Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

Ghent University Hospital (UZ)

Status: Completed

Conditions: Aneurysm Aortic Root; Aortic Valve, Bicuspid

Treatments: Diagnostic Test: graded bicycle test

Study type: Interventional

Funder types: Other

Identifiers

NCT04205474

HCH_VSRR_1

Details and patient eligibility

About

Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis.

This results in a normal functioning aortic valve, with a low forward gradient across the left ventricular outflow tract.

Little is known about how the repaired aortic valve behaves in conditions of controlled exercise, and how the gradients across the valve change during exercise.

Full description

In a cohort of patients operated on since 2000 with a valve sparing operation for aortic root aneurysm in the Department of Cardiac surgery of the University Hospital Ghent, Belgium, and with gradients at rest across the aortic valve of <20mmHg, a graded exercise test on a bicycle (stepwise increase of afterload) will be performed, and the gradient across the aortic valve will be monitored by transthoracic echocardiography at each exercise level. Patients with tricuspid and bicuspid valves will be compared. An age matched, unoperated, and asymptomatic control group with normal functioning tricuspid and bicuspid valves will be examined with the same exercise protocol.

The purpose of the study is the description of the gradients across the aortic valve during exercise, and the discrimination of risk factors that may induce increased gradients.

The hypothesis is that patients with bicuspid valves will demonstrate higher gradients than patients with tricuspid valves, in operated and unoperated individuals.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• been operated with a valve sparing root procedure in the University Hospital Ghent, Belgium, since 2000
• being able to perform an exercise test on a reclining bicycle
• normal left ventricular function

Exclusion criteria

• <18 years or >60 years of age
• peak gradient across the aortic valve at rest of >20mmHg
• decreased left ventricular function

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

VSRR with tricuspid aortic valve

Active Comparator group

Description:

Patients with a tricuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm

Treatment:

Diagnostic Test: graded bicycle test

VSRR with bicuspid aortic valve

Active Comparator group

Description:

Patients with a bicuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm

Treatment:

Diagnostic Test: graded bicycle test