LAA ligation device safe, successful in persistent AF
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The Lariat left atrial appendage ligation device was safe and successful at excluding the left atrial appendage in patients with persistent atrial fibrillation, researchers reported at the American Heart Association Scientific Sessions.
Outcomes for ablation of persistent AF by pulmonary vein antral isolation (PVAI) alone have been historically suboptimal, according to David J. Wilber, MD, cardiologist and professor at Loyola University Medical Center in Hines, Illinois.
“Adjunct strategies targeting sites outside the pulmonary vein antra to improve outcomes, including foci and/or substrate in the left atrial appendage, have been the subject of recent intense investigation,” Wilber said during the presentation.
In the prospective, multicenter, randomized aMAZE trial, Wilber and colleagues tested whether the Lariat left atrial appendage (LAA) ligation system (AtriCure) adjunctive to PVAI would lower the recurrence of atrial arrhythmia — defined as AF, atrial flutter or atrial tachycardia lasting longer than 30 seconds — in patients with persistent AF.
The primary efficacy endpoint was freedom from documented atrial arrhythmias at 12 months after PVAI, with no new or increased dosage of class I or III antiarrhythmic drugs. A composite of predefined 30-day post-LAA ligation serious adverse events compared with a performance goal of less than 10% served as the primary safety endpoint.
The study included 610 patients (mean age, 66.6 years; 27% women) from 53 U.S. sites. Patients were randomly assigned 2:1 to LAA ligation plus PVAI (treatment; n = 404) or PVAI only (control; n = 206).
Data revealed that the treatment arm had a primary safety endpoint rate of 3.4% (95% Bayesian CI, 2-5), with the following events reported: bleeding (2.2%); serious injury to cardiac/related structure requiring surgical intervention (0.8%); and vascular injury requiring surgical treatment, hospital admission or packed red blood cells (0.3%).
In addition, researchers found high LAA closure rates with the device at 12 months after PVAI, ranging from 85% to 99%.
Primary efficacy endpoint results indicated that freedom from atrial arrhythmias at 12 months after PVAI was 64.3% in the treatment arm compared with 59.9% in the control arm; this difference failed to meet the criterion for superiority.
“The Lariat system appears to be safe and successfully excludes the LAA in this first prospective, rigorous and independently monitored clinical trial evaluating Lariat LAA ligation,” Wilber said. “Adjunctive LAA ligation was not superior to [pulmonary vein] antral isolation alone in reducing recurrent atrial arrhythmias in the overall persistent AF population undergoing initial AF ablation. Exploratory analysis suggests that in the subgroup with early persistent AF and larger LA volumes, adjunctive LAA ligation may provide improved rhythm control. Further investigation is required to verify these exploratory observations.”
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Wilber DJ, et al. LBS.03. Prevention to Intervention in Atrial Arrhythmias. Presented at: American Heart Association Scientific Sessions; Nov. 13-15, 2021 (virtual meeting).
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