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

NCT03038204 | Unknown DMC

• 1 other identifier: FederalCCS 001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mitral Regurgitation

Keywords

Papillary muscles approximation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml)

  1 year

• Ejection fraction (%)

  1 year

• Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm)

  1 year

• Tenting area (mm^2)

  1 year

Other Outcomes (11)

• Age (years)

  1 year

• Body mass index (kg/m^2)

  1 year

• Body surface area (m^2)

  1 year

Study Arms (2)

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

MVA+CABG

patients with ischemic cardiomyopathy who underwent coronary artery bypass grafting and mitral valve annuloplasty.

Interventions

The papillary muscle approximation PROCEDURE

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.

PMA+MVA+CABG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Ischemic cardiomyopathy,
• Ischemic mitral regurgitation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Federal Centre of Cardiovascular Surgery, Russia: lead

Related Publications (7)

• 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.

  PMID: 22549757 BACKGROUND

• 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.

  PMID: 23882872 RESULT

• 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.

  PMID: 25500293 RESULT

• 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.

  PMID: 18036963 RESULT

• 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.

  PMID: 18544392 RESULT

• 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.

  PMID: 23428660 RESULT

• 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.

  PMID: 24893928 RESULT

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Cardiovascular surgeon

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 31, 2017
• Study Start: February 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share