Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial

Abstract

AimsFunctional 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.Methods and resultsThe 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).ConclusionPercutaneous reduction of FMR using a coronary sinus approach is associated with reverse LV remodelling. Significant clinical improvements persisted up to 24 months.

Therapeutic decision-making for patients with fluctuating mitral regurgitation

“…Given the close proximity of the circumflex artery to the coro nary sinus, ischaemia related MR worsening should be excluded before co nsidering the transcoronary sinus procedure unsuccessful. 69 Other strategies Although they are currently unavailable for clinical use, some percutaneous devices have been considered for secondary MR treatment to promote favourable LV remodelling with a direct approach. 1 Some devices are designed to correct the distortion in LV shape and annular dilatation using a system of chordae release through the left ventricle between the two papillary muscles, with subsequent anteroposterior LV reduc tion, by shortening of the implanted chordae.…”

Emerging Trends in Heart Valve Engineering: Part III. Novel Technologies for Mitral Valve Repair and Replacement

“…First and second generations of the Carillon device were studied in the Amadeus and Titan clinical trials respectively. 56,58 Patients who received the device had significant benefits with reductions in quantitative measures of functional MR severity, sustained LV remodeling and improved quality of life. However, this technology does have several important limitations including: (1) Concern for the anatomic distance between the coronary sinus and the mitral annulus in some patients with dilated hearts.…”

“…This simple anatomic separation means that the device affects a cinch of the left atrial wall and not the mitral annulus thus failing to reduce MR severity; (2) The implication of the close relationship between the coronary sinus and the circumflex coronary artery that can be inadvertently compressed if the artery courses between the coronary sinus and the annulus; and (3) The finding that several patients had fractures of the Nitinol wire ribbon in both clinical trials. 56,58 While indirect annuloplasty exploits the coronary sinus position, direct annuloplasty devices have also been developed to more closely replicate the surgical approach to annular area reduction. The Mitralign TM system (Mitralign Inc., Tewksbury, MA) takes a retrograde transventricular approach to deliver a suture annuloplasty.…”

Anatomical variants of left circumflex artery, coronary sinus and mitral valve can determine safety of percutaneous mitral annuloplasty

“…The latest study -TITAN (Trans catheter Implantation of Carillon Mitral Annuloplasty Device) proved that percutaneous CS-based mitral annuloplasty can significantly and safely reduce functional mitral regurgitation in HF patients. It was also documented that left ventricle reverse remodeling occurred over 12 months and that improved measures of clinical outcome occurred over 24 months [5].…”