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Biomedical subjects

John P Cheatham

Publications and source records attributed to John P Cheatham.

11 recordsLinked to original sources
PubMed2006

Transcatheter closure of perimembranous ventricular septal defects using the new Amplatzer membranous VSD occluder: results of the U.S. phase I trial.

OBJECTIVES: This phase I study attempted to report the initial safety and efficacy results of transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using the new Amplatzer Membranous VSD Occluder (AGA Medical Corp., Golden Valley, Minnesota) in the U.S. BACKGROUND: The most common congenital heart disease is PmVSD. Surgical repair is widely accepted, but still carries a small but definite risk of morbidity and mortality. METHODS: Between October 2003 and August 2004, a total of 35 patients with PmVSD underwent an attempt of transcatheter closure under transesophageal and/or intracardiac echocardiographic guidance. The median age was 7.7 years (range, 1.2 to 54.4 years) and median weight was 25 kg (range, 8.3 to 110 kg). The median Qp/Qs ratio was 1.8 (range, 1 to 4), and the median VSD size as assessed by echocardiography was 7 mm (range, 4 to 15 mm). RESULTS: The attempt to place a device was successful in 32 patients (91%). The median device size used was 10 mm (range, 6 to 16 mm). The complete closure rates by echocardiography at 10 min (transesophageal/intracardiac), 24 h, 1 month, and 6 months (transthoracic) were 47% (15/32), 63% (20/32), 78% (25/32), and 96% (27/28), respectively. The median fluoroscopy time was 36 min (range, 14 to 191 min), and the median total procedure time was 121 min (range, 67 to 276 min). Three patients (8.6%) had serious adverse events of complete heart block, peri-hepatic bleeding, and rupture of tricuspid valve chordae tendineae. No other patient encountered serious adverse events during the follow-up. CONCLUSIONS: Transcatheter closure of a PmVSD is technically feasible and seems safe enough in children over 8 kg in weight to warrant continuation of clinical trials to assess the long-term safety and efficacy.

Adolescent↗
PubMed2006

Assessment of in-stent stenosis in small children with congenital heart disease using multi-detector computed tomography: a validation study.

OBJECTIVES: Our purpose was to investigate the diagnostic reliability of multi-detector computed tomography (MDCT) in assessing in-stent stenosis compared to digital angiography (DA) in small children. BACKGROUND: Little is known about the feasibility of using MDCT to assess stents placed to treat children with congenital heart disease (CHD). METHODS: Twenty-two children (median age [range], 2(3/4) [(1/2) to 12] years) with 42 transcatheter placed stents (median diameter: 7.2 [3.4-16.3] mm) in the pulmonary arteries (n = 36), aorta (2), PDA (1), and SVC (3) underwent both MDCT and DA due to suspected hemodynamic problems. RESULTS: Independent "blinded" observers were able to measure stent and minimal luminal diameters in 115 out of 124 (93%) stent segments on MDCT and DA. The interobserver variability was low (mean difference: 0.5, SD 0.8 mm) with high correlation (r = 0.97; P < .0001). The percent stenosis by MDCT correlated well with DA (r = 0.89, P < .0001; mean error 2.7, SD 10.4%). For all grades of stenosis, the sensitivity and specificity for MDCT were 58% and 97%, respectively. At a threshold of approximately > or =20% stenosis sensitivity became >98%. All stent associated complications [fracture (4), vascular narrowings (11)] were diagnosed by MDCT. As the stent diameter increased, there was significantly reduced variability between MDCT and DA for in-stent stenosis (P < .0001). CONCLUSION: In small children, MDCT is a feasible and promising method for assessing stent associated complications in the treatment of CHD. Cardiac surgeons and interventional cardiologists might rely on this imaging modality to plan specific interventions more precisely and to assess the results upon follow up.

Angiography, Digital Subtraction↗
PubMed2006

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.

Adolescent↗
PubMed2006

Transcatheter devices used in the management of patients with congenital heart disease.

The availability of transcatheter devices has revolutionized the management of patients with congenital heart and vascular disease. Many patients that were in the past exclusively treated through open heart surgical procedures can now be managed using a percutaneous approach. This article describes those devices that are, at present, most frequently used in the USA for transcatheter therapy of congenital heart disease, which have, or are about to receive, US premarket approval. It also focuses on devices for occlusion of septal defects and vascular structures, as well as endovascular stents. In addition, the most important outcome data are discussed.

Cardiac Catheterization↗
PubMed2005

Radiofrequency perforation and cutting balloon septoplasty of intact atrial septum in a newborn with hypoplastic left heart syndrome using transesophageal ICE probe guidance.

Newborns with hypoplastic left heart syndrome and intact atrial septum present an emergent and unique challenge to a children's heart center. This case report describes new transcatheter techniques (use of radiofrequency energy to perforate the atrial septum followed by cutting balloon and static balloon septoplasty) and novel use of a transesophageal ICE probe.

Catheter Ablation↗
PubMed2005

Congenital superior vena cava obstruction causing anasarca and respiratory failure in a newborn: successful transcatheter therapy.

Superior vena cava (SVC) obstruction is a rare entity in the pediatric population. It usually presents in association with either previous cardiac surgery or external compression from a neoplasm. We present the case of an infant born with congenital SVC obstruction and significant bilateral chylothorax and anasarca necessitating mechanical ventilation. Successful placement of an intravascular stent led to resolution of the chylothoraces with rapid clinical improvement.

Angioplasty, Balloon↗
PubMed2004

Usefulness of multislice computed tomography angiography to evaluate intravascular stents and transcatheter occlusion devices in patients with d-transposition of the great arteries after mustard repair.

Percutaneous interventions can treat long-term complications after Mustard atrial switch operation in patients with d-transposition of the great arteries (d-TGA), but follow-up for these procedures has not been established. Four patients with d-TGA and previous Mustard operation underwent percutaneous placement of covered stents to relieve superior and inferior vena caval baffle obstructions and leaks. At 6 to 13 months, assessment with 16-slice spiral computed tomography identified stent patency as well as lead placement and visualization of additional devices.

Adult↗
PubMed2004

Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk.

The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk. There have been rare occurrences of adverse events with development of pericardial effusion after ASO placement. Identification of high-risk cases, early recognition, and prompt intervention may minimize the future risks of adverse events. In all patients who developed hemodynamic compromise after ASO placement, echocardiograms (pre-, intra-, and postprocedure), atrial septal defect (ASD) size (nonstretched, stretched), size of the device used, cineangiograms, and operative records were reviewed by a panel selected by AGA Medical Corporation. The findings were compared to the premarket approval data obtained from FDA-approved clinical trials that were conducted in the United States, before the device was approved. A total of 28 cases (14 in United States) of adverse events were reported to AGA Medical. All erosions occurred at the dome of the atria, near the aortic root. Deficient aortic rim was seen in 89% and the defect described as high ASD, suggesting deficient superior rim. The device to unstretched ASD ratio was significantly larger in the adverse event group when compared to the FDA trial group. The incidence of device erosion in the United States was 0.1%. The risk of device erosion with ASO is low and complications can be decreased by identifying high-risk patients and following them closely. Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing. Patients with small pericardial effusion at 24 hr should have closer follow-up.

Adolescent↗
PubMed2004

Fontan completion without surgery.

An ideal Fontan procedure would minimize complications while maximizing flow dynamics through the circuit. We report our early experience with a new combined surgical/transcatheter approach which enables a nonoperative, transcatheter Fontan completion. The conceptual rationale of this management strategy, as well as surgical and catheterization techniques, are discussed.

Catheterization↗