The new patent foramen ovale occluder FIGULLA in complex septal anatomy: a case series

Abstract

Background: The appropriate treatment strategy for secondary stroke prevention in patients with cryptogenic stroke and patent foramen ovale (PFO) remains challenging. The aim of this study was to describe a case series of patients with PFO and complex septal anatomy who underwent percutaneous correction using a FIGULLA (Occlutech®) septal occluder (FSO). Patients: Ten consecutive patients (6 females, 4 males, mean age 41.6 ± 16.0 years, range 17-52 years; Group 1) with cryptogenetic stroke and/or transient cerebral ischemia and complex septal anatomy, as defined by intraprocedural transesophageal echocardiogram (TEE) were compared with a group of 25 patients (10 females, 15 males, mean age 43.7 ± 12.3 years; Group 2) with usual tunnel-like PFO anatomy in whom PFO was closed by an Amplatzer septal occluder (ASO; AGA®). Results: No significant differences were noted between Group 1 and Group 2 for immediate success rate, residual intraprosthetic shunt at the end of the procedure, discharge, 1, 6 and 12 months follow up, number of attempts, procedure time, fluoroscopy time, or cardiac complication (atrial arrhythmias, device embolism). The only significant difference was shown for delivery sheath size (11 ± 2 versus 9 ± 1 F) and incidence of local hematoma (30% versus 12 %) between Group 1 and Group 2, without any clinical consequence (need of transfusion) or increase in length of stay. Conclusion: FSO shows high performance in patients with PFO and complex septal anatomy when compared with patients with PFO and uncomplicated atrial anatomy treated by ASO. Its favorable behavior is probably related to fabric features such as the total amount of metal and the presence of titanium.

Patent foramen ovale and atrial fibrillation as causes of cryptogenic stroke: is treatment with surgery superior to device closure and anticoagulation? A review of the literature

“…Device closure was successful in only 87% of cases, which is similar to previous device closure studies with the STARFlex® device ( 52 ), but lower than that reported for other PFO closure devices ( 53 – 56 ). AF and major vascular complications were significantly higher in the device group, although the latter had no further implications for the patients, which was confirmed in other trials ( 57 , 58 ). The population in the CLOSURE I trial had several atherosclerotic risk factors, including increased body mass index, diabetes, hypertension, and history of ischemic heart disease predicting recurrent ischemic neurologic events; however, a diagnosis of AF after trial enrollment portended the greatest risk of recurrent events ( 59 ).…”

Day-Case Patent Foramen Ovale Closure Under Transthoracic Echocardiography and Fluoroscopic Guidance: A Safe and Cost-Effective Approach as Compared to Conventional Hospitalization

“…Longer monitoring ideally for at least 72 H should be recommended. The incidence of AF/Flutter, 4.6% in our population, has been reported between 0.4-6.6% [1][2][3][4]6,7,9,[11][12][13][14][15][16][17][18]. Trabattoni has mentioned more supraventricular arrhythmias with Amplatzer versus Figulla but difference was not significant concerning paroxysmal AF [16], as similarly noted in the present study.…”

“…Both occluders achieved good results in terms of procedural success with a low rate of complication and a high rate of full occlusion. In fact, no inferiority of Occlutech devices compared to the Amplatzer devices could be established, as already noted [5,9,13,16]. Both devices are effective and safe for transcatheter PFO occlusion.…”

“…Second, for more complex anatomy according to our pre-selection, there is a need for a better imaging system during device release such as TOE or ICE than the classic TTE [6]. These imaging modalities have also been proposed in anatomical difficulties such as persistent Eustachian valve, long PFO tunnel, ASA with excessive mobility, hypertrophy of the interatrial septum [5,6,12,13]. However, these 2 imaging methods present also risks such as need for general anesthesia with prolonged procedure recovery times with TOE guidance or additional vascular puncture and significant cost for ICE.…”

Mid-term results of interventional closure of patent foramen ovale with the Occlutech Figulla® Flex II Occluder

“…Few studies on PFO closure were performed using the Occlutech Figulla ® devices, and to our knowledge no reports on the third generation Figulla ® Flex II PFO Occluder are available [15, 18–20, 22–24]. …”