Percutaneous LAA closure devices show promise

New data have shown that left atrial appendage closure with the Amplatzer Cardiac Plug and Lariat device provide a safe treatment strategy for patients with atrial fibrillation.

These results signal the potential for more widespread use of percutaneous left atrial appendage (LAA) closure in the future, according to an accompanying editorialist.

The studies and editorial were published recently in the Journal of the American College of Cardiology.

Amplatzer

In the first study, researchers from Canada evaluated the Amplatzer Cardiac Plug (St. Jude Medical) in 52 patients with nonvalvular AF from seven centers. Most patients received 1 to 3 months of dual antiplatelet therapy after the procedure and single antiplatelet therapy thereafter. Patients had a mean age of 74 ± 8 years and a median CHADS2 score of 3. Transesophageal echocardiography (TEE) was performed at 6-month follow-up in 74% of patients.

Researchers successfully performed the procedure in 98.1% of patients. The main complications were device embolization (1.9%) and pericardial effusion (1.9%), and there were no cases of periprocedural stroke.

At follow-up (mean, 20 ± 5 months), the following complications occurred: death (5.8%); stroke (1.9%); pericardial effusion (1.9%); and major bleeding (1.9%). There were no cases of systemic embolism or device thrombosis.

Researchers also reported a 16.2% presence of mild peridevice leak at 6 months with TEE.

Lariat

The Lariat device (SentreHEART), another device for LAA occlusion, was tested in a separate study by investigators from the United States and Poland. The device features a snare with a pre-tied suture that is guided epicardially over the LAA.

For the study, researchers enrolled 89 patients with AF and performed percutaneous ligation of the LAA with the Lariat. TEE and contrast fluoroscopy confirmed LAA closure immediately, followed by TEE alone at 1 day, 30 days, 90 days and 1 year after LAA ligation.

Overall, LAA litigation was successful in 85 patients (96%), of whom 81 had complete immediate closure. Researchers observed a ≤2-mm residual LAA leak by TEE color Doppler evaluation in three patients, and one patient had a ≤3-mm jet by TEE. No device-related complications were reported, although three access-related complications (during pericardial access, n=2; transseptal catheterization, n=1) occurred.

Adverse events included severe postoperative pericarditis (n=2), unexplained sudden death (n=2), late strokes thought to be non-embolic (n=2) and late pericardial effusion (n=1).

At 1 month and 3 months after ligation, 95% of the patients had complete LAA closure as determined by TEE. Of the patients undergoing 1-year TEE (n=65), there was 98% complete LAA closure rate, which included patients with previous leaks.

Tempered enthusiasm

With the current high level of interest in LAA interventions, Zoltan G. Turi, MD, with the Cooper University Hospital and Cooper Medical School of Rowan University, Camden, N.J., wrote in an accompanying editorial that enthusiasm should be tempered until there are more data.

“The increasing number of tools available for the assault on the LAA makes it likely that these procedures will increase substantially. However, there are a number of yet-to-be explored ramifications, including effects other than embolus prevention, such as on the release of natriuretic peptides and on lipid metabolism,” he wrote.

Pending a more solid evidence base, Turi said considerable prudence in patient selection for each of the devices should be exercised.

“Until then, although long-term anticoagulation is cumbersome and has its own significant (but well-established) toxicities, for those who are appropriate candidates, it remains the best studied approach as well as the standard of care,” he said.

For more information:

Bartus K. J Am Coll Cardiol. 2013;62:108-118.

Turi ZG. J Am Coll Cardiol. 2013;62:119-120.

Urena M. J Am Coll Cardiol. 2013;62:96-102.