A Pediatric Heart Network trial compared outcomes in infants with single right ventricle anomalies undergoing Norwood procedures randomized to modified Blalock-Taussig shunt (MBTS) or right ...ventricle-to-pulmonary artery shunt (RVPAS). Doppler patterns in the neo-aorta and RVPAS may characterize physiologic changes after staged palliations that affect outcomes and right ventricular (RV) function.
Neo-aortic cardiac index (CI), retrograde fraction (RF) in the descending aorta and RVPAS conduit, RVPAS/neo-aortic systolic ejection time ratio, and systolic/diastolic (S/D) ratio were measured early after Norwood, before stage II palliation, and at 14 months. These parameters were compared with transplantation-free survival, length of hospital stay, and RV functional indices.
In 529 subjects (mean follow-up period, 3.0 ± 2.1 years), neo-aortic CI and descending aortic RF were significantly higher in the MBTS cohort after Norwood. The RVPAS RF averaged <25% at both interstage intervals. Higher pre-stage II descending aortic RF was correlated with lower RV ejection fraction (R = -0.24; P = .032) at 14 months for the MBTS cohort. Higher post-Norwood CI (5.6 vs 4.4 L/min/m(2), P = .04) and lower S/D ratio (1.40 vs 1.68, P = .01) were correlated with better interstage transplantation-free survival for the RVPAS cohort. No other Doppler flow patterns were correlated with outcomes.
After the Norwood procedure, infants tolerated significant descending aortic RF (MBTS) and conduit RF (RVPAS), with little correlation with clinical outcomes or RV function. Neo-aortic CI, ejection time, and S/D ratios also had limited correlations with outcomes or RV function, but higher post-Norwood neo-aortic CI and lower S/D ratio were correlated with better interstage survival in those with RVPAS.
Pediatric Ablation Charges and Costs Are Rising. Introduction: Catheter ablation has been shown to be effective for pediatric tachyarrhythmias, but the associated charges and costs have not been ...described in the recent era. Understanding such contemporary trends may identify ways to keep an effective therapy affordable while optimizing clinical outcomes.
Methods: We used the 1997–2009 Kids’ Inpatient Databases to examine trends in charges and costs for pediatric catheter ablation and identify determinants of temporal changes.
Results: There were 7,130 discharges for catheter ablation in the sample. Mean age at ablation was 12.1 ± 0.2 years. Patients with congenital heart disease (CHD) made up 10% of the sample. Complications occurred in 8% of discharges. Mean total charges rose 219% above inflation (from $23,798 ± 1,072 in 1997 to $75,831 ± 2,065 in 2009). From 2003 to 2009, costs rose 25% (from $20,459 ± 780 in 2003 to $25,628 ± 992 in 2009). Charges for ablation increased markedly relative to surgical procedures, but with a similar slope to other catheter‐based interventions. Multivariable analysis revealed that year (P < 0.0001), payer (P = 0.0002), CHD (P < 0.0001), valvular heart disease (P = 0.0004), cardiomyopathy (P = 0.0009), hospital region (P < 0.0001), length of stay (P < 0.0001), and complications (P < 0.0001) predicted increased charges. The same factors also predicted increased costs. Charges and costs varied considerably by region, particularly for high‐volume centers (P < 0.0001).
Conclusions: Charges and costs for pediatric catheter ablation increased relative to other procedures and significantly outstripped inflation. Further study of complications, length of stay, and regional differences may help control rising costs while maintaining quality of care. (J Cardiovasc Electrophysiol, Vol. 24, pp. 162‐169, February 2013)
Recent years have seen an exponential increase in the variety of healthcare data captured across numerous sources. However, mechanisms to leverage these data sources to support scientific ...investigation have remained limited. In 2013 the Pediatric Heart Network (PHN), funded by the National Heart, Lung, and Blood Institute, developed the Integrated CARdiac Data and Outcomes (iCARD) Collaborative with the goals of leveraging available data sources to aid in efficiently planning and conducting PHN studies; supporting integration of PHN data with other sources to foster novel research otherwise not possible; and mentoring young investigators in these areas. This review describes lessons learned through the development of iCARD, initial efforts and scientific output, challenges, and future directions. This information can aid in the use and optimisation of data integration methodologies across other research networks and organisations.
In fiscally challenging times, scientists must seek creative strategies and leverage existing resources to advance research.
This review describes programmes supported by the National Heart, Lung, ...and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to promote research in paediatric cardiology and congenital heart disease (CHD).
An understanding of NHLBI-supported research programmes will help investigators identify opportunities to collaborate with existing systems and use scientific results from existing efforts to catalyse future research in CHD.
Tele-echocardiography has the potential to bring real-time diagnoses to neonatal facilities without in-house pediatric cardiologists. Many neonates in rural areas, smaller cities, and community ...hospitals do not have immediate access to pediatric sonographers or echocardiogram interpretation by pediatric cardiologists. This can result in suboptimal echocardiogram quality, delay in initiation of medical intervention, unnecessary patient transport, and increased medical expenditures. Telemedicine has been used with increased frequency to improve efficiency of pediatric cardiology care in hospitals that are not served by pediatric cardiologists. Initial reports suggest that telecardiology is accurate, improves patient care, is cost-effective, enhances echocardiogram quality, and prevents unnecessary transports of neonates in locations that are not served by pediatric cardiologists.
We report the largest series to evaluate the impact of telemedicine on delivery of pediatric cardiac care in community hospitals. We hypothesized that live telemedicine guidance and interpretation of neonatal echocardiograms from community hospitals is accurate, improves patient care, enhances sonographer proficiency, allows for more efficient physician time management, increases patient referrals, and does not result in increased utilization of echocardiography.
Using desktop videoconferencing computers, pediatric cardiologists guided and interpreted pediatric echocardiograms from 2 community hospital nurseries 15 miles from a tertiary care center. Studies were transmitted in real-time using the H.320 videoconferencing protocol over 3 integrated services digital network lines (384 kilobits per second). This resulted in a frame rate of 23 to 30 frames per second. Sonographers who primarily scanned adult patients but had received additional training in echocardiography of infants performed the echocardiograms. Additional views were suggested as deemed necessary by the interpreting physician, and interpretations were made during the videoconference. The results of the echocardiogram and recommendations for patient care were communicated to the referring physician over the telemedicine system. Analyses of accuracy, patient treatment, echocardiogram quality, time to diagnosis, pediatric cardiologist practice time management, patient referral patterns, and echocardiography utilization were conducted prospectively.
A total of 500 studies in 364 patients were transmitted during a 30-month period. The most common indication for echocardiography was to rule out congenital heart disease (208 of 500 studies). Signs and symptoms that prompted this concern included cyanosis, murmur, tachypnea, genetic syndrome, arrhythmia, abnormal fetal echocardiogram, and maternal diabetes. Other indications included suspected patent ductus arteriosus (PDA; 182 of 500 studies), intracardiac clot or catheter position, persistent pulmonary hypertension, and hemodynamic instability. Cardiac diagnoses included complex congenital heart disease (n = 16), noncritical heart disease (n = 107), and PDA (n = 86). Additional diagnoses included persistent pulmonary hypertension (n = 12), septal hypertrophy (n = 18), right atrial mass/clot/vegetation (n = 11), and decreased cardiac function (n = 6). An umbilical venous catheter was visualized in the left atrium in 9% (45 of 500) of all studies. No significant abnormalities were found in 244 studies. Major diagnoses were confirmed by subsequent review of videotape in all studies. Comparison of final videotape interpretation to initial telemedicine diagnosis resulted in 1 minor diagnostic change (membranous versus inlet ventricular septal defect). Echocardiograms were performed in subsequent visits in 264 patients. The diagnosis was altered in 3 patients. Telemedicine had an immediate impact on patient care in 151 transmissions. The most common interventions were indomethacin treatment for PDA (n = 76), retraction of umbilical venous catheters from the left atrium (n = 45), inotropic or anticongestive therapy (n = 19), anticoagulation (n = 8), and prostaglandin infusion (n = 8). Nineteen patients were transported to our hospital because of the telemedicine diagnosis. Inpatient or outpatient cardiology follow-up was recommended in an additional 131 studies and did not result in any change in the initial management. The most common diagnoses in these patients were ventricular septal defect (n = 56), atrial septal defect (n = 21), septal hypertrophy (n = 9), intracardiac thrombosis (n = 8), and pulmonary valve stenosis (n = 4). We speculate that the immediate availability of an echocardiographic diagnosis likely prevented unnecessary transport in 14 cases. Recommendations for additional views or adjustment of echocardiography machine settings were made in 95% of transmissions. Real-time guidance was especially helpful in suprasternal notch and subcostal sagittal imaging. Depth, color Doppler sector size, and color Doppler scale were frequently adjusted from routine adult settings during the teleconference. The average time from request for echocardiogram to completion of the videoconference was 28 +/- 14 minutes. This was significantly shorter than the waiting time (12 +/- 16 hours) for the videotape to be delivered by courier. Telemedicine eliminated the need for consultation in 194 cases and allowed the cardiologist to delay the visit until the end of the day in an additional 26 cases. This resulted in average time savings of 4.2 person-hours/wk based on travel and consultation time. Utilization of echocardiography was similar before (35 of 1000 births) and after (33 of 1000 to 43 of 1000) telemedicine installation. The percentage of neonatal echocardiograms that were interpreted by our practice increased from 63% to 81% at 1 hospital and from 0% to 100% at the other hospital.
Real-time transmission of neonatal echocardiograms from community hospitals over 3 integrated services digital network lines is accurate and has the potential to improve patient care, enhance echocardiogram quality, aid sonographer education, and have a positive impact on referral patterns and time management without increasing the utilization of echocardiography.
Objective The purpose of this analysis was to evaluate a novel strategy for reporting adverse events in the Pediatric Heart Network’s randomized surgical trial of systemic–pulmonary artery shunt ...versus right ventricle–pulmonary artery conduit in infants with hypoplastic left heart syndrome. The strategy was developed to align the reporting process with the needs of a surgical trial while maintaining participant safety. Methods Adverse event reporting was analyzed for 2 groups of study subjects: those randomized to a trial arm during a period in which a standard adverse event reporting system was used (period 1) and those randomized after institution of a system that focused serious adverse event reporting on 6 sentinel events (period 2). The analysis encompassed the period from randomization (Norwood surgery) to hospital discharge from stage II surgery. Adverse event rates were compared using a Poisson regression model for the number of events per subject. Results From period 1 to period 2, the rate of serious adverse events requiring expedited reporting decreased as expected (0.42 vs 0.14/subject/month of follow-up; P < .001). Subjects with a serious (sentinel) adverse event in period 2 had a significantly higher rate of death and cardiac transplantation. Conclusions The new adverse event reporting system successfully targeted subjects at highest risk, while decreasing the administrative burden associated with adverse event reports. This methodology may be of benefit in trials evaluating surgical or device-based interventions and in critically ill populations where many common clinical events would qualify as serious adverse events in the context of a drug trial.
Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health–National Heart, Lung, and Blood Institute ...(NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators.
In recent years, however, the NHLBI has strongly embraced an expansion of pediatric research in all areas related to its mandate, including sickle-cell anemia and other inherited blood disorders, ...asthma, neonatal respiratory distress syndrome, sleep disorders, and congenital and acquired heart disease. The term pediatric covers a broad developmental spectrum, with implications ranging from differential drug metabolism at various ages to concerns about the impact of clinical study interventions on growth. ...pediatric studies need to include children in various phases of development, often following them for extended periods of time, which adds substantially to the costs and time commitment on the part of subjects and research teams (2).
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