Indirect mitral annuloplasty in patients with reduced or preserved ejection fraction: A real-world, single-centre...

We aim to evaluate the real-world effectiveness and safety of the Carillon Mitral Contour System (CMCS) for indirect annuloplasty in patients with heart failure (HF) and secondary mitral regurgitation (SMR).

This was a single-centre retrospective study of 204 consecutive patients (age 83 ± 6 years, 68% female, 72% HFrEF) with NYHA class II-IV HF and moderate and moderate-to-severe (grade 2 + or 3+) SMR planned for CMCS implantation between 2021 and 2024. Echocardiographic variables, B-type natriuretic peptide (BNP) and NYHA functional class were routinely assessed prior to the procedure and, in those with a successful implantation, after 3 months. The device was successfully implanted in 201 (98.5%) patients; the remaining 3 had unsuitable coronary sinus anatomy. Procedural complications occurred in 10.4% and included circumflex artery compression requiring percutaneous coronary intervention (9.5%); coronary sinus injury (1.5%); procedural mortality (0%). At 3 months, NYHA class improved by ≥1 category in 94% of patients and 98% achieved NYHA class I or II. MR decreased by ≥1 grade in 91% of patients, with all patients classified as grade 1+ or 2+ post-procedure. Vena contracta width decreased (6.43 ± 0.84 to 3.85 ± 1.19 mm; P < 0.001), and there was a reduction of LA area from 44.4 ± 6.0 to 35.4 ± 5.1 cm² (P < 0.001). Diastolic filling was improved (change in E/E' ratio from 20.1 ± 5.5 to 14.0 ± 3.8; P < 0.001), systolic pulmonary artery pressure was lower in follow-up (44 ± 11 to 35 ± 9 mm; P < 0.001), and there was also a clinically relevant reduction in median BNP levels from 2849 to 1390 pg/mL (P < 0.001). These changes were not different between HFrEF and HFpEF.

In this single-centre observational cohort study, CMCS implantation success was high, and associated with low complication rates, improvements in symptoms and echocardiographic variables, and clinically relevant reductions in BNP levels.