Transposition of Great Vessels
Conditions
Brief summary
Celsior® is an organ preservation solution used for the harvesting and the preservation of solid organs. Its use as a crystalloid cardioplegia solution has been established recently. Its main advantage is the long duration of myocardial protection. Compared to the other cardioplegia solutions, it allows a reduced amount of solution administered during the surgery and fewer interruptions during the intervention for the administration of supplemental doses of cardioplegia for long and complex operations. The objective of this register is to compare the safety and the efficacy of Celsior® to the old cardioplegia solution Saint-Thomas used as cardioplegia solution in surgery of the transposition of great vessels, the arterial switch operation.
Interventions
DRUGCELSIOR® group
Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.
DRUGSaint-Thomas group
Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient of neonatal age at the time of the intervention * Patients with a transposition of the great vessels with intact septum and with the arterial switch operation performed as a corrective procedure * CELSIOR® used as cardioplegia solution between 2012 and 2019 * Saint-Thomas used as cardioplegia solution (control group) between 2005 and 2011
Exclusion criteria
* Major cardiovascular malformations needing correction during the surgery for the transposition of great vessels including : interventricular communication, coarctation of the aorta, interruption of the aortic arch * Significant anomalies of coronary arteries origin or paths including : intramural course, single coronary ostium * Opposition to participate in this retrospective research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death at 30 days after surgery | 30 days | Death at 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative troponin levels | 48 hours | Troponin in ng/L |
| Cardiac rhythm assessment | 24 hours | Percentage of abnormal rhythm |
| Variation of pre- and post-operative creatinine levels | 24 hours | Creatinine in µmol/L |
| Intensive care unit length of stay | 30 days | In days |
Countries
France
Contacts
Primary ContactJulia MITCHELL, MD
Backup ContactNaoual EL JONHY
Outcome results
None listed