Postapproval Study Evaluates Amplatzer Septal Occluder for Closure of Secundum ASD
August 14, 2017—Findings from a multicenter, prospective postapproval study of percutaneous closure of secundum atrial septal defects (ASDs) with the Amplatzer septal occluder (Abbott Vascular, formerly St. Jude Medical) were published online by Daniel R. Turner, MD, et al in Circulation: Cardiovascular Interventions. The investigators sought to evaluate the risk of hemodynamic compromise and obtain medium-term survival data on patients who underwent implantation of the Amplatzer device.
As summarized in Circulation: Cardiovascular Interventions, patients in the study were prospectively enrolled at 50 sites in the United States and followed for 2 years. Between 2008 and 2012, ASD closure with the Amplatzer septal occluder was attempted in 1,000 patients (range, 0.3–83.6 years of age; mean, 21 ± 22 years of age). Procedural closure occurred in 97.9%, with 1-month and 2-year closure in 98.5% and 97.9%, respectively.
The study showed that hemodynamic compromise occurred in six patients (0.65%); this was due to dysrhythmia in two patients, device embolization in one patient, and cardiac erosion in three patients. The rate of cardiac erosion was 0.3% (range, 12–171 days from implantation; average, 83 days from implantation).
The investigators concluded that closure of ASDs with the Amplatzer septal occluder device is safe and effective, with rare incidence of hemodynamic compromise and cardiac erosion. The risk factors for cardiac erosion after device closure are not yet clear, advised the investigators in Circulation: Cardiovascular Interventions.