Safety Of Transcatheter Closure Research Articles

The Outcomes of Transcatheter Closure in Patients with Patent Ductus Arteriosus at Haji Adam Malik General Hospital, Indonesia

BACKGROUND: Patent ductus arteriosus (PDA) is one of the most common acyanotic congenital heart diseases. The incidence of PDA is approximately 1 in 500 full-term neonates. The current management of PDA includes pharmacological and surgical treatments. Transcatheter closure is a preferable PDA treatment than pharmacological intervention, for medications have a higher failure rate in premature infants. Several studies have reported the efficacy and safety of transcatheter closure in smaller and lower-weight infants. AIM: This study aims to describe the outcomes of transcatheter closure of PDA, which are complete closure, migrating device, and residuals, while also investigating factors that might affect these outcomes. METHODS: A descriptive cross-sectional study was conducted from January to March 2018 in the pediatric cardiology outpatient clinic of Haji Adam Malik Hospital, Medan, Indonesia. All PDA patients who underwent transcatheter closure were included in this study. We collected patients’ demographic data (age and sex), PDA size (categorize into large, moderate, and small), and PDA closure outcomes from medical records. The collected data were then analyzed with SPSS. RESULTS: One hundred and two children were included in this study, comprised 34 (33.3%) males and 68 (66.7%) females, with a mean age of 4.3 (±4.02) years old and the mean size of the defects 4.4 (±2.25) mm. Transcatheter closure with Lifetech® PDA Occluder was performed in 95 (93.1%) and MFO® in 7 (6.9%) patients. Small residuals were found in three patients, device migration was found in one patient. No relationship was found between the size of PDA and the outcomes measured. CONCLUSION: We concluded that transcatheter closure remains an effective treatment for PDA, with a considerable success rate.

Transcatheter closure of Patent ductus arteriosus at Shahid Gangalal National Heart Centre, Kathmandu, Nepal

Background and Aims: In the current era, transcatheter closure of patent ductus arteriosus (PDA) using either coils or device is a well-established procedure. The aim of this study was to assess safety of transcatheter closure of PDA at Shahid Gangalal national heart Centre, Kathmandu, Nepal.Methods: It was a single centre, retrospective study conducted between March 2007 to March 2017. Cardiac catheterization laboratory records of all consecutive patients who underwent PDA device closure were included. A lateral view Aortic angiogram was performed to determine the morphology and size of the duct. Device type and size was selected as per the aortogram. A second aortic angiogram was performed 5 min after device deployment to determine the success of the closure. Echocardiography was done next day of the procedure to assess success of the closure.Result: During the study period 126 patients were attempted for transcatheter closure of PDA. Six patient were thought to have unfavorable size or shape, and transcatheter occlusion was not attempted. In one patients attempt was made to close the duct with cook coil which embolized to pulmonary artery. One hundred and nineteen patient PDA was successfully closed. Among the 119 patients 89 were female and 30 were male. The PDA was closed by Amplatzer duct occluder in 99 patients, Life tech PDA occluder in 14 patients, Hyperion PDA occluder in two patients, Post-infarct Muscular VSD Occluder in four patients.Conclusions: Transcatheter closure of PDA can be done safely with high success rate.

Novel delivery technique for atrial septal defect closure in young children utilizing the GORE® CARDIOFORM® septal occluder.

To develop a novel delivery technique to overcome vascular size limitations for device closure of a secundum ASD in the young patient. The efficacy, clinical utility, and safety of transcatheter closure in comparison to surgical closure are well established; however, access vessel size remains a potential limitation to device selection in the young patient. A retrospective medical record review of all cases of secundum ASD closure between April 2015 and April 2016 utilizing a novel delivery method described herein at two separate academic institutions. The device is disassembled allowing the delivery sheath to serve as the introducer. It is advanced to the RA with re-introduction of the device allowing for deployment in the standard fashion. Overall, 10 patients underwent secundum ASD closure via this novel delivery technique. There were six females (60%) and the average age at time of the procedure was 4.2 years ± 1.6 years (range 2-6 years). The majority of patients had an isolated secundum ASD (70%) with the primary indication for closure being right ventricular volume overload (90%). All patients had successful placement of a GORE® CARDIOFORM® Septal Occluder (GCSO) with no or trivial residual shunt. No patients had vascular complications related to the procedure. We describe a novel technique for ASD closure using the GCSO delivery sheath as the access sheath, which reduces the vascular access size requirement by 25%, thus addressing one common limitation for percutaneous device closure of a secundum ASD in young patients. © 2016 Wiley Periodicals, Inc.

Efficacy and safety of transcatheter closure in adults with large or small atrial septal defects.

BackgroundIn most patients with secundum atrial septal defects (ASD), transcatheter closure is the preferred treatment strategy, but whether device size affects clinical outcomes is unknown. We sought to study the efficacy and safety of large closure devices compared to the use of smaller devices.MethodsUsing a single-center, prospective registry of adult patients undergoing transcatheter ASD closure, patients receiving a large closure device (waist diameter ≥25 mm, n = 41) were compared to patients receiving smaller devices (waist diameter ≤24 mm, n = 66). We analyzed pre-interventional clinical, hemodynamic and echocardiographic data, interventional success and complication rates, and 6-month clinical and echocardiographic outcomes. The primary efficacy outcome was successful ASD closure achieved by a single procedure and confirmed by lack of a significant residual shunt at 6 months. The primary safety outcome was a composite of device embolization, major bleeding, and new-onset atrial arrhythmia occurring within 6 months.ResultsTranscatheter ASD closure using large devices was successful in 90 % compared to 97 % of patients receiving smaller devices as defined by the primary efficacy outcome (p = 0.20). The primary safety outcome occurred in 4 patients of the large and 6 patients of the small device group, resulting in an event-free rate of 90 and 91 %, respectively (p = 0.89). Similar significant symptomatic improvement was observed in both treatment groups after 6 months, indicated by a 50 % increase in the fraction of patients in NYHA class I (p < 0.0001 vs. baseline).ConclusionsTranscatheter closure in this cohort of patients with large or small ASD was effective with similar complication rates during short-term follow-up irrespective of the size of the implanted device.

Endovascular treatment of postinfarction ventricular septal defects

&lt;p&gt;&lt;strong&gt;Aim:&lt;/strong&gt; The study was designed to evaluate the possibility and safety of transcatheter closure of postinfarction ventricular septal defects in different periods after acute myocardial infarction.&lt;br /&gt;&lt;strong&gt;Methods:&lt;/strong&gt; Over a period from 2010 to 2015 15 patients (11 females and 4 males) underwent transcatheter closure of postinfarction ventricular septal defects. The time from the onset of infarction to the intervention varied between 1 day and 6 months (mean 10.9 weeks). Three patients were treated in an acute phase of infarction (two weeks or less). The defect size ranged 7-24 mm (mean 13.5 mm), while the implanted devices sized 12-34 mm (mean 22.8 mm). The procedure and screening time amounted to 67-170 (mean 115.3) and 14-78 (mean 32.5) minutes respectively.&lt;br /&gt;&lt;strong&gt;Results:&lt;/strong&gt; A successful device implantation occurred in all but one patient whose occluder was dislodged. This patient later underwent successful surgical VSD closure. Occluder implantation failed to improve the clinical status of two patients in a critical condition. They developed multiple organ failure and died at 2 and 9 days after the procedure.&lt;br /&gt;&lt;strong&gt;Conclusion:&lt;/strong&gt; Transcatheter closure of postinfarction ventricular septal defects may be an alternative to surgery in patients with suitable anatomy and multiple comorbidities. However, in-hospital mortality remains high, even after successful occluder implantation.&lt;/p&gt;

Application of Amplatzer vascular Plug II in pediatric coronary artery fistula patients treated with transcat-heter closure

Objective To investigate the feasibility and safety of transcatheter closure of coronary artery fistula (CAF) with Amplatzer vascular PlugⅡ(AVPⅡ) in pediatric patients. Methods Between June 2012 and October 2015, 5 children aged 0.9 to 7.0 years old and weighted 10 to 21 kg with CAF were admitted to the Department of Pediatric Cardiology in Shandong Provincial Hospital Affiliated to Shandong University.Aortic root angiography was used first to confirm the origin, shape, branches, drainage and the diameter of the orifice of CAF by deploying the pigtail catheter.The AVPⅡwas retrogradely deployed into targeted artery through guiding catheter and aortic angiography was performed before releasing the plug. Results All the 5 children underwent transcatheter closure by AVPⅡsuccessfully.Two cases were involved with right coronary-right ventricular fistula, 1 case of left anterior descending coronary-right ventricular fistula (residual fistula after surgical repair), and 1 case of left circumflex coronary-left atrial fistula.Four children had a single fistula, and 1 case had double fistulas.The diameter of the orifice ranged from 2.00 to 5.96 mm, and the selected occluders from 8 to 14 mm.The ratio of diameter of occluder to fistula orifice ranged from 2.3 to 3.4.All the patients were followed up for 4 to 44 months.Two patients developed instant minor and modera-te aortic regurgitation.No other complications such as thrombosis, embolization, residual shunt, arrhythmia, coronary dissection or perforation occurred. Conclusions Transcatheter closure of CAF by AVPⅡin pediatric patients is feasible and safe.Aortic regurgitation should be noted, especially during the procedure. Key words: Coronary artery fistula; Transcatheter closure; Plug; Arotic regurgitation

Emergency and sub-emergency transcatheter closure of patent ductus arteriosus in infants

Objective To explore the effects and follow-up findings of emergency and sub-emergency transcatheter closure of patent ductus arteriosus (PDA) in infants. Methods A retrospective study was performed to analyze the effects, complications, immediate and mid-term follow-up outcomes in 12 infants with PDA from Guangzhou Women and Children's Medical Center between March 2008 and April 2014 in order to evaluate the efficacy and safety of transcatheter closure of PDA in infants.All cases were diagnosed preoperatively as pneumonia, and 10 cases had congestive heart failure.Pulmonary symptoms showed no obvious change after regular internal medicine therapies. Results Twelve devices (100%) were successfully implanted.Echocardiogram was performed 3 days after the procedures and showed no residual shunt in any case.Left ventricular end-diastolic dimension[(31.3±5.4) mm], left atrial diameter[(18.2±3.4) mm], left ventricular ejection fraction(LVEF)[(56.8±8.7)%], pulmonary artery systolic pressure and mitral regurgitation were decreased or alleviated in contrast with those before the procedures(all P 0.05). Left pulmonary artery blood flow velocity was increased in 3 cases.The maximal descending aorta blood flow velocity was 1.9 m/s and 2.4 m/s respectively in 2 cases, blood flow velocity of left pulmonary artery and descending aorta were blow 2.3 m/s, pressure gradient was less than 2.9 kPa in 23-28 months after the procedure and no patient received any other intervention. Conclusions Emergency and sub-emergency transcat-heter closure of PDA in infants is safe and feasible, but long-term follow-up is needed in patients with increased left pulmonary artery blood flow velocity and/or descending aorta blood flow velocity. Key words: Patent ductus arteriosus; Interventional therapy; Emergency and sub-emergency; Infant

Transcatheter closure of coronary artery fistulas in infants and children: A French multicenter study.

The short-term efficacy and safety of transcatheter closure (TCC) for the management of coronary artery fistulas (CAFs) was investigated in pediatric patients. CAFS are rare with potentially severe complications and their management is still a matter of debate. Percutaneous closure appears to be the treatment of choice in anatomically suitable vessels but limited data are available in the pediatric population. This retrospective, observational, multicenter, national study included patients under 16 years of age who underwent TCC of a congenital CAF. Patients with additional congenital heart defect were excluded. 61 patients (36 girls, 25 boys) with a median age of 0.6 year [0-15.4] at diagnosis and 3.9 years [0-16] at procedure were included. The CAF was large in 48 patients (79%); it was distal in 23 (38%) and proximal in 22 (36%). Most patients (77%) were asymptomatic at diagnosis. Clinical signs of congestive heart failure were present in seven patients (11%). Perioperative complications included three cases of ST elevation myocardial infarction (exclusively during attempted closure of a distal CAF), three devices migrations, and one case of leg ischemia. One patient died after surgical closure of a large distal CAF that could not be closed by TCC. Follow-up data were collected for 43 patients (70%) for a median of 91 days [0-4,824]. The Kaplan-Meyer estimate for complete occlusion at 2 years was 73 ± 7.6%. TCC in the pediatric population appears to be effective and associated with few complications.

Transcatheter closure of large patent ductus arteriosus with severe pulmonary arterial hypertension: Short and intermediate term results

Objective:To assess the efficacy and safety of transcatheter closure (TCC) of patent ductus arteriosus (PDA) with severe pulmonary arterial hypertension (PHT).Background:TCC of small and moderate-sized PDAs is well established. However, there is a paucity of data on TCC of large PDA with severe PHT.Methods:This is a retrospective observational study of 76 patients with large PDA and severe PHT who were referred for TCC. Multiple clinical and investigational parameters were evaluated to decide the reversibility of PHT. Following the TCC, patients were serially followed up to assess the efficacy and safety of closure and its impact on PHT.Results:Of 76 patients, nine were found to have PDA with Eisenmenger's syndrome. Of remaining 67, two were thought to have irreversible PHT based on hemodynamic data obtained after balloon occlusion of the duct. Sixty five patients, who eventually underwent TCC of PDA, had a median age of 9.1 years (range 1 month to 40 years). The weight ranged between 2.5 to 62 kg (median 14 kg). The PDA size was 9.1 ± 4.6 mm. The mean systolic pulmonary artery pressure was 66.9 ± 15.3 mm Hg. Duct occluder was used in 63 and muscular ventricular septal defect closure device in 2. The follow up was available in 56 (86%) with a mean follow up period of 65 ± 34 months. All the patients had complete closure of the PDA at 6 months follow up. Mild obstruction of left pulmonary artery (n=3) and aortic isthmus flow (n=6) was noted at the time of discharge. During the follow up, partial or complete resolution of PHT was observed in all the patients in whom Doppler-derived right ventricular systolic pressure was recorded (available in 40 of 56 patients).Conclusions:TCC of large PDA with severe PHT and significant left to right shunt was found to be effective and safe in the short and intermediate term.

Clinical Efficiency and Safety Analysis of Transcatheter Closure of Multiple Atrial Septal Defects in Adults

Transcatheter closure of atrial septal defects (ASDs) is currently a reliable alternative to surgery, even though challenging in patients with multiple ASDs. The aim of this study was to evaluate the clinical efficiency and safety of transcatheter closure in multiple ASDs. Multiple ASDs were diagnosed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE). The occlusive condition and distance between 2 adjacent ASDs were measured by TTE examination. Then, the number and size of the occluder(s) was determined. TTE examinations were performed after transcatheter closure as follow-up. The transcatheter procedure was successful in 15 patients with multiple ASDs, using a single occluder in 9 patients and 2 occluders in the remaining 6 patients. Overall, 21 ASD occluders were implanted. During a follow-up period of 6 mo to 5 y, a slight residual shunt was found in 1 patient without any symptoms; a moderate residual shunt was identified at the inferior vena cava and the occluder was removed by surgery 1 mo after procedure. Other complications, including endocarditis, arrhythmia, thromboembolism, and atrioventricular valve damage were not recorded in any of the 15 patients during the follow-up period. Transcatheter closure of multiple ASDs is safe and efficient. Two occluders are necessary for the distance of 2 ASDs more than 7 mm, and a single occluder is sufficient for those 7 mm or less.

Closure of Large Patent Ductus Arteriosus in Infants

The purpose of this study was to evaluate the feasibility, clinical outcome, and resource utilization of transcatheter closure of large, symptomatic patent ductus arteriosus (PDA) in young infants, and compare the results with those of surgery. From January 2003 to December 2006, successful transcatheter implantation of the Amplatzer duct occluder was performed in 20 young infants (< or = 3 months of age) with large PDA who suffered from severe congestive heart failure despite medical treatment. The data was compared with a historical control of 18 young infants who underwent surgical ligation of PDA. Patient ages ranged from 18 to 89 days (mean 51.8) in the study group and 13 to 82 days (mean 39.9) in the control group. Patient weight ranged from 2.7 to 7.1 kg (mean 4.24) in study group and 2.5 to 5.7 kg (mean 3.79) in the control group. Between the 2 groups, there was no significant difference in the rate of complications. Patients who underwent transcatheter closure utilized significantly fewer resources (length of hospital stay and total cost) than those who underwent surgery. In conclusion, percutaneous device occlusion with Amplatzer duct occluder in small, symptomatic infants is feasible and more cost-effective compared with surgery. In experienced hands with careful preprocedural evaluation and delicate manipulation, the safety of transcatheter closure with Amplatzer ductus occluder in this age group can be assured and major complication avoided. Revision of the delivery sheath, making it kink-resistant, and PDA shape-tailored devices should further optimize the procedure.

Clinical results of percutaneous closure of large secundum atrial septal defects in children using the Amplatzer septal occluder

We reviewed our experience using the Amplatzer septal occluder (AGA Medical, Golden Valley, MN, USA) to close large, secundum-type atrial septal defects (ASDs) in children. Between June 2002 and December 2005, 52 patients (mean age 13.5 +/- 8.7 years) underwent transcatheter closure of large (> or =25 mm), secundum ASDs with the use of the Amplatzer septal occluder (ASO). Groups 1 and 2 included patients with a retroaortic rim of <5 mm (n = 39) or > or =5 mm (n = 13), respectively. All procedures were performed with general anesthesia and transesophageal echocardiographic guidance except for 10 patients, which involved local anesthesia and three-dimensional transthoracic echocardiography. Successful device implantations, device sizes, approaches, complications, and closure rates were assessed. Device implantation was successful in 50 patients (96.1%), with no difference between groups (95% vs 100%, P>0.05). In 2 patients, implantation failed because of embolism or deployment failure. Device were larger in group 1 than in group 2 (29.7 +/- 4.2 vs 26.7 +/- 3.8 mm, P = 0.04). The right upper pulmonary-vein approach was more common in group 1 than in group 2 (P = 0.0001). Complications and closure rates did not differ between the groups (P > 0.05). Transcatheter closure of large, secundum ASD by using the ASO device was feasible, and complication rates were low. A deficient retroaortic rim did not preclude successful device implantation; however, a large device may be needed to close large ASD. Close long-term follow-up is necessary to determine the safety of transcatheter closure of large ASDs in children.

HELEX Septal Occluder for transcatheter closure of patent foramen ovale: multicentre experience.

Patients with cryptogenic embolic events and a patent foramen ovale (PFO) are at risk of paradoxical embolism causing recurrent cerebral events; however, transcatheter PFO closure remains controversial. The aim of this multicentre trial was to demonstrate the feasibility and safety of transcatheter closure of PFO with the HELEX Septal Occluder. The study enrolled 128 patients (66 female; mean age, 50 years). Mean (+/-SD) PFO size was 10+/-3.7 mm; 38 patients also had an atrial septal aneurysm. Device implantation was successful in 127 patients. Device-related events during implantation or follow-up were device embolisation, wire-frame fracture, and retrieval cord breaks (two cases each; no sequelae). Other adverse events included atrial arrhythmia (two patients), migraine, convulsion, and transient ischaemic attack (one case each). There were no recurrent strokes, deaths, perforations, or accumulations of thrombi on the device. Within a mean follow-up period of 21+/-11 months, complete PFO closure using one device was achieved in 114 patients (90%). Five patients with a moderate to large residual shunt received a second device. The HELEX Occluder can be used for PFO closure. Device- and procedure-related complications are rare. The closure procedure appears to reduce recurrence rates of stroke and transient ischaemic attack.