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BACKGROUND: Recent studies suggest the transplantation of Hepatitis C (HCV) hearts from viremic donors is associated with comparable 1 year survival to nonviremic donors. Though HCV viremia is a known risk factor for accelerated atherosclerosis, data on cardiac allograft vasculopathy (CAV) outcomes are limited. We compared the incidence of CAV in heart transplant recipients from HCV viremic donors (nucleic acid amplification test positive; NAT+) compared to non-HCV infected donors (NAT-). METHODS: We retrospectively reviewed annual coronary angiograms with intravascular ultrasound from April 2017 to August 2020 at two large cardiac transplant centers. CAV was graded according to ISHLT guidelines. Maximal intimal thickness (MIT) ≥ 0.5 mm was considered significant for subclinical disease. RESULTS: Among 270 heart transplant recipients (mean age 54; 77% male), 62 patients were transplanted from NAT+ donors. CAV ≥ grade 1 was present in 8.8% of the NAT+ versus 16.8% of the NAT- group at 1 year, 20% versus 28.8% at 2 years, and 33.3% versus 41.5% at 3 years. After adjusting for donor age, donor smoking history, recipient BMI, recipient, hypertension, and recipient diabetes, NAT+ status did not confer increased risk of CAV (HR.80; 95% CI.45-1.40, p = 0.43) or subclinical IVUS disease (HR.87; 95% CI.58-1.30, p = 0.49). Additionally, there was no difference in the presence of rapidly progressive lesions on IVUS. CONCLUSION: Our data show that NAT+ donors conferred no increased risk for early CAV or subclinical IVUS disease following transplantation in a cohort of heart transplant patients who were treated for HCV, suggesting the short-term safety of this strategy to maximize the pool of available donor hearts.
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Transplante de Coração , Hepatite C , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Doadores de Tecidos , Estudos Retrospectivos , Transplante de Coração/efeitos adversos , Viremia/epidemiologia , Viremia/etiologia , Seguimentos , Hepatite C/etiologia , Hepacivirus , Aloenxertos , TransplantadosRESUMO
BACKGROUND: Danon disease (DD) is a rare X-linked dominant cardioskeletal myopathy caused by mutations in the lysosome-associated membrane protein-2 (LAMP-2) gene that is usually lethal without cardiac transplantation. The purpose of this study was to characterize post-transplant outcomes in a large cohort of patients with DD who underwent cardiac transplantation. METHODS: The clinical phenotype and outcome data of patients with DD who underwent cardiac transplantation (nâ¯=â¯38; 19 males and 19 females) were obtained from 8 centers. Study outcomes included graft survival, defined as death or retransplantation, and episodes of acute cellular and antibody-mediated rejection and cardiac allograft vasculopathy at 1 year. RESULTS: Median follow-up time after transplantation for the entire cohort was 4.4 years (IQR: 1.5-12.8 years). The median age at transplant for the cohort was 20.2 years (15.8-27.9 years), with no difference in age between sexes. Median pretransplant left-ventricular ejection fraction for the entire cohort was 30% (range 11%-84%). Males had higher pretransplant aspartate aminotransferase, alanine aminotransferase and creatine phosphokinase levels than females (P < 0.001). There were 2 deaths in the entire cohort and 2 retransplants. There was no difference in actuarial graft survival between males and females (Pâ¯=â¯0.8965); the estimated graft survival was 87.1% (95%CI: 63.6%-95.9%) at 5 years. One episode (2.7%) of antibody-mediated rejection, grade 2, and 7 episodes (19%) of acute cellular rejection, grade 2 or 3, were reported in patients who survived to discharge (6 females and 1 male; Pâ¯=â¯0.172). CONCLUSIONS: Heart transplantation outcomes are acceptable in DD with high probabilities of 5-year graft survival for males and females suggesting that cardiac transplantation is an effective treatment option for DD patients.
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Doença de Depósito de Glicogênio Tipo IIb , Insuficiência Cardíaca , Transplante de Coração , Feminino , Doença de Depósito de Glicogênio Tipo IIb/diagnóstico , Doença de Depósito de Glicogênio Tipo IIb/genética , Doença de Depósito de Glicogênio Tipo IIb/cirurgia , Rejeição de Enxerto/epidemiologia , Humanos , Masculino , Estudos Retrospectivos , Volume Sistólico , Função Ventricular EsquerdaAssuntos
Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Miocardite , SARS-CoV-2/metabolismo , Vacinação/efeitos adversos , Vacina de mRNA-1273 contra 2019-nCoV , Adulto , Vacina BNT162 , COVID-19/sangue , Vacinas contra COVID-19/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Miocardite/sangue , Miocardite/induzido quimicamente , Miocardite/diagnóstico por imagem , Miocardite/fisiopatologiaRESUMO
Gene therapy is defined by the introduction of new genes or the genetic modification of existing genes and/or their regulatory portions via gene replacement and gene editing strategies, respectively. The genetic material is usually delivered though cardiotropic vectors such as adeno-associated virus 9 or engineered capsids. The enthusiasm for gene therapy has been hampered somewhat by adverse events observed in clinical trials, including dose-dependent immunologic reactions such as hepatotoxicity, acquired hemolytic uremic syndrome and myocarditis. Notably, gene therapy for Duchenne muscular dystrophy has recently been approved and pivotal clinical trials are testing gene therapy approaches in rare myocardial conditions such as Danon disease and Fabry disease. Furthermore, promising results have been shown in animal models of gene therapy in hypertrophic cardiomyopathy and arrhythmogenic cardiomyopathy. This review summarizes the gene therapy techniques, the toxicity risk associated with adeno-associated virus delivery, the ongoing clinical trials, and future targets.
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Cardiomiopatias , Cardiomiopatia Hipertrófica , Insuficiência Cardíaca , Distrofia Muscular de Duchenne , Animais , Humanos , Insuficiência Cardíaca/terapia , Cardiomiopatias/terapia , Cardiomiopatias/tratamento farmacológico , Distrofia Muscular de Duchenne/genética , Distrofia Muscular de Duchenne/terapia , Terapia Genética/métodos , Vetores GenéticosRESUMO
BACKGROUND: More women of childbearing age are surviving after heart transplantation (HT), many of whom have a desire to become pregnant. Limited data exist evaluating patients' perspectives, receipt of counseling, and knowledge surrounding contraception, pregnancy, breastfeeding, and medication safety after HT. METHODS: We conducted a voluntary, confidential, web-based cross-sectional survey of women who were childbearing age (defined as 18-45 years) at the time of HT. Transplants occurred between January 2005 and January 2020. Surveys were conducted across 6 high-volume HT centers in the United States. RESULTS: There were 64 responses from women who were of childbearing age at the time of HT. Twenty-five women (39.1%) were pregnant before HT, and 6 (9.4%) women reported at least 1 pregnancy post-transplant. Fifty-three percent (n=34) reported they did not receive enough information on post-HT pregnancy before listing for HT, and 26% (n=16) did not discuss their ability to become pregnant with their care team before proceeding with HT. Following HT, 44% (n=28) still felt that they had not received enough information regarding pregnancy. The majority of women (n=49, 77%) had discussed contraception to prevent unplanned pregnancy with their transplant team. Twenty percent (n=13) reported that pregnancy was never safe after transplantation based on the information they had received from their transplant providers. CONCLUSIONS: Many women feel they are not receiving adequate counseling with regard to posttransplant reproductive health. This survey highlights an opportunity to improve both provider education and patient communication to better support women with HT desiring posttransplant pregnancy.
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Conhecimentos, Atitudes e Prática em Saúde , Transplante de Coração , Humanos , Feminino , Gravidez , Adulto , Estudos Transversais , Pessoa de Meia-Idade , Adulto Jovem , Adolescente , Estados Unidos , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/psicologia , Anticoncepção/métodos , Educação de Pacientes como Assunto , Complicações Cardiovasculares na GravidezRESUMO
OBJECTIVE: The purpose of this study was to estimate a gestational age threshold at which the benefits of treatment with weekly courses of antenatal corticosteroids (ACS) during preterm labor outweigh the risks. STUDY DESIGN: Risk-benefit ratios by gestational age were determined with the use of a Markov microsimulation decision-analysis model with a 1-week cycle length. Single course and multiple (weekly to a maximum of 4) courses of ACS by gestational age of entry (23 weeks to 31 weeks 6 days' gestation) were compared. Benefits were composite events (respiratory distress syndrome, chronic lung disease, severe intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, or stillbirth) averted. Risks were small head circumference and small for gestational age. RESULTS: More composite events are averted (benefits) than risks acquired (ratio, 6:1) when multiple courses of ACS are initiated at 26 weeks' gestation. When multiple courses of ACS are initiated at 29 weeks' gestation, the risk-benefit ratio is 1. Beyond 29 weeks, there is a suggestion of more risk than benefit. CONCLUSION: The model suggests that multiple courses of ACS that are initiated at <29 weeks' gestation may have increased benefit compared with risks. Further analyses are needed to determine the long-term clinical significance of these findings.
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Corticosteroides/uso terapêutico , Técnicas de Apoio para a Decisão , Doenças do Prematuro/prevenção & controle , Trabalho de Parto Prematuro , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Hemorragias Intracranianas/prevenção & controle , Cadeias de Markov , Método de Monte Carlo , Gravidez , Síndrome do Desconforto Respiratório do Recém-Nascido/prevenção & controle , Medição de RiscoRESUMO
BACKGROUND: In recent years, there has been growing interest in evaluating the health and economic impact of medical devices. Payers increasingly rely on cost-effectiveness analyses in making their coverage decisions, and are adopting value-based purchasing initiatives. These analytic approaches, however, have been shaped heavily by their use in the pharmaceutical realm, and are ill-adapted to the medical device context. METHODS: This study focuses on the development and evaluation of left ventricular assist devices (LVADs) to highlight the unique challenges involved in the design and conduct of device trials compared with pharmaceuticals. RESULTS: Devices are moving targets characterized by a much higher degree of post-introduction innovation and "learning by using" than pharmaceuticals. The cost effectiveness ratio of left ventricular assist devices for destination therapy, for example, decreased from around $600,000 per life year saved based on results from the pivotal trial to around $100,000 within a relatively short time period. CONCLUSIONS: These dynamics pose fundamental challenges to the evaluation enterprise as well as the policy-making world, which this paper addresses.
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Coração Auxiliar/economia , Invenções , Avaliação da Tecnologia Biomédica/métodos , Aquisição Baseada em Valor , Aprovação de Equipamentos , Disfunção Ventricular Esquerda/terapiaRESUMO
Dilated cardiomyopathy (DCM) is a common cause of heart failure and is the primary indication for heart transplantation. A genetic etiology can be found in 20-35% of patients with DCM, especially in those with a family history of cardiomyopathy or sudden cardiac death at an early age. With advancements in genome sequencing, the understanding of genotype-phenotype relationships in DCM has expanded with over 60 genes implicated in the disease. Subsequently, these findings have increased adoption of genetic testing in the management of DCM, which has allowed for improved risk stratification and identification of at risk family members. In this review, we discuss the genetic evaluation of DCM with a focus on practical genetic testing considerations, genotype-phenotype associations, and insights into upcoming personalized therapies.
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Danon disease is a rare X-linked autophagic vacuolar cardioskeletal myopathy associated with severe heart failure that can be accompanied with extracardiac neurologic, skeletal, and ophthalmologic manifestations. It is caused by loss of function variants in the LAMP2 gene and is among the most severe and penetrant of the genetic cardiomyopathies. Most patients with Danon disease will experience symptomatic heart failure. Male individuals generally present earlier than women and die of either heart failure or arrhythmia or receive a heart transplant by the third decade of life. Herein, the authors review the differential diagnosis of Danon disease, diagnostic criteria, natural history, management recommendations, and recent advances in treatment of this increasingly recognized and extremely morbid cardiomyopathy.
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Cardiomiopatias , Doença de Depósito de Glicogênio Tipo IIb , Insuficiência Cardíaca , Humanos , Masculino , Feminino , Doença de Depósito de Glicogênio Tipo IIb/complicações , Doença de Depósito de Glicogênio Tipo IIb/diagnóstico , Doença de Depósito de Glicogênio Tipo IIb/genética , Diagnóstico Diferencial , Consenso , Proteína 2 de Membrana Associada ao Lisossomo/genética , Cardiomiopatias/diagnóstico , Cardiomiopatias/genética , Cardiomiopatias/terapia , Insuficiência Cardíaca/diagnósticoRESUMO
A 40-year-old man with history of prior coronavirus disease 2019 (COVID-19) infection developed pleuritic chest pain 3 days after receiving the first dose of the BNT162b2 mRNA vaccine. Echocardiography results were significant for mild dysfunction and left ventricular hypertrophy. Cardiac magnetic resonance imaging showed myocardial edema as well as delayed enhancement in the inferior wall of the basal left ventricular myocardium, suggestive of acute myocarditis. This case describes the work-up, diagnosis, risk-stratification, and management of acute myocarditis post BNT162b2 mRNA vaccine.
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BACKGROUND: Previous studies have demonstrated a relationship between increasing center volume and cardiac transplant outcomes. The purpose of this study was to confirm a relationship between post-heart transplant outcomes and center experience and to determine whether this relationship persists among low- and high-risk heart transplant recipient-donor pairs. METHODS AND RESULTS: The United Network for Organ Sharing (UNOS) provided deidentified patient-level data. Analysis included 8029 heart transplant recipients aged ≥18 years and transplanted between January 1, 2001 and December 31, 2006 with follow-up available through February 3, 2009. The primary outcome was observed 1-year posttransplant graft survival. Multivariable logistic regression was used to calculate expected 1-year survival for recipients. Threshold analysis identified 3 discrete risk groups of transplant recipients: high-risk, moderate-risk, and low-risk. Three discrete risk strata for center volume: low (<10.5 recipients/yr), intermediate (10.5 to 47 recipients/yr), and high (>47 recipients/yr) were also identified. χ(2) test was used to compare 1-year survival at low- and intermediate- with high-volume centers. In multivariable logistic regression analysis, annual center volume was significantly associated with posttransplant graft survival at 1 year (odds ratio [OR]=0.995, 0.992 to 0.999; P=0.010) and primary graft failure (OR=0.985, 0.972 to 0.997; P=0.015), but not stroke (OR=0.996, 0.990 to 1.003; P=0.295), infection (OR=1.001, 0.998 to 1.003; P=0.613), or dialysis (OR=1.001, 0.997 to 1.005; P=0.522). Log-rank test demonstrated significant difference in survival between volume groups with respect to high-risk (P=0.0032) and low-risk (P=0.00415), but not moderate-risk (P=0.128) patients. CONCLUSIONS: A direct relationship existed between increasing center volume and improved graft survival. Across all recipient-donor pair risk strata, posttransplant graft survival at 1 year was significantly lower at low-volume centers. The volume-outcomes relationship was strongest in the highest-risk recipient-donor category.
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Sobrevivência de Enxerto , Transplante de Coração/mortalidade , Doadores de Tecidos , Adolescente , Adulto , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida , Transplante Homólogo , Estados UnidosRESUMO
OBJECTIVE: The relationship between volume and outcome in many complex surgical procedures is well established. BACKGROUND: No published data has examined this relationship in pediatric cardiac transplantation, but low-volume adult heart transplant programs seem to have higher early mortality. METHODS: The United Network for Organ Sharing (UNOS) provided center-specific data for the 4647 transplants performed on patients younger than 19 years old, 1992 to 2007. Patients were stratified into 3 groups based on the volume of transplants performed in the previous 5 years at that center: low [<19 transplants, n = 1135 (24.4%)], medium [1962 transplants, n = 2321(50.0%)], and high [≥63 transplants, n= 1191 (25.6%)]. A logistic regression model for postoperative mortality was developed and observed-to-expected (O:E) mortality rates calculated for each group. RESULTS: Unadjusted long-term survival decreased with decreasing center volume (P<0.0001). Observed postoperative mortality was higher than expected at low-volume centers [O:E ratio 1.39, 95% confidence interval (CI) 1.051.83]. At low volume centers, high-risk patients (1.34, 0.852.12)--especially patients 1 year old or younger (1.60, 1.072.40) or those with congenital heart disease (1.36, 0.941.96)--did poorly, but those at high-volume centers did well (congenital heart disease: 0.90, 0.361.26; age<1 year: 0.75, 0.511.09). Similar results were obtained in the subset of patients transplanted after 1996. In multivariate logistic regression modeling, transplantation at a low-volume center was associated with an odds ratio for postoperative mortality of 1.60 (95% CI, 1.142.24); transplantation at a medium volume center had an odds ratio of 1.24 (95% CI, 0.921.66). CONCLUSION: The volume of transplants performed at any one center has a significant impact on outcomes. Regionalization of care is one option for improving outcomes in pediatric cardiac transplantation.
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Transplante de Coração/mortalidade , Transplante de Coração/estatística & dados numéricos , Hospitais/estatística & dados numéricos , Criança , Transplante de Coração/normas , Hospitais/normas , Humanos , Tempo de Internação , Razão de Chances , Complicações Pós-Operatórias , Modelos de Riscos Proporcionais , Fatores de Risco , Taxa de Sobrevida , Doadores de TecidosRESUMO
Background Myocardial strain can identify subclinical left ventricular dysfunction in various cardiac diseases, but its association with clinical outcomes in genetic cardiomyopathies remains unknown. Herein, we assessed myocardial strain in patients with Danon disease (DD), a rare X-linked autophagic disorder that causes severe cardiac manifestations. Methods and Results Echocardiographic images were reviewed and used to calculate myocardial strain from a retrospective, international registry of patients with DD. Regression analyses were performed to evaluate for an association of global longitudinal strain (GLS) and ejection fraction with the composite outcome (death, ventricular assist device, heart transplantation, and implantable cardioverter defibrillator for secondary prevention). A total of 22 patients with DD (male 14 [63.6%], median age 16.5 years) had sufficient echocardiograms for analysis. Absolute GLS was reduced with a mean of 12.2% with an apical-sparing pattern observed. Univariable regression for GLS and composite outcome showed an odds ratio of 1.32 (95% CI, 1.02-1.71) with P=0.03. For receiver operating characteristic analysis, the areas under the curve for GLS and ejection fraction were 0.810 (P=0.02) and 0.605 (P=0.44), respectively. An absolute GLS cutoff of 10.0% yielded a true positive rate of 85.7% and false positive rate of 13.3%. Conclusions In this cohort of patients with DD, GLS may be a useful assessment of myocardial function and may predict clinical outcomes. This study highlights the potential use of myocardial strain phenotyping to monitor disease progression and potentially to predict clinical outcomes in DD and other genetic cardiomyopathies.
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Doença de Depósito de Glicogênio Tipo IIb , Coração , Adolescente , Progressão da Doença , Ecocardiografia , Feminino , Doença de Depósito de Glicogênio Tipo IIb/genética , Doença de Depósito de Glicogênio Tipo IIb/patologia , Doença de Depósito de Glicogênio Tipo IIb/terapia , Coração/diagnóstico por imagem , Coração/fisiopatologia , Humanos , Masculino , Modelos Biológicos , Monitorização Fisiológica , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: There is conflicting observational data on the survival benefit cardiac implantable electronic devices (CIED) in patients with LVADs. METHODS: Patients in whom an LVAD was implanted between January 2008 and April 2017 in the multinational Trans-Atlantic Registry on VAD and Transplant (TRAViATA) registry were separated into four groups based on the presence of CIED prior to LVAD implantation: none (n = 146), implantable cardiac defibrillator (ICD) (n = 239), cardiac resynchronization without defibrillator (CRT-P) (n = 28), and CRT with defibrillator (CRT-D) (n = 111). RESULTS: A total of 524 patients (age 52 years ±12, 84.4% male) were followed for 354 (interquartile range: 166-701) days. After multivariable adjustment, there were no differences in survival across the groups. In comparison to no device, only CRT-D was associated with late right ventricular failure (RVF) (hazard ratio 2.85, 95% confidence interval [CI] 1.42-5.72, p = 0.003). There was no difference in risk of early RVF across the groups or risk of ICD shocks between those with ICD and CRT-D. CONCLUSION: In a multinational registry of patients with LVADs, there were no differences in survival with respect to CIED subtype. However, patients with a pre-existing CRT-D had a higher likelihood of late RVF suggesting significant long-term morbidity in those with devices capable of LVlead pacing post LVAD implantation.
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Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Insuficiência Cardíaca , Coração Auxiliar , Eletrônica , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
BACKGROUND: Geographic variations in management and outcomes of individuals supported by continuous-flow left ventricular assist devices (CF-LVAD) between the United States (US) and Europe (EU) is largely unknown. METHODS: We created a retrospective, multinational registry of 524 patients who received a CF-LVAD (either HVAD or Heartmate II) between January 2008 and April 2017. Follow up spanned from date of CF-LVAD implant to post-HTx period with a median follow up of 44.8 months. RESULTS: The cohort included 299 (57.1%) EU and 225 (42.9%) US patients. Although the US cohort was significantly older with a higher prevalence of comorbidities, survival was similar between the cohorts (US 63.1%, EU 68.4% at 5 years, unadjusted log-rank test p = 0.43).Multivariate analyses suggested that older age, higher body mass index, elevated creatinine, use of temporary mechanical circulatory support prior CF-LVAD, and implantation of HVAD were associated with increased mortality. Among CF-LVAD patients undergoing HTx, the median time on CF-LVAD support was shorter in the US, meanwhile US donors were younger. Finally, the pattern of adverse events (stroke, gastrointestinal bleedings, late right ventricular failure, and driveline infection) during support differed significantly between US and EU. CONCLUSIONS: Although waitlisted patients in the US on CF-LVAD have higher risk comorbid conditions, the overall outcome is similar in US and EU. Geographic variations with regards to donor characteristics, duration of CF-LVAD support prior to transplant, and adverse events on support can explain the disparity in the utilization of mechanical bridge to transplant strategy between US and EU.
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Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Idoso , Europa (Continente)/epidemiologia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/cirurgia , Coração Auxiliar/efeitos adversos , Humanos , Sistema de Registros , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: To determine the relationship between body mass index (BMI) at the time of transplant and posttransplant survival and morbidity. SUMMARY BACKGROUND DATA: The recent International Society for Heart and Lung Transplantation listing criteria for heart transplantation stated that candidates should achieve a BMI <30 kg/m-or percent ideal body weight <140%-before listing for cardiac transplantation. However, data to support these recommendations are limited and often conflicting. METHODS: United Network of Organ Sharing provided de-identified patient-level data. Analysis included 19,593 orthotopic heart transplant recipients aged >or=18 years and transplanted January 1 1995-December 31 2005. Follow-up data were provided through February 8, 2008. Recipients were stratified by BMI at the time of transplantation: BMI <18.5 (underweight), 18.5 to 24.99 (normal weight), 25 to 29.99 (overweight), 30 to 34.99 (obesity class I), and >or=35 (obesity class II/III). The primary outcome measure was post-transplant survival. RESULTS: Risk-adjusted median survival in the underweight, normal weight, overweight, obesity I, and obesity II/III groups was 8.31, 10.20, 10.03, 9.51, and 9.05 years, respectively. In multivariate Cox proportional hazards regression, BMI in the overweight (HR = 1.08, 0.99-1.17; P = 0.055) and obesity I (HR = 1.05, 0.99-1.12; P = 0.091) ranges were not associated with significantly diminished survival. However, BMI in the underweight (HR = 1.26, 1.11-1.43; P < 0.001) and obesity II/III (HR = 1.18, 1.01-1.38; P = 0.030) ranges were associated with diminished posttransplant survival. CONCLUSION: Findings from this analysis do not suggest that obesity I (BMI of 30-34.99) is associated with significantly higher morbidity and mortality. However, underweight and obesity II/III recipients have significantly higher morbidity and mortality compared with other groups.
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Índice de Massa Corporal , Transplante de Coração/mortalidade , Peso Corporal , Feminino , Transplante de Coração/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Guias de Prática Clínica como Assunto , Taxa de Sobrevida , Listas de EsperaRESUMO
BACKGROUND: Given conflicting findings of previous studies, much remains to be understood regarding a volume-outcomes relationship (VOR) in transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was: 1) to determine if, after the initial learning curve (LC), a VOR for balloon-expandable (BE) TAVR persisted; and 2) to determine if LCs and VORs differed across different device generations. METHODS: Data collected by the TVT registry for BE valve implants from November 2011 through January 2017 were included in this analysis (n = 61,949). Primary outcomes included 30-day all-cause mortality, stroke, and major vascular complications. For each center, all implants were ordered chronologically according to case sequence number (CS#). To determine where the learning curve terminated (LCT), a grid search analysis was applied across a range of CS# from 10 to 300 by increments of 1. After LCT, the VOR was assessed by examining case volume/month by center. This analysis was performed separately for: 1) all BE valve types; 2) Sapien 3 (S3) only; and 3) S3 in BE valve naïve sites. RESULTS: In experience with all commercially available BE valve types, there was an initial LC that terminates around case #201. After the initial LC, a volume-outcomes relationship was no longer evident. In analysis limited to S3, there was no demonstrable LC or VOR. Likewise, there was no demonstrable LC or VOR with S3 for BE valve naïve sites. CONCLUSIONS: After a case experience of 200 cases, there was LCT; subsequent to initial learning, a VOR was no longer evident. In the S3-only analysis, there was no LC or no demonstrable VOR. With current-generation BE-TAVR, centers should expect to achieve consistently excellent outcomes even during early case experience.
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Hospitais com Baixo Volume de Atendimentos/estatística & dados numéricos , Curva de Aprendizado , Sistema de Registros , Substituição da Valva Aórtica Transcateter/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , MasculinoRESUMO
BACKGROUND: In non-valvular atrial fibrillation (NVAF) patients, congestive heart failure (CHF) confers an increased risk of stroke or systemic thromboembolism. This risk is present in both heart failure (HF) with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). It is unclear if clinicians account for both types of CHF in their NVAF anticoagulation practices. Accordingly, we characterized current outpatient anticoagulation trends in NVAF patients with HFpEF compared to patients with HFrEF. METHODS: The outpatient NCDR PINNACLE-AF registry was analyzed to identify patients with NVAF and CHF. The study population was subdivided into HFpEF (ie, LVEF ≥ 40%) and HFrEF (LVEF < 40%). Anticoagulation rates by CHF group were compared and stratified by CHA2 DS2 -VASc score. RESULTS: A total of 340 127 patients with NVAF and CHF were identified, of whom 248 136 (73.0%) were classified as HFpEF and 91 991 (27.0%) as HFrEF. Patients with HFpEF had higher mean CHA2 DS2 -VASc scores and were more likely to be female, older, and have hypertension (P < 0.001). Unadjusted anticoagulation rates were significantly lower in patients with HFpEF compared to those with HFrEF (60.6% vs 64.2%, respectively). Lower rates of anticoagulation in the HFpEF group persisted after risk adjustment (RR: 0.93 [95% CI: 0.91, 0.94]). Stratification by CHA2 DS2 -VASc score demonstrated that lower rates of anticoagulation in patients with HFpEF persisted until a score of ≥5. CONCLUSIONS: Patients with NVAF and HFpEF have significantly lower anticoagulation rates when compared to their HFrEF counterparts. These findings suggest a potential underappreciation of HFpEF as a risk factor in patients with NVAF.
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Anticoagulantes/administração & dosagem , Fibrilação Atrial/complicações , Insuficiência Cardíaca/complicações , Sistema de Registros , Tromboembolia/prevenção & controle , Administração Oral , Idoso , Fibrilação Atrial/tratamento farmacológico , Feminino , Seguimentos , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Masculino , Estudos Retrospectivos , Volume Sistólico/fisiologia , Tromboembolia/etiologiaRESUMO
BACKGROUND: Risk factors for post-operative conduction disturbances after cardiac valve surgery requiring a permanent pacemaker (PPM) are poorly characterized. OBJECTIVES: The aim of this study was to investigate the timing and risk factors for PPM implantation after mitral or aortic valve surgery. METHODS: All patients who underwent open aortic or mitral valve surgery between January 1996 and December 2014 were reviewed using New York State's mandatory hospital discharge database. Patients with prior cardiac surgery or pre-existing PPM were excluded. The primary endpoint was PPM implantation within 1 year. RESULTS: Among 77,882 patients, 63.8% (n = 49,706) underwent aortic valve replacement (AVR), 18.9% (n = 14,686) underwent mitral valve replacement (MVR), 10.5% (n = 8,219) underwent mitral valve repair (MVr), 5.4% (n = 4,202) underwent AVR plus MVR, and 1.4% (n = 1,069) underwent AVR plus MVr. The 1-year PPM implantation rate was 4.5% after MVr, 6.6% after AVR, 9.3% after AVR plus MVr, 10.5% after MVR, and 13.3% after AVR plus MVR (p < 0.001). Across all groups, the majority of PPMs were implanted during the index hospitalization (79.9%). MVr was associated with the lowest risk for PPM and AVR plus MVR with the highest risk. Older age, history of arrhythmias, pre-operative conduction disturbances, and concomitant index procedures were associated with increased risk for PPM during the index hospitalization. Conversely, beyond 30 days, chronic comorbidities were associated with increased risk for PPM. CONCLUSIONS: Conduction disturbances requiring PPM remain a common adverse event after valve surgery. Identifying patients at risk for PPM will help facilitate perioperative planning and inform clinical decision making regarding post-operative rhythm surveillance.