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Medical device surveillance: gender differences in pulmonary artery rupture after pulmonary artery catheterization
Ronald G Kaczmarek1, Chih-Hsin K Liu, Thomas P Gross
1Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850, USA. rxk@cdrh.fda.gov
Insights
Pulmonary artery (PA) rupture is a rare but fatal complication of PA catheterization. This study found women are at significantly higher risk for PA rupture than men, necessitating clinical awareness.
Area of Science:
- Cardiology
- Medical Devices
- Patient Safety
Background:
- Pulmonary artery (PA) rupture is a rare, life-threatening complication associated with PA catheterization.
- Understanding risk factors is crucial for preventing adverse outcomes.
Purpose of the Study:
- To investigate the incidence and characteristics of PA rupture following PA catheterization.
- To identify potential demographic risk factors for this complication.
Main Methods:
- Analysis of 71 PA rupture case reports from the FDA's Medical Device Reporting (MDR) system (1991-2001).
- Examination of the Nationwide Inpatient Sample (NIS) database for PA catheter use patterns.
- Statistical analysis to compare rupture rates between genders.
Main Results:
- 71 cases of PA rupture were identified, with a high mortality rate (47 deaths, 24 injuries).
- The mean age of affected patients was 74 years.
- Women constituted a significantly higher proportion of cases (52/71) compared to men (10/71).
Conclusions:
- Women appear to be at a significantly increased risk of PA rupture after PA catheterization.
- Healthcare providers should maintain heightened awareness of this potential complication.
Background:
Pulmonary artery (PA) rupture is a rare but often fatal complication of PA catheterization.
Methods:
An analysis was performed of all the case reports of PA rupture after PA catheterization that were submitted to the Food and Drug Administration's Medical Device Reporting (MDR) system between the years 1991 and 2001. The MDR system is a national passive surveillance system that includes adverse event reports from such sources as manufacturers and healthcare professionals. The Nationwide Inpatient Sample (NIS), a massive, nationally representative database maintained by the Agency for Healthcare Research and Quality, was examined to study patterns of PA catheter use.
Results:
A total of 71 PA rupture cases were identified from the MDR data. The most likely outcome following PA rupture was death. These PA ruptures were associated with 47 deaths and 24 injuries. The range of reported ages of the cases was between 40 and 91 years, with a mean age of 74 years. Of the 71 PA rupture cases, 52 were in women and 10 were in men, with gender not reported in 9 of the cases. There were significantly more cases in women than expected (Mantel-Haenszel common odds ratio estimate = 5.84, 95% confidence interval = 2.97 - 11.46, p < 0.001).
Conclusions:
These data suggest that women may be at significantly greater risk of PA rupture after PA catheterization than men. Clinicians must be aware of the potential for this complication of PA catheterization.
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