Background

Patent foramen ovale (PFO) is implicated in the pathogenesis of clinical conditions such as cryptogenic stroke and migraine with aura. This study evaluated the challenges of sizing a PFO with different contemporary imaging modalities and assessed the relationship between PFO size and severity of the right-to-left shunt (RLS).

Methods

Patients who were referred to interventional cardiology with the diagnosis of a PFO and had undergone intra-procedural balloon sizing (n = 147), transesophageal echocardiogram (TEE) imaging (n = 67), or intracardiac echocardiogram (ICE) imaging (n = 73) at the time of workup were included in this study. TEE and ICE were used to obtain PFO length and height during normal respiration. A sizing balloon was used to obtain PFO width and height after the septum primum was opened with balloon inflation.

Results

The mean PFO length measured by TEE and ICE differed significantly (n = 27, 13.0 ± 4.1 vs. 9.9 ± 3.2 mm, p = .001). The mean PFO height measured by TEE and ICE (n = 27, 1.4 ± 0.6 vs. 1.7 ± 0.6 mm, p = .04), TEE and sizing balloon (n = 56, 1.5 ± 1.2 vs. 10.5 ± 4.2 mm, p < .0001), and ICE and sizing balloon (n = 66, 1.7 ± 0.7 vs. 9.1 ± 3.7 mm, p < .0001) also differed significantly. A poor correlation existed between anatomic PFO length or height and functional Spencer TCD grade RLS flow with Valsalva, irrespective of the imaging modality used.

Conclusions

The determination of a PFO size is dependent on the imaging modality used. Sizing balloon demonstrates a larger width or height than ultrasound imaging methods, such as TEE and ICE, because a PFO remains closed most of the time, leading the echocardiogram to underestimate the potential PFO size. Additionally, PFO length and height correlate poorly with the functional RLS grade. These findings imply that ultrasound-based size characterization should not be used to determine whether a PFO should be closed.

Percutaneous patent foramen ovale (PFO) closure is recommended for secondary prevention of paradoxical embolism through a PFO. In the United States, two Food and Drug Administration-approved PFO closure devices are currently available, and the choice depends on operator preference and PFO anatomy. Although these devices are easy to implant, there are several potential complications. As opposed to the Amplatzer PFO Occluder, there has been no published case of atrial erosion with Gore closure devices. This report describes two cases of pericardial tamponade due to perforation of the atrial wall induced by a wire frame fracture of the Gore Helex and Cardioform devices.