M-TEER reduces heart failure hospitalization risk across all health status levels in mitral regurgitation
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Key Takeaway
Consider M-TEER for symptomatic patients with secondary mitral regurgitation regardless of baseline health status, but interpret subgroup findings cautiously.
This study is a subgroup analysis of a randomized controlled trial evaluating mitral transcatheter edge-to-edge repair (M-TEER) using the MitraClip device versus medical therapy alone in patients with symptomatic heart failure and moderate-to-severe ventricular secondary mitral regurgitation. The analysis stratified patients by baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary scores into tertiles to assess whether health status influenced treatment effect.
The authors found that M-TEER reduced the risk of cardiovascular death or heart failure hospitalization across all KCCQ-CSS tertiles, with hazard ratios favoring the intervention. However, the trend across tertiles was not statistically significant. Similarly, total heart failure hospitalizations were reduced consistently. At 6 months, patients in the M-TEER group were more likely to achieve clinically meaningful improvements in KCCQ-CSS (≥5, ≥10, and ≥15 points) and less likely to experience deterioration.
Key limitations include that this is a subgroup analysis from a single RCT, and confidence intervals for some outcomes were wide, crossing 1.0. The primary outcome of the overall trial was not explicitly stated, and the P-trend for the composite endpoint was not significant, suggesting the effect may not vary by baseline health status.
Clinically, these results suggest that M-TEER may provide consistent symptomatic benefit across a range of baseline health status in appropriately selected patients. However, the uncertainty in some estimates warrants cautious application, and patient selection should remain individualized.
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View Original Abstract ↓
BACKGROUND AND AIMS: Mitral transcatheter edge-to-edge repair (M-TEER) using the MitraClip device improves clinical outcomes in patients with moderate-to-severe ventricular secondary mitral regurgitation (vSMR) and heart failure (HF). This study evaluated whether the effects of M-TEER on clinical outcomes vary by baseline health status, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), and assessed the impact of M-TEER on health status post-randomization.
METHODS: The RESHAPE-HF2 trial included patients with symptomatic HF and moderate-to-severe vSMR (mean effective regurgitant orifice area .25 cm2; 14% >.40 cm2, 23% <.20 cm2). The impact of baseline KCCQ-clinical summary score (CSS) on the effect of M-TEER on clinical outcomes was assessed using Cox proportional hazards models. Changes post-randomization in health status and responder analyses were performed to assess the odds ratio (OR) of improvement and deterioration in KCCQ scores.
RESULTS: Among 505 patients, M-TEER reduced cardiovascular death or HF hospitalization risk [hazard ratio (HR): .71 (.48-1.05), .50 (.29-.85), and .73 (.38-1.41)] across KCCQ-CSS tertiles of <38.9, 38.9-66.1, and >66.1, respectively (P-trend = .53). Similar results were seen for total HF hospitalization (P-trend = .48). M-TEER improved KCCQ-CSS, total symptom score, and overall summary score at 1, 6, 12, and 24 months compared to medical therapy alone (P < .05 at all time points). More patients in the M-TEER arm experienced a ≥5-point [OR 3.38 (2.09-5.45)], ≥10-point [OR 3.12 (1.93-5.02)], and ≥15-point [OR 3.25 (1.94-5.45)] improvement, and less patients had a ≥5-point deterioration [OR .34 (.19-.57)] in KCCQ-CSS at 6 months. Similar results were seen across other KCCQ domains and all time points.
CONCLUSIONS: In patients with HF and moderate-to-severe vSMR, M-TEER showed a consistent trend towards a lower risk of HF hospitalization, with or without cardiovascular death, across all KCCQ-CSS tertiles and improved health status over time.
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