Minimally Invasive Cardiac Surgery by Kofidis Theo;

Author:Kofidis, Theo;
Language: eng
Format: epub
Publisher: Taylor & Francis Group
Published: 2021-01-11T00:00:00+00:00

Coronary Sinus-Based Percutaneous Mitral Annuloplasty

The Carillon Mitral Contour System is a fixed-length, double-anchor nitinol device that is designed to be positioned within the coronary sinus to reduce functional mitral regurgitation (FMR).

FIGURE 9.2.15 Animation of the implantation of a Carillon device. It is one of the devices used for indirect annuloplasty. Three prospective, multi-center trials involving more than 100 patients have shown that this system is effective, efficient and flexible. There is improvement of at least one NYHA class and at least a 50% reduction in regurgitation volume as a result of reversal of annular dilation in 80% of patients [7] (Figure 9.2.15).

FIGURE 9.2.16 Patient case demonstrating real-time implantation of Carillon device. In addition, the AMADEUS study has shown improved clinical and echocardiographic parameters when used in patients with FMR, with an acceptable safety profile. However, there were problems of wire-form fractures seen next to the proximal anchor locking mechanism at high-strain locations on the device. Even though the wire-form fractures were clinically benign, the device was modified and named mXE2, which underwent the TITAN II study to further evaluate its safety and integrity [8]. Of 36 patients with congestive heart failure, reduced left ventricular function and at least moderate FMR who underwent implantation of the mXE2, there was one major adverse event within 30 days – non-device-related mortality – which occurred 17 days post-implantation. There was clinical improvement as evidenced by echocardiographic reductions in degree of FMR and better 6-min walk test results, as per the two previous studies. In addition, the previously seen device fractures were not seen in TITAN II. The next phase will be for the use of Carillon device in a blinded randomized trial of symptomatic patients with FMR in Europe and Australia (Figure 9.2.16 and Figure 9.2.17).

FIGURE 9.2.17 Carillon® Mitral Contour System: right-heart transcatheter mitral valve repair (TMVr) device. Reproduced with permission of Cardiac Dimensions Pty. Ltd. © 2020.

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