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Septal occluder safe, effective in transcather atrial septal defect closure
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At 2-year follow-up, a septal occluder device was deemed safe and effective for transcatheter closure of atrial septal defects, according to new data published in Circulation: Cardiovascular Interventions.
The ASD PMS II study is the largest prospective trial to report the hemodynamic compromise rate and medium-term survive data on patients after septal occluder device (Amplatzer Septal Occluder [ASO], St. Jude Medical) implantation, according to researchers.
Atrial septal defect (ASD) is among the most common congenital heart defects that require intervention, and although the septal occluder device was approved in 2001 in the U.S. for transcatheter closure of secundum ASD, concerns of cardiac injury with hemodynamic compromise after implantation are still evident, the researchers wrote.
“Despite the numerous favorable reports ... there is concern about the rare occurrence of cardiac injury with hemodynamic compromise after ASO implantation,” Daniel R. Turner, MD, of the division of pediatric cardiology at Children’s Hospital of Michigan and Wayne State University, and colleagues wrote. “Despite clear, published recommendations from an advisory panel formed in an attempt to decrease the incidence of cardiac injury, a small and largely unknown risk of cardiac injury persists after ASO implantation.”
Turner and colleagues conducted a large prospective, nonrandomized, multicenter clinical study to evaluate the real-world risk of hemodynamic compromise in septal occluder device recipients, as well as to assess safety and efficacy of the septal occluder device and its delivery system.
One thousand patients with a mean age of 21 ± 22 years received atrial septal defect closure using the septal occluder device between 2008 and 2012.
Results of the study showed an occurrence of procedural closure in 97.9% of patients and a 98.5% closure rate at 1 month and 97.9% closure rate at 2 years.
Six participants (0.65%) had an occurrence of hemodynamic compromise due to dysrhythmia, device embolization or cardiac erosion.
Researchers found a 0.3% average rate of cardiac erosion between 12 and 171 days after implantation.
Although the results show rare cases of hemodynamic compromise after septal occluder device implantation and lower rates among patients who received appropriately sized devices in the trial, device erosion should still be considered, according to the researchers.
“The associated risk factors for erosion are not yet clear,” they wrote. “Further study is necessary to estimate the risk and hazard ratios of erosion after device placement for patients with and without prespecified risk factors.” – by Dave Quaile
Disclosures: The study was sponsored by St. Jude Medical (now Abbott). Turner reports he receives consulting fees from St. Jude Medical. Please see the study for all other authors’ relevant financial disclosures.
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