Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital Heart Disease

Not yet recruiting

• Conditions: Critical Congenital Heart Disease

• Registration Number: NCT05351125
• Lead Sponsor: YHAlattar

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).

Study Timeline

• Study First Submitted: 2022-03-28
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-25
• Last Update Submitted: 2022-04-25
• Study First Posted: 2022-04-28
• Last Update Posted: 2022-04-28
• Study Start: 2022-06-28
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delineation of failure of the procedure and its causes	immediate post procedure up to 1montn	failure of cardiac catheterization with urgent referral to surgery
the effect of cardiac catheter interventions in infants < 3 months with critical congenital heart disease on morbidity and mortality	6 months post catheterization	the success rates of urgent cardiac cathetrization; Type of procedure.; Procedural outcome:

Secondary Outcome Measures

Name	Time	Method
Complications of trans catheter intervention	6 month	Complications; 1. major complications ( Life-threatening complications requiring urgent unplanned surgery or intervention) as cardiac tamponade, cardiac perforation, cardiac valve injury, allergy to anesthesia or drugs, and CPR maneuvers.; 2. (Procedure-related non-life-threatening complications) as: Vascular thrombosis at the site of access, arrhythmia, hypothermia, aggravation of hypoxia, renal insufficiency, and blood loss.
the least and sufficient Procedure time , the radiation time and its side effects	6 months	3. Procedure time including (anesthesia time, access time, catheter intervention time, and fluoroscopy time)