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BACKGROUND: Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients. OBJECTIVES: The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on outcomes in patients with HF. METHODS: Following GUIDE-HF (Hemodynamic-GUIDEd Management of Heart Failure Trial), with U.S. Food and Drug Administration input, PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial) was changed from a randomized to a single-arm, open label trial, conducted at 75 centers in the USA and Europe. Eligible patients had chronic HF with NYHA functional class III symptoms, irrespective of the ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The primary effectiveness endpoint at 6 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.43 events/patient, established from previous hemodynamic monitoring trials. Primary safety endpoints at 6 months were freedom from device- or system-related complications or pressure sensor failure. RESULTS: Between February 7, 2020, and March 31, 2023, 456 patients were successfully implanted in modified intent-to-treat cohort. The 6-month event rate was 0.15 (95% CI: 0.12-0.20) which was significantly lower than performance goal (0.15 vs 0.43; P < 0.0001). Freedom from device- or system-related complications was 99.2% and freedom from sensor failure was 99.8% through 6 months. CONCLUSIONS: Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the use of seated mPAP monitoring and extend the growing body of evidence that pulmonary artery pressure-guided management improves outcomes in heart failure. (Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial [PROACTIVE-HF]; NCT04089059).
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Mechanical ventilation for respiratory failure due to COVID-19 is associated with significant morbidity and mortality. Veno-venous extracorporeal membrane oxygenation (ECMO) is an attractive management option. This study sought to determine the effect of ECMO on hospital mortality and discharge condition in this population. We conducted a retrospective multicenter study to emulate a pragmatic targeted trial comparing ECMO to mechanical ventilation without ECMO for severe COVID-19. Data were gathered from a large hospital network database in the US. Adults admitted with COVID-19 were included if they were managed with ECMO or mechanical ventilation for severe hypoxemia and excluded if they had significant comorbidities or lacked functional independence on admission. The groups underwent coarsened exact matching on multiple clinical variables. The primary outcome was adjusted in-hospital mortality; secondary outcomes included ventilator days, intensive care days, and discharge destination. A total of 278 ECMO patients were matched to 2,054 comparison patients. Adjusted in-hospital mortality was significantly less in the ECMO group (38.8% vs. 60.1%, p < 0.001). Extracorporeal membrane oxygenation was associated with higher rates of liberation from mechanical ventilation, intensive care discharge, and favorable discharge destination. These findings support the use of ECMO for well-selected patients with severe acute respiratory failure due to COVID-19.
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COVID-19 , Oxigenação por Membrana Extracorpórea , Síndrome do Desconforto Respiratório , Insuficiência Respiratória , Adulto , Humanos , Estudos de Coortes , COVID-19/complicações , COVID-19/terapia , Oxigenação por Membrana Extracorpórea/efeitos adversos , Respiração Artificial , Estudos Retrospectivos , Síndrome do Desconforto Respiratório/etiologia , Síndrome do Desconforto Respiratório/terapia , Insuficiência Respiratória/etiologia , Insuficiência Respiratória/terapiaRESUMO
Background: Acute decompensated heart failure (HF) and cardiogenic shock (CS) frequently are refractory to conservative treatment and require mechanical circulatory support (MCS). We report our early clinical experience and evaluate patient outcomes with the newer generation surgical Impella 5.5. Methods: Seventy patients that underwent Impella 5.5 implantation between October 2019 and December 2021 at a single center were enrolled in this study. Pre-operative characteristics, peri-operative clinical course information, and post-operative outcomes were retrospectively collected. Results: Fifty-seven (81%) patients survived to discharge, and 51 (76%) patients survived at the time of the first 30 days post-discharge visit. Thirty-one patients (44%) received Impella support for a bridge to advanced surgical heart failure therapy (transplant or durable left ventricular assist device [LVAD]), 27 (39%) cases were used for a bridge to recovery/decision and 12 (17.1%) cases was used for planned perioperative support for high-risk cardiac surgery procedure. Conclusion: Our results suggest that Impella 5.5 provides favorable survival in the management of HF and CS, particularly used for a bridge to heart transplant or LVAD. Early extubation and mobilization with high flow circulatory support allowed effective tailoring of MCS approaches from peri-operative support for high-risk cardiac surgery, bridge to recovery, and to advanced surgical heart failure therapy.
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Acute respiratory distress syndrome (ARDS) in COVID-19 patients is associated with poor clinical outcomes and high mortality rates, despite the use of mechanical ventilation. Veno-Venous Extracorporeal membrane Oxygenation (VV-ECMO) in these patients is a viable salvage therapy. We describe clinical outcomes and survival rates in 52 COVID-19 patients with ARDS treated with early VV-ECMO at a large, high-volume center ECMO program. Outcomes included arterial blood gases, respiratory parameters, inflammatory markers, adverse events, and survival rates. Patients' mean age was 47.8 ± 12.1 years, 33% were female, and 75% were Hispanic. At the end of study period, 56% (n = 29) of the patients survived and were discharged and 44% (n = 23) of the patients expired. Survival rate was 75.0% (9 out of 12) in patients placed on ECMO prior to mechanical ventilation. Longer duration on mechanical ventilation prior to ECMO intervention was associated with a 31% (aOR = 1.31, 95% CI, 1.00-1.70) increased odds of mortality after adjusting for age, gender, BMI, number of comorbid conditions, and post-ECMO ventilator days. Early and effective ECMO intervention in critical ill COVID-19 patients might be a valuable strategy in critical care settings to increase their odds of survival.
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COVID-19 , Oxigenação por Membrana Extracorpórea , Síndrome do Desconforto Respiratório , Adulto , Oxigenação por Membrana Extracorpórea/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Síndrome do Desconforto Respiratório/diagnóstico , Síndrome do Desconforto Respiratório/terapia , SARS-CoV-2 , Ventiladores MecânicosRESUMO
The role of veno-venous extracorporeal membrane oxygenation therapy (V-V ECMO) in severe COVID-19 acute respiratory distress syndrome (ARDS) is still under debate and conclusive data from large cohorts are scarce. Furthermore, criteria for the selection of patients that benefit most from this highly invasive and resource-demanding therapy are yet to be defined. In this study, we assess survival in an international multicenter cohort of COVID-19 patients treated with V-V ECMO and evaluate the performance of several clinical scores to predict 30-day survival. METHODS: This is an investigator-initiated retrospective non-interventional international multicenter registry study (NCT04405973, first registered 28 May 2020). In 127 patients treated with V-V ECMO at 15 centers in Germany, Switzerland, Italy, Belgium, and the United States, we calculated the Sequential Organ Failure Assessment (SOFA) Score, Simplified Acute Physiology Score II (SAPS II), Acute Physiology And Chronic Health Evaluation II (APACHE II) Score, Respiratory Extracorporeal Membrane Oxygenation Survival Prediction (RESP) Score, Predicting Death for Severe ARDS on VV ECMO (PRESERVE) Score, and 30-day survival. RESULTS: In our study cohort which enrolled 127 patients, overall 30-day survival was 54%. Median SOFA, SAPS II, APACHE II, RESP, and PRESERVE were 9, 36, 17, 1, and 4, respectively. The prognostic accuracy for all these scores (area under the receiver operating characteristic-AUROC) ranged between 0.548 and 0.605. CONCLUSIONS: The use of scores for the prediction of mortality cannot be recommended for treatment decisions in severe COVID-19 ARDS undergoing V-V ECMO; nevertheless, scoring results below or above a specific cut-off value may be considered as an additional tool in the evaluation of prognosis. Survival rates in this cohort of COVID-19 patients treated with VV ECMO were slightly lower than those reported in non-COVID-19 ARDS patients treated with V-V ECMO.
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OBJECTIVES: Ghrelin is an anabolic hormone that is elevated in heart failure (HF), with resistance to its anabolic effects. This resolves after heart transplantation (HTx). Ghrelin exists in acylated and des-acyl forms, with the acylated form being primarily responsible for endocrine actions. We tested the hypothesis that ghrelin derangements in HF are due to inadequate acylation and that this resolves post transplantation. DESIGN: Plasma levels of des-acyl and acylated ghrelin and acylated/total ratios were assessed in HF (n = 20), post-HTx (n = 35), and healthy controls (n = 4), and correlated with each other and with clinical parameters. RESULTS: Median (interquartile range) of des-acyl ghrelin level, was 167 (121-195) pg/ml in HF versus 149 (130-223) pg/ml in post-HTx, p = NS. Acylated ghrelin level was 76 (51-99) pg/ml versus 13 (0-30) pg/ml, p < 0.001. Acylated/total ratios were 0.33 (0.20-0.47) versus 0.08 (0-0.13), p < 0.001. The correlation between acylated and total ghrelin levels was greater in HF than that in HTx. Acyl ghrelin correlated inversely with body mass index in HF, but not in HTx. CONCLUSION: Acylated ghrelin and the acylated/total ratio were dramatically higher in HF compared with those in HTx. Acylation rather than secretion of ghrelin is upregulated in HF and the resistance to ghrelin's anabolic and appetite-stimulating effects is not at the level of acylation, but downstream at the ghrelin-receptor level.
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Grelina , Insuficiência Cardíaca , Transplante de Coração/métodos , Acilação , Idoso , Índice de Massa Corporal , Feminino , Grelina/sangue , Grelina/metabolismo , Insuficiência Cardíaca/metabolismo , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Regulação para CimaRESUMO
A 77-year-old man presented with Evans syndrome (ES), hard palate thickening, gastrointestinal (GI) hemorrhage, acute myocardial infarction (AMI) and pleural and pericardial effusions. The patient responded well to emergent ES treatment with high-dose steroids and intravenous immunoglobulin. Investigation revealed lymphoplasmacytic lymphoma (LPL) as well as amyloidosis in the hard palate, lymph nodes, and pericardium. Considering his age, non-myelosuppressive agents were administered, with the exception of dose-reduced cyclophosphamide. The patient developed neutropenic fever, atrial fibrillation and subsequently died. This report describes the first LPL patient with ES. LPL is generally an indolent disease. However, as in our patient, it can be life threatening because of its complications. ES contributed to his GI hemorrhage, severe anemia, and thus AMI at the time of presentation. Probable cardiac amyloidosis played a role in the latter phase (i.e. cardiac arrhythmia and hypotension during sepsis). Although rare, the presence of ES and amyloidosis should be investigated diligently in elderly LPL patients. Instead of aggressive myelosuppressive chemotherapy agents, targeted therapies might be considered in these fragile patients.
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Amiloidose/complicações , Anemia Hemolítica Autoimune/complicações , Macroglobulinemia de Waldenstrom/complicações , Idoso , Amiloidose/tratamento farmacológico , Anemia Hemolítica Autoimune/tratamento farmacológico , Ciclofosfamida/uso terapêutico , Evolução Fatal , Humanos , Imunoglobulinas Intravenosas/uso terapêutico , Masculino , Palato Duro/patologia , Macroglobulinemia de Waldenstrom/tratamento farmacológicoRESUMO
Bacterial endocarditis is a complex disease that is associated with significant morbidity and mortality. Staphylococcus aureus is an organism commonly responsible for acute bacterial infective endocarditis. Patients many times develop an acute fulminant infection resulting in multiple complications, even in the face of adequate therapy. We report an unusual case of S. aureus acute bacterial infective endocarditis in an immunocompromised patient resulting in multiple cardiac complications, including bacterial pericarditis with effusion, mycotic aneurysm of one of the coronary arteries, a valvular vegetation leading to an aneurysmal dilatation at the mitral-aortic junction (intervalvular fibrosa), and a fistulous communication between the left ventricle and left atrium. We present detailed echocardiographic images of these anomalies, which were subsequently confirmed intraoperatively. The patient underwent open heart surgery with pericardial patch repair of the mitral-aortic intervalvular fibrosa aneurysm and fistula.
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Aneurisma Coronário/diagnóstico por imagem , Ecocardiografia Transesofagiana , Endocardite Bacteriana/complicações , Fístula/diagnóstico por imagem , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/etiologia , Infecções Estafilocócicas/complicações , Procedimentos Cirúrgicos Cardíacos/métodos , Terapia Combinada , Aneurisma Coronário/etiologia , Aneurisma Coronário/cirurgia , Endocardite Bacteriana/diagnóstico , Fístula/etiologia , Fístula/cirurgia , Seguimentos , Átrios do Coração , Ventrículos do Coração , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/cirurgia , Medição de Risco , Índice de Gravidade de Doença , Infecções Estafilocócicas/diagnóstico , Infecções Estafilocócicas/tratamento farmacológico , Resultado do TratamentoRESUMO
BACKGROUND: Substantial weight gain frequently occurs after cardiac transplant (CT) and increases the risk of secondary disease. It is unclear, however, if weight gain after CT is related to glucocorticoid immunosuppressive therapy. METHODS: A retrospective chart review was performed on the first 200 patients undergoing CT and the first 200 patients undergoing renal transplant (RT) at Columbia Presbyterian Medical Center, starting in January 2000. Patients who survived 1 year and had their weight recorded at transplant were included in the study. Rejection episodes and prednisone treatment was recorded for CT patients. Regression analysis was used to determine predictors of weight gain. RESULTS: A total of 158 CT patients and 128 RT patients were included in the data analysis. The weight of CT patients at time of transplant was (mean +/- SD) 76.3 +/- 14.6 kg and increased by 10.3 +/- 10.6 kg (p < 0.05) by 1-year post-transplant. Pre-transplant weight of the RT patients was 74.1 +/- 20.1 kg; by 1-year post-RT, weight increased by 3.5 +/- 8.6 kg (p < 0.05). The weight gain in CT patients was significantly greater than in the RT patients (p < 0.001). Post-transplant weight change in multiple regression models was related to age, gender (male) and transplant type (cardiac), but not to prednisone dose or pre-transplant weight. CONCLUSIONS: CT results in substantial post-surgical weight gain, which is greater than that observed for RT. Overweight and obesity development was not related to prednisone dose alone. This observation may have important clinical and research implications.
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Transplante de Coração , Complicações Pós-Operatórias , Aumento de Peso , Adulto , Fatores Etários , Idoso , Feminino , Humanos , Imunossupressores/efeitos adversos , Imunossupressores/uso terapêutico , Masculino , Pessoa de Meia-Idade , Prednisona/efeitos adversos , Prednisona/uso terapêutico , Estudos Retrospectivos , Fatores de Risco , Fatores SexuaisRESUMO
Sudden cardiac death (SCD) is one of the leading causes of mortality in developing countries. To prevent SCD, it is crucial to have effective tools for identifying patients at risk, given that there are now effective devices and medications that can prevent SCD. Two noninvasive electrocardiographic tools have been approved by the Food and Drug Administration and are being used clinically for identifying patients at risk for SCD: the signal-averaged electrocardiogram (SAECG) and T-wave alternans (TWA). This article reviews each of these approaches and includes a discussion of the mechanisms and a summary of the clinical studies published to date.