Parental factors impacting the enrollment of children in cardiac critical care clinical trials.

Clinical trials are abundant in adult cardiovascular medicine; however, they are rare in pediatric cardiology. Pediatric cardiac trial design may be impacted by the heterogeneous nature of the underlying cardiac defects, as well as by a strong emotional response from parents whose child will undergo a surgical intervention. The purpose of this study was to assess factors that may have an impact on parents considering enrollment of their child in a clinical trial at the time of surgical intervention. A voluntary, self-administered questionnaire (14 questions) was provided to parents of children 16 years of age or younger during the preadmission testing period. Demographic and procedure-related variables were collected for each patient. A total of 119 surveys were analyzed over a 1.5-year period. Only 8% of the parents had their child participate in a clinical trial in the past. Fifty-six percent of the parents preferred that their child's cardiologist or surgeon explain clinical trial details, with 23% preferring the principal investigator and 3% preferring the research coordinator. Fifty percent of the parents were favorably disposed to participate in a clinical trial if the drug or device was currently used by their child's doctor, and 19% were encouraged to participate if the drug or device was approved for use in adults. The majority of parents (64%) preferred to be asked about participating in a trial within 1 month prior to the planned procedure, and 40% preferred to discuss trial details at a remote time in an outpatient location. Sixty-three percent of parents believed that most of the medications currently used in children were already approved by the Food and Drug Administration. Most parents (91%) believed that clinical trials conducted in children will help improve pediatric health care; 74% believed that their child may receive potential benefit from enrolling in a trial. Finally, 43% believed that funding for trials should come from government and health care agencies, as opposed to pharmaceutical companies (24%). This survey reveals the importance of the attending physician and timing in educating parents regarding a cardiac critical care clinical trial. These data may impact the design and successful conduct of future trials.

Unrecognized pulmonary venous desaturation early after Norwood palliation confounds Gp:Gs assessment and compromises oxygen delivery.

BACKGROUND: Hemodynamic stability after Norwood palliation often requires manipulation of pulmonary vascular resistance to alter the pulmonary-to-systemic blood flow ratio (Qp:Qs). Qp:Qs is often estimated from arterial saturation (SaO2), a practice based on 2 untested assumptions: constant systemic arteriovenous O2 difference and normal pulmonary venous saturation. METHODS AND RESULTS: In 12 patients early (

Unique echocardiographic features associated with deployment of the Amplatzer atrial septal defect device.

The purpose of this study was to describe the unique echocardiographic findings associated with deployment of the Amplatzer atrial septal defect (ASD) device. Thirty-five patients (2 to 40 years old; 23 female and 12 male patients) underwent echocardiography during attempted ASD closure with the Amplatzer device. Transesophageal and transthoracic echocardiograms were performed during the placement and follow-up of the device, respectively. In 5 patients, the device was not deployed because of transesophageal echocardiography (TEE) findings (an exceedingly large defect in 3 patients, partial obstruction of the upper right pulmonary vein by the device in 1, and complex atrial septal anatomy in 1). In the remaining 30 patients, after deployment but before release, the device distorted the atrial septum from the normal vertical orientation to an oblique transverse orientation. Excessive septal distortion (i.e., > or =90 degrees in 1 patient) was associated with device embolization upon release. In other patients, TEE also identified mild splaying of the device on the aortic wall, mild abutment of the device upon the mitral valve, and temporary partial obstruction of pulmonary vein flow. Color Doppler revealed residual shunts in 21 of 29 patients immediately after release, but in none of 15 patients at 1-year follow-up. Transesophageal echocardiography is essential to ensure proper Amplatzer device placement. Distortion of the atrial septum and Amplatzer device orientation occur before release but resolve on release from the delivery cable. Small residual shunts are common early, but they resolve in 6 to 12 months.

One-year follow-up of the amplatzer device to close atrial septal defects.

The early and 1-year follow-up of a single United States center using the Amplatzer atrial septal defect closure device is reported. Complete closure was documented in all patients by 1 year after device implantation.

Evaluation of a fiberoptic blood gas monitor in neonates with congenital heart disease.

BACKGROUND: Blood gas analysis is extremely important in perioperative management of neonates with congenital heart disease, where ventilator manipulation of the pulmonary vascular resistance is crucial. Delays in blood gas analysis resulting from transport of samples to a central laboratory may compromise management of these patients. Furthermore, neonates with congenital heart defects may have lower arterial oxygen (PaO2) levels due to intracardiac right-to-left shunting. We evaluated the Sensicath System in neonatal patients following cardiac surgery by simultaneously measuring specimens on the central laboratory blood gas analyzer. METHODS: After patients returned from the operating room, the Sensicath System was connected to the arterial line. Blood was pulled across the sensor and re-infused to the patient after analysis. The accuracy and precision of the Sensicath System blood gas analysis results were assessed by comparison to simultaneous samples analyzed with a Corning 855 analyzer. The specimen-result turnaround time was recorded. 97 samples from 5 patients were compared. RESULTS: Blood gas analysis results from the Sensicath System showed acceptable accuracy and precision: partial pressure of oxygen (PO2), r2 = 0.89, bias = -4.5 mm Hg, precision = 11.8; partial pressure of carbon dioxide (PCO2), r2 = 0.59, bias = -0.4 mm Hg, precision 6.2; pH, r2 = 0.78, bias = 0.03 mm Hg, precision 0.03. The central lab specimen-result turnaround time was 13.8 +/- 7.1 minutes. The Sensicath System provided results after a 60-second analysis time with no blood loss. CONCLUSIONS: When compared to a Corning 855 blood gas analyzer, the Sensicath System was found to provide acceptable blood gas values, with no iatrogenic blood loss. This system may be especially helpful in infants with congenital heart defects, since rapid results are necessary for optimal patient care.