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.     

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

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

Cardiac perforation following transcatheter PFO closure.

From December 1998 to August 2001, transcatheter closure of patent foramen ovale (PFO) with an Amplatzer PFO occluder has been successfully performed in our center in 102 patients without severe complications. We are reporting the first known case of cardiac perforation by an Amplatzer PFO 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.     

Closure of patent foramen ovale in patients with orthodeoxia-platypnea using the amplatzer devices.

We present a series of four patients with orthodeoxia-platypnea who underwent successful transcatheter closure of their patent foramen ovale using the Amplatzer devices (Amplatzer septal occluder/Amplatzer PFO occluder). The average saturation increased from 81% to 96% with complete resolution of symptoms. The Amplatzer devices are safe and effective treatment options for patients with orthodeoxia-platypnea.     

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.     

PFO closure complications from the AGA registry

Objectives: To evaluate all complications that occurred during or after cardiac catheterizations for Amplatzer PFO device closure of patent foramen ovale (PFO), determine the cause of the complications and recommend techniques to minimize complications in the future. Background: Rare complications were reported to the manufacturer of the Amplatzer PFO occluder since the introduction of the device. Methods: A panel of independent physicians reviewed all complications reported to the manufacturer to determine whether the complication was related to the device or related to the cardiac catheterization procedure. Demographic data, echocardiograms, operative reports, and time to occurrence of complications were reviewed. Results: A total of 11 events were reported. Only two patients had device related complications (erosion), an incidence of 0.018%. Two patients were found to have additional atrial septal defect after PFO closure. Two patients were thought to have an inflammatory reaction without any serious sequelae. Five complications were related to the cardiac catheterization procedure (atrial appendage perforation). Conclusions: Device related complications after Amplatzer PFO occluder placement are extremely rare. Cardiac catheterization related complications appear to be the most common cause of the hemodynamic compromise. Careful manipulation of catheters and wires, recognition of the location of the catheter by fluoroscopy and echocardiography will decrease the risk of such complications. © 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.     

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).     

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.     

Closure of a coexisting ostium secundum atrial septal defect and patent foramen ovale using a single Amplatzer patent foramen ovale occluder device

We report the case of a 59-year-old man with cryptogenic stroke who was found to have both an ostium secundum atrial septal defect and a patent foramen ovale (PFO) by intracardiac echocardiography. Both defects were successfully occluded using a single 35-mm Amplatzer PFO occluder device inserted through the atrial septal defect.     

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 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.     

Transthoracic echocardiography guidance during percutaneous closure of patent foramen ovale

Background: Percutaneous closure of patent foramen ovale (PFO) has been increasingly performed for several indications; mostly due to cryptogenic stroke. In this study we aimed to evaluate the safety and efficacy of transthoracic echocardiographic (TTE) guidance during percutaneous closure of PFO in using the Amplatzer and Occlutech Figulla PFO occluder devices. Methods: Between October 2005 and March 2011, 139 patients (74 male, mean age: 40.4 ± 10.3) underwent transcatheter PFO closure. In all patients transesophageal echocardiography performed subsequently to diagnose, assess the size and evaluate for suitability of the defect for percutaneous closure. During the procedure fluoroscopy and TTE were used for guidance. Results: Among 139 patients, Amplatzer PFO occluder was used in 74 patients and in 65 of them Occlutech Figulla device was selected for occlusion. The indications for PFO closure were ischemic stroke in 98 (70.5%), recurrent transient ischemic attacks (TIA) in 40 (28.7%), peripheral embolism in 1 (0.8%) of the patients. In all patients, percutaneous intervention was performed successfully under TTE guidance. There have been no neurologic (recurrent strokes or TIAs) and cardiovascular complications during the immediate and long‐term follow‐up period (2–67 months, median 29). There was significant difference between the mean fluoroscopic time from the beginning which is 8.6 ± 3.4 min in the former versus 3.4 ± 1.9 min in the latter (P < 0.05). Conclusion: Our study confirms the efficacy and safety of TTE guidance during percutaneous closure of PFO, which shortens the procedural time and obviates the need for general anesthesia or endotracheal intubation. (Echocardiography 2011;28:1074‐1080)     

生物可完全降解封堵器封堵犬卵圆孔未闭的实验研究

目的 评估生物可完全降解卵圆孔未闭（patent foramen ovale，PFO）封堵器封堵犬PFO的可行性、安全性等。方法 右胸小切口开胸卵圆窝穿刺法建立犬PFO模型，即刻在直视及经胸超声心动图（TTE）引导下用生物可完全降解型PFO封堵器封堵PFO。在植入后分别于1、3、6、9和12个月各处死2只犬，进行肉眼和组织学检查。结果 10只犬成功建立PFO模型后并植入可完全降解PFO封堵器。随访见封堵器均未发生移位，表面无赘生物及血栓形成，大体解剖见内膜组织从边缘逐渐完全覆盖封堵器表面。组织病理学提示，术后6个月封堵器骨架几乎完全降解并和周围组织融为一体。结论 应用生物可完全降解PFO封堵器封堵犬PFO，降解后在体内无任何残留物，是一种安全、有效并且可行的封堵器。     

Utility of Intracardiac Echocardiography for Atrial Baffle Leak Closure in Repaired Transposition of the Great Arteries

A 27‐year‐old male with dextro‐transposition of great arteries had Senning atrial switch repair in childhood and dual‐chamber pacemaker placement for sinus node dysfunction in adulthood. Transthoracic echocardiography showed a lead in the systemic (anatomic right) ventricle. Multidetector computed tomography showed the lead perforating the baffle in the region of the body of the systemic venous atrium into the systemic ventricle. The lead was extracted, and a new lead was placed in the pulmonary (anatomic left) ventricle. A bidirectional baffle shunt persisted. The iatrogenic baffle leak was percutaneously closed with an Amplatzer septal occluder device using both intracardiac echocardiography (ICE) and three‐dimensional transesophageal echocardiography (3D‐TEE). We report the first use of ICE for baffle leak closure, which provided a good definition of the complex anatomy and guided the procedure. (Echocardiography 2010;27:E90‐E93)     

RESPECT远期随访结果能否结束PFO封堵疗效的争论？

RESPECT研究是一项前瞻性多中心随机对照试验,对卵圆孔未闭（PFO）并发不明原因脑卒中患者应用Amplatzer PFO 封堵器（St.Jude Medical,Inc.,St.Paul,MN）经导管PFO封堵+药物治疗与单独药物治疗进行对比,比较其二者在降低脑卒中复发风险方面是否有统计学差异。初步研究结果于2013年发表在新英格兰医学杂志上,其结果表明在预防不明原因脑卒中复发方面,经导管PFO封堵与药物治疗相比无统计学差异。但2015年10月15日在美国TCT会议上,公布了RESPECT研究的长期随访结果,得出了预防不明原因脑卒中复发,使用Amplatzer PFO封堵器行经导管PFO封堵优于药物治疗的最终结论。本文主要简介了RESPECT研究的主要内容和近期、远期结果,并对其作出笔者的评价。     

Turning the old school on its head: stenting as the therapy of choice for SVC syndrome.

A 38-year-old man with a history of migraine headaches with aura and one episode of ischemic stroke was found to have a patent foramen ovale (PFO). After percutaneous closure with the nickel-containing Amplatzer PFO occluder, the patient developed pericarditis, atrial fibrillation, and increased migraine headaches with aura that abated with oral prednisone. He tested positive for nickel hypersensitivity, which we conclude is the likely etiology of his pericarditis.     

Patent foramen ovale closure to prevent secondary neurologic events

In October of 2016 the United States Food and Drug Administration approved the Amplatzer Patent Foramen Ovale (PFO) occluder device for use in patients with cryptogenic stroke, to reduce the risk of recurrent stroke. This event followed 15 years of off-label use of atrial septal occluder devices, 3 randomized trials, and enormous controversy over the efficacy of this procedure. While none of the trials reached the primary endpoint needed to prove the efficacy of PFO closure in preventing recurrent stroke, meta-analyses and 5-year follow-up of 1 trial suggest that PFO closure decreases the risk of recurrent stroke, especially in sub-groups with large shunts and atrial septal aneurysms, and especially when the Amplatzer device (rather than other devices) is used. While the relative reduction in stroke associated with PFO closure is large (about 50%), the absolute reduction is low (1–2%) and must be balanced against complications of the procedure (about 3%). Thus, PFO closure is restricted to patients with cryptogenic stroke, and depends heavily on patients' personal preferences. Uncertainties about the etiology of stroke in patients with PFO and the efficacy of PFO closure cause a difficult problem for the internal medicine specialist. At one extreme the internist may wonder if every patient with a documented PFO should be referred to a cardiologist. At the other extreme, supported by specialty society guidelines, internists may conclude that PFO closure is rarely necessary. In this paper we review the current status of PFO closure and suggest a rational strategy for this procedure.     

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.