A Practical Scoring System to Select Optimally Sized Devices for Percutaneous Patent Foramen Ovale Closure

Abstract

Background Patent foramen ovale (PFO) has been linked to cryptogenic stroke, and closure has been reported to improve clinical outcomes. However, there are no clear guidelines to direct device sizing. This study sought to use patient characteristics and echocardiographic findings to create a prediction score for device sizing. Methods This was a retrospective review of patients undergoing percutaneous PFO closure at our institution between July 2010 and December 2014. Demographic and clinical characteristics were recorded, and all pre- and intraprocedural echocardiography results were evaluated. Results Thirty-six patients underwent percutaneous PFO closure during the study period. All procedures were performed using an Amplatzer Septal Occluder “Cribriform” (ASOC) device in one of three disc diameters: 25, 30, or 35 mm. Closure was indicated for cryptogenic stroke/transient ischemic attack in 75% of cases. Every case (100%) was successful with durable shunt correction at the 6-month follow-up without complications of erosion or device embolization. The presence of atrial septal aneurysm (ASA) (p = 0.027) and PFO tunnel length >10 mm (p = 0.038) were independently associated with increased device size. A scoring system of 1 point for male sex, 1 point for ASA, and 1 point for PFO tunnel >10 mm long was associated with the size of closure device implanted (p = 0.006). Conclusions A simple scoring system may be used to select an optimally sized device for percutaneous PFO closure using the ASOC device.

Sex Differences in Patients With Cryptogenic Cerebrovascular Events Undergoing Transcatheter Closure of Patent Foramen Ovale

“… 15 Interestingly, Venturini et al described a predictive model for PFO device size selection considering 3 factors, atrial septum aneurism, PFO tunnel >10 mm, and male sex, all of them being predictors of a larger disk size for closure. 12 However, in our study, the proportion of patients with right disks >25 mm was similar between male and female patients. Also, the final optimal result determined by the absence of residual shunting by echocardiography was not influenced by sex.…”

“…The only retrospective study evaluating sex differences in outcomes following PFO closure showed no differences according to sex, but the follow‐up was limited to 3 months. 11 However, recent studies reported additional sex differences among patients undergoing PFO closure, such as potential differences in device size, 12 delayed PFO closure in female patients, 13 and a higher rate of postprocedural atrial fibrillation (AF) among male patients. 14 …”

A comparison of methods to determine patent foramen ovale size

“…Accurate determination of PFO size is important for successful PFO closure. 18 An undersized PFO closure device could result in residual RLS, leading to recurrent thromboembolic events or migraine, 19 or suboptimal anchorage to the surrounding structures, increasing the risk of device embolization. 20 The use of an oversized PFO closure device, conversely, could predispose to atrial wall erosion and aortic injury.…”

Cardiac tamponade following aortic root erosion by an Amplatzer PFO-Occluder in a 41-year-old woman: Only a matter of sizing?

“…Other patientbased factors such as age, sex, body mass index, as well as anatomical factors such as presence of interatrial septal aneurysm, length of tunnel, and size of shunt play a role in the selection of the device. Therefore, this decision has to be made ultimately by the operator [4,[6][7][8]. There is general agreement that balloon sizing is not recommended for device selection [4].…”