Dataset Information

Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function.

ABSTRACT:

Aims

Increasing attention is being given to patients with heart failure and 'mid-range' left ventricular ejection fraction (LVEF, ?40% and <50%) for whom there are no approved therapies that improve prognosis. We aim to assess for the first time the effects of cardiac contractility modulation (CCM) therapy in this patient population.

Methods and results

We assessed the effects of 6- month CCM therapy on functional status, exercise tolerance and quality of life in a subgroup of 53 patients with a LVEF of 40-45% recruited in previous CCM studies, including 37 patients in the CCM group and 16 in the control group. New York Heart Association classification improved by ?1 class from baseline to 24 weeks in 80.6% (95% confidence interval [62.5%, 92.5%]) of patients in the CCM group compared with 57.1% in the control group (95% confidence interval [28.9%, 82.3%], P = 0.15). Six-minute walk distance increased significantly in the CCM group with a net between-group treatment effect of 53.9 ± 74.2 m (P = 0.05). Peak VO₂ improved in the CCM group with a net between-group treatment effect of 2.0 ± 2.8 mL/kg/min (P = 0.02). Minnesota Living with Heart Failure Questionnaire score decreased from baseline to 24 weeks with a net between-group treatment effect of -13.1 ± 21.0 (P = 0.10). There were no significant differences in the adverse event rate between the CCM and control groups.

Conclusions

These preliminary results suggest that CCM exerts favourable effects on exercise tolerance and quality of life in patients with LVEF in the range of 40-45% with an acceptable safety profile. Further randomized controlled studies are planned to prove these effects.

SUBMITTER: Tschope C

PROVIDER: S-EPMC7754749 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function.

Tschöpe Carsten C Butler Javed J Farmakis Dimitrios D Morley Deborah D Rao Ishu I Filippatos Gerasimos G

ESC heart failure 20201203 6

<h4>Aims</h4>Increasing attention is being given to patients with heart failure and 'mid-range' left ventricular ejection fraction (LVEF, ≥40% and <50%) for whom there are no approved therapies that improve prognosis. We aim to assess for the first time the effects of cardiac contractility modulation (CCM) therapy in this patient population.<h4>Methods and results</h4>We assessed the effects of 6- month CCM therapy on functional status, exercise tolerance and quality of life in a subgroup of 53 ...[more]

PMID: 33274601

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Project description:BackgroundGuideline recommendations for the treatment of heart failure with mildly reduced ejection fraction (HFmrEF) derive from small subgroups in post-hoc analyses of randomized trials.ObjectivesWe investigated predictors of renin-angiotensin system inhibitors/angiotensin receptor neprilysin inhibitors (RASI/ARNI) and beta-blockers use, and the associations between these medications and mortality/morbidity in a large real-world cohort with HFmrEF.Methods and resultsPatients with HFmrEF (EF 40-49%) from the Swedish HF Registry were included. The associations between medications and cardiovascular (CV) mortality/HF hospitalization (HFH), and all-cause mortality were assessed through Cox regressions in a 1:1 propensity score-matched cohort. A positive control analysis was performed in patients with EF < 40%, while a negative control outcome analysis had cancer-related hospitalization as endpoint. Of 12 421 patients with HFmrEF, 84% received RASI/ARNI and 88% beta-blockers. Shared-independent predictors of RASI/ARNI and beta-blockers use were younger age, being an outpatient, follow-up in specialty care, and hypertension. In the matched cohorts, use of both RASI/ARNI and beta-blocker use was separately associated with lower risk of CV mortality/HFH [hazard ratio (HR) = 0.90, 95% confidence interval (CI): 0.83-0.98 and HR = 0.82, 95% CI: 0.74-0.90, respectively] and of all-cause mortality (HR = 0.75, 95% CI: 0.69-0.81 and HR = 0.79, 95% CI: 0.72-0.87, respectively). Results were consistent at the positive control analysis, and there were no associations between treatment use and the negative control outcome.ConclusionsRASI/ARNI and beta-blockers were extensively used in this large real-world cohort with HFmrEF. Their use was safe since associated with lower mortality and morbidity. Our findings confirm the real-world evidence from previous post-hoc analyses of trials, and represent a further call for implementing guideline recommendations.

Project description:AimsThe aim of the study is to evaluate the risk of all-cause mortality or heart failure hospitalizations in ambulatory patients with heart failure with reduced and mildly reduced ejection fraction (HFrEF or HFmrEF) according to diastolic function indices. Diastolic dysfunction in HF is both common and associated with poor prognosis. However, specific cut-off values of diastolic function parameters for prognostication of hard outcomes in HF have not been conclusively established.Methods and resultsAnalysis of full echocardiographic examination of consecutive ambulatory HFrEF and HFmrEF patients seen at a single tertiary hospital between 2010 and 2021 was retrospectively done. Data on all-cause mortality or heart failure hospitalizations were obtained from the electronic medical records and national mortality registry. Patients with > moderate left heart valvular dysfunction were excluded from the study. The final cohort included 4717 patients (75% males, median age 70 years interquartile range 61.3-78.4). After adjusting for clinical or echocardiographic variables, increased rates of mortality or HF hospitalizations were found when E/e'>10, left atrial volume index (LAVI) > 40 mL/m2, E/A ratio < 0.6, deceleration time (DT) < 180 ms, peak E-wave velocity > 0.78 m/s, and sPAP > 26 mmHg. However, no significant difference in outcomes between near-normal and normal values of E/e' (< 8 compared with 8-10) or LAVI (≤34 mL/m2 compared with LAVI 34-40 mL/m2) was found.ConclusionIn patients with HFmrEF and HFrEF, slightly abnormal diastolic indices were found to be associated with worse outcomes.SummaryWe have demonstrated that in patients with heart failure with reduced and mildly reduced ejection fraction (HFrEF or HFmrEF), near-normal diastolic indices are associated with worse outcomes with the following cut-off values: max E-wave velocity > 0.78 m/s, E/e' ratio > 10, a LAVi > 40 mL/m2, DT > 180, E/A between 0.6 and 1.4, and a sPAP > 26 mmHg. Further research is needed to establish these suggested cut-off values.

Dataset Information

Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function.

Aims

Methods and results

Conclusions

Publications

Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function.

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