Cost effectiveness and clinical efficacy of patent foramen ovale closure as compared to medical therapy in cryptogenic stroke patients: A detailed cost analysis and meta-analysis of randomized controlled trials

Christopher A. Pickett, Todd C. Villines, Jon R. Resar, Edward A. Hulten

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Up to half the patients with cryptogenic stroke under the age of 55 years have been found to have a PFO. Observational studies have demonstrated a benefit from closure of PFO and several RCTs have shown a trend toward benefit. The cost and clinical effectiveness of PFO closure is unclear. Methods and results: We searched for RCTs of PFO closure in patients with cryptogenic stroke and performed a detailed cost analysis and meta-analysis of treatment outcomes based on the results of the meta-analysis. Five RCTs containing 3404 patients with cryptogenic stroke were included. Of these 1829 underwent PFO closure and 1611 received medical therapy. Mean follow-up was 4.0 years. PFO closure achieved cost effectiveness (<$50,000/Quality-adjusted life-year gained) 2.7 years (95% Confidence Interval (CI) 2.2–3.4) after closure. The incremental cost to prevent one combined end point (CEP, combined transient ischemic attack (TIA), stroke, and death) by PFO closure was $535,655(95% CI $458,329–$642,674). After 55.4 years (95%CI 51.1–60.5) of follow-up, the per patient total cost of medical therapy exceeded that of PFO closure. PFO closure demonstrated clinical efficacy with a decreased risk of CEP (pooled hazard ratio (HR = 0.43(95%CI 0.27–0.59))) and a decreased risk of stroke (HR = 0.29(95%CI 0.02–0.57)). Conclusions: In comparison to medical therapy alone, PFO closure appears to be cost-effective and clinically efficacious.

Original languageEnglish (US)
Pages (from-to)74-79
Number of pages6
JournalInternational Journal of Cardiology
Volume273
DOIs
StatePublished - Dec 15 2018

Keywords

  • Cost analysis
  • Cryptogenic stroke
  • Meta-analysis
  • Patent foramen ovale
  • Stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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