Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial Hospital, to determine the hinge washout characteristics and downstream flow patterns of the On-X valve and compared to competing designs.

Study Overview

• Status: Completed
• Conditions: Valve Heart Disease
• Intervention / Treatment: Other: MRI; Other: Transthoracic echocardiography exam

Detailed Description

Prospective, concurrent 4D flow Magnetic Resonance Imaging (MRI) and echocardiography of On-X and St Jude Medical (SJM) Masters HP or Carbomedics Carbo-seal or Carbo-seal Valsalva aortic valve replacement (AVR) patients will be performed. Echocardiography analysis will include: valve function (opening angle), pressure gradients, and degree of valve washout. MRI analysis will focus on downstream flow patterns (helicity and vorticity), energy loss, pressure recovery, and measurement of wall shear stress in the anastomosis regions.

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

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60208
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic valve disease who within the last five years underwent AVR using the On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.

Description

Inclusion Criteria:

• Male and female subjects 18-89 years of age
• Patients with aortic valve disease who within the last five years underwent AVR using the On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.

Exclusion Criteria:

• Patients contraindicated against MRI
• Patients with pacemakers, cochlear (in the ear) implants, or aneurysm clips or patients who have worked with metal
• Patients unwilling or unable to give written informed consent
• Pregnant women
• Prisoners
• Patients with an Effective Orifice Area index (EOAi) <0.85 cm2/m2

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
On-X AAP; Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP).	Other: MRI; Enrolled patients will complete a non-contrast cardiac MRI; Other: Transthoracic echocardiography exam; Enrolled patients will complete a transthoracic echocardiography exam.
SJM Masters or Carbomedics Carbo-seal; Patients with St. Jude Medical Masters HP Valved Graft with Gelweave Valsalva™ Technology or Carbomedics Carbo-seal (including Carbo-seal Valsalva) mechanical aortic valve prostheses patients	Other: MRI; Enrolled patients will complete a non-contrast cardiac MRI; Other: Transthoracic echocardiography exam; Enrolled patients will complete a transthoracic echocardiography exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Downstream flow patterns (helicity and vorticity)	MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.	3 months
Hinge washout	MRI data analysis; Yes/No	3 months
Energy loss	MRI data analysis; Irreversible energy loss quantified.Efforts will include the quantification of turbulent kinetic energy. This is representative of permanent pressure loss.	3 months
Wall shear stress (WSS)	MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejection Fraction (%)		3 months
Primary EDV (ml)	End Diastolic Volume	3 months
Normalized EDV (ml/m^2)	End Diastolic Volume	3 months
Primary ESV (mL)	End Systolic Volume	3 months
Normalized ESV (mL/m^2)	End Systolic Volume	3 months
Peak Velocity (m/s)		3 months
Mean velocity (m/s)		3 months
Peak transvalvular pressure gradient (mmHg)		3 months
Mean transvalvular pressure gradient (mmHg)		3 months
Effective Orifice Area (EOA)		3 months
Effective Orifice Area index (EOAi)		3 months

Collaborators and Investigators

• Sponsor: CryoLife, Inc.
• Collaborators: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: mechanical heart valve; On-X
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2017-1

Drug and device information, study documents

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