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.     

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.     

Percutaneous transcatheter closure of patent foramen ovale

In presence of a patent foramen ovale (PFO) with cryptogenic cerebral embolism, traditional therapy consists of oral anticoagulation or antiplatelet therapy. Surgery was considered only in case of recurrence. Transcatheter closure of PFO is currently performed. The availability of new user friendly devices and the increasing knowledge of pathophysiology, epidemiology, and follow-up of these patients has broadened the indications and marked reduced morbidity related to interventional PFO closure. This review presents the current knowledge and our own data concerning transcatheter closure of PFO.     

经皮导管左盘外包膜卵圆孔封堵器治疗卵圆孔未闭

目的 探讨经皮导管左盘外包膜卵圆孔封堵器治疗卵圆孔未闭的安全性和疗效.方法 在X线透视和超声心动图引导下经股静脉,通过10～12 F长鞘,采用左盘外包膜卵圆孔封堵器对有指征的卵圆孔未闭患者行介入治疗.术后口服阿司匹林(100 mg/d)6个月.术后24 h、1个月、3个月、6个月和1年分别行临床和超声心动图随访,以后每年随访1次.结果 共有25例卵圆孔未闭患者行卵圆孔封堵术,成功率为96%.没有发生院内不良事件和封堵器血栓形成、感染、心肌梗死等并发症.7例患者在术中出现频发性房性早搏或阵发性房性心动过速,术后很快终止.随访6～42(25±12)个月,封堵器位置正常,无房水平残余分流,未出现新发的心律失常和脑血管事件.结论 经皮导管左盘外包膜卵圆孔封堵器治疗卵圆孔未闭安全、有效.     

Causes of recurrent focal neurologic events after transcatheter closure of patent foramen ovale with the CardioSEAL septal occluder

Transcatheter patent foramen ovale (PFO) closure has been undertaken to eliminate paradoxical emboli as a cause for recurrent strokes/transient ischemic attacks (TIAs). We report the results of investigations to determine causes of all significant focal neurologic events (FNEs) after PFO closure reported to our center. Records of 216 consecutive patients who underwent PFO closure were reviewed. Patients had to have had > or =1 preceding clinical event consistent with stroke/TIA considered by a neurologist to be consistent with an embolic episode. Follow-up was recommended at 24 hours, 1 month, 6 months, 1 year, and every 1 to 2 years thereafter. All patients were requested to report any new FNE possibly suggestive of stroke/TIA to our center. Reports of evaluations were reviewed in detail. Twenty patients had an FNE 0.1 month to 40.2 months after PFO closure over 438 person-years of follow-up (mean 2.1 years, range 1 month to 7.1 years). There were 4 recurrent strokes, 2 likely directly device related. Ten patients had TIA and 6 patients had clear evidence of pathology unrelated to the device. Event rate for recurrent strokes was 0.9% per year (95% confidence interval for difference 0.3 to 2.4) and combined event rate for stroke/TIA was 3.4% per year (95% confidence interval for difference 2 to 5.6). In conclusion, transcatheter PFO occlusion can be accomplished as an outpatient procedure with minimal immediate morbidity. Patients may have multiple possible causes of recurrent FNE. Recurrence rate of cryptogenic FNE compares favorably with reports of medical management. Analysis of results from ongoing randomized trials of transcatheter PFO closure versus medical management may improve our ability to select the best treatment for individual patients.     

Late cardiac tamponade after percutaneous closure of a patent foramen ovale.

We report the case of a 35-year-old man who had a transient ischemic cerebral attack and then underwent a percutaneous closure of the patent foramen ovale (PFO) with a Cardiastar device. One year later, the patient developed a cardiac tamponade due to an important hemorrhagic pericardial effusion. Transoesophageal echocardiography showed that one of the struts had impinged on the aortic root in the region adjacent to the transverse pericardial sinus. Therefore, we speculated that the strut had passed through the aortic wall by slow erosion, leading to the pericardial effusion. Cardiac CT and subsequent surgery confirmed the perforation of the left atrial roof and the aortic root by two struts of the device. This is the first reported case of late cardiac tamponade and underscores the importance of long-term follow-up after PFO closure device implantation.     

Five-year experience with percutaneous closure of patent foramen ovale

Patent foramen ovale (PFO) has been implicated in the pathogenesis of cryptogenic stroke, arterial desaturation, decompression illness, and migraine headache (MH). This study evaluated the safety of percutaneous transcatheter PFO closure in patients with cryptogenic stroke, transient ischemic attack, or arterial desaturation. Additionally, symptomatic reduction in MH was determined after interatrial shunt closure. Of the 252 patients referred to the University of California, Los Angeles, with PFO, 131 underwent closure of the interatrial communication with a CardioSEAL (n = 30) or Amplatzer (n = 101) device. PFO morphology was evaluated with transesophageal echocardiography. Follow-up was conducted at 1 to 2 months with echocardiography, with clinical assessment annually thereafter. At an average follow-up of 30 months, there was no recurrence of any thromboembolic event (transient ischemic attack, stroke, or peripheral). There was a reduction in MH, defined as the complete resolution of headache or a >50% reduction in the number of headache days, in 85% of patients after PFO closure. Temporary problems after device implantation, including chest discomfort and palpitations, were reported in 23% of patients and occurred more frequently in patients with nickel hypersensitivity (p <0.05). In conclusion, transcatheter PFO closure is an effective and safe therapeutic modality in the prevention of thromboembolic events and MH associated with interatrial shunting in patients who present with cryptogenic stroke. Pending randomized, controlled trials are necessary to determine if this invasive approach is preferable to medical therapy for the prevention of recurrent stroke or as primary treatment for patients with MH.     

Tricuspid endocarditis with right-left auricular shunt through a patent foramen ovale

The authors report the case of a tricuspid endocarditis secondary to Streptococcus bovis with important regurgitation and severe hypoxemia secondary to a right-left atrial shunt through a patent foramen ovale, requiring a surgical treatment which included the replacement of the tricuspid valve and closure of the dehiscence in the inter-atrial septum. The presence of a patent foramen ovale in the course of a tricuspid endocarditis has been exceptionally reported. This diagnosis deserves to be evoked in case of an unexplained hypoxic condition or a systemic embolism complicating a tricuspid endocarditis. The report emphasizes the advantage of ultrasonic examinations (contrast sonocardiography, pulsated Doppler) in order to demonstrate this right-left atrial shunt in addition to the data collected about the tricuspid valve.     

Device-less patent foramen ovale closure by radiofrequency thermal energy

The goal of this study was to assess the feasibility, safety and success of a system which uses radiofrequency energy (RFE) rather than a device for percutaneous closure of patent foramen ovale (PFO). METHODS: Sixteen patients (10 men, 6 women, mean age 50 years) were included in the study. All of them had a proven PFO with documented right-to-left shunt (RLS) after Valsalva manoeuvre (VM) during transoesophageal echocardiography (TEE). The patients had an average PFO diameter of 6 +/- 2 mm at TEE and an average of 23 +/- 4 microembolic signals (MES) in power M-mode transcranial Doppler sonography (pm-TCD), measured over the middle cerebral artery. An atrial septal aneurysm (ASA) was present in 7 patients (44%). Balloon measurement, performed in all patients, revealed a stretched PFO diameter of 8 +/- 3 mm. In 2 patients (stretched diameter 11 and 14 mm respectively, both with ASA >10 mm), radiofrequency was not applied (PFO too large) and the PFO was closed with an Amplatzer PFO occluder instead. A 6-month follow-up TEE was performed in all patients. RESULTS: There were no serious adverse events during the procedure or at follow-up (12 months average). TEE 6 months after the first RFE procedure showed complete closure of the PFO in 50% of the patients (7/14). Closure appeared to be influenced by PFO diameter, complete closure being achieved in 89% (7/8) with a balloon-stretched diameter < or =7 mm but in none of the patients >7 mm. Only one of the complete closure patients had an ASA. Of the remainder, 4 (29%) had an ASA. Although the PFO was not completely closed in this group, some reduction in the diameter of the PFO and in MES was documented by TEE and pm-TCD with VM. Five of the 7 residual shunt patients received an Amplatzer PFO occluder. Except for one patient with a minimal residual shunt, all showed complete closure of PFO at 6-month follow-up TEE and pm-TCD with VM. The other two refused a closure device. CONCLUSIONS: The results confirm that radiofrequency closure of the PFO is safe albeit less efficacious and more complex than device closure. The technique in its current state should not be attempted in patients with a balloon-stretched PFO diameter >7 mm and an ASA.     

Transcatheter closure of patent foramen ovale after presumed paradoxical embolism.

BACKGROUND. Many have proposed a relation between presence of a patent foramen ovale, with or without atrial septal aneurysm, and cryptogenic stroke. The effect of foramen ovale closure on the risk for subsequent strokes is unknown. METHODS AND RESULTS. Transcatheter closure of a patent foramen ovale was undertaken in 36 patients with known right-to-left atrial shunting and presumed paradoxical emboli (31 strokes, 25 transient neurological events, four systemic arterial emboli, and two brain abscesses). Individual patients had between one and four such events. None had a left heart or carotid source of embolism; 31 of 35 had no known risk factors for stroke. Events occurred in 12 patients while they were taking warfarin. At cardiac catheterization, patent foramina ovalia were significantly larger than predicted for age in 67% of the patients. Implantation of a double-umbrella device in the patent foramen ovale was achieved in all without serious procedural complications. Of 34 who have returned for follow-up, one has a residual atrial communication that may be clinically important, five had trivial leaks, and 28 have complete closure. There have been no strokes during a mean follow-up of 8.4 months. CONCLUSIONS. Transcatheter closure of a patent foramen ovale can be accomplished with little morbidity and may reduce the risk of recurrence. Further investigations directed toward identifying the population at risk and assessing the effect of intervention are warranted.     

Physiologic closure of a symptomatic patent foramen ovale with oxygen therapy

Surgery is required for correction of a physiologically significant patent foramen ovale. We report a patient with poliomyelitis and respiratory failure in whom a patent foramen ovale became symptomatic because of hypoxemia-induced pulmonary hypertension. Oxygen therapy and mechanical ventilation reversed the pulmonary hypertension, resulting in physiologic termination of the patent foramen ovale without surgery.