Comparison of heart workload during exercise after a Ross procedure and a mechanical valve replacement

Not Applicable

• Conditions: Effect of exercise on the heart in patients who underwent a surgical aortic valve replacement with either a mechanical prosthesis or a Ross procedure; Circulatory System

• Registration Number: ISRCTN93574260
• Lead Sponsor: Montreal Heart Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-03-30
• Study Start: 2021-07-07
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 50

Inclusion Criteria

All adults between 18 and 64 years old who underwent AVR with mechanical prosthesis or with Ross procedure at our institution between 2007 and 2016.

Exclusion Criteria

1. Uncontrolled hypertension at rest (>150/90 mmHg)
2. LVEF <50%
3. Contra-indication to exercise
4. Cardiac surgery within the last 3 months
5. Pregnancy
6. Severe pulmonary hypertension (systolic pulmonary arterial pressure > 50 mmHg)
7. Atrial fibrillation
8. Cardiovascular complications (stroke, transient ischemic attack, myocardial infarction, pericardial effusion, heart failure, malignant arrhythmias) within the last 3 months
9. Patients with a permanent pacemaker
10. More than moderate mitral insufficiency
11. Contraindication to MRI
12. Impossibility to perform a stress test on an ergocycle (limiting physical capacities)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Left ventricular workload estimated by the valvulo-arterial impedance (Zva) measured at rest and during exercise.<br> (The valvulo-arterial impedance equals the sum of the systolic blood pressure (sBP) and the mean aortic valve gradient divided by the stroke volume index: Zva= [sBP + mean AV gradient] / Stroke volume index. All the 3 parameters are measured at the same time during echocardiography and CMRI.)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Energy Loss Index (ELI) calculated as [(AVAxAa)/(Aa-AVA)]/BSA at rest and during exercise<br> 2. Aortic valve area (AVA) measured by transthoracic echocardiogram (TTE) and MRI at rest and during exercise<br> 3. Ascending aorta crossectional area (Aa) measured by TTE and MRI at rest and during exercise<br> 4. Left ventricular stroke work (LVSW) calculated as (MAP + mean AV gradient) x Stroke volume x 0.0136<br> at rest and during exercise<br> 5. Aortic valve gradients measured by TTE and MRI at rest and during exercise<br> 6. LV diameters and volumes measured by TTE and MRI at rest and during exercise<br> 7. LV ejection fraction measured by TTE and MRI at rest and during exercise<br> 8. MAP, systolic arterial pressure, diastolic arterial pressure, heart rate at rest and during exercise<br>