Major complications associated with transcatheter atrial septal occluder implantation

A review of the medical literature and the manufacturer and user facility device experience (MAUDE) database

Jeffrey W Delaney, Jennifer S. Li, John F. Rhodes

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

Objective. To summarize major complications and outcome for patients receiving percutaneous closure of atrial septal communications. Design. The Medline database and the United States Food and Drug Administration manufacturer and user facility device experience databases (MAUDE) were searched for reports related to complications with atrial septal occluding devices. The medical literature documenting complication rates for these devices were reviewed and summarized. The MAUDE database complication reports were compared with those reported in the medical literature using national implant estimates. Outcome. The MAUDE database correlated in the type of complications most frequently encountered with each device. However, based on estimated total implant numbers, there is a higher incidence of major complications, including death. AGA devices had a 0.3% erosion/ perforation rate with a higher morbidity and mortality (29%) than previously reported. NMT devices had a lower incidence of erosion/ perforation rate of 0.05%. Embolization rates for the NMT devices were also lower than published European studies, possibly reflecting the US restriction of the device for closure of patent foramen ovale. Thrombus was more frequently encountered on the NMT device. Both AGA and NMT devices have been shown to be safe and effective alternatives to cardiac surgery. The MAUDE database correlated, with a very low overall complication rate, but showed a higher estimated major complication rate than the medical literature. These data demonstrate the difficulty in quantifying rare complications in the premarketing analysis and the obligation providers have to report and evaluate complications through vigilant postmarketing surveillance.

Original languageEnglish (US)
Pages (from-to)256-264
Number of pages9
JournalCongenital Heart Disease
Volume2
Issue number4
DOIs
StatePublished - Jul 1 2007

Fingerprint

Septal Occluder Device
Databases
Equipment and Supplies
Patent Foramen Ovale
Incidence
United States Food and Drug Administration

Keywords

  • ASD
  • Atrial Septal Defect
  • Catheterization
  • Complication
  • Device
  • PFO

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Surgery
  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

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abstract = "Objective. To summarize major complications and outcome for patients receiving percutaneous closure of atrial septal communications. Design. The Medline database and the United States Food and Drug Administration manufacturer and user facility device experience databases (MAUDE) were searched for reports related to complications with atrial septal occluding devices. The medical literature documenting complication rates for these devices were reviewed and summarized. The MAUDE database complication reports were compared with those reported in the medical literature using national implant estimates. Outcome. The MAUDE database correlated in the type of complications most frequently encountered with each device. However, based on estimated total implant numbers, there is a higher incidence of major complications, including death. AGA devices had a 0.3{\%} erosion/ perforation rate with a higher morbidity and mortality (29{\%}) than previously reported. NMT devices had a lower incidence of erosion/ perforation rate of 0.05{\%}. Embolization rates for the NMT devices were also lower than published European studies, possibly reflecting the US restriction of the device for closure of patent foramen ovale. Thrombus was more frequently encountered on the NMT device. Both AGA and NMT devices have been shown to be safe and effective alternatives to cardiac surgery. The MAUDE database correlated, with a very low overall complication rate, but showed a higher estimated major complication rate than the medical literature. These data demonstrate the difficulty in quantifying rare complications in the premarketing analysis and the obligation providers have to report and evaluate complications through vigilant postmarketing surveillance.",
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