Baseline echocardiographic characteristics of patients enrolled in the randomized investigation of MitraClip device in heart failure (RESHAPE HF-2) trial: comparison with COAPT and Mitra-FR
Ralph Stephan von BardelebenMuhammad Shahzeb KhanMartin GeyerTim FriedeJaved ButlerMonika DiekJutta HeinrichMarius PlaczekRoberto FerrariWilliam T. AbrahamOttavio AlfieriAngelo AuricchioAntoni Bayés‐GenísJohn G.F. ClelandGerasimos FilippatosFinn GustafssonWilhelm HaverkampMalte KelmKarl-Heinz KuckUlf LandmesserAldo P. MaggioniMarco MetraVlasis NiniosMark C. PetrieTienush RassafFrank RuschitzkaUlrich SchäferP. Christian SchulzeKonstantinos SpargiasAlec VahanianJosé Luis ZamoranoAndreas M. ZeiherMahir KarakasFriedrich KoehlerMitja LainščakAlper ÖnerNikolaos MezilisEfstratios K. TheofilogiannakosIlias NiniosMichael ChrissoherisPanagiota KourkoveliΚωνσταντίνος ΠαπαδόπουλοςGrzegorz SmołkaWojciech WojakowskiKrzysztof ReczuchFausto J. PintoŁukasz WiewiórkaZbigniew KalarusMarianna AdamoEvelyn Santiago‐VacasT. RufM. GrossJoern TongersGerd HasenfußWolfgang SchillingerPiotr PonikowskiStefan D. Anker
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Abstract:
Background: The RESHAPE-HF2 trial is aimed at evaluating the efficacy of the MitraClip device for the treatment of clinically significant functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline echocardiographic characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. Methods: The RESHAPE-HF2 study is a prospective, randomized, multicenter trial involving patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50%, and moderate-to-severe or severe FMR who are ineligible for isolated mitral valve surgery, despite receiving guideline-directed therapy. Patients were randomized 1:1 to either receive the MitraClip or be placed in a control group without the intervention. Results: For the 505 patients randomized (mean age 70 years, 20% female, mean body mass index 26.8 kg/m2), the mean LVEF in the cohort was 31±8%. The mean regurgitant volume was 37±12 mL, while mean proximal iso-velocity surface area (PISA) radius was 0.72 cm. Less than half of the patients (44%) had MR severity grade 4+. The mean effective regurgitant orifice area (EROA) among patients in RESHAPE-HF2 (0.25 cm2) was lower compared to patients in MITRA-FR (0.31 cm2) and in COAPT (0.40 cm2) trials. Regurgitant volumes in RESHAPE-HF2 were 18% lower than in than in MITRA-FR (45 mL) but 38% higher than in COAPT (27 mL). The mean LV end-diastolic volumes values in the RESHAPE-HF2, COAPT, and MITRA-FR trials were 211 mL, 193 mL, and 250 mL, respectively. Patients in RESHAPE-HF2 (41 mmHg) had a comparatively lower right ventricular systolic pressure than patients in MITRA-FR (54 mmHg) and in COAPT (44 mmHg). Patients in RESHAPE-HF2, MITRA-FR, and COAPT had a similar LVEF of around 31%. Conclusions: The baseline echocardiographic characteristics of patients in the RESHAPE-HF2 trial differ from patients in the MITRA-FR and COAPT trials. Patients enrolled in RESHAPE-HF2 had moderate-to-severe FMR, characterized by a smaller PISA radius, a lesser proportion of MR severity grade of 4+, and lower mean EROA and regurgitant volumes compared to patients in COAPT and MITRA-FR trials. LVEF was largely similar across all trials. RESHAPE-HF2 is testing TEER in a third distinct cohort of patients who have less severe FMR compared to patients in COAPT trial but have high left atrial volumes. The RESHAPE-HF2 population is also echocardiographically different from the MITRA-FR cohort.Keywords:
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Functional mitral regurgitation
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This study sought to investigate whether the percutaneous mitral regurgitation (MR) reduction with the MitraClip® system in end-stage heart failure patients with a left ventricular ejection fraction (LVEF) of <20% also effects beneficial outcome or whether the underlying myogenic problem is leading and therefore of prognostic relevance.The interventional treatment of functional mitral regurgitation (FMR) with the MitraClip® system could improve the clinical and hemodynamic outcome in patients with severely impaired left ventricular function.Between 2011 and 2016, a total of 147 patients with FMR were treated with MitraClip® at our institution. The cohort was divided into two groups: LVEF ≥ 20% (N = 126) and <20% (N = 21). Follow-up assessments included exercise capacity, 6-min walk test, probrain natriuretic peptide-measurement (ProBNP), echocardiography and right heart catheterization. Only three patients with an LVEF ≥ 20% and one patient with an LVEF < 20% were lost for follow-up.In the vast majority of patients, a reduction from severe to mild MR was demonstrated with no difference between both groups (P = 0.422). At follow-up, both subgroups experienced similar improvements in exercise capacity and hemodynamics. Patients with an LVEF < 20% were on average 5.8 years younger, while mortality rates were comparable in both groups (P = 0.760).By careful selection, even patients in the end stage of advanced LV dysfunction as the result of the underlying myogenic problem and the additional harmful effects of the high volume loading due to the FMR can exhibit significant clinical and hemodynamic improvement after MitraClip© therapy.
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Heart failure is a clinical syndrome associated with poor quality of life, substantial healthcare resource utilization, and premature mortality, in large part related to high rates of hospitalizations. The clinical manifestations of heart failure are similar regardless of the ejection fraction. Unlike heart failure with reduced ejection fraction, there are few therapeutic options for treating heart failure with preserved ejection fraction. Molecular therapies that have shown reduced mortality and morbidity in heart failure with reduced ejection have not been proven to be effective for patients with heart failure and preserved ejection fraction. The study of pathophysiological processes involved in the production of heart failure with preserved ejection fraction is the basis for identifying new therapeutic means. In this narrative review, we intend to synthesize the existing therapeutic means, but also those under research (metabolic and microRNA therapy) for the treatment of heart failure with preserved ejection fraction.
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To study the characteristics and prognostic implications of type 2 diabetes in different heart failure entities from a nationwide perspective.This observational study comprised 30,696 heart failure patients prospectively included in the Swedish Heart Failure Registry (SwedeHF) 2003-2011 from specialist care, with mortality information available until December 2014. Patients were categorized into three heart failure entities by their left ventricular ejection fraction (heart failure with preserved ejection fraction: ⩾50%, heart failure with mid-range ejection fraction: 40%-49% and heart failure with reduced ejection fraction: <40%). All-cause mortality stratified by type 2 diabetes and heart failure entity was studied by Cox regression.Among the patients, 22% had heart failure with preserved ejection fraction, 21% had heart failure with mid-range ejection fraction and 57% had heart failure with reduced ejection fraction. The proportion of type 2 diabetes was similar, ≈25% in each heart failure entity. Patients with type 2 diabetes and heart failure with preserved ejection fraction were older, more often female and burdened with hypertension and renal impairment compared with heart failure with mid-range ejection fraction and heart failure with reduced ejection fraction patients among whom ischaemic heart disease was more common. Type 2 diabetes remained an independent mortality predictor across all heart failure entities after multivariable adjustment, somewhat stronger in heart failure with left ventricular ejection fraction below 50% (hazard ratio, 95% confidence interval; heart failure with preserved ejection fraction: 1.32 [1.22-1.43], heart failure with mid-range ejection fraction: 1.51 [1.39-1.65], heart failure with reduced ejection fraction: 1.46 [1.39-1.54]; p-value for interaction, p = 0.0049).Type 2 diabetes is an independent mortality predictor across all heart failure entities increasing mortality risk by 30%-50%. In type 2 diabetes, the heart failure with mid-range ejection fraction entity resembles heart failure with reduced ejection fraction in clinical characteristics, risk factor pattern and prognosis.
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ABSTRACT: Left ventricular ejection fraction was measured by gated wall motion in 62 patients, 75 years old or older, admitted to a Geriatric Acute Assessment Ward. From this group, 42 patients not taking digitalis or other cardioactive medication were selected for analysis. Thirty of them had clinically identifiable heart disease, whereas 12 did not. Resting left ventricular ejection fractions in the 12 patients without clinically identifiable heart disease averaged 0.60 ± 0.09. None had an ejection fraction below 0.50. In the 30 patients with clinically identifiable heart disease, mean ejection fraction was 0.49 ± 0.15 (range 0.17‐0.84), P < 0.01. In the patients with heart disease, reduction of ejection fraction was correlated with either cardiac enlargement or congestive heart failure. Neither age nor electrocardiographic abnormalities added to the strength of this correlation. Fifty‐eight per cent of patients with congestive heart failure had ejection fractions 3=0.40, suggesting that congestive heart failure in this age group is frequently related to diastolic left ventricular dysfunction unaccompanied by major systolic dysfunction. The prognosis of patients with congestive heart failure and ejection fractions above 0.35 was significantly better than of patients with congestive heart failure and ejection fractions below 0.35. From these data and other data available in the literature, it is proposed that the lower limit for ejection fraction be 0.50 for patients 75 years old or older. Congestive heart failure in patients 75 years old or older appears to be associated with relatively higher ejection fractions or even with ejection fractions within the normal range. In these patients, digitalis may not be indicated, and short term‐prognosis is relatively favorable.
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Introduction: Cardiac rehabilitation has been increasingly recognized as an integral part in the management of patients with congestive heart failure. It has been shown to improve the quality of life in this patient population. However, It is unknown how much cardiac rehabilitation reduces heart failure hospitalizations in patients with heart failure with reduced ejection fraction (HFrEF) versus heart failure with preserved ejection fraction (HFpEF). Hypothesis: We hypothesize that outpatient cardiac rehabilitation is associated with reduced re-hospitalization for heart failure symptoms in patients with heart failure with HFrEF when compared with patients with HFpEF. Methods: We retrospectively analyzed data from 128 heart failure patients enrolled in an outpatient cardiac rehabilitation center from January 2015 to December 2020. The number of heart failure re-hospitalizations was measured in each of these patients. A Student t-test was used to analyze the difference between the two groups, while fisher’s test or chi square was used to analyze categorical variables. Results: Among the 128 patients enrolled in the outpatient cardiac rehabilitation center, age 68.1+-14 years, 63 (57.1%) were males. There were 70 patients (54.6%) in the HFrEF group and 58 (55.28%) in the HFpEF group. Hospitalization for acute exacerbation of heart failure symptoms was lower in the patients with HFrEF when compared with patients with HFpEF (41.3% vs 70.69% p value <0.0009). Conclusion: Outpatient cardiac rehabilitation program is associated with reduced hospitalization for heart failure symptoms in patients with HFrEF when compared to patients with HFpEF.
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Last two decade, heart failure with preserved ejection fraction was deprived from being considered as a part of spectrum of heart failure. May be heart failure with preserved ejection fraction was common but not recognized by cardiology fraternity. Heart failure with reduced ejection fraction and heart failure with preserved ejection fraction each make up about half of the overall heart failure burden. But the paradox is: morbidity and mortality in heart failure with preserved ejection fraction despite being similar to patients with heart failure with reduced ejection fraction, today’s cardiology community has not much to offer in terms of mortality reducing treatment. The term diastolic heart failure has been well replaced by heart failure with preserved ejection fraction because multiple non-diastolic abnormalities in cardiovascular function also contribute to heart failure with preserved ejection fraction and diastolic dysfunction always accompanied heart failure with reduced ejection fraction. Diagnosis of heart failure with preserved ejection fraction is an uphill task since it relies upon careful clinical evaluation, doppler (pulse wave and tissue) echocardiography, and invasive hemodynamic assessment after exclusion of potential noncardiac causes of symptoms suggestive of heart failure. Patients with heart failure with preserved ejection fraction are usually older women with a history of hypertension. Obesity, coronary artery disease, diabetes mellitus, and atrial fibrillation are also highly prevalent in heart failure with preserved ejection fraction. Cornerstone of treatment of this entity revolves around treatment of underlying cause and symptom guided therapy. Nepalese Heart Journal | Volume 10 | No.1 | November 2013| Pages 46-56 DOI: http://dx.doi.org/10.3126/njh.v10i1.9747
Diastolic heart failure
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• Chronic heart failure with preserved ejection fraction is as common as chronic heart failure with reduced ejection fraction.• After hospitalization for heart failure with preserved ejection fraction, prognosis and rehospitalization rates are comparable to heart failure with reduced ejection fraction.• Systolic function of the cardiac muscle is impaired in heart failure with preserved ejection fraction.• According to a recent consensus statement of the Heart Failure Association of the European Society of Cardiology, the diagnosis of heart failure with preserved ejection fraction remains challenging, but the use of serum brain natriuretic peptide (BNP) and tissue Doppler imaging (TDI) has increased accuracy.• Treatment of heart failure with preserved ejection fraction should be empiric, and phenotype-oriented as well as symptom-oriented.
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