Additive Prognostic Value of PALS Compared to Bernard's Staging in Patients Undergoing MV Surgery
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Speckle tracking and 2D echocardiography.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Additive Prognostic Value of Speckle Tracking Echocardiography Compared to Bernard's Staging in Patients Undergoing Mitral Valve Surgery
Overview
Mitral valve prolapse is the most common cause of mitral regurgitation requiring surgery in developed countries. While cardiac surgery is recommended for symptomatic patients, in accordance with the ESC guidelines on valvular heart disease, indications for intervention in asymptomatic patients are mainly based on two-dimensional echocardiographic criteria: the presence of left ventricular systolic dysfunction or dilatation (end-systolic diameter ≥ 40 mm and/or ejection fraction ≤ 60%); or, in patients with preserved left ventricular systolic function, the occurrence of atrial fibrillation secondary to valvular disease or pulmonary hypertension (systolic pulmonary artery pressure \> 50 mmHg); finally, significant left atrial dilatation (indexed left atrial volume ≥ 60 ml/m² or diameter ≥ 55 mm) also represents an indication. Mitral valve repair is preferred over valve replacement with a prosthesis, as it is associated with lower intraoperative mortality, better long-term survival, and fewer valve-related complications. However, the cut-off values derived from conventional echocardiography and used as indicators for surgical intervention may reflect an already severe and irreversible structural and functional cardiac alteration. Moreover, they do not consider more advanced imaging techniques such as speckle tracking echocardiography, which is now widely used in clinical practice and allows for a quantitative assessment of myocardial function through the analysis of myocardial fiber shortening in the cardiac walls. Several studies have shown that preoperative peak left atrial longitudinal strain (PALS) has prognostic value in predicting postoperative clinical outcomes in patients undergoing surgery for primary mitral regurgitation, as well as in predicting left atrial reverse remodeling; this prognostic relevance has also been observed in asymptomatic patients and in cases of less than severe mitral regurgitation. Furthermore, Bernard et al. demonstrated the prognostic value of a staging system for extra-valvular cardiac damage, assessed using two-dimensional echocardiographic data, in asymptomatic patients with moderate or severe mitral regurgitation.
Interventions
- Diagnostic test Speckle tracking and 2D echocardiography
The study will involve only the collection of data obtained from routine clinical procedures and a telephone follow-up. Preoperative echocardiographic data and pre-operative left atrial speckle tracking data will be retrieved
Primary outcome measures
- All cause or cardiovascular mortality [Time frame: 3 months]
Secondary outcome measures (1)
- Composite endpoint: all cause or cardiovascular mortality, new onset of atrial fibrillation, hospitalization for cardiovascular cause (heart failure, acute coronary syndrome) [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Patients with severe primary mitral regurgitation treated with cardiac surgery
- Age > 18 years
- Signed informed consent form/Substitute declaration in place of the signed informed consent form in the case of deceased patients
Exclusion criteria
- Known coronary artery disease
- Infective endocarditis
- Functional mitral regurgitation
- Presence of additional left-sided valvular heart disease greater than mild
- History of prior cardiac surgery
- History of rheumatic valvular disease
- Pregnancy
- Absence of a signed informed consent form/Absence of the signed substitute declaration in the case of deceased patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07151495 · 7837