RESUMEN
Whether 30-day modified Rankin Scale (mRS) scores can predict 90-day scores is unclear. This study derived and validated a model to predict ordinal 90-day mRS score in an intracerebral hemorrhage (ICH) population using 30-day mRS values and routinely available baseline variables. Adults enrolled in the Antihypertensive Treatment of Acute Cerebral Hemorrhage-2 (ATACH-2) trial between May 2011 and September 2015 with acute ICH, who were alive at 30 days and had mRS scores reported at both 30 and 90 days were included in this post-hoc analysis. A proportional odds regression model for predicting ordinal 90-day mRS scores was developed and internally validated using bootstrapping. Variables in the model included: mRS score at 30 days, age (years), hematoma volume (cm3), hematoma location (deep [basal ganglia, thalamus], lobar, or infratentorial), presence of intraventricular hemorrhage (IVH), baseline Glasgow Coma Scale (GCS) score, and National Institutes of Health Stroke Scale (NIHSS) score at randomization. We assessed model fit, calibration, discrimination, and agreement (ordinal, dichotomized functional independence), and EuroQol-5D ([EQ-5D] utility weighted) between predicted and observed 90-day mRS. A total of 898/1000 participants were included. Following bootstrap internal validation, our model (calibration slope = 0.967) had an optimism-corrected c-index of 0.884 (95% CI = 0.873-0.896) and R2 = 0.712 for 90-day mRS score. The weighted ĸ for agreement between observed and predicted ordinal 90-day mRS score was 0.811 (95% CI = 0.787-0.834). Agreement between observed and predicted functional independence (mRS score of 0-2) at 90 days was 74.3% (95% CI = 69.9-78.7%). The mean ± SD absolute difference between predicted and observed EQ-5D-weighted mRS score was negligible (0.005 ± 0.145). This tool allows practitioners and researchers to utilize clinically available information along with the mRS score 30 days after ICH to reliably predict the mRS score at 90 days.
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Hemorragias Intracraneales , Humanos , Masculino , Femenino , Anciano , Persona de Mediana Edad , Hemorragia Cerebral/complicaciones , Índice de Severidad de la Enfermedad , Escala de Coma de Glasgow , Pronóstico , Anciano de 80 o más AñosRESUMEN
Previous meta-analyses assessed andexanet alfa (AA) or prothrombin complex concentrate (PCC) products for the treatment of Factor Xa inhibitor (FXaI)-associated major bleeding. However, they did not include recent studies or assess the impact of the risk of bias. We conducted a systematic review with meta-analysis on the effectiveness of AA versus PCC products for FXaI-associated major bleeding, inclusive of the studies' risk of bias. PubMed and Embase were searched for comparative studies assessing major bleeding in patients using FXaI who received AA or PCC. We used the Methodological Index for NOn-Randomized Studies (MINORS) checklist and one question from the Joanna Briggs Institute (JBI) Critical Appraisal of Case Series tool to assess the risk of bias. Random-effects meta-analyses were performed to provide a pooled estimate for the effect of AA versus PCC products on hemostatic efficacy, in-hospital mortality, 30-day mortality, and thrombotic events. Low-moderate risk of bias studies were meta-analyzed separately, as well as combined with high risk of bias studies. Eighteen comparative evaluations of AA versus PCC were identified. Twenty-eight percent of the studies (n = 5) had low-moderate risk and 72% (n = 13) had a high risk of bias. Studies with low-moderate risk of bias suggested improvements in hemostatic efficacy [Odds Ratio (OR) 2.72 (95% Confidence Interval (CI): 1.15-6.44); one study], lower in-hospital mortality [OR 0.48 (95% CI: 0.38-0.61); three studies], and reduced 30-day mortality [OR 0.49 (95% CI: 0.30-0.80); two studies] when AA was used versus PCC products. When studies were included regardless of the risk of bias, pooled effects showed improvements in hemostatic efficacy [OR 1.36 (95% CI: 1.01-1.84); 12 studies] and reductions in 30-day mortality [OR 0.53 (95% CI: 0.37-0.76); six studies] for AA versus PCC. The difference in thrombotic events with AA versus PCC was not statistically significant in the low-moderate, high, or combined risk of bias groups. The evidence from low-moderate quality real-world studies suggests that AA is superior to PCC in enhancing hemostatic efficacy and reducing in-hospital and 30-day mortality. When studies are assessed regardless of the risk of bias, the pooled hemostatic efficacy and 30-day mortality risk remain significantly better with AA versus PCC.
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Factores de Coagulación Sanguínea , Inhibidores del Factor Xa , Factor Xa , Hemorragia , Proteínas Recombinantes , Humanos , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/uso terapéutico , Hemorragia/inducido químicamente , Factor Xa/uso terapéutico , Factor Xa/efectos adversos , Factores de Coagulación Sanguínea/uso terapéutico , Factores de Coagulación Sanguínea/administración & dosificación , Factores de Coagulación Sanguínea/efectos adversos , Proteínas Recombinantes/uso terapéutico , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/administración & dosificación , Mortalidad HospitalariaRESUMEN
The relationship between 30- and 90-day modified Rankin Scale (mRS) scores in intracerebral hemorrhage (ICH) patients was evaluated. This post hoc cohort analysis of the ATACH-2 trial included patients with acute ICH who were alive at 30 days and who had mRS scores reported at 30 and 90 days. The mRS score was then converted to a utility (EuroQol-5 Dimension-3 Level [EQ-5D-3L])-weighted mRS score. After adjustment of 30-day mRS score for key covariates using multivariable ordinal regression, the relationship between 30-day and observed 90-day functional outcome was assessed via absolute difference in the utility-weighted version. Of the 1000 trial subjects, 898 met inclusion criteria. This low-moderate severity ICH cohort had a median baseline GCS score of 15 and median hematoma volume of 9.7 mL. Observed 30-day mRS had the largest association with observed 90-day values (χ2 = 302.9, p < 0.0001). Patients generally either maintained the same mRS scores between 30 and 90 days (48 %) or experienced a 1-point (32 %) or 2-point (10 %) improvement by 90 days. The mean ± standard deviation (SD) EQ-5D-3L at 90 days was 0.67 ± 0.26. Following adjustment, the mean absolute difference between predicted and observed utility-weighted 90-day mRS scores was 0.006 ± 0.13 points and less than the estimated minimal clinically important difference of 0.13 points. The difference in average utility-weighted mRS scores at 30 and 90 days was not clinically relevant, suggesting 30-day score may be a reasonable proxy for 90-day values in patients with ICH when 90-day values are not available.
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Hemorragia Cerebral , Hematoma , Humanos , Hemorragia Cerebral/diagnóstico por imagen , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Utilization of heart from older donors is variable across centers with uncertain outcomes of recipients. We sought to utilize a national registry to examine the usage and outcomes of heart transplant (HT) recipients from older donors. We also explored the impact of current donor heart allocation scheme on the outcomes of hearts from older donors. METHODS: This observational study utilized the United Network for Organ Sharing database between 2015 and 2023 with donors categorized into age <45 years or ≥45 years and evaluated organ disposition and geographical variation. Thirty-day, 1-, and 3-year mortality, and graft failure rates were compared among recipients as per donor age group. We also evaluated annual trends in HT for each group over the follow-up period. RESULTS: A total of 24,966 adult donors were recovered: 3,742 (15.0%) were ≥45 years; 3,349 (15.6%) adults received heart from such donors with significant geographical variation, and a declining utilization in the transplantation rate in current donor allocation system. Donors with age ≥45 years had higher comorbidities and were allotted with a significantly shorter ischemic time to recipients who were significantly less likely to receive temporary mechanical circulatory support and more likely female. Unadjusted and adjusted, 30-day mortality were similar but 1- and 3-year mortality and graft failure rates were significantly higher in recipients of such donors. Spline analysis suggested a higher 1-year mortality risk at older donor age with risk increasing after age 40 years. CONCLUSIONS: Older donor age was associated with worsened 1- and 3-year mortality and graft failure for heart transplant recipients.
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Trasplante de Corazón , Donantes de Tejidos , Obtención de Tejidos y Órganos , Humanos , Trasplante de Corazón/mortalidad , Persona de Mediana Edad , Masculino , Femenino , Adulto , Donantes de Tejidos/estadística & datos numéricos , Factores de Edad , Estados Unidos/epidemiología , Sistema de Registros , Anciano , Tasa de Supervivencia/tendencias , Estudios Retrospectivos , Estudios de SeguimientoRESUMEN
BACKGROUND: Advancing age is a risk factor for developing non-valvular atrial fibrillation (NVAF) or acute venous thromboembolism (VTE). We assessed the comparative effectiveness, safety, costs, and healthcare utilization associated with rivaroxaban versus warfarin in patients of advanced age managed in the United States (US). METHODS: We conducted a systematic review of Medline and Embase through April 2023 to identify real-world evidence (RWE) studies of older adults (at least 65+ years of age) with either NVAF or VTE who received either rivaroxaban or warfarin in the US and reported an outcome of stroke or systemic embolism (SSE), ischemic stroke (IS), recurrent VTE, major bleeding, intracranial hemorrhage, costs, or healthcare resource utilization. We classified each outcome of interest per study as "positive" (lower risk), "negative" (higher risk), or "neutral" based upon the summary effect size of rivaroxaban versus warfarin. RESULTS: Twenty-nine RWE studies met inclusion criteria, mostly (83%) in NVAF populations. For SSE with rivaroxaban versus warfarin, 68.8% of studies showed positive effects and 31.2% showed neutral outcome. For major bleeding, 57.7% showed neutral effects, 38.5% showed negative effects, and 3.8% of studies showed positive effects with rivaroxaban versus warfarin. Of the two studies reporting cost data, both were positive, showing lower costs for SSE for rivaroxaban versus warfarin and neutral cost for major bleeding costs. CONCLUSIONS: This systematic review supports findings from subgroup analyses of randomized controlled trials that, compared with warfarin, rivaroxaban is associated with generally neutral or positive effects on thrombosis and a mixed picture on bleeding outcomes in older adults with either NVAF or VTE treated in the United States.
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Fibrilación Atrial , Embolia , Accidente Cerebrovascular , Tromboembolia Venosa , Trombosis de la Vena , Humanos , Estados Unidos , Anciano , Warfarina , Rivaroxabán , Fibrilación Atrial/complicaciones , Anticoagulantes , Estudios Retrospectivos , Accidente Cerebrovascular/etiología , HemorragiaRESUMEN
INTRODUCTION: The advancement of artificial intelligence (AI) has aided clinicians in the interpretation of electrocardiograms (ECGs) serving as an essential tool to provide rapid triage and care. However, in some cases, AI can misinterpret an ECG and may mislead the interpreting physician. Therefore, we aimed to describe the rate of ECG misinterpretation and its potential clinical impact in patient's management. METHODS: We performed a retrospective descriptive analysis of misinterpreted ECGs and its clinical impact from May 28, 2020 to May 9, 2021. An electrophysiologist screened ECGs with confirmed diagnosis of atrial fibrillation (AF), sinus tachycardia (ST), sinus bradycardia (SB), intraventricular conduction delay (IVCD), and premature atrial contraction (PAC) that were performed in the emergency department. We then classified the misinterpreted ECGs as wrongly diagnosed AF, ST, SB, IVCD, or PAC into the correct diagnosis and reviewed the misinterpreted ECGs and medical records to evaluate inappropriate use of antiarrhythmic drugs (AAD), beta-blockers (BB), calcium channel blockers (CCB), anticoagulation, or resource utilization of cardiology and/or electrophysiology (EP) consultation. RESULTS: A total of 4969 ECGs were screened with diagnoses of AF (2282), IVCD (296), PAC (972), SB (895), and ST (638). Among these, 101 ECGs (2.0%) were misinterpreted. Wrongly diagnosed AF (58.4%) was the most common followed by wrongly diagnosed PAC (14.9%), wrongly diagnosed ST (12.9%), wrongly diagnosed IVCD (7.9%), and wrongly diagnosed SB (6.0%). Patients with misinterpreted ECGs were aged 76.6 ± 11.6 years with male (52.5%) predominance and hypertension being the most prevalent (83.2%) comorbid condition. The misinterpretation of ECGs led to the inappropriate use of BB (19.8%), CCB (5.0%), AAD therapy (7.9%), anticoagulation (6.9%) in patients with wrongly diagnosed AF, as well as inappropriate resource utilization including cardiology (41.6%) and EP (8.9%) consultations. CONCLUSIONS: Misinterpretation of ECGs may lead to inappropriate medical therapies and increased resource utilization. Therefore, it is essential to encourage physicians to carefully examine AI interpreted ECG's, especially those interpreted as having AF.
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Inteligencia Artificial , Fibrilación Atrial , Humanos , Masculino , Estudios Retrospectivos , Fibrilación Atrial/diagnóstico , Antiarrítmicos/uso terapéutico , Electrocardiografía , Bloqueo Cardíaco , AnticoagulantesRESUMEN
OBJECTIVE: To determine the effects of intensive systolic blood pressure (SBP) lowering on the risk of major adverse kidney outcomes in people with type 2 diabetes mellitus (T2DM) and/or prediabetes and cardiovascular risk factors. RESEARCH DESIGN AND METHODS: This post hoc ACCORD-BP subgroup analysis included participants in the standard glucose-lowering arm with cardiovascular risk factors required for SPRINT eligibility. Cox proportional hazards regression models compared the hazard for the composite of dialysis, kidney transplant, sustained estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2, serum creatinine >3.3 mg/dL, or a sustained eGFR decline ≥57% between the intensive (<120 mmHg) and standard (<140 mmHg) SBP-lowering arms. RESULTS: The study cohort included 1,966 SPRINT-eligible ACCORD-BP participants (40% women) with a mean age of 63 years. The mean SBP achieved after randomization was 120 ± 14 and 134 ± 15 mmHg in the intensive and standard arms, respectively. The kidney composite outcome occurred at a rate of 9.5 and 7.2 events per 1,000 person-years in the intensive and standard BP arms (hazard ratio [HR] 1.35 [95% CI 0.85-2.14]; P = 0.20). Intensive SBP lowering did not affect the risk of moderately (HR 0.96 [95% CI 0.76-1.20]) or severely (HR 0.92 [95% CI 0.66-1.28]) increased albuminuria. Including SPRINT participants with prediabetes in the cohort did not change the overall results. CONCLUSIONS: This post hoc subgroup analysis suggests that intensive SBP lowering does not increase the risk of major adverse kidney events in individuals with T2DM and cardiovascular risk factors.
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Diabetes Mellitus Tipo 2 , Hipertensión , Fallo Renal Crónico , Estado Prediabético , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Antihipertensivos/uso terapéutico , Presión Sanguínea , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipertensión/tratamiento farmacológico , Riñón , Estado Prediabético/tratamiento farmacológico , Factores de Riesgo , Resultado del Tratamiento , Estudios de CohortesRESUMEN
OBJECTIVE: We evaluated whether the new allocation system altered induction practice patterns and affected outcomes in adult HT recipients. DESIGN: Retrospective, observational, cohort study. DATA SOURCE: This study used data from the United Network for Organ Sharing (UNOS) database. PATIENTS: We included adults (18+ years of age) who had undergone HT and received induction immunosuppression and were stratified based on surgery being before (January 1, 2015-May 31, 2018) and after (May 1, 2018-December 31, 2021) the UNOS allocation policy change. MEASUREMENTS: Outcomes of 30-day mortality, 1-year mortality, and 1-year graft failure were compared between those transplanted before and after the policy change through risk-adjusted Cox proportional hazards models while drug-treated rejection in the first year was compared using multiple logistic regression. RESULTS: Of the 7845 HT recipients who received induction therapy, 5070 (64.6%) were transplanted before and 2775 (35.4%) after the UNOS policy change. The most used induction agents were basiliximab (56.0%) and thymoglobulin (39.3%), with thymoglobulin used more often in the new (43.1%) than old system (37.2%; p < 0.001). Among adult HT recipients who received induction, risk-adjusted hazards of 30-day mortality (HR 0.89, 95% CI 0.67-1.18), 1-year mortality (HR 1.00, 95% CI 0.84-1.19), and 1-year graft failure (HR 0.83, 95% CI 0.60-1.15) were similar between the old and new systems. Conversely, the adjusted odds of drug-treated rejection in the first year was lower in the new system (OR 0.52, 95% CI 0.38-0.72). CONCLUSIONS: HT recipients in the new allocation system were more likely to receive thymoglobulin induction, which may be associated with a reduced risk of drug-treated rejection.
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Trasplante de Corazón , Inmunosupresores , Adulto , Humanos , Estudios de Cohortes , Rechazo de Injerto/prevención & control , Supervivencia de Injerto , Terapia de Inmunosupresión , Inmunosupresores/uso terapéutico , Estudios Retrospectivos , Receptores de TrasplantesRESUMEN
Complementary and alternative medicines (CAM) are commonly used across the world by diverse populations and ethnicities but remain largely unregulated. Although many CAM agents are purported to be efficacious and safe by the public, clinical evidence supporting the use of CAM in heart failure remains limited and controversial. Furthermore, health care professionals rarely inquire or document use of CAM as part of the medical record, and patients infrequently disclose their use without further prompting. The goal of this scientific statement is to summarize published efficacy and safety data for CAM and adjunctive interventional wellness approaches in heart failure. Furthermore, other important considerations such as adverse effects and drug interactions that could influence the safety of patients with heart failure are reviewed and discussed.
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Terapias Complementarias , Insuficiencia Cardíaca , Estados Unidos , Humanos , American Heart Association , Insuficiencia Cardíaca/terapiaRESUMEN
Purpose: Malignancy after heart transplantation is associated with poor outcomes. At present, no prediction model exists for any malignancy within the first year after transplant. Methods: We studied adults who underwent heart transplantation included in the multicenter, national Scientific Registry of Transplant Recipients from January 2000 through April 2021. Possible predictors of malignancy were identified based on their known association with malignancy. Multiple imputations were conducted for missing values using predictive mean matching. A multivariable logistic regression model for predicting malignancy development within the first year after transplant was developed and internally validated via 500 bootstrapped samples to estimate the optimism-corrected measures of model accuracy and performance. Results: Among the 47 212 recipients comprising 16% females, 76% whites, 7% with prior malignancy, and a median age of 56 years; 865 (2.3% of those with non-missing data) developed malignancy within the first year after transplant. Prior malignancy, older age at heart transplantation, white race, and nonischemic heart failure etiology were the strongest predictors of new malignancy. The optimism-corrected model had modest discrimination (C-statistic: 0.70, 95% CI: 0.69-0.72) and good calibration and performance (calibration slope: 0.96; Cox-Snell R2: 0.063), particularly at lower predicted risk. A nomogram for the practicing clinician was developed. Conclusions: Using selection variables previously linked to cutaneous malignancy, our model was modestly predictive of the development of any malignancy in the first year after heart transplantation. Future research could identify factors that may improve malignancy prediction, including incorporation of time-to-event data.
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Trasplante de Corazón , Neoplasias , Femenino , Adulto , Humanos , Persona de Mediana Edad , Masculino , Modelos Logísticos , Factores de RiesgoRESUMEN
Coronary allograft vasculopathy (CAV) continues to afflict a high number of heart transplant (HT) recipients, and elevated LDL is a key risk factor. Many patients cannot tolerate statin medications after HT; however, data for alternative agents remains scarce. To address this key evidence gap, we evaluated the safety and efficacy of the PCSK9i after HT through systematic review and meta-analysis. We searched Medline, Cochrane Central, and Scopus from the earliest date through July 15th, 2021. Citations were included if they were a report of PCSK9i use in adults after HT and reported an outcome of interest. Outcomes included change in LDL cholesterol from baseline, incidence of adverse events, and evidence of CAV. Changes from baseline and outcome incidences were pooled using contemporary random-effects model methodologies. A total of six studies including 97 patients were included. Over a mean follow-up of 13 months (range 3-21), PCSK9i use lowered LDL by 82.61 mg/dL (95% CI - 119.15 to - 46.07; I2 = 82%) from baseline. Serious adverse drug reactions were rarely reported, and none was attributable to the PCSK9i therapy. Four studies reported stable calcineurin inhibitor levels during PCSK9i initiation. One study reported outcomes in 33 patients with serial coronary angiography and intravascular ultrasound, and PCSK9i were associated with stable coronary plaque thickness and lumen area. One study reported on immunologic safety, showing no DSA development within 1 month of therapy. Preliminary data suggest that long-term PCSK9i therapy is safe, significantly lowers LDL, and may attenuate CAV after HT. Additional study on larger cohorts is warranted to confirm these findings.
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Trasplante de Corazón , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Inhibidores de PCSK9 , Adulto , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Inhibidores de PCSK9/uso terapéutico , LDL-ColesterolRESUMEN
BACKGROUND: Whether time-in-target range (TTR) for systolic blood pressure (SBP) associates with adverse kidney and cardiovascular events remains incompletely understood. METHODS: This study included participants in 2 clinical trials that compared intensive (<120 mm Hg) and standard (<140 mm Hg) SBP lowering. SBP-TTR for months 0 to 3 was calculated using therapeutic ranges of 110 to 130 mm Hg and 120 to 140 mm Hg for the intensive and standard arms, respectively. Adverse kidney events included the composite of dialysis, kidney transplant, serum creatinine >3.3 mg/dL, sustained eGFR <15 mL/(min·1.73 m2), or sustained eGFR decline >40%. Adverse cardiovascular events included myocardial infarction, stroke, heart failure, and cardiovascular death. Adjusted Cox proportional hazards regression models were used to estimate the association between SBP-TTR and kidney and cardiovascular events. RESULTS: Participants with higher TTR were younger and less likely to have preexisting cardiovascular disease. Compared with participants with TTR of 0%, the risk of adverse kidney events was lower for participants with TTR of >0% to 43% (hazard ratio [95% CI], 0.57 [0.42-0.76]; P<0.001), 43% to <70% (0.57 [0.42-0.78]; P=0.001), 70% to <100% (0.53 [0.38-0.74]; P<0.001), and 100% (0.33 [0.20-0.57]; P<0.001) in fully adjusted models. The risk of major adverse cardiovascular events was lower for participants with TTR of >0% to 43% (0.66 [0.52-0.83]; P=0.001), 43% to <70% (0.70 [0.55-0.90]; P=0.005), 70% to <100% (0.65 [0.50-0.84]; P=0.001), or 100% (0.56 [0.39-0.80]; P=0.001) compared with those with TTR of 0%. CONCLUSIONS: Higher SBP-TTR associates with lower risks of adverse kidney and cardiovascular events in adults with hypertension. SBP-TTR may be a potential therapeutic target and quality metric.
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Enfermedades Cardiovasculares , Hipertensión , Infarto del Miocardio , Adulto , Humanos , Presión Sanguínea/fisiología , Hipertensión/complicaciones , Hipertensión/epidemiología , Hipertensión/diagnóstico , Riñón , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/inducido químicamente , Determinación de la Presión Sanguínea , Infarto del Miocardio/tratamiento farmacológico , Antihipertensivos/uso terapéutico , Factores de RiesgoRESUMEN
OBJECTIVES: Body mass index (calculated as kilograms body weight divided by the square of heightin meters) is a known predictor of mortality after adult heart transplant but has limitations.We investigated whether inclusion of an explicit weight-height interaction effect improves prediction of mortality after heart transplant compared with body mass index. METHODS AND RESULTS: We included a cohort of 46424 adults who had undergone heart transplant as documented in the United Network for Organ Sharing database. Risk-adjusted prediction models for 1-year and 5-year mortality were constructed, one with the flexible weight-height interaction and the other with the body mass index. Overall model performance (R2) and discrimination (the Harrell concordance probability C index and the Somers Dxy rank correlation) were calculated. Compared with the body mass index model, the weight-height model had slightly improved overall performance (R2, 0.316 vs 0.313) and 1-year mortality discrimination (optimism- corrected Harrell C, 0.642 vs 0.640; Somers Dxy, 0.284 vs 0.281). Compared with the body mass index model, the weight-height model had improved overall performance (R2, 0.232 vs 0.224) and similar discrimination (optimism-corrected Harrell C, 0.600 vs 0.599; Somers Dxy, 0.200 vs 0.197) for 5-year mortality. CONCLUSIONS: Allowance for a flexible relationship between height and weight did not appreciably improve mortality prediction after heart transplant, versus body mass index, although additionalresearch is warranted.
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Estatura , Trasplante de Corazón , Adulto , Índice de Masa Corporal , Peso Corporal , Trasplante de Corazón/efectos adversos , Humanos , Resultado del TratamientoRESUMEN
INTRODUCTION: Utilization of hearts from donors with significant renal dysfunction and the impact of donor renal function on outcomes following heart transplant (HT) is unknown. We sought to investigate the trends, characteristics and outcomes associated with these donor hearts and the impact of donor renal function on survival and graft failure in adult HT recipients. METHODS: We reviewed the Scientific Registry of Transplant Recipients (SRTR) and summarized trends, characteristics and outcomes of hearts from adult donors by renal impairment. Single-organ HTs were evaluated and stratified by donors with estimated glomerular filtration rate (eGFRs) < and ≥30 ml/min. We constructed Cox proportional hazards regression models to compare time-to-mortality over 30-day, 1-, 3-, and 5-year time-horizons between groups, and the association of donor eGFR group with graft failure. RESULTS: A total of 162,586 adults were evaluated for cardiac donation, of which, 22,780 (14%) had an eGFR ≤ 30 ml/min. Donors with an eGFR ≤ 30 ml/min increased over time, from 7.2% (358/4966) in 2000 to a high of 19.5% (2283/11,728) in 2020. Such donors were significantly more likely discarded (not offered (7.9% vs. 9.8%, p < .001) or accepted (62.6% vs. 72.2%, p < .001), and less likely to be transplanted (18.0 % vs. 29.5%; p < .001). Of 41,044 HT recipients, 3906 (9.5%) had hearts from such donors. Primary graft failure was similar between groups (OR 1.20, 95% CI .91-1.58; p = .1) while adjusted mortality was lower for recipients from donors with eGFR ≤ 30 ml/min. CONCLUSIONS: More than two-third of hearts from donors with renal dysfunction are discarded. Recipients from donors with renal dysfunction sustained lower mortality post HT during the study period. Increased evaluation and utilization of donors with renal dysfunction has the potential to expand the critically low donor pool.
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Trasplante de Corazón , Enfermedades Renales , Adulto , Tasa de Filtración Glomerular , Supervivencia de Injerto , Humanos , Donantes de Tejidos , Receptores de Trasplantes , Resultado del TratamientoRESUMEN
OBJECTIVE: To perform a systematic literature review and indirect treatment comparison (ITC) to identify, summarize and quantify randomized controlled trial (RCT) evidence evaluating combination anticoagulant or P2Y12 inhibitor with low-dose aspirin versus low-dose aspirin alone for the prevention of atherothrombotic events in patients with stable coronary artery disease (CAD) and/or peripheral artery disease (PAD). METHODS: We performed an updated search of CENTRAL, MEDLINE and EMBASE through 23 August 2021 to identify RCTs of adult patients with chronic CAD and/or PAD that compared combination anticoagulant or P2Y12 inhibitor with low-dose aspirin to low-dose aspirin alone. Outcomes of interest included major adverse cardiovascular events (MACEs) including cardiovascular death, stroke, or myocardial infarction (MI) and bleeding. When needed, outcomes were pooled using random-effects models to generate hazard or risk ratios (HRs or RRs) and accompanying 95% confidence intervals (CIs). Adjusted ITCs using subsequent pooled HRs/RRs were then performed. RESULTS: Six publications reporting the results of two unique RCTs (one evaluating clopidogrel + aspirin vs. aspirin alone and the other rivaroxaban 2.5 mg twice daily + aspirin vs. aspirin alone) were analyzed. The ITC suggested that rivaroxaban + aspirin was associated with a lower risk of MACEs compared with clopidogrel + aspirin (HR = 0.82, 95% CI = 0.68-0.98). When looking at the individual components of MACE, rivaroxaban + aspirin was associated with lower risk of cardiovascular death (HR = 0.75, 95% CI = 0.57-0.98) and stroke (RR = 0.67, 95 CI = 0.49-0.93) and similar risk of MI (RR = 0.93, 95% CI = 0.70-1.23) versus clopidogrel + aspirin. No evidence of a difference in moderate-to-severe bleeding, fatal bleeding or intracranial hemorrhage (ICH) was seen between the two treatment strategies. CONCLUSIONS: Compared to clopidogrel + low-dose aspirin, the use of rivaroxaban 2.5 mg twice daily + low-dose aspirin reduced the risk of MACE, CV death and stroke including ischemic stroke in patients with or at high risk for chronic CAD and/or PAD. These benefits of rivaroxaban 2.5 mg twice daily + low-dose aspirin compared to clopidogrel + low-dose aspirin appear to be achieved without significantly increasing patients' risk of moderate-to-severe bleeding, including ICH or fatal bleeding.
Asunto(s)
Enfermedad de la Arteria Coronaria , Enfermedad Arterial Periférica , Adulto , Anticoagulantes/uso terapéutico , Aspirina/uso terapéutico , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Quimioterapia Combinada , Inhibidores del Factor Xa/uso terapéutico , Humanos , Enfermedad Arterial Periférica/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Rivaroxabán/uso terapéuticoRESUMEN
With the implementation of the new heart transplant (HT) allocation system, patients requiring biventricular support systems have the highest priority, a shorter waitlist time, and a higher frequency of HT. However, the short-term and long-term outcomes of such patients are often disputed. Hence, we examined the outcomes of these patients who underwent HT before change in allocation scheme. Additionally, we compared post-HT outcomes of extracorporeal membrane oxygenation (ECMO) with other nondischargeable biventricular (BiVAD) supported patients. We identified adult ECMO or BiVAD supported HT recipients between 2000 and 2018 in the Scientific Registry of Transplant Recipients database. We compared survival with the Kaplan-Meier method. Using overlap propensity score weighting, we constructed Cox proportional hazards regression models to determine the risk-adjusted influence of BiVAD versus ECMO on survival. Of the 730 patients HT recipients; 528 (72.3%) and 202 (27.7%) were bridged with BiVAD and ECMO, respectively. For BiVAD versus ECMO patients, the 30-day, 1-year, 3-year, and 5-year mortality rates were 8.0% versus 14.4%, 16.3% versus 21.3%, 22.4% versus 25.3%, and 26.3% versus 25.7%, respectively. Risk-adjusted post-HT survival of BiVAD and ECMO patients at 30-day (HR 1.24 [95% CI, 0.68-2.27]; P = 0.4863), 1-year (HR 1.29 [95% CI, 0.80-2.09]; P = 0.3009), 3-year (HR 1.27 [95% CI, 0.83-1.94]; P = 0.2801), and 5-year (HR 1.35, 95% CI, 0.90-2.05; P = 0.1501) were similar. Around three-fourth of the ECMO or BiVAD supported patients were alive at 5-years post-HT. The short-term and long-term post-HT survivals of groups were comparable.
Asunto(s)
Insuficiencia Cardíaca , Trasplante de Corazón , Corazón Auxiliar , Adulto , Insuficiencia Cardíaca/cirugía , Humanos , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Objective. To determine the long-term change in the Altmetric Attention Score (AAS) and its components, as well as the impact of higher AAS on citation count for articles published in major pharmacy journals.Methods. This study evaluated articles from pharmacy journals ranked in the top 10% according to their AAS in the year 2017. Correlation between the AAS and number of citations (through November 2020) was assessed using the Spearman's correlation test. A Kruskal-Wallis 1-way analysis of variance was used to compare the AAS across journals.Results. The median three-year AAS and citation count per article was 20 (25th, 75th percentile=15, 28) and 11 (6, 18), respectively. Between November 2018 and November 2020, there was no significant change in the median AAS for the 137 included articles. The only change in the AAS components was an increase in the number of Mendeley readers (22 [13, 34]). The median number of citations per article also increased (8 [4, 14]). We found a significant association between the three-year AAS and the three-year number of citations. The three-year number of Mendeley readers was associated with an increase in the 3-year number of citations. The mean three-year AAS was highest with articles published in the Journal of the American Pharmacists Association, while the mean three-year number of citations was highest for articles published in PharmacotherapyConclusion. Higher AAS scores appear to be associated with the number of citations for articles published in major pharmacy journals within three years of publication.