Efficacy of Percutaneous Closure of Patent Foramen Ovale: Comparison Among Three Commonly Used Occluders

Study Questions:

What are the short- and medium-term patent foramen ovale (PFO) closure rates for three commonly used occluders?

Methods:

One hundred and sixty-six adults were enrolled at a single center. Choice of device was at the discretion of the implanting physician. Patients with large PFOs (>30 bubbles in the left heart after Valsalva) were included. Transthoracic echocardiography with contrast and Valsalva was performed at 6-month intervals following the procedure.

Results:

Amplatzer occluders (of which 17.5% were atrial septal occluders) were used in 48% of patients, Gore Helex devices were used in 29% of cases, and Premere TM devices were used in 23% of cases. Residual shunting with Valsalva 6 months after implantation was present in 58.3% of patients with the Helex device, 39.5% with the Premere device, and 32.5% with the Amplatzer device. At final follow-up, residual shunting was present in 33.3% of patients with the Helex device, 18.5% with the Premere device, and 11% with the Amplatzer device. The residual shunt rate was significantly lower for the Amplatzer device than for the Helex device (p < 0.05) at both 6-month and final follow-up. The presence of an atrial septal aneurysm was a risk factor for residual shunting (relative risk, 24.7; 95% confidence interval, 8.2-74.4; p < 0.0001). Only one patient (0.6%) receiving a device experienced a neurologic event during the follow-up period.

Conclusions:

The authors concluded that percutaneous PFO closure is effective, although closure rates are dependent on the presence of atrial septal aneurysm and differ between occluders.

Perspective:

This study shows differential closure rates of PFO based on device selection, with the highest closure rate for the Amplatzer occluder. Several limitations should be kept in mind. First, the study was not randomized, and device selection was at the discretion of the implanting physician. Therefore, it could be argued that the nature of the defect and not the device determined the closure rates. However, there was no difference in defect size or presence of atrial septal aneurysm in patients receiving the various types of devices. There were a larger number of tunnel-type of defects in patients receiving the Premere device. Additionally, the overall complete closure rates for this study were relatively low, although they did increase with increased duration of follow-up.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Noninvasive Imaging, Congenital Heart Disease, CHD & Pediatrics and Imaging, CHD & Pediatrics and Quality Improvement, Echocardiography/Ultrasound

Keywords: Heart Aneurysm, Risk, Follow-Up Studies, Heart Defects, Congenital, Foramen Ovale, Patent, Echocardiography, Septal Occluder Device


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