Choice of Palliative Procedures for Pulmonary Atresia With Ventricular Septal Defect Patients

Meshalkin Research Institute of Pathology of Circulation

Status

Completed

Conditions

Tetralogy of Fallot With Pulmonary Atresia

Pulmonary Atresia With Ventricular Septal Defect

Treatments

Procedure: Systemic-to-pulmonary artery shunts

Procedure: Experimental: RVOT reconstruction by femoral allogenic vein valve conduit

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02861963

FAVVC

Details and patient eligibility

About

The aim is to compare effective growth true hypoplastic pulmonary arteries using Right Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)

Full description

The use of femoral allogenic vein valve conduit for Right Ventricle Outflow Tract Reconstruction is good alternative systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt). Main advantages is straight, symmetrical, pulsating, systolic blood flow in hypoplastic pulmonary artery, which stimulate growth and prepares for a radical repair. Taking into account the absence randomized studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.

Enrollment

24 patients

Sex

All

Ages

1 day to 1 year old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Patients who met the following criteria were included:

Patients with PA-VSD type A and B (by Tchervenkov) scheduled for palliative surgery
Age less than one year
Confluent pulmonary artery
Nakata Index ≤ 120 mm2/m2. Exclusion criteria

Patients who met any of the following criteria were excluded:

Discordant atrioventricular and/or discordant ventriculo-arterial connections
Concomitant pathology (pneumonia, brain damage, or enterocolitis)
Genetic syndromes (DiGeorge, Alagille, VACTER, CHARGE)
Scheduled MAPCA unifocalisation
Anomalous coronary arteries
Other surgical approaches (complete primary repair, primary unification of pulmonary blood flow, stenting RVOT, or patent ductus arteriosus, radiofrequency pulmonary valve perforation).