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Two PFO occluder devices appear equally safe and effective
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In patients who have a stroke or transient ischemic attack related to the patent foramen ovale, percutaneous patent foramen ovale closure is comparably safe and effective with both the Amplatzer device and the Figulla occluder device, according to recent findings.
In the observational registry conducted in two Italian centers, researchers evaluated 406 consecutive patients treated with the Amplatzer PFO occluder (St. Jude Medical; n = 179) or the Figulla occluder (Occlutech; n = 227) between June 2007 and October 2014. Patients underwent thorough screening, including clinical history, transthoracic echocardiography (TTE), coagulation analysis and complete laboratory assessment for thrombophilia (antithrombin III, anticardiolipin, antiphospholipid antibodies, lupus anticoagulant, protein C and S, homocysteine, and genetic tests for Factor V Leiden and factor II). Patients also underwent brain magnetic resonance or CT scans and transesophageal echocardiography before PFO closure.
The researchers semiquantitatively graded right-to-left-shunt according to the amount of microbubbles identified in the left atrium after crossing the interatrial septum on a still frame during the first five cardiac cycles of contrast entering the right atrium.
All patients were seen for clinical follow-up at 1, 6 and 12 months after the procedure, with major adverse events, including death, cryptogenic stroke or TIA, individually recorded. Arrhythmias were documented echocardiographically during a planned Holter monitoring at 1-month follow-up and prospectively recorded in the registry.
Procedural success
The researchers found that the cumulative procedural success rate was 99.5%, owing to late displacement of a 25-mm Amplatzer device and a 16/18-mm Figulla embolization, which were managed successfully through percutaneous device retrieval. There were no ischemic events during and after the procedure.
A contrast TTE performed in all patients within 24 hours of the procedure revealed residual shunting in 89 (22%) patients overall, with 43 (24%) in the Amplatzer group and 46 (20%) in the Figulla group.
At 6 months, contrast TTE showed a decrease in shunting and complete closure in 26 of the 43 patients treated with the Amplatzer device and in 27 of the 46 patients treated with the Figulla device (P = .96). Six-month residual shunts were grade 1 in nine (5%) patients in the Amplatzer group and in nine (4%) patients in the Figulla group; residual shunts were grade 2 in eight (4.5%) patients treated with the Amplatzer device and 10 (4.5%) treated with the Figulla device.
Few differences
At 6-month follow-up, there was no significant difference between the groups in any of the assessed variables. None of the patients were lost to follow-up, and no deaths, recurrent embolic events or aortic erosions were documented during follow-up. Four patients from the Amplatzer group and one from the Figulla group experienced atrial fibrillation immediately after device deployment or during the first 30 days of follow-up; likewise, the Amplatzer group had a higher rate of supraventricular arrhythmias vs. the Figulla group (17% vs. 9%; P = .02).
Of the arrhythmic events, two-thirds were periprocedural or occurred during hospital stay, whereas the remainder occurred during 1-month Holter monitoring. All arrhythmias were successfully treated with pharmacologic agents.
“In our study, transcatheter percutaneous PFO closure was achieved safely and effectively with the Amplatzer and the Figulla devices,” the researchers wrote. “Acute procedural success was high. Clinical results at 12-month follow-up were comparable in the two groups, and no relevant differences in residual shunt were found as evaluated by contrast TTE.”
The Amplatzer device is the only one approved for PFO closure for prevention of recurrent stroke in the United States. – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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