Recurrent events after percutaneous closure of patent foramen ovale

Catheter Cardiovasc Interv. 2013 Oct 1;82(4):541-6. doi: 10.1002/ccd.24511. Epub 2013 Jun 27.

Abstract

Objectives: To determine the incidence of symptomatic recurrent embolic events after patent foramen ovale (PFO) closure and potential causes for these events.

Background: It is well-known that cerebral or other embolic events may occur after PFO closure.

Methods: This is a retrospective analysis of consecutive patients who underwent PFO closure for secondary prevention of embolic events at a single institution.

Results: 1,930 patients (mean age of 50 ± 13.3 years) underwent transcatheter PFO closure. Complete closure occurred in 92%. The annual recurrence rate of embolic events before PFO closure was 22.4% (785 events in 3,497 patient-years). During follow-up (mean 39 months), 63 recurrent events were documented: 25 strokes, 36 transient ischemic attacks (TIAs), and 2 peripheral embolic events. The overall annual recurrence rate after the procedure was 1% per year (63 events in 6,211 patient-years). The majority of events occurred in patients without residual shunts (54/63). There was no significant association between the presence of a residual shunt and recurrent events [hazard ratio (HR) 1.7; 95% confidence interval (CI) 0.8-3.6, P = 0.16]. The most common cause for recurrent events was atherosclerosis. Nine out of 63 events were considered likely or possible paradoxical embolism due to residual shunt [stroke (2), TIA (5), and peripheral embolism (2)]. After PFO closure, the annual rate of events potentially related to paradoxical embolism was 0.14% (9 events in 6,211 patient-years).

Conclusion: The incidence of symptomatic embolic events after PFO closure is low. Most recurrent events are related to coexistent conditions associated with thromboembolic risk rather than residual shunts.

Keywords: patent foramen ovale; percutaneous closure; stroke.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization* / adverse effects
  • Comorbidity
  • Embolism, Paradoxical / epidemiology
  • Embolism, Paradoxical / physiopathology
  • Embolism, Paradoxical / prevention & control*
  • Female
  • Foramen Ovale, Patent / diagnosis
  • Foramen Ovale, Patent / epidemiology
  • Foramen Ovale, Patent / physiopathology
  • Foramen Ovale, Patent / therapy*
  • Germany / epidemiology
  • Hemodynamics
  • Humans
  • Incidence
  • Ischemic Attack, Transient / epidemiology
  • Ischemic Attack, Transient / physiopathology
  • Ischemic Attack, Transient / prevention & control*
  • Male
  • Middle Aged
  • Recurrence
  • Retrospective Studies
  • Risk Factors
  • Secondary Prevention / methods*
  • Stroke / epidemiology
  • Stroke / physiopathology
  • Stroke / prevention & control*
  • Time Factors
  • Treatment Outcome
  • Young Adult