Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus.

OBJECTIVES: To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials. BACKGROUND: The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013. METHODS: The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported. RESULTS: Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12 months, 98.7% (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device-related adverse events. CONCLUSIONS: The Nit-Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device-related adverse events in a large cohort of three clinical trials.

Off-Pump Double Coronary Artery Bypass in a 14-Year-Old With Kawasaki Disease.

A 14-year-old male patient with a history of atypical Kawasaki disease at age 2 presents with triple vessel giant coronary aneurysms. Over the last several years, he began experiencing angina and dyspnea on exertion, which was a result of fully occluded right coronary and left circumflex arteries and 90% stenosis in the left anterior descending artery. He underwent off-pump coronary artery bypass using the left and right internal mammary arteries. At 18-month follow-up, there is no evidence of ischemia. Off-pump bypass is a feasible option for surgical management of the stenotic and occlusive complications of Kawasaki disease.

Closure of Secundum Atrial Septal Defects With the AMPLATZER Septal Occluder: A Prospective, Multicenter, Post-Approval Study.

BACKGROUND: Prospective data on the medium-term safety and effectiveness of the AMPLATZER Septal Occluder in clinical practice are not available. The objective of this study was to prospectively evaluate the risk of hemodynamic compromise and obtain medium-term survival data on patients implanted with the AMPLATZER Septal Occluder for percutaneous closure of secundum atrial septal defects. METHODS AND RESULTS: Subjects were enrolled prospectively at 50 US sites and followed for 2 years. Between 2008 and 2012, atrial septal defect closure with the AMPLATZER Septal Occluder was attempted in 1000 patients (aged 0.3-83.6 years, mean 21±22 years). Procedural closure occurred in 97.9%, with 1-month and 2-year closure 98.5% and 97.9%, respectively. Hemodynamic compromise occurred in 6 subjects (0.65%), because of dysrhythmia in 2, device embolization in 1, and cardiac erosion in 3. The rate of cardiac erosion was 0.3% (average 83, range 12-171 days from implant). CONCLUSIONS: Closure of atrial septal defect with the AMPLATZER Septal Occluder is safe and effective. The rate of hemodynamic compromise and cardiac erosion is rare. The risk factors for cardiac erosion after device closure are not yet clear. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00650936.

Transcatheter closure of perimembranous ventricular septal defects with the Amplatzer Vascular Plug-II.

OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of the Amplatzer Vascular Plug-II used for the closure of perimembranous ventricular septal defects. BACKGROUND: There are no FDA-approved transcatheter devices for the closure of perimembranous ventricular septal defects. Several studies have reported on the use of various devices either off-label or under clinical trial protocols. However these reports have described significant adverse events including residual shunts, complete heart block, arrhythmia, and new valve regurgitations. Thus far, no study on the Amplatzer Vascular Plug-II has been reported. METHODS: We conducted a 4-year retrospective chart review from August, 2010 to August, 2014, of patients with perimembranous ventricular septal defects associated with ventricular septal aneurysm who underwent transcatheter closure using the Amplatzer Vascular Plug-II. RESULTS: A total of 16 patients underwent Amplatzer Vascular Plug-II transcatheter closure of their perimembranous ventricular septal defects. The median age was 2.56 years (range: 0.5-27.3). Their median weight was 13.0 kg (range: 6.9-71.6). The left ventricular median defect size was 9.3 mm (range: 5.9-14.4). The right ventricular median defect size was 3.6 mm (range: 2.3-5.8). All the patients underwent successful device implantation with 83% of the patients having complete echocardiographic closure at the 1-year follow-up; however, one procedure was complicated by early device embolisation. The device was successfully retrieved and replaced with a larger device. There were no device-related outflow tract obstructions, rhythm abnormalities, or haemolysis. CONCLUSION: Application of the Amplatzer Vascular Plug-II for closure of perimembranous ventricular septal defects appears to be a safe and effective treatment option. Prospective clinical trials and longer follow-up periods are warranted.

Results of the combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus.

OBJECTIVES: This study aimed to compare the efficacy and safety of the Nit-Occlud PDA device (PFM Medical, Cologne, Germany) to benchmarks designed as objective performance criteria (OPC). BACKGROUND: The Nit-Occlud PDA is a nitinol coil-type patent ductus arteriosus (PDA) occluder with a reverse cone configuration, which is implanted using a controlled delivery system. METHODS: Patients with <4-mm minimum diameter PDA were prospectively enrolled in the Pivotal and the Continuing Access Studies from 15 sites in the United States and were followed up for 12 months post-procedure. Investigator-reported outcomes were compared to OPC including a composite success criterion, efficacy criteria of successful closure (clinical and echocardiographic), and safety criteria incidence of adverse events (serious and of total). RESULTS: The Pivotal Study enrolled patients between November 1, 2002 and October 31, 2005, and the Continuing Access Study enrolled additional patients between September 1, 2006 and October 31, 2007. A total of 357 patients were enrolled, and 347 had successful device implantations. After 12 months, 96.8% had complete echocardiographic closure (OPC = 85%) and 98.1% had clinical closure (OPC = 95%). There were no deaths or serious adverse events (OPC = 1%). The total adverse event rate was 4.7% (OPC = 6%). Composite success was 95.1% in the study patients (OPC = 80%). CONCLUSIONS: Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC.

Device closure of secundum atrial septal defects in infants weighing less than 8 kg.

This study aimed to assess the technical aspects of atrial septal defect (ASD) closure using the Amplatzer septal occluder (ASO) and the Gore Helex septal occluder (GHSO) for infants weighing less than 8 kg and to determine the safety, effectiveness, and near-to-intermediate-term outcome of the closure. The Mid-Atlantic Group of Interventional Cardiology Registry of percutaneous, transcatheter ASD closure procedures was reviewed for this analysis. Patients from 10 hospitals in the United States were included. The cohort for this report consisted of 68 patients weighing less than 8 kg (range, 2.3-7.8 kg; mean, 5.5 ± 1.6 kg) and ranging in age from 1 to 24 months (mean, 8.6 ± 4.7 months). The indications for ASD closure were failure to thrive, significant right heart enlargement, shunts otherwise thought to be hemodynamically significant, and poor overall clinical status. Devices were successfully implanted in 66 of the 68 infants (97.1 % procedural success rate). Five minor procedure-related complications occurred. At follow-up assessment, clinical status had improved significantly as measured by improved weight gain and decreased ventilator or oxygen dependence. All residual shunts spontaneously closed during the follow-up period. Six late deaths occurred, none of which were clearly device related. The ASO and GHSO can be safely and effectively implanted for ASD closure in infants weighing less than 8 kg. These procedures usually are successful and seldom complicated, resulting in significant clinical improvement.

Comparison of surgical, stent, and balloon angioplasty treatment of native coarctation of the aorta: an observational study by the CCISC (Congenital Cardiovascular Interventional Study Consortium).

OBJECTIVES: The purpose of this study was to compare the safety and efficacy of surgical, stent, and balloon angioplasty (BA) treatment of native coarctation acutely and at follow-up. BACKGROUND: Controversy surrounds the optimal treatment for native coarctation of the aorta. This is the first multicenter study evaluating acute and follow-up outcomes of these 3 treatment options in children weighing >10 kg. METHODS: This is a multicenter observational study. Baseline, acute, short-term (3 to 18 months), and intermediate (>18 months) follow-up hemodynamic, imaging data, and complications were recorded. RESULTS: Between June 2002 and July 2009, 350 patients from 36 institutions were enrolled: 217 underwent stent, 61 underwent BA, and 72 underwent surgery. All 3 arms showed significant improvement acutely and at follow-up in resting systolic blood pressure and upper to lower extremity systolic blood pressure gradient (ULG). Stent was superior to BA in achieving lower ULG acutely. Surgery and stent were superior to BA at short-term follow-up in achieving lower ULG. Stent patients had shorter hospitalization than surgical patients (2.4 vs. 6.4 days; p < 0.001) and fewer complications than surgical and BA patients (2.3%, 8.1%, and 9.8%; p < 0.001). The BA patients were more likely to encounter aortic wall injury, both acutely and at follow-up (p < 0.001). CONCLUSIONS: Stent patients had significantly lower acute complications compared with surgery patients or BA patients, although they were more likely to require a planned reintervention. At short-term and intermediate follow-up, stent and surgical patients achieved superior hemodynamic and integrated aortic arch imaging outcomes compared with BA patients. Because of the nonrandomized nature of this study, these results should be interpreted with caution.

Percutaneous closure of patent ductus arteriosus: a multiinstitutional registry comparing multiple devices.

BACKGROUND: There are no guidelines and multiple devices available now for closure of PDA. OBJECTIVE: We sought to determine which devices are used and their outcomes. METHODS: Prospectively collected data on closure of PDA at 12 US catheterization labs was entered into the MAGIC data registry between November 2005 and September 2008. RESULTS: PDA closure was accomplished in 357 of 359 attempted closures during the study period. Mean age, weight, and minimum ductal diameter were 4.3 ± 6.8 years, 18.7 ± 18.4 kg, and 2.1 ± 1.4 mm, respectively. Devices used were Gianturco coils (161/359), Amplatzer Duct Occluder (ADO, 174/359), Flipper coils (18/359), and other devices (6/359). Gianturco coils had the least fluoroscopy and contrast exposure (8.7 ± 7.5 min, P = 0.00001, 2.6 ± 1.4 cm(3) kg(-1), P = 0.00001). Immediate angiographic success rates were 96.9% (156/161) for Gianturco coils, 89.7% (156/174) for the ADO, 100% (18/18) for Flipper coils, and 66.7% (4/6) for other devices. Major complication rates were 0.6% for Gianturco coils (1/161), 1.7% for ADO (3/174), and 83.3% for other devices (4/6). Minor complication rates by device were 1.9% for Gianturco coils (3/161), 2.3% for ADO (4/174), and 16.7% (1/6) for other devices. CONCLUSIONS: Gianturco coils, the ADO and Flipper coils were immediately successful with low complication profiles. The ADO and Gianturco coils were the predominate devices. The ADO was the device of choice for PDA > 3 mm with good success. In PDA < 3 mm, the Gianturco coil is as effective and safe as the ADO with less cost, less radiation, and less contrast exposure. © 2010 Wiley-Liss, Inc.

Community use of the amplatzer atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect study.

The objective of this study was to determine the initial safety and results of unrestricted multi-institution routine community use of the Amplatzer Septal Occluder (ASO) for atrial septal defect (ASD) closure. A multicenter, nonrandomized prospective study was performed in 13 pediatric cardiology centers from November 2004 to September 2007. Data were collected at the time of cardiac catheterization and 1 day postimplant. Four hundred seventy-eight patients underwent cardiac catheterization for ASO device closure of an ASD. The median age was 6 years (range, <1-83 years), and the mean weight was 37.2 kg (range, 2.6-148 kg). Procedural success was 96% (458/478 patients), with deficient rims being the major single reason for failed implantation (9/20). Major and minor complication rates were 1.1% and 4.8%, respectively, and were not different between simple and complex ASD groups. Success at 24 h was 99.4% (333/335) in the simple ASD group and 100% (120/120) in the complex ASD group. The presence of large defects, the presence of multiple defects, the use of multiple devices, and a weight <8 kg were significantly associated with a residual shunt (small to moderate) at 24 h. In conclusion, the ASO device in routine clinical practice for simple and complex ASD closure has an immediate safety and effectiveness profile equal to that reported in the initial pivotal FDA trial for simple ASDs. Based on the evolution in care posed by the ASO and the lack of consensus on patient selection in complex ASDs, this study points out the need to redefine the optimal patient and possibly broaden the indications for device closure of ASDs.

Development of the MAGIC congenital heart disease catheterization database for interventional outcome studies.

As the field of catheter-based therapies for congenital heart disease continues to expand, we lack the evidence-based data to make appropriate therapeutic decisions in the catheterization laboratory. A stumbling block to the determination of evidence-based therapies is our inability to simply and reliably share outcome data across multiple centers. We investigated whether a commonly used congenital heart disease catheterization database program (PedCath) could be used as an automatic catheterization data submission tool to a central database for outcome analysis. To test the feasibility of such a tool for collaborative outcomes research we formed a national group of seven congenital heart disease centers, the Mid-Atlantic Group of Interventional Cardiology, to warehouse and analyze catheterization data. We successfully modified PedCath to transfer the results of catheter-based therapies on 256 therapeutic procedures for atrial septal defect (ASD) closure, coarctation of the aorta angioplasty and stenting, and pulmonary and aortic balloon valvuloplasties over a 13-month pilot period. Short-term follow-up within the 13-month period was received on 31 patients. This study demonstrated the successful development of a simple process, requiring minimal data entry for investigators from around the world to share cardiac catheterization data for long-term outcome determination of catheter-based therapies for congenital heart disease.

Triple-balloon pulmonary valvuloplasty: an advantageous technique for percutaneous repair of pulmonary valve stenosis in the large pediatric and adult patients.

This report describes a new valvuloplasty procedure for the treatment of pulmonary valve stenosis (PVS) and large pulmonary valve annulus (PVA) diameters using a triple-balloon valvuloplasty (TBV) technique. We sought to demonstrate the safety and efficacy of this new technique. Percutaneous balloon pulmonary valvuloplasty (BPV) is the preferred treatment for PVS. BPV in older patients with large PVA remains a challenge, even when the double-balloon valvuloplasty technique is performed. The technique was first attempted in a case where a large single balloon was unsuccessful and double-balloon valvuloplasty met with technical difficulties. Three subsequent patients underwent the procedure safely and successfully. An algorithm is presented to determine balloon size for TBV. The median PVA diameter was 23.9 mm. Balloon diameters ranged from 12 to 18 mm. The median peak right ventricular-to-pulmonary artery systolic pressure gradient was 43.5 mm Hg before valvuloplasty and was reduced to 12 mm Hg following intervention. No major complications were encountered. Percutaneous valvuloplasty using TBV can be performed safely and provides excellent clinical results. This technique offers advantages over single-balloon and double-balloon valvuloplasty techniques, especially in treatment of PVS in large pediatric or adult patients.

Real-time 3D echocardiography-guided transcatheter device closure of atrial septal defects.

We report our initial experience using real-time (live) three-dimensional (3D) transthoracic echocardiographic imaging under conscious sedation as a guide for transcatheter device closure of atrial septal defects. We believe this may be a feasible, safe, and effective alternative to the standard practice of transesophageal echocardiography, which requires general anesthesia and endotacheal intubation. Three-dimensional echocardiography may better define atrial septal anatomy and adjacent structures in planning for and performing percutaneous device closure of selected atrial septal defects.