Figulla Flex Research Articles

Percutaneous ASD closure of children weighing less than 10 kg

Background: Traditionally the procedure of percutaneous ASD closure is carried out in children weighing more than 15 kg. The aim of this study was to discuss the success, efficacy and safety of the percutaneous closure of symptomatic ASD in children weighing less than 10 kg.Material and methods: This study was performed in two centres. A total of 44 patients were included. Demographic and angiographic data of these patients were gathered retrospectively from patients’ records. Main indications for ASD closure were: failure to thrive, recurrent respiratory infections, bronchopulmonary dysplasia and genetic syndromes.Results: Median weight of patients was 9.0(8.12–9.50) kg. Bodyweight of 22 patients was less than 3 percentiles. In the follow-up, this number was lowered to 9 patients at 12 months. Median age of patients was 18.0(12.0–285) months. Minimum age and weight of patients was 3 months and 4.5 kg, respectively. Median mean pulmonary pressure was 24.0(20.0–29.5). The values of median defect size were measured in Cath lab as 13.0(10.75–15.3) mm. Median device size was 13(9–15) mm. Defect size was evaluated according to body weight and body surface area. The ratio of weight per defect size was 0.65(0.54–0.84) also the ratio of body surface area per defect size was 0.032(0.028–0.04). The ratio of total septum per device diameter was 2.5(2.1–3.1). Types of devices used were Amplatzer Septal Occluder, Cera Flex Septal Occluder, Figulla Flex II Atrial Septal Occluder, Memopart Septal Occluder. All cases were closed successfully, but the device had to be retrieved in one patient after successful positioning because it was detected that device compressed the aorta. No major complications were seen.Conclusion: In the experienced centres, percutaneous ASD closure can be done effectively and safely in symptomatic children weighing less than 10 kg.

Percutaneous closure of a large atrial septal defect in a child with severe dextroscoliosis: A case report.

In this study, we present the case of an 11-year-old child with cachexia, severe dextroscoliosis, pectus carinatum, secondary restrictive pulmonary disease, and an incidental finding of a large ostium secundum atrial septal defect (ASD) that was identified on preoperative assessment for surgical correction of the spinal deformity. Transthoracic and transesophageal echocardiography confirmed significant left-to-right shunting with a pulmonary blood flow to systemic blood flow ratio (Qp/Qs) of 3.18 through a 14 mm defect with good circumferential rims, larger than 5 mm. Despite significant left-to-right shunting, the defect was found prior to the development of pulmonary hypertension or right heart enlargement. The decision to close the atrial septal defect by percutaneous intervention was preferred over surgical closure, due to the restrictive pulmonary physiology and low body mass index (12.6 kg/m2). Percutaneous closure of the ASD was successfully performed under general anesthesia using an Occlutech Figulla Flex II ASD device, with no residual shunt. Surgical correction of the dextroscoliosis was subsequently performed with good results. A comprehensive clinical and echocardiographic evaluation is needed in patients with skeletal abnormalities in order to rule out associated congenital heart defects, which may impose therapeutic challenges.

Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE)

IntroductionSafety and efficacy data on patent foramen ovale (PFO) closure with the Occlutech Figulla Flex II device are lacking. We undertook a fully monitored prospective Registry on PFO closure using this device. Methods100 patients undergoing PFO closure were enrolled into the OPPOSE Registry at 6 UK centres. The primary endpoint was PFO closure (grade 0 or 1 shunt) at 6-month BCTTE assessed by Corelab. Secondary endpoints included implantation success, complications, and atrial fibrillation during follow-up. Results100 patients aged 43.8±11.5years, 53% male, were recruited. Indications for PFO closure included stroke (56%), TIA (29%) systemic embolism (4%) and MI (3%). Closure was undertaken under GA (44%) or LA (56%), with TOE (45%), ICE (31%), no imaging (20%) or TTE (3%). Balloon sizing was used in 98% of cases and showed a tunnel length of 7.3±3.6mm, primum-secundum separation of 7.0±2.9mm and basal inlet width of 8.5±3.5mm. Implantation was successful in all cases using 18mm (9%), 25mm (80%), 30mm (10%) and 35mm (1%) devices. 5 patients were lost to follow-up. 92 patients underwent six-month BCTTE. The primary endpoint of PFO closure (grade 0 or 1 shunt) at six months was 79.3%. One patient developed major bleeding (BARC 3b), one patient required vascular surgery, and in one patient device embolization was noted at six months and a larger device implanted. There was one case of new atrial fibrillation. ConclusionsThis first prospective monitored data for the Occlutech Figulla Flex II device demonstrates good safety and efficacy data at implant and six-month follow-up.

Transcatheter closure of an atrial septal defect with high risk of erosion using a Figulla Flex II atrial septal defect occluder

An 85-year-old man with a high risk for open heart surgery underwent a percutaneous closure of an atrial septal defect that lacked adequate aortic and superior rims. To avoid the risk for erosion, a Figulla Flex II ASD occluder was selected for the procedure. Implantation was successful, and no complications were observed during the 6 months of follow-up.

TCT-28 Occlutech Percutaneous PFO Closure: Safety and Efficacy Registry (OPPOSE)

Safety and efficacy data on patent foramen ovale (PFO) closure with the Occlutech Figulla Flex II device are lacking. We undertook a fully monitored prospective Registry on PFO closure using this device. 100 patients undergoing PFO closure were prospectively enrolled into the OPPOSE Registry at 6

Optimal septum alignment of the Figulla Flex occluder to the atrial septum in patients with secundum atrial septal defects.

To investigate the implantation safety, anatomic performance and septal alignment of the Occlutech Figulla Flex occluder (FFO) device, an atrial septal defect (ASD) closure device with specific left-sided deployment characteristics and right-sided septal alignment properties. Between January 2011 and December 2013 we prospectively collected the change of orientation of the device to the septum during the release process and the feasibility of implantation of the FFO in 122 patients. The mean age was 10.7 years (±10.2), weight 32.9 kg (±20.3), and height 129.4 cm (±30). Devices used were 9 (n=13), 10.5 (n=16), 12 (n=16), 15 (n=39), 18 (n=17), 21 (n=8), 24 (n=5), 27 (n=7) and 30 mm (n=3) in size. No additional implantation techniques were required. Before release, the mean angles of the left and right-sided discs were 29.2° (±9.9°) and 43.4° (±9.2°) to the body axis, and 18.7° (±8.7°) and 27.0° (±10°) immediately thereafter. Thus, there was only a slight change in orientation of the left-sided (10.6°±7.5°) and right-sided (16.3°±7.9°) discs. The design of this occluder system results in an ideal septum alignment which increases its feasibility as well as patient safety during implantation.

Percutaneous closure of a gigantic patent ductus arteriosus (PDA) with pulmonary hypertension with an atrial septal defect occluder in a 35-year-old woman

Patent ductus arteriosus (PDA) is a common form of congenital heart defects (CHD); it counts for about 5–10 % of all CHD with an incidence of one in 2,500–5,000 live births [1]. In general, volume overload of the left atrium and left ventricle caused by the shunt and pulmonary vascular disease is clear indication for closure of the defect, whereas the risk of endocarditis and aneurysm formation of the PDA is under discussion. If untreated, a large PDA will regularly lead to pulmonary hypertension, heart failure and Eisenmenger syndrome [2]. PDA was the first example of congenital heart disease to be treated by transcatheter closure, and has now become an established form of treatment for the majority of patients with very few side effects. After the initial description in 1967 by Porstmann a large variety of different devices have been described (i.e., Rashkind device, Sideris buttoned device, various PDA coils, as well as specific PDA occluder devices such as the Amplatzer PDA-occluders [3]). Nowadays, percutaneous PDA closure has proved to be safe and effective with shortand long-term results comparable to surgical closure including those cases with mild and moderate pulmonary hypertension [2]. A common problem of all commercially available devices is the inability to close PDAs larger than 14 mm diameter based on manufacturer’s recommendations. Therefore, the majority of large PDAs are often closed surgically, although there are occasional case reports of very large PDAs closed with Amplatzer VSD or ASD Occluders [4, 5]. In the following report, we describe a case of successful transcatheter closure of an extremely large PDA measuring minimal 24 mm with an off-label use of a 24 mm Occlutech Figulla Flex ASD Occluder. A 35-year-old African woman (weight 77 kg, height 167 cm, BMI 27.6) was referred to our institution with an unknown heart disease for further evaluation. Clinically, she was in apparent heart failure (New York Heart Association III), transcutaneous oxygen saturation was 96 % and auscultation revealed a pronounced second heart sound and diastolic murmur. Her exercise performance measured by a 6-min walk test was 215 m only. The ECG revealed signs of right heart pressure load, and by echocardiography the estimated right ventricle pressure was 100 mmHg. This was caused by a very large PDA. It was noteworthy that the patient was human immunodeficiency virus positive. For further hemodynamic evaluation, the patient underwent a diagnostic catheterization. The PDA had a minimal diameter of 22 mm and an ampulla of 40 mm (see Fig. 1). The systemic arterial blood pressure was 115/66 mmHg (mean 85 mmHg) and the pulmonary arterial blood pressure 107/67 mmHg (mean 85 mmHg). The calculated pulmonary vascular resistance index (PVRI) was 12.6 Wood Units and the cardiac index (CI) 5.1 l/min/m. For further testing of the pulmonary vasoreagibility, the PDA was balloon occluded with a 30-mm sizing balloon. When the balloon was stabilized in the PDA, the minimal waist measured 24 mms. Thereafter, vasoreagibility of the M. Froehle (&) N. A. Haas C. Happel K. T. Laser Department for Congenital Heart Defects, Heart and Diabetes Center, North-Rhine Westphalia, Georgstrasse 11, 32545 Bad Oeynhausen, Germany e-mail: mfroehle@hdz-nrw.de

Seven years results in percutaneous closure of atrial septal defect and patent foramen ovale (single center experience)

Cardiologia CROATICA Background: The aim of this report is to present 7 years results in percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO) in Magdalena hospital, and to assess the safety and efficacy of this procedure. Methods: From April 2007 to March 2013, we performed transcatheter ASD and PFO closure in 58 consecutive symptomatic patients (pts). There were 34 percutaneous closures of ASDs and 24 percutaneous closure of PFOs. Indication for ASD closure was significant left-to-right shunt associated with RV overload and mild to moderate pulmonary artery hypertension. Diameter of ASDs were in range from 12 to 28 mm (average diameter 17 mm). For all pts. we used Occlutech Figulla Flex ASD and PFO Closure Device (I and II generation) sized from 15 to 30 mm. Closure of PFO was clinically indicated for secondary prevention in pts. with previous cryptogenic cerebrovascular events due to presumed paradoxical embolism. Pre-procedurally thromboembolic events were: 19 ischemic strokes (79%), and 5 transient ischemic attacks (20.8%). All procedures were performed with conscious sedation anesthesia under fluoroscopic and transesophageal echocardiography (TEE) guidance. Aspirin and clopidogrel were recommended at least for for 20 weeks after procedure for all patients. Results: Primary success of percutaneous closure was achived in all patients. The in-hospital complications were: self-limited supraventricular arrhythmia in 2 pts (3.4%); paroxismal atrial fibrillation in 1 pts (1.7%); minimal groin hematoma in 1 pts (1.7%). Control TEE pefomed after 20 weeks revealed mild residual shunt due to the lack of complite epitelisation of ocluder in 3 pts (5.1%), and aspirin and clopidogrel were recommended for another 20 weeks. No device malfunction, erosion, valvular regurgitation or thrombus formation were occurred so far.