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.     

Left atrial dysfunction in elderly patients with patent foramen ovale and atrial septal aneurysm

Objective Recently it has been suggested that, in patients with large patent foramen ovale （PFO） and atrial septal aneurysms （ASA）, a certain amount of left atrial （LA） dysfunction may be active as an alternate mechanism promoting arterial embolism. Following this hypothesis, elderly patients, being more susceptible to atrial chambers stiffness, should present a more severe LA dysfunction profile. We sought to evaluate the grade of LA dysfunction in elderly patients submitted to transcatheter PFO closure. Methods We retrospectively enrolled 28 consecutive patients with previous stroke （mean age 674-12.5 years, 18 females） referred to our centre for catheter-based PFO closure after recurrent stroke. Baseline values of LA passive and active emptying, LA conduit function, LA ejection fraction, and spontaneous echocontrast （SEC） in the LA and LA appendage were compared with those of 50 atrial fibrillation patients, as well as a sex/age/cardiac risk matched population of 70 healthy controls. Results Pre-closure elderly subjects demonstrated significantly greater reservoir function as well as passive and active emptying, with reduced conduit function and LA ejection fraction, when compared to healthy and younger patients. After closure in elderly patients, LAparameters did not return completely to the levels of healthy patients, whereas LA dysfunction in younger subjects returned normal. Conclusions This study suggests that elderly patients have more severe LA dysfunction than younger patients, which affects the LA remodelling after closure.     

Catheter closure of perforated secundum atrial septal defect under intracardiac echocardiographic guidance using a single amplatzer device: feasibility of a new method

OBJECTIVES: Little is known about the feasibility and effectiveness of perforated secundum atrial septal defects (ASDs) transcatheter closure. This study tested whether this type of fenestration can be percutaneously closed using a single Amplatzer PFO or Cribriform Occluder device in a patch-like fashion under intracardiac echocardiographic (ICE) guidance and monitoring. METHODS: Twenty-four adult patients with perforated ASDs underwent transcatheter single Amplatzer PFO or Cribriform Occluder device closure by using ICE as the primary imaging tool, both for crossing the flap valve and monitoring each stage of the procedure. The entire atrial septum and fossa ovalis end diastolic dimensions on 2 orthogonal ICE planes, as well as the distance between the eccentric guidewire passage and the more adjacent rim of the fossa ovalis on the longitudinal ICE plane, have been measured. RESULTS: On the basis of the ICE fossa ovalis size and its geometric evaluation, in order to completely cover the fossa ovalis with a single device, 2 Amplatzer PFO Occluders 25 mm, 9 Amplatzer PFO Occluders 35 mm, and 13 Amplatzer Cribriform Occluders (four 25 mm and nine 35 mm) have been implanted successfully. During follow-up (31.4, 7.2 months), complete closure by contrast echo color Doppler occurred in 16/24 (67%) patients after 24 hours, 19/24 (79%) after 1 mouth, 20/24 (83%) after 3 months, 22/24 (92%) after 1 year, and 23/24 (96%) after 2 years. CONCLUSIONS: Transcatheter closure of perforated ASDs using a single Amplatzer Occluder device under ICE guidance appears to be a suitable procedure, providing a low rate of residual shunting.     

Long‐Term Outcomes and Complications of Intracardiac Echocardiography‐Assisted Patent Foramen Ovale Closure in 1,000 Consecutive Patients

Backgrounds

Long‐term fate of patients submitted to patent foramen ovale (PFO) closure is still unclear. The aim of the study was to evaluate the incidence of atrial fibrillation (AF), aortic or atrial free wall erosion, device thrombosis (DT), new onset or worsening of mitral valve regurgitation (MVR), and recurrent cerebral ischemic events in the long‐term follow up after intracardiac echocardiography (ICE)—aided PFO closure in a large population.

Methods

We reviewed the medical and instrumental data of 1,000 consecutive patients (mean age 47.3 ± 17.1 years, females) prospectively enrolled in 2 centres over a 13 years period (February 1999–February 2012) for R‐to‐L shunt ICE‐aided catheter‐based closure using different devices.

Results

Immediate success was 99.8%. Implanted devices were Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). On a mean follow‐up of 12.3 ± 0.6 years (minimum 4‐ maximum 17 years), permanent AF occurred in 0.5%, DT was apparent in 0.5%, new onset or worsening of MVR was observed in 0.2%, whereas recurrent cerebral ischemic events were 0.8%. Occlusion rate was 93.8%. No aortic or atrial free wall erosion has been observed.

Conclusion

ICE‐aided closure of PFO using different devices, appeared very safe and effective on very long‐term follow up with low incidence of erosion, DT, recurrent ischemic events, MVR new onset or worsening, and permanent AF.

     

Patent foramen ovale closure in over-60-years old patients with diastolic dysfunction

Background Patent foramen ovale (PFO)-related stroke is a possible and not easily manageable occurrence in ≤60-years-old patients due to the presence of different comorbidities and in particular of diastolic dysfunction which is considered as a contraindication to PFO closure.The grade of diastolic dysfunction for which PFO closure is contraindicated and whether there are changes in diastolic dysfunction class after closure have not been investigated in deep yet.Methods We prospectively enrolled patients who were referred to our centre over a 12 months period for PFO transcatheter closure having echocardiographic demonstration of diastolic dysfunction (≤Ⅲ class diastolic dysfunction).Echocardiography was scheduled at 1,6 and 12 months in order to assess changes in haemodynamic parameters of left ventricle function.Results Thirteen out of 80 patients referred to our centre (16.2%,mean age 65 + 6.4 years) over a 24-month period were enrolled in the study (Table 1).Eighteen Amplatzer PFO Occluder 25 mm and one 35 mm,two Amplatzer 25/25 mm Cribriform Occluder and two 25 nun Premere Occlusion System were successfully implanted with no intraoperative complications.As collateral findings on ICE 8/12 patients (66.7 %) had hypertrophy of the interatrial septum (thickness of the rims ＞ 1.2 mm) probably imputable to hypertensive cardiomyopathy.Four patients developed atrial fibrillation during the first month post-implantation,all successfully treated with antiarrhythmic drugs.After a mean follow-up of 40±4.3 months left ventricle performance indices (ejection fraction and end-diastolic volume) and diastolic dysfunction parameters (E/A,deceleration time,diastolic dysfunction class) did not change significantly.Conclusion The present study suggests that PFO transcatheter closure may be safely performed in aged patients with diastolic dysfunction class 1-2.(J Geriatr Cardio12008;5:3-6.)     

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)     

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)     

Percutaneous catheter closure of atrial septal defect. Short-term and mid-term results

INTRODUCTION: Percutaneous closure of atrial septal defects (ASD) is becoming more frequent. PATIENTS AND METHOD: From October 1997 to October 2002, 209 patients, age 0.4-70 (mean 19.5) years, were catheterized to close an ASD or patent foramen ovale (PFO). Transesophageal echocardiography was performed simultaneously in all patients. Two hundred and six patients had ASD (25 multiple ASDs) and 3 had PFO. Three devices were used, the Amplatzer Atrial Septal Occluder (ASO), CardioSeal (CS), and Starflex (SF). RESULTS: Device implantation was achieved in 181 patients (87%) but had to be abandoned in 28 patients, generally because the ASD was too large. One hundred and seventy-four ASOs were implanted in 172 patients with ASD (2 ASOs were implanted in 2 patients with double ASD) and CS/SF in 9 patients (3 patients with PFO and 6 with ASD). The procedure was effective in 166/172 (96%) ASO implantations and in 8/9 (89%) CS/SF implantations. The procedure was unsuccessful in 7 patients and the device had to be removed (6 ASO and 1 SF). The occlusion rate with ASO was 88% after 24 hours, 91% after 1 month, 95% after 1 year, 97% after 2 years, and 100% after 4 and 5 years. All defects treated with SF/CS were closed successfully after 24 hours. In one case the ASO device was embolized to the aorta. In the first month after ASO implantation, supraventricular tachycardia appeared in 2 patients and transient left ventricular failure in 2 patients. No late complications were observed. CONCLUSION: Percutaneous catheter closure of selected types of ASD using the Amplatzer Atrial Septal Occluder, CardioSeal, or Starflex should be offered to patients as non-surgical alternative. The type of device used depends on the defect size and morphology as well as the surgeon's experience. The presence of multiple defects does not exclude the possibility of a successful percutaneous catheter closure.     

Percutaneous closure of patent foramen ovale: “Closed” door after the lastrandomized trials?简

Patent foramen ovale (PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials (CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them (PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one (CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure (1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed (1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reduce the risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.     

Long‐Term Contrast Echocardiography and Clinical Follow‐Up after Percutaneous Closure of Patent Foramen Ovale Using Two Different Atrial Septal Occluder Devices

Introduction

Percutaneous patent foramen ovale (PFO) closure by means of a septal occluder device (SOD) is a well‐known therapeutic strategy for the secondary prevention of paradoxical embolic neurological events. The aim of this study was to provide long‐term echocardiographic and clinical follow‐up data on patients who had undergone percutaneous PFO closure with 2 different SOD.

Methods

We selected 2 groups of patients treated with 2 different SOD: Group A: 52 patients with an Amplatzer^® PFO Occluder and Group B: 49 patients with a Figulla Flex^® device. All patients underwent follow‐up Bubble Test Transthoracic Echocardiography (BTTE) and clinical examination. The results were compared with those recently reported in a group of patients with similar characteristics, but that had been treated conservatively, which acted as a control group.

Results

The mean follow‐up after PFO closure was 53 months. The Amplatzer^® PFO Occluder and the Figulla Flex were used in 52 (51.5%) and 49 (48.5%) of patients, respectively. We found no significant difference in the rate of effective PFO closure between the devices: Amplatzer 91.4%, Figulla 93.9% (P = 0.71). One patient (1.0%) suffered a recurrent neurologic event. BTTE was positive (BTTE+) in 8 patients (8%), 5 with an Amplatzer, and 3 with a Figulla device (P = 0.516). Only 1 patient with BTTE+ had a recurrent TIA (12.5%). No significant relationship was found between device dimensions and BTTE+ (P = 0.062). In the control group (163 patients), the recurrence of neurologic events was 9.2% (15 events), that was significantly higher in respect to the patients who had undergone percutaneous closure of the PFO.

Conclusions

Percutaneous PFO closure was associated with a remarkably low risk of recurrent embolic neurological events, and no long‐term device‐related major complications. No statistically significant difference emerged between the 2 different SODs regarding BTTE positivity. Long‐term follow‐up showed that the recurrence of neurological events has been significantly higher in the group treated in a conservative way.

     

Figulla ASD Occluder versus Amplatzer Septal Occluder: A Comparative Study on Validation of a Novel Device for Percutaneous Closure of Atrial Septal Defects

Objectives: Occlutech Figulla ASD Occluder (FSO) is an alternative device to Amplatzer Septal Occluder (ASO) with some structural innovations including increased flexibility, minimizing the amount of material implanted, and absence of the left atrial clamp. We aimed to report our experiences with FSO and compare the outcomes of this novel device versus ASO. Interventions: Between December 2005 and February 2009, 75 patients diagnosed with secundum atrial septal defects underwent transcatheter closure. The FSO device was used in 33 patients, and the ASO was used in 42. Results: Patient characteristics, stretch size of the defect, device left disc size, procedure, and fluoroscopy time were similar between the groups. However, the difference between device waist size and stretched diameter of the defect was significantly higher, and device delivery sheath was significantly larger in FSO group and device left disc size was significantly lower in the FSO group. In all subjects, the residual shunt was small to trivial during follow‐up and the reduction in prevalence of residual shunt with time was similar in both groups (P = 0.68). We found no differences in complication rate between the two devices; however, device embolization to the pulmonary bifurcation in one patient was recorded as major complication in FSO device group. Conclusions: Both devices are clinically safe and effective in ASD closure. FSO device has similar outcomes when compared to ASO device. Difficulties in selecting the correct device size in larger defects and larger venous sheath requirement need to be evaluated in further studies.     

Left Atrial Dysfunction in Patients with Patent Foramen Ovale and Atrial Septal Aneurysm Scheduled for Transcathter Closure May Play a Role in Aura Genesis

Background: It has been suggested that a left atrial (LA) dysfunction induced by large shunt and large atrial septal aneurysm (ASA) may act as a concurrent mechanism of arterial embolism in patients with patent foramen ovale (PFO) and prior stroke. We aimed to evaluate the potential contribution of this mechanism as trigger of migraine in patients with PFO. Methods: From January 2007 to September 2009, we prospectively enrolled subjects with migraine who underwent percutaneous PFO closure. Echocardiographic parameter of LA dysfunction was evaluated: pre‐ and postoperative values were compared to values of different sex and heart rate matched populations: 30 healthy patients, 21 migraine patients without PFO (MwoPFO), and a group of 25 PFO patients without migraine (PFOwoM). The Migraine Disability Assessment Score (MIDAS) was used to assess the incidence and severity of migraine. Results: Forty‐five patients (38 females, mean age 38 ± 6.7 years, mean MIDAS 35.8 ± 4.7, and 28 patients with migraine with aura) fulfilled the inclusion criteria. After successful percutaneous closure (mean follow‐up of 18.2 ± 4.8 months), PFO closure remained complete in 95%; 35 of 45 patients reported resolution or amelioration of migraine (mean MIDAS score 12.3 ± 8.8, P < 0.03). All patients with aura reported aura resolution. Preclosure values demonstrated significantly greater LA dysfunction, when compared with healthy and MwoPFO groups. Among patients in the study group, only patients with migraine with aura showed LA dysfunction comparable to PFOwoM patients. Conclusion: This study suggests that LA dysfunction probably does not contribute to migraine itself but may play a role in the genesis of aura symptoms. (J Interven Cardiol 2010;23:370–376)     

Figulla PFO occluder versus Amplatzer PFO occluder for percutaneous closure of patent foramen ovale

Background : Percutaneous closure of patent foramen ovale (PFO) has been shown safe and feasible using several devices. The Occlutech Figulla single layer PFO Occluder (FPO) constitutes an alternative to the Amplatzer PFO Occluder (APFO). Objectives : We report our experience with both devices in a single‐center case–control study. Methods : Twenty patients undergoing percutaneous PFO closure using an FPO for secondary prevention of paradoxical embolism or diving were blindly matched with 20 patients receiving an APFO during the same time period. Contrast transesophageal echocardiography (TEE) was performed 6 months after device implantation to assess for residual shunting and device‐associated thrombus. Results : Patient baseline characteristics were well matched by study design. Procedural success was 95% with FPO vs. 100% for APFO (P = 1.0), with 3 (15%) peri‐procedural complications with FPO vs. none with APFO (P = 0.24). These comprised one asymptomatic device embolization in the descending aorta with percutaneous retrieval, one transient ischemic attacks, and one suspected device endocarditis. Contrast TEE at 6 months showed significantly more residual shunts in the FPO‐group (39% vs. 0%; P = 0.01). Two FPO patients with a moderate residual shunt underwent implantation of a second device (APFO 25 mm) vs. none in the APFO group (P = 0.48). No thrombi were observed in either group. During 1.7 ± 0.7 years of follow‐up, no death or recurrent embolic event occurred. Conclusions : According to this single‐center case–control study, PFO closure with the FPO appears less efficacious than with the APFO. © 2010 Wiley‐Liss, Inc.     

Percutaneous closure of patent foramen ovale: “Closed” door after the last randomized trials?

Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials(CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them(PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one(CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure(1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed(1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reducethe risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.     

Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients

OBJECTIVES: The purpose of this study was to investigate the incidence, morphology, and clinical course of thrombus formation after catheter closure of intra-atrial shunts. BACKGROUND: Post-procedure detailed information about thrombotic material on different devices for transcatheter closure is missing. METHOD: A total of 1,000 consecutive patients were investigated after patent foramen ovale (PFO) (n = 593) or atrial septal defect (ASD) (n = 407) closure. Transesophageal echocardiography (TEE) was scheduled after four weeks and six months. Additional TEEs were performed as clinically indicated. RESULTS: Thrombus formation in the left atrium (n = 11), right atrium (n = 6), or both (n = 3) was found in 5 of the 407 (1.2%) ASD patients and in 15 of the 593 (2.5%) PFO patients (p = NS). The thrombus was diagnosed in 14 of 20 patients after four weeks and in 6 of 20 patients later on. The incidence was: 7.1% in the CardioSEAL device (NMT Medical, Boston, Massachusetts); 5.7% in the StarFLEX device (NMT Medical); 6.6% in the PFO-Star device (Applied Biometrics Inc., Burnsville, Minnesota); 3.6% in the ASDOS device (Dr. Ing, Osypka Corp., Grenzach-Wyhlen, Germany); 0.8% in the Helex device (W.L. Gore and Associates, Flagstaff, Arizona); and 0% in the Amplatzer device (AGA Medical Corp., Golden Valley, Minnesota). The difference between the Amplatzer device on one hand and the CardioSEAL device, the StarFLEX device, and the PFO-Star device on the other hand was significant (p < 0.05). A pre-thrombotic disorder as a possible cause of the thrombus was found in two PFO patients. Post-procedure atrial fibrillation (n = 4) and persistent atrial septal aneurysm (n = 4) had been found as significant predictors for thrombus formation (p < 0.05). In 17 of the 20 patients, the thrombus resolved under anticoagulation therapy with heparin or warfarin. In three patients, the thrombus was removed surgically. CONCLUSIONS: The incidence of thrombus formation on closure devices is low. The thrombus usually resolves under anticoagulation therapy.     

Device-less patent foramen ovale closure by radiofrequency thermal energy

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

Transcatheter closure of secundum atrial septal defect in a patient with dextrocardia using the Amplatzer septal occluder

Transcatheter closure of secundum atrial septal defects (ASD) in patients with levocardia is performed routinely using various investigational devices. A 6-yr-old child with dextrocardia, situs inversus, and secundum ASD measuring 13 mm by TEE underwent successful transcatheter closure using a 15 mm Amplatzer Septal Occluder with complete closure of the defect. Cathet. Cardiovasc. Diagn. 43:291–294, 1998. © 1998 Wiley-Liss, Inc.     

Percutaneous patent foramen ovale closure using Helex and Amplatzer devices without intraprocedural echocardiographic guidance

Objectives: We compared procedural outcomes of patients undergoing patent foramen ovale (PFO) closure using Helex (W.L. Gore & Assoc., Flagstaff, AZ, USA) and Amplatzer (AGA Medical Corp., Plymouth, MN, USA) devices using intracardiac echocardiographic (ICE) versus fluoroscopic‐only guidance. Background: Use of transesophageal or ICE to guide PFO closure is associated with patient discomfort and cost. While fluoroscopic guidance of septal closure using Amplatzer is well established, there is no published experience for Helex. Methods: We performed a single‐center, single‐operator analysis of patients undergoing PFO closure using Helex or Amplatzer occluders. Device and guidance strategy was selected by the operator. Results: Of the 132 PFO patients, 23 were closed with Helex, and 109 were closed with Amplatzer (103 Cribriforms, 4 PFO occluders, and 2 atrial septal occluders). Fluoroscopic guidance was used for 15 (65%) Helex and 102 (94%) Amplatzer cases. Successful device placement was achieved in all patients with a 1.5% complication rate (1 arrhythmia and 1 device embolization). Procedure time was shorter for fluoroscopic guidance of Amplatzer cases compared to ICE guidance (P = 0.023), and for Amplatzer versus Helex cases (P = 0.0004). Among the Helex cases, there were no differences in procedure or fluoroscopy time comparing ICE to fluoroscopic guidance. There was no residual shunting by transthoracic echocardiographic bubble study in 93% of Helex and 95% of Amplatzer cases at 6 months. Conclusions: Use of right atrial angiography and fluoroscopic‐only guidance for PFO closure using Helex and Amplatzer devices provides an efficient alternative to ICE guidance. While procedure and fluoroscopy times were significantly shorter for Amplatzer versus Helex cases, these times were similar for Helex comparing fluoroscopy versus ICE guidance. (J Interven Cardiol 2011;24:271–277)     

Transcatheter closure of patent foramen ovale in patients with cerebral ischemia

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

Occlusion of interatrial communications with the Amplatzer device: experience in 48 consecutive patients

Both secundum atrial septal defect (ASD) and patent foramen ovale (PFO) have been closed interventionally using several different occluding devices. At a single institution we strived for interventional occlusion of interatrial communications using the Amplatzer device exclusively. During a study period of 22 months, we studied 48 patients ranging in age from 1 to 48 years with an ASD (n = 45) or a PFO (n = 3). Successful implantation of an Amplatzer device was possible in 92% of the patients, and 95% of these patients had a complete early closure of their defect. There were no complications related to the procedure. We conclude that interventional closure of interatrial communications with the Amplatzer device is feasible and safe for selected patients.