Key result
Carillon device cuts HFH ~40% vs GDMT alone in functional MR and severe LV enlargement.
Why the study?
The clinical impact of the Carillon percutaneous mitral valve annuloplasty device in patients with secondary mitral regurgitation and severe left ventricular dilation is not well established.
Does percutaneous mitral valve annuloplasty added to guideline-directed medical therapy improve echocardiographic parameters, functional outcomes, and heart failure hospitalizations in patients with functional mitral regurgitation and severe left ventricular enlargement?
Meta-Analysis (n=95)
Yes
Does percutaneous mitral valve annuloplasty added to guideline-directed medical therapy improve echocardiographic parameters, functional outcomes, and heart failure hospitalizations in patients with functional mitral regurgitation and severe left ventricular enlargement?
Percutaneous mitral valve annuloplasty improves mitral valve function, left ventricular morphology, and clinical outcomes in patients with functional mitral regurgitation, suggesting severe baseline LV dilation should not preclude device eligibility.
May support Carillon consideration despite severe LV enlargement; leaves open need for dedicated RCTs to confirm benefit.
This study sought to determine the effect of percutaneous mitral valve annuloplasty with the Carillon device versus guideline-directed medical therapy (GDMT) alone in patients with secondary mitral regurgitation (MR) and severe left ventricular (LV) enlargement. The clinical impact of the Carillon device in patients with severe LV dilation is not well established. This is a pooled analysis involving 3 prospective trials (TITAN [Transcatheter Implantation of Carillon Mitral Annuloplasty Device], TITAN II, and REDUCE FMR [CARILLON Mitral Contour System for Reducing Functional Mitral Regurgitation] trials) in which patients with functional MR and severe LV enlargement (LV end-diastolic diameter >65 mm) were treated with GDMT and the Carillon device versus GDMT alone. Key outcomes of this analysis were changes over 1 year of follow-up in mitral valve and LV echocardiographic parameters, functional outcome, quality of life, mortality, and heart failure hospitalization (HFH). A total of 95 patients (67 in the Carillon group, 28 in the GDMT group) with severe LV enlargement were included. In the Carillon group, all mitral valve and LV morphology parameters were significantly improved at 1 year. Regurgitant volume decreased by 12 ml (p < 0.001), MR grade decreased by 0.6 U (p < 0.001), LV end-diastolic volume decreased by 25 cm3 (p = 0.005), and LV end-systolic volume decreased by 21 cm3 (p = 0.01). Significant functional improvement differences were also noted between the Carillon group and the GDMT group including an improvement of Kansas City Cardiomyopathy Questionnaire score (15 ± 4 vs. 6 ± 6; p = 0.03). The incidence of HFH was 29.9% versus 50.0% and the cumulative rate of HFH was 0.43 versus 0.75 (p < 0.001). In patients with functional MR and severe LV enlargement, the Carillon device improved mitral valve function, LV morphology, and functional outcome compared with patients receiving GDMT only. Preoperative LV dimension should not be a limiting factor when evaluating patient eligibility or anticipated response to therapy with the Carillon device.
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Anker et al. (2021) conducted a meta-analysis in Secondary mitral regurgitation and severe left ventricular enlargement (n=95). Percutaneous mitral valve annuloplasty with the Carillon device vs. Guideline-directed medical therapy (GDMT) alone was evaluated on Heart failure hospitalization (HFH) incidence (p=<0.001). In patients with functional MR and severe LV enlargement, the Carillon device reduced heart failure hospitalization incidence compared to GDMT alone (29.9% vs 50.0%; P<0.001).
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