Computational Assessment of Bioprosthetic Aortic Valve Function

Comparing the In-vivo Haemodynamic and Biomechanical Performance of Rapid-deployment Edwards Intuity Elite System and Edwards Magna Ease Valve

Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve. Edwards Magna Ease and Intuity Elite bioprosthetic valves have similar leaflets and mounting designs. However, the valves are implanted in the patient in different ways (one is stitched to the wall of the left ventricular outflow tract, and the other is held in place by the radial force of the valve skirt). The study aims to understand in more detail how the different valves interact with the left ventricular outflow tract and aortic root.

Study Overview

• Status: Not yet recruiting
• Conditions: Valve Heart Disease; CFD
• Intervention / Treatment: Diagnostic test: Computed Tomography, Magnetic Resonance Imaging

Detailed Description

The implantation of a bioprosthetic valve is the established surgical technique when replacing the aortic valve to treat various aortic valve diseases. Many different bioprosthetic valves are available. The design and implantation technique in each system would result in different interaction with the left ventricular outflow tract (LVOT) and the aortic root, leading to different flow profiles that may induce platelet aggregation and affect the long-term performance of the bioprosthesis and its durability. Additionally, complications such as valve thrombosis may occur. However, it is not currently clear which bioprostheses/patients are more prone to thrombosis or degradation of the valve. This study aims to develop fluid-structure interaction (FSI) models, which can model blood flow and wall/valve mechanics, using realistic patient-specific geometries and flow conditions which correlate with the true performance of the valve in the imaged patients, and to assess and compare such performances to understand the benefits and challenges with various bioprosthetic valves.

FSI models combine computational fluid mechanics (CFD) with structural wall mechanics modelling. This is an alternative approach that allows detailed assessment of flow patterns and estimation of wall shear stress and pressure within blood vessels, and therefore has been applied increasingly to gain better insights into the hemodynamics in cardiovascular diseases

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Saeed Mirsadraee, MD, Ph.D; Phone Number: 02073528121; Email: s.mirsadraee@rbht.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

20 informed and consented patients who undergo the Intuity Elite (n=10) and Magna EASE (n=10) valves will be prospectively enrolled. The patients will be evaluated at 3- and 12-months post valve replacement.

Description

Inclusion Criteria:

• Male and female patients aged 18 years or over.
• Patients diagnosed with aortic valve disease, and scheduled to undergo Edwards Magna Ease or Intuity Elite and free of exclusion criteria below.
• The patient is willing and able to understand the Patient Information Sheet and provide written informed consent.
• The patient must agree to comply with the study imaging protocol as required at prespecified times.

Exclusion Criteria:

• Inability to provide valid informed consent.
• Male and female patients aged < 18 years of age.
• Contraindications for CT angiography: renal failure (Cr>250 μmol/L or eGFR<30 mL/min) due to the additional risk of contrast medium nephrotoxicity or allergy to iodine.
• Women of childbearing age who have not had a hysterectomy and/or who may be breastfeeding.
• History of cardiac pacing device insertion, or any other MRI incompatible device implants.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Implantation	Diagnostic test: Computed Tomography, Magnetic Resonance Imaging; Computed Tomography, Magnetic Resonance Imaging
Rapid Deployment	Diagnostic test: Computed Tomography, Magnetic Resonance Imaging; Computed Tomography, Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood flow velocities	Blood flow velocities (cm/s) will be quantified for each bioprosthesis at 3 levels: subvalvular (LVOT and native annulus), transvalvular, the aortic root, and the proximal ascending aorta. Velocities more than 20cm/s will be taken as abnormal.	12 months
Time average wall shear stress (TAWSS)	TAWSS will be quantified for each bioprosthesis at 3 levels: subvalvular (LVOT, the aortic root, and the proximal ascending aorta. TAWSS under 0.5Pa is taken as low, 0.51-2.0 as moderately increased, >2.0 Pa as severely increased TAWSS.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's satisfaction	A questionnaire will be designed to score valve-related clinical symptoms following the intervention.	12 months
Evidence of major adverse cardiac and cerebrovascular events (MACCE)	Evidence of MACCE (Stroke and myocardial infarction in the first 12 months post procedure)	12 months
Mortality	Evidence of mortality during the 12 months post procedure.	12 months

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: Imperial College London; Edwards Lifesciences
• Investigators: Principal Investigator: Saeed Mirsadraee, MD, Ph.D, Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Bioprosthesis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: 316308

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: Yes
• product manufactured in and exported from the U.S.: No