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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right ventricle outflow tract reconstruction | Experimental | RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure |
|
| Systemic-to-pulmonary artery shunts | Active Comparator | systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: RVOT reconstruction by femoral allogenic vein valve conduit | Procedure | Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation |
| Measure | Description | Time Frame |
|---|---|---|
| Growth of pulmonary arteries | -Index Nakata ≥ 150 mm/m2 | From 6 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of further re interventions |
| 1 year |
| Complications |
|
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Inclusion criteria
Patients who met the following criteria were included:
Patients who met any of the following criteria were excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Y Omelchenko, PhD | Meshalkin Research Institute of Pathology of Circulation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk State Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24418205 | Result | Hibino N, He D, Yuan F, Yu JH, Jonas R. Growth of diminutive central pulmonary arteries after right ventricle to pulmonary artery homograft implantation. Ann Thorac Surg. 2014 Jun;97(6):2129-33. doi: 10.1016/j.athoracsur.2013.10.046. Epub 2014 Jan 10. | |
| 24686154 | Result | Zheng S, Yang K, Li K, Li S. Establishment of right ventricle-pulmonary artery continuity as the first-stage palliation in older infants with pulmonary atresia with ventricular septal defect may be preferable to use of an arterial shunt. Interact Cardiovasc Thorac Surg. 2014 Jul;19(1):88-94. doi: 10.1093/icvts/ivu052. Epub 2014 Mar 30. |
| Label | URL |
|---|---|
| Growth of diminutive central pulmonary arteries after right ventricle to pulmonary artery homograft implantation | View source |
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| Systemic-to-pulmonary artery shunts | Procedure | Modified Blalock-Taussig shunt performed between the right subclavian and pulmonary arteries or the left subclavian and pulmonary arteries of the type "end to side". |
|
| 1 year |
| 21958799 | Result | Barozzi L, Brizard CP, Galati JC, Konstantinov IE, Bohuta L, d'Udekem Y. Side-to-side aorto-GoreTex central shunt warrants central shunt patency and pulmonary arteries growth. Ann Thorac Surg. 2011 Oct;92(4):1476-82. doi: 10.1016/j.athoracsur.2011.05.105. |
| 9485256 | Result | Gates RN, Laks H, Johnson K. Side-to-side aorto-Gore-Tex central shunt. Ann Thorac Surg. 1998 Feb;65(2):515-6. doi: 10.1016/s0003-4975(97)01126-0. |
| Side-to-side aorto-GoreTex central shunt warrants central shunt patency and pulmonary arteries growth. | View source |
| Side-to-side aorto-Gore-Tex central shunt | View source |
| ID | Term |
|---|---|
| C562833 | Pulmonary Atresia With Ventricular Septal Defect |
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