Related Experiment Video
Updated: Jun 19, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Impact of occluder device type on success of percutaneous closure of atrial septal defects--a medium-term follow-up
Michael Becker1, Dorothee Frings, Jörg Schröder
1University Hospital RWTH Aachen, Department of Cardiology, Aachen, Germany. mibecker@ukaachen.de
Insights
The Amplatzer occluder demonstrated superior performance in percutaneous closure of patent foramen ovale and atrial septal defects, showing fewer residual shunts and lower thromboembolic event rates compared to Starflex and Cardiastar devices.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Patent foramen ovale (PFO) and atrial septal defects (ASDs) are common cardiac anomalies.
- Percutaneous closure is a standard treatment for selected patients, particularly those with paradoxical embolism.
- Occluder device choice may influence procedural outcomes and long-term efficacy.
Purpose of the Study:
- To compare the efficacy and safety of different occluder devices (Amplatzer, Starflex, Cardiastar) for PFO and ASD closure.
- To evaluate rates of residual shunts and thromboembolic events at medium-term follow-up.
- To identify risk factors for adverse events after percutaneous closure.
Main Methods:
- A retrospective study of 302 patients undergoing percutaneous PFO or ASD closure between 1997 and 2006.
- Patients received either Amplatzer, Starflex, or Cardiastar occluders.
- Follow-up included transesophageal echocardiography at 1, 3, and 6 months, and assessment of thromboembolic events over a mean of 31 months.
Main Results:
- The Amplatzer group had significantly fewer residual shunts at 6 months compared to Starflex and Cardiastar (P=0.0005).
- Occluder type was a significant risk factor for residual shunts (P=0.0033).
- The annual recurrence rate of thromboembolic events was lower with Amplatzer (1.3%) versus Starflex (3.9%) and Cardiastar (3.6%) (P=0.0467). Atrial septal aneurysm was a significant risk factor for thromboembolic events (P=0.0168).
Conclusions:
- Percutaneous closure of PFO/ASD is a safe procedure with low complication rates.
- Significant differences exist among Amplatzer, Cardiastar, and Starflex occluders regarding defect closure and thromboembolic event recurrence.
- Amplatzer devices appear to offer better long-term outcomes in terms of shunt closure and thromboembolic event prevention.
Objective:
To identify differences between various occluder types regarding thromboembolic event rates and existence of residual shunts during medium-term follow-up.
Methods:
Three hundred nine consecutive patients with presumed paradoxical embolism and scheduled for percutaneous closure of patent foramen ovale or atrial septal defect between 1997 and 2006 were considered for this study. Device implantation failed in seven patients (nonstable device position), so 302 patients (46 +/- 12 years, 190 males) formed the study group using Amplatzer (n = 208), Starflex (n = 61), and Cardiastar (n = 33) occluders. Follow-up transesophageal echocardiography was performed 1, 3, and 6 months after implantation.
Results:
Periinterventional complications occurred in two patients (cardiac arrhythmias). There were more residual shunts in the Starflex and Cardiastar group than in the Amplatzer group at 6-month follow-up (8/61 vs. 7/33 vs. 8/208, P = 0.0005). Performing logistic regression, the type of occluder device was a significant risk factor for the presence of residual shunt 6 months after implantation (P = 0.0033; Cardiastar vs. Amplatzer OR 6.346, 95% CI 1.998 - 20.156; Starflex vs. Amplatzer OR 4.369, 95% CI 1.444 - 13.222). During mean follow-up of 31 +/- 8 months 16 recurrent thromboembolic events occurred; the annual recurrence was 2.1% for combined end-point stroke, TIA, and peripheral embolism (Amplatzer: 1.3%, Starflex: 3.9%, and Cardiastar: 3.6%, P = 0.0467). The presence of an atrial septal aneurysm was the only significant risk factor (P = 0.0168, OR 3.664, 95% CI 1.263 - 10.630) for the occurrence of thromboembolic events.
Conclusions:
Percutaneous closure of patent foramen ovale or atrial septal defect is a safe procedure with little incidence of peri- and postprocedural complications. There is a significant difference between the Amplatzer, Cardiastar, and Starflex occluders in regard to complete closure of the defects and annual recurrence of thromboembolic events.
