Patent foramen ovale closure in patients with transient ischemia attack/stroke

Paradoxical embolism through a patent foramen ovale (PFO) has been recognized as a potential cause of transient ischemia attack (TIA) and stroke especially in younger patients. The therapeutic options are medical treatment (antiaggregation or anticoagulation) with an annual recurrence rate of 3% to 4% for stroke or TIA, surgical PFO closure, or catheter closure. Randomized studies are ongoing; however, the results will not be available soon. Since August 1994, we have attempted catheter closure of a PFO in 281 patients (age 17 to 79 years, mean 46.8 +/- 13.2) with paradoxical embolism. Of these, 184 patients had at least one embolic stroke, 112 patients at least one TIA, and 15 patients at least one peripheral embolism. The diameter of the PFO, measured with a balloon catheter, ranged from 3 mm to 24 mm with a mean of 10 +/- 3.5 mm. Implantation of the occluder was technically successful in all patients (two attempts in four patients). Seven different devices were used: 26 Sideris buttoned, 11 ASDOS, 19 Angel Wings, 98 PFO-Star, 37 Cardioseal-Starflex, 57 Amplatzer and, 33 Helex devices. One patient suffered from septicemia and subsequently died. In 2 patients, device embolization occurred during or after the procedure (1 Sideris, 1 PFO-Star; catheter retrieval successful). Thirty-seven patients had other minor complications without long-term sequelae: atrial fibrillation within the first weeks after implantation in five patients, asymptomatic thrombus on the device at routine transesophageal echocardiogram (TEE) in 7 patients (1 Angel Wings, 1 ASDOS, 1 CardioSeal, 4 PFO-Star), and device frame fracture in 25 patients (2 Sideris, 4 ASDOS, 1 Angel Wings, 1 CardioSeal, 17 PFO-Star). No complications occurred with the newer devices (Amplatzer and Helex). A residual shunt after 6 months was found in 5.5% of the patients who had completed their 6-month TEE follow-up. In two patients, a second occluder was implanted because of a residual shunt. During a follow-up period of 1 month to 71 months (mean 12 +/- 16 months, 268 patient years), a recurrence of an embolic event (seven TIA, two stroke) occurred in eight patients. None of these occurred with the newer devices (Amplatzer, Helex). Freedom from recurrence of the combined end point of TIA, ischemic stroke, and peripheral embolism was 95.7% (95% CI: 89.0%-98.4%) at 1 year and 94.1% (95% CI: 80.1-98.4%) at 3 years. Catheter PFO closure is a technically simple procedure. With the newer devices and increasing experience, the success rate has improved and the complication rate has decreased. The advantage of the procedure is that closing the defect means a causal treatment. However, catheter closure of PFO despite a very low morbidity has inherent potential risks like any other interventional procedure. Furthermore, selection of patients who definitely have PFO as the cause of their cerebral event has not been defined. For these reasons, further studies are warranted.     

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.     

Closure of patent foramen ovale for paradoxical emboli: intermediate-term risk of recurrent neurological events following transcatheter device placement

OBJECTIVES: We report the largest and the longest follow-up to date of patients who underwent transcatheter patent foramen ovale (PFO) closure for paradoxical embolism. BACKGROUND: Closure of a PFO has been proposed as an alternative to anticoagulation in patients with presumed paradoxical emboli. METHODS: Data were collected for patients following PFO closure with the Clamshell, CardioSEAL or Buttoned Devices at two institutions. RESULTS: There were 63 patients (46 +/- 18 years) with a follow-up of 2.6 +/- 2.4 years. Fifty-four (86%) had effective closure of the foramen ovale (trivial or no residual shunt by echocardiography) while seven (11%) had mild and two (3%) had moderate residual shunting. There were four deaths (leukemia, pulmonary embolism, sepsis following a hip fracture and lung cancer). There were four recurrent embolic neurological events following device placement: one stroke and three transient events. The stroke occurred in a 56-year-old patient six months following device placement. A follow-up transesophageal echocardiogram showed a well seated device without residual shunting. Two of the four events were associated with suboptimal device performance (one patient had a significant residual shunt and a second patient had a "friction lesion" in the left atrial wall associated with a displaced fractured device arm). The risk of recurrent stroke or transient neurological event following device placement was 3.2% per year for all patients. CONCLUSION: Transcatheter closure of PFO is an alternative therapy for paradoxical emboli in selected patients. Improved device performance may reduce the risk of recurrent neurological events. Further studies are needed to identify patients most likely to benefit from this intervention.     

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 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.     

Patent foramen ovale using the Premere device: the results of the CLOSEUP trial

OBJECTIVES: The CLOSEUP trial was conducted to determine the safety and effectiveness of the Premere closure device in closure of patent foramen ovale (PFO). BACKGROUND: PFO is a relatively common congenital condition, associated with cryptogenic stroke and migraine with aura. The Premere device is specifically designed to close PFO of variable size and length, with right and left anchor arms connected by a flexible tether. The device has an open architecture, a low profile, and a small surface area on the left atrial side which may discourage thrombus formation. METHODS: Patients between 18 and 65 years of age who had a cryptogenic ischemic stroke or a transient ischemic attack and a PFO underwent percutaneous PFO closure using the Premere device. RESULTS: Of the 73 enrolled patients, six patients had atrial anatomy not appropriate for the Premere; 27 patients received the 15 mm and 40 patients received the 20 mm device. Implantation was successful in all patients. At 6 months of follow-up, 86% of patients had no shunt that could be provoked with Valsalva as assessed during contrast echocardiography. Closure rates were better with the 20 mm versus the 15 mm device, and three patients with residual shunt had atrial septal aneurysms at baseline. One patient had transient atrial fibrillation which resolved by 3 months. There were no instances of thrombus, death, or stroke. CONCLUSIONS: These data demonstrate that the Premere device can safely and effectively close PFO. Additional studies should be undertaken to demonstrate the effectiveness of PFO closure in reducing thrombo-embolic events such as stroke.     

Catheter closure of the persistent foramen ovale: mid-term results in 162 patients

Four different types of occluder systems were used to close a persistent foramen ovale (PFO) in 162 patients with paradoxical embolic events. Ninety-eight patients had ischemic stroke, 60 transient ischemic attacks (TIA) or prolonged reversible ischemic neurological deficit (PRIND), and 4 had peripheral arterial embolism. The age of the patients was 40.2 +/- 11.9 years and the ischemic event had happened 7 +/- 10 months before device closure. CardioSeal and Amplatzer occluders were the most commonly used devices (73 and 77 cases, respectively). Implantations were successful in all patients. Serious catheter-related complications included two device embolizations and two venous bleedings. Six patients had documented supraventricular arrhythmias within the first month after implantation, which disappeared spontaneously within some weeks without therapy in three patients; the other three patients with atrial fibrillation needed conversion to sinus rhythm. Residual leaks were found in 5 out of 116 patients who had been followed by transesophageal echocardiography (TEE) and one leak was closed by a second device. During a follow-up period of 19.4 +/- 16.2 months per patient, TIA and PRIND occurred in 3 of 116 patients. Interventional closure of PFO is a simple, effective and quick method that is superior to surgery and avoids the problems of life-long anticoagulation.     

Interventional occlusion of foramen ovale and atrial septal defects after paradoxical embolism incidents

Two hundred and fifty-one patients with a persistent foramen ovale (PFO), mean age 43.3 +/- 12.4 years, underwent catheter closure between 6/1995 and 6/2001. One hundred and forty-one had an ischemic stroke, 99 a transient ischemic attack (TIA) or prolonged reversible ischemic neurologic deficit, 5 peripheral arterial embolism, 4 suffered from decompression sickness after diving and 2 had transient global amnesia. Fifty-nine of them had multiple events in spite of antiplatelet or anticoagulant therapy. The patients received five different devices: 13 Rashkind Occluders, 20 Amplatzer septal Occluders, 109 Amplatzer PFO-Occluders, 73 CardioSEAL and 36 STAR-Flex devices. Time of fluoroscopy was 8.3 +/- 4.5 min. In three patients a device embolized and had to be removed from the groin vessels. We saw five inguinal or retroperitoneal venous hematomas with the need for operation in one patient. One early and one late perforation of the left atrium caused by a guide wire and a left-atrial disc, respectively, also needed surgery. Fourteen patients had documented late arrhythmias. Six patients with atrial fibrillation needed drugs or cardioversion while the other patients with runs of supraventricular tachycardia, atrial flutter and multiple extrasystoles needed no therapy. On transesophageal echocardiography (TEE) 6 months after implantation we found four significant residual leaks. These patients had the defect closed with a second device. In addition a secundum atrial septal defect (ASD) was closed in 17 patients (mean age 38 +/- 10.5 years) with Amplatzer septal Occluders (12) and CardioSEAL devices (5). These patients had experienced eight strokes and nine TIAs, 3 of them had had multiple events. Two of these patients had a significant residual defect and one had atrial flutter following the procedure. Two hundred and two PFO-patients and 12 ASD patients were followed for 6-62 (24.6 +/- 14.2) months; 2 died due to a traffic accident and a myocardial infarction, respectively. Four patients had another neurologic event following PFO-closure. We now overlook 210 patients with 348.6 symptom-free patient years and have a 1-year recurrence rate of neurologic events of 1.9%. Catheter closure of the PFO and atrial septal defect is a simple, effective and quick method which ensures a high closure rate, avoids life-long anticoagulation and has a low recurrence rate of neurologic events.     

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.     

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.     

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.     

Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder)

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3+/-1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder.     

Percutaneous PFO Closure with Amplatzer PFO Occluder: Predictors of Residual Shunts at 6 Months Follow‐up

Objective. The objective of this study was to assess predictors of residual shunts after percutaneous patent foramen ovale (PFO) closure with Amplatzer PFO occluder (AGA Medical Corporation, Golden Valley, MN, USA). Methods. All percutaneous PFO closures, using Amplatzer PFO occluder performed at a tertiary center between May 2002 and August 2006, were reviewed. Follow‐up, including saline contrast transesophageal echocardiography, was performed in all patients 6 months after the intervention. Patients. A total of 135 procedures were performed. Mean age of the patients was 51 years. The indication for PFO closure was an ischemic cerebrovascular event in 92%, paradoxical systemic embolism in 4%, and a diving accident in 4%. Recurrent events prior to PFO closure were noted in 34%. A concomitant atrial septal aneurysm was present in 61%. Results. At 6 months follow‐up, a residual shunt was detected in 26 patients (19%). Residual shunts were more common in patients with an atrial septal aneurysm (27 vs. 8%, P= .01) and in patients treated with a 35‐mm compared with a 25‐mm device (39 vs. 15%, P= .01). A concomitant atrial septal aneurysm remained independently associated with residual shunts when controlled for body mass index, gender, age, atrial dimensions, and presence of a Chiari network (odds ratio 4.1, 95% confidence intervals 1.1–15.0). Conclusion. The presence of atrial septal aneurysms in patients undergoing percutaneous PFO closure with an Amplatzer PFO occluder significantly increases the rate of residual shunts at 6 months follow‐up, even if 35‐mm devices are used.     

Transcatheter closure as standard treatment for most interatrial defects: experience in 200 patients treated with the Amplatzer Septal Occluder.

To judge whether an Amplatzer Septal Occluder can be used as standard therapy instead of surgery for closure of atrial septal defects we report our experiences in 200 patients. Of these patients, 127 had an atrial septal defect with haemodynamically significant left-to-right shunt, 68 patients a persistent oval foramen after presumed paradoxical embolism, and 5 had a fenestration after Fontan-repair. Mean age was 29.8 years (0.8 to 77.7 years). Body weight ranged from 6.9 to 120.0 kg (mean 51.5 kg). After diagnostic cardiac catheterization, and balloon-sizing of the defect, we implanted Amplatzer Septal Occluders with stents of 4 to 28 mm diameter. Follow-up studies were obtained after 48 hours, and one, six, and twelve months. Transcatheter closure of the atrial septal defect proved successful in all without any relevant residual shunts. In particular, complete closure was achieved in all patients after presumed paradoxical embolism. The mean period of follow-up is 9.5 months, with a range from 0.4 to 23.5 months, giving a total of 1898 patient months. The occlusion rate after three month was 98.1%. A trivial haemodynamically insignificant residual shunt remained in 1.9% of the patients. Fluoroscopy times ranged from 0 to 43.5 minutes, with a median of 8.7 minutes. The excellent results in the short and medium term in children and adults have resulted in using this device routinely at the present time for closure of central atrial septal defects up to a diameter of 28 mm. Final judgement, however, is only possible after long-term follow-up.     

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.     

Transcatheter treatment of atrial septal aneurysm associated with patent foramen ovale for prevention of recurrent paradoxical embolism in high-risk patients

OBJECTIVES: This study sought to investigate the safety and efficacy of transcatheter treatment of atrial septal aneurysm (ASA) associated with patent foramen ovale (PFO). BACKGROUND: Patients with both ASA and PFO are at high risk for recurrent paradoxical embolism. METHODS: The procedural, echocardiographic, and clinical outcomes of 141 patients with ASA + PFO and > or =1 paradoxical embolic event undergoing transcatheter treatment were compared with 220 patients with PFO alone. RESULTS: Device success (ASA + PFO, 99.3%; PFO alone, 99.5%; p = 0.75) and procedural complications (ASA + PFO, 0.7%; PFO alone, 3.2%; p = 0.12) were similar in both groups. Maximal atrial septal excursion in patients with ASA + PFO decreased from 16 +/- 4 mm before to 4 +/- 3 mm after the intervention (p < 0.0001). At 6 months follow-up, right-to-left shunt was abolished in 120 (86%) patients with ASA + PFO, compared to 187 (85%) patients with PFO alone (p = 0.80). Freedom from recurrent transient ischemic attack, stroke, and peripheral embolism at 4 years was 95% (ASA + PFO) and 94% (PFO alone, p = 0.70), respectively. A residual right-to-left shunt after the intervention was the only predictor for recurrence (hazard ratio [HR] 6.9; 95% confidence interval [CI] 1.3 to 36.9, p < 0.03) in patients with ASA + PFO. CONCLUSIONS: Transcatheter treatment of ASA + PFO is safe and effective in patients with paradoxical embolism. The procedure effectively abolishes right-to-left shunt and decreases atrial septal mobility. Long-term prevention of recurrent events appears favorable when compared to patients with PFO alone.     

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.     

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.     

Transcatheter closure of interatrial communications for secondary prevention of paradoxical embolism: single-center experience

BACKGROUND: Patients with a patent foramen ovale (PFO) after cerebral, coronary, or systemic embolic events of presumed paradoxical origin are at risk for recurrent thromboembolism. We report our single-center experience of interventional closure of interatrial communications for secondary prevention of presumed paradoxical embolism. Methods and Results- Since 1997, percutaneous closure of interatrial communications was performed at our institution in 66 patients (mean age 47.8+/-12.7 years; 31 males) with a PFO or an atrial septal defect and at least 1 documented presumed paradoxical thromboembolic event. Fifty-eight patients had cerebral embolism, 10 had coronary embolism, and 3 had peripheral embolism. Several patients experienced multilocal arterial embolism. Fifty-four patients had a PFO, 33 of them with an atrial septal aneurysm, and 12 had an atrial septal defect. The implantation procedure was successful and without complication in all patients. After 3 months, only 2 patients showed a residual shunt, which disappeared in both cases after 12 months. In 112.2 patient-years of follow-up (range, 5 weeks to 3.5 years), we have not seen any recurrent thromboembolic event. CONCLUSIONS: Interventional closure of interatrial communications is a safe and effective therapeutic option for the secondary prevention of presumed paradoxical embolism. To further evaluate this strategy, randomized trials comparing interventional closure with anticoagulation have been initiated by us and others.     

Incidence of extracerebral paradoxical embolisms in patients with intracardiac shunts

BACKGROUND: Although extracerebral embolism accounts for 5-10% of all paradoxical embolisms, it still remains a ghostlike entity in cardiovascular pathophysiology. The aim of this brief report was to analyze the profile of patients with paradoxical extracerebral embolism and intracardiac shunts, and the role of shunt closure on the recurrence of extracerebral paradoxical embolism (EPE) in a population of patients evaluated for patent foramen ovale (PFO)/atrial septal defect (ASD) transcatheter closure. METHODS: From July 2003 to December 2006, 150 patients (mean age 51.4+/-15.1 years, range13-78 years, M/F=49/101) were planned for transcatheter closure of PFO/ASD at our institutional program of Adult Congenital Heart Disease Management. Clinical history and medical records of all patients were reviewed searching for association of PFO/ASD, stroke, and presumptive EPE. RESULTS: Association of PFO with presumptive EPE was found in nine patients (6%, mean age 40.1+/-14 years, M/F=3/6). Five patients had ST-elevation myocardial infarction (mean value of troponin was 15.3+/-2.1 ng/ml), while four patients had inferior limb acute ischemia. In patients with coronary embolism, coronary angiography was performed immediately after chest pain onset revealing normal coronary artery and only a mild hypokinesia. In patients with peripheral acute ischemia, early (>4 h from symptoms onset) angiography demonstrated normal main peripheral vessel and an embolic closure of popliteal artery (one patient), distal tibial artery (two patients), or peroneal artery (one patient) that normalized with heparin therapy in a few hours except in one patient. Migraine with aura was present in seven of nine patients. Cerebral MRI revealed previous ischemic areas in four of nine patients. Coagulation disorders were detected in six of nine patients. Echocardiography demonstrated a large to medium PFO in seven patients and a cribrosus ASD in two patients. CONCLUSION: Although a large study is required to assess optimal diagnosis and clinical implications of EPE, the clinical profile emerging from our study may help to identify some easy criteria of diagnosis in order to improve diagnosis and decrease the recurrence of such probably underestimated manifestations of PFO/ASD.