Is routine ultrasound guidance really necessary for closure of patent foramen ovale using the Amplatzer PFO occluder?

Objectives:

The aim of the study was to evaluate safety, efficacy, and long‐term clinical outcome of percutaneous closure of patent foramen ovale (PFO closure) in a low volume center using the Amplatzer PFO occluder without echocardiographic guidance.

Background:

Most centers perform PFO closure either by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) guidance for optimal device selection. As TEE is poorly tolerated by patients in supine position and ICE is a costly alternative that increases vascular access complications, we wanted to assess the safety and efficacy of PFO closure by fluoroscopic guidance only.

Methods:

Before PFO closure, all patients had a diagnostic contrast‐TEE and morphological classification of PFO. All PFO closures were performed using the 25‐mm Amplatzer PFO occluder with fluoroscopic guidance only. Intraprocedural echocardiography was replaced by right atrial opacification using contrast angiography. Contrast TEE was done after 6 weeks, contrast TTE after 3, 6, and 12 months postprocedural.

Results:

In all 92 patients (52.4 ± 1.5 years), a 25‐mm Amplatzer PFO occluder was implanted in the correct position. Total fluoroscopic time was 8.4 ± 0.6 minutes and the application of contrast medium was 122.5 ± 5.8 mL. By contrast‐TEE, 12 patients (13 %) showed a small residual shunt (grade 1). During follow‐up (2.09 ± 0.13 years) two patients (2.1%) suffered from a recurrent event (TIA in both cases).

Conclusions:

Percutaneous closure of PFO using the 25‐mm Amplatzer PFO occluder guided by fluoroscopy only is a safe and efficacious intervention for nearly all patients. © 2009 Wiley‐Liss, Inc.     

Feasibility of percutaneous closure of atrial septal defects in adults under transthoracic echocardiography guidance using the Figulla atrial septal defect occluder device

Background

Closure of atrial septal defect (ASD) among adults under transthoracic echocardiography (TTE) guidance using devices other than the Amplatzer Septal Occluder has not been extensively tested.

Single centre experience with GORE-HELEX septal occluder for closure of PFO

Several devices are available for percutaneous patent foramen ovale (PFO) closure. Over the past 3 years our planned treatment strategy of PFO closure has been routine use of the GORE-HELEX septal occluder device, followed by 6 months of aspirin therapy. We present the safety and feasibility of routinely using this device for all patients undergoing percutaneous PFO closure, with 3-month transthoracic echocardiogram (TTE) follow up. In total, 75 adult patients (44.0+/-11.7 years; 45.3% male) were referred for PFO closure during the study period. All patients underwent echocardiography prior to PFO closure. In 5 patients no PFO was found, and 1 patient had an atrial secundum defect closed using the Amplatzer septal occluder. Of the 69 remaining patients with PFO, 68/69 (98.6%) underwent closure with the GORE-HELEX device. Six of 69 cases required device retrieval and 5 of 6 were replaced successfully with a second GORE-HELEX device. One of the 6, a large PFO associated with atrial septal aneurysm, was replaced using the Amplatzer septal occluder. There were no major complications. At 3-month follow up, 65/68 (95.6%) had no residual shunt on TTE, and 3 patients had small residual shunts thought to be related to incomplete endothelialisation at 3 months. In conclusion, percutaneous PFO closure using the GORE-HELEX septal occluder device is safe and feasible, with no major peri-procedural complications and excellent short-term results at 3-month follow up.     

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)     

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 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.     

经胸超声心动图监测下用Amplatzer封堵器治疗房间隔缺损

目的：评价在经胸超声心动图(TTE)监测下用Amplatzer封堵器介入治疗房间隔缺损(ASD)的可行性及实用价值。方法：全组共18例继发孔型ASD患者，均在常规C型臂X线机透视和TTE指导下经导管置入Amplatzer封堵器。结果：18例患者中有2例未放置成功而改为开胸手术；16例均成功置入Amplatzer封堵器，即刻完全堵闭，术后随访3个月至2年，TTE示ASD仍被完全封闭，未见残余分流。随访期间无任何并发症。结论：在TTE和X线透视指导下用Amplatzer封堵器治疗继发孔型ASD安全可行，具有一定实用价值。     

Safety and feasibility of day case patent foramen ovale (PFO) closure facilitated by intracardiac echocardiography

Ultrasound guided patent foramen ovale (PFO) closure has traditionally utilized transoesophageal echocardiography (TOE) under general anaesthesia. Some centres use fluoroscopic guidance alone to facilitate day case PFO closure. Intracardiac echocardiography (ICE) is performed via femoral vein access using an 11 Fr sheath providing accurate guidance without the necessity for general anaesthesia. The safety and feasibility of PFO closure using ICE guidance as a day case procedure have not been documented. We present a consecutive series of patients undergoing planned day case PFO closure under ICE guidance with transthoracic echocardiogram (TTE) follow up. Patients excluded from day case PFO closure were those with early pregnancy or unfavourable social circumstances. 53 consecutive adult patients (44.2+/-11.0 years; 24 males) were planned for day case PFO closure facilitated by ICE. Referral indications were stroke or TIA (n=39), peripheral embolism (n=6), decompression sickness (n=7) and severe migraine (n=1). All 53 patients underwent ICE, with 9/53 (17%) having an atrial septal aneurysm. In 5 patients no PFO was found. In the remaining 48 patients, PFO closure was achieved using the HELEX occluder (n=47) or the Amplatzer device (n=1). Mean procedure and fluoroscopy times were 31.0+/-12.4 and 5.3+/-3.9 min respectively. One patient failed same day discharge due to groin haematoma. There were no other complications. At 3 month follow up, 45/48 (94%) had no residual shunt, with 3 patients having small residual shunts on colour flow Doppler. In conclusion, percutaneous PFO closure as a day case procedure is safe and feasible when facilitated by ICE.     

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.     

Cobrahead Deformity in the Right Atrial Disc of a New-Generation Occlutech Figulla Flex II Atrial Septal Defect Occluder Device

Cobrahead deformity is a known (but uncommon) phenomenon associated with the left atrial disc of the Amplatzer or Occlutech Figulla septal occluder device during percutaneous transcatheter atrial septal defect closure. It has also been postulated that the right atrial disc of the Amplatzer septal occluder device might upon occasion exhibit the cobrahead malformation. To date, only one case report concerning the cobrahead deformity in the right atrial disc of an Amplatzer septal occluder has been published, if we discount a report published as a letter to the manufacturer.Here we present the first report (known to us) of a cobrahead deformity in the right atrial disc of an Occlutech Figulla Flex II atrial septal defect occluder device during transcatheter closure of a complex atrial septal defect.     

Percutaneous management of cyanosis in Fontan patients using Amplatzer occluders

Objectives : To determine causes of cyanosis and to evaluate percutaneous management of cyanosis in a group of consecutive Fontan patients. Background : A variety of communications allow a right‐to‐left shunt in Fontan circulation causing cyanosis and these communications are amenable to percutaneous closure. Methods : Between November 1997 and November 2007, 45 consecutive patients ranging in age from 2.5 to 26 years (median 8 years) with Fontan circulation and cyanosis underwent cardiac catheterization and percutaneous closure of superfluous communications using different types of Amplatzer occluders. Results : Altogether, 51 communications were detected and 50 of them were closed. In 5 patients (11.1%), multiple communications were present and were closed. Fenestration was detected in 37 of 41 patients (90.2%) after total cavopulmonary connection and all were closed by Amplatzer septal occluders. Five venous collaterals were revealed in 3 of 41 patients (7.3%) with total cavopulmonary anastomosis and were closed by Amplatzer vascular plugs. In 3 patients, lateral tunnel leaks were detected and were closed by Amplatzer PFO occluders. In 4 patients after Kawashima operation, 3 major pulmonary arterio‐venous malformations and single venous collateral contributed to the cyanosis and all were closed using Amplatzer vascular plugs. Conclusions : Different communications cause cyanosis in Fontan patients. Progressive decline of percutaneous oxygen saturation is suggestive of development of venous collaterals or pulmonary arteriovenous malformations. Superfluous communications are amenable to percutaneous closure using various types of Amplatzer occluders. A novel use of an Amplatzer PFO occluder for the percutaneous closure of a lateral tunnel leak is described. © 2008 Wiley‐Liss, Inc.     

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.     

Percutaneous closure of a patent foramen ovale via left axillary vein approach with the Amplatzer Cribriform septal occluder

Percutaneous closure of a patent foramen ovale (PFO) was successfully performed via the left axillary vein in a 52-year-old female with a history of left posterior cerebral artery embolic cerebrovascular accident (CVA) and inferior vena cava (IVC) interruption with a Simon Nitinol Filter precluding standard access via the common femoral vein. Utilizing a 6 French Amplatzer 180 degrees patent ductus arteriosus delivery sheath and a 25-mm Amplatzer Cribriform occluder, the PFO was successfully closed utilizing general anesthesia and transesophageal echocardiography guidance. This case demonstrates the advantages of the axillary vein approach over the internal jugular or hepatic vein approach in patients with anatomy precluding standard percutaneous closure.     

Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism. Periprocedural safety and mid-term follow-up results of three different device occluder systems.

AIMS: Interventional PFO closure has previously been reported to reduce the risk for recurrent thromboembolic events. The aim of the present study was to evaluate three different occluder systems in respect to (a) the safety and practicability and (b) the mid-term risk of recurrent thromboembolic events. METHODS AND RESULTS: Since 08/98 until 12/02, 307 consecutive patients (138 women, 169 men, mean age 43 years) with a symptomatic PFO underwent PFO closure using the PFO-Star ( n=177), Amplatzer PFO occluder ( n=69) and CardioSeal/Starflex ( n=61 ). Implantation was successful in all patients. Periinterventional complications occurred in 9 patients (5x ST-segment elevations, 1x arteriovenous fistula, 2x TIA, 1x device dislodgement). All of them were reversible and not associated with a specific type of device. During the median follow-up of 24 months (25/75th percentiles: 14/37 months), the annual risk of recurrence was 0.6% for TIA, 0% for stroke and 0.2% for peripheral embolism (PFO-Star: 0.8%, Amplatzer PFO occluder: 0.7% and CardioSeal/Starflex: 1.0%). CONCLUSION: Interventional PFO closure appears to be safe and a promising technique in symptomatic PFO patients with a low incidence of periinterventional complications and recurrent thromboembolic events using three different devices (PFO-Star, Amplatzer PFO occluder or the CardioSeal/Starflex).     

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)     

Clinical Experience of Percutaneous Patent Foramen Ovale Closure Using the Amplatzer PFO Occluder in Japanese Patients to Prevent the Recurrence of Cryptogenic Stroke

Objective Percutaneous patent foramen ovale (PFO) closure is a procedure widely used to prevent recurrence of cryptogenic stroke. Since December 2019, the Amplatzer PFO occluder device has been available in Japan through medical insurance. However, data on the clinical experience with this device are lacking, as it has been approved for use in only a limited number of institutions. This study assessed the clinical data of Japanese patients who underwent PFO closure using the Amplatzer PFO occluder. Methods Between February and October 2020, 14 patients at our institution underwent percutaneous PFO closure using the Amplatzer PFO occluder. The procedural characteristics, safety, and adverse events were retrospectively analyzed. Results The mean age of the patients was 52.4±13.3 years old, and 57.1% were women. Deep vein thrombosis was revealed in 2 patients, and the risk of paradoxical embolism score was 6.6±1.2 points. The PFO height and tunnel length were 2.3±1.4 mm and 11.5±4.1 mm. All patients had a PFO during the bubble study of grade >3 at the Valsalva maneuver on transthoracic echocardiography or transesophageal echocardiography. The average diameter of the PFO measured using a stiff guidewire and sizing balloon was 5.1±1.3 and 7.9±2.3 mm, respectively. Almost all cases (92.9%) were performed with a 25-mm device and without significant complications within approximately 1 hour. Conclusion Percutaneous closure using Amplatzer PFO occluder is a safe procedure for Japanese patients. However, further investigations with a larger sample and longer follow-up are needed to confirm this result.     

Percutaneous closure of patent foramen ovale

AIM: To review the safety and efficacy of percutaneous closure of patent foramen ovale (PFO) in symptomatic patients without the use of general anaesthesia or echocardiographic guidance. METHOD: All patients accepted for percutaneous PFO closure by our service from August 2002 to August 2004 were included. Patient demographics and clinical information were obtained from clinical records and by telephone interview. Follow-up outcomes recorded were recurrence of systemic thromboembolism, residual shunt, and change in pattern of migraines. RESULTS: Forty consecutive adult patients, of whom 19 (48%) had an atrial septal aneurysm (ASA), underwent PFO closure using the Amplatzer occluder device with fluoroscopic guidance alone. Their mean age was 45 +/- 10 years (range 23-63 years) and 24 (60%) were male. The indications for closure were ischaemic stroke (n = 26), transient ischaemic attack (TIA) (n = 8), both stroke and TIA (n = 2), refractory hypoxia (n = 2), platypnoea-orthodeoxia (n = 1) and severe migraine with seizures (n = 1). Twenty patients suffered a single neurological event and 16 suffered >1 event, including six with only radiographic evidence of >1 event. Mean procedure time was 17.7 +/- 9.6 min and fluoroscopy time was 6.7 +/- 7.3 min. Implanted device sizes were 18 mm (n = 1), 25 mm (n = 37) and 35 mm (n = 2). In 33 patients, the procedure was performed as a day-case. No complications were encountered. No further neurological events occurred in 39 patients at a mean follow-up time of 11 +/- 7 months (3-25 months) nor was a significant shunt detected in the 34 who underwent follow-up echocardiography. CONCLUSIONS: Percutaneous closure of PFO with or without ASA, under local anaesthesia and without echocardiographic guidance, is a safe and effective procedure which can be performed as a day-case. This has now become our standard clinical practice.     

A new device to close secundum atrial septal defects: First clinical use to close multiple defects in a child

Transcatheter device closure of secundum atrial septal defects (ASD) has become an accepted treatment modality. Currently, the only device that can be used for large defects is the Amplatzer Septal Occluder. We report on a new device (Occlutech Figulla), to close multiple ASDs in a child with two large defects using 12 and 15 mm devices. © 2008 Wiley‐Liss, Inc.     

Periprocedural Outcomes of Fluoroscopy-Guided Patent Foramen Ovale Closure With Selective Use of Intracardiac Echocardiography

BackgroundRecent randomized trials have confirmed the role of patent foramen ovale (PFO) closure in the secondary prevention of cryptogenic stroke. Guidelines have suggested a central role for intraprocedural imaging using intracardiac echocardiography (ICE). However, this modality may not be required to achieve safe and effective closure. We aimed to examine the periprocedural outcomes of PFO closure retrospectively, using fluoroscopic guidance in patients with cryptogenic stroke, with provisional ICE guidance driven by anatomic and procedural factors.MethodsA retrospective chart review of consecutive patients who underwent PFO closure in a single centre using the Amplatzer PFO occluder (AGA Medical Corporation, Plymouth, Minnesota) for cryptogenic stroke was conducted. Outcomes analyzed included procedural data, periprocedural complications, length of stay, and factors contributing to the use of intraprocedural imaging.ResultsBetween 2006 and 2017, 467 patients underwent PFO closure for cryptogenic stroke with the Amplatzer PFO occluder; 381 patients underwent closure with fluoroscopy alone, and 86 with ICE and fluoroscopic guidance. Periprocedural arrhythmic complications occurred in 1.3% in the fluoroscopy group and 1.2% in the ICE group (P = 1.000). Vascular complications occurred in 0.5% in the fluoroscopy group and 2.3% (P = 0.323) in the ICE group. One device embolized requiring surgical intervention. There was no in-hospital mortality or stroke. Same-day discharge occurred in 97.6% of patients.ConclusionOur single-centre experience suggests that PFO closure can be safely conducted under fluoroscopic guidance alone with provisional adjunctive ICE use limited to specific anatomic situations.     

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)