ESC Heart Failure
Giallauria et al.
December 2020
An individual patient data meta‐analysis was conducted from 3 prospective studies that enrolled 209 heart failure patients with reduced ejection fraction patients and functional mitral regurgitation (FMR). Patients implanted with the Carillon Mitral Contour System or control were assessed for 12-month outcomes relating to mitral regurgitation severity, left ventricular (LV) remodeling, functional status, and heart failure‐related hospitalization.
- Patients implanted with the device showed significantly improved hemodynamics, MR severity (regurgitant volume and MR grade), left ventricular volume (LVEDV) and left atrial volume (LAV), as compared to those patients who did not receive a device at 12 months.
- Improvement of symptoms as assessed by change in NYHA class also significantly favored device implantation vs control (p<0.00001) with 69.9% (51/73) of implanted patients with baseline class III or IV improving by at least one class at 12 months.
- Similarly, the rate of hospitalizations due to heart failure (HFH) was significantly reduced in implanted patients (45.3% vs 64%, p=0.04).
- Sensitivity analysis performed on subjects with more severe MR (MR grade 3+/4+) at baseline supported the overall cohort in terms of hemodynamic improvement and maintained a significant improvement in HFH (43.9% vs 82.9%, p=0.04).
In conclusion, this comprehensive meta‐analysis of individual patient data has shown that the CARILLON device provides statistically significant and clinically meaningful benefits in LV volumes, NYHA functional class and indexes of mitral valve performance, along with a reduction in the rate of subsequent HFH.
