Left Atrial Appendage Closure Device Research Articles

Initial practice of left atrial appendage closure device in Japan; single-center experience

BackgroundThe left atrial appendage closure (LAAC) device for patients with nonvalvular atrial fibrillation (NVAF) has recently been introduced in Japan. However, clinical data of Japanese patients are insufficient. MethodsIn this single-center study, 55 consecutive patients (mean age, 74 years) who received LAAC therapy from September 2019 to December 2020 were analyzed. The WATCHMAN implant procedure (Boston Scientific, St. Paul, MN, USA) was performed under transesophageal echocardiography and general anesthesia for all cases. ResultsThe baseline CHA2DS2-VASc score was 4.6 ± 1.4, and the baseline HAS-BLED score was 3.8 ± 0.9. All procedures (98.2%) were successful, except for one, and no procedure-related complications were observed. After the procedures, various antithrombotic regimens were employed according to the bleeding risk of each patient; warfarin was used in 27 patients (49%), direct oral anticoagulants (DOACs) were used in 22 patients (40%), and dual antiplatelet therapy (DAPT) was employed in 6 patients. During a mean follow-up of 360 days, three cases of device-related thrombus (DRT) were detected. One DRT case was related to ischemic stroke. Nine patients had major bleeding during follow-up: two patients received DOACs, six patients received DAPT, and one patient received aspirin. ConclusionsIn this initial Japanese experience, LAAC therapy for high bleeding risk patients with NVAF seems feasible. Optimal antithrombotic regimens are warranted for better clinical outcomes.

A Comparative Study of Three Imaging Modalities for Size Selection of a Watchman Left Atrial Appendage Closure Device.

PurposeTo compare the results of computed tomography angiography (CTA), transesophageal echocardiography (TEE), and digital subtraction angiography (DSA) measurements and analyze their accuracy, correlation, and consistency in patients who have successfully undergone left atrial appendage closure (LAAC).Materials and MethodsA total of 157 non-valvular atrial fibrillation (AF) patients who underwent LAAC with Watchman devices were included in the study. The maximum diameter and depth of LAA were recorded using CTA, TEE, and DSA. Correlations and agreements were compared.ResultsThe LAAC procedure was performed successfully in all patients using the Watchman device. There was no significant difference between DSA and TEE measurements of the diameter of the LAA ostium. LAA ostium diameter obtained by CTA, however, was greater than that from DSA and TEE. Correlations were good between LAA ostium diameter measured by TEE, CTA, and DSA and Watchman device size. DSA measurements and actual device size showed the widest limits of agreement, followed by TEE; CTA measurements showed the narrowest limits of agreement. For LAA depth measurements, mean CTA measurements were higher than those of TEE and DSA. There was no significant difference in depth measurements among the three imaging modalities.ConclusionCTA, TEE, and DSA measurements exhibited good correlations with Watchman device size. The ostium diameter and depth of the LAA measured by CTA were greater than those measured by TEE and DSA. The relevance and concordance of CTA measurements were the strongest.

Temporal Changes and Clinical Implications of Delayed Peridevice LeakFollowing Left Atrial AppendageClosure.

The aim of this study was to assess temporal changes and clinical implications of peridevice leak (PDL) after left atrial appendage closure. Endocardial left atrial appendage closure devices are alternatives to long-term oral anticoagulation (OAC) for patients with atrial fibrillation. PDL >5mm may prohibit discontinuation of OAC. Patients included in the study had: 1) successful Watchman device implantation without immediate PDL; 2) new PDL identified at 45 to 90days using transesophageal echocardiography; 3) eligibility for OAC; and 4) 1 follow-up transesophageal echocardiographic study for PDL surveillance. Relevant clinical and imaging data were collected by chart review. The combined primary outcome included failure to stop OAC after 45 to 90days, transient ischemic attack or stroke, device-related thrombi, and need for PDL closure. Relevant data were reviewed for 1,039 successful Watchman device implantations. One hundred eight patients (10.5%) met the inclusion criteria. The average PDL at 45 to 90days was 3.2 ± 1.6mm. On the basis of a median PDL of 3mm, patients were separated into≤3mm (n=73) and >3mm (n=35) groups. In the≤3mm group, PDL regressed significantly (2.2 ± 0.8mm vs 1.6 ± 1.4mm; P=0.002) after 275 ± 125days. In the >3mm group, there was no significant change in PDL (4.9 ± 1.4mm vs 4.0 ± 3.0mm; P=0.12) after 208 ± 137days. The primary outcome occurred more frequently (69% vs 34%; P=0.002) in the >3mm group. The incidence of transient ischemic attack or stroke in patients with PDL was significantly higher compared with patients without PDL, irrespective of PDL size. New PDL detected by transesophageal echocardiography at 45 to 90days occurred in a significant percentage of patients and was associated with worse clinical outcomes. PDL≤3mm tended to regress over time.

Percutaneous left atrial appendage closure for stroke prevention in patients with atrial fibrillation: Current status and future perspective

Atrial fibrillation (AF) is one of the most prevalent arrythmias worldwide and associated with an increased risk of stroke and systemic thromboembolism. Stroke prevention with direct oral anticoagulation (DOAC) is recommended in patients with non-valvular AF (NVAF) at high risk of stroke. WATCHMANTM percutaneous left atrial appendage closure (LAAC) device is currently introduced as an alternative to DOAC for patients with NVAF ineligible for long-term administration of DOAC due to high risk of bleeding. This review article may contribute to recognize the paradigm shift in which stroke prevention should be carried out topically but not systemically, because left atrial appendage (LAA) is the main source of thrombus formation in AF patients. In addition, this review article introduces the current knowledge and future perspective of LAAC strategy and technology.

OP188 Post-Launch Evidence Generation Studies For Medical Devices In Spain: Integrating Real World Evidence Into Decision-Making

IntroductionA national act (Order SSI/1356/2015) regulating Post-Launch Evidence Generation (PLEG) studies was set in Spain in 2015. These PLEG studies are to inform decisions about technologies already included in the Benefit Portfolio of the Spanish National Health System (SNHS) in order to confirm/exclude/modify their terms of use. Once a PLEG is established the selected hospitals provide the technology according to a common protocol and register outcomes until the required sample size is reached.MethodsThe PLEG studies are prospective, observational and single arm studies on safety, effectiveness and cost-effectiveness of a technology in real practice. The technology is selected because of the identification of an evidence gap, usually through a health technology assessment (HTA) report made by an agency of the Spanish Network of HTA Agencies (RedETS). The execution of a PLEG is assigned to one of the RedETS Agencies, which is responsible of delivering annual reports and a final report when the objectives are reached.ResultsThe following six PLEG studies, all of them on medical devices, have been launched in Spain so far, i) Endobronchial valve for patients with persistent air leak; ii) Biodegradable esophageal stent; iii) Percutaneous mitral valve repair system by clip; iv) Left Atrial Appendage Closure Device; v) Sensor-based glucose monitoring systems for children with type 1 diabetes mellitus; vi) Left ventricular assist devices for destination therapy. Five studies will finish their data collection by the end of 2020 or during 2021.ConclusionsA new national procedure using PLEG has been made available in Spain facilitating the use of real-world evidence to inform national decision-making on the financing of selected technologies due to uncertainties about their effectiveness, safety, cost-effectiveness and organizational impact. The studies are requiring a high amount of coordination tasks, as they are involving an average of 21 hospitals each. The usefulness and suitability of this procedure to achieve its objectives must be evaluated once their results are available.

Abstract 13529: Efficacy and Safety of Direct Oral Anticoagulants and the Watchman™ Atrial Appendage Closure Device in Non-Valvular Atrial Fibrillation: A Network Meta-Analysis of Randomized Controlled Trials

Introduction: The efficacy and safety of the Watchman TM (WM) left atrial appendage closure device in atrial fibrillation (AF) was determined in randomized controlled trials (RCTs) with warfarin treatment of the control group. Direct oral anticoagulants (DOAC) have largely superseded warfarin in contemporary clinical practice for stroke and thromboembolism prevention in AF. Network meta-analysis (NMA) allows integration of direct and indirect evidence in evaluating relative effects of three or more interventions. Because there are no direct comparisons of WM with DOACs, we performed a NMA to compare the efficacy and safety of WM to DOACs in patients with AF. Methods: We searched PubMed, EMBASE, and Google Scholar from January 1990 until March 2021 for prospective RCTs that evaluated the efficacy and safety of warfarin, WM, and DOACs in pairwise comparisons of patients with AF. The co-primary outcomes of interest were i) thromboembolic events including stroke, and ii) major bleeding events. Comparative outcomes were assessed by odds ratios (OR) with 95% confidence intervals (CI). Stata version 17.0 software was used for the analysis. Results: A total of 60,652 patients with AF enrolled in 10 RCTs were included. There was no difference in stroke or thromboembolism prevention between WM and DOAC [OR =1.04 (95% CI: 0.61-1.75; 9 trials) (Figure panel A). Similarly, there was no significant difference in major bleeding risk between WM vs DOAC [OR = 1.87 (95% CI: 1.0 – 3.52] (Figure panel B). No significant heterogeneity or publication bias was found. Conclusions: Based on this NMA, WM appears to provide no benefit in prevention of thromboembolism/stroke compared to DOAC in patients with AF. However, a reduction in the risk of major bleeding with WM cannot be ruled out. Future RCTs are necessary to better quantify the risk and benefit of WM compared to DOAC for patients with AF.

Atrial appendage closure in patients with heart failure and atrial fibrillation: industry-independent single-centre study.

AimsTo evaluate outcomes of percutaneous left atrial appendage closure (LAAC) in patients with congestive heart failure (CHF) and non‐valvular atrial fibrillation (AF) in a consecutive, industry‐independent registry associated with periprocedural success and complications during long‐term follow‐up.Methods and resultsFor this analysis, we included patients who underwent transcatheter LAAC from January 2014 to December 2019 at the University Heart Center in Lübeck, Germany, and compared patients with presence of CHF defined as patients with a reduced left ventricular ejection fraction (LVEF ≤ 40%), patients with a mid‐range LVEF (LVEF 41–49%), patients with diastolic dysfunction and preserved LVEF (LVEF ≥ 50%), and patients with right‐sided heart failure and impaired right ventricular function (tricuspid annular plane systolic excursion < 17) to patients undergoing LAAC with no CHF. Primary endpoints were defined as periprocedural complications, and complications during long‐term follow‐up presented as major adverse cardiac and cerebrovascular events (MACCE). A total of 300 consecutive patients underwent LAAC. Of these, 96 patients in the CHF group were compared with 204 patients in the non‐CHF group. Implantation success was lower in CHF group in comparison with non‐CHF group (99.5% vs. 96%, P = 0.038); otherwise, there were no differences in periprocedural complications between groups. Patients with CHF showed a significantly higher incidence of MACCE rate (31.9% vs. 15.1%, P = 0.002) and more deaths (24.2% vs. 7%, P ≤ 0.001) during long‐term follow‐up. In Cox multivariable regression analysis, CHF was an independent predictor of mortality after LAAC implantation at long‐term follow‐up (hazard ratio 3.23, 95% confidence intervals 1.52–6.86, P = 0.002).ConclusionsImplantation of LAAC devices in patients with non‐valvular AF and CHF is safe. The increased mortality in patients with CHF compared with patients without CHF during the long‐term follow‐up is mainly attributed to comorbidities associated with CHF.

Advances in Neurocardiology: Focus on Atrial Fibrillation.

Advances in Neurocardiology: Focus on Atrial Fibrillation.

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use.

The authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device. The CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation. Patients with atrial fibrillation at high stroke risk (CHA2DS2-VASc score≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45days and 1 year. Twenty-two patients (63.7% with CHA2DS2-VASc scores≥3, 76.2% with HAS-BLED scores≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45days, 1 significant leak (≥5mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization. This first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.

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

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

PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH HEMOSTASIS DISORDERS AND ANTICOAGULANT CONTRAINDICATION

<h3>BACKGROUND</h3> We report our single center experience with percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) and primary hemostasis disorders (HD). In randomized percutaneous LAAC trials, this HD population is under-represented. <h3>METHODS AND RESULTS</h3> Consecutive patients with primary HD who underwent LAAC were included. Baseline procedural characteristics and clinical events during follow-up were prospectively collected. From 2013 to 2021, 205 patients underwent percutaneous LAAC and 17 (8.2%) had proven HD: thrombocytopenia (n=5), myelodysplastic syndrome (n=6), Von Willebrand syndrome (n=4), type A hemophilia (n=1) and dysfibrinogenemia (n=1). Median age was 78 YO, CHA2DS2VASc and HAS-BLED scores were 5 and 3, respectively. Periprocedural plasmatic management was required in 47% of patients. The LAAC device implantation was successful in all cases. Post-procedural antithrombotic regimen for the first six weeks consisted of reduced direct oral anticoagulant (DOA) in 8 patients, full dose DOA in 1, dual-antiplatelet in 6, aspirin in 1 and no therapy in 1. The transesophageal echocardiography, 45 days post-procedure, showed optimal device position, adequate sealing in all patients and no clots. After this initial period post-LAAC the long-term antithrombotic regimen was single-antiplatelet in 16 patients and no therapy in 1 patient. After a median follow-up of 1.0 year (25-75 IQR: 0.4-2.2), no thrombo-embolic or bleeding events occurred. <h3>CONCLUSION</h3> The percutaneous LAAC in patients with atrial fibrillation and primary hemostasis disorders appeared to be a safe and effective alternative for stroke and bleeding prevention at mid-term follow-up. These promising results warrant larger studies to confirm our experience.

Successful Percutaneous Retrieval of an Embolized Left Atrial Appendage Closure Device in the Left Ventricular Outflow Tract.

Successful Percutaneous Retrieval of an Embolized Left Atrial Appendage Closure Device in the Left Ventricular Outflow Tract.

Autopsy findings of left atrial appendage closure device

We report an autopsy case of an 80-year-old woman who underwent left atrial appendage closure with a WATCHMAN (Boston Scientific, St. Paul, MN, USA) device. This is the first report of histologic assessment following left atrial appendage closure with a WATCHMAN device at 3 months. Gross and histopathological examinations revealed neoendocardial coverage of the WATCHMAN device. Partial endothelialization was verified by CD34 staining; however, it remains unclear when complete endothelialization is likely to occur.

Successful New Generation LAA Closure Device Implantation After Prior Incomplete Surgical LAA Ligation

We present a case of percutaneous closure of a prior incomplete surgical left atrial appendage (LAA) ligation after a failed closure attempt using the first-generation Watchman device. The new generation Watchman FLX device (Boston Scientific) was implanted in this technically and anatomically challenging LAA patient using multimodality fusion imaging. (Level of Difficulty: Advanced.)

Left atrial appendage closure : Current data and future developments

Catheter-based left atrial appendage closure (LAAC) is currently apotential treatment option for stroke prevention in patients with atrial fibrillation and high risk for stroke/embolism as well as high bleeding risk. Due to improvements in LAAC devices, advances in implantation techniques and growing experience of the interventional teams, the safety profile of LAAC has significantly improved in recent years. These developments have led to a currently comprehensive exploration of novel indications for LAAC, such as patients with atrial fibrillation and a low risk of hemorrhage, patients with atrial fibrillation after pulmonary vein ablation or patients after electrical isolation of the left atrial appendage. The treatment principle of closure of the left atrial appendage is supported by new data, which show the effectiveness of surgical closure of the left atrial appendage with respect to a reduction of the risk of stroke, at least partly in conjunction with oral anticoagulation during cardiological surgical interventions. Currently, the application in the clinical practice is reflected by a high degree of active studies. These randomized studies are testing the use of LAAC in new fields of application and together with the new developments in implantation techniques should define the optimal future use of the methods for the clinical practice. The current potential indications for the LAAC procedure, ongoing randomized clinical trials and advances in device development, implantation planning and technique as well as future developments in the field of LAAC treatment are summarized and discussed in this review article.

B-PO04-147 TRENDS IN EARLY STROKE AND MORTALITY IN EPICARDIAL VERSUS ENDOCARDIAL LEFT ATRIAL APPENDAGE CLOSURE IN ATRIAL FIBRILLATION: NATIONWIDE READMISSIONS DATABASE 2016-2018

Percutaneous left atrial appendage closure (LAAC) devices have emerged as an important alternative to anticoagulation for stroke prevention in patients with atrial fibrillation. National data on recent trends and early complication rates associated with endocardial (endo) LAAC and epicardial (epi) LAAC procedures are limited. To examine the rates and predictors of stroke, mortality, and procedural complications occurring either during index admission or within 90-day readmission after LAAC using a national administrative database. We evaluated 24,198 admissions for LAAC procedures (22,963 endo LAAC and 1,235 epi LAAC) between 2016-2018 using the Nationwide Readmissions Database. Admissions between October and December were excluded to permit 90-day readmission follow-up. Using ICD-10-CM codes, complications occurring during index admission and 90-day readmission were identified. Early stroke and early mortality were defined as events occurring during index admission or readmission. Rates of complications were compared with Fisher's exact test. Multivariable logistic regression was used to identify independent predictors of procedural complications as well as combined early stroke and mortality. Compared to epi LAAC, endo LAAC was associated with lower rates of procedural complications (2.8% vs. 14.5%; p < 0.001), index mortality (0.2% vs. 0.9%; p = 0.003), early mortality (0.5% vs. 1.5%; p = 0.004), and early stroke (0.7% vs. 2.4%; p < 0.001). Between 2016 and 2018, the rates of procedural complications as well as early stroke and mortality did not change significantly. Epi LAAC (aOR 4.5; P<0.0001), coagulopathy (aOR 3.5; P < 0.001), heart failure (aOR 2.2; P < 0.001), and pulmonary hypertension (aOR 2.0; P = 0.002) were independently associated with LAAC procedural complications. Female sex (aOR 1.7; P=0.001), epi LAAC (aOR 2.5; P<0.001), and coagulopathy (aOR 3.3; P=0.001) were independently associated with early stroke and mortality. Endocardial LAAC is associated with lower rates of procedural complications, early stroke, and mortality. In this contemporary real-world analysis over a 3-year period, there was no significant decline in LAAC-associated complications.

B-PO01-078 REAL-WORLD CLINICAL OUTCOMES WITH A NEXT-GENERATION LEFT ATRIAL APPENDAGE CLOSURE DEVICE: FIRST REPORT FROM THE FLXIBILITY POST-APPROVAL STUDY

The WATCHMAN FLX left atrial appendage (LAA) closure device received CE-mark and FDA approval based on the results of the PINNACLE FLX IDE study, but evidence of outcomes with this next-generation device in everyday clinical practice is limited. The FLXibility Post-Approval Study collected real-world data on patients implanted with a WATCHMAN FLX in a commercial clinical setting. Patients with an appropriate current WATCHMAN FLX indication and life expectancy >1 year were considered eligible for enrollment. Patients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45-120 days post-implant and a final follow-up at 1 year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centers in Europe, the mean age was 74.6±8.0 years, mean CHA2DS2-VASc score was 4.2±1.6, mean HAS-BLED score was 2.6±1.0, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients; 97.0% (289/298) required only 1 device for an implantation attempt and no patient required >2 devices. A total of 71.4% (212/297) required only a single deployment for optimal device positioning and a further 14.1% (42/297) only needed 1 recapture. The post-implant medication regimen was DAPT for 87.3% (262/300). First follow-up visit is complete for 99% of surviving patients (283/289). At first follow-up, core-lab adjudicated complete seal for evaluable patients was 87.6% (149/170), 12.4% (21/170) had leak <5mm, and 0% had >5mm leak; 5 patients (1.7%) had device-related thrombus detected during scheduled imaging at first follow-up; all were asymptomatic. Kaplan-Meier adverse event rates through 45 days were: all-cause death 2.0% (n=6; only 1 was procedure/device-related), stroke 0.3% (n=1; ischemic), pericardial effusion requiring surgery or pericardiocentesis 1.0% (n=3), major bleeding (BARC 3 or 5) 5.3% (n=16), device embolization 0.3% (n=1), and no device migration. The WATCHMAN FLX device had excellent procedural success rates, with high effective LAA closure rates and low short-term complications in everyday clinical practice.

Percutaneous Extraction of a Migrated WATCHMAN™ Device After Seven Months

Rarely, a left atrial appendage closure device may chronically migrate to an unfavorable position postoperatively, requiring removal. We present the details of a case in which a WATCHMAN™ device (Boston Scientific, Natick, MA, USA) implanted seven months prior was found to have migrated with protrusion 0.91 cm outside the left atrial appendage together with a 90° tilt and peridevice leakage. Adopting a femoral arterial retrograde approach, a 27-mm WATCHMAN™ device was temporarily positioned in the ascending aorta for cerebroembolic protection, never released from the connecting wire. Extraction of the original WATCHMAN™ device was performed using an endoscopic grasping tool, with subsequent device re-implantation of a new device and removal of the temporarily positioned device in the ascending aorta.

Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.

In the US, the most significant morbidity and mortality associated with non-valvular atrial fibrillation (NVAF) is embolic stroke, with 90% of thrombus originating from the left atrial appendage (LAA). Anticoagulation is the preferred treatment for the prevention of stroke in NVAF patients, but clinical studies have demonstrated high levels of non-compliance and increased risk of bleeding or ineligibility for anticoagulation therapy, especially in the elderly population where the incidence of NVAF is highest. Alternatively, stroke may be preventing using clinically approved surgical and catheter-based devices to exclude or occlude the LAA, but these devices continue to be plagued by peri-device leaks and thrombus formation because of residual volume. To overcome these limitations, Cor Habere (Louisville, KY) and the University of Louisville are developing a LAA closure device (StrokeShield) that completely occludes and collapses the LAA to minimize the risk of stroke. The StrokeShield device is a collapsible occluder (nitinol reinforced membrane) that completely covers the LAA orifice with an expandable conical coil anchor that attaches to the myocardium. The device is designed for catheter-based delivery and expands to completely occlude the LAA orifice and collapse the LAA. The primary advantages of the StrokeShield system are a completely sealed LAA (no peri-device flow or residual space) and smooth endothelialized connection to the left atrial wall with minimal risk of cardiac bleeding and tamponade. We tested proof-of-concept of a prototype StrokeShield device in acute (n = 2) and chronic 60-day (n = 2) healthy canine models. Acute results demonstrated that the conical coil securely attached to the myocardium (5N pull-out force) and the Nitinol umbrella fully deployed and covered the LAA ostium. Results from the chronic implants demonstrated long-term feasibility of device placement with no procedural or device-related intra- or post-operative complications, secure placement and correct positioning of the device with no device migration. The device successfully occluded the LAA ostium and collapsed the LAA with no interference with the mitral valve, circumflex coronary artery, or pulmonary veins. Necropsy demonstrated no gross signs of thrombus or end-organ damage and the device was encapsulated in the LAA. Histology demonstrated mature neointima covering the device with expected foreign body inflammatory response. These early positive results will help to guide the iterative design process for the continued development of the StrokeShield system.

The use of cardiac computed tomography angiography in the assessment of percutaneous left atrial appendage closure – Review and experts recommendations endorsed by the Société française d’imagerie cardiaque et vasculaire diagnostique et interventionnelle

Atrial fibrillation is the most common cause of arrhythmia which is responsible for over 15% of ischemic strokes, most of these being secondary to migration of a left atrial appendage (LAA) thrombus. In patient with contraindication to anticoagulant therapy, percutaneous closure system placement may be indicated. Cardiac computed tomography (CT) angiography plays a central role in the initial assessment as well as in the follow-up. The purpose of the pre-implantation cardiac CT angiography is to evaluate the anatomy of the LAA in order to select the most suitable prosthesis and check for any contraindication to device implantation. Image analysis is divided into four steps that include analysis of the approach; search for a thrombus in the LAA; investigation of the anatomy of the LAA (morphology of the LAA, dimensions of the LAA and choice of device) and cardiac and thoracic assessments. Follow-up involves CT examination to check for correct placement of the device and to detect any complications. On the basis of the results of currently available published research, a panel of experts has issued recommendations regarding cardiac CT angiography prior to percutaneous LAA closure device placement, which were further endorsed by the Société française d’imagerie cardiaque et vasculaire diagnostique et interventionnelle (SFICV).