Valvular & structural heart diseaseCohort study
Twenty-Year Follow-Up After Patent Foramen Ovale Closure in Patients With Paradoxical Embolism
- Cohort study
- single-centre
- prospective procedure and early follow-up data collection
- retrospective long-term follow-up
- consecutive patients
Authors' conclusion
The results of this cohort study with 20-year follow-up showed the sustained very long-term safety and efficacy of transcatheter PFO closure, with less than 1% rate of recurrent stroke events. However, bleeding events occurred in about 1 in 10 patients and were more frequent in women and in patients under long-term antithrombotic therapy.
Study context
- Population
- Patients with patent foramen ovale (PFO) closure for cryptogenic stroke, transient ischemic attack (TIA) or peripheral embolism, 2001–2006, tertiary university hospitalfollow-up incomplete in 5
- Participants
- 130 patients
- Outcome
- Long-term clinical outcomes:
- Medical record review
- Telephone interviews
- Follow-up
- 20 years
Main finding
As reported in the abstract
All-cause death
20 patients (15.3%)
Noncardiovascular death
12.2%
Recurrent stroke
1 stroke [0.04 per 100 patients, per year]
Recurrent TIA
6 TIAs [0.25 per 100 patients, per year]
Observational data: associations, not effects.
Further findings
| Outcome | P value |
|---|---|
| Thrombophilia prevalence, recurrent ischemic event vs none · 33% vs 4.8% | P = 0.04 |
Discontinued antithrombotic treatment
- Up to 20.5% discontinued antithrombotic treatment; none had an ischemic event
Safety
Bleeding events · 20-year follow-up
- Any bleeding
- 17 patients (13%)
- Major bleeding
- 9 cases (6.9%)
- Bleeding, women vs men
- 19.4% vs 6.3%; P = .03
- Bleeding, long-term antithrombotic therapy vs discontinued
- 17% vs 0%; P = .04
Original publication
Summarised from the published abstract; every number is checked against it