RESUMEN
INTRODUCTION: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.
Asunto(s)
Análisis Costo-Beneficio , Oxigenación por Membrana Extracorpórea , Corazón Auxiliar , Choque Cardiogénico , Humanos , Choque Cardiogénico/terapia , Choque Cardiogénico/economía , Oxigenación por Membrana Extracorpórea/economía , Oxigenación por Membrana Extracorpórea/métodos , Corazón Auxiliar/economía , Estudios Prospectivos , Estudios Retrospectivos , Italia , Calidad de Vida , Estudios Multicéntricos como Asunto , Presupuestos , Estudios Observacionales como AsuntoRESUMEN
This study examines whether payments from a left ventricular assist device manufacturer to cardiologists performing percutaneous coronary intervention were associated with any use of the devices.
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Cardiólogos , Insuficiencia Cardíaca , Corazón Auxiliar , Medicare Part B , Humanos , Cardiólogos/economía , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/terapia , Corazón Auxiliar/economía , Corazón Auxiliar/estadística & datos numéricos , Corazón Auxiliar/tendencias , Estados Unidos/epidemiología , Estudios Transversales , Adulto , Persona de Mediana Edad , Masculino , Femenino , Medicare Part B/economía , Medicare Part B/estadística & datos numéricos , Medicare Part B/tendenciasRESUMEN
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.
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Técnicas de Apoyo para la Decisión , Costos de la Atención en Salud , Insuficiencia Cardíaca/terapia , Trasplante de Corazón , Corazón Auxiliar/economía , Medicina Estatal/economía , Receptores de Trasplantes , Análisis Costo-Beneficio , Femenino , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Reino Unido/epidemiología , Función Ventricular Izquierda/fisiologíaRESUMEN
BACKGROUND: Left ventricular assist device (LVAD) implantation improves outcomes in advanced heart failure, however, the optimal frequency of outpatient assessments to improve cost-effectiveness and potentially avert readmissions is unclear. METHODS: To test if varying the frequency of follow-up after LVAD implantation reduces readmissions and improves cost-effectiveness, a less intensive follow-up (LIFU) strategy with scheduled visits at 1 month and then every 6 months was compared to an intensive follow-up (IFU) group with scheduled visits at 1, 2, and 4 weeks, and then every 3 months post-implant. We developed a decision-tree model to evaluate the cost-effectiveness of different follow-up schedules at 3, 6, and 12-months. The readmission rates for LIFU and IFU, along with the associated costs, were estimated using data from the IBM MarketScan Commercial Claims Databases (2015-2018). A total of 349 patients were enrolled, with 193 and 156 in the IFU and LIFU groups. RESULTS: Patients with IFU were found to have a lower risk for readmission at 3 months (HR: 0.69, 95% confidence interval (CI): 0.60-0.79), but this difference diminished overtime at 6 months (HR: 0.84, 95% CI: 0.73-0.96) and 12 months (HR: 0.94, 95% CI: 0.83-1.06). The incremental net benefit of IFU, when compared with LIFU, is greatest in the first 3 months and also diminishes over time (3 months: $19616, 6 months $9257, 12 months $717). CONCLUSIONS: An initial IFU strategy, followed by a period of de-escalation at the 6-month post-implant mark in lower-risk patients, may be a more cost-effective strategy to provide follow-up care while not predisposing patients to a higher risk of readmission.
Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Análisis Costo-Beneficio , Estudios de Seguimiento , Insuficiencia Cardíaca/terapia , Corazón Auxiliar/economía , Humanos , Readmisión del Paciente , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Due to the high cost of left ventricular assist device (LVAD) therapy, payer type may be an important factor in determining eligibility. How payer type influences outcomes after LVAD implantation is unclear. We, therefore, aimed to study the association of health insurance payer type with outcomes after durable LVAD implantation. METHODS: Using STS-INTERMACS (Society of Thoracic Surgeons-Interagency Registry for Mechanically Assisted Circulatory Support), we studied nonelderly adults receiving a durable LVAD from 2016 to 2018 and compared all-cause mortality and postindex hospitalization adverse event episode rate by payer type. Multivariable Fine-Gray and generalized linear models were used to compare the outcomes. RESULTS: Of the 3251 patients included, 26.0% had Medicaid, 24.9% had Medicare alone, and 49.1% had commercial insurance. Compared with commercially insured patients, mortality did not differ for patients with Medicaid (subdistribution hazard ratio, 1.00 [95% CI, 0.75-1.34], P=0.99) or Medicare (subdistribution hazard ratio, 1.09 [95% CI, 0.84-1.41], P=0.52). Medicaid was associated with a significantly lower adjusted incidence rate (incidence rate ratio, 0.88 [95% CI, 0.78-0.99], P=0.041), and Medicare was associated with a significantly higher adjusted incidence rate (incidence rate ratio, 1.16 [95% CI, 1.03-1.30], P=0.011) of adverse event episodes compared with commercially insured patients. CONCLUSIONS: All-cause mortality after durable LVAD implantation did not differ significantly by payer type. Payer type was associated with the rate of adverse events, with Medicaid associated with a significantly lower rate, and Medicare with a significantly higher rate of adverse event episodes compared with commercially insured patients.
Asunto(s)
Insuficiencia Cardíaca/terapia , Corazón Auxiliar/efectos adversos , Corazón Auxiliar/economía , Seguro de Salud , Medicare/economía , Adulto , Anciano , Femenino , Insuficiencia Cardíaca/fisiopatología , Hospitalización/economía , Humanos , Incidencia , Seguro de Salud/economía , Masculino , Persona de Mediana Edad , Sistema de Registros , Estudios Retrospectivos , Estados UnidosRESUMEN
BACKGROUND: In a stable, inotrope-dependent pediatric patient with dilated cardiomyopathy, we evaluated the cost-effectiveness of continuous-flow VAD implantation compared to a watchful waiting approach using chronic inotropic therapy. METHODS: We used a state-transition model to estimate the costs and outcomes of 14-year-old (INTERMACS profile 3) patients receiving either VAD or watchful waiting. We measured benefits in terms of lifetime QALYs gained. Model inputs were taken from the literature. We calculated the ICER, or the cost per additional QALY gained, of VADs and performed multiple sensitivity analyses to test how our assumptions influenced the results. RESULTS: Compared to watchful waiting, VADs produce 0.97 more QALYs for an additional $156 639, leading to an ICER of $162 123 per QALY gained from a healthcare perspective. VADs have 17% chance of being cost-effective given a cost-effectiveness threshold of $100 000 per QALY gained. Sensitivity analyses suggest that VADs can be cost-effective if the costs of implantation decrease or if hospitalization costs or mortality among watchful waiting patients is higher. CONCLUSIONS: As a bridge to transplant, VADs provide a health benefit to children who develop stable, inotrope-dependent heart failure, but immediate implantation is not yet a cost-effective strategy compared to watchful waiting based on commonly used cost-effectiveness thresholds. Early VAD support can be cost-effective in sicker patients and if device implantation is cheaper. In complex conditions such as pediatric heart failure, cost-effectiveness should be just one of many factors that inform clinical decision-making.
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Cardiomiopatía Dilatada/economía , Cardiomiopatía Dilatada/cirugía , Análisis Costo-Beneficio , Costos de la Atención en Salud/estadística & datos numéricos , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/cirugía , Corazón Auxiliar/economía , Adolescente , Cardiomiopatía Dilatada/tratamiento farmacológico , Cardiotónicos/economía , Cardiotónicos/uso terapéutico , Simulación por Computador , Insuficiencia Cardíaca/tratamiento farmacológico , Humanos , Cadenas de Markov , Modelos Económicos , Años de Vida Ajustados por Calidad de Vida , Estados Unidos , Espera Vigilante/economíaRESUMEN
OBJECTIVES: Adoption of implantable left ventricular assist devices has dramatically improved survival and quality of life in suitable patients with end-stage heart failure. In the era of value-based healthcare delivery, assessment of clinical outcomes and resource use associated with left ventricular assist devices is warranted. METHODS: Adult patients undergoing left ventricular assist device implantation from 2008 to 2016 were identified using the National Inpatient Sample. Hospitals were designated as low-volume, medium-volume, or high-volume institutions based on annual institutional left ventricular assist device case volume. Multivariable logistic regression was used to evaluate adjusted odds of mortality across left ventricular assist device volume tertiles. RESULTS: Over the study period, an estimated 23,972 patients underwent left ventricular assist device implantation with an approximately 3-fold increase in the number of annual left ventricular assist device implantations performed (P for trend <.001). In-hospital mortality in patients with left ventricular assist devices decreased from 19.6% in 2008 to 8.1% in 2016 (P for trend <.001) and was higher at low-volume institutions compared with high-volume institutions (12.0% vs 9.2%, P < .001). Although the overall adjusted mortality was higher at low-volume compared with high-volume institutions (adjusted odds ratio, 1.66; 95% confidence interval, 1.28-2.15), this discrepancy was only significant for 2008 and 2009 (low-volume 2008 adjusted odds ratio, 5.5; 95% confidence interval, 1.9-15.8; low-volume 2009 adjusted odds ratio, 2.3; 95% confidence interval, 1.4-3.8). CONCLUSIONS: Left ventricular assist device use has rapidly increased in the United States with a concomitant reduction in mortality and morbidity. With maturation of left ventricular assist device technology and increasing experience, volume-related variation in mortality and resource use has diminished. Whether the apparent uniformity in outcomes is related to patient selection or hospital quality deserves further investigation.
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Procedimientos Quirúrgicos Cardíacos , Corazón Auxiliar , Implantación de Prótesis , Adulto , Anciano , Procedimientos Quirúrgicos Cardíacos/economía , Procedimientos Quirúrgicos Cardíacos/mortalidad , Procedimientos Quirúrgicos Cardíacos/estadística & datos numéricos , Estudios de Cohortes , Femenino , Ventrículos Cardíacos/cirugía , Corazón Auxiliar/economía , Corazón Auxiliar/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Implantación de Prótesis/economía , Implantación de Prótesis/mortalidad , Implantación de Prótesis/estadística & datos numéricos , Estados UnidosAsunto(s)
Insuficiencia Cardíaca/cirugía , Corazón Auxiliar/economía , Cobertura del Seguro/economía , Centers for Medicare and Medicaid Services, U.S./legislación & jurisprudencia , Insuficiencia Cardíaca/economía , Trasplante de Corazón/economía , Trasplante de Corazón/legislación & jurisprudencia , Humanos , Cobertura del Seguro/legislación & jurisprudencia , Estados UnidosRESUMEN
The number of patients with left ventricular assist devices (LVAD) has increased over the years and it is important to identify the etiologies for hospital admission, as well as the costs, length of stay and in-hospital complications in this patient group. Using the National Readmission Database from 2010 to 2015, we identified patients with a history of LVAD placement using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code V43.21. We aimed to identify the etiologies for hospital admission, patient characteristics, and in-hospital outcomes. We identified a total of 15,996 patients with an LVAD, the mean age was 58 years and 76% were males. The most common cause of hospital readmission after LVAD was heart failure (HF, 13%), followed by gastrointestinal (GI) bleed (11.8%), device complication (11.5%), and ventricular tachycardia/fibrillation (4.2%). The median length of stay was 6 days (3-11 days) and the median hospital costs was $12,723 USD. The in-hospital mortality was 3.9%, blood transfusion was required in 26.8% of patients, 20.5% had acute kidney injury, 2.8% required hemodialysis, and 6.2% of patients underwent heart transplantation. Interestingly, the most common cause of readmission was the same as the diagnosis for the preceding admission. One in every four LVAD patients experiences a readmission within 30 days of a prior admission, most commonly due to HF and GI bleeding. Interventions to reduce HF readmissions, such as speed optimization, may be one means of improving LVAD outcomes and resource utilization.
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Corazón Auxiliar/efectos adversos , Readmisión del Paciente/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Anciano , Bases de Datos Factuales , Femenino , Insuficiencia Cardíaca/cirugía , Corazón Auxiliar/economía , Costos de Hospital , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Readmisión del Paciente/economía , Complicaciones Posoperatorias/etiología , Estudios RetrospectivosAsunto(s)
Insuficiencia Cardíaca/terapia , Corazón Auxiliar/estadística & datos numéricos , Medicaid , Implantación de Prótesis/estadística & datos numéricos , Sistema de Registros , Insuficiencia Cardíaca/economía , Corazón Auxiliar/economía , Humanos , Implantación de Prótesis/economía , Estados UnidosRESUMEN
There is limited data on the cost-effectiveness of continuous-flow left ventricular assist devices (LVAD) in the United States particularly for the bridge-to-transplant indication. Our objective is to study the cost-effectiveness of a small intrapericardial centrifugal LVAD compared with medical management (MM) and subsequent heart transplantation using the respective clinical trial data. We developed a Markov economic framework. Clinical inputs for the LVAD arm were based on prospective trials employing the HeartWare centrifugal-flow ventricular assist device system. To better assess survival in the MM arm, and in the absence of contemporary trials randomizing patients to LVAD and MM, estimates from the Seattle Heart Failure Model were used. Costs inputs were calculated based on Medicare claim analyses and when appropriate prior published literature. Time horizon was lifetime. Costs and benefits were appropriately discounted at 3% per year. The deterministic cost-effectiveness analyses resulted in $69,768 per Quality Adjusted Life Year and $56,538 per Life Year for the bridge-to-transplant indication and $102,587 per Quality Adjusted Life Year and $87,327 per Life Year for destination therapy. These outcomes signify a substantial improvement compared with prior studies and re-open the discussion around the cost-effectiveness of LVADs.
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Insuficiencia Cardíaca/terapia , Corazón Auxiliar/economía , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Cadenas de Markov , Medicare , Estudios Prospectivos , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Estados UnidosRESUMEN
In-vitro cardiovascular experiments provide an effective means for characterizing structural or hemodynamic features of medical devices before they are tested on animals or used in clinical practice. In-vitro experiments simulate complicated cardiovascular systems with blood pumps, vessels and valves, but without human or animal subjects. Therefore, such experiments are free from ethical issues and present large cost savings in comparison to in-vivo experiments. In this study, we aimed to design a fully programmable pulsatile flow pump that can consistently and accurately reproduce a wide range of physiological flow waveforms without costly transient flowmeter in the system. An iterative control algorithm (ICA) was used to minimize the differences between the desired and produced flow waveforms. Our results confirm that the developed pulsatile pump can replicate flow waveforms accurately, with root mean square errors (RMSEs) of 0.64 L/min and 0.52 mL for the flow rate and stroke volume, respectively.
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Corazón Auxiliar , Flujo Pulsátil , Costos y Análisis de Costo , Diseño de Equipo , Corazón Auxiliar/economíaRESUMEN
This study aims to identify the major components of left ventricular assist device (LVAD)-related costs in a population on long-term mechanical circulatory support to gain insight into opportunities for improvements in quality, safety, and efficiency of care for end-stage heart failure patients. This was a single institution, retrospective cost analysis of patients who received a Heartmate II or HeartWare LVAD between November 2005 and October 2015. Payments for hospitalization for device implantation and subsequent readmissions were represented as the institution's 2015 Medicare reimbursement rate. The incidence, average Medicare reimbursement, and length of stay of readmissions were analyzed for the first year postimplant. A full year of LVAD-related hospitalizations in patients surviving ≥12 months, has a median Medicare reimbursement of $247,208. The most common complications related to ventricular assist devices were gastrointestinal bleeding, driveline infection, stroke, and pump thrombosis. Over 90% of total costs were incurred during the initial hospitalization. Seventy-five percent of first-time readmissions occurred within the first 4 months post discharge. Intensive care unit costs accounted for the single largest cost category during readmissions for all of the 4 most common complications. The trends demonstrated suggest that longer lengths of LVAD support in appropriately selected patients results in progressively decreasing cost-per-month up to 12 months, given the large upfront cost of device implantation and relatively modest additional costs of readmissions. This analysis emphasizes the importance of devices with improved complication profiles and clinical protocols to reduce unnecessary intensive care unit stays to increase the cost effectiveness of long-term ventricular assist device therapy.
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Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/terapia , Corazón Auxiliar/economía , Costos de Hospital , Hospitalización/economía , Implantación de Prótesis/economía , Función Ventricular Izquierda , Adulto , Anciano , Análisis Costo-Beneficio , Cuidados Críticos/economía , Femenino , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Humanos , Tiempo de Internación/economía , Masculino , Medicare/economía , Persona de Mediana Edad , Readmisión del Paciente/economía , Implantación de Prótesis/efectos adversos , Implantación de Prótesis/instrumentación , Implantación de Prótesis/mortalidad , Recuperación de la Función , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.
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Insuficiencia Cardíaca/terapia , Corazón Auxiliar , Implantación de Prótesis/efectos adversos , Implantación de Prótesis/instrumentación , Choque Cardiogénico/terapia , Enfermedades Vasculares/epidemiología , Función Ventricular Izquierda , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Bases de Datos Factuales , Femenino , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Corazón Auxiliar/economía , Costos de Hospital , Mortalidad Hospitalaria , Humanos , Incidencia , Pacientes Internos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Implantación de Prótesis/economía , Implantación de Prótesis/mortalidad , Medición de Riesgo , Factores de Riesgo , Choque Cardiogénico/economía , Choque Cardiogénico/mortalidad , Choque Cardiogénico/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiología , Enfermedades Vasculares/economía , Enfermedades Vasculares/mortalidad , Enfermedades Vasculares/terapia , Adulto JovenRESUMEN
OBJECTIVE: The initial costs of a CF-VAD exceed those of a PF-VAD. However, the safety profile of CF-VAD is superior and the possibility of outpatient device support may justify the additional initial costs. This study analyzed the cost-utility of CF-VAD use in the pediatric population. METHODS: A Markov-state transition model was constructed for the clinical course of the two VAD subtypes from implantation until death with variables extracted from internal financial records and the published literature. The modeled population consisted of pediatric heart failure patients who met indications for VAD implant (INTERMACS profile 1 or 2) and were size-eligible for either a PF-VAD or CF-VAD. RESULTS: The cost-utility analysis illustrated that CF-VAD is both more effective and less costly compared to PF-VAD at base-case conditions. Sensitivity analyses demonstrated that only in extreme conditions did a CF-VAD strategy not meet criteria for cost-effectiveness (if readmission rate >20% weekly, neurologic event rate >8% weekly, or CF-VAD discharge rates <18% in a month) or VAD support duration shortens to ≤12 weeks. CONCLUSION: While the implantation costs of a CF-VAD exceed those of a PF-VAD, after 12 weeks of device support CF-VAD becomes the more cost-effective strategy if the anticipated outpatient device care is sufficiently long. The cost efficacy of the CF-VAD will be further heightened as initiatives that result in earlier and safer discharges, as well as reductions in readmission rates continue to be successful.
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Análisis Costo-Beneficio , Insuficiencia Cardíaca/cirugía , Trasplante de Corazón , Corazón Auxiliar/economía , Adolescente , Niño , Preescolar , Humanos , Periodo Preoperatorio , Diseño de Prótesis , Flujo Sanguíneo Regional , Adulto JovenRESUMEN
OBJECTIVES: The use of ventricular assist devices for pediatric patients with heart failure is increasing, but is associated with significant morbidity and mortality. Our objectives were to describe the admission outcomes and resource utilization of pediatric patients supported with ventricular assist devices, utilizing a multicenter database. DATA SOURCES: Pediatric Health Information System database (comprising 49 nonprofit children's hospitals). STUDY SELECTION: Retrospective cohort analysis of the database from January 2006 to September 2015 for all admissions less than or equal to 21 years old with ventricular assist device implantation. DATA EXTRACTION: The primary outcome was hospital mortality. The secondary outcomes were hospital length of stay and adjusted cost. DATA SYNTHESIS: We analyzed 744 ventricular assist device implantations (740 patients), 422 (57%) males, and 363 (49%) non-Hispanic white. Median age at admission was 5.9 years (interquartile range, 0.9-13.5 yr), and median length of stay was 69 days (interquartile range, 36-122 d). The overall hospital mortality was 188 (25%), whereas 395 (53%) were transplanted and 141 (19%) were discharged on ventricular assist device. Extracorporeal membrane oxygenation was used, in addition to ventricular assist device, in 340 (46%). The majority of ventricular assist device implantations (453, 61%) were from 2011 to 2015 (compared to 2006-2010). More patients discharged on ventricular assist device from 2011 to 2015 (23% vs 13% in 2006-2010; p = 0.001). There was no difference in median age, mortality, length of stay, or adjusted costs between these time periods. On multivariable analysis, underlying congenital heart disease, renal failure, liver congestion, sepsis, cerebrovascular accident, and extracorporeal membrane oxygenation were associated with hospital mortality. Sepsis and ventricular assist device replacement/repair were associated with higher adjusted cost and longer length of stay. CONCLUSIONS: The pediatric ventricular assist device experience continues to grow, with a significant increase in the number of patients undergoing ventricular assist device implantation and a higher proportion being discharged from hospital on ventricular assist device support in recent years. Underlying congenital heart disease, renal failure, sepsis, cerebrovascular accident, and extracorporeal membrane oxygenation are significantly associated with hospital mortality.
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Corazón Auxiliar/estadística & datos numéricos , Mortalidad Hospitalaria , Tiempo de Internación/estadística & datos numéricos , Adolescente , Niño , Preescolar , Bases de Datos Factuales , Oxigenación por Membrana Extracorpórea/estadística & datos numéricos , Femenino , Trasplante de Corazón/estadística & datos numéricos , Corazón Auxiliar/efectos adversos , Corazón Auxiliar/economía , Costos de Hospital/estadística & datos numéricos , Humanos , Lactante , Masculino , Estudios RetrospectivosRESUMEN
New health technologies often yield health benefits, but often at a high cost. In Australia, the processes for public reimbursement of high-cost pharmaceuticals and medical devices are different, potentially resulting in inequity in support for new therapies. We explore how reimbursement is different for medical devices compared with pharmaceuticals, including whether higher cost-effectiveness thresholds are accepted for pharmaceuticals. A literature review identified the challenges of economic evaluations for medical devices compared with pharmaceuticals. We used the ventricular assist device as a case study to highlight specific features of medical device funding in Australia. We used existing guidelines to evaluate whether ventricular assist devices would fulfil the requirements for the "Life-Saving Drugs Program", which is usually reserved for expensive life-extending pharmaceutical treatments of serious and rare medical conditions. The challenges in conducting economic evaluations of medical devices include limited data to support effectiveness, device-operator interaction (surgical experience) and incremental innovations (miniaturisation). However, whilst high-cost pharmaceuticals may be funded by a single source (federal government), the funding of high-cost devices is complex and may be funded via a combination of federal, state and private health insurance. Based on the Life-Saving Drugs Program criteria, we found that ventricular assist devices could be funded by a similar mechanism to that which funds high-cost life-extending pharmaceuticals. This article highlights the complexities of medical device reimbursement. Whilst differences in available evidence affect the evaluation process, differences in funding methods contribute to inequitable reimbursement decisions between medical devices and pharmaceuticals.
Asunto(s)
Corazón Auxiliar/economía , Reembolso de Seguro de Salud/economía , Esperanza de Vida , Medicamentos bajo Prescripción/economía , Australia , Análisis Costo-Beneficio , Toma de Decisiones , Humanos , Seguro de SaludRESUMEN
Importance: Hospitalizations for durable left ventricular assist device (LVAD) implants are expensive and increasingly common. Insights into center-level variation in Medicare spending for these hospitalizations are needed to inform value improvement efforts. Objective: To examine center-level variation in Medicare spending for durable LVAD implant hospitalizations and its association with clinical outcomes. Design, Setting, and Participants: Retrospective cohort study of linked Medicare administrative claims and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) clinical data comprising 106 centers in the United States providing durable LVAD implant. Centers were grouped into quartiles based on the mean price-standardized Medicare spending of their patients. The study included Medicare beneficiaries receiving primary durable LVAD implant between January 2008 and December 2014. Data were analyzed between November 2017 and October 2018. Main Outcomes and Measures: Price-standardized Medicare payments and clinical outcomes. Overall and component (facility diagnosis-related group payments, outlier payments, physician services) payments and clinical outcomes (postimplant length of stay and adverse events) were compared across payment quartiles. Results: The study sample included 4442 hospitalized patients, with mean (SD) age of 63.0 (10.8) years, 18.7% female, 27.2% nonwhite, and 6.1% Hispanic ethnicity. Among 4442 hospitalizations, the mean (SD) price-standardized Medicare payment was $176â¯825 ($60â¯286) and ranged from $122â¯953 to $271â¯472 across 106 centers. The difference in price-standardized payments between lowest and highest spending quartiles was $55â¯446 ($152â¯714 vs $208â¯160; 36%; P < .001), with outlier payments making up most of the difference ($42â¯742; 77%), followed by DRG ($6929; 13%) and physician services ($5774; 10%). After risk standardization, there was a modest decline in the difference in payments between quartiles ($53â¯221; 35%), with outlier payments accounting for a larger proportion of the difference (84%). After adjusting for patient characteristics, higher price-standardized payment quartiles were associated with longer postimplant length of stay but were not associated with any adverse events. Conclusions and Relevance: Medicare payments for durable LVAD implant hospitalizations vary widely across centers; this was not well explained by prices or case mix. While associated with longer postimplant length of stay, increased spending was not associated with adverse events. As the supply and demand for durable LVAD therapy continues to rise, identifying opportunities to reduce variation in spending from both explained and unexplained sources will ensure high-value use.
Asunto(s)
Gastos en Salud/estadística & datos numéricos , Corazón Auxiliar/economía , Hospitalización/economía , Medicare/economía , Anciano , Femenino , Corazón Auxiliar/efectos adversos , Hospitalización/estadística & datos numéricos , Humanos , Tiempo de Internación/economía , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Acampadores DRG/economía , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
Postcardiac surgery cardiogenic shock (PCCS) is seen in 2% to 6% of patients who undergo cardiac surgery. There are limited large-scale data on the use of mechanical circulatory support (MCS) in these patients. This study sought to evaluate the in-hospital mortality, trends, and resource utilization for PCCS admissions with and without MCS. A retrospective cohort of PCCS between 2005 and 2014 with and without the use of temporary MCS was identified from the National Inpatient Sample. Admissions for permanent MCS and heart transplant were excluded. Propensity-matching for baseline characteristics was performed. The primary outcome was in-hospital mortality and secondary outcomes included trends in use, hospital costs and lengths of stay. In the period between 2005 and 2014, there were 132,485 admissions with PCCS, with 51.3% requiring MCS. The intra-aortic balloon pump was the predominant device used with a steady increase in other devices. MCS use for more frequent in younger patients, males and those with higher co-morbidity. There was a decrease in MCS use across all demographic categories and hospital characteristics over time. Older age, female sex, previous cardiovascular morbidity and MCS use were independently predictive of higher in-hospital mortality. In 6,830 propensity-matched pairs, PCCS admissions that required MCS use, had higher in-hospital mortality (odds ratio 2.4; p<0.001), higher hospital costs ($98,759 ± 907 vs $81,099 ± 698; p<0.001) but not a longer length of stay compared with those without MCS use. In conclusion, in patients with PCCS, this study noted a steady decrease in MCS use. Use of MCS identified PCCS patients at higher risk for in-hospital mortality and greater resource utilization.