Transcatheter edge-to-edge repair is better than medical therapy alone in patients with heart failure and mitral regurgitation

Key take-aways 

• Patients with heart failure often have mitral regurgitation (MR), where the mitral valve does not close properly, resulting in blood flowing the wrong way through the valve. 
• In the RESHAPE-HF2 trial, mitral transcatheter edge-to-edge repair (M-TEER) was found to be more effective than optimal medical therapy alone in patients with heart failure and moderate to severe MR ineligible for surgery. 
• M-TEER was associated with improved health status and no safety concerns. 
• These new data provide conclusive evidence for the benefits of M-TEER in patients who currently have limited treatment options.  

London, United Kingdom – 31 August 2024: Mitral transcatheter edge-to-edge repair (M-TEER) reduced cardiovascular death and heart failure (HF)-related hospitalisations with improved health status in patients with HF and moderate to severe functional mitral regurgitation (FMR), according to late-breaking research presented in a Hot Line session today at ESC Congress 2024.¹  

“Patients with FMR who are ineligible for surgery have limited treatment options. When M-TEER was studied previously, mainly in patients with severe FMR, one trial showed positive effects² while the other was neutral.³ RESHAPE-HF2 now provides additional compelling evidence for using M-TEER over optimal medical therapy alone, which will help to guide medical decision making,” said Principal Investigator, Professor Stefan Anker from the Charite University Hospital, Berlin, Germany. 

This investigator-initiated randomised controlled trial recruited patients with symptoms of HF (New York Heart Association [NYHA] class ≥2) despite optimal guideline-directed medical therapy, who had left ventricular ejection fraction [LVEF] ≥20% and ≤50%, MR grade 3+ or 4+, and had 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 1:1 to M-TEER plus optimal medical therapy or optimal medical therapy alone. 

The three primary endpoints were: 1) composite rate of total (first and recurrent) HF hospitalisations and cardiovascular death within 24 months; 2) the rate of total HF hospitalisations within 24 months; and 3) the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score, which assesses the impact of HF on quality of life.  

In total, 505 patients were randomised from 30 centres in nine countries. The mean age was 70 years and 20% were female. The mean LVEF was 31% and HF was NYHA class III or IV in around three-quarters of patients. The mean KCCQ overall summary score was 46, which indicates significant symptoms and limitations due to HF. 

At 24 months, the rate of total hospitalisations for HF and cardiovascular death was significantly lower in the M-TEER group vs. the control group (37.0 per 100 patient-years vs. 58.9 per 100 patient-years; rate ratio 0.64; 95% confidence interval [CI] 0.48–0.85; p=0.002). The rate of total hospitalisations for HF within 24 months was significantly reduced by 41% in the M-TEER group vs. the control group (26.9 per 100 patient-years vs. 57.8 per 100 patient-years; rate ratio 0.59; 95% CI 0.42–0.82; p=0.002). In addition, the mean (standard deviation [SD]) change from baseline to 12 months in the KCCQ overall summary score was greater (improved) in the M-TEER group (+21.6 [26.9]) than in the control group (+8.0 [24.5]), resulting in a mean difference of +10.9 points (95% CI 6.8–15.0; p<0.001). 

During the total follow-up of 38.1 (18.1) months, there was no difference between the groups for all-cause mortality (17.0% in the M-TEER group vs. 18.5% in the control group; hazard ratio 0.90; 95% CI 0.71–1.13). Periprocedural adverse events were reported in 4 patients (1.6%) in the M-TEER group. 

Professor 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.” 

ENDS