RESUMO
BACKGROUND: Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease. METHODS: We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed. RESULTS: A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days. CONCLUSIONS: Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.).
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Idoso , Feminino , Humanos , Masculino , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Insuficiência Cardíaca/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento , Insuficiência da Valva Tricúspide/cirurgiaRESUMO
Microvascular dysfunction (MVD) is considered a form of cardiac allograft vasculopathy (CAV), independently associated with poor prognosis after heart transplantation (HTX). It is unknown whether traditional risk factors for CAV are also applicable to MVD. We retrospectively analyzed factors associated with MVD in 94 HTX recipients who completed a PET scan after a normal baseline left heart catheterization excluding epicardial CAV. MVD was defined by abnormal PET blood flow. The mean age was 52 ± 14 and MVD was found in 49 patients (53%). No donor risk factors were significantly associated with recipient MVD. Recipients risk factors for MVD included-diabetes mellitus (51% vs. 27%, p = 0.016) and hypertension (78% vs. 49%, p = 0.004) in patients with and without MVD, respectively. In a multivariate model, recipient hypertension and diabetes were the only significant determinants of MVD development (OR = 2.63, 95% CI [1.69-36.98], p = 0.009 and OR 2.1, 95% CI [1.10-15.38], p = 0.035, respectively). In conclusion, MVD was more associated with metabolic risk determinants rather than traditional CAV risk factors.
Assuntos
Transplante de Coração , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Complicações Pós-Operatórias , Humanos , Feminino , Masculino , Transplante de Coração/efeitos adversos , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Prognóstico , Seguimentos , Adulto , Aloenxertos , Doença da Artéria Coronariana/etiologia , Doença da Artéria Coronariana/diagnóstico por imagem , Rejeição de Enxerto/etiologia , Rejeição de Enxerto/diagnóstico por imagem , Doenças Vasculares/etiologia , Doenças Vasculares/diagnóstico por imagem , Microcirculação , TransplantadosRESUMO
INTRODUCTION: Donation after circulatory death (DCD) donors are becoming an important source of organs for heart-transplantation (HT), but there are limited data regarding their use in multiorgan-HT. METHODS: Between January 2020 and June 2023, we identified 87 adult multiorgan-HTs performed using DCD-donors [77 heart-kidney, 6 heart-lung, 4 heart-liver] and 1494 multiorgan-HTs using donation after brain death (DBD) donors (1141 heart-kidney, 165 heart-lung, 188 heart-liver) in UNOS. For heart-kidney transplantations (the most common multiorgan-HT combination from DCD-donors), we also compared donor/recipient characteristics, and early outcomes, including 6-month mortality using Kaplan-Meier (KM) and Cox hazards-ratio (Cox-HR). RESULTS: Use of DCD-donors for multiorgan-HTs in the United States increased from 1% in January to June 2020 to 12% in January-June 2023 (p < 0.001); but there was a wide variation across UNOS regions and center volumes. Compared to recipients of DBD heart-kidney transplantations, recipients of DCD heart-kidney transplantations were less likely to be of UNOS Status 1/2 at transplant (35.06% vs. 69.59%) and had lower inotrope use (22.08% vs. 43.30%), lower IABP use (2.60% vs. 26.29%), but higher durable CF-LVAD use (19.48% vs. 12.97%), all p < 0.01. Compared to DBD-donors, DCD-donors used for heart-kidney transplantations were younger [28(22-34) vs. 32(25-39) years, p = 0.004]. Recipients of heart-kidney transplantations from DCD-donors and DBD-donors had similar 6-month survival using both KM analysis, and unadjusted and adjusted Cox-HR models, including in propensity matched cohorts. Rates of PGF and in-hospital outcomes were also similar. CONCLUSIONS: Use of DCD-donors for multiorgan-HTs has increased rapidly in the United States and early outcomes of DCD heart-kidney transplantations are promising.
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Sobrevivência de Enxerto , Transplante de Coração , Doadores de Tecidos , Obtenção de Tecidos e Órgãos , Humanos , Feminino , Masculino , Obtenção de Tecidos e Órgãos/estatística & dados numéricos , Transplante de Coração/mortalidade , Pessoa de Meia-Idade , Doadores de Tecidos/provisão & distribuição , Estados Unidos , Seguimentos , Adulto , Prognóstico , Taxa de Sobrevida , Estudos Retrospectivos , Morte EncefálicaRESUMO
AIMS: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone. METHODS AND RESULTS: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03). CONCLUSION: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.
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Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Masculino , Humanos , Feminino , Valva Tricúspide/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Resultado do Tratamento , Sistema de Registros , Insuficiência Cardíaca/complicaçõesRESUMO
BACKGROUND: Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection fraction. The AccuCinch Transcatheter Left Ventricular Restoration system consists of a series of anchors connected by a cable implanted along the LV base that is cinched to the basal free wall radius. We evaluated the echocardiographic and clinical outcomes following transcatheter left ventricular restoration. METHODS AND RESULTS: We analyzed 51 heart failure patients with a left ventricular ejection fraction between 20% and 40%, with no more than 2+ mitral regurgitation treated with optimal medical therapy, who subsequently underwent transcatheter left ventricular restoration. Serial echocardiograms, Kansas City Cardiomyopathy Questionnaire scores, and 6-minute walk test distances were measured at baseline through 12 months. Primary analysis end point was change in end-diastolic volume at 12 months compared with baseline. Patients (nâ¯=â¯51) were predominantly male (86%) with a mean age of 56.3 ± 13.1 years. Fluoroscopy showed LV free wall radius decreased by a median of 9.2 mm amounting to a 29.6% decrease in the free wall arc length. At 12 months, the LV end-diastolic volume decreased by 33.6 ± 34.8 mL (P < .01), with comparable decreases in the LV end-systolic volume. These decreases were associated with significant improvements in the overall Kansas City Cardiomyopathy Questionnaire score (16.4 ± 18.7 points; P < .01) and 6-minute hall walk test distance (45.9 ± 83.9 m; P < .01). There were no periprocedural deaths; through the 1-year follow-up, 1 patient died (day 280) and 1 patient received a left ventricular assist device (day 13). CONCLUSIONS: In patients with heart failure with reduced ejection fraction without significant mitral regurgitation receiving optimal medical therapy, the AccuCinch System resulted in decreases of LV volume, as well as improved quality of life and exercise endurance. A randomized trial is ongoing (NCT04331769).
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Cardiomiopatias , Insuficiência Cardíaca , Insuficiência da Valva Mitral , Disfunção Ventricular Esquerda , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda , Remodelação VentricularRESUMO
In heart failure (HF) patients, the pathophysiological mechanisms of severe exercise intolerance and impaired exercise capacity are related to both central and peripheral abnormalities. The central abnormalities in HF patients include impaired cardiac function and chronotropic incompetence (CI). Indeed, CI, the inability to adequately increase heart rate (HR) from rest to exercise often exhibited by HF patients, is related to activation of the sympathetic nervous system (SNS) yielding a rise in circulating norepinephrine (NE). CI may result from downregulation of ß-adrenergic receptors, ß-blocker usage, high baseline HR, or due to a combination of factors. This paper discusses the role of elevated NE in altering chronotropic responses in HF patients and consequently resulting in impaired exercise capacity. We suggest that future research should focus on the potential treatment of CI with rate-adaptive pacing, using a sensor to measure physical activity, without inducing deleterious hormonal activation of the sympathetic system.
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Insuficiência Cardíaca , Norepinefrina , Humanos , Tolerância ao Exercício , Antagonistas Adrenérgicos beta , Exercício Físico/fisiologia , Frequência Cardíaca/fisiologia , Teste de EsforçoRESUMO
The use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in adults for refractory cardiogenic shock has risen exponentially during the prior decade. Although VA-ECMO provides cardiopulmonary support, it can alter left ventricular (LV) loading conditions leading to LV distension, which makes the lungs susceptible to congestion and promotes intracardiac thrombosis. These conditions can be alleviated by pharmacologic and mechanical unloading, but gaps in knowledge remain on optimal timing and methods of this approach. This review provides an overview of the epidemiology of VA-ECMO, describes pathophysiology and methods for monitoring and reducing LV loading and summarizes contemporary studies examining the association between LV unloading and adverse events. We offer a simple protocol for implementing LV unloading during VA-ECMO to provide pulmonary protection and improve outcomes.
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Oxigenação por Membrana Extracorpórea , Trombose , Adulto , Humanos , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/métodos , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia , Pulmão , Ventrículos do Coração/diagnóstico por imagemRESUMO
PURPOSE: Hemorrhagic stroke (HS) is a devastating complication during extracorporeal membrane oxygenation (ECMO) but markers of risk stratification during COVID-19 are unknown. Lactate dehydrogenase (LDH) is a readily available biomarker of cell injury and permeability. We sought to determine whether an elevated LDH before ECMO placement is related to the occurrence of HS during ECMO for COVID-19. METHODS: Adult patients with COVID-19 requiring ECMO between March 2020 and February 2022 were included. LDH values prior to ECMO placement were captured. Patients were categorized into high (> 750 U/L) or low (≤ 750 U/L) LDH groups. Multivariable regression modeling was used to determine the association between LDH and HS during ECMO. RESULTS: There were 520 patients that underwent ECMO placement in 17 centers and 384 had an available LDH. Of whom, 122 (32%) had a high LDH. The overall incidence of HS was 10.9%, and patients with high LDH had a higher incidence of HS than those with low LDH level (17% vs 8%, p = 0.007). At 100 days, the probability of a HS was 40% in the high LDH group and 23% in those with a low LDH, p = 0.002. After adjustment for clinical covariates, high LDH remained associated with subsequent HS (aHR: 2.64, 95% CI 1.39-4.92). Findings were similar when restricting to patients supported by venovenous ECMO only. CONCLUSION: Elevated LDH prior to ECMO cannulation is associated with a higher incidence of HS during device support. LDH can risk stratify cases for impending cerebral bleeding during ECMO.
Assuntos
COVID-19 , Oxigenação por Membrana Extracorpórea , Acidente Vascular Cerebral Hemorrágico , Adulto , Humanos , COVID-19/terapia , Oxigenação por Membrana Extracorpórea/efeitos adversos , Estudos Retrospectivos , Lactato DesidrogenasesRESUMO
IMPORTANCE: Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety. OBJECTIVE: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding. DESIGN, SETTING, and PARTICIPANTS: This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months. Intervention: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen. MAIN OUTCOMES AND MEASURES: The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events. RESULTS: Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics. CONCLUSIONS AND RELEVANCE: In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04069156.
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Insuficiência Cardíaca , Coração Auxiliar , Acidente Vascular Cerebral , Tromboembolia , Masculino , Humanos , Feminino , Aspirina/efeitos adversos , Coração Auxiliar/efeitos adversos , Fibrinolíticos/efeitos adversos , Método Duplo-Cego , Insuficiência Cardíaca/fisiopatologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/tratamento farmacológico , Inibidores da Agregação Plaquetária/efeitos adversos , Hemorragia/etiologia , Tromboembolia/etiologia , Tromboembolia/prevenção & controleRESUMO
Regulatory oversight for heart transplant programs is currently under review by the United Network for Organ Sharing (UNOS). There is concern whether 1-year patient and graft survival truly represent heart transplant center performance. Thus, a forum was organized by the Thoracic and Critical Care Community of Practice (TCC COP) of the American Society of Transplantation (AST) for the heart transplant community to voice their opinions on matters involving program performance monitoring by UNOS. A TCC COP work group was formed to review outcome metrics for adult heart transplantation and culminated in a virtual community forum (72 participants representing 61 heart transplant programs) on November 12-13, 2020. One-year posttransplant survival is still considered an appropriate and important measure to assess program performance. Waitlist mortality and offer acceptance rate as pretransplant metrics could also be useful measures of program performance, recognizing that outside factors may influence these metrics. In depth discussion of these metrics and other issues including auditing thresholds, innovations to reduce risk-averse behavior and personally designed program scorecards are included in this meeting proceedings.
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Benchmarking , Transplante de Coração , Adulto , Sobrevivência de Enxerto , Humanos , Estados Unidos , Listas de EsperaRESUMO
BACKGROUND: Cardiac intensive care units (CICUs) serve medically complex patients with multiorgan dysfunction. Whether a CICU that is staffed full time by heart failure (HF) specialists is associated with decreased mortality is unclear. METHODS AND RESULTS: A retrospective review of consecutive CICU admissions from January 1, 2012, to December 31, 2016, was performed. In January 2014, the CICU changed from an open unit staffed by any cardiologist to a closed unit managed by HF specialists. Patients' baseline characteristics were determined, and a multivariate regression analysis was performed to ascertain mortality rates in the CICU. Baseline severity of illness was higher in the closed/HF specialist CICU model (P< 0.001). Death occurred in 101 of 1185 patients admitted to the CICU (8.5%) in the open-unit model and in 139 of 2163 patients (6.4%) admitted to the closed/HF specialist model (absolute risk reduction 2.1%, 95% confidence interval [CI] 0.1-4.0%; Pâ¯=â¯0.01). The transition from an open to a closed/HF specialist model was associated with a lower overall CICU mortality rate (odds ratio [OR] 0.63; 95% CI 0.43-0.93). Prespecified interaction with a mechanical circulatory support device and unit model showed that treatment with such a device was associated with lower mortality rates in the closed/HF specialist model of a CICU (OR 0.6; 95% CI 0.18-0.78; P for interaction <0.01). CONCLUSION: Transition to a closed unit model staffed by a dedicated HF specialist is associated with lower CICU mortality rates.
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Unidades de Cuidados Coronarianos , Insuficiência Cardíaca , Insuficiência Cardíaca/terapia , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva , Estudos Retrospectivos , Recursos HumanosRESUMO
In a multicenter, retrospective analysis of 435 patients with refractory COVID-19 placed on V-V ECMO, cannulation by a single, dual-lumen catheter with directed outflow to the pulmonary artery was associated with lower inpatient mortality.
Assuntos
COVID-19 , Oxigenação por Membrana Extracorpórea , COVID-19/terapia , Cateterismo/métodos , Catéteres , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/métodos , Humanos , Estudos RetrospectivosRESUMO
OBJECTIVES: Cardiac injury has been reported in up to 20%-to-30% of patients with COVID-19, and severe disease can lead to cardiopulmonary failure. The role of mechanical circulatory support in these patients remains undetermined. The authors here aimed to determine the characteristics and outcomes of patients with COVID-19 requiring venoarterial extracorporeal membrane oxygenation (VA ECMO) or veno-arterial-venous (VAV) ECMO support. DESIGN AND SETTING: A multicenter, retrospective case series. PARTICIPANTS: The cohort consisted of adult patients (18 years of age and older) with confirmed COVID-19 requiring VA ECMO or VAV ECMO support in the period from March 1, 2020, to April 30, 2021. Outcomes were recorded until July 31, 2021. MEASUREMENTS AND MAIN RESULTS: To show factors related to death during hospitalization, patients were grouped as survivors and nonsurvivors. Kaplan-Meier analysis was used to estimate 90-day in-hospital mortality. Overall, 37 patients from 12 centers comprised the study cohort. The median patient age was 44 years old (interquartile range [IQR], 35-52), and 12 (32%) were female patients. The duration of ECMO support ranged from 2-to-132 days. At the end of the follow-up period, 13 patients (35%) were discharged or transferred alive, and 24 patients (65%) died during the hospitalization. The cumulative in-hospital mortality at 90 days was 64% (95% confidence interval: 47-81). During the time from intubation to VA ECMO or VAV ECMO initiation (1 day [IQR 0-7.5] v 6 days [IQR 2.5-14], p = 0.0383), body mass index (32 [IQR 26-36] v 37 [IQR 33-40], p = 0.009), and baseline C-reactive protein (7.15 v 38.9 mg/dL, p = 0.009) were higher in those who expired. CONCLUSION: Only one-third of the patients with COVID-19 requiring VA ECMO or VAV ECMO survived to discharge. Close monitoring of at-risk patients with early initiation of ECMO with circulatory support may further improve outcomes.
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COVID-19 , Oxigenação por Membrana Extracorpórea , Adolescente , Adulto , COVID-19/terapia , Feminino , Mortalidade Hospitalar , Humanos , Estimativa de Kaplan-Meier , Masculino , Estudos RetrospectivosRESUMO
Advanced imaging is often used to supplement clinical information in guiding management for patients with heart failure. 3 dimensional (3D) imaging datasets allow for a better understanding of the relevant cardiac spatial anatomic relationships. 3D printing technology takes this one step further and allows for the creation of patient-specific physical cardiac models. In this review, we summarize some of the recent innovative applications of this technique to patients with heart failure from different etiologies, to provide more patient-directed care.
Assuntos
Insuficiência Cardíaca , Impressão Tridimensional , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/terapia , HumanosRESUMO
The optimal duration and frequency of routine surveillance endomyocardial biopsy (EMB) have been questioned in the current era of heart transplantation (HT), where the advances in immunosuppression and donor selection strategies have led to a decline in acute allograft rejection. We investigated the utility of routine EMB beyond 6 months post-HT. A single-center retrospective review was performed on 2963 EMBs from 220 HT recipients over 10 years. Each EMB was categorized into protocol or symptom-triggered biopsy and reviewed for rejection. Heart transplant recipients with ≥2 known risk factors for rejection were designated as an elevated risk group. The majority of rejections occurred within 3 months following HT. The yield of routine protocol EMBs was significantly lower than symptom-triggered EMBs, not only during the first 6 months post-HT (1.6% vs. 33.3%, P < .0001), but more so during the 6-12 months (0.1% vs 83.0%, P < .0001). A similar pattern was observed in heart transplant recipients at both elevated and standard risk for rejection. In conclusion, EMB was found to be a low-yield screening modality for rejection beyond 6 months post-HT.
Assuntos
Rejeição de Enxerto , Transplante de Coração , Biópsia , Rejeição de Enxerto/etiologia , Miocárdio , Estudos RetrospectivosRESUMO
BACKGROUND: In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure. METHODS: In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points. RESULTS: Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02). CONCLUSIONS: In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).
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Insuficiência Cardíaca/terapia , Coração Auxiliar , Desenho de Prótese , Adulto , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Coração Auxiliar/efeitos adversos , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Reoperação/estatística & dados numéricos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Trombose/etiologia , Resultado do Tratamento , Teste de CaminhadaRESUMO
BACKGROUND: The safety and effectiveness of oral anticoagulation (OAC) after an ischemic stroke in older patients with heart failure (HF) without atrial fibrillation remains uncertain. METHODS: Utilizing Get With The Guidelines Stroke national clinical registry data linked to Medicare claims from 2009-2014, we assessed the outcomes of eligible patients with a history of HF who were initiated on OAC during a hospitalization for an acute ischemic stroke. The cumulative incidences of adverse events were calculated using Kaplan-Meier curves and adjusted Cox proportional hazard ratios were compared between patients discharged on or off OAC. RESULTS: A total of 8,261 patients from 1,370 sites were discharged alive after an acute ischemic stroke and met eligibility criteria. Of those, 747 (9.0%) were initiated on OAC. Patients on OAC were younger (77.2±8.0 vs. 80.5±8.9 years, p<0.01). After adjustment for clinical covariates, the likelihood of 1 year mortality was higher in those on OAC (aHR: 1.22, 95% CI 1.05-1.41, p<0.01), while no significant differences were noted for ICH (aHR: 1.34, 95% CI 0.69-2.59, p=0.38) and recurrent ischemic stroke (aHR: 0.78, 95% CI 0.54-1.15, p = 0.21). The likelihood of all-cause bleeding (aHR: 1.59, 95% CI 1.29-1.96, p<0.01) and all-cause re-hospitalization (aHR: 1.14, 95% CI 1.02-1.27, p = 0.02) was higher for those on OAC. CONCLUSION: Initiation of OAC after an ischemic stroke in older patients with HF in the absence of atrial fibrillation is associated with death, bleeding and re-hospitalization without an associated reduction in recurrent ischemic stroke. If validated, these findings raise caution for prescribing OAC to such patients.
Assuntos
Fibrilação Atrial , Isquemia Encefálica , Insuficiência Cardíaca , AVC Isquêmico , Acidente Vascular Cerebral , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/epidemiologia , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/epidemiologia , Humanos , Medicare , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Estados Unidos/epidemiologiaRESUMO
The relationship between severity of obesity and outcomes in heart failure (HF) has long been under debate. We studied index HF admissions from the 2013-14 National Readmission Database. Admissions were separated into three weight-based categories: non-obese (Non-Ob), obese (Ob), and morbidly obese (Morbid-Ob) to analyze hospital mortality and readmission at 30 days and 6 months. We investigated etiologies and predictors of 30-day readmission among these weight categories. We studied a total of 578,213 patients of whom 3.0% died during index hospitalization (Non-Ob 3.3% vs. Ob 1.9% vs. Morbid-Ob 1.9%; p < 0.01). Non-Ob comprised 79.5%, Ob 9.9%, and Morbid-Ob 10.6% of patients. Morbid-Ob patients were the youngest among age categories and more likely to be female. In-hospital mortality during readmission at 30 days and 6 months was significantly lower among Morbid-Ob and Ob compared with Non-Ob patients (all p < 0.01). Thirty-day readmission among Morbid-Ob was lower than Non-Ob and higher than Ob patients (19.6% vs. 20.5% vs. 18.6%, respectively; p < 0.01). Morbid-Ob patients were less likely to be readmitted for cardiovascular etiologies compared with both Ob and Non-Ob (45.0% vs. 50.3% vs. 50.6%; p < 0.01). Multivariable regression analysis revealed that Ob (adjusted odds ratio 0.84, 95% confidence intervals 0.82-0.86) and Morbid-Ob (aOR 0.83, 95% CI 0.81-0.85) were independently associated with lower 30-day readmission. Readmission at 6 months was highest among Morbid-Ob followed by Non-Ob and Ob (51.1% vs. 50.2% vs. 49.1%, p < 0.01). Morbid-Ob and Ob patients experience lower in-hospital mortality during index HF admission and during readmission with 30 days or 6 months compared with Non-Ob. Morbid-Ob patients experience greater readmission at 6 months despite the lower rate at 30 days post discharge. Morbid-Ob patients are most likely to be readmitted for non-cardiovascular causes.
Assuntos
Insuficiência Cardíaca , Obesidade Mórbida , Assistência ao Convalescente , Feminino , Insuficiência Cardíaca/epidemiologia , Hospitalização , Humanos , Masculino , Obesidade Mórbida/complicações , Obesidade Mórbida/epidemiologia , Alta do Paciente , Readmissão do Paciente , Estudos Retrospectivos , Fatores de RiscoRESUMO
BACKGROUND: The use of the HeartMate 3 (HM3) left ventricular assist device (LVAD) is expanding. Despite being associated with lower rates of adverse events and increased survival, outflow graft obstruction (OGO) has been reported in patients with HM3. The incidence and best management of this serious complication remain unclear. METHODS: We describe six cases of HM3 OGO occurring in five patients in our institutional HM3 cohort. Four cases underwent computed tomography angiography and in two percutaneous angiography was directly performed to confirm the diagnosis. In four cases, percutaneous repair of the OG was performed using common interventional cardiology (IC) techniques. RESULTS: Our institutional incidence of OGO was 7% (event rate of 0.05 per patient year); much higher than the previously reported incidence of 1.6%. All cases occurred in the bend relief covered segment. Only two patients had apparent OG twisting, and in two, OGO occurred despite placement of an anti-twist clip at the time of implant. External compression seems to play a role in most cases. Balloon "graftoplasty" and stent deployment via the femoral artery alleviated the obstruction and normalized LVAD flow in all patients who underwent percutaneous repair. The use of self-expanding stents allowed for downsizing of the procedural access site to 10 Fr. No serious procedure-related complications occurred. CONCLUSION: OGO is common in HM3 patients, external compression due to biomaterial accumulated surrounding the OG is a common etiology. Percutaneous repair using standard IC techniques is safe and feasible in cases of compression with or without partial twisting.
Assuntos
Insuficiência Cardíaca , Coração Auxiliar , Coração Auxiliar/efeitos adversos , Humanos , Stents , Resultado do TratamentoRESUMO
The clinical spectrum of COVID-19 in heart transplant recipients has not been fully defined, because asymptomatic and sub-clinical cases are difficult to capture. Seroprevalence surveys are an important tool to identify not just cases that have come to clinical attention, but all previously infected recipients. We performed a seroprevalence survey of the adult heart transplant program at a large New York City Hospital System. A total of 232 (87% of recipients being followed) subjects were tested, of whom 37 (15.9%) were found to be previously infected. This is comparable to the overall rate of prior infection in the NYC metro area. Disease course tended to be more severe than in the general population; however, this was at least partially driven by traditional risk factors of age and comorbidities. Lastly, 9 of 10 recipients who were initially found to be PCR positive subsequently tested positive for antibodies, confirming the ability of this population to mount a humoral response. In conclusion, prevalence of COVID-19 in heart transplant recipients on immunosuppression was comparable to that in the general population of NYC, and 90% of those with an initially positive viral swab developed antibodies. In those who are infected, disease course tends to be more severe.