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Updated: Jun 20, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Percutaneous closure of patent foramen ovale: head-to-head comparison of two different devices
Jean-Marc Meier1, Alexandre Berger, Alain Delabays
1Cardiology Service, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Insights
The Starflex occluder achieved significantly higher patent foramen ovale (PFO) closure rates compared to the PFO-Star device. This study highlights device choice as crucial for successful PFO closure in high-risk patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Patent foramen ovale (PFO) closure is a key treatment for cryptogenic stroke in high-risk patients.
- Device selection is critical for successful percutaneous PFO closure.
- Limited comparative data exists for different PFO closure devices.
Purpose of the Study:
- To prospectively compare the efficacy and safety of two distinct devices for percutaneous PFO closure.
- To evaluate complete PFO closure rates and clinical outcomes.
- To identify factors influencing successful PFO closure.
Main Methods:
- A prospective study involving 40 high-risk patients undergoing percutaneous PFO closure.
- Patients were chronologically assigned to either the PFO-Star (n=20) or Starflex (n=20) device.
- Primary endpoint: complete PFO closure at 6 months via echocardiography. Secondary endpoints: complications and 1-year clinical recurrence.
Main Results:
- Complete PFO closure rates were significantly higher with the Starflex occluder (90%) compared to the PFO-Star device (50%) (p=0.001).
- Major peri-procedural complications, including device thrombus and aorto-right atrial fistula, occurred only in the PFO-Star group.
- No clinical recurrence was observed at 1-year follow-up in either group.
Conclusions:
- Device type significantly impacts the rate of complete PFO closure.
- The Starflex occluder demonstrated superior efficacy and a potentially better safety profile compared to the PFO-Star device.
- These findings emphasize the importance of device selection in percutaneous PFO closure for preventing paradoxical embolism.
Abstract:
Percutaneous closure of patent foramen ovale (PFO) has been proposed as the treatment of choice for young high-risk patients who suffered cryptogenic stroke and/or peripheral paradoxical embolism. We sought to compare prospectively two different devices used for percutaneous PFO closure.Prospective data were collected on 40 high risk patients (females: 38%, mean age : 44 +/- 11 years, interatrial septal aneurysm >10 mm: 68%) who underwent percutaneous PFO closure after cryptogenic stroke (n = 38) or peripheral paradoxical embolism (n = 2). Chronologically, 20 patients were first treated by a PFO-Star (Cardia, Burnsville, MI) device. Then, 20 other patients received a Starflex occluder (NMT, Boston, MA). The primary endpoint was complete PFO closure at 6 months as assessed by transthoracic contrast echocardiography. Secondary endpoints were major peri- or post procedural complications and clinical recurrence at 1 year follow-up.Baseline clinical and anatomical characteristics were comparable for both groups. Complete PFO closure was observed in 50% (PFO-Star) and 90% (Starflex) of patients (p=0.001) respectively. Major peri-procedural complications occurred in the PFO-star group only: right-sided device thrombus (1 patient) and aorto-right atrial fistula (1 patient). At 1 year follow-up, no clinical recurrence occurred.In conclusion, despite the absence of clinical recurrence in this high-risk population with presumed paradoxical embolism, complete PFO closure at 6 months follow-up was significantly related to the type of closure device used.
