Clinical trial NCT03038204: The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation
Official title: The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Regurgitation
Keywords: Papillary muscles approximation
Lead sponsor: The Federal Centre of Cardiovascular Surgery, Russia
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ischemic cardiomyopathy and coexisting IMR were enrolled in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mitral regurgitation severity (1,2 or 3)
timeFrame: 1 year
Secondary outcomes:
measure: End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml)
timeFrame: 1 year
measure: Ejection fraction (%)
timeFrame: 1 year
measure: Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm)
timeFrame: 1 year
measure: Tenting area (mm^2)
timeFrame: 1 year
Other outcomes:
measure: Age (years)
timeFrame: 1 year
measure: Body mass index (kg/m^2)
timeFrame: 1 year
measure: Body surface area (m^2)
timeFrame: 1 year
measure: NYHA (I, II, III or IV)
timeFrame: 1 year
measure: EuroSCORE
timeFrame: 1 year
measure: Six minute walk test (m)
timeFrame: 1 year
measure: Hypertension (absence, stage 1, 2 or 3)
timeFrame: 1 year
measure: Diabetes mellitus (absence, insulin-dependent or noninsulin-dependent)
timeFrame: 1 year
measure: Obesity (absence, class 1, 2 or 3)
timeFrame: 1 year
measure: Multifocal atherosclerosis (presence or absence)
timeFrame: 1 year
measure: COPD (absence, GOLD 1, 2, 3 or 4)
timeFrame: 1 year
Locations:
Study officials:
References:
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. Epub 2012 May 1.
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 Jun;68(3):271-8. doi: 10.1080/ac.68.3.2983421.
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, 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.
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. doi: 10.1016/j.athoracsur.2007.04.056.
citation: 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.
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. doi: 10.1253/circj.cj-12-1148. Epub 2013 Feb 20.
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: 10.1186/1749-8090-9-98.