Left Ventricular Reverse Remodeling in Aortic Valve Replacement With Single Strip Pericardium and Mechanical Valve: A Comparative Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Change in 6 Minute Walking Test Performance (meters)
- Last Updated
- 6 years ago
Overview
Brief Summary
Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia. In addition to the expensive cost, patients who have mechanical prosthetic valve have an increased risk of infection of the prosthetic valve and developing thrombo-embolism thus have to consume a lifelong anticoagulant therapy that increase risk of bleeding. A surgical technique using autologous pericardium is an alternative to prosthetic valve replacement, one of which is a single pericardium strip technique that uses modified autologous pericardium technique from Ozaki et al and Duran et al.
The objective of this study is to investigate the outcome of aortic valve replacement with a single pericardium strip of autologous pericardium in patients with aortic stenosis.
This study will be conducted at the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia, by using quasi experimental type time series design. Subjects are patients with aortic stenosis who are candidates for valve replacement. Inclusion criteria is having low to moderate surgical risk (EuroScore II <5). The sampling method used in this study is non-probability consecutive sampling. This study will assess the outcome of the aortic valve replacement (valve hemodynamic, left ventricular reverse remodelling, sST2, 6MWT) at 3 months and 6 months post-aortic valve replacement.
It is expected that aortic valve replacement using a single strip of autologous pericardium will have good valve hemodynamic outcome, yield left ventricular reverse remodelling, decrease sST2 level, show upgrade in 6MWT, and have shorter aortic cross clamp time so that it can be an alternative to aortic valve replacement using mechanical prosthetic valve that is less expensive and have good outcomes in patient with aortic stenosis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged more than 10 years old
- •Patients with aortic valve stenosis with an indication of aortic valve replacement having low to moderate surgical risk (EuroScore II \<5)
- •The patient or guardian (the research subject's parent) agrees to follow the study
Exclusion Criteria
- •Patients who have previously underwent aortic valve replacement
- •Patients with aortic stenosis due to bicuspid aortic valve
- •Patients with autoimmune disease
- •Patients with mixed connective tissue disease
Outcomes
Primary Outcomes
Change in 6 Minute Walking Test Performance (meters)
Time Frame: before surgery, 3 months and 6 months after surgery
Subjects will be asked to walk for six minutes on a given track then the distance achieved will be measured in meters
Change in Left Ventricular End Systolic Diameter
Time Frame: before surgery, 3 months and 6 months after surgery
Left Ventricular End Systolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Change in Ejection Fraction Percentage
Time Frame: before surgery, 3 months and 6 months after surgery
Ejection Fraction Percentage assessed by Trans-thoracic Echocardiography with modified Simpson's volumetric method (BiPlane measurement: apical 4 chambers and apical 2 chambers)
Change in Left Ventricular End Diastolic Diameter
Time Frame: before surgery, 3 months and 6 months after surgery
Left Ventricular End Diastolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Change in Soluble Suppression of Tumorigenicity-2 (sST2) Level
Time Frame: before surgery, 3 months and 6 months after surgery
Level of soluble Suppression of Tumorigenicity-2 measured in nano gram per mili Liters (ng/mL) by quantitative sandwich enzyme immunoassay technique assessed with Quantikinine Elisa
Change in 6 Minute Walking Test Performance (METs)
Time Frame: before surgery, 3 months and 6 months after surgery
The result of distance in meters of the six minute walking test will be converted to VO2max by the given formula: (distance in meters x 0.03) + 3.98 = VO2max Then the VO2max will be converted to METs by given formula: VO2max : 3.5 = METs
Secondary Outcomes
- Effective Height of Aortic Valve in mili meters(at the time of surgery)
- Aortic Regurgitation Severity(before surgery)
- Aortic Stenosis Severity(before surgery)
- Duration of Hospitalization(at the time of surgery)
- Number of Valve Replacement and/or Repair(at the time of surgery)
- Aortic Cross Clamp Time in minute(at the time of surgery)
- Surgery Time in minute(at the time of surgery)
- Cardiopulmonary Bypass Time in minute(at the time of surgery)
- Coaptation Height of Aortic Valve Leaflet in mili meters(at the time of surgery)
- Aortic Jet Velocity Value in m/s(before surgery)
- Mean Trans-aortic Pressure Gradient Value in mmHg(before surgery)