The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patients groups, comparisons with pharmacological stroke prophylaxis, surgical approaches, and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies, and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.

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Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies

The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy Besides an assessment of the effectiveness of the therapy in specific patient groups, comparisons with pharmacological stroke prophylaxis, surgical approaches and other device-based therapies are warranted This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available

Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies

Objectives
This study aimed to provide a systematic review of device-associated thrombosis (DAT) after left atrial appendage occlusion (LAAO) with the Watchman, Amplatzer Cardiac Plug, and Amulet devices.

Background
DAT is known as a complication of LAAO but data about its clinical impact is scarce.

Methods
A systematic review of studies evaluating the incidence, treatment and clinical implications of DAT from January 2008 to September 2015 was conducted.

Results
A total of 30 studies describing DAT events were included in the analysis. The overall incidence of DAT was 3.9% (82 DAT for 2118 implanted devices). The median time from procedure to diagnosis of DAT was 1.5 months (IQR: 0–2.9). Most cases were diagnosed with transesophageal echocardiogram (TEE). The treatment consisted of low molecular weight heparin (LMWH) in 45.5% of cases, and oral anticoagulation (OAC) or other treatment modalities in 54.5%. Complete thrombus resolution was achieved in 95.0% of cases (100% with LMWH and 89.5% with OAC). Treatment duration varied greatly with a median treatment duration of 45 days (IQR: 14–135). Clinical events related to DAT consisted of neurologic events namely two transient ischemic attacks (2.4%) and four ischemic strokes (4.9%).

Conclusions
DAT is an infrequent complication of percutaneous LAAO. It occurs mainly early after the procedure and is associated with a low rate of neurological complications. In the majority of cases, diagnosis is made during follow-up imaging with TEE. Anticoagulation treatment seems to be safe and highly effective. Further studies are needed to evaluate the optimal management of DAT. © 2017 Wiley Periodicals, Inc.

Device-associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet.

Aims While LAA closure has recently been incorporated into both European and US guidelines for stroke prevention, uncertainties regarding post-procedural drug therapy so far limit its adoption. The aim of this analysis is to compare real-world outcome data stratified for the post-procedural drug regimen employed. Methods and results One thousand and five patients were implanted with a WATCHMAN device in the prospective EWOLUTION study at 47 centres; 73.5% of the patients were deemed contraindicated for long-term OAC therapy. Here we report on three-month data including the first follow-up TOE exam for 94% of the study population. Following LAA closure, patients received DAPT, VKA, NOAC, single antiplatelet or no therapy (60.3%, 15.4%, 10.9%, 7% and 6.5%, respectively). Device thrombus (2.6%), stroke (0.4%) and major bleeding SAE (2.6%) rates were low overall and did not vary by post-implantation medication strategy. Patients on NOAC had the lowest bleeding rate, without an increase in device thrombus or stroke rates. Conclusions LAA closure with the WATCHMAN device is feasible in patients with a relative or absolute contraindication to oral anticoagulation. Neither DAPT nor NOAC therapy leads to a significant increase in device thrombus, stroke or bleeding compared to the standard VKA regimen. Numerically, NOAC therapy had the lowest event rate.

Safety and efficacy of early anticoagulation drug regimens after WATCHMAN left atrial appendage closure: three-month data from the EWOLUTION prospective, multicentre, monitored international WATCHMAN LAA closure registry.

Background
The use of oral anticoagulation or dual antiplatelet therapy (DAPT) is recommended within the first 45 days after left atrial appendage (LAA) closure using the Watchman device because of incomplete device endothelialization. This study reports for the first time the feasibility of novel oral anticoagulants (NOAC) in these patients.

Hypothesis
NOAC therapy is safe and effective after LAA closure.

Methods
Interventional LAA closure was performed successfully in 45 patients. Of these, 18 patients received NOAC during the first 45 days after implantation and 27 patients received DAPT. Transesophageal echocardiography was conducted 45 days after implantation. The primary study endpoint was abnormal thrombus apposition 45 days after implantation. Secondary study endpoints were death from any cause, major adverse cardiac and cerebrovascular events (MACCE), and major bleedings.

Results
After 45 days, transesophageal echocardiography revealed no abnormal thrombus apposition. During a follow-up of 417 ± 323 days, 7 patients died. No stroke or transient ischemic attack occurred. Nonfatal myocardial infarction occurred in 1 patient. There was a nonsignificant trend for lower all-cause mortality (P = 0.159) and occurrence of MACCE (P = 0.096) in the NOAC group compared with the DAPT group. Overall, 6 patients suffered from a major bleeding (NOAC, n = 3; DAPT, n = 3). In NOAC group, major bleedings (at day 205, 688, and 736) occurred long after termination of NOAC therapy. There was no significant difference in the frequency of major bleedings in different groups.

Conclusions
Our pilot study suggests that NOAC therapy within the first 45 days after interventional LAA closure is safe and effective.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/clc.22478

Initial Experience With Novel Oral Anticoagulants During the First 45 Days After Left Atrial Appendage Closure With the Watchman Device

Aims: The WATCHMAN ® device was proven non-inferior to oral anticoagulation (OAT). However, periprocedural risks and uncertainty regarding patients with absolute contraindication for OAT limit the overall utilisation of this approach. We investigated the periprocedural safety of dual platelet inhibition and primary utilisation of larger device diameters in order to minimise peri-device leakage and repositioning of the device during the implantation process. Methods and results: Since 2010, 59 consecutive patients have been treated with the WATCHMAN ® device and followed for 6 months. In patients with contraindications to warfarin, dual antiplatelet therapy (DAPT) was used during the first 45 days after implantation instead of warfarin. Device size was chosen 15-30% greater than the LAA diameter in order to minimise device repositioning and leakage, and to prevent device embolisation. Small, non-trabecularised recessi at the superior ridge towards the inferior, left pulmonary vein were regularly observed and followed by transoesophageal echo regarding thrombus formation. We observed a 3.3% rate of pericardial effusions and a 5% rate of thrombi at the device during the healing period of 45 days and no device embolisations. One thromboembolic event without clinical sequelae was observed during the six-month follow-up period. All patients stopped DAPT at six months as no primary or secondary leakage >5 mm around the device perimeter was observed. Conclusions: Our data suggest that DAPT can be used safely during the first 45 days in patients with contraindications to warfarin. An algorithm employing larger devices in relation to the LAA ostium with consecutively larger compression improved procedural safety compared to the current standard regarding leakage and device repositioning.

New technical and anticoagulation aspects for left atrial appendage closure using the WATCHMAN® device in patients not taking warfarin

TCT-177 Long-term follow-up after interventional left atrial appendage occlusion in a real world collective: Data from the ALSTER-LAA Registry and comparison with results from the ARISTOTLE trial

Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis and a high surgical risk. Recent data on intermediate-risk patients will probably enlarge the indication for TAVR. In the beginning of the TAVR era, relevant (>mild) aortic regurgitation (AR) was a common finding after TAVR; it was associated with worse outcome compared with patients without significant AR. To date, several improvements in imaging, grading of severity and treatment have been done and will be discussed in this article. AR after TAVR still is a strong and independent predictor of 1-year mortality and every effort should be made to prohibit its development.

Update on the significance of postprocedural aortic regurgitation after transcatheter aortic valve replacement on postprocedural prognosis

AIMS Correct sizing of the ostium is a crucial step in left atrial appendage (LAA) occlusion procedures. However, unfavorable anatomy of the ostium often complicates the assessment of the true ostium diameter. We hypothesized that area-derived diameter (ADD) and perimeter-derived diameter (PDD) from three-dimensional transesophageal echocardiogram (3D-TEE) can facilitate this step of the procedure as compared with two-dimensional (2D) measurements. METHODS AND RESULTS For 55 patients within the ALSTER-LAA registry, retrospective analysis of PDD and ADD was correlated with 2D measurements used during the procedure to ascertain correct size of the Watchman device (Boston Scientific). The observed data were put into relation to the calculated area of the device with 10%-30% compression and the clinical outcome after 30 days. 3D area and perimeter measurements of the LAA ostium matched the calculated range of the different device sizes. Recapture during implantation, gaps <5 mm, and device size changes were more often observed when ADDs would also have suggested the use of a larger device. CONCLUSION 3D ADDs and PDDs are feasible to use in device size decisions. Employing these measurements may allow operators to further reduce intraprocedural recapture maneuvers, peridevice leakage, and device size changes.

Improved Algorithm for Ostium Size Assessment in Watchman Left Atrial Appendage Occlusion Using Three-Dimensional Echocardiography.

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Papers

New technical and anticoagulation aspects for left atrial appendage closure using the WATCHMAN® device in patients not taking warfarin

TCT-177 Long-term follow-up after interventional left atrial appendage occlusion in a real world collective: Data from the ALSTER-LAA Registry and comparison with results from the ARISTOTLE trial

Update on the significance of postprocedural aortic regurgitation after transcatheter aortic valve replacement on postprocedural prognosis

Improved Algorithm for Ostium Size Assessment in Watchman Left Atrial Appendage Occlusion Using Three-Dimensional Echocardiography.