Abstract Background Advances in heart failure (HF) treatment have achieved a reduction of death in HF patients in the last two decades. Indeed, not only mortality has been reduced but also the mode of death might have been modified through these years. Purpose To assess the causes of death in outpatients attended in a HF Unit since the year 2002 up to the year 2018. Methods Causes of death were classified as follows: progression of HF (worsening HF or treatment-resistant HF, in the absence of another cause); sudden death (any unexpected death, witnessed or not, of a previously stable patient with no evidence of worsening HF or any other known cause of death); acute myocardial infarction; stroke; procedural (post-diagnostic or post-therapeutic); other cardiovascular causes (e.g., rupture of an aneurysm, peripheral ischemia, or aortic dissection), and non-cardiovascular. Patients who died of unknown cause were excluded from the analysis. Fatal events were identified from the clinical records of patients with HF, hospital wards, the emergency room, general practitioners, or by contacting the patient's relatives. Furthermore, data were verified from the databases of the Catalan and Spanish Health Systems. Trends on every cause of death were assessed by linear regression. Results Since August 2001 to May 2018, 2295 HF patients were admitted to the HF clinic (age 66.4±12.8 years, 71% men, 49% from ischemic aetiology, mean LVEF 35.2% ± 14). During the 17 years of the study, 1201 deaths were recorded. Seventy-eight patients (6.5% of deaths) were excluded due to unknown cause of death. The evolution in the mode of death by years is shown in the figure. Two trends were observed: a decrease in sudden death (p=0.05) and a very significant linear increase in non-cardiovascular causes of death (p<0.001). The decrease of sudden death was mainly driven from changes observed in the first 10 years (p=0.014); thereafter the incidence of sudden death remained stable (p=0.18). Remarkably we did not observe significant changes in HF progression as mode of death (p=0.17). Conclusions During the 17 years of the study, a very significant trend towards higher percentage of non-cardiovascular deaths was progressively observed. On the other hand, percentage of sudden death showed a gradual decrease, mainly driven from the changes observed in the first 10 years.
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.
BackgroundWhether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain.MethodsWe conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status).ResultsA total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P=0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P=0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%).ConclusionsAmong patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.)
Abstract Background Heart Failure (HF) is the first cause of hospitalizations in people older than 65 years. Often patients suffer recurrent hospital admissions. Objective To assess recurrent HF-related hospitalizations during very long-term follow-up in a cohort of HF outpatients managed in an ambulatory structured HF Unit. Methods End of follow-up was 31.8.2019 (at least 1-year follow-up for alive patients, up to 18 years). Heart failure hospitalizations were defined as unplanned hospitalizations of at least 24 hours due to worsening heart failure and were identified from clinic records, hospital wards, or electronic Catalan history record. Death was recorded from the same sources and Spanish Health System and Spanish Death Registry. Lost information during follow-up was adequately censored (1 patient for survival status and 37 for HF-related hospitalizations). Results A total of 2355 patients were included. Follow-up span a total of 12,472 patients-years. 1682 HF-related hospitalizations were recorded in 725 patients (13.5 per 100 patients-years). Number of admissions ranged from 0 in 1630 patients to 22 in 1 patient (patients with hospitalizations, median 2 [Q1-Q3, 1–3]; 118 patients had 4 or more hospitalizations). HF hospitalization density incidence was higher during the 10 first years in patients with HF hospitalizations in the precedent year before HF Clinic baseline visit (table). By contrast, if only patients who died during follow-up were considered (N=1299), hospitalization trends significantly increased in their last period of life: 11.7%, 8.9%, 13.6%, 20.8% and 44.9% from the first to the last period (quintile) of their trajectory, respectively. Conclusions HF hospitalizations occur during the whole HF trajectory, with an increasing trend at the end of the every patient trajectory. Funding Acknowledgement Type of funding source: None
Abstract Background Heart failure (HF) contemporary management has significantly improved over the past two decades leading to better survival. How application of the contemporary HF management guidelines affects the risk of death estimated by available web-based risk scores is not elucidated. Objective To assess changes in mortality risk prediction after a after a 12-month management period in a multidisciplinary HF Clinic. Methods Out of 1,689 consecutive patients with HF admitted at our ambulatory HF Clinic from May 2006 to November 2018, those who completed one year follow-up were considered for the study. Patients without NTproBNP measurement or with more than 3 missing variables for risk estimation were excluded. Three contemporary web-based HF risk scores were evaluated: MAGGIC-HF, Seattle HF Model (SHFM) and the Barcelona Bio-HF Calculator containing NTproBNP (BCN Bio-HF). Risk of all-cause death at one year and at 3 years were calculated at baseline and re-evaluated after 12-month management in a multidsisciplinary HF Clinic. Wilcoxon paired data test was used to compare changes in mortality risk estimation over time and test equality of matched pairs for comparing estimated change among tools. 442 patients used to derive the Barcelona Bio-HF Calculator were excluded for discrimination purposes. Results 1,157 patients were included (age 65.7±12.7 years, 70.4% men). A significant reduction in mortality risk estimation was observed with the three HF risk scores evaluated at 12-months (Table). The BCN Bio-HF model showed significantly different changes in risk estimation, fact that indeed was partnered with numerically better discrimination. AUC at 1 and 3 years, respectively, were: BCN Bio-HF (0.773 and 0.775), MAGGIC HF (0.686 and 0.748) and SHFM (0.773 and 0.739). Conclusions The three web-based risk scores evaluated showed a significant reduction in mortality risk estimation after 12 month management in a multidisciplinary HF Clinic. The BCN Bio-HF score showed higher reduction in estimated risk, together with better discrimination, likely because it incorporates contemporary treatment and use of biomarkers. Funding Acknowledgement Type of funding source: None
We assessed differences in long-term all-cause and cardiovascular (CV) mortality in heart failure (HF) outpatients based on the etiology of HF. Consecutive patients admitted to the HF Clinic from August 2001 to September 2019 (N = 2587) were considered for inclusion. HF etiology was divided into ischemic heart disease (IHD), dilated cardiomyopathy (DCM), hypertensive heart disease, alcoholic cardiomyopathy, drug-induced cardiomyopathy (DICM), valvular heart disease, and hypertrophic cardiomyopathy. All-cause death and CV death were the primary end points. Among 2387 patients included in the analysis (mean age 66.5 ± 12.5 years, 71.3% men), 1317 deaths were recorded (731 from CV cause) over a maximum follow-up of 18 years (median 4.1 years, interquartile range (IQR) 2-7.8). Considering IHD as the reference, only DCM had a lower risk of all-cause death (adjusted hazard ratio (aHR) 0.68, 95% confidence interval (CI) 0.56-0.83, p < 0.001), and only DICM had a higher risk of all-cause death (aHR 1.47, 95% CI 1.02-2.11, p = 0.04). However, almost all etiologies had a significantly lower risk of CV death than IHD. Among the studied HF etiologies, DCM and DICM have the lowest and highest risk of all-cause death, respectively, whereas IHD has the highest adjusted risk of CV death.
Abstract Background Although sudden cardiac death (SCD) has progressively decreased in the last decade, it remains an important cause of death in patients with heart failure (HF). Differences based on clinical management and regional characteristics might be important. Purpose To assess the prevalence of SCD along 20 years of study in HF outpatients of different aetiologies managed in a multidisciplinary HF Clinic, and compare this prevalence with the expected proportional occurrence according to the acknowledged Seattle Proportional Risk Model (SPRM) score. Methods In a prospective observational registry of real-life HF outpatients, modes of death were classified as SCD (any unexpected death, witnessed or not, of a previously stable patient with no evidence of worsening HF or any other known cause of death) and non-SCD (progression of HF, acute myocardial infarction, stroke, procedural, other cardiovascular causes and non-cardiovascular). Results From August 2001 to May 2021, 2772 outpatients with known cause of death and with SPRM score available were included. Out of them, 1351 (48.7%) died during a median follow-up of 3.8 years [IQR 1.6–7.8], up to 20 years. Observed prevalence of SCD in the 1351 dead patients was 13.6% while predicted SPRM prevalence was 39.6%. Annual SPRM predicted SCD mortality rate was 3.0% while observed SCD annual mortality rate was 1.3%. Figure 1 depicts cumulative incidence of causes of death through the study period. A lower prevalence of SCD was observed in every quintile of SPRM risk (Figure 2). This lower prevalence of SCD was observed independently of left ventricular ejection fraction group, ischemic or non-ischaemic aetiology and implantable cardiac defibrillator (ICD). Although the baseline SPRM predicted risk of SCD showed a significant decreasing trend (p=0.005) along the periods of admission at the Unit, the lower observed prevalence of SCD was seen in all periods of admission. Conclusions The prevalence of SCD through a perspective of 20 years in a Mediterranean HF outpatient cohort managed in a multidisciplinary HF Clinic was significantly lower than that expected according to the SPRM independently of degree of predicted risk, ischaemic aetiology, period of admission and implanted ICD. Regional lifestyle and dietary habits may have an impact on the lower rate of SCD in this Mediterranean cohort, and deserve further in-depth analyses. Funding Acknowledgement Type of funding sources: None.
Abstract Background Telemonitoring of body weight, blood pressure and heart rate has extensively been used to facilitate early recognition of heart failure (HF) decompensations in order to prevent hospital admissions. Mixed results have been shown by different clinical trials regarding the effectiveness of telemonitoring in HF management. It is recognized that HF decompensation starts with an increase in intra cardiac filling pressure. The relationship between daily pulmonary artery pressure (PAP) values measurements and body weight is not completely established. Purpose To study the relationship between daily changes in body weight and invasive daily measurements such as diastolic PAP assessed by a pulmonary artery pressure sensor (CardioMEMS). Methods Eleven patients with left sided chronic HF implanted with a CardioMEMS device were included in the study (age 75±9 years, ejection fraction 52±10%). Daily measured body weight and pulmonary artery pressures were recorded during 6 months. The primary endpoint was to assess the correlation between the “PAP deviation” – defined as the difference between daily diastolic PAP and mean diastolic PAP over the study period – and the “weight deviation” – defined as the difference between daily body weight determinations and mean body weight. Results During the 6-months study period, 1766 body weight and diastolic PAP measurements were recorded (158±47 daily measurements per patient). We found a weak although significant correlation between changes in body weight and changes in diastolic PAP (Figure 1). When analyzing data individually, no patient presented a strong correlation between the two variables. Conclusions Our results suggest that repeated measurements of body weight have limited utility in detecting left sided heart failure decompensations. More complex and patient-specific thresholds for the biometric measurements are needed to improve early detection of decompensation in HF patients. For the development of early detection algorithms, we may learn from invasive methods, such as the CardioMEMS device. Funding Acknowledgement Type of funding sources: None.
Abstract Aims To investigate the distribution of left atrioventricular coupling index (LACI) among patients with heart failure and left ventricular ejection fraction (LVEF) < 50% and to explore its association with the combined endpoint of all-cause death or HF hospitalization at long-term follow-up. Methods and results Patients with HF and LVEF < 50% undergoing cardiac magnetic resonance were evaluated. Patients with atrial fibrillation or flutter were excluded. Left atrioventricular coupling index was measured as the ratio between the left atrial (LA) and the LV end-diastolic volumes. Patient population was divided according to LACI tertiles and followed up. Total of 478 patients (mean age 62 ± 12 years, 78% male) were included. The median value of LACI was 27.1% (interquartile range 19.9–34.5). Patients within the worst LACI tertile (≥30.9%) showed smaller LV volumes and larger LA volumes as compared with patients in the first or second tertile (LACI 6.2–22.2 and LACI 22.3–30.9, respectively). Left atrioventricular coupling index was significantly associated with the combined endpoint [hazard ratio (HR) 1.87, P = 0.01]. After adjusting for sex, age, ischaemic HF aetiology, LVEF, LA reservoir strain, diabetes mellitus, LV scar, mitral regurgitation, and LVEDVi, LACI remained significantly associated with the combined endpoint (HR 1.77, P = 0.02). Patients with the highest LACI values had worse outcomes compared with patients in first and second tertiles (HR 1.69, P = 0.02 and HR 1.77, P = 0.02, respectively). Conclusion In patients with HF and LVEF <50%, LACI is independently associated with adverse events. Patients with most impaired left atrioventricular coupling have the worst clinical outcomes.