title: Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial.
abstract: OBJECTIVE
  Functional mitral regurgitation (FMR) contributes to morbidity and mortality in heart failure (HF) patients. The aim of this study was to determine whether percutaneous mitral annuloplasty could safely and effectively reduce FMR and yield durable long-term clinical benefit.
  
  
  RESULTS
  The impact of mitral annuloplasty (Carillon Mitral Contour System) was evaluated in HF patients with at least moderate FMR. Patients in whom the device was placed then acutely recaptured for clinical reasons served as a comparator group. Quantitative measures of FMR, left ventricular (LV) dimensions, New York Heart Association (NYHA) class, 6 min walk distance (6MWD), and quality of life were assessed in both groups up to 12 months. Safety and key functional data were assessed in the implanted cohort up to 24 months. Thirty-six patients received a permanent implant; 17 had the device recaptured. The 30-day major adverse event rate was 1.9%. In contrast to the comparison group, the implanted cohort demonstrated significant reductions in FMR as represented by regurgitant volume [baseline 34.5 ±11.5 mL to 17.4 ±12.4 mL at 12 months (P < 0.001)]. There was a corresponding reduction in LV diastolic volume [baseline 208.5 ±62.0 mL to 178.9 ±48.0 mL at 12 months (P =0.015)] and systolic volume [baseline 151.8 ±57.1 mL to 120.7 ±43.2 mL at 12 months (P =0.015)], compared with progressive LV dilation in the comparator. The 6MWD markedly improved for the implanted patients by 102.5 ±164 m at 12 months (P =0.014) and 131.9 ±80 m at 24 months (P < 0.001).
  
  
  CONCLUSIONS
  Percutaneous reduction of FMR using a coronary sinus approach is associated with reverse LV remodelling. Significant clinical improvements persisted up to 24 months.
authors.affiliation: Department of Cardiology, Poznan University, Poznan, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Siminiak
authors.forename: Justina C
authors.initials: JC
authors.lastname: Wu
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.forename: Uta C
authors.initials: UC
authors.lastname: Hoppe
authors.forename: Jerzy
authors.initials: J
authors.lastname: Sadowski
authors.forename: Janusz
authors.initials: J
authors.lastname: Lipiecki
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.forename: Amil M
authors.initials: AM
authors.lastname: Shah
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
authors.forename: David M
authors.initials: DM
authors.lastname: Kaye
authors.forename: Steven L
authors.initials: SL
authors.lastname: Goldberg
authors.forename: Wayne C
authors.initials: WC
authors.lastname: Levy
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
authors.forename: David G
authors.initials: DG
authors.lastname: Reuter
mesh_terms: D000704:Analysis of Variance; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D006305:Health Status Indicators; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D058386:Mitral Valve Annuloplasty / Q000379:methods*; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D012307:Risk Factors; D013318:Stroke Volume; D013997:Time Factors; D014463:Ultrasonography; D016277:Ventricular Function, Left