Hot Line: New data on TEER in moderate to severe functional mitral regurgitation
01 Sep 2024
Yesterday’s Hot Line on transcatheter edge-to-edge repair (TEER) began with exciting results from the RESHAPE-HF2 trial in patients with heart failure (HF) and moderate to severe functional mitral regurgitation (FMR).
Professor Stefan Anker (Charité University Hospital - Berlin, Germany) explained: “Patients who are ineligible for surgery have limited treatment options. When mitral TEER (M-TEER) was studied previously, mainly in severe FMR, the COAPT trial showed positive effects,1 while the MITRA-FR trial was neutral.2 RESHAPE-HF2 was conducted to assess the efficacy and safety of M-TEER in patients with symptomatic HF and moderate to severe FMR.”
This investigator-initiated international trial recruited patients with HF NYHA class ≥2 despite optimal guideline-directed medical therapy, who had LVEF ≥20% and ≤50%, MR grade 3+ or 4+ and a recent hospitalisation for HF or elevated plasma natriuretic peptide concentrations within the last 90 days. Patients for whom mitral valve surgery was recommended were not eligible. Patients were randomised to M-TEER plus optimal medical therapy or optimal medical therapy alone.
The primary endpoints were total (first and recurrent) HF hospitalisations and CV death within 24 months; total HF hospitalisations within 24 months and the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score.
In total, 505 patients were randomised, with a mean age of 70 years and 20% were female. The mean LVEF was 31% and around three-quarters had HF NYHA class III or IV.
At 24 months, the rate of total hospitalisations for HF and CV death was significantly reduced by 36% with M-TEER vs. control (37.0 vs. 58.9 per 100 patient-years; rate ratio 0.64; 95% CI 0.48–0.85; p=0.002).
The rate of total hospitalisations for HF within 24 months was also significantly reduced with M-TEER vs. control treatment (rate ratio 0.59; 95% CI 0.42–0.82; p=0.002). In addition, KCCQ scores improved significantly more with M-TEER at 12 months (mean difference +10.9 points vs. control; p<0.001).
During follow-up of 38 months, there was no difference for all-cause mortality (17.0% with M-TEER vs. 18.5% with control; hazard ratio 0.90; 95% CI 0.71–1.13). Periprocedural adverse events were reported in 4 patients in the M-TEER group.
Prof. Anker concluded: “These findings provide reassurance about the benefits of M-TEER in patients with moderate to severe FMR and HF, which may help to strengthen and also broaden recommendations regarding its use in the future.”
References
- Stone GW, et al. N Engl J Med. 2018;379:2307–2318.
- Obadia JF, et al. N Engl J Med. 2018;379:2297–2306.
