Novel Device Shows Promise for Safe, Effective LAA Closure

A new device designed to close the left atrial appendage (LAA) and prevent strokes in patients with atrial fibrillation (A-fib) demonstrates a high rate of successful closure with minimal access complications or periprocedural adverse events, according to an observational study published online October 10, 2012, ahead of print in the Journal of the American College of Cardiology.

The Lariat device (SentreHeart, Redwood City, CA) consists of a snare with a pre-tied suture that is guided epicardially over the LAA. It was approved for use by the United States Food and Drug Administration (FDA) in 2009.

For the single-center study, Randall J. Lee, MD, PhD, of the University of California San Francisco (San Francisco, CA), and colleagues analyzed 89 nonvalvular A-fib patients who underwent LAA ligation with the device between December 2009 and December 2010. The cohort consisted of patients who were all poor candidates for warfarin therapy, had at least 1 risk factor for embolic stroke, and were an average age of 62 years. Transesophageal echocardiography (TEE) was performed immediately after the procedure, at 1, 30, and 90 days, and again at 1 year post-ligation to confirm complete closure (defined as a residual leak of less than 1 mm by color flow Doppler).

Successful Device, Safe Outcomes

In total, 85 (96%) patients underwent successful LAA ligation, with 82 (96%) of those patients having complete closure immediately. Among the 4 patients who did not have immediate closure, 1 had pericardial adhesions preventing proper device placement, 2 had aborted procedures due to pericardial access-related complications, and 1 had a complication leading to perforation and hemopericardium. There were no device-related complications.

The median time to capture the LAA was 4 minutes, with a median procedural time of 45 minutes. Most patients (80.0%) required only 1 pericardial access attempt, with the remainder requiring 2 attempts, generally to obtain the proper orientation to deliver the Lariat snare over the LAA.

Postprocedure, 20 patients (23.5%) reported chest pain, which resolved in most cases within several days.

By 90 days, 95% of patients who underwent TEE had complete closure. By 1 year, 98% of the 65 patients who survived to the final TEE had complete closure. The sole patient who did not have complete closure had a leak of less than 2 mm.

At 6 months, there was 1 sudden cardiac death following an unrelated hospitalization, and 1 hemorrhagic stroke. At 1 year, a second death occurred in a patient who had been previously diagnosed with bradycardia and refused pacemaker implantation.

Long-term Comparison Data Needed

In a telephone interview with TCTMD, Dr. Lee said the device percutaneously performs a technique that “has been used by surgeons for many years.” The study, he emphasized, was not designed to analyze stroke prevention or outcomes, rather “the two purposes were to demonstrate closure and to see that it was safe.”

Robert J. Sommer, MD, of Columbia University Medical Center (New York, NY), commented to TCTMD in a telephone interview on the significance of Lariat data in relation to another percutaneous LAA closure device, the Watchman (Atritech, Plymouth, MN), which is currently awaiting FDA approval.

Dr. Sommer said “the Watchman trials are well on their way to proving the concept that closing the left atrial appendage is a good thing to do,” adding that LAA closure is already known to be noninferior to warfarin. “As we get further and further out and follow up with these patients, we’re going to have proof with real hard data that it’s superior to warfarin in the long term.”

The Lariat device is already being used at many centers across the United States, according to Dr. Sommer, and because “we have data that show that closure of the appendage is a good thing, if [Lariat] closes the appendage better than the device implants, in theory it should work.” However, he said he would like to see a prospective registry created so that long-term data can be compared to that of Watchman or to other medical therapy trials.

Dr. Lee added that a multicenter prospective study called Place III is in the works to further confirm efficacy of closure with the Lariat.

‘A Very Elegant Solution’

For now, in patients who “are contraindicated or intolerant of anticoagulation therapy or those who are on anticoagulation therapy but still have thrombus in their left atrial appendage, closing [off the LAA] with this device makes very sound medical rationale,” Dr. Lee noted.

Dr. Sommer agreed, calling the procedure “a very elegant solution,” given that all that remains is a single suture. Noting limitations with both the Lariat and the Watchman devices, he added, “there are some patients who will benefit best from one and benefit best from the other, but if I knew the devices were comparable in terms of their efficacy and in terms of the safety of the procedure, I would definitely choose not to have an implant if I didn’t need to.”

Ultimately, when both devices are FDA approved and available “they will be complementary and patients will have choices,” Dr. Sommer concluded.

Source:

Bartus K, Han FT, Bednarek J, et al. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: Initial clinical experience. J Am Coll Cardiol. 2012;Epub ahead of print.

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• Watchman Device for LAA Closure Provides Net Clinical Benefit vs. Warfarin in A-fib Patients
• Percutaneous LAA Closure Device Continues to Perform Well
• Long-Term Data Support Percutaneous Approach for Stroke Prevention in A-Fib