Abstract 3216: Percutaneous Closure of Patent Foramen Ovale (PFO) and Atrial Septal Defects (ASD): Incidence and Complication Rates in the United States Adult Population
Introduction: PFO/ASD closure may prevent recurrent events among patients with cryptogenic stroke.
Hypothesis: Despite a lack of randomized trial evidence supporting the role of PFO/ASD closure for the secondary prevention of stroke, anecdotal evidence suggests increasing use of this procedure. We suspected that complication rates would be higher at hospitals performing fewer procedures.
Methods: We used data from the 1998–2003 Healthcare Cost and Utilization Project to produce a U.S. national estimate for the number of percutaneous PFO/ASD closures (ICD-9 code 35.52) among patients 20 years and older without other congenital heart disease. The analysis was limited, when the data was available, to procedures done on hospital day 1 or 2. Length of stay (LOS), total hospital charges and complication rates during admission were calculated.
Results: The number of procedures increased markedly over the 6 study years (national estimate per year: 81, 85, 240, 414, 1923, 3230). Patient age averaged 51.8 years, 58.0% were female, and of those with valid data 83.8% were white, 4.1% were black, and 7.3% were Hispanic. A total of 96 hospitals in the sample did at least 1 procedure, and 50.0% of all procedures were done at 6 high volume hospitals (50 or more total procedures). High volume hospitals had lower mean charges ($27,265 v. 31,585, p<0.001), shorter LOS (1.2 v. 1.9 days, p<0.001), and fewer patients with LOS>2 days (3.4 v.12.0%, p<0.001), but there was no difference in the mean number of comorbid diseases. These high volume hospitals had a lower overall complication rate (4.4 v. 10.1%, see Table 1⇓) and tended towards fewer blood transfusions (0.9 v. 2.1%, p=0.09). In a multivariate model low hospital procedure volume was a predictor of complications (OR= 2.34; 95% CI 1.46–3.75).
Conclusions: Percutaneous PFO/ASD closure is increasingly common. Complications are not infrequent, and a significant number appear related to inexperience with this new procedure.