Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

Study Overview
=================
Brief Summary
-----------------
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.

Detailed Description
-----------------
Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. But the question remains what is best for patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended myoectomy with mitral valve repair a or replacement.

Official Title
-----------------
Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.

Conditions
-----------------
Hypertrophic Obstructive Cardiomyopathy

Intervention / Treatment
-----------------
* Procedure: myoectomy
* Procedure: Mitral valve surgery
* Procedure: Mitral valve surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to sign Informed Consent and Release of Medical Information forms Age ≥ 18 years obstructive hypertrophic cardiomyopathy surgically significant mitral insufficiency II-IV (NYHA), average systolic pressure gradient greater than 50 mm Hg. Art. at rest; basal or medium ventricular obstruction Exclusion Criteria: Related defect of the aortic valve; Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis); Surgically significant coronary artery lesions; Patients requiring implantation of a cardioverter-defibrillator

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: extended myectomy + MVreplacement<br>Procedure: extended myoectomy, mitral valve surgery Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy with full isscheniem subvalvular apparatus and mitral valve replacement. Evaluation results will be made myoectomy as TEE and direct tensiometer. | Procedure: myoectomy<br>* The scheme of Extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.<br>* Other names: Extended myoectomy;Procedure: Mitral valve surgery<br>* 41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.<br>* Other names: mitral valve replacement;|
| Other: extended myectomy + MVrepair<br>Procedure: extended myoectomy, mitral valve surgery Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy which supplemented resection and release of the papillary muscles and the mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group. Evaluation results will be made myoectomy as TEE and direct tensiometer . | Procedure: myoectomy<br>* The scheme of Extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.<br>* Other names: Extended myoectomy;Procedure: Mitral valve surgery<br>* 41 patients will be performed mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group.<br>* Other names: mitral valve repair;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pressure gradient in the output section of the left ventricle |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertrophic cardiomyopathy, mitral valve