a c statistic of 0.82 (95% CI, 0.80-0.84), the CHADS2 index was the most accurate predictor of stroke. The stroke rate per 100 patient-years without antithrombotic therapy increased by a factor of 1.5 (95% CI, 1.3-1.7) for each 1-point increase in the CHADS2 score: 1.9 (95% CI, 1.2-3.0) for a score of 0; 2.8 (95% CI, 2.0-3.8) for 1; 4.0 (95% CI, 3.1-5.1) for 2; 5.9 (95% CI, 4.6-7.3) for 3; 8.5 (95% CI, 6.3-11.1) for 4; 12.5 (95% CI, 8.2-17.5) for 5; and 18.2 (95% CI, 10.5-27.4) for 6. Conclusion The 2 existing classification schemes and especially a new stroke risk index, CHADS2, can quantify risk of stroke for patients who have AF and may aid in selection of antithrombotic therapy.

Validation of clinical classification schemes for predicting stroke: results from the national registry of atrial fibrillation☆

Atrial fibrillation (AF) is the most common clinically relevant cardiac arrhythmia. The estimated prevalence in the general population is 1–2% and increases with age.1–8

Patients with AF are at increased risk of thromboembolism, in particular ischaemic stroke. The risk of stroke in patients with non-valvular (essentially non-rheumatic) AF is ∼5% per year.9 Moreover, strokes related to AF are associated with a higher mortality and morbidity when compared with non-AF strokes, emphasizing the need for more effective stroke prevention in these patients.10

The CHADS2 score (cardiac failure, hypertension, age, diabetes, stroke counted double) was established to assess the risk of thrombo-embolic events in patients with AF of non-valvular origin.11 Although there is a clear relationship between the CHADS2 score and stroke rate, the CHA2DS2-VASc score has recently been introduced and adopted by the European Society of Cardiology (ESC) as well as by American Heart Association, American College of Cardiology, and Heart Rhythm Society and other national bodies’ guidelines for AF in an attempt to improve risk stratification in the low-risk group by considering additional stroke risk factors (gender, vascular disease) in addition to old factors including cardiac failure, hypertension, age (divided to two risk classes) diabetes, and stroke that may influence a decision for anticoagulation therapy.12

Prospective and randomized studies show that oral anticoagulation (OAC) significantly reduces the risk of thromboembolism.13 However, this treatment is underutilized in patients with AF due to poor patient compliance, contraindications, and potential bleeding complications.14–18

The pathogenesis of thrombogenesis in AF is multifactorial and includes the Virchow triad of events leading to thrombus formation, i.e. endothelial or endocardial damage or dysfunction, abnormal blood stasis, and altered haemostasis, platelet function, and fibrinolysis.19

There is evidence for endothelial damage, as …

EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion

Percutaneous Left Atrial Appendage Closure With the AMPLATZER Cardiac Plug Device in Patients With Nonvalvular Atrial Fibrillation and Contraindications to Anticoagulation Therapy

Objectives Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. Methods Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. Results Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). Conclusions Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.

Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug.

Percutaneous left atrial appendage closure technology for stroke prevention in patients with atrial fibrillation has significantly advanced in the past 2 decades. Several devices are under clinical investigation, and a few have already received Conformite Europeene (CE)-mark approval and are available in many countries. The WATCHMAN device (Boston Scientific, Natick, Massachusetts) has the most supportive data and is under evaluation by the U.S. Food and Drug Administration for warfarin-eligible patients. The Amplatzer Cardiac Plug (St. Jude Medical, Plymouth, Minnesota) has a large real-world experience over the past 5 years, and a randomized trial comparing Amplatzer Cardiac Plug with the WATCHMAN device is anticipated in the near future. The Lariat procedure (SentreHEART Inc., Redwood City, California) has also gained interest lately, but early studies were concerning for high rates of serious pericardial effusion and major bleeding. The current real-world experience predominantly involves patients who are not long-term anticoagulation candidates or who are perceived to have high bleeding risks. This pattern of practice is expected to change when the U.S. Food and Drug Administration approves the WATCHMAN device for warfarin-eligible patients. This paper reviews in depth the procedural techniques, safety, and outcomes of the current leading devices.

Percutaneous Left Atrial Appendage Closure: Procedural Techniques and Outcomes

Background: Left atrial appendage (LAA) is the main source of left atrial thrombus that causes stroke in patients with non-valvular atrial fibrillation (NVAF). This study reported the initial safety, feasibility, and 1-yr clinical outcomes following AMPLATZER cardiac plug (ACP) implantation in Asia-Pacific region.Methods: Twenty NVAF patients (16 males, age 68 ± 9 yr) with high risk for developing cardioembolic stroke (CHADS2 score: 2.3 ± 1.3) and contraindications to warfarin received ACP implants from June 2009 to May 2010. Patients received general anesthesia (n = 9) or controlled propofol sedation (n = 11) and the procedures were guided by fluoroscopy and transesophageal echocardiography (TEE). Clinical follow-up was arranged at 1 month and then every 3 months after implantation, whereas, a TEE was scheduled at 1 month upon completion of dual anti-platelet therapy.Results: The LAA was successfully occluded in 19/20 patients (95%) at two Asian centers. One procedure was abandoned because of catheter-related thrombus formation. Other complications included coronary artery air embolism (n = 1) and TEE-attributed esophageal injury (n = 1). The median procedural and fluoroscopic times were 79 (IQR: 59–100) and 18 (IQR 12–27) minutes, respectively. The mean size of implant was 23.6 ± 3.1 mm. The average hospital stay was 1.8 ± 1.1 days. Follow-up TEE showed all the LAA orifices were sealed without device-related thrombus formation. No stroke or death occurred at a mean follow-up of 12.7 ± 3.1 months. Conclusions: Our preliminary data suggested LAA closure with ACP is safe, feasible with encouraging 1-yr clinical outcomes. Further large-scaled trials are needed to confirm the efficacy of this device. © 2011 Wiley Periodicals, Inc.

Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience.

Percutaneous closure of secundum atrial septal defect (ASD) by various devices has been proven to be an effective and safe treatment modality for patients with congenital heart diseases. However, we have to be aware of the potential early and late complications like device embolization and formulate plan for rescue procedures. We have reported a case of successful closure of a large secundum ASD in a 23-year-old woman by a 40 mm Amplatzer septal occluder (ASO), which embolized into the right ventricle 4 hr after the procedure. This had caused palpitation and nonsustained ventricular tachycardia. Patient safety was our most important concern and after discussion with the cardiac surgeons and the patient, we would like to make a percutaneous stepwise attempt for retrieval. We first applied an endocardial biopsy forcep to grap the disk of the ASO to fix and stabilize the dislodged device. This would prevent the device from obstructing the inflow and outflow tract and causing catastrophic consequences. Then, a 15-mm Amplatz gooseneck snare was used to catch exactly at the connecting hub of the ASO disk, and the whole apparatus could then be cautiously and safely retrieved out from her body without complications. This had saved her from an unplanned emergency open heart operation that carried significant bleeding complication.

Boron Cheung Wah Cheng

Papers

Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience.

Retrieval of an embolized amplatzer septal occluder.