Key result
The Cardioform device achieved 100% effective PFO closure compared to 85-93% for other devices, but had a higher rate of atrial fibrillation (13% vs 4% for Helex and Amplatzer PFO).
Why the study?
Transcutaneous PFO closure prevents recurrent stroke, and residual shunt rate is a metric of technical success, prompting comparison across different closure devices.
Does the choice of PFO closure device affect the rate of residual right-to-left shunt and periprocedural complications in patients undergoing transcutaneous PFO closure?
Cohort (n=320)
No
Does the choice of PFO closure device affect the rate of residual right-to-left shunt and periprocedural complications in patients undergoing transcutaneous PFO closure?
The Gore Cardioform Septal Occluder provides more robust PFO closure compared to other devices, but its use is associated with a higher risk of transient atrial fibrillation.
Higher AF risk with Cardioform warrants caution in device selection; leaves open whether superior closure justifies increased arrhythmia incidence.
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.
No takes yet. Share an insight, caveat, or question.
Fleming et al. (2019) conducted a cohort in Patent foramen ovale (n=320). Cardioform device vs. Amplatzer Cribriform, Helex, Amplatzer ASO, CardioSEAL, and Amplatzer PFO devices was evaluated on Effective closure (absence of residual right-to-left shunt). The Cardioform device achieved 100% effective PFO closure compared to 85-93% for other devices, but had a higher rate of atrial fibrillation (13% vs 4% for Helex and Amplatzer PFO).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: