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The purpose of the study is to assess the role of mitral valve apparatus in the development of outflow tract obstruction in patients with hypertrophic cardiomyopathy and to identify the best surgical treatment modality to relieve outflow tract obstruction in such patients
It is well-known that mitral valve plays an important role in the development of left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. In order to further investigate this phenomenon, the following study aims to compare mitral valve geometry indices, as assessed by transthoracic echocardiography, two- and three-dimentional transesophageal echocardiography and mitral valve quantification analysis, and papillary musles' function, as assessed by 2D speckle tracking imaging, in patients with hypertrophic obstructive cardiomyopathy, patients with arterial hypertension and left ventricular hypertrophy and people without structural heart disease. This will provide information on the geometric characteristics of mitral valve that predispose to the development of obstruction. Futhermore, patients with hypertrophic obstructive cardiomyopathy that are eligible for the surgical relief of obstruction will be randomised into four groups according to the modality of intervention. These groups are as follows: 1) isolated extended septal myectomy; 2) extended septal myectomy + edge to edge mitral valve repair; 3) extended septal myectomy + posterior lealfet sliding plasty; 4) extended septal myectomy + secondary chordae transection. After surgery, said indices will be reassessed and the degree of outflow tract obstruction relief noted, in order to elicit which geometrical changes are produced by each type of intervention. Patients will be followed long-term, up to 5 years, in order to define whether the addition of the intervention on mitral valve helps abolish the residual gradient more effectively, and whether it translates into any survival benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypertrophic cariomyopathy, isolated septal myectomy | Active Comparator | Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy |
|
| hypertrophic cariomyopathy, septal myectomy + edge-to-edge | Experimental | Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique) |
|
| hypertrophic cariomyopathy, septal myectomy + sliding plasty | Experimental | Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique) |
|
| hypertrophic cariomyopathy, septal myectomy + chordae | Experimental | Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection |
|
| Arterial hypertension + left ventricular hypertrophy | No Intervention | Patients with arterial hypertension with left ventricular hypertrophy whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isolated septal myectomy | Procedure |
| ||
| septal myectomy + edge-to-edge mitral valve repair |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | patients' survival without hospital admissions due to the recurring sympthoms | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Residual left vetricular outflow tract gradient | left ventricular outflow tract gradient measured by continuous doppler from 5-chamber apical view | 5 years |
| Mitral regurgitation | degree of mitral regurgitation assessed by color doppler, regurgitant volume measured using PISA method |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Pavlyukova, MD, PhD | Cardiology Research Institute, Tomsk NRMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences | Tomsk | 634012 | Russia |
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| Control | No Intervention | Patients without structural heart disease whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy |
| Procedure |
|
| septal myectomy + posterior leaflet sliding plasty | Procedure |
|
| septal myectomy + secondary chordae transection | Procedure |
|
| 5 years |
| Papillary muscles' funcion | papillary muscles' strain and strain rate assessed by 2D speckle tracking imaging | 5 years |
| Mitral valve geometry | indices of mitral valve geometry assessed by 2D transthoracic and transesophageal echocardiography and mitral valve quantification analysis | 10 days |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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