Taming the “cobra”: An approach to “Cobra-Like” formation seen in the occlutech atrial septal defect and patent foramen ovale occluders (original) (raw)
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Türk Kardiyoloji Derneği arşivi : Türk Kardiyoloji Derneğinin yayın organıdır, 2010
We evaluated the efficiency and safety of the Occlutech Figulla device in percutaneous closure of secundum atrial septal defects (ASD). The study included 28 patients (17 women, 11 men; mean age 43 years) who underwent percutaneous transcatheter closure using the Occlutech Figulla device for secundum ASDs causing a hemodynamically significant shunt. Defect size was estimated by transthoracic (TTE) and transesophageal (TEE) echocardiography, and also by balloon sizing in nine patients. The patients were followed-up for six months and were examined by TTE. The mean defect size was 20.3+/-2.1 mm on TTE, 22.1+/-1.9 mm on TEE, and 24.2+/-2.4 mm on balloon sizing. The mean device size was 26.8+/-3.6 mm (range 6 to 36 mm). The mean procedure time was 44.7+/-21.4 minutes. The device was placed successfully in all the patients. A small residual flow was seen immediately after device placement in three patients (10.7%), which disappeared in two patients at three months, and in one patient at ...
Journal of interventional cardiology, 2012
Background: Percutaneous closure of secundum type atrial septal defect (ASD) and patent foramen ovale (PFO) has gained widespread use in recent years. Herein, we evaluated the safety and efficacy of the Occlutech R Figulla devices for PFO and ASD closure in a reference tertiary center. Methods: All 143 patients (46.9% male, mean age 39.3 ± 12.2 years) who underwent transcatheter PFO (n = 85) and ASD (n = 58) closure with Occlutech R Figulla devices between February 2009 and October 2011 were included in this study. An echocardiographic follow-up examination was performed at the 1st, 6th, and 12th month visits. Results: The devices were successfully implanted in all 143 patients (100%). In-hospital periprocedural complications were device embolization (0.7%; 1 ASD patient), atrial fibrillation (1.4%; 1 ASD and 1 PFO patients), supraventricular tachycardia (0.7%; 1 PFO patient), and vascular access hematoma (0.7%; 1 ASD patient). Among ASD patients, 2 patients had trivial (jet width <1 mm in diameter) and 1 patient had small (1-2 mm) residual shunts before hospital discharge, which disappeared after the 6-month visit. During the mean 15.4 ± 9.6 months follow-up, all patients were asymptomatic and no ischemic stroke, cardiac perforation, device erosion, embolization, thrombus formation, or malposition of the device was observed. Conclusions: Percutaneous PFO and secundum type ASD closure with the novel Occlutech R Figulla Occluder devices without left atrial central pin and with significantly reduced meshwork was safe, feasible, and effective. (J Interven Cardiol 2012; * * :1-7)
Percutaneous device closure of atrial septal defect and patent foramen ovale
The present study investigated the feasibility of totally transthoracic echocardiography-guided percutaneous device occlusion of atrial septal defects (ASDs) without using x-ray equipment. Between September and December 2014, we performed totally transthoracic echocardiography-guided percutaneous device occlusion for 20 patients with secundum ASD without using x-ray equipment. We carried out percutaneous femoral vein puncture, used a specialized delivery sheath during operation, and closed the ASD by releasing an occluder. All 20 patients experienced successful occlusion and smoothly went through the perioperative period. The average procedure time ranged from 30 to 40 minutes (32.4 ± 3.5 minutes), and the size of the implanted occluder ranged from 20 to 38 mm (25.4 ± 5.8 mm). No occluder displacements, residual fistula, or thrombus-related complications after the procedure. There was no clinical death, no arrhythmia, no hemolysis, no infection, or embolism during patients' hospitalization and the follow-up period. Totally transthoracic echocardiography-guided percutaneous device occlusion of ASDs without the use of x-ray equipment may be safe and feasible. Abbreviations: ASD = atrial septal defect, CHD = congenital heart diseases, ECG = electrocardiogram, TEE = transesophageal echocardiography, TTE = transthoracic echocardiography.
2012
Objective: To evaluate the effectiveness of the Occlutech Figulla occluder device in the treatment of ostium secundum atrial septal defect. Methods: This is a retrospective review which was conducted between June 2008-June 2011 involving 54 cases with ostium secundum atrial septal defect who underwent transcatheter closure using the Occlutech Figulla device at Queen Alia Heart Institute. All procedures were performed under general anaesthesia with continuous Transesophageal Echocardiographic monitoring. Clinical and echocardiographic assessments were performed after 24 hours and then after one, three and six months respectively. The results are presented as means, standard deviations and percentages. Results: From the 54 cases, 33 patients (61%) were females. Their mean age and weight were 16.47±11.8 year, 38.4 ± 20.7kg respectively. The mean atrial septal defect diameter by Transesophageal Echocardiogram was 13.2 ± 4.2mm, and the mean atrial septal defect size of the implanted devi...
Journal of interventional cardiology, 2016
To evaluate the mid-term outcomes after percutaneous closure of the secundum atrial septal defects (ASD) using the Figulla-Occlutech device (FOD). Transcatheter closure has become the method of choice for most patients with ASD. Although the FOD may have some advantageous characteristics there is a paucity of data on later outcomes after the use of this relatively new device. Observational, single arm study including 200 non-consecutive patients who underwent ASD closure between 04/09 and 07/15 in 2 centers. Device performance, deployment technique, and immediate and mid-term outcomes were assessed. Median age and weight were 24 years (4-72) and 58 kg (15-92), respectively. Single defects were observed in 171 patients (median size of 19 mm). The remainder had multiple or multifenestrated defects. Implantation of FOD (median size of 24 mm) was successful in all (99%), but 2 patients (1 with deficient postero-inferior rim; 1 with a large ASD for the size of the child). Embolization wi...
Percutaneous Closure of Patent Foramen Ovale and Atrial Septal Defect
JAMA, 2008
Percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO) has become increasingly utilized. The indications and results of percutaneous closure are diverse. Aim: To assess the indications, results, and complications of percutaneous closure of ASD and PFO in our tertiary center.
Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2017
The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO. This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events...
Journal of Interventional Cardiology, 2009
Objective: To identify differences between various occluder types regarding thromboembolic event rates and existence of residual shunts during medium-term follow-up. Methods: Three hundred nine consecutive patients with presumed paradoxical embolism and scheduled for percutaneous closure of patent foramen ovale or atrial septal defect between 1997 and 2006 were considered for this study. Device implantation failed in seven patients (nonstable device position), so 302 patients (46 ± 12 years, 190 males) formed the study group using Amplatzer TM (n = 208), Starflex TM (n = 61), and Cardiastar TM (n = 33) occluders. Follow-up transesophageal echocardiography was performed 1, 3, and 6 months after implantation. Results: Periinterventional complications occurred in two patients (cardiac arrhythmias). There were more residual shunts in the Starflex TM and Cardiastar TM group than in the Amplatzer TM group at 6-month follow-up (8/61 vs. 7/33 vs. 8/208, P = 0.0005). Performing logistic regression, the type of occluder device was a significant risk factor for the presence of residual shunt 6 months after implantation (P = 0.0033; Cardiastar TM vs. Amplatzer TM OR 6.346, ; Starflex TM vs. Amplatzer TM OR 4.369,). During mean follow-up of 31 ± 8 months 16 recurrent thromboembolic events occurred; the annual recurrence was 2.1% for combined end-point stroke, TIA, and peripheral embolism (Amplatzer TM : 1.3%, Starflex TM : 3.9%, and Cardiastar TM : 3.6%, P = 0.0467). The presence of an atrial septal aneurysm was the only significant risk factor (P = 0.0168, OR 3.664, for the occurrence of thromboembolic events. Conclusions: Percutaneous closure of patent foramen ovale or atrial septal defect is a safe procedure with little incidence of peri-and postprocedural complications. There is a significant difference between the Amplatzer TM , Cardiastar TM , and Starflex TM occluders in regard to complete closure of the defects and annual recurrence of thromboembolic events. (J Interven Cardiol 2009;22:503-510)
Successful percutaneous closure of spiral atrial septal defect
Echo Research and Practice, 2014
SummaryThe case report of a 15-year-old patient with an unusual form of atrial septal defect is described. Echocardiography showed separation of the secundum and primum atrial septums due to abnormal posterior and leftward attachment of the primum septum into the roof of the left atrium. The morphology has been variably described as a ‘double’ atrial septum or ‘spiral’ atrial septal defect. Despite the technical challenge of this form of atrial septal defect, it was effectively closed by ensuring that all relevant septal structures were incorporated between the discs of the occlusion device. This was associated with a stable position and good medium-term outcome. This contrasts with the experience of others where device embolisation or technical failure has been described.Learning pointsThe spiral atrial septal defect is characterised by an apparently ‘double’ atrial septum.Such atrial septal defects (ASDs) have been associated with a high rate of technical failure of transcatheter ...