Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.
Study Details
Study Description
Brief Summary
To compare of mid-term results of total correction of tetralogy of fallot between preservation of pulmonary valve and trans-annular patching , thus avoiding PV regurgitation during TOF repair , this will determine the value of this procedure over trans-annular patching regarding to right ventricular performance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Surgical repair of congenital lesions associated with right ventricular outflow tract obstruction frequently requires the destruction of pulmonary valve (PV) competents including the pulmonary annulas. The resulatnt pulmonary insufficiency may lead to late functional deterioration of right ventricular performance. Acute right ventricular dysfunction has been associated with poor pulmonary runoff, tricuspid valve regurgitaion and pulmonary hypertension. Preservation of PV comptence may prevent both early and late right ventricular failure. Total repair of tetralogy of fallot is a corrective surgical procedure that involves closure of the ventricular septal defect (VSD) and relief of right ventricular outflow tract (RVOT) obstruction. The surgeon must decide whether the right ventricular outflow tract size will be sufficient to allow for the entire cardiac output to traverse it without causing extreme elevation in right ventricular pressure or will go for trans-annular patch. Recently interest has shifted to preserving the integrity of the pulmonary valve annulus thus avoiding pulmonary valve regurgitation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TOF repair with preservation of PV Surgical intervention by repair of Tetralogy of Fallot with preservation of pulmonary valve, recently interested has shifted to preserving the integrity of the pulmonary valve. |
Procedure: TOF repair with trans-annular patch VS preservation of PV
One group study
|
| Experimental: TOF repair with trans-annular patch Surgical intervention by repair of Tetralogy of Fallot with trans-annular patch, right ventricular hypertrophy, right ventricular dilatation and pulmonary vavle regurgitation has been recognized as one of the most important risk factors for both right and left ventricular performance after the repair of Tetralogy of Fallot. |
Procedure: TOF repair with trans-annular patch VS preservation of PV
One group study
|
Outcome Measures
Primary Outcome Measures
- Gender [One week for preoperative assessment.]
Parameters will be measured include gender preoperatively
- Body weight [One week for preoperative assessment.]
Parameters will be measured include body weight in kilograms preoperatively
- Height [One week for preoperative assessment.]
Parameters will be measured include height in meters preoperatively
- Oxygen saturation , RV function [One week for preoperative assessment.]
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % preoperatively
- include median RVOT gradient and degree of PV stenosis [One week for preoperative assessment.]
Parameters will be measured include median RVOT gradient in mmhg , degree of PV stenosis by peak gradient across the PV in mmhg preoperatively
- PV annulus and PV z-score [One week for preoperative assessment.]
Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm preoperatively
- degree of PV regurge, degree of TR and RV size [One week for preoperative assessment.]
Parameters will be measured include degree of PV regurge jet size by color doppler,degree of TR by jet area -central jets in cm^2 , RV size (RV diastolic area in cm^ , RV systolic area in cm^ ) preoperatively
- Age [One week for preoperative assessment]
Parameters will be measured include age in months preoperatively
Secondary Outcome Measures
- Gender [Pre-discharge postoperative assessment within one month]
Parameters will be measured include gender pre-discharge postoperative assessment.
- Body weight [Pre-discharge postoperative assessment within one month]
Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment.
- Height [Pre-discharge postoperative assessment within one month]
Parameters will be measured include height in meters pre-discharge postoperative assessment.
- Oxygen saturation , RV function [Pre-discharge postoperative assessment within one month]
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % Pre-discharge postoperative assessment.
- Median RVOT gradient and degree of PV stenosis [Pre-discharge postoperative assessment within one month]
Parameters will be measured include median RVOT gradient in mmhg , degree of PV stenosis by peak gradient across the PV in mmhg pre-discharge postoperative assessment.
- PV annulus and PV z-score [Pre-discharge postoperative assessment within one month]
Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm pre-discharge postoperative assessment.
- degree of PV regurge, degree of TR and RV size [Pre-discharge postoperative assessment within one month]
Parameters will be measured include degree of PV regurge jet size by color doppler,degree of TR by jet area -central jets in cm^2 , RV size (RV diastolic area in cm^ , RV systolic area in cm^ ) pre-discharge postoperative assessment.
- Median cross clamp time and CPB time [Pre-discharge postoperative assessment within one month]
Parameters will be measured include Median cross clamp time in minutes and CPB time in minutes pre-discharge postoperative assessment.
- ICU stay [Pre-discharge postoperative assessment within one month]
Parameters will be measured include ICU stay days pre-discharge postoperative assessment.
- Time till weaning from mechanical ventilator [Pre-discharge postoperative assessment within one month]
Parameters will be measured include Time till weaning from mechanical ventilator in hours pre-discharge postoperative assessment.
- Age [Pre-discharge postoperative assessment within one month]
Parameters will be measured include age in months pre-discharge postoperative assessment.
Other Outcome Measures
- Gender [Reassessment after 6 months.]
Parameters will be measured include gender in follow up after 6 months.
- Body weight [Reassessment after 6 months.]
Parameters will be measured include body weight in kilograms in follow up after 6 months.
- Height [Reassessment after 6 months.]
Parameters will be measured include body height in meters in follow up after 6 months.
- Oxygen saturation , RV function [Reassessment after 6 months.]
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % in follow up after 6 months.
- include median RVOT gradient and degree of PV stenosis [Reassessment after 6 months.]
Parameters will be measured include include median RVOT gradient in mmhg and degree of PV stenosis by peak gradient across the PV in mmhg in follow up after 6 months.
- PV annulus and PV z-score [Reassessment after 6 months.]
Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm in follow up after 6 months.
- degree of PV regurge, degree of TR and RV size [Reassessment after 6 months.]
Parameters will be measured include degree of PV regurge jet size by color doppler,degree of TR by jet area -central jets in cm^2 , RV size (RV diastolic area in cm^ , RV systolic area in cm^ ) in follow up after 6 months.
- Age [Reassessment after 6 months.]
Parameters will be measured include age in months in follow up after 6 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients undergoing elective total correction of tetralogy of Fallot.
-
Any age group.
-
Normal pulmonay branches
Exclusion Criteria:
-
Patients associated with other congenital anomalies.
-
Regarding PV morphology, patients with pulmonary atresia , absence of PV.
-
Patients with anomalous coronary artery anatomy obstructs access to the RV
-
Extra-cardiac illness that is expected to limit survival to less than 5 years.e.g active hepatitis or significant hepatic or renal disorders.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Study Chair: Ahmed M. El-Minshawy, Prof, Assiut University
- Study Director: Mahmoud Kh Abdelatif, Ass.lecturer, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
- Kwak JG, Kim WH, Kim ER, Lim JH, Min J. One-Year Follow-up After Tetralogy of Fallot Total Repair Preserving Pulmonary Valve and Avoiding Right Ventriculotomy. Circ J. 2018 Nov 24;82(12):3064-3068. doi: 10.1253/circj.CJ-18-0690. Epub 2018 Oct 5.
- Vida VL, Angelini A, Guariento A, Frescura C, Fedrigo M, Padalino M, Sanders SP, Thiene G, Stellin G. Preserving the pulmonary valve during early repair of tetralogy of Fallot: Anatomic substrates and surgical strategies. J Thorac Cardiovasc Surg. 2015 May;149(5):1358-63.e1. doi: 10.1016/j.jtcvs.2015.01.030. Epub 2015 Jan 21.
- TOF repair