Percutaneous Left Atrial Appendage Occlusion Research Articles

Utilization and procedural adverse outcomes associated with Watchman device implantation.

The Food and Drug Administration (FDA) approval of the Watchman device [percutaneous left atrial appendage occlusion (LAAO)] has resulted in the widespread use of this procedure in many centres across the USA. We sought to estimate the nationwide utilization and frequency of adverse outcomes associated with Watchman device implantation. The objective of this study was to evaluate the Watchman device implantation peri-procedural complications and comparison of the results with the previous studies. The National Inpatient Sample (NIS) was queried for all hospitalizations with a primary diagnosis of atrial fibrillation or atrial flutter during the year 2016 with percutaneous LAAO during the same admission (ICD-10 code-02L73DK). The frequency of peri-procedural complications, including mortality, procedure-related stroke, major bleeding requiring blood transfusion, and pericardial effusion, was assessed. We compared the complication rates with the published randomized controlled trials and the European Watchman registry. An estimated 5175 LAAO procedures were performed in 2016. The majority of procedures was performed in males (59.1%), age ≥75 years (58.7%), and White (83.1%). The overall complication rate was 1.9%. The in-hospital mortality was 0.29%. Pericardial effusion requiring pericardiocentesis was the most frequent complication (0.68%). Bleeding requiring transfusion was noted in 0.1% of device implants. The rates of post-procedure stroke and systemic embolism were 0% and 0.29%, respectively. Percutaneous LAAO with the Watchman device in the USA is associated with low in-hospital complications and a similar safety profile to a recently published EWOLUTION cohort. The complication rates were lower than those reported in the major randomized clinical trials (RCTs). We report the frequency of peri-procedural complications of the LAAO using the Watchman device from the NIS database. We also compare the frequency of peri-procedural complications with the previously published RCTs and EWOLUTION cohort. Our findings are in concordance with findings from EWOLUTION cohort and compare favourably with RCTs.

Application of Transesophogeal Echocardiography in Percutaneous Left Atrial Appendage Occlusion

Objective: To evaluate the use of transesophogeal echocardiography (TEE) for percutaneous left atrial appendage (LAA) occlusion. Methods: LAA occlusion was performed in 20 atrial fibrillation (AF) patients with non-valvular lesions, including nine males and 11 females. TEE was used for the preoperative measurement of the maximal LAA orifice diameter and LAA depth and the guidance of atrial septum puncture. The release of the occluder during the occlusion procedure was also performed under TEE monitoring. Results: All 20 patients underwent successful occlusion of the LAA under the guidance of TEE. There were two (10.0%) cases with mild residual shunt after occlusion, among which only one (5.0%) patient still retained slight residual shunt at one month postoperative. All the other (95.0%) patients revealed no residual shunt. There was no difference between the maximal LAA orifice diameter (22.75 ± 4.85 mm vs. 22.15 ± 4.23) and LAA depth (36.60 ± 5.51 vs. 35.00 ± 4.76) derived from TEE and the digital subtraction angiography (DSA) measurement. Both the max orifice diameter and LAA depth measured by TEE were strongly correlated with that measured by DSA, with r = 0.75, P < 0.001 and r = 0.82, P < 0.001, respectively. Conclusions: TEE can accurately estimate the maximal LAA orifice diameter and LAA depth and provide an important reference for preoperative occluder size selection. It can also be used for intraoperative guidance and assessing results during the operation. TEE is of great importance for LAA occlusion.

Percutaneous Left Atrial Appendage Occlusion: A View From the UK.

AF is associated with an increased risk of thromboembolic events, which is usually managed with oral anticoagulation therapy. However, despite a broad range of anticoagulant options and improved uptake in anticoagulation over the past decade, there are some limitations to this approach. Percutaneous left atrial appendage occlusion has been shown to be an effective alternative in this setting, and population data suggest a clear demand for this procedure. Over the past decade, several important changes to the commissioning and delivery of this service have occurred in the UK. In this article, the authors describe the use of percutaneous left atrial appendage occlusion in the UK and discuss the challenges that lie ahead.

Catheter-based closure of multiple residual leaks after percutaneous left atrial appendage occlusion with the Watchman® device

Catheter-based closure of multiple residual leaks after percutaneous left atrial appendage occlusion with the Watchman® device

Catheter-based closure of multiple residual leaks after percutaneous left atrial appendage occlusion with the Watchman® device

Catheter-based closure of multiple residual leaks after percutaneous left atrial appendage occlusion with the Watchman® device

Left Atrial Appendage Occlusion: Past, Present and Future.

There are several situations whereby oral anticoagulation may be unsuitable for stroke prevention in patients with atrial fibrillation (AF). Percutaneous left atrial appendage (LAA) occlusion has received much attention in this area. Various devices have already been developed and tested for this purpose. Data from registries and cohort studies have indicated favourable short- and long-term outcomes with LAA occlusion, and several international guidelines recommend its use in AF patients with contraindications to oral anticoagulation. However, prospective controlled trials in this very population are lacking. Furthermore, while modelling studies on cost analyses have suggested that LAA occlusion may be a cost-effective strategy compared with standard medical therapy, these have not been performed in high-risk patients who may have limited survival in the medium to long term. Thus, while LAA occlusion offers promise, there is a strong need for additional research to investigate its exact role, its long-term outcomes and cost efficacy.

Percutaneous left Atrial Appendage Occlusion for Stroke Prevention in Patients with Atrial Fibrillation

Patients with atrial fibrillation (AF) have a fivefold higher risk of stroke than persons in sinus rhythm. Effective stroke prevention is achieved with oral anticoagulants such as vitamin K antagonists or nonvitamin K oral anticoagulants. An alternative for stroke prevention in patients with AF is the closure of the left atrial appendage (LAA) with a percutaneously applied closure system. The two large randomized studies PROTECT-AF and PREVAIL failed to show superiority of LAA closure over anticoagulation in patients with AF. Meta-analyses of studies and registries, however, suggest that LAA closure has particular advantages with regard to the reduction of severe bleeding complications. Currently, several prospective randomized studies are being conducted in different patient populations to evaluate the benefit of LAA closure in comparison to standard of care. Currently, LAA closure is recommended in patients after intracranial hemorrhage, with advanced renal failure, after severe gastrointestinal bleeding, in patients with a high risk of recurrent ischemic stroke and elderly patients with high risk of bleeding and falling.

P1433Prevalence and location of residual leaks following percutaneous left atrial appendage occlusion: the importance of 3D transesophageal echocardiography

Abstract Background The left atrial appendage (LAA) shape and size are very variable, and incomplete appendage closure or persistent leaks around the device are common following device placement. Limited studies reported the rate of peri-device leaks (PDL) after percutaneous left atrial appendage closure, and the impact of 3D transesophageal echocardiography (3D-TEE) on the detection of those leaks. Aim To describe the rate and location of leaks 1 month after percutaneous closure of the LAA, with and without the use of 3D-TEE. Methods A cohort study of consecutive patients (P) who were submitted to a percutaneous LAA closure with success in one interventional cardiology centre, between May 2010 and October 2018, were included. Clinical and echocardiography data were recorded and analysed. Two groups were created: Group A (GA) included patients until August 2015 submitted to 2D TEE on follow up (N= 48) versus Group B (GB), which was composed of patients submitted to 3D-TEE after August 2015 (N= 76). Results A total of 124 P had an in-hospital admission for LAA closure, with control TEE 1 month after the procedure. Mean age was 73 ± 7 years old, with 62.9% male patients. The procedure was guided by TEE (52%) or intra cardiac echocardiography (ICE) (48%).Transeptal puncture was preferred (95% of the procedures). The most used device was Amulet (62%) vs ACP (23%) and Watchman (15%). In the follow up TEE, 20% of patients had only 1 leak and 2% had 2 leaks. Of the detected leaks,31% were considered minor (&amp;lt; 1 mm), 35% moderate (1-3 mm) and 34% major (&amp;gt; 3 mm). Patients with leaks had a larger LAA diameter (22 ± 4 mm vs. 17 ± 3 mm, P = 0.01). Of the detected leaks, 50% were located in the superior portion of the device, 23% were located in the inferior portion, 8% in the posterior portion and 8% in the lateral portion. In GA the rate of leaks was 14% vs 24.5% in GB, with differences also when specified the size of the leak – minor (GA 2% vs GB 8.8%), moderate (GA 8% vs GB 8.1%) and major (GA 4% vs GB 7.6%). Conclusion The use of 3D echocardiography, 1 month after successful percutaneous LAA closure, augmented the rate of detection of device leaks. It remains to be studied the clinical impact of this finding.

3D printing in adult cardiovascular surgery and interventions: a systematic review.

3D printing in adult cardiac and vascular surgery has been evaluated over the last 10 years, and all of the available literature reports benefits from the use of 3D models. In the present study, we analyzed the current applications of 3D printing for adult cardiovascular disease treated with surgical or catheter-based interventions, including the clinical medical simulation of physiological or pathology conducted with 3D printing in this field. A search of PubMed and MEDLINE databases were supplemented by searching through bibliographies of key articles. Thereafter, data on demographic, clinical scenarios and application, imaging modality, purposes of using with 3D printing, outcomes and follow-up were extracted. A total of 43 articles were deemed eligible and included. 296 patients (mean age: 65.4±14.2 years; male, 58.2%) received 3D printing for cardiac and vascular surgery or conditions [percutaneous left atrial appendage occlusion (LAAO), TAVR, mitral valve disease, aortic valve replacement, coronary artery abnormality, HOCM, aortic aneurysm and aortic dissection, Kommerell’s diverticulum, primary cardiac tumor and ventricular aneurysm]. Eight papers reported the utility of 3D printing in the medical simulator and training fields. Most studies were conducted starting in 2014. Twenty-six was case report. The major scenario used with 3D printing technology was LAAO (50.3%) and followed by TAVR (17.6%). CT and echocardiography were two main imaging techniques that were used to generate 3D-printed heart models. All studies showed that 3D-printed models were helpful for preoperative planning, orientation, and medical teaching. The important finding is that 3D printing provides a unique patient-specific method to assess complex anatomy and is helpful for intraoperative orientation, decision-making, creating functional models, and teaching adult cardiac and vascular surgery, including catheter-based heart surgery.

1% Aspiration, 99% Perspiration: Acute Left Atrial Thrombus During Percutaneous Left Atrial Appendage Occlusion

A 71-year-old man with chronic atrial fibrillation underwent insertion of a left atrial appendage occlusion device. Before release, a large thrombus was noted within the left atrium, attached to the left atrial appendage occluder delivery system. With continuous negative pressure, the device was deployed and thrombus successfully aspirated with no clinical sequelae. (Level of Difficulty: Intermediate.)

Combined pulmonary vein stenosis stenting and left atrial appendage occlusion in a patient with hemoptysis after atrial fibrillation ablation

BackgroundPulmonary vein stenosis (PVS) after radiofrequency ablation for non-valvular atrial fibrillation (AF) is an uncommon but serious complication. PVS stenting can rapidly restore pulmonary flow and improve symptoms with long-term low incidence of restenosis. However, high risk of thrombosis remains if AF is recurrent, especially for CHA2DS2-VASc > 2.Case presentationA 67-year-old man with diabetes, hypertension and a history of stroke underwent radiofrequency pulmonary vein isolation for persistent AF 1 year ago. Six months later he developed recurrent respiratory infection and massive hemoptysis. Computed tomography pulmonary angiography revealed severe left pulmonary vein stenosis. Simultaneous percutaneous PVS stenting and left atrial appendage occlusion were performed to resolve recurrent hemoptysis and prevent stroke. The clinical follow-up indicated a good short and mid-term result with significant improvement of symptoms.ConclusionsSimultaneous PVS stenting and left atrial appendage occlusion is feasible and effective in patients with recurrence of AF and hemoptysis induced by radiofrequency ablation for AF.

Percutaneous left atrial appendage occlusion yields favorable neurological outcomes in patients with non-valvular atrial fibrillation

Percutaneous left atrial appendage occlusion yields favorable neurological outcomes in patients with non-valvular atrial fibrillation

CHANGES OF LEFT ATRIAL APPENDAGE ORIFICE FOLLOWING PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE USING THREE-DIMENSIONAL ECHOCARDIOGRAPHY

Percutaneous left atrial appendage occlusion (LAAO) with the Watchman device is increasingly performed in patients with atrial fibrillation and long-term contraindications for anticoagulation. Changes of LAA orifice size following LAAO and its impact on left upper pulmonary venous (LUPV) velocities

Left Atrial Appendage Occlusion for Patients with Transcatheter Aortic Valve Replacement, MitraClip, Percutaneous Coronary Intervention, and Ablation for Atrial Fibrillation: Optimizing Long-Term Patient Outcomes.

Interventional cardiologists and electrophysiologists perform various procedures to improve the quality and longevity of life. The mitigation of stroke risk in patients with atrial fibrillation may be ignored when considering other more acute or urgent situations, such as severe coronary or valvular heart disease requiring treatment or symptomatic atrial fibrillation necessitating ablation. However, we must keep this long-term stroke risk in mind to optimize patients' overall outcomes. Percutaneous left atrial appendage occlusion is an important option in those who present with high stroke and bleeding risk. Ongoing studies will help provide objective data in this arena.

LEFT ATRIAL APPENDAGE SEAL FOLLOWING PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION

Percutaneous left atrial appendage (LAA) occlusion is well established as an alternative to anticoagulation therapy for stroke prophylaxis among patients with non-valvular atrial fibrillation (NVAF). Only the Watchman® device has FDA approval for this indication. Based on the design of the initial

CRT-600.32 Intracardiac Vs Transesophageal Echocardiography for Percutaneous Left Atrial Appendage Occlusion: An Updated Meta-Analysis

Transesophageal echocardiography (TEE) is standard imaging modality for guiding percutaneous left atrial appendage occlusion. Intracardiac echocardiography may be a suitable alternative with advantages like avoiding intubation and general anesthesia PubMed, EMBASE, and Google Scholar databases were

Initial anticoagulation experience with standard-dose rivaroxaban after Watchman left atrial appendage occlusion

Warfarin is now recommended as the standard anti-thrombotic regimen to allow complete endothelialization over the Watchman device post percutaneous left atrial appendage occlusion (LAAO). However, the need for frequent monitoring, narrow therapeutic range, dietary restrictions and multiple drug interactions associated with warfarin have contributed to increasing uptake of non-vitamin K oral anticoagulants (NOACs) worldwide. At present, the feasibility and safety of NOACs instead of warfarin post-LAAO is lacking. Patients who underwent successful Watchman device implantation between October 1, 2016 and September 30, 2017 were enrolled in a retrospective database. And only patients who received rivaroxaban in the periprocedural period were included in this study. Transesophageal echocardiography (TEE) follow-up was scheduled at 6 weeks, at 6 months, and at 12 months post-implantation to detect device-related thrombosis (DRT) or peri-device leak. Meanwhile, thromboembolic and bleeding events were also evaluated at the time of follow-up. Totally, 57 Watchman devices were successfully implanted and 10 patients who were allocated to rivaroxaban at the dosage of 20 mg once daily were included. During the follow-up, none of the patients using rivaroxaban experienced DRT, peri-device leak, thromboembolic complications and major bleeding events, except for 2 patients who suffered minor bleeding during the 6 weeks follow-up. This study suggests that a short course of standard-dose rivaroxaban following Watchman LAAO is associated with low incidence of thrombotic complications and bleeding events, and might be a feasible alternative regimen in Chinese. Further randomized trials and large sample of real-world studies are needed to validate our finding.

Feasibility of Left Atrial Appendage Occlusion in Left Atrial Appendage Thrombus: A Systematic Review.

This study aimed to investigate the feasibility and safety of left atrial appendage occlusion (LAAO) procedures in patients with persistent left atrial appendage (LAA) thrombus. The left atrial appendage (LAA) is the most common site of thrombus formation in patients with nonvalvular atrial fibrillation (AF). Oral anticoagulation (OAC) is used to prevent and treat AF-related thrombus. However, a significant proportion of patients may not be eligible for long-term OAC therapy. In many cases, OAC may fail to resolve the thrombus. Left atrial appendage occlusion (LAAO) may be a potential option in such cases. Major LAAO studies have excluded patients with LAA thrombus, and it is not known whether LAAO procedures in the presence of LAA thrombus is feasible and safe. This was a systematic review of patient-level data of all published cases of LAAO in the presence of LAA thrombus. There was a total of 58 patients included in the study. Most of the patients had a distally located thrombus in the LAA. All cases underwent successful implantation of LAAO devices with some procedural modifications. Amulet was the most commonly used device (50%). A cerebral protection device was used in 17 (29%) patients, and procedural transesophageal echocardiography was used in most of the cases. One stroke (1.7%) and 2 (3.4%) device-related thromboses were noted during the mean follow-up of 3.4 ± 7months. Percutaneous LAAO procedures appear to be feasible in patients with a distally located persistent LAA thrombus when performed by experienced operators with some technical modifications. Further studies are required to determine the long-term safety and efficacy of this approach.

Left atrial appendage occlusion: a critical appraisal updated with recent evidence.

To allow readers to fully appreciate the uncertainties with this novel yet invasive approach to stroke prevention. Percutaneous left atrial (LA) appendage occlusion has emerged as potential nonpharmacologic means to prevent stroke and systemic embolism in patients with atrial fibrillation. Yet the evidence underpinning this new technology is not definitive. In this review, we consider the internal and external validity of the regulatory trials, pathophysiologic basis for LA appendage occlusion and clinical tradeoffs of the procedure.

P1799 The importance of 3D imaging techniques in left atrial appendage closure: landing zone eccentricity influence on peri-device leak incidence and its implication in long-term clinical outcomes

Abstract Background A complex left atrial appendage (LAA) morphology and a non-circular landing zone (LZ) are frequently encountered in patients undergoing percutaneous LAA occlusion (LAAO). Three-dimensional (3D) imaging modalities as 3D transoesophageal echocardiography (3D TOE) and cardiac computed tomography (CCT) should be preferred over two dimensional techniques for better evaluation of LAA diameters, especially for the LZ. In fact, non-circular shape could impair the choice of occluder device size and may be implicated in the occurrence of residual leaks. Incomplete LAA occlusion is recognized to be associated with thromboembolic events. Purpose The aim of the study was to evaluate the utility of 3D imaging techniques to predict LAA device size and the landing zone eccentricity index as a potential predictor of residual peri-device leaks and to assess their clinical implications on long-term follow-up. Methods It was a retrospective, single-center study including 137 consecutive patients undergoing successful LAAO from January 2010 to July 2018. Pre-procedural 3D TOE and CCT were used to predict device size based upon LZ diameters and quantify LAA orifice eccentricity. Leaks were defined as the presence of peri-device flow at 2D TOE immediately after the device implantation and at 3 months follow-up. Leaks were classified as significant (color jet width ≥4 mm) or minor (&amp;lt;3 mm). A clinical evaluation of thromboembolic events was performed at 48 ± 27 months from the procedure. Results LAAO closure was performed implanting either Amulet or Watchman devices (n = 98 and n = 40, respectively). The assessment of LZ measurements with 3D TOE and CCT showed a significant correlation with the device size selected on the basis of 2D techniques (r = 0.82 and r = 0.74, respectively). As concerns the peri-device leaks, the presence of an eccentric LZ (eccentricity index &amp;gt;0.20) was not associated to the development of post-procedural leaks in the overall population; a significant correlation was detected only in the subgroup of patients treated with the Amulet device (p = 0.045). Residual leaks included only 1 significant leak (0.7%) after Amulet device implantation, which was related to a major neurological event (stroke) and 47 (34%) minor leaks (n = 28 in the Amulet group, n = 19 in the Watchman group). In this last population, 2 patients (1.5%) developed minor neurological events (transient ischemic attack). Conclusions 3D TOE and CCT better predict device size overcoming the limit of 2D imaging techniques undersizing. In eccentric LAA, Watchman device may reduce the incidence of peri-device leaks. The presence of significant residual leaks is uncommon but associated with major clinical events, whilst minor leaks are relatively frequent but do not seem to be related to life-threatining thromboembolic accidents.