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.     

Transcatheter patent foramen ovale closure is effective in reducing migraine independently from specific interatrial septum anatomy and closure devices design

BackgroundRelationships between migraine improvement after transcatheter patent foramen ovale (PFO) closure and both specific interatrial septum anatomy and different devices design have not been investigated yet. We sought to assess effectiveness of transcatheter PFO closure in reducing or curing migraine with aura in patients with previous paradoxical embolism in relation with specific interatrial septum anatomy and different closure devices.Methods and ResultsWe prospectively enrolled 34 patients (22 female and 12 male, mean age 40±3.7 years) who were referred to our centre over a 12-month period for PFO transcatheter closure and migraine with aura and previous paradoxical embolism. All procedures were performed using mechanical intracardiac echocardiographic guidance. Patients were assigned to Amplatzer PFO or ASD Multifenestrated Occluder and Premere Occlusion System implantation dependently from intracardiac echocardiography anatomical findings, which included short-channel with moderate atrial septal aneurysm (ASA) in 6 patients (17.6 %), long-channel with moderate ASA in 3 patients (8.8%), short-channel with huge ASA in 5 patients (14.7%), multifenestrated ASA in 4 patients (11.7%), long-channel PFO without ASA in 10 patients (29.4%), and long-channel PFO with mild ASA in 6 patients (17.6%). Accordingly, 18 patients received an Amplatzer Occluder (9 PFO Occluder and 7 ASD Multifenestrated Occluder), and 16 received a Premere Occlusion System. After a mean follow-up of 9.0±2.8 months, all patients improved their migraine symptoms (mean Migraine Disability Assessment Score 30±1.5 at baseline versus 6.0±2.9 in the follow up, P<.03) independently from specific interatrial septum anatomy and different closure devices.ConclusionAlthough our study had several limitations, it suggests that independently from interatrial septum anatomy and device type, PFO closure in patients with migraine with aura resulted in a high rate of migraine improvement.     

Association of interatrial shunts and migraine headaches: impact of transcatheter closure

OBJECTIVES: To examine the relationship between patent foramen ovale (PFO) or atrial septal defect (ASD) with the incidence of migraine headache (MHA) and assess whether closure of the interatrial shunt in patients with MHA would result in improvement of MHA. BACKGROUND: Migraine headache is present in 12% of adults and has been associated with interatrial communications. This study examined the relationship between PFO or ASD with the incidence of MHA and assessed whether closure of the interatrial shunt in patients with MHA would result in improvement of MHA. METHODS: A sample of 89 (66 PFO/23 ASD) adult patients underwent transcatheter closure of an interatrial communication using the CardioSEAL (n = 22), Amplatzer PFO (n = 43), or the Amplatzer ASD (n = 24) device. RESULTS: Before the procedure, MHA was present in 42% of patients (45% of patients with PFO and 30% of patients with ASD). At three months after the procedure, MHA disappeared completely in 75% of patients with MHA and aura and in 31% of patients with MHA without aura. Of the remaining patients, 40% had significant improvement (>or=2 grades by the Migraine Disability Assessment Questionnaire) of MHA. CONCLUSIONS: Transcatheter closure of PFO or ASD results in complete resolution of MHA in 60% of patients (75% of patients with migraine and aura) and improvement in symptoms in 40% of the remaining patients. Interatrial communications may play a role in the etiology of MHA either through paradoxic embolism or humoral factors that escape degradation in bypassing the pulmonary circulation. A randomized trial is needed to determine whether transcatheter closure of interatrial shunts is an effective treatment for MHA.     

Early-mid term follow-up results of percutaneous closure of the interatrial septal defects with occlutech figulla devices: a single center experience

Background: Percutaneous closure of secundum type atrial septal defect (ASD) and patent foramen ovale (PFO) has gained widespread use in recent years. Herein, we evaluated the safety and efficacy of the Occlutech® Figulla devices for PFO and ASD closure in a reference tertiary center. Methods: All 143 patients (46.9% male, mean age 39.3 ± 12.2 years) who underwent transcatheter PFO (n = 85) and ASD (n = 58) closure with Occlutech® Figulla devices between February 2009 and October 2011 were included in this study. An echocardiographic follow‐up examination was performed at the 1st, 6th, and 12th month visits. Results: The devices were successfully implanted in all 143 patients (100%). In‐hospital periprocedural complications were device embolization (0.7%; 1 ASD patient), atrial fibrillation (1.4%; 1 ASD and 1 PFO patients), supraventricular tachycardia (0.7%; 1 PFO patient), and vascular access hematoma (0.7%; 1 ASD patient). Among ASD patients, 2 patients had trivial (jet width <1 mm in diameter) and 1 patient had small (1–2 mm) residual shunts before hospital discharge, which disappeared after the 6‐month visit. During the mean 15.4 ± 9.6 months follow‐up, all patients were asymptomatic and no ischemic stroke, cardiac perforation, device erosion, embolization, thrombus formation, or malposition of the device was observed. Conclusions: Percutaneous PFO and secundum type ASD closure with the novel Occlutech® Figulla Occluder devices without left atrial central pin and with significantly reduced meshwork was safe, feasible, and effective. (J Interven Cardiol 2012;25:375–381)     

Characteristics of adult patients with atrial septal defects presenting with paradoxical embolism

Background : The association between patent foramen ovale (PFO), atrial septal aneurysm, and cryptogenic stroke due to paradoxical embolism has been established. The correlation between atrial septal defect (ASD) in adults and paradoxical embolism is less well defined. Methods : We examined our single center experience with 329 adult patients undergoing percutaneous device closure of interatrial communication defects to identify clinical and morphologic differences among adult patients with ASDs who presented with or without paradoxical embolism. Comparison was made with patients with PFO. Results : Although a significant left‐to‐right shunt was the predominant indication for ASD closure, 20 patients (14%) presented with a paradoxical embolism. These patients tended to be younger and had smaller defects (both by size and shunt ratio) than ASD patients without paradoxical embolism, and were more likely to be female than PFO patients. Conclusions : The incidence of adult patients with ASD who presented with paradoxical embolism is higher than expected and suggests that this diagnosis should be considered in patients with cryptogenic stroke. © 2009 Wiley‐Liss, Inc.     

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.     

Light anti-thrombotic regimen for prevention of device thrombosis and/or thrombotic complications after interatrial shunts device-based closure

AimsThe optimal antiplatelet therapy after atrial septal defect (ASD) or patent foramen ovale device closure (PFO) remain to be established. We evaluated the safety and effectiveness of 6-month 100 mg Aspirin (ASA) regimen in the very long-term follow up after intracardiac echocardiography (ICE) –aided interatrial shunt closure in a large retrospective cohort.MethodsSingle-center retrospective analysis which included medical and instrumental data of 789 consecutive patients referred to our institution over a 15 years period due interatrial shunt catheter-based closure.ResultsFinally, 734 patients were included in the analysis (mean age 46.1 ± 14.6 years, 398 females): ASD and PFO closure were successfully performed in 281 and 453 patients, respectively. Over the follow-up period, no major bleeding events were observed while the rate of minor bleeding events was 0.9%. Tolerance problems were detected in 3.4% of cases (n==28). In 11 patients (1.5%) an abnormal complete blood count was detected and monitored up to normalization. On a mean follow –up of 10.3 ± 3.0 years (range 1–15), 10 patients (1.36%) had a persistent moderate shunt 12 months after closure and maintained Aspirin 100 mg life-long, whereas the remaining 724 suspended the treatment after 6 months. Device thrombosis in ASD and PFO groups were 0% and 0.2%, respectively. A cerebral ischemic event occurred in 0.4% of the entire cohort.ConclusionsA regimen of 100 mg of ASA for six months after ASD/PFO closure appeared to be both safe and effective in preventing device thrombosis and major bleedings.     

Encerramento percutâneo de defeitos do septo interauricular guiado por ecocardiograma intracardíaco − A experiência de um centro

IntroductionDevice closure of interatrial communications has become a well-established technique to treat left-to-right shunt associated with atrial septal defect (ASD) and to prevent paradoxical embolism in patients with patent foramen ovale (PFO). Guidance by transesophageal echocardiography (TEE) is the standard practice but intracardiac echocardiography (ICE) is a feasible and safe alternative for monitoring these procedures.ObjectivesTo report our experience in the percutaneous closure of ASD and PFO guided by ICE.MethodsWe retrospectively reviewed all patients with ASD or PFO who underwent percutaneous closure guided exclusively by ICE between January 2008 and December 2010. All patients were followed clinically with regular echocardiographic evaluation (at discharge, one month, three, six and twelve months) to exclude residual shunt and device malposition.ResultsA total of 127 patients (mean age 46.6±12.2 years; 71% female) underwent transcatheter device closure of ASD or PFO during the study period. Device deployment with ICE monitoring was 100% successful, with a low rate of complications and eliminating the need for additional imaging techniques.ConclusionsICE provides anatomical detail of ASD/PFO and cardiac structures, facilitating congenital cardiac interventional procedures. It eliminates the major drawbacks associated with TEE and enables the interventional cardiologist to control all aspects of the procedure without relying on additional echocardiographic support.     

Percutaneous closure of multiple defects of the atrial septum: Procedural results and long‐term follow‐up

Background : The percutaneous closure of single atrial septal defect (ASD) is a valid alternative to surgery. Objectives : To assess the feasibility of percutaneous treatment of multiple ASDs. Methods : Between 1998 and 2007, 165 out of 1280 consecutive patients undergoing ASD percutaneous closure at our institution showed multiple defects that were classified in four categories: double atrial septal defects (d‐ASD), multifenestrated atrial septal defects (f‐ASD), multifenestrated defects with no signs of right heart overload (f‐PFO), and complex cases (c‐ASD). The following end points were taken into consideration: (1) immediate procedural success; (2) long term safety and efficacy. In this study, up to 81% of multiple ASDs were suitable for percutaneous closure. Results : Multiple device implantations were required in 47% of cases, especially in patients with d‐ASD and c‐ASD. Complication rate, residual shunt, and long term outcome were comparable among the four different categories. In particular, at long term follow‐up (6 ± 2 years) no patient required further surgical or percutaneous treatment and complete closure was confirmed in 99% of cases. Conclusions : Percutaneous closure of multiple ASDs is feasible and associated with a good outcome. A thorough identification and analysis of morphological aspects are mandatory in order to select the appropriate device and the optimal strategy. © 2010 Wiley‐Liss, Inc.     

Outcome after percutaneous closure of a patent foramen ovale using the Intrasept™ device

Objectives : This multi‐centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept? device. Background : PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo‐embolism. Currently, different devices are used for PFO closure. Methods : Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo‐embolism. Peri‐procedural and mid‐term complications were reported. Results : Four‐hundred thirty patients (mean age 50.7 ± 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow‐up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri‐procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid‐term follow‐up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04). Conclusion : This multi‐centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo‐embolic events. © 2008 Wiley‐Liss, Inc.     

Transcatheter patent foramen ovale closure for secondary prevention of paradoxical embolic events: Acute results from the FORECAST registry

Patients with patent foramen ovale (PFO) and paradoxical embolism are at increased risk for recurrent events. Percutaneous PFO closure is a new treatment modality aimed at secondary prevention. We report the multicenter experience of interventional closure of PFO using two different devices in 272 patients. The mean age was 51 ± 14.2 years and 52.9% were males. The implantation procedure resulted in an initial complete shunt closure rate of 74.3% with a periprocedural complication rate of 6.6%. There were no deaths or pericardial tamponade. The mean procedure time was less than 44 min under either conscious sedation, local or general anesthesia. This is the largest report to date demonstrating the procedural safety, reliability, and feasibility of the transcatheter PFO closure technique with the STARFlex and CardioSEAL septal implants. Randomized clinical trials are currently in progress to identify patients most likely to benefit from this intervention. Catheter Cardiovasc Interv 2004;62:512–516. © 2004 Wiley‐Liss, Inc.     

Electrocardiographic changes and arrhythmias following percutaneous atrial septal defect and patent foramen ovale device closure

Objectives: To compare pre‐ and post‐procedure electrocardiograms (ECGs) in a large cohort of patients after percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO). Background: Percutaneous device closure of ASD or PFO is commonplace. Conduction and rhythm anomalies associated with percutaneous device placement have been reported. Methods: We reviewed records for all patients who underwent percutaneous device closure of ASD or PFO at our institution from 1999 to 2008. Pre‐procedure ECG and Holter studies were compared to available short term (<2 months after placement) and intermediate follow‐up (>2 months) ECG or Holter. Results: Pre‐ and post‐procedural ECGs were available in 610 patients (305 females, average age 50 ± 18.1 years, range 1–91 years, 384 PFO, 184 ASD, 42 with multiple defects, mean device size 16 mm, range 5–38 mm). We report an incidence of 5.2% (32/610) of arrhythmias in the 4 months following device placement, including 29 patients with atrial tachyarrhythmias (ATs, 22 fibrillation, 7 flutter), 1 with junctional tachycardia, and 2 with heart block. Among other findings, the average P‐wave duration was increased on intermediate follow‐up as compared to early follow‐up (P < 0.001). Development of new‐onset 1st degree AV Block after the procedure was associated with an increased risk of ATs post‐procedure (P < 0.0001). Conclusion: We report a low risk of clinically significant post‐procedure arrhythmias after device placement. Clinically significant heart block occurred in only two patients (0.3%). Changes in several markers of atrial conduction were found, suggesting an effect of device closure on intra‐atrial conduction. © 2011 Wiley‐Liss, Inc.     

A suture not always the ideal solution: Problems encountered in developing a suture‐based PFO closure technique

Objectives: To summarize our experiences with the first‐in‐man suture‐based patent foramen ovale (PFO) closure technique. Background: PFO is often present with the occurrence of cryptogenic stroke and migraine with aura. Successful PFO closure can be performed percutaneously using catheter techniques with many different closure devices. The described novel closure system is intended to deliver, via endovascular access, a suture into the atrial septal wall tissue for closure of PFO. Methods: Eleven patients, between 22 and 58 years of age (mean 46.6 ± 9.6), who had a cryptogenic ischemic stroke, TIA, or a peripheral embolism and a PFO were considered for percutaneous closure with this technique. Results: The mean stretched diameter of the defect evaluated during balloon sizing was 8.8 ± 0.4 mm (range 7–12.5). Delivery of the suture was successful in all patients. No intraprocedural complications occurred. During the follow up, complete closure could be achieved in one patient. Six patients with significant residual shunting during follow‐up had successful closure using a conventional device. One patient was lost for follow‐up after the 3‐month visit. The residual shunt in the remaining three patients was very small and they declined to be treated with a conventional device. No complications occurred during the follow up. Conclusions: Transcatheter application of a suture for closure of PFO is technically feasible and safe. However, despite successful suturing of the septum primum to the septum secundum, the PFO did not close in most of the patients. © 2008 Wiley‐Liss, Inc.     

Intracardiac echo-guided radiofrequency catheter ablation of atrial fibrillation in patients with atrial septal defect or patent foramen ovale repair: a feasibility, safety, and efficacy study

Introduction: Patients with atrial septal defect (ASD) are at higher risk for atrial fibrillation (AF) even after repair. Transseptal access in these patients is perceived to be difficult. We describe the feasibility, safety, and efficacy of pulmonary vein antral isolation (PVAI) in these patients. Method: We prospectively compared post‐ASD/patent foramen ovale (PFO) repair patients (group I, n = 45) with age‐gender‐AF type matched controls (group II, n = 45). All the patients underwent PVAI through a double transseptal puncture with a roving circular mapping catheter technique guided by intracardiac echocardiography (ICE). The short‐term (3 months) and long‐term (12 month) failure rates were assessed. Results: In group I, 23 (51%) had percutaneous closure devices and 22 (49%) had a surgical closure. There was no significant difference between group I and II in the baseline characteristics. Intracardiac echo‐guided double transseptal access was obtained in 98% of patients in group I and in 100% of patients in group II. PVAI was performed in all patients, with right atrial flutter ablation in 7 patients in group I and in 4 patients in group II. Over a mean follow‐up of 15 ± 4 months, group I had higher short‐term (18% vs 13%, P = 0.77) and long‐term recurrence (24% vs 18%, P = 0.6) than group II. There was no significant difference in the perioperative complications between the two groups. Echocardiography at 3 months showed interatrial communication in 2 patients in group I and 1 patient in group II, which resolved at 12 months. Conclusion: Percutaneous AF ablation using double transseptal access is feasible, safe, and efficacious in patients with ASD and PFO repairs.     

Percutaneous atrial shunt closure using the novel Occlutech Figulla device: 6-month efficacy and safety

Background: The Occlutech Figulla Occluder is a new innovative device for percutaneous closure of a patent foramen ovale (PFO) and an atrial septum defect (ASD). We describe the safety and efficacy of this new device at 6‐month follow‐up. Methods: All 82 consecutive patients (51% female, mean age 49.0 ± 13.6 years) who underwent percutaneous PFO (n = 48) or ASD (n = 34) closure between October 2008 and October 2009 were included. Results: Implantation success was 100%. The in‐hospital complications were two new onset supraventricular tachycardia (SVT) (2.4%, both ASD patients), nine minimal groin hematoma's (11.0%, 4 PFO and 5 ASD patients), and one transient ST elevation during the procedure (1.2%, ASD patient). During 6 months follow‐up (n = 79), no major complications or reoccurrences of cerebral thrombo‐embolic events did occur. Seven patients (8.9%, 6 PFO and 1 ASD patient) experienced a new SVT. One patient developed a recurrent cerebral hemorrhage 5 months after ASD closure, which appeared not to be related to the procedure. Using contrast transthoracic echocardiography 6 months after PFO closure (n = 45), a residual shunt was present in 30.2% of the patients (small 25.6%, moderate 4.6%, severe 0%). In the ASD group (n = 34), a residual shunt was observed in 32.5% (small 17.7%, moderate 14.7%, severe 2.9%). Conclusion: The Occlutech Figulla Occluder appears to be easy to use, effective, and safe for percutaneous closure of PFO and ASD. We report a low complication rate but a relative high percentage of small residual shunts 6 months after closure. (J Interven Cardiol 2011;24:264–270)     

Percutaneous closure of patent foramen ovale for migraine headaches refractory to medical treatment

Background : Patent foramen ovale (PFO) has been linked to migraine, and several retrospective studies reported an improvement in migraine prevalence or frequency after PFO closure for other reasons, mostly for secondary prevention of paradoxical embolism or following diving accidents. We investigated the outcome of patients undergoing PFO closure solely for migraine headaches refractory to medical treatment. Methods : Seventeen patients (age 44 ± 12 years; 76% female; one atrial septal aneurysm) underwent percutaneous PFO closure using the Amplatzer PFO Occluder (AGA Medical Corporation, Golden Valley, MN). An 18‐mm device was used in two patients, a 25‐mm device in 13, and a 35‐mm device in two. The interventions were solely guided by fluoroscopy, without intraprocedural echocardiography. Results : All implantation procedures were successful. There were no peri‐procedural complications. Contrast transesophageal echocardiography after Valsalva maneuver at 6 months showed complete PFO closure in 16 patients (94%), whereas a minimal residual shunt persisted in one (6%). During 2.7 ± 1.5 years of follow‐up, no deaths and no embolic events occurred. After PFO closure, migraine headaches disappeared in four patients (24%), and improved in eight additional patients (47%). Three patients (18%) reported a decrease of their headaches by 75%, three patients (18%) a decrease of 50%, and two patients (12%) a decrease of 25%, while headaches remained unchanged in five patients (29%). No patient experienced worsening headaches. Moreover, the prevalence of migraine with aura decreased from 82 to 24% (P = 0.002). Conclusions : These results suggest that percutaneous PFO closure durably alters the spontaneous course of shunt associated migraine. © 2009 Wiley‐Liss, Inc.     

Transcatheter Interatrial Shunt Closure as a Cure for Migraine: Can it be Justified by Paradoxical Embolism—Risk-Driven Criteria?

BackgroundSome ongoing trials have suggested that closure of the patent foramen ovale (PFO) may reduce migraine symptoms. We sought to assess the safety and effectiveness of migraine treatment by means of PFO transcatheter closure using paradoxical embolism risk-driven criteria.MethodsWe enrolled 75 patients (48 women and 27 men, mean age 40 ± 3.7 years) who were referred to our center over a 12-month period for a prospective study to evaluate severe disabling migraine, despite antiheadache therapy and the PFO. Migraine Disability Assessment Score (MIDAS) was used to assess the incidence of migraine headache and severity. Criteria for intervention included all of the following: basal shunt, curtain shunt pattern on transcranial Doppler, presence of interatrial septal aneurysm, 3 to 4 class MIDAS score, symptomatic significant aura, coagulation abnormalities, migraine refractory to conventional drugs.ResultsOn the basis of the inclusion criteria, we shortlisted 20 patients (12 women, mean age 35 ± 6.7 years, mean MIDAS score 38.9 ± 5.8) for transcatheter closure of PFO and excluded the rest who were referred to the neurologist for medical therapy. The procedure was successful in all of the patients with no perioperative or in-hospital complications. After a mean follow-up of 10 ± 3.1 months (range 6–14), all patients’ migraine symptoms improved (mean MIDAS score 3.0 ± 2.1, P < 0.03) with PFO complete closure in all patients on transesophageal and transcranial Doppler ultrasound.ConclusionIn this small pilot series, we adopted the criteria which in our opinion best reflected the risk of paradoxical embolism in these patients. By adopting the proposed criteria, primary transcatheter closure of the PFO resulted in a significant reduction in migraine.     

Transcatheter Closure of Patent Foramen Ovale (PFO) in Patients with Paradoxical Embolism: Procedural and Follow‐Up Results after Implantation of the Amplatzer®‐Occluder Device

Background: Prevalence of patent foramen ovale (PFO) with detectable right‐to‐left shunt is higher in young adults with transient ischemic attack (TIA) and stroke compared to the general population. So far, published series included different occluder systems, various indications and regimens of postprocedural anticoagulation. In our experience, occluder systems may be associated with an increased prevalence of thrombus formation, which has also reported by other groups. The aim of the present study was to evaluate the follow‐up results after implantation of the Amplatzer® occluder in patients with PFO using a consistent anticoagulation regimen. Methods and Results: One‐hundred and fourteen patients with PFO (60 men; age: 47 ± 13 years) and ≥1 thromboembolic event were included. Other causes for embolism were excluded. PFO‐closure was successful in all patients. All patients were treated with aspirin (100 mg/day) and clopidogrel (75 mg/day) for 6 months. TEE was repeated at a mean of 10.3 months. Mean clinical follow‐up period was 18 ± 9 months. After a mean of 10 months, no patient had either a significant residual shunt nor a suspected thrombus formation on the occluder. During follow‐up, 5 patients suffered from neurological events (1 stroke, 2 TIAs, 2 epileptic seizures), though complete closure of the PFO was documented by TEE. One patient suffered from bleeding complications (upper GI‐bleeding). Conclusion: Percutaneous closure of PFO in symptomatic patients by Amplatzer® occluder represents an effective therapy with a low incidence of peri‐interventional complications and recurrent thromboembolism. Thrombus formations on the occluder system were not detected in this cohort. (J Interven Cardiol 2011;24:85–91)     

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.     

Pulmonary function changes in children after transcatheter closure of atrial septal defect

This study was performed to assess changes in pulmonary function test (PFT) and pulmonary outcome after transcatheter closure of atrial septal defect (ASD) in pediatric patients. A total 55 pediatric patients undergoing transcatheter ASD closure received PFT at baseline (day before ASD closure), and at 3 days and 6 months after procedure. Forced vital capacity (FVC), forced expired volume in 1 sec (FEV₁), FEV₁ to FVC ratio (FEV₁/FVC), peak expiratory flow (PEF), and mean forced expiratory flow during the middle half of FVC (FEF_25–75) were measured. Individually, subjects were classified by spirometry as normal, obstructive or restrictive, to evaluate the effect of transcatheter closure on pulmonary outcome. These 55 children had significantly reduced mean PEF and FEF_25–75 (84 ± 24%, P = 0.040 and 76 ± 22%, P = 0.010, respectively) at baseline, with FEF_25–75 reduced significantly at 3 days and 6 months (78 ± 24%, P = 0.010 and 81 ± 24%, P = 0.040, respectively) after transcatheter closure. Six months after transcatheter closure of ASD, significant improvement was observed in mean FVC (94 ± 19% vs. 98 ± 15%, P = 0.034) and FEV₁ (90 ± 20% vs. 96 ± 19%, P = 0.008). Assessed individually, better pulmonary outcome was found in patients without pulmonary hypertension (PH) (χ² = 8.333, P = 0.044). PFT disturbance was observed in significant flow limitation in the peripheral airway of ASD patients. Improved PFT was found after transcatheter closure and better pulmonary outcome was observed in patients without PH. ASD children need monitoring pulmonary function and should receive transcatheter closure before PH develops. Pediatr Pulmonol. 2009; 44:1025–1032. ©2009 Wiley‐Liss, Inc.