging-guided cohort, the prospective model-guided patients achieved higher implantation success and shorter procedural times (P<.05) without complications. Clinical device compression (r=0.92) and protrusion (r=0.95) agreed highly with model testing (P<.0001). Predictors for sizing mismatch were nonwindsock morphology (odds ratio, 4.7) and prominent LAA trabeculations (odds ratio, 7.1). In patients undergoing LAA occlusion, device size selection in agreement with 3D-printed model-based sizing is associated with improved safety and efficacy. Preprocedural device sizing with 3D models in adjunct to imaging guidance may lead to superior outcomes.

A strategic roadmap of the Italian Society of Interventional Cardiology (SICI-GISE) to ensure patient's access to appropriate treatment

In comparison with the international scenario, in Italy the penetration of several important scientific and technological innovations in the field of cardiovascular intervention appears to be inadequate both in terms of number of patients treated with respect to the actual need, and inhomogeneity between the different geographical areas of the country. One of the main institutional objectives of the Italian Society of Interventional Cardiology (SICI-GISE) is to develop a roadmap to guarantee homogeneous access throughout the whole national territory to treatments that are recommended by the major international guidelines. The present document focuses on four main areas of cardiovascular intervention: (i) transcatheter treatment of aortic valve stenosis, (ii) percutaneous mitral valve repair, (iii) prevention of cardioembolic stroke through percutaneous left atrial appendage occlusion in patients with non-valvular atrial fibrillation, (iv) optimization of coronary revascularization with the aid of the functional study of coronary lesions. The purpose of this document is to describe the clinical profile and the economic impact of the aforementioned methods, the current clinical, organizational and management barriers to treatment access in the national territory and the possible solutions for overcoming the aforementioned barriers.

Antithrombotic approaches in patients undergoing left atrial appendage occlusion: current evidence and future perspectives

Percutaneous left atrial appendage occlusion is a novel therapeutic option for stroke prevention in patients with atrial fibrillation and contraindication to oral anticoagulant therapy. However, after left atrial appendage occlusion with the most commonly used devices, a short period of antithrombotic therapy is indicated to allow complete endothelialization of the device and to prevent device thrombosis. Post-procedure antithrombotic strategies are often performed empirically, because of the lack of clear evidence. The present article summarizes the main evidence and recommendations of the scientific societies about antithrombotic therapy after percutaneous left atrial appendage occlusion, suggesting individualized antithrombotic strategies based on the patient's hemorrhagic and thrombotic risk.

CONCOMITANT PULMONARY VEIN ISOLATION AND LEFT ATRIAL APPENDAGE OCCLUSION FOR ATRIAL FIBRILLATION: A META-ANALYSIS OF SAFETY AND EFFICACY OUTCOMES

Pulmonary vein isolation (PVI) is an effective treatment for symptomatic atrial fibrillation (AF) with 50% to 90% freedom from recurrent AF. Percutaneous left atrial appendage occlusion (LAAO) has emerged as an alternative therapy for stroke risk reduction in patients with non-valvular AF who cannot