Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Hypertrophic Obstructive Cardiomyopathy

Treatments: Procedure: Mitral valve surgery; Procedure: myoectomy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02054221

1957

HOCM - 95

Details and patient eligibility

About

Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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82 participants in 2 patient groups

extended myectomy + MVreplacement

Other group

Description:

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.

Treatment:

Procedure: myoectomy

Procedure: Mitral valve surgery

Procedure: Mitral valve surgery

extended myectomy + MVrepair

Other group

Description:

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 .

Treatment:

Procedure: myoectomy

Procedure: Mitral valve surgery

Procedure: Mitral valve surgery