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Published on: February 26, 2013
Long-Term Outcomes and Complications of Intracardiac Echocardiography-Assisted Patent Foramen Ovale Closure in 1,000
Gianluca Rigatelli1,2, Luigi Pedon3, Roberto Zecchel3
1Section of Adult Congenital and Adult Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy. jackyheart71@yahoo.it.
Insights
Intracardiac echocardiography-aided patent foramen ovale (PFO) closure is safe and effective long-term. This study found low rates of atrial fibrillation, device thrombosis, mitral regurgitation, and recurrent stroke events after PFO closure.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Long-term outcomes after patent foramen ovale (PFO) closure remain incompletely understood.
- Evaluating complications such as atrial fibrillation (AF), device thrombosis (DT), and recurrent cerebral ischemia is crucial.
Purpose of the Study:
- To assess the long-term safety and efficacy of intracardiac echocardiography (ICE)-aided PFO closure.
- To determine the incidence of key adverse events including AF, DT, mitral valve regurgitation (MVR), and cerebral ischemic events.
Main Methods:
- A prospective review of 1,000 patients undergoing ICE-aided PFO closure using various devices over 13 years.
- Data collection included immediate success rates, device types, and long-term follow-up for specific complications.
Main Results:
- Immediate closure success rate was 99.8%.
- On average follow-up of 12.3 years, permanent AF occurred in 0.5%, DT in 0.5%, new/worsened MVR in 0.2%, and recurrent cerebral events in 0.8%.
- No cases of aortic or atrial free wall erosion were observed.
Conclusions:
- ICE-aided PFO closure with different devices demonstrates excellent very long-term safety and efficacy.
- Low rates of major adverse events, including erosion, DT, recurrent ischemia, MVR changes, and AF, support its use.
Backgrounds:
Long-term fate of patients submitted to patent foramen ovale (PFO) closure is still unclear. The aim of the study was to evaluate the incidence of atrial fibrillation (AF), aortic or atrial free wall erosion, device thrombosis (DT), new onset or worsening of mitral valve regurgitation (MVR), and recurrent cerebral ischemic events in the long-term follow up after intracardiac echocardiography (ICE)-aided PFO closure in a large population.
Methods:
We reviewed the medical and instrumental data of 1,000 consecutive patients (mean age 47.3 ± 17.1 years, females) prospectively enrolled in 2 centres over a 13 years period (February 1999-February 2012) for R-to-L shunt ICE-aided catheter-based closure using different devices.
Results:
Immediate success was 99.8%. Implanted devices were Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). On a mean follow-up of 12.3 ± 0.6 years (minimum 4- maximum 17 years), permanent AF occurred in 0.5%, DT was apparent in 0.5%, new onset or worsening of MVR was observed in 0.2%, whereas recurrent cerebral ischemic events were 0.8%. Occlusion rate was 93.8%. No aortic or atrial free wall erosion has been observed.
Conclusion:
ICE-aided closure of PFO using different devices, appeared very safe and effective on very long-term follow up with low incidence of erosion, DT, recurrent ischemic events, MVR new onset or worsening, and permanent AF.
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