Patent Foramen Ovale Closure in Patients with Transient Ischemia Attack/Stroke

Abstract

Paradoxical embolism through a patent foramen ovale (PFO) has been recognized as a potential cause of transient ischemia attack (TIA) and stroke especially in younger patients. The therapeutic options are medical treatment (antiaggregation or anticoagulation) with an annual recurrence rate of 3% to 4% for stroke or TIA, surgical PFO closure, or catheter closure. Randomized studies are ongoing; however, the results will not be available soon. Since August 1994, we have attempted catheter closure of a PFO in 281 patients (age 17 to 79 years, mean 46.8 +/- 13.2) with paradoxical embolism. Of these, 184 patients had at least one embolic stroke, 112 patients at least one TIA, and 15 patients at least one peripheral embolism. The diameter of the PFO, measured with a balloon catheter, ranged from 3 mm to 24 mm with a mean of 10 +/- 3.5 mm. Implantation of the occluder was technically successful in all patients (two attempts in four patients). Seven different devices were used: 26 Sideris buttoned, 11 ASDOS, 19 Angel Wings, 98 PFO-Star, 37 Cardioseal-Starflex, 57 Amplatzer and, 33 Helex devices. One patient suffered from septicemia and subsequently died. In 2 patients, device embolization occurred during or after the procedure (1 Sideris, 1 PFO-Star; catheter retrieval successful). Thirty-seven patients had other minor complications without long-term sequelae: atrial fibrillation within the first weeks after implantation in five patients, asymptomatic thrombus on the device at routine transesophageal echocardiogram (TEE) in 7 patients (1 Angel Wings, 1 ASDOS, 1 CardioSeal, 4 PFO-Star), and device frame fracture in 25 patients (2 Sideris, 4 ASDOS, 1 Angel Wings, 1 CardioSeal, 17 PFO-Star). No complications occurred with the newer devices (Amplatzer and Helex). A residual shunt after 6 months was found in 5.5% of the patients who had completed their 6-month TEE follow-up. In two patients, a second occluder was implanted because of a residual shunt. During a follow-up period of 1 month to 71 months (mean 12 +/- 16 months, 268 patient years), a recurrence of an embolic event (seven TIA, two stroke) occurred in eight patients. None of these occurred with the newer devices (Amplatzer, Helex). Freedom from recurrence of the combined end point of TIA, ischemic stroke, and peripheral embolism was 95.7% (95% CI: 89.0%-98.4%) at 1 year and 94.1% (95% CI: 80.1-98.4%) at 3 years. Catheter PFO closure is a technically simple procedure. With the newer devices and increasing experience, the success rate has improved and the complication rate has decreased. The advantage of the procedure is that closing the defect means a causal treatment. However, catheter closure of PFO despite a very low morbidity has inherent potential risks like any other interventional procedure. Furthermore, selection of patients who definitely have PFO as the cause of their cerebral event has not been defined. For these reasons, further studies are warranted.

Recurrent cerebrovascular ischaemic events in patients with interatrial septal abnormalities: a follow-up study

“…Surgery has been superseded by the percutaneous transcatheteral approach due to the absence of open-heart surgery [25]. After early experiences in which the success in the reduction of ischaemic events was balanced by a high rate of periprocedural complications, subsequent studies using multiple device systems have demonstrated similar rates of recurrent thromboembolic events [26][27][28][29][30][31][32][33].…”

Intracardiac echocardiography: an ideal guiding tool for device closure of interatrial communications

“…Transesophageal echocardiography (TEE) is considered the standard approach to guide those interventions, 6 but supine patients do not tolerate the transesophageal probe well, so that most centers use more or less extensive fluoroscopic imaging when performing device closure, although fluoroscopy cannot sufficiently depict the spatial relation between occluder device and cardiac structures next to the interatrial communication. Rapidly growing clots on the device are not shown either.…”

Initial experience in Brazil with the Helex septal occluder for percutaneous occlusion of atrial septal defects

“…Surgical occlusion has been sporadically reported in the literature 38,39 , with recurrence rates similar to those found with clinical treatment (3-5%) However, it has intrinsic disadvantages because it is an invasive procedure with significant morbidity, especially regarding thoracotomy and extracorporeal circulation. With the advent and improvement of devices for occlusion of atrial septal defects, these patients have also been successfully treated in the catheterization laboratory [40][41][42][43][44] . Despite the absence of prospective and randomized studies in the literature, comparing clinical treatment with anticoagulants and percutaneous closure of atrial septal defects, longitudinal studies from series of patients suggest that percutaneous treatment is, at least, as effective as clinical treatment, decreasing the recurrence rate to around 2-4% per year [41][42][43][44][45] .…”

“…With the advent and improvement of devices for occlusion of atrial septal defects, these patients have also been successfully treated in the catheterization laboratory [40][41][42][43][44] . Despite the absence of prospective and randomized studies in the literature, comparing clinical treatment with anticoagulants and percutaneous closure of atrial septal defects, longitudinal studies from series of patients suggest that percutaneous treatment is, at least, as effective as clinical treatment, decreasing the recurrence rate to around 2-4% per year [41][42][43][44][45] . Furthermore, taking into account the intention to treat it is probably more effective because it is permanent, since many patients discontinue anticoagulant treatment after some time.…”