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1.
J Card Fail ; 2024 Mar 21.
Artigo em Inglês | MEDLINE | ID: mdl-38521486

RESUMO

BACKGROUND: Patients with left ventricular assist devices (LVADs) require interruption of warfarin for invasive procedures, but parenteral bridging is associated with many complications. Four-factor prothrombin complex concentrate (4F-PCC) can temporarily restore hemostasis in patients undergoing anticoagulation with warfarin. OBJECTIVES: This pilot study evaluated the strategy of using variable-dose 4F-PCC to immediately and temporarily reverse warfarin before invasive procedures without holding warfarin in patients with LVADs. The duration of effect of 4F-PCC on factor levels and time to reestablish therapeutic anticoagulation post procedure were assessed. METHODS: Adult patients with LVADs and planned invasive procedures were enrolled from a single center. Warfarin was continued uninterrupted. The 4F-PCC dose administered immediately pre-procedure was based on study protocol. International normalized ratio (INR)- and vitamin K-dependent factor levels were collected before and during the 48 hours after 4F-PCC administration. The use of parenteral bridging, International Society for Thrombosis and Haemostasis major and clinically relevant nonmajor bleeding (CRNMB) and thromboembolic events at 7 and 30 days were collected. RESULTS: In 21 episodes of 4F-PCC reversal, median baseline INR was 2.7 (IQR 2.2-3.2). The median dosage of 4F-PCC administered was 1794 units (IQR 1536-2130). At 24 and 48 hours post 4F-PCC administration, median INRs were 1.8 (IQR 1.7-2.0) and 2.0 (IQR 1.9-2.4). Two patients required postoperative bridging. One patient experienced major bleeding within 72 hours, and 2 experienced CRNMB within 30 days. There were no thromboembolic events. Baseline and post 4F-PCC vitamin K-dependent factor levels corresponded with changes in INR values. The median time to achieve therapeutic INR post-procedure was 2.5 days (IQR, 1-4). CONCLUSION: Administration of 4F-PCC for temporary reversal of warfarin for invasive procedures in patients with LVADs allowed for continued warfarin dosing with minimal use of post-intervention bridging, limited bleeding and no thromboembolic events.

2.
Transplantation ; 107(4): 961-969, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36525554

RESUMO

BACKGROUND: The DONATE HCV trial demonstrated the safety and efficacy of transplanting hearts from hepatitis C viremic (HCV+) donors. In this report, we examine the cost-effectiveness and impact of universal HCV+ heart donor eligibility in the United States on transplant waitlist time and life expectancy. METHODS: We developed a microsimulation model to compare 2 waitlist strategies for heart transplant candidates in 2018: (1) status quo (SQ) and (2) SQ plus HCV+ donors (SQ + HCV). From the DONATE HCV trial and published national datasets, we modeled mean age (53 years), male sex (75%), probabilities of waitlist mortality (0.01-0.10/month) and transplant (0.03-0.21/month) stratified by medical urgency, and posttransplant mortality (0.003-0.052/month). We assumed a 23% increase in transplant volume with SQ + HCV compared with SQ. Costs (2018 United States dollar) included waitlist care ($2200-190 000/month), transplant ($213 400), 4-wk HCV treatment ($26 000), and posttransplant care ($2500-11 300/month). We projected waitlist time, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs [$/QALY, discounted 3%/year]; threshold ≤$100 000/QALY). RESULTS: Compared with SQ, SQ + HCV decreased waitlist time from 8.7 to 6.7 months, increased undiscounted life expectancy from 8.9 to 9.2 QALYs, and increased discounted lifetime costs from $671 400/person to $690 000/person. Four-week HCV treatment comprised 0.5% of lifetime costs. The ICER of SQ + HCV compared with SQ was $74 100/QALY and remained ≤$100 000/QALY with up to 30% increases in transplant and posttransplant costs. CONCLUSIONS: Transplanting hearts from HCV-infected donors could decrease waitlist times, increase life expectancy, and be cost-effective. These findings were robust within the context of current high HCV treatment costs.


Assuntos
Hepatite C Crônica , Hepatite C , Humanos , Masculino , Estados Unidos , Pessoa de Meia-Idade , Antivirais/uso terapêutico , Análise Custo-Benefício , Hepatite C/diagnóstico , Hepatite C/tratamento farmacológico , Hepacivirus , Doadores de Tecidos , Anos de Vida Ajustados por Qualidade de Vida , Hepatite C Crônica/tratamento farmacológico
3.
J Heart Lung Transplant ; 41(2): 174-186, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34922821

RESUMO

BACKGROUND: The clinical and cost-effectiveness of left ventricular assist device (LVAD) therapy for patients with advanced heart failure (HF) who are ineligible for heart transplantation is debated in the UK. This study develops an indirect comparison between the fully magnetically levitated HeartMate 3 (HM 3) LVAD and medical therapy (MT) to evaluate expected clinical and cost-effectiveness in the UK National Health Service (NHS) context. METHODS: We performed an economic analysis comparing the HM3 pump against the HeartMate II LVAD (MOMENTUM 3), and then another analysis comparing MT with the first- and second-generation HeartMate XVE pump LVAD and HeartMate II LVAD for the same patient population (REMATCH and ROADMAP, respectively). By bridging those 2 analyses, an indirect comparison between HM3 and MT in the form of a network meta-analysis was developed. A literature search was performed to select the most appropriate pair of studies for this purpose. Outcomes were adjusted to produce Kaplan-Meier curves for the cost-effectiveness evaluation by using a decision-analytic model. Data were extrapolated linearly over a 5-year time horizon. Uncertainty and additional scenarios were addressed by one-way and probabilistic sensitivity analysis. Local costs and health utility were used from England, thereby representing the UK context. RESULTS: The incremental cost-effectiveness ratio (ICER) for LVAD vs MT in transplant ineligible patients with advanced HF was estimated to be £47,361 per quality-adjusted life year gained, with a 97.1% probability of being cost-effective at £50,000. In a subgroup of patients who are inotropic therapy dependent (INTERMACS 1-3 severity profile), the ICER was £45,616, while for a population with less-ill ambulatory HF (INTERMACS profile 4-7) the ICER changed to £64,051. CONCLUSIONS: This study provides evidence that HM3 LVAD therapy in advanced HF patients ineligible for heart transplantation may be cost-effective compared to MT in the NHS UK-England context. The ICER is lowest for patients dependent on inotropic support, but exceeds the willingness to pay threshold of £50,000 in ambulatory noninotropic therapy dependent advanced HF patients.


Assuntos
Técnicas de Apoio para a Decisão , Custos de Cuidados de Saúde , Insuficiência Cardíaca/terapia , Transplante de Coração , Coração Auxiliar/economia , Medicina Estatal/economia , Transplantados , Análise Custo-Benefício , Feminino , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Reino Unido/epidemiologia , Função Ventricular Esquerda/fisiologia
4.
J Heart Lung Transplant ; 40(5): 323-333, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33744086

RESUMO

BACKGROUND: Several distinctly engineered left ventricular assist devices (LVADs) are in clinical use. However, contemporaneous real world comparisons have not been conducted, and clinical trials were not powered to evaluate differential survival outcomes across devices. OBJECTIVES: Determine real world survival outcomes and healthcare expenditures for commercially available durable LVADs. METHODS: Using a retrospective observational cohort design, Medicare claims files were linked to manufacturer device registration data to identify de-novo, durable LVAD implants performed between January 2014 and December 2018, with follow-up through December 2019. Survival outcomes were compared using a Cox proportional hazards model stratified by LVAD type and validated using propensity score matching. Healthcare resource utilization was analyzed across device types by using nonparametric bootstrap analysis methodology. Primary outcome was survival at 1-year and total Part A Medicare payments. RESULTS: A total of 4,195 de-novo LVAD implants were identified in fee-for-service Medicare beneficiaries (821 HeartMate 3; 1,840 HeartMate II; and 1,534 Other-VADs). The adjusted hazard ratio for mortality at 1-year (confirmed in a propensity score matched analysis) for the HeartMate 3 vs HeartMate II was 0.64 (95% CI; 0.52-0.79, p< 0.001) and for the HeartMate 3 vs Other-VADs was 0.51 (95% CI; 0.42-0.63, p < 0.001). The HeartMate 3 cohort experienced fewer hospitalizations per patient-year vs Other-VADs (respectively, 2.8 vs 3.2 EPPY hospitalizations, p < 0.01) and 6.1 fewer hospital days on average (respectively, 25.2 vs 31.3 days, p < 0.01). The difference in Medicare expenditures, conditional on survival, for HeartMate 3 vs HeartMate II was -$10,722, p < 0.001 (17.4% reduction) and for HeartMate 3 vs Other-VADs was -$17,947, p < 0.001 (26.1% reduction). CONCLUSIONS: In this analysis of a large, real world, United States. administrative dataset of durable LVADs, we observed that the HeartMate 3 had superior survival, reduced healthcare resource use, and lower healthcare expenditure compared to other contemporary commercially available LVADs.


Assuntos
Gastos em Saúde/estatística & dados numéricos , Insuficiência Cardíaca/terapia , Transplante de Coração , Ventrículos do Coração/fisiopatologia , Coração Auxiliar , Pontuação de Propensão , Idoso , Feminino , Seguimentos , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Resultado do Tratamento , Estados Unidos/epidemiologia , Listas de Espera/mortalidade
5.
Curr Opin Organ Transplant ; 26(1): 69-76, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33278151

RESUMO

PURPOSE OF REVIEW: Timely referral of eligible candidates for consideration of advanced therapies, such as a heart transplantation or mechanical circulatory support is essential. The characteristics of heart transplantation candidates have changed significantly over the years, leading to a more complex evaluation process. The present review summarizes recent advances in the evaluation process for heart transplantation eligibility. RECENT FINDINGS: The heart transplantation allocation policy was recently reviewed in the USA in an effort to reduce waitlist mortality and to ensure fair geographic allocation of organs to the sickest patients. Moreover, patients with chronic infectious diseases, as well as malignancies, are being currently considered acceptable candidates for transplantation. Listing practices for heart transplantation vary between programmes, with a greater willingness to consider high-risk candidates at higher-volume centres. SUMMARY: The ultimate decision to place high-risk candidates on the heart transplantation waitlist should be based on a combination of quantitative and qualitative data analysis informed by clinical judgement, and the chronic shortage of organ donors makes this process an important ethical concern for any society. Future guidelines should discuss approaches to achieve fair organ allocation while preserving improved outcomes after transplantation.


Assuntos
Doação Dirigida de Tecido/estatística & dados numéricos , Transplante de Coração/métodos , Obtenção de Tecidos e Órgãos/métodos , Listas de Espera , Alocação de Recursos para a Atenção à Saúde , Transplante de Coração/mortalidade , Humanos , Encaminhamento e Consulta/estatística & dados numéricos , Doadores de Tecidos/estatística & dados numéricos
7.
Circ Heart Fail ; 12(11): e005914, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31718320

RESUMO

BACKGROUND: Center differences in short-term survival after heart transplant (HT) are known. We sought to compare long-term graft survival (freedom from death or retransplantation) at currently active United States HT centers stratified by performance for short-term survival. METHODS: We used the Organ Procurement and Transplant Network database to identify subjects ≥18 years old who received primary HT during 2000 to 2014 at US centers active during 2013 and 2014. Follow-up was available until March 2016. Center case-mix was assessed by computing expected 90-day mortality and short-term performance by 90-day standardized mortality ratio (SMR; observed/expected mortality). Centers were stratified by case-mix as transplanting low-, intermediate-, and high-risk patients and by short-term performance as SMR quintiles. Center-level differences in long-term graft survival were assessed by risk-adjusted, mixed-effects Weibull survival models with center as a random effect. RESULTS: We analyzed 25 467 HT recipients at 96 centers. Those receiving HT at centers with superior (lower) 90-day SMR had longer graft survival (P for trend <0.001). Survival difference among SMR groups remained significant in 90-day conditional survivors (P for trend <0.001). There was significant center-level variation in risk-adjusted graft survival censored at 5 years (P<0.001) and with all follow-up (P<0.001). Adjusting for 90-day SMR was associated with 62% reduction in center variation in 5-year graft survival and 56% reduction in center variation in overall graft survival. CONCLUSIONS: HT recipients at centers with superior short-term outcomes have longer graft survival on long-term follow-up. Allocating resources to improve patient care processes and transplant expertise at high-SMR centers may improve short-term and overall survival after HT.


Assuntos
Sobrevivência de Enxerto , Disparidades em Assistência à Saúde , Transplante de Coração , Avaliação de Processos e Resultados em Cuidados de Saúde , Indicadores de Qualidade em Assistência à Saúde , Sobreviventes , Adolescente , Adulto , Idoso , Bases de Dados Factuais , Feminino , Transplante de Coração/efeitos adversos , Transplante de Coração/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Reoperação , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Adulto Jovem
8.
JACC Heart Fail ; 7(1): 56-62, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30553907

RESUMO

OBJECTIVES: This study examined longitudinal trends in types of payers for adult heart transplantations in the United States. BACKGROUND: In the last decade, volume of heart transplantations in the United States has substantially increased, a trend that has coincided with Medicaid expansion and greater insurance coverage in the general U.S. POPULATION: Limited data are available characterizing the changes in payer mix supporting these recent increases in heart transplantation activity. METHODS: De-identified data were obtained from the Organ Procurement and Transplantation Network for heart transplantation recipients 18 to 64 years of age in the United States between 1997 and 2017. Primary sources of insurance payment were determined at the time of transplantation in aggregate and stratified by sex and race. Changes in volume and payer mix of patients added to the candidate waitlist between 1997 and 2017 were also examined. RESULTS: A total of 36,340 adults from 18 to 64 years of age underwent heart transplantations between 1997 and 2017. Support by public payer insurance increased from 28.2% (in 1997) to a peak of 48.8% (in 2016). Medicaid coverage increased from 9.4% in 1997 to 15.5% in 2007 and remained stable to 2017 (14.7%; ß-coefficient: +0.23% [0.04]; p < 0.001 for trend). Medicare beneficiaries accounted for 18.2% of recipients in 1997, 22% in 2007, and 30.3% in 2016 (ß-coefficient: +0.60% [0.06]; p < 0.001 for trend). The proportion of transplantation candidates receiving Medicare coverage increased over time across all races and both sexes. Similar aggregate patterns were observed in waitlist trends for adult heart transplantation candidates. CONCLUSIONS: Public payer insurance has emerged as an increasingly dominant source of funding for adult heart transplantations in the United States, supporting nearly half of all transplants in 2017.


Assuntos
Financiamento Governamental/tendências , Transplante de Coração/economia , Medicaid/tendências , Medicare/tendências , Adolescente , Adulto , Negro ou Afro-Americano , Feminino , Humanos , Cobertura do Seguro , Seguro Saúde/tendências , Masculino , Pessoa de Meia-Idade , Mecanismo de Reembolso , Fatores Sexuais , Estados Unidos , População Branca , Adulto Jovem
9.
Circulation ; 138(18): 1923-1934, 2018 10 30.
Artigo em Inglês | MEDLINE | ID: mdl-29807933

RESUMO

BACKGROUND: The MOMENTUM 3 trial compares the centrifugal HeartMate 3 (HM3) with the axial HeartMate II (HMII) continuous-flow left ventricular assist system in patients with advanced heart failure, irrespective of the intended goal of therapy. The trial's 2-year clinical outcome (n=366) demonstrated superiority of the HM3 for the primary end point (survival free of a disabling stroke or reoperation to replace or remove a malfunctioning pump). This analysis evaluates health resource use and cost implications of the observed differences between the 2 devices while patients were enrolled in the trial. METHODS: We analyzed all hospitalizations and their associated costs occurring after discharge from the implant hospitalization until censoring (study withdrawal, heart transplantation, and pump exchange with a nonstudy device or death). Each adjudicated episode of hospital-based care was used to calculate costs (device-attributable and non-device-attributable event costs), estimated by using trial data and payer administrative claims databases. Cost savings stratified by subgroups (study outcome [transplant, death, or ongoing on device], intended goal of therapy, type of insurance, or sex) were also assessed. RESULTS: In 366 randomly assigned patients, 361 comprised the as-treated group (189 in the HM3 group and 172 in the HMII group), of whom 337 (177 in the HM3 group and 160 in the HMII group) were successfully discharged following implantation. The HM3 arm experienced fewer total hospitalizations per patient-year (HM3: 2.1±0.2 versus HMII: 2.7±0.2; P=0.015) and 8.3 fewer hospital days per patient-year on average (HM3: 17.1 days versus HMII: 25.5 days; P=0.003). These differences were driven by patients hospitalized for suspected pump thrombosis (HM3: 0.6% versus HMII: 12.5%; P<0.001) and stroke (HM3: 2.8% versus HMII: 11.3%; P=0.002). Controlled for time spent in the study (average cumulative cost per patient-year), postdischarge HM3 arm costs were 51% lower than with the HMII (HM3: $37 685±4251 versus HMII: $76 599±11 889, P<0.001) and similar in either bridge to transplant or destination therapy intent. CONCLUSIONS: In this 2-year outcome economic analysis of the MOMENTUM 3 trial, the HM3 demonstrated a reduction in rehospitalizations, hospital days spent during rehospitalizations, and a significant cost savings following discharge in comparison with the HMII left ventricular assist system, irrespective of the intended goal of therapy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02224755.


Assuntos
Atenção à Saúde/economia , Insuficiência Cardíaca/terapia , Coração Auxiliar/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Custos e Análise de Custo , Feminino , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/patologia , Transplante de Coração , Coração Auxiliar/efeitos adversos , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Acidente Vascular Cerebral/etiologia , Trombose/etiologia , Resultado do Tratamento , Adulto Jovem
10.
J Am Coll Cardiol ; 69(23): 2845-2861, 2017 Jun 13.
Artigo em Inglês | MEDLINE | ID: mdl-28595702

RESUMO

Continuous-flow left ventricular assist devices (LVADs) have revolutionized advanced heart failure care. These compact, fully implantable heart pumps are capable of providing meaningful increases in survival, functional capacity, and quality of life. Implantation volumes continue to grow, but several challenges remain to be overcome before LVADs will be considered as the therapy of choice for all patients with advanced heart failure. They must be able to consistently extend survival for the long term (7 to 10 years), rather than the midterm (3 to 5 years) more typical of contemporary devices; they must incorporate design elements that reduce shear stress and avoid stasis to reduce the frequent adverse events of bleeding, stroke, and pump thrombosis; and they must become more cost-effective. The advancements in engineering, implantation technique, and medical management detailed in this review will highlight the progress made toward achieving lifelong LVAD support and the challenges that remain.


Assuntos
Insuficiência Cardíaca , Qualidade de Vida , Análise Custo-Benefício , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/psicologia , Insuficiência Cardíaca/cirurgia , Coração Auxiliar , Humanos
11.
Am J Cardiol ; 118(9): 1350-1355, 2016 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-27772698

RESUMO

Innovative treatment strategies for decompensated heart failure (HF) are required to achieve cost savings and improvements in outcomes. We developed a decision analytic model from a hospital perspective to compare 2 strategies for the treatment of decompensated HF, ambulatory diuretic infusion therapy, and hospitalization (standard care), with respect to total HF hospitalizations and costs. The ambulatory diuretic therapy strategy included outpatient treatment with high doses of intravenous loop diuretics in a specialized HF unit whereas standard care included hospitalization for intravenous loop diuretic therapy. Model probabilities were derived from the outcomes of patients who were treated for decompensated HF at Brigham and Women's Hospital (Boston, MA). Costs were based on Centers for Medicare and Medicaid reimbursement and the available reports. Based on a sample of patients treated at our institution, the ambulatory diuretic therapy strategy was estimated to achieve a significant reduction in total HF hospitalizations compared with standard care (relative reduction 58.3%). Under the base case assumptions, the total cost of the ambulatory diuretic therapy strategy was $6,078 per decompensation episode per 90 days compared with $12,175 per 90 days with standard care, for a savings of $6,097. The cost savings associated with the ambulatory diuretic strategy were robust against variation up to 50% in costs of ambulatory diuretic therapy and the likelihood of posttreatment hospitalization. An exploratory analysis suggests that ambulatory diuretic therapy is likely to remain cost saving over the long-term. In conclusion, this decision analytic model demonstrates that ambulatory diuretic therapy is likely to be cost saving compared with hospitalization for the treatment of decompensated HF from a hospital perspective. These results suggest that implementation of outpatient HF units that provide ambulatory diuretic therapy to well-selected subgroup of patients may result in significant reductions in health care costs while improving the care of patients across a variety of health care settings.


Assuntos
Assistência Ambulatorial , Insuficiência Cardíaca/tratamento farmacológico , Hospitalização/estatística & dados numéricos , Inibidores de Simportadores de Cloreto de Sódio e Potássio/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/economia , Boston , Árvores de Decisões , Feminino , Insuficiência Cardíaca/economia , Hospitalização/economia , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Inibidores de Simportadores de Cloreto de Sódio e Potássio/administração & dosagem , Inibidores de Simportadores de Cloreto de Sódio e Potássio/economia , Resultado do Tratamento
12.
Am J Manag Care ; 21(1): 39-47, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25880149

RESUMO

OBJECTIVES: To examine comorbidity and therapy use rates in a Medicaid population with heart failure (HF), evaluate hospitalization risk as a function of comorbidity and therapy use, and assess the impact of modification on costs to the Medicaid program. STUDY DESIGN: Historical prospective cohort study. Claims were from adult enrollees in Maryland Medicaid (managed care organization or fee-for-service) diagnosed with HF between 2005 and 2009. METHODS: The end point was first hospitalization after index HF. Average hazard ratios (HRs) were estimated by multivariate weighted Cox regression. Budget impact of modifications was assessed using annual number-needed-to-treat calculations and external estimate of average cost of HF hospitalization. RESULTS: Most patients were >45 years (71%), women (56%), and black (60%). Medication use: beta-blockers (26%), angiotensin-converting enzyme inhibitors and/or angiotensin II receptor antagonists (ACEi/ARBs) (29%), aldosterone antagonists (5%), and others including nitrates-hydralazine (37%). Nearly all (98%) were diagnosed with 1 or more comorbidities. Relative risk of hospitalization was higher with most, but not all, comorbidities investigated. ACEi/ARBs (HR, 0.77; CI, 0.73-0.81), beta-blockers (HR, 0.83; CI, 0.79-0.87), and other cardiovascular drugs (HR, 0.76; CI, 0.72-0.80) had beneficial effects. A 20% increase in the use prevalence of ACEi/ARBs and beta-blockers translated to annual Medicaid savings of at least $85 and $57 per HF patient, respectively. CONCLUSIONS: Findings call attention to comorbidities and optimization of disease-modifying therapy in Medicaid patients with HF. Certain disease-modifying medications mitigated risk, but were used infrequently. Substantive outcome improvement and savings to Medicaid may be achieved with small changes in prescribing rates or comorbidity prevalence.


Assuntos
Fármacos Cardiovasculares/economia , Custos de Cuidados de Saúde , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/economia , Hospitalização/economia , Medicaid/economia , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/farmacologia , Estudos de Casos e Controles , Comorbidade , Feminino , Reforma dos Serviços de Saúde , Necessidades e Demandas de Serviços de Saúde , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Hospitalização/estatística & dados numéricos , Humanos , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Modelos de Riscos Proporcionais , Estudos Prospectivos , Medição de Risco , Estados Unidos
14.
J Heart Lung Transplant ; 33(4): 372-81, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24582837

RESUMO

BACKGROUND: Chronically supported left ventricular assist device (LVAD) patients may be candidates for novel therapies aimed at promoting reverse remodeling and myocardial recovery. However, the effect of hemodynamic unloading with a LVAD on myocardial viability and LV function in chronically supported LVAD patients has not been fully characterized. We aimed to develop a non-invasive imaging protocol to serially quantify native cardiac structure, function, and myocardial viability while at reduced LVAD support. METHODS: Clinically stable (n = 18) ambulatory patients (83% men, median age, 61 years) supported by a HeartMate II (Thoratec, Pleasanton, CA) LVAD (median durations of heart failure 4.6 years and LVAD support 7 months) were evaluated by echocardiography and technetium-99m ((99m)Tc)-sestamibi single photon emission computed tomography (SPECT) imaging at baseline and after an interval of 2 to 3 months. Echocardiographic measures of LV size and function, including speckle tracking-derived circumferential strain, were compared between ambulatory and reduced LVAD support at baseline and between baseline and follow-up at reduced LVAD support. The extent of myocardial viability by SPECT was compared between baseline and follow-up at reduced LVAD support. RESULTS: With reduction in LVAD speeds (6,600 rpm; interquartile range: 6,200, 7,400 rpm), LV size increased, LV systolic function remained stable, and filling pressures nominally worsened. After a median 2.1 months, cardiac structure, function, and the extent of viable myocardium, globally and regionally, was unchanged on repeat imaging while at reduced LVAD speed. CONCLUSIONS: In clinically stable chronically supported LVAD patients, intrinsic cardiac structure, function, and myocardial viability did not significantly change over the pre-specified time frame. Echocardiographic circumferential strain and (99m)Tc-sestamibi SPECT myocardial viability imaging may provide useful non-invasive end points for the assessment of cardiac structure and function, particularly for phase II studies of novel therapies aimed at promoting reverse remodeling and myocardial recovery in LVAD patients.


Assuntos
Ecocardiografia , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/cirurgia , Coração Auxiliar , Hemodinâmica/fisiologia , Contração Miocárdica/fisiologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/fisiopatologia , Sobrevivência de Tecidos/fisiologia , Tomografia Computadorizada de Emissão de Fóton Único , Função Ventricular Esquerda/fisiologia , Idoso , Ecocardiografia Doppler , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Ventrículos do Coração/fisiopatologia , Humanos , Interpretação de Imagem Assistida por Computador , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Tecnécio Tc 99m Sestamibi , Remodelação Ventricular/fisiologia
15.
Vasc Health Risk Manag ; 9: 245-54, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23696706

RESUMO

Low dose aspirin therapy plays a fundamental role in both the primary and secondary prevention of cardiovascular events. Although the evidence using low dose aspirin for secondary prevention is well-established, the decision to use aspirin for primary prevention is based on an evaluation of the patient's risk of cardiovascular events compared to their risk of adverse events, such as bleeding. In addition to the risk of bleeding associated with long term aspirin administration, upper gastrointestinal side effects, such as dyspepsia often lead to discontinuation of therapy, which places patients at an increased risk for cardiovascular events. One option to mitigate adverse events and increase adherence is the addition of esomeprazole to the medication regimen. This review article provides an evaluation of the literature on the concomitant use of aspirin and esomeprazole available through February 2013. The efficacy, safety, tolerability, cost effectiveness, and patient quality of life of this regimen is discussed. A summary of the pharmacokinetic and pharmacodynamic interactions between aspirin and esomeprazole, as well as other commonly used cardiovascular medications are also reviewed. The addition of esomeprazole to low dose aspirin therapy in patients at high risk of developing gastric ulcers for the prevention of cardiovascular disease, significantly reduced their risk of ulcer development. Pharmacokinetic and pharmacodynamic studies suggested that esomeprazole did not affect the pharmacokinetic parameters or the antiplatelet effects of aspirin. Therefore, for those patients who are at a high risk of developing a gastrointestinal ulcer, the benefit of adding esomeprazole likely outweighs the risks of longer term proton pump inhibitor use, and the combination can be recommended. Administering the two agents separately may also be more economical. On the other hand, for those patients at lower risk of developing a gastrointestinal ulcer, both the additional risk and cost make the inclusion of a proton pump inhibitor unwarranted.


Assuntos
Aspirina/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Esomeprazol/uso terapêutico , Gastroenteropatias/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Bomba de Prótons/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Aspirina/efeitos adversos , Aspirina/economia , Aspirina/farmacocinética , Doenças Cardiovasculares/economia , Análise Custo-Benefício , Combinação de Medicamentos , Custos de Medicamentos , Esomeprazol/efeitos adversos , Esomeprazol/economia , Esomeprazol/farmacocinética , Feminino , Gastroenteropatias/induzido quimicamente , Gastroenteropatias/economia , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Seleção de Pacientes , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/economia , Inibidores da Agregação Plaquetária/farmacocinética , Inibidores da Bomba de Prótons/efeitos adversos , Inibidores da Bomba de Prótons/economia , Inibidores da Bomba de Prótons/farmacocinética , Qualidade de Vida , Fatores de Risco , Resultado do Tratamento
17.
J Cardiovasc Med (Hagerstown) ; 13(6): 360-7, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22472850

RESUMO

BACKGROUND: B-type natriuretic peptide (BNP) levels provide diagnostic and prognostic information in heart failure. This study determined the frequency of BNP assessment and analyzed demographic characteristics, clinical variables and the utilization of guideline-recommended heart failure therapies by BNP level in outpatients with reduced left ventricular ejection fraction (LVEF). METHODS AND RESULTS: The IMPROVE HF registry (The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) is a prospective cohort study of patients at least 18 years of age with a LVEF 35% or less and chronic heart failure or previous myocardial infarction (MI) presenting to cardiology and multispecialty practices. The medical records of 15,381 patients were reviewed. BNP was measured in 4213 (27.4%) patients and the median plasma BNP level was 384 pg/ml (interquartile range 158-877 pg/ml). Patients were stratified by plasma BNP measurements into the following tertiles: 219 pg/ml or less, more than 219 to 649 pg/ml, and more than 649 pg/ml. Jugular venous distension, pedal edema, rales and systolic murmur on physical examination and elevated renal function parameters were associated with higher BNP levels. BNP assessment and elevated BNP levels were not associated with greater use of any of the quality of care measures. However, patients with a BNP in the top tertile were less likely to be treated with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or aldosterone antagonists compared with patients with a BNP in the bottom tertile. CONCLUSION: Among practices participating in IMPROVE HF, BNP was not measured in most outpatients with reduced LVEF and chronic heart failure or previous MI. BNP assessment or the BNP level in patients with recorded measurements, with few exceptions, did not impact the utilization of guideline-recommended therapies.


Assuntos
Insuficiência Cardíaca/sangue , Peptídeo Natriurético Encefálico/sangue , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Doença Crônica , Estudos de Coortes , Feminino , Fidelidade a Diretrizes , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Prognóstico , Estudos Prospectivos , Sistema de Registros , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia
20.
Mayo Clin Proc ; 85(2): 180-95, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-20118395

RESUMO

Chronic heart failure (CHF) remains the only cardiovascular disease with an increasing hospitalization burden and an ongoing drain on health care expenditures. The prevalence of CHF increases with advancing life span, with diastolic heart failure predominating in the elderly population. Primary prevention of coronary artery disease and risk factor management via aggressive blood pressure control are central in preventing new occurrences of left ventricular dysfunction. Optimal therapy for CHF involves identification and correction of potentially reversible precipitants, target-dose titration of medical therapy, and management of hospitalizations for decompensation. The etiological phenotype, absolute decrease in left ventricular ejection fraction and a widening of QRS duration on electrocardiography, is commonly used to identify patients at increased risk of progression of heart failure and sudden death who may benefit from prophylactic implantable cardioverter-defibrillator placement with or without cardiac resynchronization therapy. Patients who transition to advanced stages of disease despite optimal traditional medical and device therapy may be candidates for hemodynamically directed approaches such as a left ventricular assist device; in selected cases, listing for cardiac transplant may be warranted.


Assuntos
Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Antagonistas Adrenérgicos beta/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Bloqueadores dos Canais de Cálcio/uso terapêutico , Cardiotônicos/uso terapêutico , Doença Crônica , Desfibriladores Implantáveis , Gastos em Saúde/tendências , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/etiologia , Transplante de Coração , Coração Auxiliar , Hospitalização/tendências , Humanos , Programas de Rastreamento , Prevalência , Prevenção Primária , Prognóstico , Vasodilatadores/uso terapêutico
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