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Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale
- Fleming, Rubine Gevorgyan;
- Kumar, Preetham;
- West, Brian;
- Noureddin, Nabil;
- Rusheen, Joshua;
- Aboulhosn, Jamil;
- Tobis, Jonathan M
Published Web Location
https://doi.org/10.1002/ccd.28527Abstract
OBJECTIVES: To compare residual shunt rate and complications associated with six different devices used for PFO closure. BACKGROUND: Transcutaneous PFO closure is an effective treatment for preventing recurrent stroke in patients with a history of cryptogenic stroke. The rate of residual shunt is one metric by which the technical success of PFO closure can be measured. METHODS: Patients who underwent PFO closure at a single center between February 2001 and July 2019 were retrospectively enrolled in the study. Right-to-left shunt at baseline and during follow-up was assessed using transcranial Doppler (TCD) or transthoracic echocardiography (TTE). Periprocedural and device-related complications, including atrial fibrillation, were also assessed. RESULTS: Of 467 PFO closures performed during this period, 320 patients received quantitative assessment of right-to-left shunting both before and after percutaneous closure. The highest effective closure was achieved with the Cardioform device (100%, n = 104), followed by the Amplatzer Cribriform (93%, n = 14), Helex (90%, n = 137), Amplatzer ASO (88%, n = 17), CardioSEAL (86%, n = 14), and Amplatzer PFO (85%, n = 33) devices. The most common significant adverse event was atrial fibrillation, which was more common with the Cardioform device (13%) than the Helex (4%) or the Amplatzer PFO (4%) devices. CONCLUSIONS: The Gore Cardioform Septal Occluder provides more robust closure of a PFO when compared to other devices but its effectiveness is offset by the higher prevalence of transient atrial fibrillation.
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