Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
- Conditions
- Aortic Valve CalcificationAortic Valve StenosisAortic StenosisValve Stenoses, Aortic
- Interventions
- Procedure: Mechanical Prosthetic ValveProcedure: Single Strip Pericardium
- Registration Number
- NCT04056832
- Lead Sponsor
- Fakultas Kedokteran Universitas Indonesia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mechanical Prosthetic Valve Mechanical Prosthetic Valve Aortic Valve Replacement using mechanical prosthetic valve Single Strip Pericardium Single Strip Pericardium Aortic Valve Replacement using single strip of patient's autologous pericardium
- Primary Outcome Measures
Name Time Method Change in 6 Minute Walking Test Performance (meters) 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 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 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 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 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) 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 Outcome Measures
Name Time Method Effective Height of Aortic Valve in mili meters at the time of surgery Effective Height of Aortic Valve measured in mili meters from Aortic annulus to the highest point of Aortic Valve coaptation by Trans-oesophageal Echocardiography in mid-oesophageal long axis view
Aortic Regurgitation Severity before surgery Aortic Regurgitation Severity classified as mild, moderate, and severe based on Recommendations from American Society of Echocardiography
Aortic Stenosis Severity before surgery Aortic Stenosis Severity classified as mild, moderate, and severe based on Recommendations from European Association of Echocardiography and American Society of Echocardiography (EAE/ASE)
Duration of Hospitalization at the time of surgery Number of days of Hospitalization since admission date to discharge date
Number of Valve Replacement and/or Repair at the time of surgery Number of valves being replaced and/or repaired
Aortic Cross Clamp Time in minute at the time of surgery The time from Aortic Cross Clamp On to Cross Clamp Off
Surgery Time in minute at the time of surgery The time from first incision to finished closing surgical wound
Cardiopulmonary Bypass Time in minute at the time of surgery The time from begin Cardiopulmonary Bypass (CPB) On to CPB Off
Coaptation Height of Aortic Valve Leaflet in mili meters at the time of surgery Aortic Valve Coaptation height measured in mili meters by Trans-oesophageal Echocardiography on mid-oesophageal long axis view
Aortic Jet Velocity Value in m/s before surgery Aortic Jet Velocity value measured in meters per second (m/s) by Color Wave Doppler on Trans-thoracic Echocardiography
Mean Trans-aortic Pressure Gradient Value in mmHg before surgery Mean Trans-aortic Pressure Gradient Value measured in mili meters Hydrargyrum (mmHg) with Bernoulli equation on Trans-thoracic Echocardiography
Trial Locations
- Locations (1)
Cipto Mangunkusumo Central National Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia