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The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation

The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03038204
Acronym
PMA
Enrollment
100
Registered
2017-01-31
Start date
2016-02-29
Completion date
2021-03-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

Papillary muscles approximation

Brief summary

Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt.

Detailed description

Ischemic mitral regurgitation develops in 10-50% of patients after myocardial infarction. Among several surgical procedures, mitral ring annuloplasty has been the method of choice for a considerable period. However, mitral regurgitation recurrence after surgery has a reported occurrence that ranges from 5% to 58%. Careful consideration of the mechanisms underlying recurrence of mitral regurgitation after annuloplasty might explain the unsatisfactory outcomes. The pathophysiology of IMR is complex and results from the imbalance between closing and tethering forces acting on the mitral valve. Enlargement of the left ventricular chamber, and displacement of papillary muscles in apical and lateral direction increase the tethering forces. Left ventricular and papillary muscle dyssynchrony, reduced myocardial contractility decrease closing forces, which lead to impaired leaflet coaptation and appearance of mitral regurgitation. Thus, treatment of mitral insufficiency requires an integrated approach affecting all units of the pathogenesis of MR recurrence. Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt. This study is conducted to identify the positive qualities and safety of this technique.

Interventions

PROCEDUREThe papillary muscle approximation

Surgery is performed through median sternotomy, aortic and bicaval cannulation, normothermic perfusion, and antegrade cardioplegia with the use of cardioplegic solution. After coronary anastomosis, the mitral valve is exposed by a transseptal incision. The papillary muscles are approximated through the mitral valve at the level of papillary muscles heads. Nonabsorbable, braided sutures of 2-0 (Ethibond, Ethicon, Inc.) with PTFE felt pledgets are used for this purpose. Annuloplasty mitral rings of different sizes are anchored using multiple deep U-shaped stitches of Ethibond 2-0 (Ethicon, Inc., USA). After MV repair, the LV is forcefully filled with saline water to test the valve competence. After satisfactory hydraulic test walls of the heart chambers are sutured.

Sponsors

The Federal Centre of Cardiovascular Surgery, Russia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Ischemic cardiomyopathy, * Ischemic mitral regurgitation.

Exclusion criteria

* Degenerative mitral valve disease, * Unstable angina, * Recent myocardial infarction (\< 6 months), * Papillary muscles rupture, * Severe right ventricular dysfunction, * Multiple organ failures, * Concomitant left ventricular reconstruction, * Aortic valve procedures.

Design outcomes

Primary

MeasureTime frameDescription
Mitral regurgitation severity (1,2 or 3)1 yearMitral regurgitation severity is the main indicator of the effectiveness of mitral valve plasty. Evaluation of mitral regurgitation was performed in accordance with the recommendations of the American Society of Echocardiography (ASE). Recurrence of mitral regurgitation 2 and more was considered as significant.

Secondary

MeasureTime frameDescription
Ejection fraction (%)1 yearAssessment of myocardial contractility.
Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm)1 yearAssessment of the impact of the surgery on the mitral valve configuration.
Tenting area (mm^2)1 yearAssessment of the impact of the surgery on the configuration of the mitral valve.
End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml)1 yearAssessment of left ventricular dimensions.

Other

MeasureTime frameDescription
Body mass index (kg/m^2)1 yearDescription and comparison of groups of patients.
Body surface area (m^2)1 yearDescription and comparison of groups of patients.
NYHA (I, II, III or IV)1 yearDescription and comparison of groups of patients.
EuroSCORE1 yearDescription and comparison of groups of patients.
Six minute walk test (m)1 yearDescription and comparison of groups of patients.
Hypertension (absence, stage 1, 2 or 3)1 yearDescription and comparison of groups of patients. Impact of the factor on the long-term survival.
Diabetes mellitus (absence, insulin-dependent or noninsulin-dependent)1 yearDescription and comparison of groups of patients. Impact of the factor on the long-term survival.
Obesity (absence, class 1, 2 or 3)1 yearDescription and comparison of groups of patients. Impact of the factor on the long-term survival.
Multifocal atherosclerosis (presence or absence)1 yearDescription and comparison of groups of patients. Impact of the factor on the long-term survival.
COPD (absence, GOLD 1, 2, 3 or 4)1 yearDescription and comparison of groups of patients. Impact of the factor on the long-term survival.
Age (years)1 yearDescription and comparison of groups of patients

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026