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Challenges and lessons learned from the Pediatric Heart Network Normal Echocardiogram Database study
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- Dongngan Truong, Leo Lopez, Peter C. Frommelt, Jessica Stelter, Brenda Ni, Meryl S. Cohen, Ashwin Prakash, Steven D. Colan, Christopher Spurney, Jonathan Soslow, Gail D. Pearson, Joseph Mahgerefteh, Ritu Sachdeva, Ricardo Pignatelli, Felicia Trachtenberg, Mario Stylianou, Karen Altmann, Kathleen A. Rathge, Joseph Camarda, Shahryar Chowdhury, Andreea Dragulescu, Michele Frommelt, Olukayode Garuba, Brian Soriano, Shubhika Srivastava, Poonam Thankavel, Mary E. van der Velde, L. LuAnn Minich, For the Pediatric Heart Network Investigators
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- Journal:
- Cardiology in the Young / Volume 30 / Issue 4 / April 2020
- Published online by Cambridge University Press:
- 17 March 2020, pp. 456-461
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Background:
The Pediatric Heart Network Normal Echocardiogram Database Study had unanticipated challenges. We sought to describe these challenges and lessons learned to improve the design of future studies.
Methods:Challenges were divided into three categories: enrolment, echocardiographic imaging, and protocol violations. Memoranda, Core Lab reports, and adjudication logs were reviewed. A centre-level questionnaire provided information regarding local processes for data collection. Descriptive statistics were used, and chi-square tests determined differences in imaging quality.
Results:For the 19 participating centres, challenges with enrolment included variations in Institutional Review Board definitions of “retrospective” eligibility, overestimation of non-White participants, centre categorisation of Hispanic participants that differed from National Institutes of Health definitions, and exclusion of potential participants due to missing demographic data. Institutional Review Board amendments resolved many of these challenges. There was an unanticipated burden imposed on centres due to high numbers of echocardiograms that were reviewed but failed to meet submission criteria. Additionally, image transfer software malfunctions delayed Core Lab image review and feedback. Between the early and late study periods, the proportion of unacceptable echocardiograms submitted to the Core Lab decreased (14 versus 7%, p < 0.01). Most protocol violations were from eligibility violations and inadvertent protected health information disclosure (overall 2.5%). Adjudication committee reviews led to protocol changes.
Conclusions:Numerous challenges encountered during the Normal Echocardiogram Database Study prolonged study enrolment. The retrospective design and flaws in image transfer software were key impediments to study completion and should be considered when designing future studies collecting echocardiographic images as a primary outcome.
Late outcomes in children with Shone’s complex: a single-centre, 20-year experience
- George T. Nicholson, Michael S. Kelleman, Caridad M. De la Uz, Ricardo H. Pignatelli, Nancy A. Ayres, Christopher J. Petit
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- Journal:
- Cardiology in the Young / Volume 27 / Issue 4 / May 2017
- Published online by Cambridge University Press:
- 26 July 2016, pp. 697-705
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Objective
Shone’s syndrome is a complex consisting of mitral valve stenosis in addition to left ventricle outflow obstruction. There are a few studies evaluating the long-term outcomes in this population. We sought to determine the long-term outcomes in our paediatric population with Shone’s syndrome and the factors associated with left heart growth.
MethodsAll patients diagnosed with Shone’s syndrome with biventricular circulation treated between 1978 and 2010 were reviewed. Baseline echocardiograms and data from catheterisations were also reviewed. Number of interventions (surgical+transcatheter), incidence of mitral valve replacement, and incidence of heart transplantation were tracked. Survival of the population and left heart structural growth were also reviewed.
ResultsA total of 121 patients with Shone’s syndrome presented at a median age of 28 days (0–17.3 years) and were followed-up for 7.2 years (0.01–35.5 years). These patients underwent 258 interventions during the study period, and the presence of coarctation was associated with repeat left heart interventions. The 10-year, transplant-free survival was 86%. Presence of pulmonary hypertension was associated with mortality. Left heart structural growth was seen for mitral and aortic valve annuli and left ventricular end-diastolic dimension over time.
ConclusionsShone’s syndrome patients undergo a number of left heart interventions. Coarctation of the aorta is associated with an increased likelihood for repeat interventions. Survival appears to be more favourable than expected. Significant left heart growth will occur in the population. Pulmonary hypertension is associated with an increased risk of mortality.
Echocardiographic presentations of endocarditis, and risk factors for rupture of a sinus of Valsalva in childhood
- Colin J. McMahon, Nancy Ayres, Ricardo H. Pignatelli, Wayne Franklin, Thomas A. Vargo, J. Timothy Bricker, Howaida G. El-Said
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- Journal:
- Cardiology in the Young / Volume 13 / Issue 2 / April 2003
- Published online by Cambridge University Press:
- 18 April 2005, pp. 168-172
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Background: In recent years, the diagnosis of infective endocarditis has been enhanced by the use of echocardiography. We sought, therefore, to review its effect on the management of endocarditis in children. Methods: We reviewed all the patients presenting to our institution for evaluation for infective endocarditis from May 1994 to January 2002. The patients were stratified according to whether or not they had congenitally malformed hearts. Results: Of the 90 referred patients identified, 46 (51%) had positive ultrasonic findings. Of these, we excluded 26 patients because of the presence of indwelling lines. The remaining 20 patients with features of endocarditis had a median age of 6.5 years, and a range from 0.14 to 8.5 years. There were 4 patients with normal hearts, and 16 with congenital cardiac malformations. We identified rupture of a sinus of Valsalva in four patients, with rupture into the left ventricle in two, and into the right ventricle and right atrium in one each. The mitral valve was involved in six patients, the aortic valve in another six, including all four with rupture of the sinus of Valsalva, both mitral and aortic valves in three, the pulmonary trunk in three patients, and the tricuspid valve and a Blalock-Taussig shunt in one patient each. Organisms isolated included Streptococcus mitis in 4 patients, Streptococcus pneumoniae in 2 patients, Streptococcus sanguis in 1, Staphylococcus aureus in 3, Staphylococcus epidermidis in 1, and Enteroccocus in 2. Cultures proved negative in 7 patients. Surgical intervention was needed in 12 patients, and one died (5%). Only the left-sided chambers were involved in those with normal hearts. Both patients infected with Streptococcus pneumoniae had rupture of a sinus of Valsalva. Conclusion: Involvement of the left-sided chambers is more likely in structurally normal hearts, and in cases with rupture of a sinus of Valsalva, in which case infection with Streptococcus pneumonia should be suspected.