The Cadiobrand device is implanted through a transseptal approach and makes a reduction in the mitral annulus area. The study included 24 patients with moderate mitral regurgitation (functional class III- IV) and high surgical risk. The device was successfully implanted in all cases reducing the annular size by 92 % and to the same extent the degree of impairment.
Concerning safety, a mortality of 8%, a recurrence of the regurgitation of 4%, need for surgery of 4% and bleeding complications in 4% was observed. At 6 months follow-up, 90 % of patients had minor or equal level of mitral regurgitation of 2 and 88% were in functional class I or II.
Conclusion
The transcatheter mitral annuloplasty is a feasible procedure with a comparable safety to other percutaneous procedures. Improves regurgitation at 6 months follow up as well as the functional class.
Francesco Maisano
2014-05-22
Title: Percutaneous mitral valve direct annuloplasty with a “surgical-like” device multicentre feasibility trial