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Contemporary anticancer therapies frequently have different efficacy and side effects in men and women. Yet, whether women are well-represented in pivotal trials supporting contemporary anticancer drugs is unknown. Leveraging the Drugs@FDA database, clinicaltrials.gov, MEDLINE, and publicly available FDA-drug-reviews, we identified all pivotal (phase II and III) non-sex specific trials supporting FDA-approval of anticancer drugs (1998-2018). Observed-enrollment-rates were compared to expected-population-rates derived from concurrent US-National-Cancer-Institute's Surveillance-Epidemiology-and-End-Results (SEER) reported rates and US-Census databases. Primary outcome was the proportional representation of women across trials, evaluated by a participation-to-prevalence ratio (PPR), according to cancer type. Secondary outcome was the report of any sex-specific analysis of efficacy and/or safety, irrespective of treatment-arm. Overall, there were 148 trials, enrolling 60,216 participants (60.5 ± 4.0 years, 40.7% female, 79.1% biologic, targeted, or immune-based therapies) evaluating 99 drugs. Sex was reported in 146 (98.6%) trials, wherein 40.7% (24,538) were women, compared to 59.3% (35,678) men (p < .01). Altogether, women were under-represented in 66.9% trials compared to the proportional incidence of cancers by respective disease type; weight-average PPR of 0.91 (relative difference: -9.1%, p < .01). Women were most under-represented in gastric (PPR = 0.63), liver (PPR = 0.71), and lung (PPR = .81) cancer trials. Sex-based safety data was reported in 4.0% trials. There was no association between adequate female enrollment and drug efficacy (HR: 0.616 vs. 0.613, p = .96). Over time, there was no difference in the percentage of women recruited into clinical trials. Among pivotal clinical trials supporting contemporary FDA-approved cancer drugs, women were frequently under-represented and sex-specific-efficacy and safety-outcomes were commonly not reported.
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Maternal mortality is a major public health crisis in the United States. Cardiovascular disease (CVD) is a leading cause of maternal mortality and morbidity. Labor and delivery is a vulnerable time for pregnant individuals with CVD but there is significant heterogeneity in the management of labor and delivery in high-risk patients due in part to paucity of high-quality randomized data. The authors have convened a multidisciplinary panel of cardio-obstetrics experts including cardiologists, obstetricians and maternal fetal medicine physicians, critical care physicians, and anesthesiologists to provide a practical approach to the management of labor and delivery in high-risk individuals with CVD. This expert panel will review key elements of management from mode, timing, and location of delivery to use of invasive monitoring, cardiac devices, and mechanical circulatory support.
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Multiple guidelines exist for the diagnosis and management of heart failure with preserved ejection fraction (HFpEF). We systematically reviewed current guidelines and recommendations, developed by national and international medical organizations, on the management of HFpEF in adults to aid clinical decision-making. We searched MEDLINE and EMBASE on 28 February 2024 for publications over the last 10 years as well as websites of organizations relevant to guideline development. Of the ten guidelines and recommendations retrieved, seven showed considerable rigour of development and were subsequently retained for analysis. There was consensus on the definition of HFpEF and the diagnostic role of serum natriuretic peptides and resting transthoracic echocardiography. Discrepancies were identified in the thresholds of serum natriuretic peptides and transthoracic echocardiography parameters used to diagnose HFpEF. There was agreement on the general pharmacological and supportive management of acute and chronic HFpEF. However, differences exist in strategies to identify and address specific phenotypes. Contemporary guidelines for HFpEF management agree on measures to avoid its development and the consideration of cardiac transplantation in advanced disease. There were discrepancies in recommended frequency of surveillance for patients with HFpEF and sparse recommendations on screening for HFpEF in the general population, use of diagnostic scoring systems, and the role of newly emerging therapies.
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BACKGROUND: Sarcoidosis is associated with a poor prognosis. There is a lack of data examining the outcomes and readmission rates of sarcoidosis patients with heart failure (SwHF) and without heart failure (SwoHF). We aimed to compare the impact of non-ischemic heart failure on outcomes and readmissions in these two groups. METHODS: The US Nationwide Readmission Database was queried from 2010 to 2019 for SwHF and SwoHF patients identified using the International Classification of Diseases, 9th and 10th Editions. Those with ischemic heart disease were excluded, and both cohorts were propensity matched for age, gender, and Charlson Comorbidity Index (CCI). Clinical characteristics, length of stay, adjusted healthcare-associated costs, 90-day readmission and mortality were analyzed. RESULTS: We identified 97,961 hospitalized patients (median age 63 years, 37.9% male) with a diagnosis of sarcoidosis (35.9% SwHF vs 64.1% SwoHF). On index admission, heart failure patients had higher prevalences of atrioventricular block (3.3% vs 1.4%, P < .0001), ventricular tachycardia (6.5% vs 1.3%, P < .0001), ventricular fibrillation (0.4% vs 0.1%, P < .0001) and atrial fibrillation (22.1% vs 7.5%, P < .0001). SwHF patients were more likely to be readmitted (hazard ratio 1.28, P < .0001), had higher length of hospital stay (5 vs 4 days, P < .0001), adjusted healthcare-associated costs ($9,667.0 vs $9,087.1, P < .0001) and mortality rates on readmission (5.1% vs 3.8%, P < .0001). Predictors of mortality included heart failure, increasing age, male sex, higher CCI, and liver disease. CONCLUSION: SwHF is associated with higher rates of arrhythmia at index admission, as well as greater hospital cost, readmission and mortality rates compared to those without heart failure.
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Bases de Dados Factuais , Insuficiência Cardíaca , Readmissão do Paciente , Pontuação de Propensão , Sarcoidose , Humanos , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/economia , Masculino , Feminino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Sarcoidose/complicações , Sarcoidose/mortalidade , Sarcoidose/epidemiologia , Sarcoidose/economia , Idoso , Estados Unidos/epidemiologia , Tempo de Internação/estatística & dados numéricos , ComorbidadeRESUMO
Background: Transcatheter aortic valve replacement (TAVR) are not offered equitably to vulnerable population groups. Adequate levels of insurance may narrow gaps among patients with higher social vulnerability index (SVI). Among a national population of individuals with commercial or Medicare insurance, we sought to determine whether SVI was associated with urgency of receipt of TAVR for aortic stenosis. Methods and results: Using Optum's de-identified Clinformatics Data Mart Database (CDM), we identified admissions for TAVR with aortic stenosis between January 2018 and March 2022. Admission urgency was identified by CDM claims codes. SVI was cross-referenced to patient zip codes and grouped into quintiles. Generalized linear mixed effects models were used to predict the probability of a TAVR admission being urgent based on SVI quintiles, adjusting for patient and hospital-level covariates. Results: Among 6680 admissions for TAVR [median age 80 years (interquartile range 75-85), 43.9 % female], 8.5 % (n = 567) were classified as urgent. After adjusting for patient and hospital-level variables, there were no significant differences in the odds of urgent admission for TAVR according to SVI quintiles [OR 5th (greatest social vulnerability) vs 1st quintile (least social vulnerability): 1.29 (95 % CI: 0.90-1.85)]. Conclusions: Among commercial or Medicare beneficiaries with aortic stenosis, SVI was not associated with admission urgency for TAVR. To clarify whether cardiovascular care delivery is improved across SVI with higher paying beneficiaries, future investigation should identify whether relationships between SVI and TAVR urgency vary for Medicaid beneficiaries compared to commercial beneficiaries.
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Importance: Barriers to heart transplant must be overcome prior to listing. It is unclear why Black men and women remain less likely to receive a heart transplant after listing than White men and women. Objective: To evaluate whether race or gender of a heart transplant candidate (ie, patient on the transplant waiting list) is associated with the probability of a donor heart being accepted by the transplant center team with each offer. Design, Setting, and Participants: This cohort study used the United Network for Organ Sharing datasets to identify organ acceptance with each offer for US non-Hispanic Black (hereafter, Black) and non-Hispanic White (hereafter, White) adults listed for heart transplant from October 18, 2018, through March 31, 2023. Exposures: Black or White race and gender (men, women) of a heart transplant candidate. Main Outcomes and Measures: The main outcome was heart offer acceptance by the transplant center team. The number of offers to acceptance was assessed using discrete time-to-event analyses, nonparametrically (stratified by race and gender) and parametrically. The hazard probability of offer acceptance for each offer was modeled using generalized linear mixed models adjusted for candidate-, donor-, and offer-level variables. Results: Among 159â¯177 heart offers with 13â¯760 donors, there were 14â¯890 candidates listed for heart transplant; 30.9% were Black, 69.1% were White, 73.6% were men, and 26.4% were women. The cumulative incidence of offer acceptance was highest for White women followed by Black women, White men, and Black men (P < .001). Odds of acceptance were less for Black candidates than for White candidates for the first offer (odds ratio [OR], 0.76; 95% CI, 0.69-0.84) through the 16th offer. Odds of acceptance were higher for women than for men for the first offer (OR, 1.53; 95% CI, 1.39-1.68) through the sixth offer and were lower for the 10th through 31st offers. Conclusions and Relevance: The cumulative incidence of heart offer acceptance by a transplant center team was consistently lower for Black candidates than for White candidates of the same gender and higher for women than for men. These disparities persisted after adjusting for candidate-, donor-, and offer-level variables, possibly suggesting racial and gender bias in the decision-making process. Further investigation of site-level decision-making may reveal strategies for equitable donor heart acceptance.
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Negro ou Afro-Americano , Disparidades em Assistência à Saúde , Insuficiência Cardíaca , Transplante de Coração , Obtenção de Tecidos e Órgãos , População Branca , Adulto , Feminino , Humanos , Masculino , Negro ou Afro-Americano/estatística & dados numéricos , Estudos de Coortes , Transplante de Coração/estatística & dados numéricos , Fatores Sexuais , Obtenção de Tecidos e Órgãos/estatística & dados numéricos , Doadores de Tecidos/estatística & dados numéricos , Estados Unidos/epidemiologia , Listas de Espera , População Branca/estatística & dados numéricos , Fatores Raciais , Disparidades em Assistência à Saúde/etnologia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/etnologia , Insuficiência Cardíaca/cirurgiaRESUMO
Cardiac allograft vasculopathy (CAV) is a significant determinant of long-term survival in heart transplant recipients. Standard CAV screening typically utilizes invasive coronary angiography (ICA). Quantitative flow ratio (QFR) is a computational method for functional testing of coronary stenosis, and may add diagnostic value to ICA in assessing CAV. Consecutive subjects who received heart transplantation and underwent two separate routine coronary angiograms between January 2013 and April 2016 were enrolled. Coronary angiograms and IVUS were performed per local protocol at 1, 2, 3 and 5 years post-transplant. QFR was calculated offline. CAV was assessed semi-quantitively based on coronary angiogram results. Twenty-two patients were enrolled. Mean time from transplant to first included ICA was 2.1 years. QFR in at least 1 coronary vessel was interpretable in 19/22 (86%) of initial ICA (QFR1). QFR1 correlated well with the CAV score derived from the second ICA (CAV2) with a clustering of CAV at lower QFR values. In a receiver-operating characteristic (ROC) analysis, an optimal QFR threshold of 0.88 yielded 0.94 sensitivity and 0.67 specificity (AUC of 0.79) for at least non-obstructive subsequent CAV. Initial angiographically and intravascular ultrasound derived CAV severity poorly predicted subsequent CAV severity. QFR derived from invasive coronary angiography predicts subsequent development of CAV more accurately than angiography and intravascular ultrasound. This novel method of coronary flow assessment in recipients of heart transplantation may be useful to diagnose and predict subsequent CAV development.
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Doença da Artéria Coronariana , Transplante de Coração , Humanos , Angiografia Coronária/métodos , Valor Preditivo dos Testes , Transplante de Coração/efeitos adversos , Coração , Aloenxertos/irrigação sanguínea , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/etiologia , Doença da Artéria Coronariana/terapiaRESUMO
BACKGROUND: Black patients with peripartum cardiomyopathy (PPCM) have disproportionately worse outcomes than White patients, possibly related to variable involvement of cardiovascular specialists in their clinical care. We sought to determine whether race was associated with cardiology involvement in clinical care during inpatient admission and whether cardiology involvement in care was associated with higher claims of guideline-directed medical therapy (GDMT) a week after hospital discharge. METHODS: Using Optum's de-identified Clinformatics® Data Mart (CDM), we included Black and White patients' first hospital admission for PPCM from 2008 to 2021. Cardiology involvement in clinical care was defined as the receipt of attending care from a cardiovascular specialist during admission. GDMT included beta-blockers (BB) for all patients and triple therapy (BB, angiotensin-responsive medications, and mineralocorticoid receptor antagonists) for non-pregnant patients. Logistic regression was used to determine the associations between cardiology involvement in clinical care during admission and (1) patient race and (2) GDMT prescription, adjusting for age and comorbidities. RESULTS: Among 668 patients (32.6% Black, 67.4% White, 93.3% commercially insured), there was no significant difference in the odds of cardiology involvement in clinical care by race (aOR: 1.41; 95%CI: 0.87-2.33, P=0.17). Inpatient cardiology care was associated with 2.75 times increased odds of having a prescription claim for GDMT (BB) for White patients (aOR: 2.75; 95%CI 1.50-5.06, P=0.001), and the estimated effect size was similar but not statistically significant for Black patients (aOR: 2.20, 95% CI, 0.84-5.71, P=0.11). The interaction between race and cardiology involvement in clinical care was not statistically significant for the receipt of BB prescription. Among 274 non-pregnant patients with PPCM (37.2% Black, 62.8% White), 5.8% received triple GDMT. Of these, none of the Black patients lacking cardiology care had triple GDMT. However, cardiology involvement in care was not significantly associated with triple GDMT for either race. CONCLUSIONS: Among a commercially insured population within PPCM, race was not associated with cardiology involvement in clinical care during hospitalization. However, cardiology involvement in care was associated with significantly higher odds of prescription claims for BB for only White patients. Additional strategies are needed to support equitable GDMT prescription.
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BACKGROUND: Durable left ventricular assist devices (VADs) improve survival in eligible patients, but allocation has been associated with patient race in addition to presumed heart failure (HF) severity. OBJECTIVES: This study sought to determine racial and ethnic differences in VAD implantation rates and post-VAD survival among patients with ambulatory HF. METHODS: Using the INTERMACS (Interagency Registry of Mechanically Assisted Circulatory Support) database (2012-2017), this study examined census-adjusted VAD implantation rates by race, ethnicity, and sex in patients with ambulatory HF (INTERMACS profile 4-7) using negative binomial models with quadratic effect of time. Survival was evaluated using Kaplan-Meier estimates and Cox models adjusted for clinically relevant variables and an interaction of time with race/ethnicity. RESULTS: VADs were implanted in 2,256 adult patients with ambulatory HF (78.3% White, 16.4% Black, and 5.3% Hispanic). The median age at implantation was lowest in Black patients. Implantation rates peaked between 2013 and 2015 before declining in all demographic groups. From 2012 to 2017, implantation rates overlapped for Black and White patients but were lower for Hispanic patients. Post-VAD survival was significantly different among the 3 groups (log rank P = 0.0067), with higher estimated survival among Black vs White patients (12-month survival: Black patients: 90% [95% CI: 86%-93%]; White patients: 82% [95% CI: 80%-84%]). Low sample size for Hispanic patients resulted in imprecise survival estimates (12-month survival: 85% [95% CI: 76%-90%]). CONCLUSIONS: Black and White patients with ambulatory HF had similar VAD implantation rates but rates were lower for Hispanic patients. Survival differed among the 3 groups, with the highest estimated survival at 12 months in Black patients. Given higher HF burden in minoritized populations, further investigation is needed to understand differences in VAD implantation rates in Black and Hispanic patients.
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Insuficiência Cardíaca , Coração Auxiliar , Adulto , Humanos , Insuficiência Cardíaca/cirurgia , Resultado do Tratamento , Modelos de Riscos Proporcionais , Estimativa de Kaplan-Meier , Sistema de RegistrosRESUMO
BACKGROUND: The implications of coronavirus disease 2019 (COVID-19) infection on outcomes after invasive therapeutic strategies among patients presenting with acute myocardial infarction (AMI) are not well studied. HYPOTHESIS: To assess the outcomes of COVID-19 patients presenting with AMI undergoing an early invasive treatment strategy. METHODS: This study was a cross-sectional, retrospective analysis of the National COVID Cohort Collaborative database including all patients presenting with a recorded diagnosis of AMI (ST-elevation myocardial infarction (MI) and non-ST elevation MI). COVID-19 positive patients with AMI were stratified into one of four groups: (1a) patients who had a coronary angiogram with percutaneous coronary intervention (PCI) within 3 days of their AMI; (1b) PCI within 3 days of AMI with coronary artery bypass graft (CABG) within 30 days; (2a) coronary angiogram without PCI and without CABG within 30 days; and (2b) coronary angiogram with CABG within 30 days. The main outcomes were respiratory failure, cardiogenic shock, prolonged length of stay, rehospitalization, and death. RESULTS: There were 10 506 COVID-19 positive patients with a diagnosis of AMI. COVID-19 positive patients with PCI had 8.2 times higher odds of respiratory failure than COVID-19 negative patients (p = .001). The odds of prolonged length of stay were 1.7 times higher in COVID-19 patients who underwent PCI (p = .024) and 1.9 times higher in patients who underwent coronary angiogram followed by CABG (p = .001). CONCLUSION: These data demonstrate that COVID-19 positive patients with AMI undergoing early invasive coronary angiography had worse outcomes than COVID-19 negative patients.
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COVID-19 , Infarto do Miocárdio , Intervenção Coronária Percutânea , Insuficiência Respiratória , Estudos Transversais , Humanos , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/efeitos adversos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Outcomes in heart failure with reduced ejection fraction (HFrEF) are influenced by access and adherence to guideline-directed medical therapy. Our objective was to study the association between annual household income and: (1) the odds of having a claim for sacubitril/valsartan among insured patients with HFrEF and (2) medication adherence (measured as the proportion of days covered). We hypothesized that lower annual household income is associated with decreased odds of having a claim for and adhering to sacubitril/valsartan. METHODS: Using the Optum de-identified Clinformatics Data Mart, patients with HFrEF and ≥6 months of enrollment for follow-up (2016-2020) were included. Covariates included age, sex, race, ethnicity, educational attainment, US region, number of prescribed medications, and Elixhauser Comorbidity Index. Prescription for sacubitril/valsartan was defined by the presence of a claim within 6 months of HFrEF diagnosis. Adherence was defined as proportion of days covered ≥80%. We fit multivariable-adjusted logistic regression models and hierarchical logistic regression accounting for covariates. RESULTS: Among 322 007 individuals with incident HFrEF, 135 282 had complete data for analysis. Of the patients eligible for sacubitril/valsartan, 4.7% (6372) had a claim within 6 months of HFrEF diagnosis. Following multivariable adjustment, individuals in the lowest annual income category (<$40 000) were significantly less likely (odds ratio, 0.83 [95% CI, 0.76-0.90]) to have a sacubitril/valsartan claim within 6 months of HFrEF diagnosis than those in the highest annual income category (≥$100 000). Annual income <$40 000 was associated with lower odds of proportion of days covered ≥80% compared with income ≥$100 000 (odds ratio, 0.70 [95% CI, 0.59-0.83]). CONCLUSIONS: Lower household income is associated with decreased likelihood of a sacubitril/valsartan claim and medication adherence within 6 months of HFrEF diagnosis, even after adjusting for sociodemographic and clinical factors. Future analyses are needed to identify additional social factors associated with delays in sacubitril/valsartan initiation and long-term adherence.
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Aminobutiratos , Compostos de Bifenilo , Insuficiência Cardíaca , Valsartana , Aminobutiratos/uso terapêutico , Compostos de Bifenilo/uso terapêutico , Combinação de Medicamentos , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Estudos Retrospectivos , Volume Sistólico , Valsartana/uso terapêutico , Disfunção Ventricular EsquerdaRESUMO
BACKGROUND: Heart failure (HF) is a serious health condition, associated with high health care costs, and poor outcomes. Patient empowerment and self-care are a key component of successful HF management. The emergence of telehealth may enable providers to remotely monitor patients' statuses, support adherence to medical guidelines, improve patient wellbeing, and promote daily awareness of overall patients' health. OBJECTIVE: To assess the feasibility of a voice activated technology for monitoring of HF patients, and its impact on HF clinical outcomes and health care utilization. METHODS: We conducted a randomized clinical trial; ambulatory HF patients were randomized to voice activated technology or standard of care (SOC) for 90 days. The system developed for this study monitored patient symptoms using a daily survey and alerted healthcare providers of pre-determined reported symptoms of worsening HF. We used summary statistics and descriptive visualizations to study the alerts generated by the technology and to healthcare utilization outcomes. RESULTS: The average age of patients was 54 years, the majority were Black and 45% were women. Almost all participants had an annual income below $50,000. Baseline characteristics were not statistically significantly different between the two arms. The technical infrastructure was successfully set up and two thirds of the invited study participants interacted with the technology. Patients reported favorable perception and high comfort level with the use of voice activated technology. The responses from the participants varied widely and higher perceived symptom burden was not associated with hospitalization on qualitative assessment of the data visualization plot. Among patients randomized to the voice activated technology arm, there was one HF emergency department (ED) visit and 2 HF hospitalizations; there were no events in the SOC arm. CONCLUSIONS: This study demonstrates the feasibility of remote symptom monitoring of HF patients using voice activated technology. The varying HF severity and the wide range of patient responses to the technology indicate that personalized technological approaches are needed to capture the full benefit of the technology. The differences in health care utilization between the two arms call for further study into the impact of remote monitoring on health care utilization and patients' wellbeing.
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Insuficiência Cardíaca , Telemedicina , Estudos de Viabilidade , Feminino , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , TecnologiaRESUMO
Heart transplantation is the most effective long-term therapy for end-stage heart disease. There is limited data related to sudden cardiac arrest (SCA) in postheart transplant recipients. We aimed to describe the trends, and rate of SCA following heart transplantation and thereby identify clinical predictors as well as outcomes of SCA in patients post-transplant. We queried the National Inpatient Sample (NIS) with administrative codes for SCA and heart transplant. We assessed baseline differences between SCA and non-SCA admissions, with hazard ratios adjusted for age, gender, CCI, and race. Multivariable logistic regression models were generated to identify the independent predictors for SCA. There was a total of 30,020 hospitalizations of heart transplant recipients between 1999 and 2014 in the United States and among these 1,953 patients (6.5%) suffered SCA with an increasing trend of admissions for SCA. Among the patients who suffered from SCA, 18.83% died during the same hospitalization, 19.29% were discharged to a long-term facility, and 61.38% were discharged home. Multivariate analysis demonstrated that conduction system disorders (Hazard ratio [95% confidence interval]; 7.1 [4.5-11.1]), female gender (HR:1.2 [1.1-1.3]), diabetes (HR:1.4 [1.2-1.6]), and hypertension (HR:1.2 [1.1-1.4]) were the strongest predictors for SCA. SCA hospitalizations occur in 6.5% of patients post cardiac transplant and have been increasing from 1999 to 2014. Conduction block, graft rejection, female gender, hypertension, diabetes are independent predictors for SCA in heart transplant recipients.
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Transplante de Coração , Hipertensão , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Feminino , Transplante de Coração/efeitos adversos , Hospitalização , Humanos , Prevalência , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Durable mechanical circulatory support (MCS) therapy improves survival in patients with advanced heart failure. Knowledge regarding the outcomes experienced by patients with inflammatory cardiomyopathy (CM) who receive durable MCS therapy is limited. METHODS AND RESULTS: We compared patients with inflammatory CM with patients with idiopathic dilated CM enrolled in the STS-INTERMACS registry. Among 19,012 patients, 329 (1.7%) had inflammatory CM and 5978 had idiopathic dilated CM (31.4%). The patients with inflammatory CM were younger, more likely to be White, and women. These patients experienced more preoperative arrhythmias and higher use of temporary MCS. Patients with inflammatory CM had a higher rate of early adverse events (<3 months after device implant), including bleeding, arrhythmias, non-device-related infections, neurologic dysfunction, and respiratory failure. The rate of late adverse events (≥3 months) was similar in the 2 groups. Patients with inflammatory CM had a similar 1-year (80% vs 84%) and 2-year (72% vs 76%, Pâ¯=â¯.15) survival. Myocardial recovery resulting in device explant was more common among patients with inflammatory CM (5.5% vs 2.3%, P < .001). CONCLUSIONS: Patients with inflammatory CM who received durable MCS appear to have a similar survival compared with patients with idiopathic dilated CM despite a higher early adverse event burden. Our findings support the use of durable MCS in an inflammatory CM population.
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Insuficiência Cardíaca , Coração Auxiliar , Miocardite , Feminino , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Coração Auxiliar/efeitos adversos , Humanos , Miocardite/etiologia , Sistema de Registros , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Many patients with American College of Cardiology/American Heart Association Stage D (advanced) heart failure are discharged home on chronic intravenous inotropic support (CIIS) as bridge to surgical therapy or as palliative therapy. This study analyzed the clinical trajectory of patients with advanced heart failure who were on home CIIS. METHODS: We conducted a single-institution, retrospective cohort study of patients on CIIS between 2010 and 2016 (nâ¯=â¯373), stratified by indication for initiation of inotropic support. Study outcomes were time from initiation of CIIS to cessation of therapy, time to death for patients who did not receive surgical therapy and rates of involvement with palliative care. RESULTS: Overall, patients received CIIS therapy for an average of 5.9 months (standard deviation [SD] 7.3). Patients on CIIS as palliative therapy died in an average of 6.2 months (SD 6.6) from the time of initiation of CIIS, and those on CIIS as bridge therapy who did not ultimately receive surgical therapy died after an average of 8.6 months (SD 9.3). Patients who received CIIS as bridge therapy were significantly less likely to receive palliative-care consultation than those on inotropes as palliative therapy, whether or not they underwent surgery. CONCLUSIONS: In this large cohort of patients with advanced HF, patients who on CIIS as palliative therapy survived for 6.2 months, on average, with wide variation among patients. Patients who were on CIIS as bridge therapy but did not ultimately receive surgical therapy received less palliative care despite the high mortality rate in this subgroup.
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Fármacos Cardiovasculares , Insuficiência Cardíaca , Cardiotônicos/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Cuidados Paliativos , Estudos RetrospectivosRESUMO
BACKGROUND/PURPOSE: The aim of this study is to characterize the pattern and the severity of coronary artery lesions in cardiac amyloidosis. METHODS: We retrospectively compared patients with heart failure who tested positive (i.e., biopsy or gene tests - HF/CA+) against those who tested negative (HF/CA-) for cardiac amyloidosis. Groups were compared demographically and angiographically for qualitative and quantitative variables to determine patterns of involvement in the major epicardial coronary vessels. RESULTS: The study included 110 heart failure patients, of whom 55 patients (88 lesions) were in the HF/CA+ group, and 55 patients (66 lesions) were HF/CA-. Despite the advanced age of HF/CA+ patients (74.5 ± 11.0 years vs. 54.1 ± 15.0 years; p = 0.05), no severe calcification was found in the HF/CA+ group (0.0% vs. 4.5%; p = 0.018). The HF/CA+ group also had fewer ostial lesions (3.4% vs. 15.1%; p = 0.0095) and a higher, albeit not significant, Thrombolysis in Myocardial Infarction frame count (30.4 ± 12.6 vs. 26.6 ± 11 frames; p = 0.06). In the HF/CA+ group, men had a significant number of tandem lesions compared to women (14.5% vs 0.0%, p = 0.02). CONCLUSIONS: Overall, heart failure patients with cardiac amyloidosis were older but were found to have less calcified lesions, less ostial involvement, and a reduced anterograde coronary blood flow. This is the first report examining coronary lesions in heart failure patients with cardiac amyloidosis.