Benefit of LAA Closure Becomes Most Evident After 1 Year

PARIS, France—Most of the stroke protection derived from percutaneous left atrial appendage (LAA) closure does not become apparent until 1 year after treatment, according to a registry study reported May 21, 2014, at EuroPCR. Moreover, bleeding rates are also lower than would be expected based on baseline patient risk.

Using data from the multicenter Iberian Registry, researchers led by José R. López-Mínguez, MD, PhD, of Infanta Cristina University Hospital (Badajoz, Spain), looked at 167 patients with nonvalvular A-fib and contraindication to oral anticoagulation who underwent LAA closure with the Amplatzer Cardiac Plug (St. Jude Medical, Minneapolis, MN) in Spain and Portugal.

In the 158 patients (94.6%) with procedural success, cumulative 24-month adverse event rates were:

  • Death: 10.8%
  • Major bleeding: 5.7%
  • Significant non-major (relevant) bleeding: 4.4%
  • Any bleeding: 10.1%
  • Stroke: 4.4%
  • Any event: 19.0%

Device thrombosis occurred in 8.2%, atrial septal defect in 11.4%, and leak (< 3 mm) in 8.2%.

Observed rates of bleeding and stroke/TIA per year were lower than predicted by the various risk scores had patients not undergone intervention (table 1). The annual rate of death was 5.8%, and most major bleeding events were GI hemorrhage.

Table 1. Annual Event Rates (290 patient-years) Based on 24-Month Follow-up




P Value

Major Bleeding






9.6% CHADS2

< .001

“In the first year, there was a significant reduction in the rate of stroke and [TIA] that was even better in the second year,” Dr. López-Mínguez said. Close to 70% of the reduction in stroke/TIA was seen between 12 and 24 months, while nearly 55% of the decrease in bleeding became evident in the second year. Similar degrees of difference between observed and expected event rates can be seen in other registries of LAA closure, he added.

Dr. López-Mínguez concluded, “Our findings show that LAA closure with [the Amplatzer Cardiac Plug] in patients contraindicated for [oral anticoagulation] is a reasonably safe therapeutic option associated with fewer thromboembolic and hemorrhagic events than those expected from risk scores, particularly after the first year post-implantation following endothelization and withdrawal of antiplatelet therapy.”

Study Details

Transesophageal echocardiography (was performed before treatment to rule out the possibility of thrombus in the LAA and at least twice thereafter between 1 and 6 months. Each patient was given clopidogrel (600-mg loading dose plus maintenance dose for 3 months) and aspirin (300 mg on day 1 followed by 100 mg daily for 6-12 months).

Mean age was nearly 75 years, and median risk scores were 3 for CHADS2, 4 for CHA2DS2-VASC, and 3 for HAS-BLED. The most common procedural indications were GI hemorrhage (30.5%) and intracranial hemorrhage (22.8%).


López-Mínguez JR. The Iberian registry: 2-year clinical outcome after left atrial appendage closure with the Amplatzer cardiac plug device in patients with non-valvular atrial fibrillation and contraindications for anticoagulation therapy. Presented at: EuroPCR; May 21, 2014; Paris, France.



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  • Dr. López-Mínguez reports serving as a proctor for St. Jude Medical on LAA closure.