Daniel H. Gruenstein

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.

Stenting of Aortic Coarctation: Acute, Intermediate, and Long-Term Results of a Prospective Multi-Institutional Registry—Congenital Cardiovascular Interventional Study Consortium (CCISC)

Introduction: Since the 1980s, stent implantation has evolved as an important therapeutic strategy for coarctation of the aorta. However, available data is frequently flawed by short follow‐up, lack of adequate follow‐up imaging, and retrospective nature of data collection. Methods: Data was prospectively collected using a multicenter registry congenital cardiovascular interventional study consortium (CCISC). Between 2000 and 2009, 302 patients from 34 centers with a median weight of 58 kg underwent stent implantation for coarctation. Eligible patients (44%) completed intermediate follow‐up (3–18 months) with integrated imaging (cath, CT, MRI), whereas 21% completed long‐term follow‐up (>18–60 months). Procedural success was defined as UL/LL systolic gradient of less than 20 mm Hg, lack of significant recurrent obstruction, and freedom from unplanned repeat intervention. Results: Acute procedural success was 96%. Cumulative intermediate success was 86%, and cumulative long‐term success was 77%. Unplanned repeat interventions were required in 4%, and aortic wall complications were seen in 1% of patients (dissection n = 1 and aneurysm n = 3). Other adverse events (n = 15) occurred mainly acutely and included technical complications such as stent malposition (n = 9). At long‐term follow‐up, 23% of patients continued to have systolic blood pressure above the 95th centile, 9% had an upper‐to‐lower limb blood pressure gradient in excess of 20 mm Hg, and 32% were taking antihypertensive medication. Conclusions: This study documented acute, intermediate, and long‐term outcome data comparable or superior with other surgical or interventional series. However, even with successful initial stent therapy, patients continue to require long‐term follow‐up and have associated long‐term morbidity, relating to aortic wall complications, systemic hypertension, recurrent obstruction as well as need for repeat intervention.

CRISP: Catheterization RISk score for pediatrics: A Report from the Congenital Cardiac Interventional Study Consortium (CCISC)

We sought to develop a scoring system that predicts the risk of serious adverse events (SAEs) for individual pediatric patients undergoing cardiac catheterization procedures.

Pericardial effusion after pediatric hematopoietic cell transplant.

PE can occur following HCT. However, the incidence, etiology, risk factors, and treatment remain unclear. We performed a retrospective study evaluating 355 pediatric recipients of HCT treated at a single institution between January 2005 and August 2010. No cases of PE were identified in the autologous HCT (auto‐HCT) recipients (0/43), while 19% (57/296) of allogeneic HCT (allo‐HCT) developed PE. Among the 57 PE patients, 40 (70%) were males; the median age at transplantation was 6.6 yr (0.1–17.3 yr). Thirty‐six patients (63%) had significant PE with 23 patients (40%) treated by pericardiocentesis, and 19 (33%) experiencing recurrent PE. OS rates for patients who developed PE were 84% at 100 days and 65% at three yr after HCT. Risk factors associated with PE on multivariate analysis included myeloablative conditioning (p = 0.01), delayed neutrophil engraftment (p < 0.01), and CMV + serostatus of the recipient (p = 0.03). Recipients with non‐malignant diseases were significantly less likely to die after development of PE (p = 0.02 and 0.004 when comparing with standard and high‐risk diseases, respectively). In summary, PE is a common and significant complication of pediatric allo‐HCT. Prospective studies are needed to better determine the etiology and optimal method of PE treatment after HCT.

Standardizing radiation dose reporting in the pediatric cardiac catheterization laboratory-a multicenter study by the CCISC (Congenital Cardiovascular Interventional Study Consortium).

We examine normalized air Kerma area product (PKA) by body weight (PKA/BW) as a reference value of radiation dose and benchmark PKA/BW in pediatric laboratories using a multicenter registry database.

Experimental evaluation of a new articulated Amplatzer® ductal occluder device without fabric†

Objectives: To describe a new percutaneous PDA device. Background: The ADO II was developed by AGA Medical for closure of small‐moderate sized PDAs via a small delivery catheter from an antegrade or retrograde catheter approach. The objective of this study was to evaluate the technical feasibility, safety, and efficacy of the ADO II in a canine PDA model. Methods: The ADO‐II consists of multi‐layer nitinol wire braid with symmetric retention disks and an articulating connecting center waist, without sewn‐in polyester, that can be delivered though a 4‐5F catheter. A PDA was surgically created in nine dogs. Transcatheter occlusion of the PDA was performed using the ADO II. Angiographic and hemodynamic data were obtained at 7, 30, 60, and 90 days post‐procedure. The devices were then harvested for pathology. Results: Devices were placed transarterially (n = 8) and transvenously (n = 1). All PDAs were occluded and there were no significant pressure gradients (P > 0.05) at the immediate and 90 post‐implant evaluations. Pathology found endothelial coverage on all aortic and pulmonary disks, except at the tip of the microscrew. There were no procedural complications. One canine was euthanized 4 hr after device implant because of a clinical deterioration. The staff veterinarian and pathologist concluded that the animals illness was not device related. Conclusions: The Amplatzer ADO II devices can be safely deployed in animal models of PDAs, with complete resolution of the PDA shunt. The lower profile and symmetry of the ADO II allows for venous or arterial approach and smaller delivery catheter size. The ADO‐II is expected to be a preferred alternative for closure of small‐moderate PDAs.

Transcatheter closure of the perimembranous ventricular septal defect—preclinical trial of a new amplatzer device

Objectives: This study assessed the feasibility and efficacy of implanting a new nitinol device for closure of perimembranous ventricular septal defects in a swine model. Background: Perimembranous ventricular septal defect occurs in 80% of patients requiring treatment for congenital heart disease. Methods: The Amplatzer perimembranous ventricular septal occluder device (pmVSO2 device, AGA Medical Company, Plymouth MN) is a new transcatheter Nitinol device containing polyester fabric designed to close the perimembranous ventricular septal defect (VSD). The device has 75% reduction in radial force, 45% reduction in clamping force, and increased stability as compared to the previous version. The device was implanted in six swine with naturally occurring perimembranous VSD with immediate, 1, 7, ∼30, and ∼90 day followup by echocardiography, angiography, and final pathological examination. Results: The device was successfully implanted in all animals and was retrievable and repositionable. There was complete occlusion of the VSD in five of six cases without embolization. There was no thrombus formation on the device or occurrence of complete heart block. A single instance of a tiny residual shunt was attributed to capture of tricuspid valve apparatus. Conclusions: The success of this animal study confirms safety and feasibility of the Amplatzer pmVSO2 device. Human trials are planned.

Palliative balloon angioplasty in a cat with right pulmonary arterial branch stenoses and concurrent absence of the left pulmonary artery.

Unilateral absence of the left or right pulmonary artery with concurrent contralateral pulmonary arterial branch stenoses is an exceptionally rare disorder. We describe this anomaly in a cat with severe exercise intolerance and respiratory distress. Transthoracic echocardiography and angiography demonstrated the absence of the left pulmonary artery with concurrent right pulmonary branch stenosis. Palliative balloon angioplasty of the right pulmonary artery substantially reduced right ventricular systolic pressure load and alleviated the patients clinical signs.

Stent placement for palliation of cor triatriatum dexter in a dog with suspected patent foramen ovale

An 11 month old spayed, female dog presented with exercise intolerance and cyanosis upon exertion. Echocardiography revealed an imperforate cor triatriatum dexter with mild tricuspid valve dysplasia, an underfilled right ventricle and significant right to left shunting across a presumptive patent foramen ovale. Balloon dilation of the abnormal atrial membrane was initially successful in creating a communication between the right atrial chambers, but stenosis of the original perforation and persistent clinical signs prompted a second intervention. A balloon expandable biliary stent was placed across the abnormal partition, improving caudal venous return to the right ventricle and reducing the right to left shunt. Three months after stent placement, resting oxygen saturation had normalized. Six months after stent placement, exercise tolerance had improved and exertional cyanosis had resolved. Long term follow up will be necessary to assess for remodeling of the right ventricle with improved venous return. Stent placement can be considered as a palliative treatment option for cor triatriatum dexter, especially for stenosis post-balloon dilation.

Successful Coil Embolization of a Large Ascending Aortic Pseudoaneurysm Following Explantation of the EXCOR Pediatric Ventricular Assist Device in a Patient With Acute Fulminant Myocarditis.

Mechanical ventricular assistance has become a reliable tool for the support of children and infants with heart failure. The devices have shown efficacy both as a bridge to transplantation and as a bridge to recovery. The potential complications that may occur with long-term support have not been fully described. This article reports the occurrence of a large pseudoaneurysm associated with the ascending aorta following explantation of the EXCOR Pediatric ventricular assist device. A management strategy for this potentially lethal complication is described.