Pulmonary Hypertension
Conditions
Keywords
pulmonary hypertension, pulmonary artery denervation, mitral valve disease
Brief summary
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
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.
Interventions
PROCEDURESurgical ablation of ganglion plexus pulmonary artery.
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.
PROCEDUREmitral valve surgery
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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death of the patient | 3 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean pulmonary artery pressure in invasive monitoring | 3weeks; 6 and 12 months after the procedure. | Patients will be installed catheter Swan-Ganz in the intensive care unit for invasive measurement of pulmonary artery pressure. |
| Exercise tolerance (the 6 minute walk test (6MWD) | 3weeks; 6 and 12 months after the procedure. | the 6 minute walk test (6MWD) |
| quality of life | 3weeks; 6 and 12 months after the procedure. | SF-36 questionnaire |
| adverse events | 3 weeks | complications associated with the procedure plexus ganglion ablation, such as perforation of the pulmonary artery, pulmonary artery dissection, pulmonary embolism. |
Countries
Russia
Contacts
Primary ContactAleksandr V Bogachev-Prokophiev, MD PhD
Outcome results
None listed