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Trends in the Use of Percutaneous Closure of Patent Foramen Ovale and Atrial Septal Defect in Adults, 1998-2004
To the Editor: Percutaneous closure of patent foramen ovale/atrial septal defect (PFO/ASD) is perceived as having minimal risk and has been proposed for a broad array of indications.1 The widespread application of this procedure, especially PFO closure, is controversial because of limited data on its efficacy and safety in many settings, including prevention of recurrent cryptogenic stroke.2 We studied trends in the prevalence of PFO/ASD closure in the United States.
Methods
We analyzed data from 1998 through 2004 of the Nationwide Inpatient Sample, the largest publicly available all-payer US inpatient database; this stratified sample approximates a 20% sample of US community hospitals. The Hospital of the University of Pennsylvania institutional review board granted an exemption for this study.
The cohort included participants aged 20 years or older with a procedure code from the International Classification of Diseases, Ninth Revision (ICD-9) designating "Repair of ASD with prosthesis, closed technique" (ICD-9 35.52) on the first or second hospital day. Patients with other congenital heart disease were excluded. An equivalent surgical PFO/ASD closure (ICD-9 35.51) population was identified for trend comparison.
Covariates included age, sex, procedure year, number of comorbidities,3 and hospital characteristics (teaching status and size). Outcomes of interest were length of stay, hospital charges, and complication rates (defined by ICD-9 codes corresponding to reported complications of percutaneous PFO/ASD closure, repeat procedure, or death). Codes that could alternatively refer to preexisting conditions correlated with PFO/ASD (eg, arrhythmia or stroke) were only classified as complications if specifically designated as such.
General trends over the entire study period were calculated using linear regression.4 However, because of changes in techniques and devices used, we limited detailed analysis of complications to procedures performed between 2002 and 2004. Analyses were conducted with SAS 9.01 (SAS Institute Inc, Cary, North Carolina) and accounted for survey design and clustering. A P value of less than .05 was considered significant.
Results
In the sample population, the unweighted annual number of percutaneous PFO/ASD closure procedures increased 58-fold over the study period, while the number of surgical procedures showed little change (Table). The weighted national estimate of the annual number of percutaneous PFO/ASD closure procedures increased 50-fold over the study period, while the number of surgical PFO/ASD closures remained comparatively stable. The estimated percentage of PFO/ASD closures performed percutaneously in the United States increased from 18.5% to 92.5%.
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Table. Adults Undergoing Percutaneous and Surgical PFO/ASD Closure, Nationwide Inpatient Sample, 1998-2004a
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Between 2002 and 2004, 7.3% of patients (95% confidence interval [CI], 5.7%-8.9%) sustained a complication, with bleeding complications reported in 2.9% of cases (95% CI, 1.9%-3.8%) and blood transfusions in 1.0% of cases (95% CI, 0.5%-1.6%). The complication rate did not change significantly over time (P = .22). Occurrence of complications was associated with a patient's number of comorbidities (per comorbidity, odds ratio = 1.79; 95% CI, 1.38-2.17; P < .001) and was independently associated with longer mean length of stay (5.55 days [95% CI, 4.23-6.86] vs 1.22 days [95% CI, 1.13-1.32]; P < .001) and higher charges ($61 325 [95% CI, $48 926-$73 724] vs $28 466 [95% CI, $26 048-$30 954]; P < .001).
Comment
Percutaneous PFO/ASD closure is increasingly common and has supplanted surgery as the method of choice. For perspective, in the 7 years following the introduction of coronary stents, their use in the Medicare population increased about 7-fold, and coronary revascularization procedures overall increased less than 2-fold.5
Study limitations include use of ICD-9 codes, which have not been validated for epidemiologic studies of PFO/ASD closure and do not distinguish PFO from ASD; limited information on procedural indications; and lack of data to explain the rise in procedure volume. Given the stable surgical PFO/ASD closure volume, the growth in percutaneous volume likely reflects not only the availability of a less invasive technique, but also identification of a new population that may benefit from PFO/ASD closure.
However, the increasing use and widespread availability of PFO/ASD closure despite the lack of data on efficacy and long-term safety is concerning, especially in regards to PFO closure for cryptogenic stroke and migraine headache. Moreover, this trend appears to have impeded enrollment in trials aimed at providing data essential to defining the appropriate clinical role for this procedure.6
Author Contributions: Dr Opotowsky had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Opotowsky.
Acquisition of data: Opotowsky.
Analysis and interpretation of data: Opotowsky, Landzberg, Kimmel, Webb.
Drafting of the manuscript: Opotowsky.
Critical revision of the manuscript for important intellectual content: Opotowsky, Landzberg, Kimmel, Webb.
Statistical analysis: Opotowsky, Kimmel.
Administrative, technical, or material support: Opotowsky.
Study supervision: Landzberg, Webb.
Financial Disclosures: Dr Landzberg reported receiving grant and research support from AGA Medical Corporation and NMT Medical Inc. No other author reported any disclosures related to this article.
Disclaimer: The authors of this letter are responsible for its contents. No statement in this letter should be construed as an official position of the Agency for Healthcare Research and Quality or the US Department of Health and Human Services.
Previous Presentations: An abstract of the preliminary data was presented at the American Heart Association Scientific Sessions; Chicago, Illinois; November 14, 2006.
Alexander R. Opotowsky, MD, MPH
alexander.opotowsky{at}uphs.upenn.edu
Department of Medicine
University of Pennsylvania Medical Center
Philadelphia
Michael J. Landzberg, MD
Department of Medicine
Brigham and Women's Hospital
Boston, Massachusetts
Stephen E. Kimmel, MD, MSCE;
Gary D. Webb, MD
Department of Medicine
University of Pennsylvania Medical Center
Philadelphia
1. Landzberg MJ, Khairy P. Indications for the closure of patent foramen ovale. Heart. 2004;90(2):219-224.
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2. Maisel WH, Laskey WK. Patent foramen ovale closure devices: moving beyond equipoise. JAMA. 2005;294(3):366-369.
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3. Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998;36(1):8-27.
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4. Houchens RL, Elixhauser A. Using the HCUP nationwide inpatient sample to estimate trends (updated for 1988-2004). Rockville, MD: US Agency for Healthcare Research and Quality; 2006;2006-05:1-53. http://www.hcup-us.ahrq.gov/reports/methods.jsp. Accessed March 23, 2007.5. Lucas FL, DeLorenzo MA, Siewers AE, Wennberg DE. Temporal trends in the utilization of diagnostic testing and treatments for cardiovascular disease in the United States, 1993-2001. Circulation. 2006;113(3):374-379.
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6. Slottow TL, Steinberg DH, Waksman R. Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel meeting on patent foramen ovale closure devices. Circulation. 2007;116(6):677-682.
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Letters Section Editor: Robert M. Golub, MD, Senior Editor.
JAMA. 2008;299(5):521-522.
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