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Percutaneous Mitral Valve Annuloplasty in Patients With LV Enlargement
Quick Takes
- Carillon Mitral Annuloplasty Device improves mitral valve function, LV morphology, and functional outcome in patients with functional MR and severe LV enlargement.
- It would be important to evaluate the efficacy of this device when compared to newer therapies including maximally tolerated doses of ARNI and SGLT2 inhibitors.
- The next step is to obtain survival data with this device.
Study Questions:
What is 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?
Methods:
This is a pooled analysis involving three 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). The cumulative number of HFHs in each group was assessed using the Nelson-Aalen cumulative hazard function. Associations between regurgitant volume and LV morphology were analyzed using the Pearson correlation coefficient.
Results:
The study cohort was comprised of 95 patients (67 in the Carillon group, 28 in the GDMT group) with severe LV enlargement. In the Carillon group, all mitral valve and LV morphology parameters were significantly improved at 1 year. Specifically, mitral 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 HFHs was 0.43 versus 0.75 (p < 0.001).
Conclusions:
The study authors concluded that 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. In addition, they surmised that preoperative LV dimension should not be a limiting factor when evaluating patient eligibility or anticipated response to therapy with the Carillon device.
Perspective:
This is an important study because it suggests that mechanical therapy of the mitral valve may result in favorable remodeling. However, more data are needed to determine whether the Carillon device improves survival. In addition, it would be important to evaluate the efficacy of this device when compared to newer therapies including maximally tolerated doses of angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose co-transporter-2 (SGLT2) inhibitors.
Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Heart Failure and Cardiac Biomarkers, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation
Keywords: Cardiac Surgical Procedures, Cardiomyopathies, Echocardiography, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Hypertrophy, Left Ventricular, Mitral Valve Annuloplasty, Mitral Valve Insufficiency, Neprilysin, Quality of Life, Receptors, Angiotensin
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