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Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial

Janusz Lipiecki1, Tomasz Siminiak2, Horst Sievert3

  • 1Centre de Cardiologie Interventionnelle, Pôle Santé République Clermont-Ferrand , France.

Open Heart
|August 6, 2016
PubMed

Insights

A modified Carillon device effectively treats functional mitral regurgitation (FMR) in heart failure patients. This percutaneous therapy improved patient outcomes and resolved previous device fracture issues, paving the way for further trials.

Area of Science:

  • Cardiology
  • Medical Devices
  • Heart Failure Research

Background:

  • Functional mitral regurgitation (FMR) worsens outcomes in congestive heart failure (CHF) and cardiomyopathy patients.
  • Percutaneous coronary sinus-based therapies aim to reduce FMR.

Purpose of the Study:

  • Evaluate the safety and efficacy of a modified Carillon device for FMR treatment.
  • Assess the modified device's performance in patients with cardiomyopathy and FMR.

Main Methods:

  • 36 patients with CHF, reduced ejection fraction (<40%), and moderate-to-severe FMR received the Carillon device implant.
  • The study monitored adverse events, FMR severity, functional class, and 6-minute walk tests.

Main Results:

  • One non-device-related death occurred within 30 days post-implant.
  • Significant reductions in FMR and improvements in functional class and walk tests were observed.
  • Crucially, the issue of device anchor fractures seen in prior studies was not observed.

Conclusions:

  • The modified Carillon device shows promise for treating FMR, improving clinical and echocardiographic parameters.
  • This revised device successfully addressed the prior anchor fracture problem.
  • The modified device is slated for use in an upcoming blinded, randomized trial for symptomatic FMR patients.
Abstract

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