Real world long-term outcomes among adults undergoing transcatheter patent foramen closure with amplatzer PFO occluder
Related Experiment Video
Updated: Aug 27, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Lusine Abrahamyan1, Madeleine Barker2, Christoffer Dharma3
1Toronto General Hospital Research Institute, University Health Network (UHN), Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Insights
Transcatheter closure of patent foramen ovale (PFO) using the Amplatzer device shows excellent safety and effectiveness for cryptogenic stroke patients. Older patients experienced more adverse events, and new atrial fibrillation was common.
Area of Science:
- Cardiology
- Interventional Cardiology
- Neurology
Background:
- Patent foramen ovale (PFO) is a congenital heart defect linked to cryptogenic stroke.
- Transcatheter PFO closure is a treatment option for affected adults.
Purpose of the Study:
- To evaluate real-world outcomes of adult patients undergoing transcatheter PFO closure.
- Assess the safety and effectiveness of the Amplatzer PFO Occluder in a large cohort.
Main Methods:
- Retrospective cohort study linking clinical registry and administrative databases.
- Inclusion of 479 adult patients undergoing PFO closure between 1999 and 2017.
- Analysis of short-term (in-hospital, 30-day) and long-term (mean 9.1 years) outcomes.
Main Results:
- 100% procedural success with 96% same-day discharge.
- Low in-hospital complication rate (2.5%).
- Long-term adverse events included TIA (4%), stroke (1.5%), and new-onset atrial fibrillation (7.6%). Composite stroke/TIA/death rate was 10.9%.
Conclusions:
- Transcatheter PFO closure with Amplatzer PFO Occluder demonstrates excellent real-world safety and effectiveness for cryptogenic stroke.
- Outcomes are comparable to randomized trials and other long-term studies.
- New-onset atrial fibrillation is a frequent adverse event; further research into post-discharge management is warranted.
Background:
Patent foramen ovale (PFO) is a congenital heart defect associated with an increased risk of cryptogenic stroke. We aimed to evaluate real-world outcomes of adult patients undergoing transcatheter PFO closure with the Amplatzer PFO Occluder.
Methods:
In this single centre, retrospective cohort study, we linked a detailed clinical registry with provincial administrative databases to obtain short and long-term outcomes. Validated algorithms were used to established baseline comorbidities and adverse outcomes.
Results:
Between 1999 and 2017, 479 patients had PFO closure with an Amplatzer PFO Occluder. The average age of the patients was 47.3 years (standard deviation (SD) = 12.4), and 54.7% were males. The procedural success was 100%, and 96% of patients were discharged on the same day. Any in-hospital complication was observed in 2.5% (n = 12) of patients. At 30 days post-discharge, 18% of patients had an ED visit and 5% a hospitalization. Over a mean follow-up of 9.1 (SD = 3.8) years, 4% experienced TIA, 1.5% stroke, and 7.6% atrial fibrillation. The composite outcome of stroke/TIA/death was observed in 10.9% of patients (1.22 events per 100 person-years). Patients >60 years old experienced higher rates of adverse events than younger patients.
Conclusions:
In this large real-world cohort of patients with cryptogenic stroke, we observed excellent safety and effectiveness outcomes for PFO closure conducted with Amplatzer PFO Occluder, similar to randomized controlled trials or other long-term cohort studies. New onset atrial fibrillation was one of the most commonly adverse events. Future studies should investigate early post-discharge management of patients to prevent readmissions.
