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1.
Circulation ; 140(18): 1463-1476, 2019 10 29.
Artigo em Inglês | MEDLINE | ID: mdl-31524498

RESUMO

BACKGROUND: Outcome trials in patients with type 2 diabetes mellitus have demonstrated reduced hospitalizations for heart failure (HF) with sodium-glucose co-transporter-2 inhibitors. However, few of these patients had HF, and those that did were not well-characterized. Thus, the effects of sodium-glucose co-transporter-2 inhibitors in patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown. METHODS: DEFINE-HF (Dapagliflozin Effects on Biomarkers, Symptoms and Functional Status in Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate ≥30 mL/min/1.73m2, and elevated natriuretic peptides. In total, 263 patients were randomized to dapagliflozin 10 mg daily or placebo for 12 weeks. Dual primary outcomes were (1) mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score, or a ≥20% decrease in NT-proBNP. RESULTS: Patient characteristics reflected stable, chronic HF with reduced ejection fraction with high use of optimal medical therapy. There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL (95% CI 1089-1304), P=0.43). For the second dual-primary outcome of a meaningful improvement in Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP, 61.5% of dapagliflozin-treated patients met this end point versus 50.4% with placebo (adjusted OR 1.8, 95% CI 1.03-3.06, nominal P=0.039). This was attributable to both higher proportions of patients with ≥5-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary score (42.9 vs 32.5%, adjusted OR 1.73, 95% CI 0.98-3.05), and ≥20% reduction in NT-proBNP (44.0 vs 29.4%, adjusted OR 1.9, 95% CI 1.1-3.3) by 12 weeks. Results were consistent among patients with or without type 2 diabetes mellitus, and other prespecified subgroups (all P values for interaction=NS). CONCLUSIONS: In patients with heart failure and reduced ejection fraction, use of dapagliflozin over 12 weeks did not affect mean NT-proBNP but increased the proportion of patients experiencing clinically meaningful improvements in HF-related health status or natriuretic peptides. Benefits of dapagliflozin on clinically meaningful HF measures appear to extend to patients without type 2 diabetes mellitus. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02653482.

3.
ESC Heart Fail ; 5(3): 316-321, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29498245

RESUMO

AIMS: Remote haemodynamic monitoring (RHM) decreases hospitalization rates in patients with chronic heart failure (HF). Many patients with chronic HF develop pulmonary hypertension (PH) secondary to left heart disease with some acquiring combined pre-capillary and post-capillary PH (Cpc-PH). The efficacy of RHM in achieving pulmonary pressure reductions in patients with Cpc-PH vs. isolated post-capillary PH (Ipc-PH) is unknown. The purpose of this study is to evaluate whether a higher baseline diastolic pressure gradient (DPGbaseline ) measured at the time of CardioMEMS™ HF sensor implantation is associated with lower reductions in pulmonary artery diastolic pressures (PADP). METHODS AND RESULTS: This was a retrospective analysis of 32 patients meeting clinical indications for CardioMEMS™ implantation. DPGbaseline categorized patients as Cpc-PH (DPG ≥ 7 mmHg) or Ipc-PH (DPG < 7 mmHg). Minimum achievable PADP (PADPmin ) and ∆PADP (PADPbaseline  - PADPmin ) were determined. Pearson's correlation analysis and comparison of mean pressure changes were assessed. Median age was 69 years, and median left ventricular ejection fraction (LVEF) was 25%. Eight patients (25%) had a LVEF ≥40%. Twenty-five patients (78%) met criteria for Ipc-PH and seven (22%) for Cpc-PH. Neither PADPmin (ρ = 0.27; P = 0.13) nor ΔPADP (ρ = 0.07; P = 0.72) was correlated with DPGbaseline . A trend towards higher ΔPADP was seen in Cpc-PH vs. Ipc-PH patients (15.2 vs. 9.88 mmHg; P = 0.12). There was a moderate positive correlation between baseline PADP and ΔPADP [ρ = 0.55 (0.26-0.76); P < 0.001]. CONCLUSIONS: Decreased PADP reduction was not seen in Cpc-PH vs. Ipc-PH patients. Higher PADPbaseline was associated with greater ΔPADP. Larger studies are needed to elaborate our findings.


Assuntos
Insuficiência Cardíaca Diastólica/complicações , Hipertensão Pulmonar/fisiopatologia , Sistemas Microeletromecânicos , Monitorização Fisiológica/instrumentação , Pressão Propulsora Pulmonar/fisiologia , Telemedicina , Idoso , Determinação da Pressão Arterial , Diástole , Desenho de Equipamento , Feminino , Seguimentos , Insuficiência Cardíaca Diastólica/fisiopatologia , Hospitalização/tendências , Humanos , Hipertensão Pulmonar/etiologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resistência Vascular , Função Ventricular Esquerda
4.
Clin Med Insights Case Rep ; 10: 1179547617723643, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28890659

RESUMO

Loeffler endocarditis is a rare restrictive cardiomyopathy caused by abnormal endomyocardial infiltration of eosinophils, with subsequent tissue damage from degranulation, eventually leading to fibrosis. Although an uncommon entity, it is still a disease with significant morbidity and mortality. Often identified only at late stages, treatment options are limited once fibrosis occurs, usually requiring heart failure medications or surgical intervention. We present a unique case of a woman with remote history of hypereosinophilic syndrome, attributed to treatment of rheumatoid arthritis with infliximab, who presented with symptoms of heart failure refractory to medical management and was found to have Loeffler endocarditis. The severe progression of the disease required surgical intervention with endocardial stripping to treat the right-sided diastolic heart failure.

5.
J Am Coll Cardiol ; 69(19): 2357-2365, 2017 May 16.
Artigo em Inglês | MEDLINE | ID: mdl-28330751

RESUMO

BACKGROUND: In the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Functional Class III Heart Failure Patients) trial, heart failure hospitalization (HFH) rates were lower in patients managed with guidance from an implantable pulmonary artery pressure sensor compared with usual care. OBJECTIVES: This study examined the effectiveness of ambulatory hemodynamic monitoring in reducing HFH outside of the clinical trial setting. METHODS: We conducted a retrospective cohort study using U.S. Medicare claims data from patients undergoing pulmonary artery pressure sensor implantation between June 1, 2014, and December 31, 2015. Rates of HFH during pre-defined periods before and after implantation were compared using the Andersen-Gill extension to the Cox proportional hazards model while accounting for the competing risk of death, ventricular assist device implantation, or cardiac transplantation. Comprehensive heart failure (HF)-related costs were compared over the same periods. RESULTS: Among 1,114 patients receiving implants, there were 1,020 HFHs in the 6 months before, compared with 381 HFHs, 139 deaths, and 17 ventricular assist device implantations and/or transplants in the 6 months after implantation (hazard ratio [HR]: 0.55; 95% confidence interval [CI]: 0.49 to 0.61; p < 0.001). This lower rate of HFH was associated with a 6-month comprehensive HF cost reduction of $7,433 per patient (IQR: $7,000 to $7,884), and was robust in analyses restricted to 6-month survivors. Similar reductions in HFH and costs were noted in the subset of 480 patients with complete data available for 12 months before and after implantation (HR: 0.66; 95% CI: 0.57 to 0.76; p < 0.001). CONCLUSIONS: As in clinical trials, use of ambulatory hemodynamic monitoring in clinical practice is associated with lower HFH and comprehensive HF costs. These benefits are sustained to 1 year and support the "real-world" effectiveness of this approach to HF management.


Assuntos
Insuficiência Cardíaca/prevenção & controle , Hospitalização/estatística & dados numéricos , Monitorização Ambulatorial , Idoso , Idoso de 80 Anos ou mais , Feminino , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
6.
Circulation ; 135(16): 1509-1517, 2017 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-28219895

RESUMO

BACKGROUND: Elevated pulmonary artery (PA) pressures in patients with heart failure are associated with a high risk for hospitalization and mortality. Recent clinical trial evidence demonstrated a direct relationship between lowering remotely monitored PA pressures and heart failure hospitalization risk reduction with a novel implantable PA pressure monitoring system (CardioMEMS HF System, St. Jude Medical). This study examines PA pressure changes in the first 2000 US patients implanted in general practice use. METHODS: Deidentified data from the remote monitoring Merlin.net (St. Jude Medical) database were used to examine PA pressure trends from the first consecutive 2000 patients with at least 6 months of follow-up. Changes in PA pressures were evaluated with an area under the curve methodology to estimate the total sum increase or decrease in pressures (mm Hg-day) during the follow-up period relative to the baseline pressure. As a reference, the PA pressure trends were compared with the historic CHAMPION clinical trial (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Functional Class III Heart Failure Patients). The area under the curve results are presented as mean±2 SE, and P values comparing the area under the curve of the general-use cohort with outcomes in the CHAMPION trial were computed by the t test with equal variance. RESULTS: Patients were on average 70±12 years old; 60% were male; 34% had preserved ejection fraction; and patients were followed up for an average of 333±125 days. At implantation, the mean PA pressure for the general-use patients was 34.9±10.2 mm Hg compared with 31.3±10.9 mm Hg for CHAMPION treatment and 32.0±10.5 mm Hg for CHAMPION control groups. The general-use patients had an area under the curve of -32.8 mm Hg-day at the 1-month time mark, -156.2 mm Hg-day at the 3-month time mark, and -434.0 mm Hg-day after 6 months of hemodynamic guided care, which was significantly lower than the treatment group in the CHAMPION trial. Patients consistently transmitted pressure information with a median of 1.27 days between transmissions after 6 months. CONCLUSIONS: The first 2000 general-use patients managed with hemodynamic-guided heart failure care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared with the pivotal CHAMPION clinical trial. These data demonstrate that general use of implantable hemodynamic technology in a nontrial setting leads to significant lowering of PA pressures.


Assuntos
Monitorização Ambulatorial da Pressão Arterial/métodos , Artéria Pulmonar/fisiopatologia , Pressão Propulsora Pulmonar/fisiologia , Idoso , Feminino , Humanos , Masculino
7.
Clin Cardiol ; 40(3): 170-176, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27878990

RESUMO

BACKGROUND: The real-world impact of remote pulmonary artery pressure (PAP) monitoring on New York Heart Association (NYHA) class improvement and heart failure (HF) hospitalization rate is presented here from a single center. HYPOTHESIS: METHODS: Seventy-seven previously hospitalized outpatients with NYHA class III HF were offered PAP monitoring via device implantation in a multidisciplinary HF-management program. Prospective effectiveness analyses compared outcomes in 34 hemodynamically monitored patients to a group of similar patients (n = 32) who did not undergo device implantation but received usual care. NYHA class and 6-minute walk testing were assessed at baseline and 90 days. All hospitalizations were collected after 6 months of the implantation date (average follow-up, 15 months) and compared with the number of hospitalizations experienced prior to hemodynamic monitoring. RESULTS: Patients in both groups had similar distributions of age, sex, and ejection fraction. After 90 days, 61.8% of the monitored patients had NYHA class improvement of ≥1, compared with 12.5% in the controls (P < 0.001). Distance walked in 6 minutes increased by 54.5 meters in the monitored group (253.0 ± 25.6 meters to 307.4 ± 26.3 meters; P < 0.005), whereas no change was seen in the usual-care group. After implantation, 19.4% of the monitored group had ≥1 HF hospitalization, compared with 100% who had been hospitalized in the year prior to implantation. The monitored group had a significantly lower HF hospitalization rate (0.16; 95% confidence interval: 0.06-0.35 hospitalizations/patient-year) compared with the year prior (1.0 hospitalizations/patient-year; P < 0.001). CONCLUSIONS: Hemodynamic-guided HF management leads to significant improvements in NYHA class and HF hospitalization rate in a real-world setting compared with usual care delivered in a comprehensive disease-management program.


Assuntos
Gerenciamento Clínico , Eletrodos Implantados , Insuficiência Cardíaca/diagnóstico , Hemodinâmica/fisiologia , Monitorização Fisiológica/instrumentação , Avaliação de Programas e Projetos de Saúde , Telemedicina/instrumentação , Idoso , Desenho de Equipamento , Feminino , Seguimentos , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Hospitalização/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Tecnologia de Sensoriamento Remoto/instrumentação , Volume Sistólico , Fatores de Tempo
8.
J Invasive Cardiol ; 28(7): 273-9, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27342204

RESUMO

The CardioMEMS heart failure system is a recent Food and Drug Administration approved device that can be implanted in patients with New York Heart Association class III heart failure and allows remote monitoring of pulmonary artery pressures. There is limited published information regarding the implantation procedure. Successful use of the CardioMEMS heart failure system requires an understanding of the technical issues surrounding the implantation procedure. The goal of the present review is to provide a summary of the implantation procedure, discuss the required imaging steps, review procedural supplies, and present a series of case studies to illustrate clinically relevant issues that may arise during sensor implantation.


Assuntos
Insuficiência Cardíaca , Cuidados Intraoperatórios/métodos , Complicações Intraoperatórias/prevenção & controle , Implantação de Prótese , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/cirurgia , Humanos , Monitorização Intraoperatória/métodos , Implantação de Prótese/efeitos adversos , Implantação de Prótese/instrumentação , Implantação de Prótese/métodos , Artéria Pulmonar/diagnóstico por imagem , Índice de Gravidade de Doença
9.
Circ Heart Fail ; 9(1): e002296, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26721914

RESUMO

BACKGROUND: Hematologic adverse events are common during continuous flow left ventricular assist device support; yet, their relation to antiplatelet therapy, including aspirin (ASA) dosing, is uncertain. METHODS AND RESULTS: A single-center retrospective review of all patients supported by a continuous flow left ventricular assist device (Heart Mate II) from June 2006 to November 2014 was conducted. Patients were categorized into 3 groups: (1) ASA 81 mg+dipyridamole 75 mg daily (n = 26) with a target international normalized ratio (INR) of 2 to 3 from June 2006 to August 2009; (2) ASA 81 mg daily (n = 18) from September 2009 to August 2011 with a target INR of 1.5 to 2; and (3) ASA 325 mg daily from September 2011 to November 2014 with a target INR of 2 to 3 (n = 70). Hemorrhagic and thrombotic outcomes were retrieved ≤ 365 days after implantation. Cumulative survival free from adverse events was calculated using Kaplan-Meier curves and Cox proportional hazard ratios were generated. Hemorrhagic events occurred in 6 patients on ASA 81 mg+dipyridamole (26%; 0.42 events per patient year; mean INR at event, 2.2), 4 patients on ASA 81 mg (22%; 0.38 events per patient year; mean INR at event, 2.0), and in 38 patients on ASA 325 mg (54%; 1.4 events per patient year; mean INR at event, 2.2); P = 0.004. Patients on ASA 325 mg had a higher adjusted hazard ratio of 2.9 (95% confidence interval, 1.2-7.0 versus ASA 81 mg+dipyridamole; P = 0.02) and 3.4 (95% confidence interval, 1.2-9.5 versus ASA 81 mg; P = 0.02) for hemorrhagic events. Thrombotic events rates were not different between groups. CONCLUSIONS: High-dose ASA in Heart Mate II patients treated concomitantly with warfarin is associated with an increased hazard of bleeding but does not reduce thrombotic events.


Assuntos
Aspirina/efeitos adversos , Dipiridamol/efeitos adversos , Insuficiência Cardíaca/terapia , Coração Auxiliar/efeitos adversos , Hemorragia/induzido quimicamente , Inibidores da Agregação de Plaquetas/efeitos adversos , Trombose/prevenção & controle , Adulto , Idoso , Anticoagulantes/efeitos adversos , Distribuição de Qui-Quadrado , Intervalo Livre de Doença , Quimioterapia Combinada , Feminino , Insuficiência Cardíaca/sangue , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Hemorragia/diagnóstico , Hemorragia/epidemiologia , Humanos , Coeficiente Internacional Normatizado , Estimativa de Kaplan-Meier , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Cidade de Nova Iorque/epidemiologia , Prevalência , Modelos de Riscos Proporcionais , Desenho de Prótese , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombose/diagnóstico , Trombose/epidemiologia , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda , Varfarina/efeitos adversos
11.
Circ Heart Fail ; 8(3): 551-6, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25870369

RESUMO

BACKGROUND: Adverse events (AEs), such as intracranial hemorrhage, thromboembolic event, and progressive aortic insufficiency, create substantial morbidity and mortality during continuous flow left ventricular assist device support yet their relation to blood pressure control is underexplored. METHODS AND RESULTS: A multicenter retrospective review of patients supported for at least 30 days and ≤18 months by a continuous flow left ventricular assist device from June 2006 to December 2013 was conducted. All outpatient Doppler blood pressure (DOPBP) recordings were averaged up to the time of intracranial hemorrhage, thromboembolic event, or progressive aortic insufficiency. DOPBP was analyzed as a categorical variable grouped as high (>90 mm Hg; n=40), intermediate (80-90 mm Hg; n=52), and controlled (<80 mm Hg; n=31). Cumulative survival free from an AE was calculated using Kaplan-Meier curves and Cox hazard ratios were derived. Patients in the high DOPBP group had worse baseline renal function, lower angiotensin-converting enzyme inhibitor or angiotensin receptor blocker usage during continuous flow left ventricular assist device support, and a more prevalent history of hypertension. Twelve (30%) patients in the high DOPBP group had an AE, in comparison with 7 (13%) patients in the intermediate DOPBP group and only 1 (3%) in the controlled DOPBP group. The likelihood of an AE increased in patients with a high DOPBP (adjusted hazard ratios [95% confidence interval], 16.4 [1.8-147.3]; P=0.012 versus controlled and 2.6 [0.93-7.4]; P=0.068 versus intermediate). Overall, a similar association was noted for the risk of intracranial hemorrhage (P=0.015) and progressive aortic insufficiency (P=0.078) but not for thromboembolic event (P=0.638). Patients with an AE had a higher DOPBP (90±10 mm Hg) in comparison with those without an AE (85±10 mm Hg; P=0.05). CONCLUSIONS: In a population at risk, higher DOPBP during continuous flow left ventricular assist device support was significantly associated with a composite of AEs.


Assuntos
Pressão Sanguínea , Insuficiência Cardíaca/terapia , Coração Auxiliar , Função Ventricular Esquerda , Adulto , Idoso , Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Distribuição de Qui-Quadrado , Intervalo Livre de Doença , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Coração Auxiliar/efeitos adversos , Humanos , Hemorragias Intracranianas/mortalidade , Hemorragias Intracranianas/fisiopatologia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , New York/epidemiologia , Prevalência , Modelos de Riscos Proporcionais , Desenho de Prótese , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Tromboembolia/mortalidade , Tromboembolia/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
12.
Case Rep Transplant ; 2014: 946961, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25431733

RESUMO

Increased hepatic iron load in extrahepatic organs of cirrhotic patients with and without hereditary hemochromatosis portends a poorer long term prognosis after liver transplant. Hepatic as well as nonhepatic iron overload is associated with increased infectious and postoperative complications, including cardiac dysfunction. In this case report, we describe a cirrhotic patient with alpha 1 antitrypsin deficiency and nonhereditary hemochromatosis (non-HFE) that developed cardiogenic shock requiring mechanical circulatory support for twenty days after liver transplant. Upon further investigation, she was found to have significant iron deposition in both the liver and heart biopsies. Her heart regained complete and sustained recovery following ten days of mechanical biventricular support. This case highlights the importance of preoperatively recognizing extrahepatic iron deposition in patients referred for liver transplantation irrespective of etiology of liver disease as this may prevent postoperative complications.

13.
Clin Med Insights Cardiol ; 8(Suppl 1): 87-92, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25861225

RESUMO

As we continue to care for an older and sicker end-stage heart failure population, it has become challenging to evaluate patients based on current risk scores that mainly focus on subjective symptoms and patient disability. For generations, geriatricians have sought to identify the body's underlying vulnerabilities that characterize frailty. More recently, cardiologists have begun to recognize this entity in their own practice. Several studies have suggested rates of frailty as high as 50% in patients with cardiovascular disease. However, despite recognizing frailty, it remains difficult to define. Like heart failure, frailty is a biologic syndrome that affects multiple organ systems. Measures of frailty are shown to strongly correlate with adverse outcomes in the health care system.

14.
Case Rep Cardiol ; 2013: 750794, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24829808

RESUMO

Diuretics, including furosemide, metolazone, and spironolactone, have historically been the mainstay of therapy for acute decompensated heart failure patients. The addition of an aquaretic-like vasopressin antagonist may enhance diuresis further. However, clinical experience with this quadruple combination is lacking in the acute setting. We present two hospitalized patients with acute decompensated heart failure due to massive fluid overload treated with a combination strategy of triple diuretics in conjunction with the aquaretic tolvaptan. The first patient lost 72.1 lbs. (32.7 kg) with an average urine output of 3.5 to 7.5 L/day over eight days on combined therapy with furosemide, metolazone, spironolactone, and tolvaptan. The second patient similarly achieved a weight loss of 28.2 lbs. (12.8 kg) over 4 days on the same treatment. Both patients maintained stable serum sodium, potassium, and creatinine over this period and remained out of the hospital for more than 30 days. Thus, patients hospitalized with acute decompensated heart failure due to volume overload can achieve euvolemia rapidly and without electrolytes disturbances using this regimen, while being under the close supervision of a team of cardiologists and nephrologists. Additionally, this therapy can potentially decrease the need for ultrafiltration and the length of hospital stay.

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