Ablation of the Pulmonary Artery With High Pulmonary Hypertension During Mitral Valve Surgery

Study Overview
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Brief Summary
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The aim of this prospective randomized study was to evaluate the effectiveness and safety of the original ablation procedures ganglion plexus pulmonary artery with simultaneous correction of valvular heart disease, complicated by high pulmonary hypertension.

Detailed Description
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Pulmonary hypertension is a serious condition, the severity of which is often underestimated. About 10% of significant mitral heart disease complicated by high pulmonary hypertension (more than 60 mm Hg). Up to 70% of patients retain this level of pulmonary hypertension after successful treatment of heart valve disease.The quality of life of patients with persistent high pulmonary hypertension is significantly lower than in patients with mild to moderate degree. Risks of recurrent tricuspid insufficiency and right ventricular dysfunction is much higher. Despite the use of modern drug therapy of pulmonary hypertension in patients with valvular heart disease satisfactory clinical effect is achieved only in a small number of patients. Our team proposed a new original method of ablation of the pulmonary artery with simultaneous open cardiac surgery correction of mitral heart disease in patients with high baseline pulmonary hypertension.

Official Title
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Surgical Ablation of Ganglion Plexuses of the Pulmonary Artery in Patients With Valvular Heart Disease, Complicated by High Pulmonary Hypertension May Reduce Its Degree.

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Procedure: Surgical ablation of ganglion plexus pulmonary artery.
* Procedure: mitral valve surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mitral stenosis or insufficiency complicated by high pulmonary hypertension (mean pulmonary artery pressure in invasive monitoring more than 35 mm Hg), which are subject to surgical treatment. Exclusion Criteria: pulmonary stenosis; pulmonary embolism in history; congenital heart disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study group<br>Procedure: mitral valve surgery, surgical ablation of ganglion plexus pulmonary artery. Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. During the operation, a standard surgical procedure for the treatment of heart valve disease will be complemented by the ablation zone of bifurcation of the pulmonary artery, surgical ablation of ganglion plexus pulmonary artery. For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement. Procedure will be considered effective in the face of declining average pressure in the pulmonary artery for invasive monitoring of 10mm Hg and more. | Procedure: Surgical ablation of ganglion plexus pulmonary artery.<br>* Performed ablation zone pulmonary artery bifurcation, at 2mm proximal direction and a distal direction in the left and right branches of the pulmonary artery using the electrophysiological device Atricure.<br>* Other names: radiofrequency ablation;Procedure: mitral valve surgery<br>* The standard procedure for mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement, depending upon the particular morphological condition of the mitral valve.<br>* Other names: mitral velve replacement;|
| Active Comparator: The control group<br>Procedure:mitral valve surgery. Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. Patients will be made standard procedure correction mitral valve disease without pulmonary artery denervation. For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement only. | Procedure: mitral valve surgery<br>* The standard procedure for mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement, depending upon the particular morphological condition of the mitral valve.<br>* Other names: mitral velve replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death of the patient |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pulmonary artery pressure in invasive monitoring | Patients will be installed catheter Swan-Ganz in the intensive care unit for invasive measurement of pulmonary artery pressure. | 3weeks; 6 and 12 months after the procedure. | 
| Exercise tolerance (the 6 minute walk test (6MWD) | the 6 minute walk test (6MWD) | 3weeks; 6 and 12 months after the procedure. | 
| quality of life | SF-36 questionnaire | 3weeks; 6 and 12 months after the procedure. | 
| adverse events | complications associated with the procedure plexus ganglion ablation, such as perforation of the pulmonary artery, pulmonary artery dissection, pulmonary embolism. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary hypertension, pulmonary artery denervation, mitral valve disease