Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale.

Journal: Catheterization And Cardiovascular Interventions : Official Journal Of The Society For Cardiac Angiography & Interventions
Published:
Abstract

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.

Authors