Late presentation of CardioSEAL PFO closure device fracture and thrombus formation three years after device implantation

Transcatheter closure of patent foramen ovale (PFO) is a promising alternative to surgical closure or anticoagulation therapy in patients with a history of cryptogenic stroke. Although a number of transcatheter closure devices have been developed and used outside of the United States, the two commonly used devices in the United States are the StarFLEX CardioSEAL and the Amplatzer Occluder. Several complications, both early and late, associated with the devices have been reported in 6-11% of patients. The rates of complication vary with the different devices. Complications include device-related thrombi, embolization, device malposition, fracture, air embolism, arrhythmias, pericardial effusion, need for surgical intervention and death. As reported in the literature, the incidence of longterm complications beyond 1 year is rare. We report a case of a very late presentation of CardioSEAL device arm fracture associated with left atrial thrombus 3 years after device implantation.     

Use of balloon pull-through technique to assist in CardioSEAL device closure of patent foramen ovale.

CardioSEAL device closure of patent foramen ovale (PFO) has been advocated for the treatment of patients with cryptogenic stroke. Using the standard delivery technique, partial deployment of the CardioSEAL device can occur, especially in patients with a thick septum secundum and/or long PFO tunnel. We hypothesized that using a left atrial-to-right atrial balloon pull-through to make the septum primum incompetent would result in improved final device position regardless of septal thickness or tunnel length. Catheterization reports, cineangiograms, and transesophageal echocardiograms of 51 patients who underwent CardioSEAL device closure of PFO between March 2000 and August 2002 were retrospectively reviewed. Group 1 (n = 21) included patients with CardioSEAL placement using the standard technique and group 2 (n = 30) included patients with CardioSEAL placement using the balloon pull-through technique. There were no differences between the groups in terms of age (43.6 vs. 45.3 years; P = NS), weight (83.3 vs. 89.9 kg; P = NS), septum secundum thickness (6.4 vs. 7.0 mm; P = NS), PFO tunnel length (15.5 vs. 13.1 mm; P = NS), or device size. In group 1, 4/21 (19%) had partial deployment of the CardioSEAL device, while in group 2, no partial CardioSEAL deployment (0/30) was observed. No complications were associated with the balloon pull-through technique. We conclude that the left atrial-to-right atrial balloon pull-through technique is safe and may allow for better final position of the CardioSEAL device during PFO closure.     

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.     

Endobronchial closure of bronchopleural fistula with Amplatzer PFO device

Bronchopleural fistula (BPF) is a feared postoperative complication of pneumonectomy that carries significant morbidity and mortality. BPF can be treated by various surgical and medical techniques. Endobronchial techniques have been used for the delivery of biological glue, sealants, coils, and covered stents with variable degrees of success, depending on the size of the fistula. A recent case report described the endobronchial closure of a BPF through the implantation of an Amplatzer ASD device, commonly used for transcatheter closure of atrial septal defects. In this case report, we describe closure of a BFP using the Amplatzer PFO device.     

Incidence of thrombus formation on the CardioSEAL and the Amplatzer interatrial closure devices

Transcatheter closure for atrial septal defect (ASD) and patent foramen ovale (PFO) is a promising alternative to surgical closure or anticoagulant therapy. A potential complication is thrombus formation on the device after implantation. From February 2001 to June 2003, 66 patients with atrial communication were treated successfully with the Amplatzer device (16 septal and 20 PFO occluders) or the CardioSEAL device (30). Patients were discharged on antiplatelet medication (aspirin and clopidogrel) and/or anticoagulation. Fifty patients (76%) had transesophageal echocardiography (TEE) 1 month after device implantation (28 +/- 10 days). No patient experienced a thromboembolic episode during follow-up. TEE revealed that thrombus formation occurred more frequently on the CardioSEAL device (5 of 23 patients; 22%) than on the Amplatzer device (0 of 27 patients; 0%) (p = 0.02). Although thrombus disappeared or markedly diminished after additional anticoagulation therapy in 3 patients, 1 patient had surgical explantation of the device due to progressive increase in the size of thrombus with hypermobility despite intensive anticoagulation therapy. There was no variable associated with the presence of thrombus formation on the occluder other than the use of the CardioSEAL device. One month after insertion, the CardioSEAL device is more likely to have thrombus present than the Amplatzer device.     

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.     

Mitral paravalvular leak closure by antegrade percutaneous approach using amplatzer PFO closure device

Percutaneous closure of paravalvular leaks is becoming a more widely practiced technique. We describe the technique we used to deploy an Amplatzer PFO closure device to treat a prosthetic mitral paravalvular leak. The procedure was performed under real time 3D trans‐oesophageal echo and fluoroscopic guidance requiring a trans‐septal puncture and utilising an 035″ Safari wire which was developed for TAVR implantation. An excellent result was achieved acutely and at 4 month follow‐up. © 2016 Wiley Periodicals, Inc.     

Profound hypoxaemia corrected by PFO closure device in carcinoid heart disease.

A 66-year-old man with known metastatic carcinoid tumor presented with increasing dyspnoea, right heart failure and marked hypoxaemia which did not correct with oxygen. Echocardiography demonstrated severe tricuspid regurgitation, moderate pulmonary regurgitation and marked right heart dilatation. The inter-atrial septum was aneurysmal, with a large patent foramen ovale (PFO) with continuous right to left shunting. Cardiac catheterization demonstrated oxygen saturations of 96% in the pulmonary veins and 74% in the left atrium with a significant right to left shunt. During percutaneous closure of the PFO, anaesthetic induction resulted in marked systemic hypotension and worsening hypoxia related to systemic vasodilatation and increased shunting. PFO flow was temporarily obstructed with a sizing balloon resulting in a rapid increase in arterial oxygen saturation from 60% to >90%, but marked systemic hypotension due to acute left ventricular preload reduction, requiring volume replacement and adrenaline. Following deployment of a PFO occluder device, prominent pulsatile splaying of the right and left discs was noted due to the severe tricuspid regurgitation, resulting in some residual inter-atrial shunting. Arterial oxygen saturation was 83%, increasing to 92% at day 4 post-procedure as tissue organization occurred within the device, and the patient reported improvement in dyspnoea.     

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.     

Transseptal technique of percutaneous PFO closure results in persistent interatrial shunting.

Our goal was to review the effectiveness of the transseptal and tunnel techniques of patent foramen ovale (PFO) closure. Percutaneous PFO closure is an increasingly common treatment for prevention of paradoxical embolism and is typically performed by passing the device through the defect tunnel itself. The transseptal technique, in which the septum primum is punctured to create a hole through which the device is passed, has been proposed for patients with long-tunnel PFO. From May 2001 to December 2003, 120 patients underwent PFO closure at our institution and were included in this analysis. Defect closure was assessed by transesophageal echocardiography (TEE) with bubble study. Clinical follow-up data were obtained by clinic visits or standardized telephone interviews. Device closure was successfully completed in all patients, with 12 (10%) undergoing transseptal closure and 108 (90%) undergoing tunnel closure. Immediately following the procedure, complete closure occurred in 6 of 12 (50%) of the transseptal group and 88 of 108 (81.5%) of the tunnel group (P = 0.0120). Of the 89 patients (74.2%) who returned for 6-month TEE, complete closure was demonstrated in 4 out of 10 (40%) of the transseptal group and 58 out of 79 (73.4%) of the tunnel group (P = 0.0303). There have been four transient ischemic attacks during a mean follow-up of 11 months. The transseptal technique of PFO closure results in a higher proportion of patients with persistent interatrial shunting when compared with the tunnel technique. Whether this is due to a difference in technique, device, or patient anatomy is unclear.     

Transcatheter PFO closure with a prominent Eustachian valve

We report the successful PFO closure in a 57-year old woman with complex atrial anatomy. To avoid the risk of interfering with the occluder device due to a prominent Eustachian valve, a Helex Septal Occluder was implanted. Differential therapeutic considerations and specific device characteristics are outlined.     

Avoiding pacemaker lead entrapment during PFO closure

We present a case of a patient with a history of cryptogenic stroke and implanted dual‐chamber pacemaker referred for transcatheter closure of patent foramen ovale (PFO). During the procedure ventricular lead of the pacemaker was found to run alongside the PFO. This interrupted correct positioning and deployment of the Amplatzer occluder without sandwiching of the lead. A self‐prepared pigtail catheter with a cut off tip was used to move the lead away from the PFO. Subsequently, an occluder was successfully placed. In conclusion, difficulties in Amplatzer occluder placement in patients with implanted pacemaker may be overcome by a manoeuvre which prevents lead entrapment by the device. © 2008 Wiley‐Liss, Inc.     

Five-year experience with percutaneous closure of patent foramen ovale

Patent foramen ovale (PFO) has been implicated in the pathogenesis of cryptogenic stroke, arterial desaturation, decompression illness, and migraine headache (MH). This study evaluated the safety of percutaneous transcatheter PFO closure in patients with cryptogenic stroke, transient ischemic attack, or arterial desaturation. Additionally, symptomatic reduction in MH was determined after interatrial shunt closure. Of the 252 patients referred to the University of California, Los Angeles, with PFO, 131 underwent closure of the interatrial communication with a CardioSEAL (n = 30) or Amplatzer (n = 101) device. PFO morphology was evaluated with transesophageal echocardiography. Follow-up was conducted at 1 to 2 months with echocardiography, with clinical assessment annually thereafter. At an average follow-up of 30 months, there was no recurrence of any thromboembolic event (transient ischemic attack, stroke, or peripheral). There was a reduction in MH, defined as the complete resolution of headache or a >50% reduction in the number of headache days, in 85% of patients after PFO closure. Temporary problems after device implantation, including chest discomfort and palpitations, were reported in 23% of patients and occurred more frequently in patients with nickel hypersensitivity (p <0.05). In conclusion, transcatheter PFO closure is an effective and safe therapeutic modality in the prevention of thromboembolic events and MH associated with interatrial shunting in patients who present with cryptogenic stroke. Pending randomized, controlled trials are necessary to determine if this invasive approach is preferable to medical therapy for the prevention of recurrent stroke or as primary treatment for patients with MH.     

Fracture of a GORE HELEX Septal Occluder following PFO closure in a diver

Decompression illness (DCI) is more common in divers with a patent foramen ovale (PFO), and transcatheter PFO closure is being increasingly performed in patients with an episode of DCI who want to continue diving. A range of closure devices are available and the choice in an individual case depends on operator preference and PFO anatomy. The GORE HELEX Septal Occluder, introduced in 1999 primarily for secundum atrial defect closure, is a compliant non self‐centering device composed of a wire helical framework on which a microporous membrane is mounted. The device is fixed in place by a unique interlocking mechanism that passes through the center of the device from the left to the right atrial disc, thereby securing it onto the interatrial septum. Here, we present a case of a locking loop fracture and review the literature concerning this unusual complication. © 2009 Wiley‐Liss, Inc.     

Device closure rates of simple atrial septal defects optimized by the STARFlex device.

OBJECTIVES: This study sought to review the outcomes of 3 generations of closure devices for secundum atrial septal defects (ASDs) at a single institution. BACKGROUND: Transcatheter closure of ASDs is now increasingly performed with devices that have been modified over time to improve performance. METHODS: A review of prospective clinical trials of Clamshell (C.R. Bard Inc., Murray Hill, New Jersey), CardioSEAL (NMT Medical Inc., Boston, Massachusetts), and STARFlex (NMT Medical Inc.) closure devices for simple ASDs was performed. The entry criteria for these trials were age > or =2 years, isolated secundum ASD, evidence of right ventricular volume overload, and maximum stretched diameter varying from 20 to 25 mm. Successful outcomes were defined as no more than small residual leak (< or =2 mm) with absence of a severe complication or the need for an additional device or surgery. RESULTS: A total of 72 Clamshell, 30 CardioSEAL, and 42 STARFlex devices were placed in uncomplicated ASDs. Each device modification resulted in improved closure rates, with the STARFlex device achieving a 93% complete closure rate with a device/stretched diameter ratio significantly smaller than with the other devices (p = 0.001). Severe complications occurred in 5 Clamshell, 1 CardioSEAL, and 0 STARFlex cases. Successful outcomes increased for each generation of device (79%, 93%, and 98% respectively, p = 0.009). There have been no long-term complications for either the CardioSEAL or the STARFlex devices. CONCLUSIONS: Modifications in 3 generations of devices have resulted in improved results for percutaneous ASD closure.     

Cardiac perforation and tamponade 3 months after transcatheter PFO closure by STARFlex device: A case report

Percutaneous Patent Foramen Ovale (PFO) closure after paradoxical embolism has become established as a safe, effective and validated procedure. The use of dedicated devices by experienced operators allows for low complication rates and good clinical results in the prevention of paradoxical embolism recurrence. This has led to a widespread use of the technique. However, late complications have been reported after the implantation of different types of devices. We report the first case of cardiac tamponade due to atrial wall erosion, which occurred three months after the implantation of a STARflex device (Nitinol Medical Technologies, Boston, Massachusetts, USA) in a 57 year‐old‐patient Transoesophageal echocardiographic images and surgical views of the perforation related to the device are presented. This report describes treatment of a late complication that arose following implantation of a STARflex device. © 2008 Wiley‐Liss, Inc.     

Implantation of a second closure device in patients with residual shunt after percutaneous closure of patent foramen ovale.

Percutaneous closure of patent foramen ovale (PFO) in patients with presumed paradoxical embolism yields complete occlusion in > 90% of patients using contemporary closure devices. Patients with a residual shunt after percutaneous PFO closure have been found at increased risk for recurrent paradoxical events. Treatment options for such patients include medical treatment using antiplatelet drugs or oral anticoagulation, surgical device removal and patch closure, and percutaneous implantation of a second closure device. We report our experience with implantation of a second closure device in 10 patients with more than a minimal residual shunt < or = 6 months after percutaneous PFO closure. Procedure and fluoroscopy times were similar for the initial and repeat intervention (32 vs. 30 min and 5 vs. 6 min, respectively; P = NS). There were no procedural complications during implantation of the second closure device. Follow-up transesophageal echocardiography 6 months after the second percutaneous intervention revealed complete PFO closure in nine (90%) patients. Therefore, implantation of a second closure device in patients with persistence of more than a residual shunt after percutaneous PFO closure appears safe and effective.     

Transcatheter closure of atrial septal defects with the STARFlex device: early results and follow-up

BACKGROUND: The STARFlex (SF) device is a CardioSEAL (CS) double-umbrella device that has been modified by the addition of a self-centering mechanism comprised of nitinol springs connected between the two umbrellas and a flexible core wire with a pin-pivoting connection. This paper compares the results of atrial septal defect (ASD) closure with CardioSEAL and STARFlex devices. PATIENTS AND METHODS: Between December 1996 and March 2000, 117 patients underwent ASD closure with CardioSEAL (n = 79) and STARFlex (n = 38). The mean age (17 years), weight (49 kg), and ASD size (15 mm) were similar in the two groups. The procedures were performed under general anesthesia with both fluoroscopic and transesophageal echocardiographic monitoring. IMMEDIATE RESULTS: The devices were successfully implanted in all patients. Ten patients had multiple ASDs. A single device was used in four patients (CardioSEAL in three, STARFlex in one), while a simultaneous placement of two CardioSEAL (one patient) or two STARFlex (five patients) were performed in six patients. The results are summarized as follows: [table: see text] Follow-Up Results: On follow-up clinical exam, electrocardiograms, chest X-rays, and echocardiograms were obtained at 1, 6, and 12 months. [table: see text] During follow-up there were no deaths, endocarditis, rhythm disturbances, or other complications. Arm fractures were observed almost exclusively with large CardioSEAL devices (40 mm, less frequently with 33 mm), and only in one 33-mm STARFlex device. There were no clinical complications related to fractures. CONCLUSIONS: The STARFlex device seems to offer better results than the CardioSEAL, with significantly lower rates of residual shunts and arm fractures.     

The role of device closure of patent foramen ovale in patients with cryptogenic stroke

One of the most frequent causes of cardiac embolism in cryptogenic stroke is a paradoxical embolus, which originate from systemic venous source though an unidentified patent foramen ovale (PFO). PFO is a common finding in the general population with a prevalence of 25% to 30%. Transcatheter PFO device closure is known to be feasible and safety treatment for such patients. In recent years, several randomized controlled trials (RCTs) have been conducted to address the superiority of PFO closure over medical therapy alone in the prevention of stroke recurrence in patients with PFO. In contrast to findings from early 3 RCTs, recent 4 RCTs could successfully show the benefits of PFO device closure compared with medical therapy, with less peri‐ and postprocedural complication. Based on these data, PFO device closure is recommended to carefully select cryptogenic stroke patients aged from 18 to 65 years, with a high probability of a causal role of the PFO in stroke events. However, it is still uncertain whether PFO closure is superior to oral anticoagulants therapy in these patients. Therefore, further prospective randomized trials are needed to address the efficacy of PFO device closure to oral anticoagulants therapy.     

Transcatheter closure of atrial septal defect with a CardioSEAL device

Transcatheter closure of an interatrial septal defect (ASD) with a CardioSEAL device was successfully performed on 12 Taiwanese children. There were five boys and seven girls, aged from 3.6-13.9 (8.3+/-3.2) years and with body weight of 15-57 (33.7+/-14.7) kgs. After one year of follow-up studies, which included physical examination, ECG, chest X-ray and echocardiography, complete closure of ASD was achieved in nine (75%) patients. Two children with a trivial residual shunt were asymptomatic and without audible cardiac murmur. A girl had a small residual left to right atrial shunt by color Doppler echocardiography, but without audible cardiac murmur. There were no immediate or intermediate complications. Transcatheter implantation of the CardioSEAL device is a safe and proper treatment for children with non-complicated small to medium secundum ASD.