Cardiovascular Diseases Clinical Trial
To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women with corrected congenital heart disease and the risk of prematurity and occurrence of congenital heart defects in offspring.
BACKGROUND:
Since 1960, surgical advances have led to correction of congenital heart defects in children
who otherwise may not have achieved maturity. Consequently, it became increasingly important
to understand the long-term morbidity, mortality and functional status of these patients.
Because of the tremendous outlay of time, money and personnel devoted to prolonging the
lives of children with congenital heart defects, it was vital to examine the accomplishment
of long-term goals: achievement of a normal lifespan as a functioning, effective member of
society.
DESIGN NARRATIVE:
Preoperative, operative, and postoperative data for each patient were entered into the
registry data base at chart review. Follow-up for each patient was gathered by mail
questionnaire, telephone survey, and the National Death Index. Questionnaires assessed
morbidity, functional status, and reproduction. Pregnancy and major events were confirmed
from physicians' records. Follow-up for tetralogy of Fallot, ventricular septal defect, and
atrial septal defect was conducted in years 1, 3, and 5, and for transposition of the great
arteries, aortic stenosis, pulmonic stenosis, patent ductus arteriosus, and coarctation of
the aorta in years 2 and 4. Chart review was completed in year 2 and cases were then
identified prospectively. Actuarial analysis and Cox proportional hazards models determined
mortality, major morbidity, and their risk factors. Reproductive data were analyzed per
years of fertility for the cohort, and compared to Oregon population statistics. During
1988-1989, chart review and data abstraction were completed for children having surgical
corrections from 1958-1987 for the eight defects under study. Also, during 1988-1989,
children undergoing cardiac surgery for the eight defects were added to the registry.
The study was renewed in 1993 to sustain and expand the registry of all Oregon children 18
years of age or younger undergoing surgical repair from 1958 to the present of 14 major
congenital heart defects: tetralogy of Fallot (TOF), ventricular septal defect (VSD), atrial
septal defect (ASD), coarctation of the aorta, pulmonic stenosis (PS), aortic stenosis (AS),
transposition of the great arteries, patent ductus arteriosus (PDA), tricuspid atresia (TA),
total anomalous pulmonary venous return (TAPVR), pulmonary atresia with intact ventricular
septum (PA), PA with VSD, partial atrioventricular canal (AVC), and complete AVC. The first
eight defects were included in the registry: TOF (n =438). VSD (n =402), ASD (n =496), COA
(n =479), AS (n = 175), PS (n = 200), TGA (n = 169), and PDA (n = 533). All cases of
surgical treatment of TA, TAPVR, PA, PA with VSD, and partial and complete AVC from 1958 to
the present were added to the registry. Preoperative, operative, and postoperative data for
each patient were entered into the database from chart review. Each hospital was visited
twice yearly to ascertain new cases. Individuals were followed every two years for
intercurrent events by mailed questionnaire or phone interview. Questionnaires and
interviews assessed major morbidity, functional status, and reproduction. Pregnancy, major
events, and recurrent CHD were confirmed by medical records. Actuarial analysis and the Cox
proportional hazards model determined mortality, morbidity, and their risk factors, and
compared observed survival with expected population survival. Reproductive data were
analyzed per years of fertility for cohort, and compared to Oregon population statistics.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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