Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

NCT ID: NCT02054221

Last Updated: 2015-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-05-31

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

extended myectomy + MVreplacement

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.

Group Type: OTHER

myoectomy

Intervention Type: PROCEDURE

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.

Mitral valve surgery

Intervention Type: PROCEDURE

41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.

extended myectomy + MVrepair

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 .

Group Type: OTHER

myoectomy

Intervention Type: PROCEDURE

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.

Mitral valve surgery

Intervention Type: PROCEDURE

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.

Interventions

myoectomy

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.

Intervention Type: PROCEDURE

Mitral valve surgery

41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.

Intervention Type: PROCEDURE

Mitral valve surgery

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.

Intervention Type: PROCEDURE

Other Intervention Names

Extended myoectomy; mitral valve replacement; mitral valve repair

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksandr V Bogachev-Prokophiev, PhD

Role: PRINCIPAL_INVESTIGATOR

Meshalkin Research Institute of Pathology of Circulation

Locations

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, Novosibirsk Territory, Russia

Countries

Russia

References

Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation

Reference Type: BACKGROUND

Bogachev-Prokophiev A, Afanasyev A, Zheleznev S, Fomenko M, Sharifulin R, Kretov E, Karaskov A. Mitral valve repair or replacement in hypertrophic obstructive cardiomyopathy: a prospective randomized study. Interact Cardiovasc Thorac Surg. 2017 Sep 1;25(3):356-362. doi: 10.1093/icvts/ivx152.

Reference Type: DERIVED

PMID: 28575282 (View on PubMed)

Other Identifiers

1957

Identifier Type: OTHER

Identifier Source: secondary_id

HOCM - 95

Identifier Type: -

Identifier Source: org_study_id