Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects

Review of registry of complications and recommendations to minimize future risk

Zahid Amin, Ziyad M. Hijazi, John L. Bass, John P. Cheatham, William E. Hellenbrand, Charles S. Kleinman

Research output: Contribution to journalReview article

380 Citations (Scopus)

Abstract

The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk. There have been rare occurrences of adverse events with development of pericardial effusion after ASO placement. Identification of high-risk cases, early recognition, and prompt intervention may minimize the future risks of adverse events. In all patients who developed hemodynamic compromise after ASO placement, echocardiograms (pre-, intra-, and postprocedure), atrial septal defect (ASD) size (nonstretched, stretched), size of the device used, cineangiograms, and operative records were reviewed by a panel selected by AGA Medical Corporation. The findings were compared to the premarket approval data obtained from PDA-approved clinical trials that were conducted in the United States, before the device was approved. A total of 28 cases (14 in United States) of adverse events were reported to AGA Medical. All erosions occurred at the dome of the atria, near the aortic root. Deficient aortic rim was seen in 89% and the defect described as high ASD, suggesting deficient superior rim. The device to unstretched ASD ratio was significantly larger in the adverse event group when compared to the FDA trial group. The incidence of device erosion in the United States was 0.1%. The risk of device erosion with ASO is low and complications can be decreased by identifying high-risk patients and following them closely. Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing. Patients with small pericardial effusion at 24 hr should have closer follow-up.

Original languageEnglish (US)
Pages (from-to)496-502
Number of pages7
JournalCatheterization and Cardiovascular Interventions
Volume63
Issue number4
DOIs
StatePublished - Dec 1 2004
Externally publishedYes

Fingerprint

Septal Occluder Device
Atrial Heart Septal Defects
Registries
Equipment and Supplies
Pericardial Effusion
Hemodynamics
Clinical Trials
Incidence

Keywords

  • Amplatzer septal occluder
  • Atrial septal defect
  • Catheterization
  • Complications

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects : Review of registry of complications and recommendations to minimize future risk. / Amin, Zahid; Hijazi, Ziyad M.; Bass, John L.; Cheatham, John P.; Hellenbrand, William E.; Kleinman, Charles S.

In: Catheterization and Cardiovascular Interventions, Vol. 63, No. 4, 01.12.2004, p. 496-502.

Research output: Contribution to journalReview article

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abstract = "The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk. There have been rare occurrences of adverse events with development of pericardial effusion after ASO placement. Identification of high-risk cases, early recognition, and prompt intervention may minimize the future risks of adverse events. In all patients who developed hemodynamic compromise after ASO placement, echocardiograms (pre-, intra-, and postprocedure), atrial septal defect (ASD) size (nonstretched, stretched), size of the device used, cineangiograms, and operative records were reviewed by a panel selected by AGA Medical Corporation. The findings were compared to the premarket approval data obtained from PDA-approved clinical trials that were conducted in the United States, before the device was approved. A total of 28 cases (14 in United States) of adverse events were reported to AGA Medical. All erosions occurred at the dome of the atria, near the aortic root. Deficient aortic rim was seen in 89{\%} and the defect described as high ASD, suggesting deficient superior rim. The device to unstretched ASD ratio was significantly larger in the adverse event group when compared to the FDA trial group. The incidence of device erosion in the United States was 0.1{\%}. The risk of device erosion with ASO is low and complications can be decreased by identifying high-risk patients and following them closely. Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing. Patients with small pericardial effusion at 24 hr should have closer follow-up.",
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