Clinical trial NCT03968601: Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery
Official title: Prediction of Post-operative Left Ventricular Dysfunction in Primitive, Chronic Mitral Regurgitation Surgery With Preserved Ejection Fraction, by Pre-operative Global Longitudinal Strain Measure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Mitral Regurgitation
Preserved Ventricular Ejection Fraction
Keywords: Severe mitral regurgitation
Preserved ventricular ejection fraction
Global Longitudinal Strain
Post-operative ventricular dysfunction
Echocardiography
Mitral surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with another form of cardiopathy, such as dilated or hypertrophic cardiomyopathy, ischemic or rhythmic cardiopathy.

* Patients with another valvular heart disease, such as significant aortic regurgitation or stenosis and significant mitral stenosis.
* Poor echogenicity, insufficient for the different measures.
* Severe pulmonary disease, inducing pulmonary hypertension.
* Other causes of pulmonary hypertension.
* Patients included in other studies with interventions able to interfere with our measures.
* Pregnant women.

Brief summary: Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery and it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits.

The current guidelines recommend surgery in patients with symptomatic severe mitral regurgitation or in asymptomatic patients who develop early signs of left ventricular (LV) dysfunction as a result of the MR.

However, it remains difficult to determine optimal timing for surgery with the current guidelines.

Early-stage LV dysfunction with normal LVEF predicts post-operative LV decompensation and poor prognosis and longitudinal myocardial function is suitable for detection of minor myocardial damage in patients with MR.

Thus, inestigators want to study the value of LV global longitudinal strain (GLS) to predict postoperative LV dysfunction in patients with chronic severe MR and preserved pre-operative LVEF.

The principal aim is to prove that the optimal timing for surgery, in asymptomatic chronic severe primary MR with preserved LVEF, is before GLS alteration, and that investigators should not wait for LV dilatation of dysfunction.

Detailed description: Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery.

In these patients, mitral repair is associated with excellent outcomes in terms of post-operative left ventricular (LV) function, and long-term survival when performed before the onset of severe symptoms, LV dysfunction or dilatation, pulmonary hypertension, and atrial fibrillation.

Thus, it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits.

The current guidelines recommend surgery in patients with symptomatic severe mitral regurgitation or in asymptomatic patients who develop early signs of left ventricular (LV) dysfunction as a result of the MR. LV dysfunction has been defined as LV ejection fraction (EF) 30% to 60% and/or LV end-systolic dimension (ESD) up to 45 mm.

However, it remains difficult to determine optimal timing for surgery with the current guidelines.

LVEF and LVESD, parameters proposed in the guideline, are difficult to interpret due to the influence of hemodynamic parameters of MR.

In asymptomatic patients who consider undergoing surgery, LVESD is rarely more than 45 mm.

In addition, LVEF in patients with severe MR often remains normal or higher, and subclinical LV dysfunction might be masked due to MR lowering of LV afterload.

Early-stage LV dysfunction with normal LVEF predicts post-operative LV decompensation and poor prognosis.

Therefore, it is a great challenge to identify potential LV dysfunction at an early stage and to perform surgery to prevent the development of irreversible LV dysfunction in patients with chronic severe MR.

Longitudinal myocardial function has been considered more sensitive than radial function and is therefore suitable for detection of minor myocardial damage in patients with MR.

A 2017 study proved that pre-operative GLS ≤ -18.4% can predict a preserved post-operative LVEF \>50%.

Therefore, invetsigators want to study the value of LV global longitudinal strain (GLS) to predict postoperative LV dysfunction in patients with chronic severe MR and preserved pre-operative LVEF.

The principal aim is to prove that the optimal timing for surgery, in asymptomatic chronic severe primary MR with preserved LVEF, is before GLS alteration, and that investigators should not wait for LV dilatation of dysfunction.

Thus, investigators will recruit patients before surgery, measuring GLS during pre-operative conventional echography, and follow-up patients at 8 days, 1 month and 6 months to determine whether LVEF is preserved or not.

Eligibility criteria: Inclusion Criteria:

* Stage 3 or 4, primary and chronic mitral regurgitation, going for a planned surgery, with pre-operative left ventricular ejection fraction \> 60% and left ventricular end-systolic dimension \< 45mm.
* Able to consent.
* With a National Social Security number.

Exclusion Criteria:

-

Primary outcomes:
measure: Pre-operative global longitudinal strain rate among patients going for mitral surgery.
timeFrame: During pre-operative visit
Secondary outcomes:
measure: Functional impact in terms of walking distance.
timeFrame: This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
measure: Measure Quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
measure: Dyspnoea
timeFrame: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits.
measure: Left ventricular function
timeFrame: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits.
measure: All-cause mortality, as the total number of death during the follow-up
timeFrame: At 8 days, 1-month and 6-months
measure: Cardiovascular mortality, as the number of death from cardiovascular disease during the follow up
timeFrame: At 8 days, 1-month and 6-months
measure: Number of patients hospitalized due to heart failure during the follow up
timeFrame: At 8 days, 1-month and 6-months
measure: Pre-operative right ventricular function (measured by Tricuspid Annular Plane Systolic Excursion - TAPSE, Peak Systolic Velocity in DTI mode and Fractional Area Change).
timeFrame: These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits
measure: Pre-operative pulmonary arterial pressure determined by tricuspid regurgitation peak velocity
timeFrame: These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
measure: Left ventricular ejection index
timeFrame: During pre-operative visit.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Guillaume Clerfond
role: PRINCIPAL_INVESTIGATOR
References: