Influence of Timing of Switch Operation in Transposition of Great Arteries

July 19, 2022 updated by: Denis SCHMARTZ, Brugmann University Hospital
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Scientific background and motivation

The transposition of great vessels (TGV) is a congenital heart defect in which the aorta follows the right ventricle and the pulmonary artery follows the left ventricle. At birth, the pulmonary and systemic circulations work in parallel and the communication between them depends on shunts in the cardiac stage (permeability of the Botal hole) or in the supra-cardiac (ducis arteriosus).

It's the most common congenital heart disease and his incidence is estimated between 0.7 and 0.8 per 1000 births. It's a pathology that may be associated with other heart defects, such as interventricular communication (IVC) or pulmonary stenosis, but rarely with a chromosomal abnormality or malformative syndrome.

TGV's manifestation is an isolated cyanosis, refractory to oxygen. And mortality reaches 90% in the first year of life in absence of treatment.

TGV's management has evolved over the last 50 years. First, thanks to the antenatal ultrasound diagnosis, allowing early strategies in postnatal to maintain a shunt between the two circulations (Prostaglandin and Balloon atrial septostomy). Then, by the evolution of corrective surgeries; indeed atrial repair techniques (Senning and Mustard) have given way to the arterial Switch with coronary reimplantation by microsurgery.

When it's possible, the operation takes place during the first week of life. Indeed, it's well established that surgical delay leads to a risk of left ventricle's deconditioned4 and sometimes impaired brain growth. But the risks of a premature surgery are less clear: Operability of the newborn, ability to tolerate an intervention under extracorporeal circulation (ECC), difficulties related to physiological pulmonary arterial hypertension at birth must be considered in the operative indication.

The ideal timing for surgery is still poorly defined. In 2014, Anderson et al showed better results for arterial Switches performed on the third day of life6. On the other hand, Kumar et al, also studied the relationship between operative timing and morbi/mortality of several congenital heart surgeries including the arterial Switch but they found no relationship between them.

Study design

The investigators would like to establish if there is a relationship between the age of the newborn at the time of surgery and postoperative morbi/mortality. Therefore, the investigators want to review all the medical records of children operated on a TGV by the arterial Switch technique at HUDERF between 2008 and 2020. The morbidity/mortality criteria observed will be the same as those usually used in studies conducted on paediatric cardiac surgery at HUDERF:

  1. The data of interest will be extracted from a database built up over years summing up the medical records of cardiac operated patients since 2002.
  2. Statistics:

2.1. Children will be divided into two groups according to the primary outcome (present or absent). They will be matched using a propensity analysis and then compared in terms of operating time.

2.2. The influence of operative time on the occurrence of the primary outcome will also be analysed by a linear regression technique in which the parameter "operating time" will be considered as a continuous variable.

Study Type

Observational

Enrollment (Actual)

151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From operation until 28 days postoperatively
death (percent) during hospitalization
From operation until 28 days postoperatively
Incidence (percent) of severe postoperative morbidity
Time Frame: From operation until 28 days postoperatively

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brugmann University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

June 10, 2022

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-PED-Timing_Switch

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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