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PFO Closure (pfo + closure)
Selected AbstractsPatent Foramen Ovale and Migraine,Bringing Closure to the SubjectHEADACHE, Issue 4 2006Todd J. Schwedt MD There is increasing interest in the relationship between migraine and patent foramen ovale (PFO). PFO is more common in migraineurs with aura, and migraine with aura is more prevalent in patients with PFO. Retrospective analyses of PFO closure for stroke prevention and decompression illness in divers have suggested that migraineurs with and without aura may derive significant benefit from PFO closure, but to date no prospective, randomized, sham-controlled study to confirm this has been completed. Herein we review published data regarding the relationship between migraine and PFO and discuss the rationale, justification, and important factors to consider in the conduct of prospective, controlled, clinical trials designed to evaluate the efficacy and safety of percutaneous device closure of PFO for migraine prevention. [source] Incomplete Aneurysm Coverage after Patent Foramen Ovale Closure in Patients with Huge Atrial Septal Aneurysm: Effects on Left Atrial Functional RemodelingJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2010GIANLUCA RIGATELLI M.D. Background: Large devices are often implanted to treat patent foramen ovale (PFO) and atrial septal aneurysm (ASA) with increase risk of erosion and thrombosis. Our study is aimed to assess the impact on left atrium functional remodeling and clinical outcomes of partial coverage of the approach using moderately small Amplatzer ASD Cribriform Occluder in patients with large PFO and ASA. Methods: We prospectively enrolled 30 consecutive patients with previous stroke (mean age 36 ± 9.5 years, 19 females), significant PFO, and large ASA referred to our center for catheter-based PFO closure. Left atrium (LA) passive and active emptying, LA conduit function, and LA ejection fraction were computed before and after 6 months from the procedure by echocardiography. The preclosure values were compared to values of a normal healthy population of sex and heart rate matched 30 patients. Results: Preclosure values demonstrated significantly greater reservoir function as well as passive and active emptying, with significantly reduced conduit function and LA ejection fraction, when compared normal healthy subjects. All patients underwent successful transcatheter closure (25 mm device in 15 patients, 30 mm device in 6 patients, mean ratio device/diameter of the interatrial septum = 0.74). Incomplete ASA coverage in both orthogonal views was observed in 21 patients. Compared to patients with complete coverage, there were no differences in LA functional parameters and occlusion rates. Conclusions: This study confirmed that large ASAs are associated with LA dysfunction. The use of relatively small Amplatzer ASD Cribriform Occluder devices is probably effective enough to promote functional remodeling of the left atrium. (J Interven Cardiol 2010;23:362,367) [source] Transcatheter Closure of Patent Foramen Ovale in Patients with Paradoxical Embolism.JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2008Follow-up Results after Implantation of the Starflex® Occluder Device with Conjunctive Intensified Anticoagulation Regimen, Procedural Background:Prevalence of patent foramen ovale (PFO) is higher in patients with paradoxical embolism and associated with increased risk for recurrent thromboembolic events. By percutaneous closure of PFO, surgical closure or permanent oral anticoagulation can be avoided. So far, published series included different occluder systems and various indications and regimens of postprocedural anticoagulation. The aim of the present study was to evaluate the short- and long-term results after implantation of the Starflex® occluder in patients with PFO using an intensified anticoagulation regimen. Methods and Results:154 patients with PFO (94 men; age: 44 ± 13 years) and >1 thromboembolic event were included. Other causes for embolism were excluded. PFO closure was successful in 147 patients (95.5%). All patients were treated with phenprocoumon (INR 2.5) and aspirin (100 mg/die) for 6 months. Transesophageal echocardiography (TEE) was repeated at 6 months. Mean clinical follow-up period was 26 ± 18 months. After 6 months, five patients had a significant residual shunt, and five patients had suspected thrombus formation on the occluder. In three of these five patients, the occluder was surgically removed and foreign body reaction was noted. During follow-up, nine patients suffered from neurological events (two strokes, seven transient ischemic attacks [TIA]), though complete closure of the PFO was documented by TEE. Two patients died during follow-up; three patients had bleeding complications. Conclusion:Percutaneous closure of PFO in symptomatic patients by Starflex® occluder represents an effective therapy with a low incidence of periinterventional complications and recurrent thromboembolism. However, thrombus formation at the occluder system may occur in some patients despite an aggressive anticoagulation regimen. [source] Patent Foramen Ovale Using the Premere Device: The Results of the CLOSEUP TrialJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2006FRANZISKA BÜSCHECK M.D. Objectives: The CLOSEUP trial was conducted to determine the safety and effectiveness of the Premere closure device in closure of patent foramen ovale (PFO). Background: PFO is a relatively common congenital condition, associated with cryptogenic stroke and migraine with aura. The Premere device is specifically designed to close PFO of variable size and length, with right and left anchor arms connected by a flexible tether. The device has an open architecture, a low profile, and a small surface area on the left atrial side which may discourage thrombus formation. Methods: Patients between 18 and 65 years of age who had a cryptogenic ischemic stroke or a transient ischemic attack and a PFO underwent percutaneous PFO closure using the Premere device. Results: Of the 73 enrolled patients, six patients had atrial anatomy not appropriate for the Premere; 27 patients received the 15 mm and 40 patients received the 20 mm device. Implantation was successful in all patients. At 6 months of follow-up, 86% of patients had no shunt that could be provoked with Valsalva as assessed during contrast echocardiography. Closure rates were better with the 20 mm versus the 15 mm device, and three patients with residual shunt had atrial septal aneurysms at baseline. One patient had transient atrial fibrillation which resolved by 3 months. There were no instances of thrombus, death, or stroke. Conclusions: These data demonstrate that the Premere device can safely and effectively close PFO. Additional studies should be undertaken to demonstrate the effectiveness of PFO closure in reducing thrombo-embolic events such as stroke. [source] Indication and Techniques of Transcatheter Closure of Patent Foramen OvaleJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 6 2003RAINER SCHRÄDER M.D. A potential causal relationship of a patent foramen ovale (PFO) and a stroke was first suggested by Cohnheim in 1877.1 Today, this correlation is generally accepted. However, there is still no "gold standard" for the treatment of patients with presumed paradoxical embolism. This article reviews the epidemiology of and the diagnostic methods for PFO, the clinical relationship between PFO and cerebral ischemia, as well as indications and techniques for transcatheter closure of PFO. In the author's opinion, transcatheter PFO closure represents an elegant management for selected patients at risk. (J Interven Cardiol 2003;16:543,551) [source] Biodisk: A new device for closure of patent foramen ovale: A feasibility study in swine,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2010Dusan Pavcnik MD Abstract Purpose: To evaluate the feasibility, effectiveness, and safety of a porcine small intestinal submucosa (SIS)-covered Biodisk (BD) for the closure of patent foramen ovale (PFO) in swine. Methods: Twelve piglets (9,30 kg) with PFO ranging in size from 6 to 12 mm were used for the in vivo testing. The BD device consisted of two basic nitinol wire components covered with platinum coil, a flexible SIS-covered ring, and an anchor. The BD was advanced through an 8-Fr sheath from the femoral vein. Nine acute animals were used to test the BD for deployment, stability, immediate shunt closure, and device repositioning before or after its detachment. To assess retrievability, four devices were deployed and intentionally embolized into the RA (n = 2) and LA (n = 2). The effectiveness of the device was evaluated by angiocardiography. EKG was recorded before and after PFO closure for 3 hr. From the 12 animals, nine were acute and three were followed; one for 6 weeks, one for 12 weeks, and one for 16 weeks. Results: Successful device implantation was achieved in all animals with no shunting of contrast media observed during follow-up in. One animal needed to have device repositioned for complete PFO occlusion because of suboptimal placement at the first attempt. The device was easily placed and retrieved before detachment in all nine animals in the acute study. None of the BDs spontaneously embolized during release or on follow-up. EKG did not demonstrate arrhythmias during or after treatment. Four intentionally embolized BDs were easily retrieved with an Amplatz goose neck snare. Macroscopic and histologic evaluation of the three long-term animals showed that devices were well incorporated in the atrial septum with complete shunt closure. The SIS showed progressive remodeling with the host cells. There was also progressive endothelization of the BD device. Conclusion: The BD device deployment is feasible, safe, and effective. Long-term studies are needed to evaluate its long-term effectiveness. © 2010 Wiley-Liss, Inc. [source] Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2009Single-Centre Experience Abstract Background: Percutaneous closure of patent foramen ovale (PFO) is routinely performed with nonbiological devices, characterized by a persistent low-grade inflammatory response. We report our experience about PFO closure with a bioabsorbable device, BioSTAR® (NMT Inc, USA). Methods: From September 2007 to September 2008, 14 patients with migraine (eight with aura) and cerebral magnetic resonance positive for silent ischemia and nine patients with prior cardiovascular accident (CVA) underwent closure of PFO using BioSTAR®. One patient had heterozygosis for sickle-cell-anaemia. Nickel allergy was present in eight patients. Echocardiogram was performed at 24 hr, one and 6 months. At 6 and 12 months a contrast-transcranial-doppler (c-TCD) and a trans-oesophageal echocardiogram (TOE) were scheduled, respectively. Results: BioSTAR® was successfully implanted in 22 patients (96%). The mean procedural time and the mean fluoroscopy time were 22 ± 6 and 4 ± 2 minutes, respectively. The mean in-hospital stay was 3 ± 0.5 days. After a mean follow-up of 7.8 ± 3.5 months there was an hemorrhagic stroke related to double antiaggregation. No other CVA or allergic reactions were registered. There were two cases of atrial arrhythmia. Fifteen patients had not residual shunts at c-TCD, while in four patients we observed a trivial microbubbles passage. The TOE, achieved in nine patients without contrast, showed the device well positioned, with a low profile and without thrombus. Conclusions: In our experience PFO closure with BioSTAR® is safe and efficacious in preventing recurrent CVA. Its use could be advantageous in patients with nickel allergy and haematological disorders. The potential benefits of this device need to be certified in a larger cohort of patients with a longer follow-up. © 2009 Wiley-Liss, Inc. [source] Management of patients with refractory migraine and PFO: Is MIST I Relevant?CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2008Jonathan Tobis MD Abstract The results of the randomized clinical trial entitled: Migraine Intervention with Starflex Technology (MIST), produced surprising and disappointing results on the effect of PFO closure to decrease migraine headaches. There have been allegations of misrepresentation of the effectiveness of this device. These issues have significant implications in how randomized clinical trials are performed that will impact current and future planned trials of PFO closure to treat migraine headaches. © 2008 Wiley-Liss, Inc. [source] Use of balloon pull-through technique to assist in CardioSEAL device closure of patent foramen ovaleCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2003Kavitha Chintala MD Abstract CardioSEAL device closure of patent foramen ovale (PFO) has been advocated for the treatment of patients with cryptogenic stroke. Using the standard delivery technique, partial deployment of the CardioSEAL device can occur, especially in patients with a thick septum secundum and/or long PFO tunnel. We hypothesized that using a left atrial-to-right atrial balloon pull-through to make the septum primum incompetent would result in improved final device position regardless of septal thickness or tunnel length. Catheterization reports, cineangiograms, and transesophageal echocardiograms of 51 patients who underwent CardioSEAL device closure of PFO between March 2000 and August 2002 were retrospectively reviewed. Group 1 (n = 21) included patients with CardioSEAL placement using the standard technique and group 2 (n = 30) included patients with CardioSEAL placement using the balloon pull-through technique. There were no differences between the groups in terms of age (43.6 vs. 45.3 years; P = NS), weight (83.3 vs. 89.9 kg; P = NS), septum secundum thickness (6.4 vs. 7.0 mm; P = NS), PFO tunnel length (15.5 vs. 13.1 mm; P = NS), or device size. In group 1, 4/21 (19%) had partial deployment of the CardioSEAL device, while in group 2, no partial CardioSEAL deployment (0/30) was observed. No complications were associated with the balloon pull-through technique. We conclude that the left atrial-to-right atrial balloon pull-through technique is safe and may allow for better final position of the CardioSEAL device during PFO closure. Catheter Cardiovasc Interv 2003;60:101,106. © 2003 Wiley,Liss, Inc. [source] Preliminary experience with a new 18 mm Amplatzer PFO occluder for small persistent foramen ovaleCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2003Peter Ewert MD Abstract We report our initial experience with a new 18 mm Amplatzer PFO device for the closure of small PFO. Patients were selected by a semiquantitative sizing procedure using the circle of a diagnostic pigtail catheter instead of a sizing balloon. In all eight patients, the device was easy to implant without problems. Due to its size, it has the potential to minimize the risk of inadvertent atrial erosion or perforation after deployment and thus will enhance the safety of interventional PFO closure. Cathet Cardiovasc Intervent 2003;59:518,521. © 2003 Wiley-Liss, Inc. [source] | ||||||||||