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LAACS: LAA closure protects brain from ischemic events during open heart surgery
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Patients who underwent left atrial appendage closure during open heart surgery had reduced the risk for long-term ischemic brain damage, according to the LAACS study presented at the European Society of Cardiology Congress.
“It seems as if surgical left atrial appendage closure on occasion to open heart surgery does protect the brain against ischemic events, and that was regardless of a previous atrial fibrillation diagnosis,” Jesper Park-Hansen, MD, a medical doctor in the department of cardiology at Bispebjerg/Frederiksberg University Hospital in Copenhagen, Denmark, said in the presentation.
Park-Hansen said during the presentation that AF occurs between 30% and 67% of the time in open heart surgery, and 1% to 3% of patients who have CABG experience a stroke within 1 year.
Researchers analyzed data from 187 patients who underwent CABG, valve surgery or both. Patients were randomly assigned to undergo closure of the LAA (n = 101) or not (n = 86).
The combined endpoint was stroke, transient ischemic attack or new silent cerebral infarction. Patients were followed up for up to 6 years. The secondary endpoint was stroke or TIA.
Of the intention-to-treat group, 141 patients underwent the assigned protocol.
In the intention-to-treat group, 14 patients assigned no closure and five patients assigned the closure procedure had ischemic cerebral events (P = .02). The per-protocol population had 14 ischemic cerebral events in those assigned no closure and four events in those assigned the closure procedure (P = .04).
The secondary endpoint occurred in eight patients assigned no closure and three patients assigned the closure procedure in the intention-to-treat group (P = .07). In the per-protocol group, eight patients assigned no closure and two patients assigned the closure procedure had events (P = .09).
Of the 14 events experienced by patients assigned the closure procedure, nine occurred 1 year after follow-up. The LAA closure procedure was not linked to any adverse events.
“This is the first study, and we’re eager to move on with a study on a larger scale. That is the next step for us,” Park-Hansen said. – by Darlene Dobkowski
Reference:
Park-Hansen J. Late Breaking Clinical Trials 3. Presented at: European Society of Cardiology Congress; August 26-30, 2017; Barcelona, Spain.
Disclosure: Park-Hansen reports that he has no relevant financial disclosures.
Perspective
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Timothy J. Gardner, MD
This was a pilot trial that provided some evidence that getting the LAA closed resulted in fewer strokes in patients having surgery. This has been an idea that has been around for a while, the theory that if we get rid of the LAA, patients who go into AF at a high rate after heart surgery will be spared the problem of stroke. This modest-sized study gave pretty good statistical evidence that there was improvement by ligating the LAA.
For us to be able to say with more confidence that this really does work in a larger population of patients, we need a pivotal randomized trial. This was a pilot trial with a small number of patients, but a pretty convincing signal that closing the LAA really made a difference.
For example, with the results from this randomized trial, a group like the NIH Cardiac Surgery Clinical Trials Group could consider a multicenter trial to see if these favorable results hold up in a larger number of patients.
Prevention of strokes under any circumstance, but especially in patients with AF, is a big focus. The commercially available Watchman device (Boston Scientific) is being implanted in some patients with AF. It can be put in with a catheter and it doesn’t require surgery.
The reason why this particular trial was so interesting is because cardiac surgery patients, even when they didn’t have AF beforehand, are prone to develop it after surgery because of the manipulation and changes that occur during surgery. This was a pretty striking positive result for a treatment to reduce strokes in a high-risk population.
If the results were duplicated in a larger, multicenter trial of patients undergoing heart surgery, that would be a very important finding.
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