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

Mitral Regurgitation Clinical Trial

— PMA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03038204
• Other study ID #: FederalCCS 001
• Status: Active, not recruiting
• Phase: N/A
• First received: January 16, 2017
• Last updated: January 28, 2017
• Start date: February 2016
• Est. completion date: March 2021

Study information

• Verified date: January 2017
• Source: The Federal Centre of Cardiovascular Surgery, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Federal Centre of Cardiovascular Surgery, Russia

References & Publications (7)

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. — View Citation

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, Tho — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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: 10.1186/1749-80 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age (years)	Description and comparison of groups of patients	1 year
Other	Body mass index (kg/m^2)	Description and comparison of groups of patients.	1 year
Other	Body surface area (m^2)	Description and comparison of groups of patients.	1 year
Other	NYHA (I, II, III or IV)	Description and comparison of groups of patients.	1 year
Other	EuroSCORE	Description and comparison of groups of patients.	1 year
Other	Six minute walk test (m)	Description and comparison of groups of patients.	1 year
Other	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
Other	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
Other	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
Other	Multifocal atherosclerosis (presence or absence)	Description and comparison of groups of patients. Impact of the factor on the long-term survival.	1 year
Other	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
Primary	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	End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml)	Assessment of left ventricular dimensions.	1 year
Secondary	Ejection fraction (%)	Assessment of myocardial contractility.	1 year
Secondary	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
Secondary	Tenting area (mm^2)	Assessment of the impact of the surgery on the configuration of the mitral valve.	1 year