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Published on: February 28, 2012
Patent foramen ovale closure in patients with cryptogenic thrombo-embolic events using the Cardia PFO occluder
Christian Spies1, Roland Strasheim, Ines Timmermanns
1Section of Cardiology, Rush University Medical Center, Chicago, IL, USA.
Insights
Transcatheter closure of patent foramen ovale (PFO) using the Cardia occluder effectively reduced thrombo-embolic events (TE). Newer generations show improved safety, with minimal thrombus formation and wire fractures, leading to reduced TE recurrence.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Cryptogenic thrombo-embolic events (TE) pose a significant clinical challenge.
- Patent foramen ovale (PFO) is implicated in a subset of TE.
- Transcatheter PFO closure offers a minimally invasive treatment option.
Purpose of the Study:
- To evaluate the long-term experience with three generations of the Cardia PFO occluder.
- To assess the safety and efficacy of PFO closure in patients with cryptogenic TE.
- To identify factors influencing recurrent TE after PFO closure.
Main Methods:
- Retrospective analysis of 403 patients undergoing interventional PFO closure between 1998 and 2004.
- Assessment of procedural success, complications, residual shunt, and device-related issues.
- Evaluation of recurrent TE rates and identification of predictive factors.
Main Results:
- Successful PFO closure in all patients with a pre-closure annual TE incidence of 3.1%.
- Peri-procedural complications occurred in 2.0% of patients.
- Recurrent TE incidence was 2.0% post-closure; atrial septal aneurysm and prior device thrombus predicted recurrence.
Conclusions:
- Generation III Cardia PFO occluders demonstrate technical improvements, virtually eliminating wire fractures and reducing thrombus formation.
- Transcatheter PFO closure with the Cardia device effectively reduces the rate of recurrent TE.
- The efficacy of the Cardia occluder is comparable to other PFO closure devices.
Aims:
We report our experience with three generations of the Cardia patent foramen ovale (PFO) occluder in patients with cryptogenic thrombo-embolic events (TE).
Methods And Results:
Between 1998 and 2004, interventional PFO closure was attempted in 403 patients. Prior to PFO closure, 605 TE occurred, translating into an annual incidence of 3.1%. PFO closure was successful in all patients. Peri-procedural complications occurred in eight patients (2.0%). At 6 months follow-up, residual shunt was present in 10.8% of patients. Transient thrombi developed on 10 devices (predominantly generation II) and asymptomatic wire fractures were detected in 14 cases (generation I and II). The annual incidence of recurrent TE was 2.0% (n=13). Atrial septal aneurysm and prior device-related thrombus formation were identified as predictors of recurrent TE.
Conclusion:
Owing to technical improvements and modified adjunctive pharmacotherapy, the rate of thrombus formation has declined and wire fractures are virtually absent in generation III devices. The overall rate of recurrent TE is reduced by transcatheter PFO closure with the Cardia PFO occluder, and seems comparable to recurrence rates reported for other devices used for this purpose.
