Clinical trial NCT05351125: Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital Heart Disease
Official title: Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Congenital Heart Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention

Brief summary: Congenital heart disease is the most common birth defect affecting mostly 1 in 100 births(1), critical congenital heart disease is when there is low systemic cardiac output which requires urgent surgery or catheter intervention in the first year of life(2), in low-income countries CCHD is associated with severe high mortality rate due to low health resources, in high-income countries, CCHD is associated with life-long morbidities and a high burden on the health care systems(1-3)

Detailed description: CCHD are classified into three major components:

Left heart obstructions representing 30-40%, complete transposition of the great arteries (mostly 30%), and right heart obstructions (20-30%).

CCHD may present with signs of low cardiac output and hypoperfusion in case of duct dependent systemic circulation or central cyanosis not responding to oxygen in duct dependent pulmonary circulation or two parallel circulations.

Critical congenital heart disease is classified into :

* Congenital heart disease with duct-dependent systemic blood flow (SBF) as:

  1. Critical aortic stenosis
  2. Critical coarctation of the aorta
* Congenital heart disease with duct-dependent pulmonary blood flow (PBF) as:

  1. Critical pulmonary stenosis.
  2. Pulmonary atresia with intact septum.
  3. Severe types of Fallot's tetralogy and pulmonary atresia with VSD.
* Complete transposition of the great arteries (d-TGA) Classified as non-mixture or inadequate shunting at atrial, ventricular, or duct level.

Recent advances in percutaneous neonatal cardiac interventions have improved survival, decreased morbidity, and mortality in newborns with CCHD compared with surgery(4).

Pediatric cardiac catheter interventions have been an established way for the management of CCHD(5).

Balloon atrial septestomy is the standard intervention for patients with D-TGA with ineffective mixing (6), BAS is indicated when there is time lag between diagnosis and arterial switch operation due to transportation and lack of competent surgical team, and it is also indicated in patients with d-TGA with restrictive inter-atrial communication(7).

Ductus arteriosus stenting is used to maintain a reliable source of pulmonary blood flow in patients with duct-dependent cyanotic CHD(5).

The main advantage of ductus arteriosus stenting is the avoidance of surgery and shunt-related side effects , also it promotes significant PA growth compared to a BT shunt alone (8).

Balloon aortic and pulmonary valvuloplasty and balloon coarctation angioplasty are now established procedures for the management of patients with critical pulmonary or aortic stenosis(9).

Eligibility criteria: Inclusion Criteria:

* All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention including

  1. Critical valvular aortic stenosis requiring aortic valvuoplasty.
  2. Pulmonary valvuloplasty for critical valvular pulmonary stenosis.
  3. Pulmonary valvuloplasty in pulmonary atresia with intact IVS after exclusion of RV-dependent coronary circulation.
  4. PDA stenting in duct dependent congenital cyanotic heart disease.
  5. Atrial septostomy to enhance atrial mixing (in transposition of great arteries with restrictive or no inter-atrial communication).
  6. Balloon angioplasty of native coarctation as a palliative measure to stabilize a patient with severely depressed ventricular function.

     Exclusion Criteria:

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  1. patent ductus arteriosus closure
  2. percutaneous temporary pacemaker implantation for arrhythmia
  3. diagnostic catheterization.
  4. prematurity
  5. low birth weight
  6. bleeding diathesis
  7. sepsis.

Primary outcomes:
measure: the effect of cardiac catheter interventions in infants < 3 months with critical congenital heart disease on morbidity and mortality
timeFrame: 6 months post catheterization
measure: Delineation of failure of the procedure and its causes
timeFrame: immediate post procedure up to 1montn
Secondary outcomes:
measure: Complications of trans catheter intervention
timeFrame: 6 month
measure: the least and sufficient Procedure time , the radiation time and its side effects
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Bakker MK, Bergman JEH, Krikov S, Amar E, Cocchi G, Cragan J, de Walle HEK, Gatt M, Groisman B, Liu S, Nembhard WN, Pierini A, Rissmann A, Chidambarathanu S, Sipek A Jr, Szabova E, Tagliabue G, Tucker D, Mastroiacovo P, Botto LD. Prenatal diagnosis and prevalence of critical congenital heart defects: an international retrospective cohort study. BMJ Open. 2019 Jul 2;9(7):e028139. doi: 10.1136/bmjopen-2018-028139.
citation: Khalil M, Jux C, Rueblinger L, Behrje J, Esmaeili A, Schranz D. Acute therapy of newborns with critical congenital heart disease. Transl Pediatr. 2019 Apr;8(2):114-126. doi: 10.21037/tp.2019.04.06.
citation: Arth AC, Tinker SC, Simeone RM, Ailes EC, Cragan JD, Grosse SD. Inpatient Hospitalization Costs Associated with Birth Defects Among Persons of All Ages - United States, 2013. MMWR Morb Mortal Wkly Rep. 2017 Jan 20;66(2):41-46. doi: 10.15585/mmwr.mm6602a1.
citation: Melekoglu AN, Baspinar O. Transcatheter cardiac interventions in neonates with congenital heart disease: A single centre experience. J Int Med Res. 2019 Feb;47(2):615-625. doi: 10.1177/0300060518806111. Epub 2018 Oct 30.
citation: Alakhfash AA, Jelly A, Almesned A, Alqwaiee A, Almutairi M, Salah S, Hasan M, Almuhaya M, Alnajjar A, Mofeed M, Nasser B. Cardiac Catheterisation Interventions in Neonates and Infants Less Than Three Months. J Saudi Heart Assoc. 2020 May 12;32(2):149-156. doi: 10.37616/2212-5043.1051. eCollection 2020.
citation: Kumar N, Shaikh AS, Kumari V, Patel N. Echocardiography guided bed side balloon atrial septostomy in dextro transposed great arteries (dTGA) with intact ventricular septum (IVS): A resource limited country experience. Pak J Med Sci. 2018 Nov-Dec;34(6):1347-1352. doi: 10.12669/pjms.346.15792.