Ring Versus Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases

Overview

This study aims to compare whether De Vega's Suture annuloplasty is equally effective in reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring annuloplasty in Rheumatic Heart Disease patients with concurrent Mitral valve replacement.

Full Title of Study: “Comparison Between Outcomes Of Ring And Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2016

Detailed Description

Functional Tricuspid regurgitation (FTR) occurs due to annular dilatation in association with left sided valve disease and is more commonly seen than primary pathology in patients with Rheumatic mitral valve disease. FTR occurs due to increased right ventricle after load that leads to either dilatation or geometric deformation of Tricuspid annulus. If left untreated, FTR may worsen and increase morbidity and mortality.

Interventions

  • Procedure: Tricuspid Annuloplasty
    • Patients will undergo repair of tricuspid regurgitation

Arms, Groups and Cohorts

  • Active Comparator: Group R (ring)
    • Patients in Group R will undergo tricuspid ring annuloplasty
  • Active Comparator: Group S (suture)
    • Patients in Group S will undergo De Vega’s suture annuloplasty

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in severity of FTR
    • Time Frame: within 3 months
    • Definitions: Improvement in FTR: refers to Mild or No TR Tricuspid regurgitation is graded as mild, moderate, and severe based on regurgitant jet area i. <5cm2 = Mild ii. 6-10cm2 = Moderate iii. >10cm2 = Severe

Secondary Measures

  • Mortality
    • Time Frame: up to 3 months of intervention
    • Mortality: Mortality within hospital stay or 3 months postoperative.

Participating in This Clinical Trial

Inclusion Criteria

  • The participants will be all patients between 15 to 75 years of age group diagnosed as a case of Rheumatic Mitral Valve disease with moderate to severe functional Tricuspid regurgitation.

Exclusion Criteria

  • Patient with organic Tricuspid Valve (TV) lesion diagnosed in Echocardiography
  • Patient with FTR requiring Mitral Valve repair
  • Patient with FTR requiring concomitant aortic valve replacement
  • Patient with FTR secondary to pathology other than Mitral valve disease

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shahid Gangalal National Heart Centre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marisha Aryal, Resident, Cardiac Surgery Dept. – Shahid Gangalal National Heart Centre
  • Overall Official(s)
    • Marisha Aryal, MBBS, Principal Investigator, Shahid Gangalal National Heart Centre
  • Overall Contact(s)
    • Binita Tamrakar, RN, +97714371322, ircsgnhc@gmail.com

References

Tang GH, David TE, Singh SK, Maganti MD, Armstrong S, Borger MA. Tricuspid valve repair with an annuloplasty ring results in improved long-term outcomes. Circulation. 2006 Jul 4;114(1 Suppl):I577-81.

Guenther T, Mazzitelli D, Noebauer C, Hettich I, Tassani-Prell P, Voss B, Lange R. Tricuspid valve repair: is ring annuloplasty superior? Eur J Cardiothorac Surg. 2013 Jan;43(1):58-65; discussion 65. doi: 10.1093/ejcts/ezs266. Epub 2012 May 24.

Sarralde JA, Bernal JM, Llorca J, Pontón A, Diez-Solorzano L, Giménez-Rico JR, Revuelta JM. Repair of rheumatic tricuspid valve disease: predictors of very long-term mortality and reoperation. Ann Thorac Surg. 2010 Aug;90(2):503-8. doi: 10.1016/j.athoracsur.2010.03.105.

Rivera R, Duran E, Ajuria M. Carpentier's flexible ring versus De Vega's annuloplasty. A prospective randomized study. J Thorac Cardiovasc Surg. 1985 Feb;89(2):196-203.

Badano LP, Muraru D, Enriquez-Sarano M. Assessment of functional tricuspid regurgitation. Eur Heart J. 2013 Jul;34(25):1875-85. doi: 10.1093/eurheartj/ehs474. Epub 2013 Jan 9. Review.

Citations Reporting on Results

Rogers JH, Bolling SF. The tricuspid valve: current perspective and evolving management of tricuspid regurgitation. Circulation. 2009 May 26;119(20):2718-25. doi: 10.1161/CIRCULATIONAHA.108.842773. Review.

McCarthy PM, Bhudia SK, Rajeswaran J, Hoercher KJ, Lytle BW, Cosgrove DM, Blackstone EH. Tricuspid valve repair: durability and risk factors for failure. J Thorac Cardiovasc Surg. 2004 Mar;127(3):674-85.

Navia JL, Nowicki ER, Blackstone EH, Brozzi NA, Nento DE, Atik FA, Rajeswaran J, Gillinov AM, Svensson LG, Lytle BW. Surgical management of secondary tricuspid valve regurgitation: annulus, commissure, or leaflet procedure? J Thorac Cardiovasc Surg. 2010 Jun;139(6):1473-1482.e5. doi: 10.1016/j.jtcvs.2010.02.046. Epub 2010 Apr 14.

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