Functional assessment of patients after percutaneous mitral valvuloplasty with Carillon™ device: a preliminary report.

Background: Functional mitral regurgitation (MR) due to dilated cardiomyopathy or coronary artery disease remains a significant clinical problem. These clinical entities lead to left ventricular enlargement, which results in annular dilation and MR. Surgical valvuloplasty is associated with a high perioperative risk. This is the reason why percutaneous techniques for mitral valve repair are under development. One of the most advanced devices for mitral annuloplasty is the Carillon™ system.

Aim: Functional assessment of patients who have undergone mitral annuloplasty using the Carillon™ device.

Methods: Fourteen consecutive patients with functional MR who had undergone successful implantation of the Carillon™ device were enrolled. The device was implanted into the venous system of the heart and applied tension to the mitral annulus in order to improve coaptation of the cusps and reduce MR. In implanted patients echocardiographic MR parameters (vena contracta, effective regurgitant orifice area) were assessed before, immediately after the procedure and during 1-month follow-up. Furthermore, the 6-minute walk test (6MWT), Naughton stress test and the NYHA functional class assessment were performed before the procedure and at 1 month. Quality of life was evaluated by the Kansas City Cardiomyopathy Questionnaire. One month after the procedure patients were also asked to compare their health status with their baseline condition.

Results: In implanted patients improvement of echocardiographic MR parameters was observed, both immediately after the procedure and during 1 month follow-up. These parameters included vena contracta (0.36 ± 0.03 and 0.31 ± 0.03 vs 0.65 ± ± 0.04 cm, both p < 0.001) as well as effective regurgitant orifice area (0.18 ± 0.02 and 0.20 ± 0.02 vs 0.28 ± 0.04 cm², p < 0.05 and p < 0.005, respectively). One month after the procedure the 6MWT (390 ± 26.25 vs 311.9 ± 15.71 m, p < 0.001), Naughton treadmill exercise test (5.06 ± 0.47 vs 3.49 ± 0.27 min, p < 0.005) and NYHA classification (1.93 ± ± 0.20 vs 2.93 ± 0.07, p < 0.005) were significantly improved. Quality of life improved from 67.93 ± 3.30 at baseline to 88.31 ± 4.02 at 1 month (p < 0.001). All the patients reported some degree of improvement at 1 month compared to baseline.

Conclusions: Implantation of the Carillon™ device in patients with functional MR leads to increased exercise capacity and improvement of selected echocardiographic MR parameters. Randomised trials are needed to assess the clinical value of the technique. Kardiol Pol 2011; 69, 3: 228-233.