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1.
JACC Heart Fail ; 2022 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-35780032

RESUMO

OBJECTIVES: The purpose of this study was to estimate meaningful thresholds for improvement or deterioration in the Kansas City Cardiomyopathy Questionnaire (KCCQ)-Total Symptom Score (TSS) in patients with heart failure with reduced ejection fraction (HFrEF) versus heart failure with preserved ejection fraction (HFpEF). BACKGROUND: Differences in clinically important thresholds in patient-reported outcomes measures such as the KCCQ remain less well established in patients with HFpEF vs HFrEF. METHODS: This secondary analysis of EMPERIAL program used anchor- and distribution-based approaches to estimate thresholds for improvement or deterioration in the KCCQ-TSS using Patient Global Impression of Severity (PGIS) as the primary anchor. Mean change in KCCQ-TSS from baseline to week 12 was calculated for each PGIS. RESULTS: A total of 312 HFrEF and 315 HFpEF patients were enrolled. At week 12, mean ± SD changes in KCCQ-TSS corresponding to PGIS changes of "any improvement," "1-category improvement," and "1-category deterioration" were 13 ± 17, 12 ± 17, -3 ± 16 points in HFrEF, and 15 ± 18, 13 ± 17, -7 ± 18 points in HFpEF. Threshold for meaningful within-patient change in KCCQ-TSS was ≥9 points in HFrEF and ≥7 points in HFpEF patients. Sensitivity and specificity of ≥9 points/ ≥7 points change was 0.65 and 0.70 for HFrEF and 0.64 and 0.66 for HFpEF. Cumulative distribution function curves of KCCQ-TSS change from baseline to week 12 showed a shift to higher scores in both HFrEF and HFpEF patients. CONCLUSIONS: In the EMPERIAL program, a change in KCCQ-TSS of ≥9 points in HFrEF and ≥7 points in HFpEF represents the minimal clinically important difference for improvement, confirming the broad range of 5-10 points as meaningful thresholds.

2.
Eur Heart J ; 2022 Jul 28.
Artigo em Inglês | MEDLINE | ID: mdl-35900838

RESUMO

AIMS: To investigate the impact of patiromer on serum potassium level and its ability to enable specified target doses of renin-angiotensin-aldosterone system inhibitor (RAASi) use in patients with heart failure and reduced ejection fraction (HFrEF). METHODS AND RESULTS: A total of 1642 patients with HFrEF and current or a history of RAASi-related hyperkalemia were screened and 1195 were enrolled in the run-in phase with patiromer and optimization of RAASi therapy (≥50% recommended dose of angiotensin-converting-enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, and 50 mg of mineralocorticoid receptor antagonist [MRA] spironolactone or eplerenone). Specified target doses of RAASi therapy were achieved in 878 (84.6%) patients; 439 were randomized to patiromer and 439 to placebo. All patients, physicians, and outcome assessors were blinded to treatment assignment. The primary endpoint was between-group difference in adjusted mean change in serum potassium. Five hierarchical secondary endpoints were assessed. At the end of treatment, the median (interquartile range) duration of follow-up was 27 (13, 43) weeks, the adjusted mean change in potassium was +0.03 mmol/L in the patiromer group and +0.13 mmol/L in the placebo group (difference in adjusted mean change between patiromer and placebo: -0.10 [95% confidence interval, CI -0.13, -0.07] mmol/L, P<0.001). Risk of hyperkalemia >5.5 mmol/L (hazard ratio [HR] 0.63; 95% CI 0.45, 0.87; P=0.006), reduction of MRA dose (HR 0.62; 95% CI 0.45, 0.87; P=0.006), and total adjusted hyperkalemia events/100 person-years (77.7 vs. 118.2; HR 0.66; 95% CI 0.53, 0.81; P<0.001) were lower with patiromer. Hyperkalemia-related morbidity-adjusted events (win ratio 1.53, P<0.001) and total RAASi use score (win ratio 1.25, P=0.048) favored the patiromer arm. Adverse events were similar between groups. CONCLUSION: Concurrent use of patiromer and high-dose MRAs reduces the risk of recurrent hyperkalemia (ClinicalTrials.gov: NCT03888066).

3.
Card Fail Rev ; 8: e21, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35815257

RESUMO

Implementation of guideline-directed medical therapy for patients with heart failure is suboptimal. The use of guideline-directed medical therapy improves minimally after heart failure hospitalisation, despite this event clearly indicating increased risk of further hospitalisation and death. In-hospital initiation and titration of guideline-directed medical therapies is one potential strategy to fill these gaps in care, both in the acute vulnerable period after hospital discharge and in the long term. The purpose of this article is to review the knowledge gaps in best practices of in-hospital initiation and up-titration of guideline-directed medical therapies, the benefits and risks of in-hospital initiation and post-discharge focused titration of guideline-directed medical therapies, the recent literature evaluating these practices, and propose strategies to apply these principles to the care of patients with heart failure with reduced ejection fraction.

4.
Eur J Heart Fail ; 2022 Jul 06.
Artigo em Inglês | MEDLINE | ID: mdl-35791663

RESUMO

AIMS: Guideline-directed medical therapy (GDMT), based on the combination of beta-blockers (BB), renin-angiotensin system inhibitors (RASI), and mineralocorticoid receptor antagonists (MRA), is known to have a major impact on the outcome of patients with heart failure with reduced ejection fraction (HFrEF). Although GDMT is recommended prior to mitral valve transcatheter edge-to-edge repair (M-TEER), not all patients tolerate it. We studied the association of GDMT prescription with survival in HFrEF patients undergoing M-TEER for secondary mitral regurgitation (SMR). METHODS AND RESULTS: EuroSMR, a European multicentre registry, included SMR patients with left ventricular ejection fraction <50%. The outcome was 2-year all-cause mortality. Of 1344 patients, BB, RASI, and MRA were prescribed in 1169 (87%), 1012 (75%), and 765 (57%) patients at the time of M-TEER, respectively. Triple GDMT prescription was associated with a lower 2-year all-cause mortality compared to non-triple GDMT (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.60-0.91). The association persisted in patients with glomerular filtration rate <30 ml/min, ischaemic aetiology, or right ventricular dysfunction. Further, a positive impact of triple GDMT prescription on survival was observed in patients with residual mitral regurgitation of ≥2+ (HR 0.62; 95% CI 0.44-0.86), but not in patients with residual mitral regurgitation of ≤1+ (HR 0.83; 95% CI 0.64-1.08). CONCLUSION: Triple GDMT prescription is associated with higher 2-year survival after M-TEER in HFrEF patients with SMR. This association was consistent also in patients with major comorbidities or non-optimal results after M-TEER.

5.
Eur J Heart Fail ; 2022 Jun 17.
Artigo em Inglês | MEDLINE | ID: mdl-35713888

RESUMO

AIMS: Heart failure with reduced ejection fraction (HFrEF) remains associated with high morbidity and mortality, poor quality of life (QoL) and significant exercise limitation. Sympatho-vagal imbalance has been shown to predict adverse prognosis and symptoms in HFrEF, yet it has not been specifically targeted by any guideline-recommended device therapy to date. Barostim™, which directly addresses this imbalance, is the first Food and Drug Administration approved neuromodulation technology for HFrEF. We aimed to analyse all randomized trial evidence to evaluate the effect of baroreflex activation therapy (BAT) on heart failure symptoms, QoL and N-terminal pro-brain natriuretic peptide (NT-proBNP) in HFrEF. METHODS AND RESULTS: An individual patient data (IPD) meta-analysis was performed on all eligible trials that randomized HFrEF patients to BAT + guideline-directed medical therapy (GDMT) or GDMT alone (open label). Endpoints included 6-month changes in 6-min hall walk (6MHW) distance, Minnesota Living With Heart Failure (MLWHF) QoL score, NT-proBNP, and New York Heart Association (NYHA) class in all patients and three subgroups. A total of 554 randomized patients were included. In all patients, BAT provided significant improvement in 6MHW distance of 49 m (95% confidence interval [CI] 33, 64), MLWHF QoL of -13 points (95% CI -17, -10), and 3.4 higher odds of improving at least one NYHA class (95% CI 2.3, 4.9) when comparing from baseline to 6 months. These improvements were similar, or better, in patients who had baseline NT-proBNP <1600 pg/ml, regardless of the cardiac resynchronization therapy indication status. CONCLUSION: An IPD meta-analysis suggests that BAT improves exercise capacity, NYHA class, and QoL in HFrEF patients receiving GDMT. These clinically meaningful improvements were consistent across the range of patients studies. BAT was also associated with an improvement in NT-proBNP in subjects with a lower baseline NT-proBNP.

6.
J Card Fail ; 2022 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-35649474

RESUMO

Emergency department (ED) providers play a critical role in the stabilization and diagnostic evaluation of patients presenting with acute heart failure (AHF), and EDs are key areas for establishing current best practices and future considerations for the disposition of and decision making for patients with AHF. These elements include accurate risk assessment; response to initial treatment and shared decision making concerning optimal venue of care; reframing of physicians' risk perceptions for patients presenting with AHF; exploration of alternative venues of care beyond hospitalization; population-level changes in demographics, management and outcomes of HF patients; development and testing of data-driven pathways to assist with disposition decisions in the ED; and suggested outcomes for measuring success.

7.
JACC Heart Fail ; 10(6): 397-403, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35654524

RESUMO

BACKGROUND: As utilization of veno-arterial extracorporeal life support (VA-ECLS) in treatment of cardiogenic shock (CS) continues to expand, clinical variables that guide clinicians in early recognition of myocardial recovery and therefore, improved survival, after VA-ECLS are critical. There remains a paucity of literature on early postinitiation blood pressure measurements that predict improved outcomes. OBJECTIVES: The objective of this study is to help identify early blood pressure variables associated with improved outcomes in VA-ECLS. METHODS: The authors queried the ELSO (Extracorporeal Life Support Organization) registry for cardiogenic shock patients treated with VA-ECLS or venovenous arterial ECLS between 2009 and 2020. Their inclusion criteria included treatment with VA-ECLS or venovenous arterial ECLS; absence of pre-existing durable right, left, or biventricular assist devices; no pre-ECLS cardiac arrest; and no surgical or percutaneously placed left ventricular venting devices during their ECLS runs. Their primary outcome of interest was the survival to discharge during index hospitalization. RESULTS: A total of 2,400 CS patients met the authors' inclusion criteria and had complete documentation of blood pressures. Actual mortality during index hospitalization in their cohort was 49.5% and survivors were younger and more likely to be Caucasian, intubated for >30 hours pre-ECLS initiation, and had a favorable baseline SAVE (Survival After Veno-arterial ECMO) score (P < 0.05 for all). Multivariable regression analyses adjusting for SAVE score, age, ECLS flow at 4 hours, and race showed that every 10-mm Hg increase in baseline systolic blood pressure (HR: 0.92 [95% CI: 0.89-0.95]; P < 0.001), and baseline pulse pressure (HR: 0.88 [95% CI: 0.84-0.91]; P < 0.001) at 24 hours was associated with a statistically significant reduction in mortality. CONCLUSIONS: Early (within 24 hours) improvements in pulse pressure and systolic blood pressure from baseline are associated with improved survival to discharge among CS patients treated with VA-ECLS.


Assuntos
Oxigenação por Membrana Extracorpórea , Insuficiência Cardíaca , Pressão Sanguínea , Insuficiência Cardíaca/etiologia , Humanos , Sistema de Registros , Choque Cardiogênico
8.
Am J Cardiol ; 178: 72-79, 2022 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-35773043

RESUMO

The 6-minute walk distance (6MWD) carries prognostic value in patients with heart failure with reduced ejection fraction (HFrEF). We performed this systematic review and meta-analysis to evaluate the effect of heart failure therapies on improvement in 6MWD. A systematic search of MEDLINE and Embase was conducted for randomized controlled trials measuring 6MWD at baseline and at follow-up in at least 50 patients with HFrEF across both arms. The primary outcome was improvement in 6MWD at follow-up. Meta-analysis was stratified in groups on the basis of medical therapy, device-based therapy, autonomic modulation, and exercise. Mean differences (MDs) with 95% confidence interval (CI) were reported across multiple studies that were included in the meta-analysis. A total of 44 studies met the inclusion criteria for systematic review; 17 of which were included for meta-analysis. Statistical analysis showed a statistically significant improvement in 6MWD in meters (m) at follow-up for device-based therapy (MD 20.01 m, 95% CI 18.71 to 21.31), autonomic modulation (MD 76.64 m, 95% CI 54.10 to 99.19), and exercise group (MD 39.52 m, 95% CI 19.68 to 59.35). Pooled analysis of medical therapy did not show statistically significant improvement in 6MWD at follow-up (MD 31.69 m, 95% CI -6.52 to 69.91). Device-based therapy (cardiac resynchronization therapy and cardiac contractility modulation), autonomic modulation, and exercise training programs are associated with improvement in 6MWD in patients with HFrEF. 6MWD is a useful test to gauge improvement in functional capacity among patients with HFrEF, especially those with severe symptomatic heart failure.

9.
Prog Cardiovasc Dis ; 2022 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-35605697

RESUMO

Mitral regurgitation (MR) is one of the common valvular heart diseases and can be broadly categorized as primary or secondary. Primary MR occurs due to abnormalities of the valvular apparatus where surgical repair offers excellent outcomes. In contrast, the underlying degree of left ventricular dysfunction plays a major role in the development of secondary MR. Recently, two randomized controlled trials, the Percutaneous Repair with the MitraClip Device for Severe Functional/ Secondary Mitral Regurgitation (MITRA-FR) and the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT), evaluated the role of transcatheter edge-to-edge repair (TEER) using MitraClip device among heart failure patients with secondary MR and observed contradictory results; this has created a considerable dilemma among clinicians for an appropriate patient selection for the transcatheter mitral valve (MV) therapies. In this review, we highlight several important differences in patient characteristics between the COAPT and MITRA-FR trials that may help explain the differences observed in outcomes. We also reviewed several key clinical, echocardiographic, and procedural characteristics that may guide clinicians in improving patient selection for transcatheter MV therapies for better outcomes.

10.
Am Heart J Plus ; 152022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35600671

RESUMO

Introduction: Clinical symptoms of heart failure commonly include fatigue, edema, and shortness of breath. Unfortunately, clinical monitoring has proven unreliable in predicting congestion and the need for hospitalization. Biosensing wearables have been developed as a potential adjunct to clinical signs and symptoms to detect congestion before it becomes severe thus preventing a heart failure hospitalization. Hypothesis: Clinical signs and symptoms of heart failure will correlate with thoracic bioimpedance measurements (ZOE®) and pulmonary capillary wedge pressure (PCWP). Methods: One hundred and fifty-five subjects undergoing right heart catheterization (RHC) were prospectively enrolled. A Zo value (ohms) was obtained, jugular venous pressure (JVP) was estimated, edema graded, and shortness of breath (SOB) assessed in all subjects. RHC was performed by a scheduled cardiologist per routine. One-way ANOVA was performed to assess the relationship between variables. A Pearson correlation coefficient was used to compare the Zo value and PCWP. Results: Neither estimated JVP (cmH2O) (p = 0.65, n = 110) nor edema scores (p = 0.12, n = 110) demonstrated a significant relationship to PCWP. The presence of subjective SOB also did not demonstrate a significant association with PCWP (p = 0.99, n = 110). There was no correlation between ZOE® and PCWP (r = -0.08, p = 0.56, n = 56). Conclusions: These findings support the idea that traditional measures for monitoring heart failure patients are limited.

11.
J Am Coll Emerg Physicians Open ; 3(2): e12695, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35434709

RESUMO

Background: Prior data has demonstrated increased mortality in hospitalized patients with acute heart failure (AHF) and troponin elevation. No data has specifically examined the prognostic significance of troponin elevation in patients with AHF discharged after emergency department (ED) management. Objective: Evaluate the relationship between troponin elevation and outcomes in patients with AHF who are treated and released from the ED. Methods: This was a secondary analysis of the Get with the Guidelines to Reduce Disparities in AHF Patients Discharged from the ED (GUIDED-HF) trial, a randomized, controlled trial of ED patients with AHF who were discharged. Patients with elevated conventional troponin not due to acute coronary syndrome (ACS) were included. Our primary outcome was a composite endpoint: time to 30-day cardiovascular death and/or heart failure-related events. Results: Of the 491 subjects included in the GUIDED-HF trial, 418 had troponin measured during the ED evaluation and 66 (16%) had troponin values above the 99th percentile. Median age was 63 years (interquartile range, 54-70), 62% (n = 261) were male, 63% (n = 265) were Black, and 16% (n = 67) experienced our primary outcome. There were no differences in our primary outcome between those with and without troponin elevation (12/66, 18.1% vs 55/352, 15.6%; P = 0.60). This effect was maintained regardless of assignment to usual care or the intervention arm. In multivariable regression analysis, there was no association between our primary outcome and elevated troponin (hazard ratio, 1.00; 95% confidence interval,  0.49-2.01, P = 0.994). Conclusion: If confirmed in a larger cohort, these findings may facilitate safe ED discharge for a group of patients with AHF without ACS when an elevated troponin is the primary reason for admission.

12.
Eur Heart J ; 43(27): 2603-2618, 2022 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-35266003

RESUMO

AIMS: During the coronavirus disease 2019 (COVID-19) pandemic, important changes in heart failure (HF) event rates have been widely reported, but few data address potential causes for these changes; several possibilities were examined in the GUIDE-HF study. METHODS AND RESULTS: From 15 March 2018 to 20 December 2019, patients were randomized to haemodynamic-guided management (treatment) vs. control for 12 months, with a primary endpoint of all-cause mortality plus HF events. Pre-COVID-19, the primary endpoint rate was 0.553 vs. 0.682 events/patient-year in the treatment vs. control group [hazard ratio (HR) 0.81, P = 0.049]. Treatment difference was no longer evident during COVID-19 (HR 1.11, P = 0.526), with a 21% decrease in the control group (0.536 events/patient-year) and no change in the treatment group (0.597 events/patient-year). Data reflecting provider-, disease-, and patient-dependent factors that might change the primary endpoint rate during COVID-19 were examined. Subject contact frequency was similar in the treatment vs. control group before and during COVID-19. During COVID-19, the monthly rate of medication changes fell 19.2% in the treatment vs. 10.7% in the control group to levels not different between groups (P = 0.362). COVID-19 was infrequent and not different between groups. Pulmonary artery pressure area under the curve decreased -98 mmHg-days in the treatment group vs. -100 mmHg-days in the controls (P = 0.867). Patient compliance with the study protocol was maintained during COVID-19 in both groups. CONCLUSION: During COVID-19, the primary event rate decreased in the controls and remained low in the treatment group, resulting in an effacement of group differences that were present pre-COVID-19. These outcomes did not result from changes in provider- or disease-dependent factors; pulmonary artery pressure decreased despite fewer medication changes, suggesting that patient-dependent factors played an important role in these outcomes. Clinical Trials.gov: NCT03387813.


Assuntos
COVID-19 , Insuficiência Cardíaca , Hemodinâmica , Humanos , Pandemias , Artéria Pulmonar
13.
JAMA Cardiol ; 7(5): 540-548, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35319725

RESUMO

Importance: Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups. The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance HF therapeutic development, has been dedicated to improving recruitment strategies for patients from diverse and historically underrepresented groups. Observations: Despite federal policies from the US Food and Drug Administration and National Institutes of Health aimed at improving trial representation, gaps in trial enrollment proportionate to the racial and ethnic composition of the HF population have persisted. Increasing trial globalization with limited US enrollment is a major driver of these patterns. Additional barriers to representative enrollment include inequities in care access, logistical issues in participation, restrictive enrollment criteria, and English language requirements. Conclusions and Relevance: Strategies for improving diverse trial enrollment include methodical study design and site selection, diversification of research leadership and staff, broadening of eligibility criteria, community and patient engagement, and broad stakeholder commitment. In contemporary HF trials, diverse trial enrollment is not only feasible but can be efficiently achieved to improve the generalizability and translation of trial knowledge to clinical practice.


Assuntos
Etnicidade , Insuficiência Cardíaca , Negros , Insuficiência Cardíaca/terapia , Humanos , Seleção de Pacientes , Grupos Raciais
14.
Eur Heart J Case Rep ; 6(2): ytac077, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35233502

RESUMO

BACKGROUND: Achieving pharmacologic rate control in patients with atrial fibrillation (AF) with rapid ventricular response (RVR) can be tricky when the patient's underlying cardiac function is decreased. We present a case illustrating how ivabradine can be useful in this clinical scenario. CASE SUMMARY: A 95-year-old woman with a history of systolic heart failure (HF) presented with acute decompensated HF in AF with RVR. Beta blockade and calcium channel blockade were avoided given her cardiac history, and diuresis with high doses of furosemide was ineffective. Her ventricular response slowed with ivabradine, allowing for rapid decongestion and a safe discharge home. DISCUSSION: Ivabradine acts on the I f current of cardiac pacemaker cells to slow heart rate (HR), and it currently carries a class IIa recommendation to reduce the risk of HF hospitalization and cardiac death in patients with left ventricular ejection fraction ≤35% and a symptomatic HR ≥70 b.p.m. Although current recommendations are for patients in sinus rhythm, ivabradine has a theoretical benefit in patients with AF given its mechanism of action. Because it does not negatively affect inotropy or blood pressure, ivabradine was used in our patient with a good clinical outcome. Our case provides an example of ivabradine's usefulness in patients with AF in RVR with a history of depressed systolic function.

15.
Eur Heart J ; 43(17): 1639-1648, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35134897

RESUMO

AIMS: Baseline renal dysfunction (RD) adversely impacts outcomes among patients with heart failure (HF) and severe secondary mitral regurgitation (MR). Heart failure and MR, in turn, accelerate progression to end-stage renal disease (ESRD), worsening prognosis. We sought to determine the impact of RD in HF patients with severe MR and the impact of transcatheter mitral valve repair (TMVr) on new-onset ESRD and the need for renal replacement therapy (RRT). METHODS AND RESULTS: The COAPT trial randomized 614 patients with HF and severe MR to MitraClip plus guideline-directed medical therapy (GDMT) vs. GDMT alone. Patients were stratified into three RD subgroups based on baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2): none (≥60), moderate (30-60), and severe (<30). End-stage renal disease was defined as eGFR <15 mL/min/1.73 m2 or RRT. The 2-year rates of all-cause death or HF hospitalization (HFH), new-onset ESRD, and RRT according to RD and treatment were assessed. Baseline RD was present in 77.0% of patients, including 23.8% severe RD, 6.0% ESRD, and 5.2% RRT. Worse RD was associated with greater 2-year risk of death or HFH (none 45.3%; moderate 53.9%; severe 69.2%; P < 0.0001). MitraClip vs. GDMT alone improved outcomes regardless of RD (Pinteraction = 0.62) and reduced new-onset ESRD [2.9 vs. 8.1%, hazard ratio (HR) 0.34, 95% confidence interval (CI) 0.15-0.76, P = 0.008] and the need for new RRT (2.5 vs. 7.4%, HR 0.33, 95% CI 0.14-0.78, P = 0.011). CONCLUSION: Baseline RD was common in the HF patients with severe MR enrolled in COAPT and strongly predicted 2-year death and HFH. MitraClip treatment reduced new-onset ESRD and the need for RRT, contributing to the improved prognosis after TMVr.


Assuntos
Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Falência Renal Crônica , Insuficiência da Valva Mitral , Insuficiência Cardíaca/epidemiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Falência Renal Crônica/epidemiologia , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/cirurgia , Resultado do Tratamento
16.
J Am Coll Cardiol ; 79(5): 504-510, 2022 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-35115106

RESUMO

With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Ensaios Clínicos como Assunto , Insuficiência Cardíaca/tratamento farmacológico , Publicações Periódicas como Assunto , Volume Sistólico/fisiologia , Insuficiência Cardíaca/fisiopatologia , Humanos
18.
Eur Heart J ; 43(5): 367-376, 2022 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-34974611

RESUMO

In the year 2021, the universal definition and classification of heart failure (HF) was published that defines HF as a clinical syndrome with symptoms and/or signs caused by a cardiac abnormality and corroborated by elevated natriuretic peptide levels or objective evidence of cardiogenic congestion. This definition and the classification of HF with reduced ejection fraction (HFrEF), mildly reduced, and HF with preserved ejection fraction (HFpEF) is consistent with the 2021 ESC Guidelines on HF. Among several other new recommendations, these guidelines give a Class I indication for the use of the sodium-glucose co-transporter 2 (SGLT2) inhibitors dapagliflozin and empagliflozin in HFrEF patients. As the first evidence-based treatment for HFpEF, in the EMPEROR-Preserved trial, empagliflozin reduced the composite endpoint of cardiovascular death and HF hospitalizations. Several reports in 2021 have provided novel and detailed analyses of device and medical therapy in HF, especially regarding sacubitril/valsartan, SGLT2 inhibitors, mineralocorticoid receptor antagonists, ferric carboxymaltose, soluble guanylate cyclase activators, and cardiac myosin activators. In patients hospitalized with COVID-19, acute HF and myocardial injury is quite frequent, whereas myocarditis and long-term damage to the heart are rather uncommon.


Assuntos
COVID-19 , Cardiomiopatias , Insuficiência Cardíaca , Aminobutiratos , Antagonistas de Receptores de Angiotensina , Compostos de Bifenilo , Insuficiência Cardíaca/tratamento farmacológico , Humanos , SARS-CoV-2 , Volume Sistólico
19.
JACC Cardiovasc Interv ; 15(4): 397-407, 2022 02 28.
Artigo em Inglês | MEDLINE | ID: mdl-35093278

RESUMO

OBJECTIVES: The aim of this study was to assess the impact of age on outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. BACKGROUND: In the COAPT trial, TEER with the MitraClip device in patients with heart failure (HF) and moderate to severe or severe secondary mitral regurgitation (SMR) reduced the risk for HF hospitalization (HFH) and all-cause mortality compared with maximally tolerated guideline-directed medical therapy (GDMT) alone. There are limited data regarding the effectiveness of MitraClip therapy in elderly patients. METHODS: Patients (n = 614) were grouped by median age at randomization (74 years) and by MitraClip treatment vs GDMT alone. The primary endpoint was the 2-year rate of death or HFH assessed by multivariable Cox regression. RESULTS: Death or HFH within 2 years occurred less frequently after treatment with the MitraClip vs GDMT alone in patients <74 years of age (37.3% vs 64.5%; adjusted HR: 0.41; 95% CI: 0.29-0.59) and ≥74 years of age (51.7% vs 69.6%; adjusted HR: 0.58; 95% CI: 0.42-0.81) (Pint = 0.17). Mortality was also consistently reduced with MitraClip treatment in young and elderly patients (Pint = 0.42). In contrast, elderly patients treated with the MitraClip vs GDMT alone tended to have a lesser reduction of HFH than younger patients (Pint = 0.03). Younger and older patients had similar improvements in quality of life after treatment with the MitraClip compared with GDMT alone. CONCLUSIONS: In the COAPT trial, MitraClip treatment of moderate to severe and severe SMR reduced the composite risk for death or HFH and improved survival and quality of life regardless of age. As such, young and elderly patients with HF and severe SMR benefit from TEER, although elderly patients may not have as great a benefit from the MitraClip device in reducing HFH.


Assuntos
Insuficiência Cardíaca , Insuficiência da Valva Mitral , Idoso , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Resultado do Tratamento
20.
Heart ; 108(9): 717-724, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35078867

RESUMO

BACKGROUND: Transcatheter edge-to-edge mitral valve repair (TMVr) improves symptoms and survival for patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and severe secondary mitral regurgitation despite guideline-recommended medical therapy (GRMT). Whether TMVr is cost-effective from a UK National Health Service (NHS) perspective is unknown. METHODS: We used patient-level data from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial to perform a cost-effectiveness analysis of TMVr +GRMT versus GRMT alone from an NHS perspective. Costs for the TMVr procedure were based on standard English tariffs and device costs. Subsequent costs were estimated based on data acquired during the trial. Health utilities were estimated using the Short-Form 6-Dimension Health Survey. RESULTS: Costs for the index procedural hospitalisation were £18 781, of which £16 218 were for the TMVr device. Over 2-year follow-up, TMVr reduced subsequent costs compared with GRMT (£10 944 vs £14 932, p=0.006), driven mainly by reductions in heart failure hospitalisations; nonetheless, total 2-year costs remained higher with TMVr (£29 165 vs £14 932, p<0.001). When survival, health utilities and costs were projected over a lifetime, TMVr was projected to increase life expectancy by 1.57 years and quality-adjusted life expectancy by 1.12 quality-adjusted life-years (QALYs) at an incremental cost of £21 980, resulting in an incremental cost-effectiveness ratio (ICER) of £23 270 per QALY gained (after discounting). If the benefits of TMVr observed in the first 2 years were maintained without attenuation, the ICER improved to £12 494 per QALY. CONCLUSIONS: For patients with HFrEF and severe secondary mitral regurgitation similar to those enrolled in COAPT, TMVr increases life expectancy and quality-adjusted life expectancy compared with GRMT at an ICER that represents good value from an NHS perspective.


Assuntos
Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Cateterismo Cardíaco/métodos , Ensaios Clínicos como Assunto , Análise Custo-Benefício , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Medicina Estatal , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
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