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PubMed2002

Thrombosis of a patent foramen ovale closure device: thrombolytic management.

Transcatheter closure of a patent foramen ovale (PFO) offers a valuable alternative to surgery in selected patients with presumed paradoxical embolism. Like for all other devices, several complications have been described. Although the majority of these complications are caused by technical problems of the device itself, thrombosis is a relatively infrequent but feared finding, as it may result in recurrent embolic events and persistent neurological deficits. The majority of the complications after implantation are dealt with by surgical removal of the device and subsequent surgical closure of the PFO. The present case report describes biatrial thrombosis of a PFO device that was successfully treated with thrombolytics and GP IIb/IIIa receptor blockers. In stable patients, this pharmaco-therapeutic approach should be attempted to save the thrombosed PFO device and could therefore offer a valuable alternative to surgical removal of the device.

Echocardiography, Transesophageal↗
PubMed2003

Treatment of recurrent stroke and pulmonary thromboembolism with percutaneous closure of a patent foramen ovale and placement of inferior vena cava filter.

The association between recurrent episodes of pulmonary embolism, stroke, and congenital anomalies of the clotting system features a condition of increased risk of recurrences despite anticoagulant therapy. We report the successful management of this association with percutaneous closure of the foramen ovale and placement of an inferior caval vein filter.

Adult↗
PubMed2003

Large left atrial thrombus formation despite warfarin therapy after device closure of a patent foramen ovale.

Appropriate anticoagulation after transcatheter device placement is controversial. Patients with no history of thromboembolism or neurologic event typically receive antiplatelet therapy for several months while the device endothelializes. For patients with a history of stroke, there are no established guidelines for postdevice anticoagulation. Most patients receive warfarin, antiplatelet therapy, or a combination. Thrombus formation after transcatheter device placement has been reported for most commercially available devices. We describe a patient who developed a left atrial thrombus after closure of a patent foramen ovale with a CardioSEAL device. The patient had a normal hypercoaguable laboratory evaluation prior to device placement. Thrombosis occurred despite warfarin therapy before and after device placement. The patient's international normalized ratio was checked every 2 weeks after device placement and ranged between 2.0 and 2.8. She had no clinical arrhythmia during this time period. The left atrial thrombus was detected on routine follow-up transthoracic echocardiogram performed 6 months after device deployment. A subsequent transesophageal echocardiogram demonstrated no residual shunt, appropriate positioning of the device, flat against the septum, and a 1 x 2 cm thrombus attached to the superior and posterior left atrial arm near the junction with the native septum. A fluoroscopic image demonstrated no arm fractures. The device and thrombus were subsequently removed at surgery without complication. This case is perplexing in that the patient received appropriate anticoagulation had a negative hypercoaguable work-up, no residual shunt, and a well-positioned device.

Adult↗
PubMed2003

Use of balloon pull-through technique to assist in CardioSEAL device closure of patent foramen ovale.

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.

Adolescent↗
PubMed2003

Pacman sign during device closure of the patent foramen ovale.

The Pacman Sign during devise closure of the patent foramen ovale refers to the aspect of the device on fluoroscopy that should be achieved before release. In an orthograde view, the cranial halves of the left and right atrial disks should appear like open jaws biting into the thick septum secundum reminding of arcade game figure Pacman about to gobble up a dot.

Adult↗
PubMed2003

Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the amplatzer PFO occluder: initial and intermediate-term results of the U.S. multicenter clinical trial.

Closure of patent foramen ovale (PFO) has been proposed as an alternative to anticoagulation in patients with presumed paradoxical emboli. We report the immediate and mid-term results of the phase 1 U.S. Multicenter Clinical Trial of patients who underwent transcatheter PFO closure for paradoxical embolism using the new Amplatzer PFO device. Fifty patients (28 male/22 female) underwent catheter closure of their PFOs at a mean age of 41 +/- 11 years. Thirty-six patients had ischemic stroke, 10 had transient ischemic attack, and 4 had peripheral embolism. Seventeen patients had atrial septal aneurysm. The implantation procedure was successful in 49/49 patients; one patient did not have a PFO. Complete closure was seen immediately after the procedure in 26/49 patients; 17 had minimal residual shunt, 4 had moderate and 2 had large residual shunts. The median fluoroscopy time was 10.5 min (2.8-43 min). There were no complications related to the device. One patient developed an arteriovenous fistula at the catheter site requiring surgical repair. At a mean follow-up interval of 16.5 +/- 7.2 months, there were no deaths or recurrent neurological or peripheral embolic events. Eight patients reported an episode of dizziness or palpitations (four of them within 18 days of the procedure). No episodes of atrial dysrhythmias were noted. Contrast bubble study at last follow-up documented complete closure in 45/48 patients; one patient had minimal, one had moderate residual shunt, and one had a large shunt. One patient was lost to follow-up. We conclude that catheter closure of PFO associated with stroke/transient ischemic attack or peripheral embolism using the new Amplatzer PFO device is a safe and effective method in preventing recurrence of such episodes. Randomized clinical trials comparing device closure versus continued medical therapy are underway.

Adult↗
PubMed2004

Antiphospholipid antibodies are common in patients referred for percutaneous patent foramen ovale closure.

Very little is known about any interaction between patent foramen ovale (PFO) and various hypercoagulable disorders that have been associated with cryptogenic stroke. Percutaneous PFO closure for secondary prevention of paradoxical thromboembolization is receiving increasing attention. Hypercoagulability may affect the potential risks and expected benefits of percutaneous PFO closure. Consecutive patients undergoing percutaneous PFO closure at a single center were screened for the presence of antiphospholipid antibodies, elevated lipoprotein(a), hyperhomocysteinemia, and dysfibrinogenemia. Sixteen of 34 patients (47%) with complete arterial hypercoagulability screening had laboratory evidence of arterial hypercoagulability. Thirteen of these patients (38%) had antiphospholipid antibodies. Antiphospholipid antibodies appear to be common in patients referred for percutaneous PFO closure for secondary prevention of systemic thromboembolic events. Thorough testing based on established recommendations is warranted. Further studies are needed regarding the interaction between PFO and various hypercoagulable disorders that have been associated with cryptogenic stroke.

Adult↗
PubMed1977

Closed foramen ovale: a potential entrance to left atrium.

The anatomy of the limbus and its relationship to the fossa ovalis were studied in 90 normal human hearts in an attempt to explain the clinical success of blunt trans-septal catheterization. Previously reported rates of patent foramen ovale (25-35% of adult specimens) were confirmed, well below the reported rate of success for blunt trans-septal catheterization (67-87%). A possible reason for this success is the fragile attachment of the fossa ovalis to its limbus in nearly all hearts without persistent patency.

Adult↗
PubMed2004

Should we be using bilateral carotid distal protection devices during the percutaneous closure of patent foramen ovale in patients with a history of paradoxical embolus?

Percutaneous closure of patent foramen ovale (PFO) is becoming standard practice, particularly in patients with a history of embolic phenomena. The acute risk of cerebrovascular accident in patients undergoing this procedure is approximately 1%. We report the first successful use of bilateral carotid artery distal protection in this situation.

Cardiac Catheterization↗
PubMed2004

Percutaneous closure of patent foramen ovale guided by intracardiac echocardiography and performed through the transfemoral approach in the presence of previously placed inferior vena cava filters: a case series.

We present three patients with cryptogenic stroke who underwent transcatheter closure of a patent foramen ovale. All patients have had history of deep venous thrombosis and pulmonary embolism with placement of inferior vena caval filters. The patients were not initially considered suitable candidates for the procedure because of risk of dislodgment of previously implanted inferior vena cava filter.

Aged↗
PubMed2004

Implantation of a second closure device in patients with residual shunt after percutaneous closure of patent foramen ovale.

Percutaneous closure of patent foramen ovale (PFO) in patients with presumed paradoxical embolism yields complete occlusion in > 90% of patients using contemporary closure devices. Patients with a residual shunt after percutaneous PFO closure have been found at increased risk for recurrent paradoxical events. Treatment options for such patients include medical treatment using antiplatelet drugs or oral anticoagulation, surgical device removal and patch closure, and percutaneous implantation of a second closure device. We report our experience with implantation of a second closure device in 10 patients with more than a minimal residual shunt < or = 6 months after percutaneous PFO closure. Procedure and fluoroscopy times were similar for the initial and repeat intervention (32 vs. 30 min and 5 vs. 6 min, respectively; P = NS). There were no procedural complications during implantation of the second closure device. Follow-up transesophageal echocardiography 6 months after the second percutaneous intervention revealed complete PFO closure in nine (90%) patients. Therefore, implantation of a second closure device in patients with persistence of more than a residual shunt after percutaneous PFO closure appears safe and effective.

Adult↗
PubMed2005

Percutaneous patent foramen ovale and atrial septal defect closure in adults: results and device comparison in 100 consecutive implants at a single center.

Closure of interatrial septal defects with percutaneous devices is increasingly common. However, the indications for closure and techniques for device implantation are diverse. We reviewed our first 100 consecutive implants to assess and compare the indications, results, complications, and evolution of techniques for percutaneous patent foramen ovale (PFO) and atrial septal defect (ASD) closure. The mean age of patients was 52 years and 70% were female. Paradoxical embolism was the predominant indication (94%) for PFO closure and significant left-to-right shunt was the most frequent indication (89%) for ASD closure. Implantation success was 94% with major complications in 3 patients (2.8%). Transesophageal echocardiography was utilized in the initial 27 procedures and then replaced by intracardiac echocardiography in subsequent ones, with an associated reduction in procedure and physician time. During 6 months of follow-up, 3 patients were readmitted for atrial arrhythmias (2 patients) and an MRI-negative neurologic event (1 patient). Echocardiography at 6 months in 83% of the PFO patients revealed moderate and severe positive contrast studies for right-to-left shunting in one third of patients, with differences between devices and insertion techniques. This single-center experience with percutaneous device closure of PFO and ASD in adults demonstrates excellent results with few complications.

Catheterization↗
PubMed2005

Rare case of pulmonary arteriovenous fistula simulating residual defect after transcatheter closure of patent foramen ovale for recurrent paradoxical embolism.

We report on a patient suffering from recurrent cerebrovascular events despite previous transcatheter closure of persistent foramen ovale (PFO) with a Helex occluder. There was evidence of persistent left-to-right atrial shunt shown by transesophageal contrast echocardiography and the patient was admitted to our institution for interventional closure of the supposed residual defect. However, the PFO was completely closed by the device and left pulmonary artery injections showed a pulmonary arteriovenous fistula in the left lower lobe. This rare malformation may well explain the recurrent paradoxical embolism. Transcatheter fistula closure with coils was performed successfully. This case underlines that the existence of an isolated pulmonary arteriovenous fistula as a right-to-left shunt in patients with cryptogenic stroke should not be overlooked, even if a PFO is present and pulmonary arteriovenous fistula is not suggested by the initial physical findings or chest X-ray.

Adult↗
PubMed2005

Submassive pulmonary embolism and paradoxical embolic stroke treated with percutaneous rheolytic thrombectomy and closure of the patent foramen ovale.

The presence of patent foramen ovale (PFO) in patients with large pulmonary emboli (PE) is associated with an increased risk of stroke and mortality. Many patients are ineligible to receive thrombolytic therapy. We present a patient with bilateral PE and cryptogenic stroke who was treated effectively with rheolytic thrombectomy with AngioJet, PFO closure with CardioSeal device, and placement of an inferior vena cava filter.

Aged↗
PubMed2006

Iatrogenic atrial septal defect, erosion of the septum primum after device closure of a patent foramen ovale as a new medical entity.

Iatrogenic atrial septal defects are described in 2 patients. They occurred after implantation of Amplatzer occluders to close a patent foramen ovale. While device erosions to the extra-atrial space have been described, erosion induced atrial septal defects are a new medical entity. They may be fairly common in the situation of an atrial septal aneurysm whipping the rim of the device incessantly. They are clinically silent and benign and require echocardiography for detection. A second device solved the problem in the cases described.

Adult↗
PubMed2006

Long-term efficacy of transcatheter patent foramen ovale closure on migraine headache with aura and recurrent stroke.

OBJECTIVES: To assess the long-term results of transcatheter patent foramen ovale (PFO) closure on migraine headache with aura (MHA) and on the risk of recurrent stroke. BACKGROUND: Transcatheter PFO closure is associated with an early improvement of MHA, and a reduction or the risk of recurrent cerebral ischemia, but the long-term outcome after the procedure is unknown. METHODS: We analyzed follow-up data of 38 consecutive patients who had undergone transcatheter PFO closure at our institution because of cryptogenic stroke and had been followed-up for at least 3 years after the procedure. Mean age at closure was 43 +/- 13 years. Thirteen patients (34%) had a diagnosis of MHA made by the primary care physician or the referring neurologist. Migraine disability assessment questionnaire (MIDAS) was used to assess MHA incidence and severity. RESULTS: After a mean follow-up of 4.8 +/- 1.4 years, two patients had a recurrent stroke (13 and 15 months after the procedure, respectively). Recurrence rate 5 years after the procedure was 5.3%. After 4.9 +/- 1.4 years from the intervention, 12/13 patients (92%, 95% CI 65-99%) had complete resolution in their MHA. Overall, MIDAS score decreased significantly (38.6 +/- 26.3 vs. 4.4 +/- 5.1, P < 0.0001) after the procedure. One patient did not report any improvement of MHA after transcatheter PFO closure, whereas one patient reported a severe relapse of MHA about 1 year after PFO closure. Freedom from recurrent MHA 5 years after the procedure was 85% (95% CI 57-97%). CONCLUSIONS: The rate of recurrent cerebral ischemia and recurrent MHA seems to be low at long-term follow-up after transcatheter PFO closure. Recurrent cerebral ischemia and relapse of MHA seem to be confined to the first 15 months after the procedure.

Adult↗