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Background In the COAPT trial, transcatheter mitral valve repair with the MitraClip plus maximally tolerated guideline-directed medical therapy (GDMT) improved clinical outcomes compared with GDMT alone in symptomatic patients with heart failure (HF) and 3+ or 4+ secondary mitral regurgitation (SMR) due to left ventricular (LV) dysfunction. Aims In this COAPT substudy, we sought to evaluate two-year outcomes in HF patients with reduced LV ejection fraction (HFrEF; LVEF ≤40%) versus preserved LVEF (HFpEF; LVEF >40%) and in those with severe (LVEF ≤30%) versus moderate (LVEF >30%) LV dysfunction. Methods The principal effectiveness outcome was the two-year rate of death from any cause or HF hospitalisations (HFH). Subgroup analysis with interaction testing was performed according to baseline LVEF; 472 patients (82.1%) had HFrEF (mean LVEF 28.0%±6.2%; range 12% to 40%) and 103 (17.9%) had HFpEF (mean LVEF 46.6%±4.9%; range 41% to 65%), while 292 (50.7%) had severely depressed LVEF (LVEF ≤30%; mean LVEF 23.9%±3.8%) and 283 (49.3%) had moderately depressed LVEF (LVEF >30%; mean LVEF 39.0%±6.8%). Results The two-year rate of death or HFH was 56.7% in patients with HFrEF and 53.4% with HFpEF (HR 1.16, 95% CI: 0.86-1.57, p=0.32). MitraClip reduced the two-year rate of death or HFH in patients with HFrEF (HR 0.50, 95% CI: 0.39-0.65) and HFpEF (HR 0.60, 95% CI: 0.35-1.05), pint=0.55. MitraClip was consistently effective in reducing the individual endpoints of mortality and HFH, improving MR severity, quality of life, and six-minute walk distance in patients with HFrEF, HFpEF, LVEF ≤30%, and LVEF >30%. Conclusions In the COAPT trial, among patients with HF and 3+ or 4+ SMR who remained symptomatic despite maximally tolerated GDMT, the MitraClip was consistently effective in improving survival and health status in patients with severe and moderate LV dysfunction and those with preserved LVEF.

Background The New York Heart Association ( NYHA ) classification has served as a fundamental tool for risk stratification of heart failure ( HF ) and determines clinical trial eligibility and candidacy for drugs and devices. However, its ability to adequately stratify risk is unclear. Methods and Results To compare NYHA class with objective assessments and survival in patients with HF , we performed secondary analyses of 4 multicenter National Institutes of Health–funded HF clinical trials that included patients classified as NYHA class II or III: TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), DIG (The Effect of Digoxin on Mortality and Morbidity in Patients With Heart Failure), HF‐ACTION (Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure), and GUIDE‐IT (Guiding Evidence‐Based Therapy Using Biomarker Intensified Treatment in Heart Failure). Twenty‐month cumulative survival was compared between classes using Kaplan–Meier curves and the log rank test. NT ‐proBNP (N‐terminal pro–B‐type natriuretic peptide), Kansas City Cardiomyopathy Questionnaire ( KCCQ ) scores, 6‐minute walk distances, left ventricular ejection fraction, and cardiopulmonary test parameters were compared using Wilcoxon rank sum tests and percentage overlap using kernel density estimations. Cumulative mortality varied significantly across NYHA classes and HF clinical trials (likelihood ratio, P NYHA class II ranged from 7% for patients in HF ‐ ACTION to 15% in GUIDE ‐ IT , whereas mortality for NYHA class III ranged from 12% in TOPCAT to 26% in GUIDE ‐ IT . There was substantial percentage overlap in values for NT ‐pro BNP levels (79% and 69%), KCCQ scores (63% and 54%), 6‐minute walk distances (63% and 54%), and left ventricular ejection fraction (88% and 83%). Similarly, there was substantial overall in values for minute ventilation–carbon dioxide production relationship (71%), maximal oxygen uptake (54%), and exercise duration (53%). Conclusions The NYHA system poorly discriminates HF patients across the spectrum of functional impairment. These findings raise important questions about the need for improved phenotyping of these patients to facilitate risk stratification and response to interventions.

The creation of an interatrial shunt in order to decompress the right or left atrium in patients with right and left ventricular failure, respectively, has been used as an alternative therapy to improve symptoms and clinical outcomes in patients with pulmonary hypertension-right heart failure and left heart failure refractory to optimal medical therapy. If ongoing randomised clinical trials further substantiate these beneficial effects in patients with chronic HF, interatrial shunting will represent an important new approach for treating this population.