Interventional closure with Amplatzer PFO occluder of patent foramen ovale in patients with paradoxical cerebral embolism

Percutaneous transcatheter closure has been proposed as an alternative to surgical closure or long-term anticoagulation in patients with presumed paradoxical embolism and patent foramen ovale (PFO). We report our mid-term results of 55 consecutive symptomatic patients (mean age: 47 years, range: 20-79) who underwent percutaneous transcatheter closure of PFO after at least one event of cerebral ischemia; 16 (29%) patients had at least one transient ischemic attack and 39 (71%) patients at least one embolic stroke. Multiple embolic events had occurred in 6 (11%) patients. Percutaneous transcatheter closure was technically successful in all 55 patients (100%). For the majority of patients, an Amplatzer PFO occluder measuring 25 mm in diameter (n=49) or an Amplatzer PFO occluder measuring 35 mm in diameter (n=6) was used. Complete occlusion by color Doppler and transesophageal contrast echocardiography investigation was achieved in 96% at follow-up 3-6 months after implantation; only 2 patients had a trivial residual shunt at follow-up. Mean fluoroscopy time was 6.7 minutes (range: 1.7-47.1), and in-hospital follow-up was uneventful except for 1 patient who developed a cardiac tamponade requiring uneventful and successful needle pericardiocentesis. At a mean follow-up of 19 months (range: 3-32) no recurrent embolic neurological events was observed. Transcatheter closure of PFO with Amplatzer PFO occluder devices is a safe and effective therapy for patients with previous paradoxical embolism and aneurysmatic or nonaneurysmatic PFO. Percutaneous closure is associated with a high success rate, low incidence of hospital complications, and freedom of cerebral ischemia events.     

A case of platypnea-orthodeoxia syndrome caused by the interaction between the presence of corrected transposition of the great arteries and patent foramen ovale

A 42-year-old was admitted to our institution for recurrent episodic dyspnea on exertion. The patient had also a history of recurrent transient ischemic attacks. Careful history taking revealed that she developed dyspnea in an upright position, whereas the symptoms were relieved in a supine position (platypnea). The patient was given the diagnosis of platypnea-orthodeoxia syndrome. Transthoracic echocardiography showed cardiac situs solitus levocardia with great artery transposition with intact interventricular septum, patent foramen ovale (PFO) and moderate right atrial dilatation. Agitated saline contrast injection demonstrated the presence of spontaneous right-to-left shunt. The patient underwent transcatheter closure of PFO. After percutaneous closure of PFO patient became asymptomatic and hypoxemia induced by orthostatic conditions did not appear again. A transthoracic echocardiography performed after two months, showed the complete closure of PFO, without residual shunt.     

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.     

卵圆孔未闭并发不明原因脑卒中患者封堵治疗的疗效和安全性

目的:探讨封堵治疗卵圆孔未闭(patent foramen ovale,PFO)并发不明原因缺血性脑卒中患者的临床疗效及安全性。方法:26例缺血性脑卒中患者,均经头颅CT或磁共振成像(MRI)证实有脑梗死病灶,排除其他脑梗死原因,如主动脉和脑血管病变,及左心系统疾病等。经颅多普勒超声(TCD)声学造影判断有右向左分流,经胸超声心动图(TTE)和(或)经食管超声心动图(TEE)证实为PFO或PFO并发房间隔瘤。所有患者均行PFO封堵治疗。结果:26例患者,静息超声测量PFO大小为1.0~4.6(2.8±1.2)mm,其中5例PFO并发房间隔瘤。TCD声学造影分流量Ⅰ级6例,Ⅱ级9例,Ⅲ级以上11例。24例封堵成功,技术成功率为92%,所用封堵器18 mm 6个、25 mm7个、30 mm 8个及35 mm 3个。未成功病例2例,主要原因为导丝无法到达左房。术后随访6个月~1年,TTE检查未见封堵器移位及心房水平残余分流,TCD声学造影检查均无右向左分流,所有患者无再发缺血性脑梗死。结论:经导管封堵PFO是一种安全有效的治疗方法,可有效减少缺血性脑卒中的再发生。     

Incidence of atrial fibrillation following transcatheter closure of atrial septal defects in adults

Transcatheter closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO) has become a routine procedure. Little is known about the effect of atrial septal device implantation on the occurrence of atrial fibrillation (AF). We evaluated the frequency of AF occurring after transcatheter PFO and ASD closure in a large population. From 1994 until 2007 a total of 1,062 patients underwent transcatheter closure of an interatrial communication. New-onset AF was defined by 12-lead electrocardiogram or Holter monitoring in patients without a history of AF at baseline. Of the 1,062 patients, 822 had a PFO and 240 had an ASD. During a median follow up of 20 months, new-onset AF was documented in 8% of patients. New-onset AF occurred in 7% of patients after PFO closure and in 12% of patients with underlying ASD. The annual incidence of new-onset AF was 2.5% and 4.1% in patients with PFO and ASD, respectively. Generally, patients with new-onset AF were older than those without AF. Device type or size did not influence the occurrence of AF. In the group of patients with PFO, residual shunt was more common in patients with AF compared with the non-AF group. In conclusion, AF is more common after PFO and ASD closure compared with the general population; although device type or size did not impact the occurrence of AF, residual shunt may influence the occurrence of AF after intervention in patients with underlying PFO.     

Exclusion of patients with arteriosclerosis reduces long-term recurrence rate of presumed arterial embolism after PFO closure

BACKGROUND: Percutaneous transcatheter closure of patent interatrial communications after presumed paradoxical embolism is used as an alternative to surgery or long-term anticoagulation for the treatment of patients who are at risk for recurrent thromboembolism. To avoid atherosclerotic events to be judged as recurrent paradoxical embolism, we prospectively excluded all patients with detectable arteriosclerosis from our series and investigated long-term results. METHODS AND RESULTS: We report the outcome of 180 patients who underwent percutaneous transcatheter closure of patent foramen ovale (PFO), PFO like atrial septal defect (ASD), or an ASD because of paradoxical embolism. One hundred four patients had cerebral embolism, 57 had transient ischemic attacks, 16 coronary embolism, and 3 had peripheral embolism. Twenty-three patients experienced multilocal arterial embolism. One hundred twenty-five patients had a PFO, 63 of them with an atrial septal aneurysm (ASA), 24 a PFO-like ASD (7 of them with an ASA), and 31 had an ASD. After 18 months, only 5 patients (2.8%) showed a trivial residual shunt. At a mean follow-up of 40 months (range 4 to 88), resulting in 602 observed patient-years, only 1 patient experienced a presumed paradoxical (coronary) embolism (calculated annual risk to suffer a recurrent thromboembolic event: 0.16%). CONCLUSIONS: Percutaneous transcatheter closure of PFO/ASD is a safe and effective therapeutic option for the secondary prevention of presumed paradoxical embolism. It is associated with a high success rate, low incidence of hospital complications, and very low frequency of recurrent systemic embolic events.     

Effect of Residual Interatrial Shunt on Migraine Burden After Transcatheter Closure of Patent Foramen Ovale

ObjectivesThis study sought to evaluate the long-term effect of transcatheter patent foramen ovale (PFO) closure on migraineurs with and without aura and examine the effect of residual right-to-left shunt.BackgroundMany studies reported improvement in migraine symptoms after PFO closure, yet randomized trials failed to reach its clinical endpoints.MethodsThe study retrospectively analyzed data from 474 patients who underwent transcatheter PFO closure at Massachusetts General Hospital. Patients completed a migraine burden questionnaire at baseline and at follow-up. Migraine severity is reported as migraine frequency (days/month), average duration (min), and migraine burden (days × min/month). Improvement following closure was defined as complete abolishment of symptoms or >50% reduction in migraine burden.ResultsA total of 110 migraineurs who underwent PFO closure were included; 77.0% had aura and 23.0% were without aura, and 91.0% had a cryptogenic stroke. During long-term median follow-up of 3.2 (interquartile range: 2.1 to 4.9) years, there was a significant improvement in migraine symptoms in migraineurs with or without aura. Migraine burden was reduced by >50% in 87.0% of patients, and symptoms were completely abolished in 48%. Presence of aura was associated with abolishment of migraine (odds ratio: 4.30; 95% confidence interval: 1.50 to 12.30; p = 0.006). At 6 months after PFO closure, residual right-to-left shunt was present in 26% of patients. Absence of right-to-left shunt was associated with improvement in migraine burden by >50% (odds ratio: 4.60; 95% confidence interval: 1.30 to 16.10; p = 0.017).ConclusionsLong-term follow-up after transcatheter PFO closure was associated with significant improvement in migraine burden. Aura was a predictor of abolishing symptoms. Absence of residual right-to-left shunt was a predictor of significant reduction in migraine burden.     

Migraine headache relief after transcatheter closure of patent foramen ovale

OBJECTIVES: The purpose of this study was to determine the effects of transcatheter patent foramen ovale (PFO) closure on migraine frequency in patients with paradoxical cerebral embolism. BACKGROUND: The prevalence of migraine headache is higher in cryptogenic stroke patients with PFO than in the general population. Previous studies have suggested that closure of the PFO may reduce migrainous symptoms. METHODS: Between April 2001 and December 2003, 162 consecutive patients with paradoxical cerebral embolism underwent transcatheter PFO closure for prevention of recurrent cryptogenic stroke or transient ischemic attack. A one-year retrospective analysis of migraine symptoms before and after PFO closure was performed. RESULTS: Active migraine was present in 35% (57 of 162) of patients, and 68% (39 of 57) experienced migrainous aura; 50 patients were available for analysis at one year. Complete resolution of migraine symptoms occurred in 56% (28 of 50) of patients, and 14% (7 of 50) of patients reported a significant (>or=50%) reduction in migraine frequency. Patients reported an 80% reduction in the mean number of migraine episodes per month after PFO closure (6.8 +/- 9.6 before closure vs. 1.4 +/- 3.4 after closure, p < 0.001). Results were independent of completeness of PFO closure at one year. CONCLUSIONS: In patients with paradoxical cerebral embolism, migraine headaches are more frequent than in the general population, and transcatheter closure of the PFO results in complete resolution or marked reduction in frequency of migraine headache.     

Management of residual shunts after initial percutaneous patent foramen ovale closure: A single center experience with immediate and long‐term follow‐up

Background: Moderate‐to‐large residual shunts following percutaneous patent foramen ovale (PFO) closure are clinically important and associated with recurrent neuroembolic events. However, their management has not been clearly established in clinical practice. We report our experience in patients of these patients with a prior history of cryptogenic stroke and/or transient ischemic attack (TIA). Methods: All patients undergoing percutaneous PFO closure were routinely screened at six‐months for residual shunts using transthoracic 2D echocardiography with antecubital administration of agitated saline contrast and color flow Doppler. Patients with evidence of moderate‐to‐large residual shunts were selected to undergo reintervention with shunt closure. Postreintervention follow‐up was performed at 24‐hr, 30 days, and every six months thereafter. Clinical predictors of the moderate‐to‐large residual shunts, and the feasibility, safety and long‐term efficacy of percutaneous residual shunt closure using a second device implant were examined. Results: Between 1995 and 2007, a total of 424 patients underwent PFO closure. Of these, 5% (21/424) had moderate‐to‐large residual shunts. Baseline characteristics among patients with moderate‐to‐large residual shunts and those with only none or small defects (n = 403) were similar. Multivariate analysis identified the 24‐hr postprocedure shunt as the only independent predictor of residual shunting at six months. Of the 21 study patients with moderate‐to‐large residual shunt (mean age, 47 ± 14), one underwent successful elective surgical repair, while the remaining 20 underwent transcatheter closure using a second device. The technique was successful in 95% (19/20), and all but one patient had complete shunt closure at six months of their percutaneous reintervention. We report no deaths, recurrent strokes or TIAs during the long‐term mean follow‐up period of 2.9 years. Conclusions: Our study suggests that in patients with moderate‐to‐large residual PFO shunts, percutaneous reintervention using a second device implant is safe and effective. © 2010 Wiley‐Liss, Inc.     

Frequency of migraine headache relief following patent foramen ovale "closure" despite residual right-to-left shunt

Retrospective studies have shown improvement in migraines after patent foramen ovale (PFO) closure. To date, no study has evaluated whether the completeness of closure affects headache status; therefore, the objective of this study was to evaluate the impact of residual right-to-left shunt (RLS) on migraine symptoms after transcatheter PFO closure in migraineurs with and without aura. This was a small-series, single-center, retrospective analysis of late follow-up data on 77 patients with presumed paradoxical embolism and migraine who underwent PFO closure for secondary stroke prevention. Power M-mode transcranial Doppler was used to assess RLS at baseline and 6 and 12 months after closure. A standardized migraine questionnaire was administered at baseline and 6, 12, and 24 months after closure. Fifty-five (71%) patients had migraine with aura. Final closure and migraine status were available for 67 patients; 23 (34%) had incomplete PFO closure, defined as 30 embolic tracks detected at final power M-mode transcranial Doppler examination (median 366 days, 95% confidence interval 332 to 474). Migraine relief (> or = 50% reduction in frequency) was independent of closure status (77% complete closure vs 83% incomplete closure, p = 0.76) at late follow-up (540 days, 95% confidence interval 537 to 711). Migraineurs with aura were 4.5 times more likely to experience migraine relief than migraineurs without aura. In conclusion, migraine relief may occur despite residual RLS after transcatheter PFO closure, which may suggest a reduction in RLS burden below a neuronal threshold that triggers migraine; however, this warrants further investigation. Migraine with aura may be an independent predictor of relief after PFO closure.     

Anomalous origin of the circumflex artery and patent foramen ovale: a rare cause of myocardial ischaemia after percutaneous closure of the defect

A 35 year old man with a history of transient ischaemic attack and atrial septal aneurysm underwent percutaneous closure of a patent foramen ovale (PFO) with a transcatheter device. After the procedure the patient developed effort angina not present previously. Transoesophageal echocardiography confirmed the absence of residual shunt but showed an abnormal linear image running behind the aortic root. Magnetic resonance imaging detected an anomalous origin of the circumflex coronary artery from the right coronary sinus. The anomalous artery was located between the aortic root and the PFO closing device, causing coronary insufficiency. This report describes a rare complication of transcatheter PFO closure.     

Shut that door: a man with contemporaneous multisite paradoxical embolization

Patent foramen ovale (PFO) has been recognized as mediator of paradoxical embolism. Concurrent multisite paradoxical embolization is a quite rarely reported occurrence. We present a case of multisite paradoxical embolism (pulmonary, cerebral, upper limb) mediated by a large right-to-left shunt mediated by a PFO with associated a redundant Eustachian valve, successfully treated with PFO transcatheter closure and vena cava filter placement.     

Discrepancy in the assessment of jailed side branch lesions by visual estimation and quantitative coronary angiographic analysis: comparison with fractional flow reserve

A 59‐year‐old man suffered a transient ischemic attack (TIA) and was found to have a patent foramen ovale (PFO). Six months after closure with a 25 mm Amplatzer PFO occluder there was a significant residual shunt at transesophageal echocardiography (TEE). A coil was implanted and TEE 4 months later showed complete closure. © 2011 Wiley‐Liss, Inc.     

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.     

Transcatheter Closure of Patent Foramen Ovale: A New Migraine Treatment?

Transcranial Doppler (TCD) is a very sensitive tool for detecting microembolic signals (MES) in the brain vessels after injection of air-mixed saline in case of right-to-left shunt (RLS). Patent foramen ovale (PFO) can be found in nearly one-half of migraineurs with aura, and, reciprocally, the prevalence of migraine in patients with stroke with PFO is exceedingly high. We aimed to monitor the passage of MES in the brain vessels during transcatheter closure of PFO and to subsequently follow-up patients for both the efficacy of the procedure and the severity of migraine. Seventeen patients suffering from migraine with aura (MA+, n = 8) or without aura (MA-, n = 9) scheduled to undergo transcatheter closure of PFO with Amplatzer PFO occluder devices for paradoxical cerebral embolism were monitored with contrast TCD (DWL, Germany) before, during, and after the procedure to estimate the magnitude of the shunt. Spontaneous embolization to the brain was also recorded. The patients were thereafter followed-up at 1, 3, and 6 months. A composite score of migraine severity, which included frequency, duration, and intensity of the attacks in the previous 3 months (range 0-10), was obtained at the time of the procedure and at the follow-up visits. Complete occlusion of PFO was achieved in all patients after 1 month in most cases. Preoperatively, the migraine score was 6.75 in MA+ and was 6 in MA--patients. After closure, the score dropped to 2.5 in MA+ and to 4.2 in MA--patients at the 6-month follow-up visit, the difference being statistically highly significant in both groups. Overall, 5 of 17 patients no longer complained of migraine, 10 of 17 were substantially improved, and two of 17 were unchanged at 6 months. Migraine aura disappeared in six of eight patients. Closure rate was very satisfactory, from a preoperative average bubble count of 42 to an average of 4 bubbles in the four patients in whom a small residual shunt was still detectable at the 6-month follow-up visit. TCD monitoring provides the most accurate assessment of RLS at the brain level. Closure of PFO with transcatheter devices results in the substantial relief of migraine in patients with stroke with large RLS.     

卵圆孔未闭封堵术治疗偏头痛的临床疗效

目的 通过比较卵圆孔未闭（patent foramen ovale,PFO）封堵前后患者偏头痛症状改善程度,评估PFO封堵术治疗偏头痛的有效性和安全性。方法 纳入2012年5月~2013年6月就诊并同期行经皮PFO封堵术的偏头痛患者。PFO封堵术后≥6个月电话或门诊随访,进行HIT-6量表评分,并记录偏头痛症状(包括发病频率、天数、程度)。比较封堵术前后偏头痛症状以及偏头痛对生活质量的影响变化。结果 32例PFO并发偏头痛患者,年龄14~59(37.00±12.26)岁,其中男14例,女18例。随访显示封堵术后偏头痛患者的HIT-6评分显著减少（P<0.05）,术后偏头痛对生活质量的影响明显降低; 偏头痛平均发作频率明显下降（P<0.05）,头痛程度明显减轻（P<0.05）。结论 PFO封堵术安全性高,可有效改善偏头痛症状及对生活质量的影响。     

Embolic Implications of Combined Risk Factors in Patients with Patent Foramen Ovale (the CARPE Criteria): Consideration for Primary Prevention Closure?

Background: Large patent foramen ovale (PFO), spontaneous right‐to‐left shunt, large atrial septal aneurysm (ASA), coagulation abnormalities, and prominent eustachian valve (EV) have all been independently suggested as risk factors for recurrent stroke. We sought to retrospectively evaluate risk of stroke and impact of transcatheter PFO closure in patients with concurrent large PFO, spontaneous right‐to‐left shunt, large ASA, coagulation abnormalities, and prominent EV. Methods: Between March 2006 and October 2008, 36 (mean age 44 ± 10.9 years, 28 females) out of 120 consecutive patients referred to our center for transcatheter PFO closure had concomitant diagnosis of (a) large PFO on transcranial Doppler (TCD) and transesophageal echocardiography (TEE), (b) spontaneous right‐to‐left shunt on TCD, (c) large ASA, (d) prominent EV, and (e) coagulation abnormalities. All patients fulfilled the standard current indications for transcatheter closure and underwent preoperative TEE and brain magnetic resonance imaging (MRI), with subsequent intracardiac echocardiographic‐guided transcatheter PFO closure. Results: Compared to the remaining PFO population in the same period, patients with all five concomitant features had more ischemic brain lesions on MRI, previous history of recurrent stroke, more frequently a history of venous thromboembolism, and more severe migraine with aura. The concomitance of all the features confers the highest risk of recurrent stroke (OR 9.9, 3.0–18 [95% CI], P < 0.001). Conclusions: Despite its small sample size and nonrandomized retrospective nature, this is the first study to suggest that patients with concurrence of all the investigated characteristics have potentially a higher risk of stroke compared to controls. We thus propose the CARP criteria as a basis for further larger, longitudinal studies to assess the potential benefits of transcatheter closure in this patient subset in the absence of clinical recurrent stroke.     

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.     

Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices

BACKGROUND: Atrial septal aneurysm is frequently associated with patent foramen ovale (PFO) and atrial septal defects (ASD). Moreover, a relationship between atrial septal aneurysm and embolic cerebrovascular events has been suggested. The aims of this study were to analyze morphological and functional characteristics of atrial septal aneurysm in PFO and ASD patients and to assess the feasibility and efficacy of different devices for transcatheter closure and the influence of atrial septal aneurysm. METHODS: Between March 1997 and May 2000 transcatheter ASD or PFO closure was attempted in 63 patients (mean age 47 +/- 13 years) with an atrial septal aneurysm using one of the following devices: Angelwings (n = 3), Cardioseal (n = 5), Cardioseal-Starflex (n = 7), Amplatzer (n = 11), Amplatzer-PFO (n = 5), PFO-Star (n = 25), or Helex (n = 7). RESULTS: Implantation was primarily successful (after the first or second attempt) in all patients. One PFO-Star device embolized 12 hours after the procedure. During follow-up (0.6-37 months, mean 10.4 +/- 9.2) a residual shunt could be detected by transesophageal echocardiography after 2 weeks in four patients and after 6 months in one patient. Three PFO patients had cerebrovascular events after implantation. Two patients had a transient ischemic attack (TIA) and one patient a stroke. A thrombus formation on the device detected in three patients disappeared after antithrombotic therapy. CONCLUSION: We conclude that ASDs and PFOs with an associated atrial septal aneurysm can be closed with different available devices. There seem to be no additional risks compared with patients without atrial septal aneurysm.     

Clinical and brain magnetic resonance imaging follow-up after percutaneous closure of patent foramen ovale in patients with cryptogenic stroke

Patent foramen ovale (PFO) closure is reported to result in fewer episodes of clinically manifest recurrent cerebral ischemia than medical treatment. We evaluated by means of magnetic resonance imaging (MRI) whether silent cerebral ischemic episodes are also decreased by PFO closure. Seventy-one patients with PFO were selected for percutaneous closure of PFO at our center. All had PFO with large right-to-left shunt documented by transcranial Doppler ultrasound and transesophageal echocardiography, > or =1 previous stroke or transient ischemic attack with MRI documentation at the index event, and no alternative cause for cerebral ischemia. MRI studies were performed in all patients 24 hours before the procedure and at 1-year follow-up (or before in the case of a suspected new neurologic event). Eight patients (11%) had >1 clinical event before the procedure. Comparing the 2 MRI studies before the procedure, silent ischemic lesions were observed in 14 other patients (20%). Thus, considering clinical and silent events together, >1 event was present at baseline in 22 patients (31%). After PFO closure (follow-up 16 +/- 7 months), 1 recurrent neurologic event occurred (1%, p = 0.02 vs preprocedural clinical events); however, urgent brain MRI results were negative. Moreover, only 1 patient showed 1 new silent lesion at brain MRI at follow-up (1%, p <0.001 vs preprocedural silent brain lesions). Considering clinical and silent events, relapses occurred in 2 patients only (p <0.001 vs before procedure). Recurrent events were limited to those with incomplete PFO closure at postprocedural transcranial Doppler ultrasound (p = 0.02). In conclusion, percutaneous PFO closure results in few clinical or silent events after 1-year follow-up, especially when complete PFO closure is successfully accomplished.