M-TEER Reduces Cardiovascular Risk, Improves Quality of Life in HF with Mitral Regurgitation

Results of RESHAPE-HF2 suggest use of mitral transcatheter edge-to-edge repair (M-TEER) was more effective than optimal medical therapy alone for reducing cardiovascular event risk among patients with heart failure and moderate to severe mitral regurgitation ineligible for surgery.

Presented at the European Society of Cardiology (ESC) Congress 2024, results of the study indicate undergoing M-TEER was associated with a reduction in total hospitalizations for heart failure and cardiovascular death as well as improvements in quality of life.

“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. 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 Stefan Anker, MD, PhD, professor of (Tissue) Homeostasis in Cardiology & Metabolism from the Charité University Hospital, Berlin, Germany.

Launched in 2015, the RESHAPE-HF2 trial was designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. The trial enrolled and randomized 505 patients from 30 sites across 9 countries in a 1:1 ratio to either M-TEER or optimal medical therapy.

Patients randomized to M-TEER received the MitraClip device within 14 days of enrollment and guideline-directed medical therapy for the duration of the follow-up period, which lasted up to 8 years. Patients randomized to the control group received guideline-directed medical therapy for the duration of the follow-up period.

For inclusion in the investigator-initiated, randomized, controlled trial, patients needed to have NYHA class II heart failure or greater despite optimal guideline-directed medical therapy, a left ventricular ejection fraction [LVEF] of 20 to 50%, grade 3+ or 4+ mitral regurgitation, and a recent hospitalization for heart failure or elevated plasma natriuretic peptide concentrations within the last 90 days.

The overall cohort was 20% female, had a mean age of 70 years, mean LVEF of 31%, mean KCCQ-OS of 46, and approximately 75% had heart failure considered as NYHA class III or IV.

The trial’s primary outcomes of interest were recurrent events of cardiovascular death and hospitalization for heart failure, recurrent events of hospitalization for heart failure, and change in KCCQ from baseline to month 12.

At baseline, the study cohort had a mean age of 70 years, mean eGFR of 56 (SD, 21) ml/min/1.73m2, mean NT-proBNP of 4185 pg/mL, a mean LVEF of 31% (SD, 8) and a mean 6-minute walking distance of 292 meters.

Upon analysis, the following associations were observed for use of M-TEER results on each of the 3 primary endpoints included in the trial:

• Cardiovascular Death and Hospitalization for Heart Failure: Rate Ratio [RR], 0.64; 95% Confidence Interval [CI], 0.48 to 0.85; P = .002
• Hospitalization for Heart Failure: RR, 0.59; 95% CI, 0.42 to 0.82; P = .002
• Change in KCCQ-OS: Least-squares mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P <.001

Secondary analyses revealed those in the M-TEER group also experienced significant improvements in the rate of grade 2 or greater mitral regurgitation at 12 months (Difference, 21.3 events; 95% CI, 10.7 to 45.8; P <.001) and mean change in 6-minute walk distance from baseline to month 12 (Difference, 20.5; 95% CI, 0.3 to 40.7; P = .05). Investigators highlighted there was no difference in all-cause mortality during the follow-up period (HR, 0.90; 95% CI, 0.71 to 1.13)

“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,” Anker added.