Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery

Severe Mitral Regurgitation Clinical Trial

— DysPO IM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968601
• Other study ID #: RNI 2018 CLERFOND
• Secondary ID: 2018-A02476-49
• Status: Completed
• Start date: March 18, 2019
• Est. completion date: April 29, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Preserved Ventricular Ejection Fraction
• Severe Mitral Regurgitation
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• Mitral regurgitation surgery such as mitral valve replacement or repair
Mitral regurgitation surgery such as mitral valve replacement or repair. All kind of mitral regurgitation surgery: replacement or repair, by median sternotomy of minimally invasive surgery, with or without tricuspid plasty

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-operative global longitudinal strain rate among patients going for mitral surgery.	Pre-operative global longitudinal strain in patients going for mitral regurgitation surgery with preserved LVEF, measured by echocardiography.	During pre-operative visit
Secondary	Functional impact in terms of walking distance.	6 Minute Walk Distance	This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
Secondary	Measure Quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Minnesota Living with Heart Failure Questionnaire (MLHFQ), evaluating : legs swelling, walking and working capacity, presence of sleeping or breathing disorders, difficulties for sport, hobbies or relationships, side effects from medications, psychologic and economic impact of the disease. The total score goes from 0 (best quality of life) to 105 (worse impact).	This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
Secondary	Dyspnoea	Use of the New York Heart Association (NYHA) Functional Classification.	This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits.
Secondary	Left ventricular function	Left ventricular ejection fraction by Simpson method.	This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits.
Secondary	All-cause mortality, as the total number of death during the follow-up	all death reported	At 8 days, 1-month and 6-months
Secondary	Cardiovascular mortality, as the number of death from cardiovascular disease during the follow up	Death by myocardial ischemia or infarction, heart failure, cardiac arrest, or cerebrovascular accident.	At 8 days, 1-month and 6-months
Secondary	Number of patients hospitalized due to heart failure during the follow up	all re-hospitalisation reported	At 8 days, 1-month and 6-months
Secondary	Pre-operative right ventricular function (measured by Tricuspid Annular Plane Systolic Excursion - TAPSE, Peak Systolic Velocity in DTI mode and Fractional Area Change).	We aim to determine whether or not right ventricular function (measured by Tricuspid Annular Plane Systolic Excursion - TAPSE, Peak Systolic Velocity in DTI mode and Fractional Area Change) can have an impact on post-operative LVEF in patients going for mitral regurgitation surgery.	These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits
Secondary	Pre-operative pulmonary arterial pressure determined by tricuspid regurgitation peak velocity	Ithe aim is to determine whether or not pulmonary hypertension (determined by tricuspid regurgitation peak velocity) can have an impact on post-operative LVEF in patients going for mitral regurgitation surgery.	These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
Secondary	Left ventricular ejection index	Impact of this novel left ventricular ejection index (defined as indexed left ventricular end-systolic diameter divided by left ventricular outflow tract time-velocity integral) on post-operative left ventricular dysfunction, compared with global longitudinal strain.	During pre-operative visit.