Despite Food and Drug Administration (FDA) approval of mitral valve transcatheter edge-to-edge repair (M-TEER) in 2013, its impact in patients with symptomatic heart failure (HF) and significant functional mitral regurgitation (MR) despite maximally tolerated guideline-directed medical therapy (GDMT) has remained in question. This uncertainty is partly due to contrasting results from previous trials such as the MITRA-FR (Percutaneous Repair With the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation).^1,2 The RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: Second Trial in Patients With Clinically Significant Functional Mitral Regurgitation) trial was an international, open-label, multicenter, randomized controlled trial designed to provide additional information regarding the safety and effectiveness of M-TEER in this patient population.³

In the RESHAPE-HF2 trial, 505 patients with systolic HF (left ventricular ejection fraction 20-50% and New York Heart Association [NYHA] class II-IV HF symptoms) and moderate to severe functional MR were randomized 1:1 to receive either M-TEER and GDMT (device group) or GDMT alone (control group). The primary endpoint was a composite of first or recurrent hospitalization for HF or cardiovascular death. After a median follow-up of 24 months, there was a statistically significant lower composite event rate in the device group compared with that of the control group (37 vs. 58.9 events per 100 patient-years; 95% confidence interval [CI], 0.48-0.85; p = 0.002). The trial data also showed a statistically significantly lower rate of HF hospitalizations in the device group compared with that in the control group (26.9 vs. 46.6 events; 95% CI, 0.42-0.82; p = 0.002). Finally, patients were symptomatically better in the device group, as measured with the Kansas City Cardiomyopathy Questionnaire-Overall Summary score, which had increased by a mean of 21.6 points in the device group compared with 8 points in the control group (95% CI, 6.8-15 points; p < 0.001).

Overall, the results of the RESHAPE-HF2 trial show that M-TEER is associated with a reduction in HF hospitalizations/death and improvement of symptoms. This association aligns more with the results of the COAPT trial than with those of the MITRA-FR trial. However, there are key differences in the studies that make a 1:1 comparison difficult. For one, the patients in the RESHAPE-HF2 trial had less severe mitral valve regurgitation than did those in the MITRA-FR and COAPT trials, although they demonstrated more severe symptoms. Even though this trial’s results contribute to clinical understanding of the impact of M-TEER in patients with HF and help guide its use, patient selection still remains challenging.

References

1. Obadia JF, Messika-Zeitoun D, Leurent G, et al.; MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med 2018;379:2297-306.
2. Giustino G, Camaj A, Kapadia SR, et al. Hospitalizations and mortality in patients with secondary mitral regurgitation and heart failure: the COAPT trial. J Am Coll Cardiol 2022;80:1857-68.
3. Anker SD, Friede T, von Bardeleben RS, et al.; RESHAPE-HF2 Investigators. Transcatheter valve repair in heart failure with moderate to severe mitral regurgitation. N Engl J Med 2024;Aug 31:[ePub ahead of print].