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Angle-closure glaucoma, or closed-angle glaucoma, is an eye condition where the iris bulges out and blocks the iridocorneal angle, resulting in a buildup of aqueous humor and increased intraocular pressure. Immediate medical attention is necessary due to the sudden onset of symptoms. The treatment for angle-closure glaucoma includes short-term and long-term approaches. Short-term treatment involves using eye drops like pilocarpine to lower intraocular pressure by increasing aqueous humor...

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Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
10:52

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Published on: December 23, 2022

Off-label closure during CLOSURE study.

Kathryn A Stackhouse1, Sachin S Goel, Athar M Qureshi

  • 1Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.

The Journal of Invasive Cardiology
|November 3, 2012
PubMed
Summary
This summary is machine-generated.

Percutaneous closure of patent foramen ovale (PFO) may not benefit all patients with cryptogenic stroke. Off-label PFO closures in higher-risk patients showed different characteristics than those in the CLOSURE I trial.

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Area of Science:

  • Cardiology
  • Neurology
  • Interventional Cardiology

Background:

  • The efficacy of percutaneous closure of patent foramen ovale (PFO) for cryptogenic stroke or transient ischemic attack is debated.
  • While registry data suggest benefits, the CLOSURE I trial found no advantage over medical therapy.

Purpose of the Study:

  • To compare patient characteristics and outcomes between the CLOSURE I trial and off-label PFO closures at a single institution.
  • To assess the generalizability of CLOSURE I trial findings to a broader patient population.

Main Methods:

  • Comparison of patients in the CLOSURE I trial with those undergoing off-label PFO closure at a large institution.
  • Prospective enrollment into an institutional registry for off-label PFO closures.
  • Analysis of demographic and clinical risk factors, including degree of right-to-left shunting.

Main Results:

  • Off-label PFO closures (n=100) significantly outnumbered CLOSURE I enrollment (n=33) at the institution.
  • Off-label patients were older and had higher rates of hypertension, hyperlipidemia, and coronary disease compared to CLOSURE I participants.
  • Off-label closures demonstrated a considerably higher prevalence of significant right-to-left shunting.

Conclusions:

  • Significant demographic and clinical differences exist between patients undergoing off-label PFO closure and those in the CLOSURE I trial.
  • Higher-risk patients with larger shunts were preferentially selected for off-label PFO closure.
  • The findings of the CLOSURE I trial may not be generalizable to all patients with cryptogenic stroke undergoing PFO closure.