Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

CryoLife, Inc.20 enrolled

Overview

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.

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

Conditions

Valve Heart Disease

Interventions

MRIOTHER

Enrolled patients will complete a non-contrast cardiac MRI

Transthoracic echocardiography examOTHER

Enrolled patients will complete a transthoracic echocardiography exam.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Downstream flow patterns (helicity and vorticity)

MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.

Time frame: 3 months

Hinge washout

MRI data analysis; Yes/No

Time frame: 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.

Time frame: 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

Time frame: 3 months

Secondary Outcomes

Ejection Fraction (%)

Time frame: 3 months

Primary EDV (ml)

End Diastolic Volume

Time frame: 3 months

Normalized EDV (ml/m^2)

End Diastolic Volume

Time frame: 3 months

Primary ESV (mL)

End Systolic Volume

Time frame: 3 months

Normalized ESV (mL/m^2)

End Systolic Volume

Time frame: 3 months

Data from ClinicalTrials.gov

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