Aortic Coarctation, Cardiac Surgery, Cohort Studies, Death, Hypertension, Infant, Newborn, Mortality, Postoperative Complications, Reoperation, Retrospective Studies, Risk Factors
Conditions
Keywords
Cohort Studies Retrospective Studies, Risk Factors, mortality, Survival Analysis
Brief summary
Multicenter Retrospective Study Over a 14-Year Period From 2010 to 2024
Detailed description
Inclusion of all neonates and infants who underwent surgical repair of aortic coarctation within the first year of life in one of the five participating surgical centers. From antenatal data to postoperative complications. Very large table. Event-free survival (events: death, recoarctation, cardiac reinterventions, hypertension) Description of patients who developed recoarctation Univariate and multivariate analysis of determinants of recoarctation (+/- death): patients with recoarctation versus others (excluding those who died without recoarctation). Main Predictive Factors and Primary Criteria to Be Tested: Antenatal diagnosis of coarctation: yes/no Prematurity: yes/no and subgroups (24-32 weeks vs. 32-37 weeks vs. term) Intrauterine growth restriction (IUGR): yes/no; IUGR vs. small for gestational age vs. normal weight Birth weight \< 2500 g vs. \> 2500 g Prostaglandin infusion: yes/no Duration of prostaglandin infusion (days) Ventricular septal defect (VSD): yes/no Bicuspid aortic valve: yes/no Hemodynamic failure: yes/no Aortic valve size: \< -2 Z-score Horizontal aorta \< 3.6 mm vs. \> 3.6 mm CT scan performed: yes/no Age at surgery: \< or \> 1 month Surgical technique: patch vs. simple/extended Crafoord repair Associated procedure: yes/no Length of ICU stay (days) Postoperative cardiovascular complication: yes/no Postoperative isthmic peak velocity: \< or \> 2 m/sec Data Collection Excel database including 934 patients from 5 centers. 127 columns from A (Anonymization number) to DX (Date of hypertension diagnosis). Primary endpoint: Prevalence and morbidity/mortality. Data divided into 13 sections: Sociodemographic data: Follow-up center, responsible physician Antenatal data: Follow-up and echocardiography results Delivery: Neonatal clinical presentation: Diagnostic echocardiography: Preoperative CT scan if performed: First intervention: Post-intervention echocardiography Second intervention if performed: Recoarctation with surgical intervention: Recoarctation with catheter intervention Last follow-up data: Weight, height, blood pressure, date of last visit, last news Date of death Exercise test results if available:
Interventions
None listed
Sponsors
Institut Saint Pierre
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Inclusion of all neonates and infants who underwent surgical repair of aortic coarctation within the first year of life in one of the five participating surgical centers. Among associated intracardiac lesions, patients with ventricular septal defect (VSD), atrial septal defect (ASD), bicuspid aortic valve, and persistent left superior vena cava are also included. \-
Exclusion criteria
Children with complex congenital heart disease (e.g., transposition of the great arteries, double outlet right ventricle, single ventricle, truncus arteriosus, interrupted aortic arch) are excluded. Patients that underwent angioplasty as first intervention will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of recoarctation after coarctation surgery | Up to 14 years post-surgery (2011-2025). | Prevalence of recoarctation among patients operated for aortic coarctation before one year of age. Recoarctation is defined by a cardiac catheterisme that showed a reduction of the lumen avec aortic isthmus of 50% and/or a peak-to-peak gradient \> 20mmHg at the level of the recoarctation. Survival analysis without recoarctation Percentage of patients and Kaplan-Meier survival curves. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| global survival in patient operated of coarctation | 2011-2025 (14 years | Proportion of patient that died (what ever the cause) after their surgery and during the follow up. |
| Proportion of systemic hypertension at last follow up in patient operated of aortic coarctation | 2011-2015 (14 years) | Regarding the systemic hypertension outcome, patients were classified as hypertensive at their last out-patient visit if they presented with diastolic and/or systolic blood pressure above the 95th percentile (according to sexe, age and height) or if they were under antihypertensive drugs To establish the onset date of systemic hypertension, outpatient cardiology visits were retrospectively reviewed from the most recent to the earliest encounter to identify: 1) the first abnormal blood pressure value and/or 2) the introduction of a hypertensive drugs. |
| Predictors of recoarctation | Up to 14 years post-surgery | Outcomes associated to recoarctation will be assessed using univariate and multivariate logistic regression models. Variables considered include demographic, anatomical, and surgical characteristics (e.g., prematurity, birth weight, prostaglandin use, surgical technique). Comparisons will be made between patients who developed recoarctation and those who did not, excluding patients who died without recoarctation Analysis of potential predictive factors using univariate and multivariate models. |
Countries
France
Contacts
STUDY_DIRECTOROscar WERNER, Dr WERNER
non afilié
PRINCIPAL_INVESTIGATORcharlotte duseigneur
institu saint pierre
Outcome results
None listed