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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Congenital Heart Disease
• Intervention / Treatment: Procedure: cardiac catheterization

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Yomna Hussein Mohammed Hussein Alattar H Alattar, assisstant lecturer; Phone Number: 01008855990; Email: alattaryomna@yahoo.com
• Study Contact Backup: Name: Khaled A Sanousy, professor; Phone Number: 0 100 306 8421; Email: Khalidelsanousy@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 hours to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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:

  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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of trans catheter intervention	Complications; 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.; (Procedure-related non-life-threatening complications) as: Vascular thrombosis at the site of access, arrhythmia, hypothermia, aggravation of hypoxia, renal insufficiency, and blood loss.	6 month
the least and sufficient Procedure time , the radiation time and its side effects	3. Procedure time including (anesthesia time, access time, catheter intervention time, and fluoroscopy time)	6 months

Collaborators and Investigators

• Sponsor: YHAlattar

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 28, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: catheterization in CHD

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