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Amplatzer cardiac plug shows promise for LAA closure
Percutaneous left atrial appendage closure with the Amplatzer cardiac plug was found to be safe in a study of 60 patients with non-valvular atrial fibrillation who were not eligible for anticoagulation with warfarin.
In the study, researchers evaluated the safety of percutaneous left atrial appendage (LAA) closure with the Amplatzer cardiac plug (ACP; AGA Medical), a catheter-based self-expanding device, in 60 patients with contraindications to oral anticoagulation therapy with warfarin. All 60 patients had non-valvular AF and CHA2DS2-VASc score of at least 1 (mean score, 4.3 ± 1.7). The mean age of the patients was 72.9 years and 38.3% were women.
Stroke risk assessment also was calculated with the CHADS2 score (mean 2.6 ± 1.4). Bleeding risk was calculated with the HAS-BLED score (mean 3.3 ± 1).
One-quarter of the patients had a history of bleeding without oral anticoagulation and 63.3% had a history of bleeding while prescribed oral anticoagulation. Other contraindications to warfarin also were present in 36.7% of the patients.
All patients underwent the procedure between 2009 and 2012. After the procedure, patients were prescribed life-long daily aspirin (100 mg) and 3 months of clopidogrel (75 mg). Patients with procedural success (95%) were followed up with office visits, telephone inquiries and direct mail contact.
During follow-up (mean, 1.8 years), the annual incidence of stroke was 0% compared with the estimated annual stroke risk based on the CHADS2 score of 5.8%. Major bleeding complications occurred in 1.9% of the patients annually compared with the estimated annual bleeding risk on warfarin of 3.7%.
As a result, percutaneous LAA closure with the ACP was found to be safe in patients with non-valvular AF and contraindications to warfarin. Combined with safety and efficacy data with the Watchman device (Boston Scientific) for LAA closure, the present study supports a continued low event rate beyond the first year of closure, the researchers wrote.
Disclosure: The study institution received honoraria, consulting fees and travel expenses from and holds stock options in several device manufacturers. See the study for a full list of financial disclosures.