Patent foramen ovale with paradoxical embolism: mid-term results of transcatheter closure in 256 patients

The purpose of this study was to assess the safety and feasibility of percutaneous interventional closure of patent foramen ovale (PFO) with or without atrial septal aneurysm (ASA) in symptomatic patients. Between June 1999 and June 2002, we performed transcatheter closure of PFO in 256 consecutive symptomatic patients (female/male = 1.45; mean age 48 +/- 16 years; range 14-75): ischemic stroke (n = 101), transient ischemic attack (n = 144), peripheral and coronary arterial embolism (n = 17); multiple events (n = 23); platypnea-orthodeoxia syndrome (n = 2); refractory hypoxemia (n = 1); and migraine aura (n = 27). The implanted devices were an Amplatzer PFO Occluder (n = 248), a Gore-HELEX Septal Occluder (n = 4), and PFO STAR (n = 4). Most procedures (n = 176.69%) were done under two-dimensional intracardiac echocardiography (ICE) guidance alone; in the last 30 patients, 3D/4D ICE reconstruction (TomTec Imaging Systems) 6mbH was obtained. In 30 cases, ICE and contrast enhanced-TCD have been used simultaneously in the catheterization laboratory. The devices were placed correctly in all patients. Mean fluoroscopy time was 9.45 +/- 5 minutes (range = 2.5-35 minutes); mean procedural time was 57 +/- 21 minutes (range = 15-135 minutes). Total occlusion rate at follow-up (mean 19 months, range 1-33) was 98.1%. No significant recurrent neurological events were observed. Transcatheter closure of PFO with or without ASA is a safe and effective, minimally invasive procedure that ensures high closure rate and avoids life-long anticoagulation. Mid-term follow-up results appear favorable with respect to recurrent thromboembolic events.     

Patent foramen ovale closure in India; Feasibility,challenges and mid-term outcomes

Patent foramen ovale closure (PFO) is an underutilized therapy, and our study explored the challenges and feasibility of PFO closure in the Indian setting.Eighty patients with Embolic Stroke of Undetermined Source (ESUS) were screened by transcranial Doppler (TCD) for PFO. Twenty-nine patients underwent successful closure.High-risk features of a long tunnel, inter-atrial septal aneurysm, and large defect were present in 31%, 28%, and 59%. Transcranial Doppler had a sensitivity and specificity of 78% and 53% (p = 0.02) to detect PFO. Anticoagulation was withdrawn in 85% of patients post closure. Two patients had residual shunts at follow-up of 19 (9,34) months.     

Patent foramen ovale percutaneous closure: indications, techniques and results

A patent foramen ovale is almost physiological (15% of the population) but can be associated with some pathological situations in which its closure can be considered. The only medical indication currently accepted is a right-left shunt without elevation of the right pulmonary pressure, whose most famous pattern is the rare platypnea-orthodeoxie syndrome. PFO may be responsible for diving decompression accidents. Before taking the decision of closing a PFO, each situation must be discussed on a case to case basis. In spite of the possible link between some kinds of migraine and PFO, according to current knowledge, there is no evidence of the efficiency of PFO closure in this situation. The secondary prevention of a cryptogenic ischaemic cerebrovascular attack on a young person with a PFO associated to a membranous septum aneurysm, is the most commonly considered indication, but we lack valid data for this indication. The PFO closing procedure is well codified and its success rate is close to 100%, with rare major complications. Residual permeability within the prosthesis ensuring the closure of the PFO decreases gradually to get under 15% after six months. The clinical result is often dramatic when treating right-left shunts. As far as the secondary prevention of cryptogenic ischaemic cerebro vascular attacks in young people is concerned, there might be some clinical benefit, but we are waiting for the results of ongoing randomized and scheduled studies.     

Percutaneous closure of patent foramen ovale in symptomatic patients

BACKGROUND: Patent foramen ovale (PFO) and atrial septal aneurysm (ASA) have been associated with stroke in young adults. Patients with PFO suffering from paradoxical embolism are at increased risk for recurrent events. Percutaneous PFO closure is a new treatment modality aimed at secondary prevention. METHODS AND RESULTS: Since April 1994, 132 consecutive patients, aged 51 +/- 12 years with PFO and with at least one paradoxical embolic event, underwent percutaneous PFO closure using six different device types. The embolic index event was an ischemic stroke in 62% of patients, a transient ischemic attack (TIA) in 33% of patients, and a peripheral embolism in 5% of patients. Thirty-six (27%) patients had PFO associated with ASA, whereas 96 (73%) patients had PFO only. The implantation procedure was successful in 130 (98%) patients. During and up to 6 years of follow-up (mean 1.8 +/- 1.6 years, 231 patient years), a total of eight recurrent embolic events were observed, with six TIAs, two peripheral emboli, and no ischemic stroke. The actuarial freedom from recurrence of the combined end point of TIA, ischemic stroke, and peripheral embolism was 95.3% (95% confidence interval [CI], 91.0%-96.4%) at 1 year and 90.5% (95% CI, 83.6%-97.2%) at 6 years. CONCLUSIONS: Percutaneous PFO closure can be performed with a high success rate. The procedure appears a promising therapeutic modality for secondary prevention of recurrent embolism in patients with PFO. Randomized trials must define its therapeutic value.     

Percutaneous patent foramen ovale closure

This article discusses percutaneous patent foramen ovale closure.     

Patent foramen ovale closure: historical perspective

The work of the pioneers in PFO closure finally may evolve into a front-line therapy for secondary prevention of stroke in selected patients who have PFO and embolic events. Current implants, although new to most of interventional cardiology and neurology, are the result of years of steady, progressive work. It seems that PFOclosure is here to stay and will become a key element in a collaborative approach between cardiology and neurology in the treatment of embolic stroke. The advances in device technology may make PFO closure sufficiently safe, effective,and durable that it may become one of the most frequent catheter laboratory procedures to be performed.     

Percutaneous closure of the patent foramen ovale

A patent foramen ovale (PFO) is a common finding present in 25% of the population. A relationship between PFO and several clinical conditions such as stroke, migraine, platypnea-orthodeoxia syndrome, neurological decompression illness in divers, high altitude pulmonary edema, sleep apnea, and economy class syndrome have been documented. Observational non-randomized studies have shown percutaneous PFO closure more effective than medical treatment for stroke prevention, in particular in patients with complete closure as well as in patients with more than one cerebrovascular event at baseline. In the case of migraine, PFO closure has been shown to result in a marked reduction in migraine burden or migraine days. PFO anatomy, epidemiological data on associated clinical conditions, comparison between percutaneous closure and medical treatment, as well as the technical aspect of the procedure are described in this review.     

Indications, techniques and results of percutaneous patent foramen ovale closure

Patent foramen ovale (PFO) has been shown to be more prevalent in certain disease states, suggesting a potentially causative role in some patients with cryptogenic stroke, migraine headache or a number of other conditions. Percutaneous PFO closure has become a reasonable treatment option in a subset of those patients. Our objective is to review the possible indications of PFO closure. We further elucidate the technical aspects of PFO closure, provide an overview of the available devices and summarize results of PFO closure procedures.     

Percutaneous closure of patent foramen ovale

AIM: To review the safety and efficacy of percutaneous closure of patent foramen ovale (PFO) in symptomatic patients without the use of general anaesthesia or echocardiographic guidance. METHOD: All patients accepted for percutaneous PFO closure by our service from August 2002 to August 2004 were included. Patient demographics and clinical information were obtained from clinical records and by telephone interview. Follow-up outcomes recorded were recurrence of systemic thromboembolism, residual shunt, and change in pattern of migraines. RESULTS: Forty consecutive adult patients, of whom 19 (48%) had an atrial septal aneurysm (ASA), underwent PFO closure using the Amplatzer occluder device with fluoroscopic guidance alone. Their mean age was 45 +/- 10 years (range 23-63 years) and 24 (60%) were male. The indications for closure were ischaemic stroke (n = 26), transient ischaemic attack (TIA) (n = 8), both stroke and TIA (n = 2), refractory hypoxia (n = 2), platypnoea-orthodeoxia (n = 1) and severe migraine with seizures (n = 1). Twenty patients suffered a single neurological event and 16 suffered >1 event, including six with only radiographic evidence of >1 event. Mean procedure time was 17.7 +/- 9.6 min and fluoroscopy time was 6.7 +/- 7.3 min. Implanted device sizes were 18 mm (n = 1), 25 mm (n = 37) and 35 mm (n = 2). In 33 patients, the procedure was performed as a day-case. No complications were encountered. No further neurological events occurred in 39 patients at a mean follow-up time of 11 +/- 7 months (3-25 months) nor was a significant shunt detected in the 34 who underwent follow-up echocardiography. CONCLUSIONS: Percutaneous closure of PFO with or without ASA, under local anaesthesia and without echocardiographic guidance, is a safe and effective procedure which can be performed as a day-case. This has now become our standard clinical practice.     

Transcatheter closure of patent foramen ovale in patients with platypnea-orthodeoxia

Platypnea-orthodeoxia is a rare syndrome characterized by the occurrence of dyspnea and hypoxemia on adoption of an upright posture (i.e., orthodeoxia) and by the absence of symptoms and hypoxemia in decubitus. This syndrome is frequently related to patent foramen ovale and right-to-left shunting. We describe two patients in whom patent foramen ovale with right-to-left shunting was observed on transthoracic and transesophageal echocardiography and who had platypnea-orthodeoxia in the absence of pulmonary disease. They underwent transcatheter closure using an Amplatz device. The echocardiographic diagnosis and closure procedure are discussed. These case reports demonstrate that closure of patent foramen ovale is an effective treatment for platypnea-orthodeoxia.     

Transhepatic closure of patent foramen ovale

Transhepatic right heart catheterization is an uncommon procedure for adult interventional cardiologists. We report its successful use for closure of a patent foramen ovale in an elderly patient without femoral vein access. Also described is a novel method of using a vascular plug to achieve hemostasis of the hepatic venous access site. © 2009 Wiley‐Liss, Inc.     

Percutaneous closure of a patent foramen ovale: single-centre experience using different types of devices and mid-term outcome

INTRODUCTION: Patent foramen ovale (PFO) has been identified as a source of paradoxical embolism and cryptogenic stroke. Low recurrence rates of ischaemic stroke after percutaneous closure have been described. We report our single-centre experience using four different types of devices. METHODS: All patients, who underwent a percutaneous PFO closure in the University Hospitals Leuven between February 1999 and December 2003, were included. The primary end point was defined as reoccurrence of stroke, transient ischaemic attack (TIA), or a peripheral thrombo-embolic event. The periprocedural and mid-term complications were reported. RESULTS: One-hundred and twelve patients, mean age 52.1 +/- 12.5 years (63 men/49 women), were included in the study. Indications for closure were cryptogenic stroke (91.9%), peripheral embolism (4.5%), obligate right-to-left shunt in Ebstein anomaly (1.8%), platypnoea syndrome or brain abscesses (both 0.9%). The Cardioseal/Starflex was used in 12, the Amplatzer PFO occluder in 35, the PFO Star/CardiaStar in 64, and the Helex in one patient. The primary end point occurred in 1.8% for stroke and 2.8% for TIA during a median follow-up of 1.9 years, range 4.9 years. Periprocedural complications were dislocation of the device (0.9%), transient arrhythmias (15.5%), aspiration pneumonia (0.9%), inguinal haematoma (3.6%), and an allergic reaction to medication (1.8%). Mid-term complications were perforation of the device (0.9%), persistent transient arrhythmias (6.3%) and thrombus formation on the device (0.9%). No significant differences in outcome or the occurrence of any type of complication could be documented between the different types of devices. CONCLUSION: Percutaneous PFO closure seems to be a highly efficient and relatively safe procedure, independent of the type of device used for closure.     

脑卒中患者经导管封堵卵圆孔临床资料分析

目的:探讨经导管封堵卵圆孔未闭(PFO),预防脑部矛盾栓塞并评价其疗效。方法:本组共6例,年龄16～67岁,均经临床经胸超声心动图或经食道超声心动图检查,证实为PFO合并右向左分流患者。6例术前均有缺血性脑梗死。患者选用PFO封堵器经导管置入,进行介入治疗。结果:本组封堵成功率为100%。所有患者均能成功置入并释放封堵器。术后1个月、3个月及6个月行经胸超声心动图检查,未见封堵器移位。术后未有脑卒中事件。结论:经导管封堵PFO是一种较有效的介入治疗方法,可用于预防由于DFO导的致脑部矛盾栓塞。     

Transcatheter closure of patent foramen ovale in patients with cerebral ischemia

OBJECTIVES: The present study was conducted to determine the safety of the transcatheter closure of a patent foramen ovale (PFO) in patients with cryptogenic cerebral ischemia and the midterm follow-up of recurrent thromboembolic events after interventional PFO closure. BACKGROUND: Current therapeutic options for stroke prevention in patients with PFO and a history of thromboembolic events include chronic antithrombotics and more invasive treatments such as surgical closure or minor invasive transcatheter permanent closure of the PFO. Promising preliminary and pilot data with the Amplatzer Septal Occluder or the PFO-Star Occluder have been reported. Systematic and long-term data are still missing. METHODS: A total of 276 consecutive patients with a PFO and a history of at least one thromboembolic event were recruited in four medical centers and underwent percutaneous PFO closure with the PFO-Star device. Follow-up data were analyzed over an average of 15.1 months, equivalent to 345 patient-years. RESULTS: The implantation was successful in all 276 patients. Peri-interventional reversible complications included transient ST-segment elevations (1.8%) and transient ischemic attack (TIA) (0.8%). Two devices have been removed surgically. During follow-up the annual recurrence rate of thromboembolic events was 1.7% for TIA, 0% for stroke and 0% for peripheral emboli. CONCLUSIONS: Interventional PFO closure with the PFO-Star device appears to be a reliable and promising technique resulting in a low recurrence rate of thromboembolic events, especially stroke in patients with a history of cryptogenic ischemia presumably due to paradoxical embolization. To our knowledge, this is the largest coherent and prospective study for interventional PFO closure.