Severe secondary Mitral Valve Regurgitation (MR) has been associated with increased hospitalization and mortality. Even though optimal medical treatment with maximum tolerated doses according to the current guidelines and resynchronization therapy have been shown benefits, there is still a group of patients that, despite this strategy, will require surgery.
Trans catheter edge-to-edge repair (TEER) has shown benefits in high risk patients, as observed in the COAPT study, even though the MITRA-FR showed different results. Despite multiple explanations, the evidence remains inconclusive.
The RESHAPE-HF2 included 505 patients with moderate or severe and symptomatic MR due to cardiac failure (CF). 250 of these patients received TEER with MitraClip and medical treatment (MT), with tolerated maximum doses according to the current guidelines, while the rest received medical treatment alone.
Primary end point was a composite including first or recurrent hospitalization for CF, cardiovascular death at 24 months and changes in quality of life (measured according to KCCQ-OS).
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Both groups had similar characteristics: mean age was 70, 80% were men, 35% diabetic, around 50% had hypertension, over 50% had suffered MI, 48% had been treated with PIC, 26% with CABG and 48% presented atrial fibrillation. Most patients were in functional class III-IV of the NYHA, and 66% had been hospitalized for CF the year before. Mean NT-proBNP was 2700 pg/ml, mean 6-min walk test distance was 300 meters and KCCQ-OS score was 43.
Mean ejection fraction was 32%, mean tele-systolic volume was 200 ml, regurgitant volume was 35 ml, effective regurgitant area was 23 mm², and 56% of patients had MR grade 3+, while 44% presented MR grade 4+.
After procedure, 93% of patients presented MR grade 1+ or 2+.
At 24 months, primary end point favored the device: first or recurrent hospitalization because of CF and cardiovascular death resulted 37% among TEER patients vs. 58.9% for MT alone (HR 0.64, CI 95% 0.48-0.85, p=0.002). First or recurrent hospitalization rate was 26.9% in the TEER groups vs 46.6% for TM (HR 0.59, CI 95% 0.42-0.82, p=0.002). Also, change in quality of life (KCCQ-OS) was significantly better for TEER patients, with a 21.6 points increase vs. 8 for MT (difference of 10.9, CI 95% 6.8-15.0, p <0.001).
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At 12 months, patients treated with the device showed lower MR (≤2+), walked longer during the 6-minute walk test and showed a better functional class (I-II), despite there being no differences in mortality.
Conclusion
Patients with moderate or severe MR undergoing medical treatment and TEER showed lower first or recurrent hospitalization rate at 24 months, and better quality of life at 12, vs. patients receiving MT alone.
Original Title: Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. RESHAPE-HF2 Trial.
Reference: S.D. Anker, et al. NEJM.org. DOI: 10.1056/NEJMoa2314328.
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