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

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.