Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve

Left Ventricular Reverse Remodeling in Aortic Valve Replacement With Single Strip Pericardium and Mechanical Valve: A Comparative Study

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Stenosis; Aortic Valve Stenosis; Aortic Valve Calcification; Valve Stenoses, Aortic
• Intervention / Treatment: Procedure: Single Strip Pericardium; Procedure: Mechanical Prosthetic Valve

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo Central National Hospital
      • Contact: Ismail Dilawar, doctor; Phone Number: +6281310567075; Email: ismail_dilawar@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Strip Pericardium; Aortic Valve Replacement using single strip of patient's autologous pericardium	Procedure: Single Strip Pericardium; The anterior pericardium is taken in accordance with the measurements made using an aortic annulus sizer or Ismail sizer. The diameter of the annulus valve is converted to circumference of the aortic valve according as a measure of the length of the pericardium. Measurement of aortic commissure height is done by measuring the distance between the lowest point of the valve attachment to the highest point on the commissure as a measure of pericardium width. The pericardium is immersed in 0.6% glutaraldehyde solution for 10 minutes, then rinsed and soaked with saline solution 3 times for 6 minutes each. After the pericardium becomes firm it is cut to be a single strip according to the length and width in the previous measurement. It is then sutured to the aortic valve annulus.; Other Names: Autologous Pericardium
Active Comparator: Mechanical Prosthetic Valve; Aortic Valve Replacement using mechanical prosthetic valve	Procedure: Mechanical Prosthetic Valve; Median incision is performed at the surgical site. Sternal retractor is placed at the sternum after median sternotomy being performed. Aortic valve is measured using aortic annulus sizer. Pledgeted suture is performed for the mattress. Sutures are performed to attach the mechanical prosthetic to the aortic annulus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Left Ventricular End Diastolic Diameter	Left Ventricular End Diastolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode	before surgery, 3 months and 6 months after surgery
Change in Left Ventricular End Systolic Diameter	Left Ventricular End Systolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode	before surgery, 3 months and 6 months after surgery
Change in Ejection Fraction Percentage	Ejection Fraction Percentage assessed by Trans-thoracic Echocardiography with modified Simpson's volumetric method (BiPlane measurement: apical 4 chambers and apical 2 chambers)	before surgery, 3 months and 6 months after surgery
Change in 6 Minute Walking Test Performance (meters)	Subjects will be asked to walk for six minutes on a given track then the distance achieved will be measured in meters	before surgery, 3 months and 6 months after surgery
Change in 6 Minute Walking Test Performance (METs)	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	before surgery, 3 months and 6 months after surgery
Change in Soluble Suppression of Tumorigenicity-2 (sST2) Level	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	before surgery, 3 months and 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coaptation Height of Aortic Valve Leaflet in mili meters	Aortic Valve Coaptation height measured in mili meters by Trans-oesophageal Echocardiography on mid-oesophageal long axis view	at the time of surgery
Effective Height of Aortic Valve in mili meters	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	at the time of surgery
Aortic Jet Velocity Value in m/s	Aortic Jet Velocity value measured in meters per second (m/s) by Color Wave Doppler on Trans-thoracic Echocardiography	before surgery
Mean Trans-aortic Pressure Gradient Value in mmHg	Mean Trans-aortic Pressure Gradient Value measured in mili meters Hydrargyrum (mmHg) with Bernoulli equation on Trans-thoracic Echocardiography	before surgery
Aortic Stenosis Severity	Aortic Stenosis Severity classified as mild, moderate, and severe based on Recommendations from European Association of Echocardiography and American Society of Echocardiography (EAE/ASE)	before surgery
Aortic Regurgitation Severity	Aortic Regurgitation Severity classified as mild, moderate, and severe based on Recommendations from American Society of Echocardiography	before surgery
Number of Valve Replacement and/or Repair	Number of valves being replaced and/or repaired	at the time of surgery
Aortic Cross Clamp Time in minute	The time from Aortic Cross Clamp On to Cross Clamp Off	at the time of surgery
Surgery Time in minute	The time from first incision to finished closing surgical wound	at the time of surgery
Cardiopulmonary Bypass Time in minute	The time from begin Cardiopulmonary Bypass (CPB) On to CPB Off	at the time of surgery
Duration of Hospitalization	Number of days of Hospitalization since admission date to discharge date	at the time of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Intensive Care Unit Stay	Number of hours in the Intensive Care Unit since after the surgery until subject is transferred to hospital ward	at the time of surgery
Duration of Ventilator Use	Number of hours of breathing assisted with ventilator since intubation until extubation	at the time of surgery

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Ismail Dilawar, doctor, Fakultas Kedokteran Universitas Indonesia

Publications and helpful links

General Publications

• d'Arcy JL, Prendergast BD, Chambers JB, Ray SG, Bridgewater B. Valvular heart disease: the next cardiac epidemic. Heart. 2011 Jan;97(2):91-3. doi: 10.1136/hrt.2010.205096. Epub 2010 Dec 13. No abstract available. Erratum In: Heart. 2011 Jul;97(13):1112.
• Coffey S, Cairns BJ, Iung B. The modern epidemiology of heart valve disease. Heart. 2016 Jan;102(1):75-85. doi: 10.1136/heartjnl-2014-307020. Epub 2015 Nov 5. No abstract available.
• Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 2013 May 30.
• Maganti K, Rigolin VH, Sarano ME, Bonow RO. Valvular heart disease: diagnosis and management. Mayo Clin Proc. 2010 May;85(5):483-500. doi: 10.4065/mcp.2009.0706.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Anticipated): January 20, 2020
• Study Completion (Anticipated): April 20, 2020

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Aortic Valve Replacement; Single Strip Pericardium; Autologous Pericardium; Mechanical Valve Replacement; Comparison of Left Ventricle Remodeling
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 011 (Nahrain Medical Research Collective (NMRC)); ETIKUI-1612576 (Other Identifier: Ethical Committee of Universitas Indonesia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No