Influence of Timing of Switch Operation in Transposition of Great Arteries

NCT05160116 | Completed

• 1 other identifier: CHUB-PED-Timing_Switch
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

Transposition of great vessels are usually corrected by an arterial switch operation. This operation is often done during the first week of life as surgical delays lead to deconditioned left ventricle. On the other hand early surgery carries also risks as neonatal physiology may have problems adapting to an intervention under cardiopulmonary bypass, possible pulmonary hypertension. Arterial switch operation between 2008 and 2020 done at our center will be reviewed. Primary outcome will be mortality or severe postoperative morbidity. Patients will be divided in 2 groups according to the presence or absence of the primary outcome. After propensity score matching, they will be analysed according to the timing of operation.

Conditions

Transposition of Great Vessels

Outcome Measures

Primary Outcomes (2)

• Mortality

  death (percent) during hospitalization

  From operation until 28 days postoperatively

• Incidence (percent) of severe postoperative morbidity

  Severe postoperatively morbidity is defined as patients meeting at least 2 of the following events: * respiratory failure defined as duration of mechanical ventilation \> 75th percentile of our cohort * prolonged inotropic support defined as duration of inotropic support \> 48 hours * renal failure defined as glomerular filtration rate (GFR) decreased more than 75% compared to preoperative GFR Every patient meeting at least 2 of these 3 events will be counted as having severe postoperative morbidity. Total incidence (expressed as percent of total population) of severe postoperative morbidity will be recorded.

  From operation until 28 days postoperatively

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children with TGV operated by an arterial switch operation between 2008 and 2020.

You may qualify if:

• Newborns with TGV and
• operated at HUDERF between 2008 and 2020 and
• arterial switch operation

You may not qualify if:

• Any surgical technique other than the switch operation for TGV
• patients operated before 2008

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Related Publications (6)

• Nagata H, Glick L, Lougheed J, Grattan M, Mondal T, Thakur V, Schwartz SM, Jaeggi E. Prenatal Diagnosis of Transposition of the Great Arteries Reduces Postnatal Mortality: A Population-Based Study. Can J Cardiol. 2020 Oct;36(10):1592-1597. doi: 10.1016/j.cjca.2020.01.010. Epub 2020 Jan 20.

  PMID: 32622839 BACKGROUND

• Sidi D, Planche C, Kachaner J, Bruniaux J, Villain E, le Bidois J, Piechaud JF, Lacour-Gayet F. Anatomic correction of simple transposition of the great arteries in 50 neonates. Circulation. 1987 Feb;75(2):429-35. doi: 10.1161/01.cir.75.2.429.

  PMID: 3802447 BACKGROUND

• Lim JM, Porayette P, Marini D, Chau V, Au-Young SH, Saini A, Ly LG, Blaser S, Shroff M, Branson HM, Sananes R, Hickey EJ, Gaynor JW, Van Arsdell G, Miller SP, Seed M. Associations Between Age at Arterial Switch Operation, Brain Growth, and Development in Infants With Transposition of the Great Arteries. Circulation. 2019 Jun 11;139(24):2728-2738. doi: 10.1161/CIRCULATIONAHA.118.037495. Epub 2019 May 28.

  PMID: 31132861 BACKGROUND

• Anderson BR, Ciarleglio AJ, Hayes DA, Quaegebeur JM, Vincent JA, Bacha EA. Earlier arterial switch operation improves outcomes and reduces costs for neonates with transposition of the great arteries. J Am Coll Cardiol. 2014 Feb 11;63(5):481-7. doi: 10.1016/j.jacc.2013.08.1645. Epub 2013 Oct 30.

  PMID: 24184243 BACKGROUND

• Kumar TK, Charpie JR, Ohye RG, Hirsch-Romano JC, Donohue JE, Yu S, Sood V, Wilkinson DA, Nelson K, Mitchell E, Goldberg CS, Gaies MG. Timing of neonatal cardiac surgery is not associated with perioperative outcomes. J Thorac Cardiovasc Surg. 2014 May;147(5):1573-9. doi: 10.1016/j.jtcvs.2013.07.020. Epub 2013 Aug 26.

  PMID: 23988282 BACKGROUND

• Willems A, Datoussaid D, Tucci M, Sanchez Torres C, De Ville A, Fils JF, Van der Linden P. Impact of On-Bypass Red Blood Cell Transfusion on Severe Postoperative Morbidity or Mortality in Children. Anesth Analg. 2016 Aug;123(2):420-9. doi: 10.1213/ANE.0000000000001425.

  PMID: 27331784 BACKGROUND

MeSH Terms

Conditions

Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Denis Schmartz, MD

  Brugmann University Hospital & HUDERF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department of Anesthesiology

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 16, 2021
• Study Start: December 15, 2021
• Primary Completion: April 30, 2022
• Study Completion: June 10, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)