Association of interatrial shunts and migraine headaches: impact of transcatheter closure

OBJECTIVES: To examine the relationship between patent foramen ovale (PFO) or atrial septal defect (ASD) with the incidence of migraine headache (MHA) and assess whether closure of the interatrial shunt in patients with MHA would result in improvement of MHA. BACKGROUND: Migraine headache is present in 12% of adults and has been associated with interatrial communications. This study examined the relationship between PFO or ASD with the incidence of MHA and assessed whether closure of the interatrial shunt in patients with MHA would result in improvement of MHA. METHODS: A sample of 89 (66 PFO/23 ASD) adult patients underwent transcatheter closure of an interatrial communication using the CardioSEAL (n = 22), Amplatzer PFO (n = 43), or the Amplatzer ASD (n = 24) device. RESULTS: Before the procedure, MHA was present in 42% of patients (45% of patients with PFO and 30% of patients with ASD). At three months after the procedure, MHA disappeared completely in 75% of patients with MHA and aura and in 31% of patients with MHA without aura. Of the remaining patients, 40% had significant improvement (>or=2 grades by the Migraine Disability Assessment Questionnaire) of MHA. CONCLUSIONS: Transcatheter closure of PFO or ASD results in complete resolution of MHA in 60% of patients (75% of patients with migraine and aura) and improvement in symptoms in 40% of the remaining patients. Interatrial communications may play a role in the etiology of MHA either through paradoxic embolism or humoral factors that escape degradation in bypassing the pulmonary circulation. A randomized trial is needed to determine whether transcatheter closure of interatrial shunts is an effective treatment for MHA.     

Encerramento percutâneo de defeitos do septo interauricular guiado por ecocardiograma intracardíaco − A experiência de um centro

IntroductionDevice closure of interatrial communications has become a well-established technique to treat left-to-right shunt associated with atrial septal defect (ASD) and to prevent paradoxical embolism in patients with patent foramen ovale (PFO). Guidance by transesophageal echocardiography (TEE) is the standard practice but intracardiac echocardiography (ICE) is a feasible and safe alternative for monitoring these procedures.ObjectivesTo report our experience in the percutaneous closure of ASD and PFO guided by ICE.MethodsWe retrospectively reviewed all patients with ASD or PFO who underwent percutaneous closure guided exclusively by ICE between January 2008 and December 2010. All patients were followed clinically with regular echocardiographic evaluation (at discharge, one month, three, six and twelve months) to exclude residual shunt and device malposition.ResultsA total of 127 patients (mean age 46.6±12.2 years; 71% female) underwent transcatheter device closure of ASD or PFO during the study period. Device deployment with ICE monitoring was 100% successful, with a low rate of complications and eliminating the need for additional imaging techniques.ConclusionsICE provides anatomical detail of ASD/PFO and cardiac structures, facilitating congenital cardiac interventional procedures. It eliminates the major drawbacks associated with TEE and enables the interventional cardiologist to control all aspects of the procedure without relying on additional echocardiographic support.     

Closure of defects of the atrial septum in adults using the Amplatzer device: 100 consecutive patients in a single center

BACKGROUND: Transcatheter device closure of atrial septal defects (ASD) is an alternative to surgery, but experience is limited in adults, especially in those with large (> 26 mm) defects. HYPOTHESIS: We investigated the safety, efficacy, and learning curve for closure of ASD and patent foramen ovale (PFO) using the Amplatzer device. METHODS: In all, 101 procedures were carried out in 100 consecutive adult patients in a single cardiac center between July 1998 and August 2002. RESULTS: Preprocedure diagnosis was ASD and PFO in 50 patients each. A device was deployed in 94 of 101 attempts (93%) in 94 of 100 patients (94%). Atrial septal defect device sizes were 10-38 mm, median 24 mm, and 40% were > 26 mm. Major complications occurred in 2 of 100 patients (2%). One ASD device displaced requiring surgery within 24 h and one patient with PFO experienced pericardial tamponade; there were no deaths. Local vascular complications occurred in 4 of 100 (4%) and late complications in 4 of 100 (4%) patients. Patent foramen ovale closure was quicker (p<0.001), required less radiation (p=0.04), and was associated with fewer local vascular complications than ASD closure (p=0.04). Deployment of ASD devices > 26 mm was not associated with increased complications, length of procedure, or radiation compared with devices < or = 26 mm (all p>0.05). Complications in the first 35 patients were more frequent than in subsequent patients: 7 of 35 (20%) versus 3 of 65 (4.6%) (p=0.04); procedure and fluoroscopy times (both p<0.001) and radiation doses (p=0.001) were also higher. CONCLUSION: The Amplatzer device is an effective method for transcatheter closure of interatrial defects in adults, including large ASDs up to 38 mm. Major complications are uncommon. A learning curve of approximately 35 cases was suggested by the decline of complications, procedure times, and radiation exposure.     

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.     

Closure of a moderately large atrial septal defect with a self-fabricated fenestrated Amplatzer septal occluder in an 85-year-old patient with reduced diastolic elasticity of the left ventricle.

Percutaneous closure of an atrial septal defect (ASD) in the elderly with reduced diastolic elasticity of the left ventricle poses a significant management challenge. We report on the case of an 85-year-old patient who was admitted for percutaneous device closure of a moderately large secundum atrial septal defect. Hemodynamic evaluation documented an increase in left atrial pressure from a mean of 12 mm Hg to a mean of 32 mm Hg after balloon test occlusion of the ASD. Two months later, after adequate pretreatment with diuretics and afterload-reducing substances, he underwent successful closure of the ASD using a self-fabricated fenestrated Amplatzer septal occluder, which resulted in a postimplantation left atrial pressure of a mean of 18 mm Hg. Recovery was unremarkable and the fenestration has remained patent for 3 months since implantation of the device. This unique case highlights the feasibility of using a self-fabricated fenestrated Amplatzer septal occluder to close interatrial communications in elderly patients with diastolic dysfunction of the left ventricle.     

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

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

Percutaneous closure of patent foramen ovale and atrial septal defect: procedure outcome and medium-term follow-up

Percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO) has become increasingly utilized. The indications and results of percutaneous closure are diverse. AIM: To assess the indications, results, and complications of percutaneous closure of ASD and PFO in our tertiary center. METHOD: Case note review and retrospective analysis of all consecutive patients undergoing percutaneous closure over a 3-year period from January 2003 to October 2005 with a mean follow-up of 19 months (4-36). Results: There were 185 consecutive patients. The mean age was 44.9 years (SD 12.9) and 53% (n = 98) were males. There was 59% (n = 109) PFO and 41% (n = 76) ASD. The predominant indication for PFO closure was cerebrovascular accident (CVA) (42.2%, n = 46)- and for ASD, dilated right ventricle (68.4%, n = 52). Of all procedures, 94.6% (n = 175) were first time and 5.4% (n = 10) were redo for residual shunt. Overall, the success rate was 96.8% (n = 179) with two patients referred for surgical closure due to the large size of ASD and unsuitability for percutaneous closure, two procedures abandoned due to pericardial effusion, and two abandoned because the PFO was too small to cross. The Amplatzer device was used in 92.7% (n = 166) and the Starflex in 7.3% (n = 13). Minor complications were recorded in 10 patients (5.4%), of which 4 (2.2%) had minor venous access bleeding, 1 patient (0.5%) had retroperitoneal hematoma, and 2 patients (1.1%) had transient atrial fibrillation. One patient (0.5%) had transient inferior ST elevation during the procedure, one patient (0.5%) reported chest pain postprocedure, and one patient (0.5%) developed septicemia 3 weeks postprocedure. Major complications were recorded in three patients (1.5%), one patient (0.5%) with retroperitoneal hematoma requiring blood transfusion and two patients (1%) with pericardial effusion following transseptal puncture, requiring aspiration. No death, stroke, or device embolization was recorded. CONCLUSION: Our experience with percutaneous closure in adults demonstrates excellent results and safety with few complications. Percutaneous device closure will replace surgical closure for many ASDs and PFOs.     

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.     

Incidence of atrial fibrillation following transcatheter closure of atrial septal defects in adults

Transcatheter closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO) has become a routine procedure. Little is known about the effect of atrial septal device implantation on the occurrence of atrial fibrillation (AF). We evaluated the frequency of AF occurring after transcatheter PFO and ASD closure in a large population. From 1994 until 2007 a total of 1,062 patients underwent transcatheter closure of an interatrial communication. New-onset AF was defined by 12-lead electrocardiogram or Holter monitoring in patients without a history of AF at baseline. Of the 1,062 patients, 822 had a PFO and 240 had an ASD. During a median follow up of 20 months, new-onset AF was documented in 8% of patients. New-onset AF occurred in 7% of patients after PFO closure and in 12% of patients with underlying ASD. The annual incidence of new-onset AF was 2.5% and 4.1% in patients with PFO and ASD, respectively. Generally, patients with new-onset AF were older than those without AF. Device type or size did not influence the occurrence of AF. In the group of patients with PFO, residual shunt was more common in patients with AF compared with the non-AF group. In conclusion, AF is more common after PFO and ASD closure compared with the general population; although device type or size did not impact the occurrence of AF, residual shunt may influence the occurrence of AF after intervention in patients with underlying PFO.     

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.     

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)     

Initial clinical experience with intracardiac echocardiography in guiding transcatheter closure of perimembranous ventricular septal defects: feasibility and comparison with transesophageal echocardiography.

Over the last several years, intracardiac echocardiography (ICE) has been employed successfully in guiding transcatheter device closure of a secundum atrial septal defect (ASD) or patent foramen ovale (PFO). Nothing is known regarding the use of ICE to guide catheter device closure of a perimembranous ventricular septal defect (PMVSD). Twelve patients (seven female/five male) who had a PMVSD (among them, three patients with associated atrial communications: two with an ASD and one with a PFO) underwent attempts at transcatheter device closure using the Amplatzer membranous VSD device of their defects, using sequential transesophageal echocardiography (TEE) and ICE guidance with general endotracheal anesthesia (five patients) and using ICE alone with conscious sedation (seven patients). The mean age of patients was 16.9 +/- 3.7, and their mean weight was 42.4 +/- 6.6. Their mean left ventricular end-diastolic dimension preclosure was 45.7 +/- 2.5. The Qp/Qs ratio ranged from 1.0 to 1.8:1. During the procedure, the ICE catheter was positioned in the right atrium (RA) in all 12 patients and the ICE catheter was advanced to the left atrium to obtain a view of the ventricular septum in 3. Both TEE and ICE provided similar anatomical views of the position of the PMVSD. Furthermore, the relationship of the defect to the aortic valve and tricuspid valves, the measured size of defect, and the guidance of various stages of device deployment were comparable by TEE and ICE. There were no complications encountered during or after closure. We conclude that ICE provides unique images of the PMVSD and measurements similar to those obtained by TEE. ICE potentially could replace TEE in most patients as a guiding imaging tool for PMVSD device closure, thus eliminating the need for general endotracheal anesthesia.     

Closure of Atrial Septal Defects With the Amplatzer Occlusion Device: Preliminary Results

Objectives. This study reports our clinical experience with transcatheter closure of secundum atrial septal defects (ASDs) in children, using the Amplatzer, a new occlusion device.Background. None of the devices previously used for transcatheter closure of interatrial communications has gained wide acceptance.Methods. We examined the efficacy and safety of the Amplatzer, a new self-centering septal occluder that consists of two round disks made of Nitinol wire mesh and linked together by a short connecting waist. Sixteen patients with secundum ASD met established two- and three-dimensional echocardiographic and cardiac catheterization criteria for transcatheter closure. The Amplatzer’s size was chosen to be equal to or 1 mm less than the stretched diameter. The device was advanced transvenously into a 7F long guiding sheath and deployed under fluoroscopic and ultrasound guidance. Once its position was optimal, it was released.Results. The mean ASD diameter by transesophageal echocardiography was 14.1 ± 2.3 mm and was significantly smaller (p < 0.001) than the stretched diameter of the ASD (16.8 ± 2.4 mm). The mean device diameter was 16.6 ± 2.3 mm. No complications were observed. After deployment of the prosthesis, there was no residual shunt in 13 (81.3%) of 16 patients. In three patients there was trivial residual shunt immediately after the procedure that had disappeared in two of them at the 3-month follow-up.Conclusions. The Amplatzer is an efficient prosthesis that can be safely applied in children with secundum ASD. However, a study including a large number of patients and a longer follow-up period are required before this technique can be widely used.     

Percutaneous patent foramen ovale and atrial septal defect closure in adults: results and device comparison in 100 consecutive implants at a single center.

Closure of interatrial septal defects with percutaneous devices is increasingly common. However, the indications for closure and techniques for device implantation are diverse. We reviewed our first 100 consecutive implants to assess and compare the indications, results, complications, and evolution of techniques for percutaneous patent foramen ovale (PFO) and atrial septal defect (ASD) closure. The mean age of patients was 52 years and 70% were female. Paradoxical embolism was the predominant indication (94%) for PFO closure and significant left-to-right shunt was the most frequent indication (89%) for ASD closure. Implantation success was 94% with major complications in 3 patients (2.8%). Transesophageal echocardiography was utilized in the initial 27 procedures and then replaced by intracardiac echocardiography in subsequent ones, with an associated reduction in procedure and physician time. During 6 months of follow-up, 3 patients were readmitted for atrial arrhythmias (2 patients) and an MRI-negative neurologic event (1 patient). Echocardiography at 6 months in 83% of the PFO patients revealed moderate and severe positive contrast studies for right-to-left shunting in one third of patients, with differences between devices and insertion techniques. This single-center experience with percutaneous device closure of PFO and ASD in adults demonstrates excellent results with few complications.     

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.     

Simultaneous Transcatheter Closure of the Left Atrial Appendage and Congenital Interatrial Communication Closure

Background: Left atrial appendage closure (LAAC) with simultaneous interventional occlusion therapy for congenital interatrial communication has become a new focus of patients with nonvalvular atrial fibrillation. Little is known about the results of mid-and long-term results. Objective: The aim of this study was to evaluate the midand long-term safety and effectiveness of simultaneous transcatheter closure of the left atrial appendage (LAA) and congenital interatrial communication closure in atrial fibrillation (AF) patients. Methods: From Jan 2016 to June 2017, 27 patients with AF were treated with simultaneous transcatheter closure of the LAA and atrial septal defect (ASD, n = 22), patent foramen ovale (PFO, n = 5). Results: The perioperative closure success rate was 96.3%, except for cardiac tamponade occurred in one ASD patient. During the median 37.6-month follow-up period, no cases of cerebrovascular or peripheral vascular embolism, bleeding, infective endocarditis or thrombosis along the occluders were observed. Of the 21 patients with NYHA Class III, nineteen had significant improvements to NYHA Classes I or II, and 81.5% of patients were free from major or minor adverse events during midand long-term follow-up. Conclusions: Simultaneous closure of the LAA and congenital interatrial communication closure is a viable option for patients with nonvalvular atrial fibrillation who are at risk of stroke or systemic embolism, and it is effective and yields excellent mid-and long-term results.     

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.     

Effect of atrial septal mobility on transcatheter closure of interatrial communications

BACKGROUND: Transcatheter techniques have evolved as alternatives to surgical closure of interatrial communications due to its less invasive nature and low morbidity. The technique may be limited by the inability to deploy the device and, thus, may be complicated by significant residual shunting. Mobile or redundant septal tissue has been implicated as a possible cause of unsuccessful closure. METHODS: To determine if atrial septal hypermobility precludes successful transcatheter device closure of interatrial communications, 69 patients (mean age 46.4 +/- 17.5 years [male:female ratio 34:35]) with periprocedural transesophageal echocardiograms were reviewed. Septal excursion was defined as the maximal transit of the interatrial septum between either side of the plane connecting the superior and inferior attachment points. Unsuccessful closure was defined as subsequent cardiac surgery to close the defect, inability to deploy the device, recurrent attempts at closure, device malalignment, residual shunting greater than mild in degree on follow-up transthoracic study, and procedural complications. RESULTS: Reasons for closure were the following: embolic events (n = 48); platypnea/orthodeoxia (n = 15); atrial septal defect with right ventricular dilatation and paroxysmal atrial tachycardia (n = 2); atrial septal defect (n = 3); and prophylactic patent foramen ovale closure in a scuba diver (n = 1). Successful closure occurred in 76% of patients (n = 53). Compared with those patients with successful transcatheter closure, the mean septal excursion in patients with failed closure was 0.66 +/- 0.56 cm versus 0.76 +/- 0.47 cm (P = not significant [NS]). CONCLUSION: Our results do not support the concern that exaggerated septal mobility compromises successful device closure of interatrial communications.     

Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices

BACKGROUND: Atrial septal aneurysm is frequently associated with patent foramen ovale (PFO) and atrial septal defects (ASD). Moreover, a relationship between atrial septal aneurysm and embolic cerebrovascular events has been suggested. The aims of this study were to analyze morphological and functional characteristics of atrial septal aneurysm in PFO and ASD patients and to assess the feasibility and efficacy of different devices for transcatheter closure and the influence of atrial septal aneurysm. METHODS: Between March 1997 and May 2000 transcatheter ASD or PFO closure was attempted in 63 patients (mean age 47 +/- 13 years) with an atrial septal aneurysm using one of the following devices: Angelwings (n = 3), Cardioseal (n = 5), Cardioseal-Starflex (n = 7), Amplatzer (n = 11), Amplatzer-PFO (n = 5), PFO-Star (n = 25), or Helex (n = 7). RESULTS: Implantation was primarily successful (after the first or second attempt) in all patients. One PFO-Star device embolized 12 hours after the procedure. During follow-up (0.6-37 months, mean 10.4 +/- 9.2) a residual shunt could be detected by transesophageal echocardiography after 2 weeks in four patients and after 6 months in one patient. Three PFO patients had cerebrovascular events after implantation. Two patients had a transient ischemic attack (TIA) and one patient a stroke. A thrombus formation on the device detected in three patients disappeared after antithrombotic therapy. CONCLUSION: We conclude that ASDs and PFOs with an associated atrial septal aneurysm can be closed with different available devices. There seem to be no additional risks compared with patients without atrial septal aneurysm.     

Transcatheter closure of atrial septal defect and interatrial communications with a new self expanding nitinol double disc device (Amplatzer septal occluder): multicentre UK experience

OBJECTIVE—To review the safety and efficacy of the Amplatzer septal occluder for transcatheter closure of interatrial communications (atrial septal defects (ASD), fenestrated Fontan (FF), patent foramen ovale (PFO)).
DESIGN—Prospective study following a common protocol for patient selection and technique of deployment in all participating centres.
SETTING—Multicentre study representing total United Kingdom experience.
PATIENTS—First 100 consecutive patients in whom an Amplatzer septal occluder was used to close a clinically significant ASD or interatrial communication.
INTERVENTIONS—All procedures performed under general anaesthesia with transoesophageal echocardiographic guidance. Interatrial communications were assessed by transoesophageal echocardiography with reference to size, position in the interatrial septum, proximity to surrounding structures, and adequacy of septal rim. Stretched diameter of the interatrial communications was determined by balloon sizing. Device selection was based on and matched to the stretched diameter of the communication.
MAIN OUTCOME MEASURES—Success defined as deployment of device in a stable position to occlude the interatrial communication without inducing functional abnormality or anatomical obstruction. Occlusion status determined by transoesophageal echocardiography during procedure and by transthoracic echocardiography on follow up. Clinical status and occlusion rates assessed at 24 hours, one month, and three months.
RESULTS—101 procedures were performed in 100 patients (86 ASD, 7 FF, 7 PFO), age 1.7 to 64.3 years (mean (SD), 13.3 (13.9)), weight 9.2 to 100.0 kg (mean 32.5 (23.5)). Procedure time ranged from 30 to 180 minutes (mean 92.4 (29.0)) and fluoroscopy time from 6.0 to 49.0 minutes (mean 16.1 (8.0)). There were seven failures, all occurring in patients with ASD, and one embolisation requiring surgical removal. Immediate total occlusion rate was 20.4%, rising to 84.9% after 24 hours. Total occlusion rates at the one and three month follow up were 92.5% and 98.9%, respectively. Complications were: transient ST elevation (1), transient atrioventricular block (1), presumed deep vein thrombosis (1), presumed transient ischaemic attack (1).
CONCLUSIONS—It appears feasible to close interatrial communications and atrial septal defects up to 26 mm stretched diameter safely with the Amplatzer septal occluder. Short term results confirm an early high occlusion rate with no major complications. Careful selection of cases based on the echocardiographic morphology of the ASD and accurate assessment of their stretched diameter is of utmost importance. Further experience with the larger devices and longer term results are required before a firm conclusion regarding its use can be made.


Keywords: interatrial communications; atrial septal defect; Amplatzer septal occluder; congenital heart defects