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

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.

Study Overview

• Status: Unknown
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Procedure: The papillary muscle approximation

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with ischemic cardiomyopathy and coexisting IMR were enrolled in this study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PMA+MVA+CABG; patients with ischemic cardiomyopathy and mitral regurgitation who underwent coronary artery bypass grafting, mitral annuloplasty, and papillary muscles approximation.	Procedure: The 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.
MVA+CABG; patients with ischemic cardiomyopathy who underwent coronary artery bypass grafting and mitral valve annuloplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitral regurgitation severity (1,2 or 3)	Mitral 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.	1 year

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Federal Centre of Cardiovascular Surgery, Russia

Publications and helpful links

General Publications

• Manabe S, Shimokawa T, Fukui T, Tabata M, Takanashi S. Impact of papillary muscle approximation on mitral valve configuration in the surgical correction of ischemic mitral regurgitation. Thorac Cardiovasc Surg. 2012 Jun;60(4):269-74. doi: 10.1055/s-0032-1304536. Epub 2012 May 1.
• Roshanali F, Vedadian A, Shoar S, Naderan M, Mandegar MH. Efficacy of papillary muscle approximation in preventing functional mitral regurgitation recurrence in high-risk patients with ischaemic cardiomyopathy and mitral regurgitation. Acta Cardiol. 2013 Jun;68(3):271-8. doi: 10.1080/ac.68.3.2983421.
• Kron IL, Hung J, Overbey JR, Bouchard D, Gelijns AC, Moskowitz AJ, Voisine P, O'Gara PT, Argenziano M, Michler RE, Gillinov M, Puskas JD, Gammie JS, Mack MJ, Smith PK, Sai-Sudhakar C, Gardner TJ, Ailawadi G, Zeng X, O'Sullivan K, Parides MK, Swayze R, Thourani V, Rose EA, Perrault LP, Acker MA; CTSN Investigators. Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2015 Mar;149(3):752-61.e1. doi: 10.1016/j.jtcvs.2014.10.120. Epub 2014 Nov 6.
• Rama A, Praschker L, Barreda E, Gandjbakhch I. Papillary muscle approximation for functional ischemic mitral regurgitation. Ann Thorac Surg. 2007 Dec;84(6):2130-1. doi: 10.1016/j.athoracsur.2007.04.056.
• Ishikawa S, Ueda K, Kawasaki A, Neya K, Suzuki H. Papillary muscle sandwich plasty for ischemic mitral regurgitation: a new simple technique. J Thorac Cardiovasc Surg. 2008 Jun;135(6):1384-6. doi: 10.1016/j.jtcvs.2007.12.034. No abstract available.
• Yamaguchi A, Adachi K, Yuri K, Kimura N, Kimura C, Tamura A, Adachi H. Reduction of mitral valve leaflet tethering by procedures targeting the subvalvular apparatus in addition to mitral annuloplasty. Circ J. 2013;77(6):1461-5. doi: 10.1253/circj.cj-12-1148. Epub 2013 Feb 20.
• Wakasa S, Kubota S, Shingu Y, Ooka T, Tachibana T, Matsui Y. The extent of papillary muscle approximation affects mortality and durability of mitral valve repair for ischemic mitral regurgitation. J Cardiothorac Surg. 2014 Jun 3;9:98. doi: 10.1186/1749-8090-9-98.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 28, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 28, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Papillary muscles approximation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: FederalCCS 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes