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

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.

Atrial fibrillation after closure of patent foramen ovale in the REDUCE clinical study

“…It cannot be ruled out that the Gore septal occluders have a higher risk for AF than the Amplatzer device although this was not supported in a randomized study of three different PFO occluders 14 and in a network meta‐analysis of randomized PFO closure studies 15 . We found no significant difference in the AF risk for the Gore Cardioform Septal Occluder versus the HELEX device opposed to results from a single‐centre PFO closure cohort 16 . Further, there may have been differential surveillance between the study arms as AF may have been more aggressively sought in device compared to control patients.…”

Patent foramen ovale closure with prosthesis for occlusion of atrial septal defect in lipomatous hypertrophy of atrial septum. Report of two cases

“…7 This evaluation is often used to compare the efficacy of different devices and the occurrence of adverse events, such as thrombus formation and atrial fibrillation. Since the different devices currently used differ in efficacy and safety 3 and in view of the different anatomical characteristics of each patient, it is reasonable to believe the customized choice of the device can impact on procedural success. 2 An alternative approach for PFO associated with lipomatous hypertrophy of the interatrial septum is based on the use of a dedicated device for the occlusion of ventricular septal defect (VSD), because this device has a longer waist (usually >7mm).…”

“…2 Percutaneous PFO occlusion is safe and effective and can be performed with different types of occluders. 3 The choice of the occlusive device must consider the anatomy of the interatrial septum and the foramen ovale, availability of the device, and team's experience. The choice usually favors proper devices for closing this structure.…”

Paravalvular Leak Closure With a Nonfenestrated Device

“…In patients with severe, transfusion-dependent hemolysis, there is a drive to achieve complete resolution of the aberrant flow (although reducing the leak size can paradoxically increase hemolysis). In the atrial septal position, the theoretical benefits of the CSO include the rapidity with which resolution of the shunt is achieved ( 15 ). We have some concern that this device is not proven in higher-pressure circulation.…”