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Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale.

TitleSafety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale.
Publication TypeJournal Article
Year of Publication2017
AuthorsMerkler AE, Gialdini G, Yaghi S, Okin PM, Iadecola C, Navi BB, Kamel H
JournalStroke
Volume48
Issue11
Pagination3073-3077
Date Published2017 Nov
ISSN1524-4628
KeywordsAdult, Age Factors, Aged, Brain Ischemia, Cardiac Catheterization, Female, Foramen Ovale, Patent, Humans, Male, Middle Aged, Postoperative Complications, Retrospective Studies, Risk Factors, Stroke
Abstract

BACKGROUND AND PURPOSE: We sought to evaluate the real-world rate of safety outcomes after patent foramen ovale (PFO) closure in patients with ischemic stroke or transient ischemic attack (TIA).

METHODS: We performed a retrospective cohort study using administrative claims data on all hospitalizations from 2005 to 2013 in New York, California, and Florida. Using International Classification of Diseases, Ninth Revision, Clinical Modification codes, we identified patients who underwent percutaneous transcatheter PFO closure within 1 year of ischemic stroke or TIA. Our outcome was an adverse event occurring during the hospitalization for PFO closure, defined as in prior studies as atrial fibrillation or flutter, cardiac tamponade, pneumothorax, hemothorax, a vascular access complication, or death. Crude rates were reported with exact confidence intervals.

RESULTS: We identified 1887 patients who underwent PFO closure after ischemic stroke or TIA. The rate of any adverse outcome during the hospitalization for PFO closure was 7.0% (95% confidence interval [CI], 5.9%-8.2%). Rates of adverse outcomes varied by age and type of preceding cerebrovascular event. In patients >60 years of age, the rate of adverse outcomes was 10.9% (95% CI, 8.6%-13.6%) versus 4.9% (95% CI, 3.8%-6.3%) in patients ≤60 years of age. The rate of adverse outcomes was 9.9% (95% CI, 7.3%-12.5%) in patients with preceding ischemic stroke versus 5.9% (95% CI, 4.7%-7.1%) after TIA.

CONCLUSIONS: Approximately 1 in 14 patients who underwent percutaneous transcatheter PFO closure after ischemic stroke or TIA experienced a serious periprocedural adverse outcome or death. The risk of adverse outcomes was highest in older patients and in those with preceding ischemic stroke.

DOI10.1161/STROKEAHA.117.018501
Alternate JournalStroke
PubMed ID28939677
PubMed Central IDPMC5699514
Grant ListR01 NS037853 / NS / NINDS NIH HHS / United States
R01 NS073666 / NS / NINDS NIH HHS / United States
K23 NS091395 / NS / NINDS NIH HHS / United States
R01 NS034179 / NS / NINDS NIH HHS / United States
R01 NS097443 / NS / NINDS NIH HHS / United States
R37 NS034179 / NS / NINDS NIH HHS / United States
R37 NS089323 / NS / NINDS NIH HHS / United States
K23 NS082367 / NS / NINDS NIH HHS / United States