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2.
J Heart Lung Transplant ; 41(2): 174-186, 2022 02.
Article in English | MEDLINE | ID: mdl-34922821

ABSTRACT

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.


Subject(s)
Decision Support Techniques , Health Care Costs , Heart Failure/therapy , Heart Transplantation , Heart-Assist Devices/economics , State Medicine/economics , Transplant Recipients , Cost-Benefit Analysis , Female , Heart Failure/economics , Heart Failure/epidemiology , Humans , Incidence , Male , Middle Aged , Quality-Adjusted Life Years , United Kingdom/epidemiology , Ventricular Function, Left/physiology
3.
Curr Med Res Opin ; 37(9): 1501-1505, 2021 09.
Article in English | MEDLINE | ID: mdl-34181489

ABSTRACT

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.


Subject(s)
Heart Failure , Heart-Assist Devices , Cost-Benefit Analysis , Follow-Up Studies , Heart Failure/therapy , Heart-Assist Devices/economics , Humans , Patient Readmission , Retrospective Studies , Treatment Outcome
4.
Circ Heart Fail ; 14(5): e008277, 2021 05.
Article in English | MEDLINE | ID: mdl-33993721

ABSTRACT

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.


Subject(s)
Heart Failure/therapy , Heart-Assist Devices/adverse effects , Heart-Assist Devices/economics , Insurance, Health , Medicare/economics , Adult , Aged , Female , Heart Failure/physiopathology , Hospitalization/economics , Humans , Incidence , Insurance, Health/economics , Male , Middle Aged , Registries , Retrospective Studies , United States
5.
Pediatr Transplant ; 25(4): e13975, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33481355

ABSTRACT

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.


Subject(s)
Cardiomyopathy, Dilated/economics , Cardiomyopathy, Dilated/surgery , Cost-Benefit Analysis , Health Care Costs/statistics & numerical data , Heart Failure/economics , Heart Failure/surgery , Heart-Assist Devices/economics , Adolescent , Cardiomyopathy, Dilated/drug therapy , Cardiotonic Agents/economics , Cardiotonic Agents/therapeutic use , Computer Simulation , Heart Failure/drug therapy , Humans , Markov Chains , Models, Economic , Quality-Adjusted Life Years , United States , Watchful Waiting/economics
6.
J Thorac Cardiovasc Surg ; 161(6): 2083-2091.e4, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32249087

ABSTRACT

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.


Subject(s)
Cardiac Surgical Procedures , Heart-Assist Devices , Prosthesis Implantation , Adult , Aged , Cardiac Surgical Procedures/economics , Cardiac Surgical Procedures/mortality , Cardiac Surgical Procedures/statistics & numerical data , Cohort Studies , Female , Heart Ventricles/surgery , Heart-Assist Devices/economics , Heart-Assist Devices/statistics & numerical data , Humans , Male , Middle Aged , Prosthesis Implantation/economics , Prosthesis Implantation/mortality , Prosthesis Implantation/statistics & numerical data , United States
8.
ASAIO J ; 66(10): 1087-1094, 2020.
Article in English | MEDLINE | ID: mdl-33136594

ABSTRACT

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.


Subject(s)
Heart-Assist Devices/adverse effects , Patient Readmission/statistics & numerical data , Postoperative Complications/epidemiology , Aged , Databases, Factual , Female , Heart Failure/surgery , Heart-Assist Devices/economics , Hospital Costs , Hospital Mortality , Humans , Male , Middle Aged , Patient Readmission/economics , Postoperative Complications/etiology , Retrospective Studies
10.
ASAIO J ; 66(8): 862-870, 2020 08.
Article in English | MEDLINE | ID: mdl-32740129

ABSTRACT

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.


Subject(s)
Heart Failure/therapy , Heart-Assist Devices/economics , Cost-Benefit Analysis , Female , Humans , Male , Markov Chains , Medicare , Prospective Studies , Quality of Life , Quality-Adjusted Life Years , United States
11.
Med Eng Phys ; 77: 118-124, 2020 03.
Article in English | MEDLINE | ID: mdl-31924498

ABSTRACT

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.


Subject(s)
Heart-Assist Devices , Pulsatile Flow , Costs and Cost Analysis , Equipment Design , Heart-Assist Devices/economics
12.
Semin Thorac Cardiovasc Surg ; 32(4): 738-746, 2020.
Article in English | MEDLINE | ID: mdl-30308249

ABSTRACT

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.


Subject(s)
Heart Failure/economics , Heart Failure/therapy , Heart-Assist Devices/economics , Hospital Costs , Hospitalization/economics , Prosthesis Implantation/economics , Ventricular Function, Left , Adult , Aged , Cost-Benefit Analysis , Critical Care/economics , Female , Heart Failure/mortality , Heart Failure/physiopathology , Humans , Length of Stay/economics , Male , Medicare/economics , Middle Aged , Patient Readmission/economics , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Prosthesis Implantation/mortality , Recovery of Function , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States
13.
Catheter Cardiovasc Interv ; 95(2): 309-316, 2020 02.
Article in English | MEDLINE | ID: mdl-31638737

ABSTRACT

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.


Subject(s)
Heart Failure/therapy , Heart-Assist Devices , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Shock, Cardiogenic/therapy , Vascular Diseases/epidemiology , Ventricular Function, Left , Adolescent , Adult , Aged , Aged, 80 and over , Databases, Factual , Female , Heart Failure/economics , Heart Failure/mortality , Heart Failure/physiopathology , Heart-Assist Devices/economics , Hospital Costs , Hospital Mortality , Humans , Incidence , Inpatients , Length of Stay , Male , Middle Aged , Prosthesis Design , Prosthesis Implantation/economics , Prosthesis Implantation/mortality , Risk Assessment , Risk Factors , Shock, Cardiogenic/economics , Shock, Cardiogenic/mortality , Shock, Cardiogenic/physiopathology , Time Factors , Treatment Outcome , United States/epidemiology , Vascular Diseases/economics , Vascular Diseases/mortality , Vascular Diseases/therapy , Young Adult
14.
Pediatr Transplant ; 23(8): e13576, 2019 12.
Article in English | MEDLINE | ID: mdl-31535775

ABSTRACT

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.


Subject(s)
Cost-Benefit Analysis , Heart Failure/surgery , Heart Transplantation , Heart-Assist Devices/economics , Adolescent , Child , Child, Preschool , Humans , Preoperative Period , Prosthesis Design , Regional Blood Flow , Young Adult
15.
Pediatr Crit Care Med ; 20(8): 744-752, 2019 08.
Article in English | MEDLINE | ID: mdl-31162368

ABSTRACT

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.


Subject(s)
Heart-Assist Devices/statistics & numerical data , Hospital Mortality , Length of Stay/statistics & numerical data , Adolescent , Child , Child, Preschool , Databases, Factual , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Heart Transplantation/statistics & numerical data , Heart-Assist Devices/adverse effects , Heart-Assist Devices/economics , Hospital Costs/statistics & numerical data , Humans , Infant , Male , Retrospective Studies
17.
Appl Health Econ Health Policy ; 17(4): 421-431, 2019 08.
Article in English | MEDLINE | ID: mdl-30906972

ABSTRACT

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.


Subject(s)
Heart-Assist Devices/economics , Insurance, Health, Reimbursement/economics , Life Expectancy , Prescription Drugs/economics , Australia , Cost-Benefit Analysis , Decision Making , Humans , Insurance, Health
18.
JAMA Cardiol ; 4(2): 153-160, 2019 02 01.
Article in English | MEDLINE | ID: mdl-30698605

ABSTRACT

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 $176 825 ($60 286) and ranged from $122 953 to $271 472 across 106 centers. The difference in price-standardized payments between lowest and highest spending quartiles was $55 446 ($152 714 vs $208 160; 36%; P < .001), with outlier payments making up most of the difference ($42 742; 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 ($53 221; 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.


Subject(s)
Health Expenditures/statistics & numerical data , Heart-Assist Devices/economics , Hospitalization/economics , Medicare/economics , Aged , Female , Heart-Assist Devices/adverse effects , Hospitalization/statistics & numerical data , Humans , Length of Stay/economics , Male , Middle Aged , Outcome Assessment, Health Care , Outliers, DRG/economics , Retrospective Studies , United States/epidemiology
19.
Am J Cardiol ; 123(3): 489-497, 2019 02 01.
Article in English | MEDLINE | ID: mdl-30473325

ABSTRACT

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.


Subject(s)
Cardiac Surgical Procedures/adverse effects , Cardiopulmonary Bypass , Extracorporeal Membrane Oxygenation , Heart-Assist Devices , Intra-Aortic Balloon Pumping , Shock, Cardiogenic/therapy , Age Factors , Aged , Cardiopulmonary Bypass/economics , Cohort Studies , Databases, Factual , Extracorporeal Membrane Oxygenation/economics , Female , Heart-Assist Devices/economics , Hospital Costs/statistics & numerical data , Hospital Mortality , Humans , Intra-Aortic Balloon Pumping/economics , Male , Retrospective Studies , Sex Factors , Shock, Cardiogenic/epidemiology , United States/epidemiology
20.
Surgery ; 164(2): 274-281, 2018 08.
Article in English | MEDLINE | ID: mdl-29885741

ABSTRACT

BACKGROUND: As the technology of ventricular assist devices continues to improve, the morbidity and mortality for patients with a ventricular assist device is expected to approach that of orthotopic heart transplantation. The present study was performed to compare perioperative outcomes, readmission, and resource utilization between ventricular assist device implantation and orthotopic heart transplantation, using a national cohort. METHODS: Patients who underwent either orthotopic heart transplantation or ventricular assist device implantation from 2010 to 2014 in the National Readmission Database were selected. RESULTS: Of the 12,111 patients identified during the study period, 5,440 (45%) received orthotopic heart transplantation, while 6,671 (55%) received ventricular assist devices. Readmissions occurred frequently after ventricular assist device implantation and orthotopic heart transplantation, with greater rates at 30 days (29% versus 24%, P=.005) and 6 months (62% versus 46%, P < .001) for the ventricular assist device cohort. Cost of readmission was greater among ventricular assist device patients at 30 days ($29,115 versus $21,586, P=.0002) and 6 months ($34,878 versus $20,144, P = .0106). CONCLUSION: Readmission rates and costs for patients with a ventricular assist device remain greater than their orthotopic heart transplantation counterparts. Given the projected increases in ventricular assist device utilization and limited transplant donor pool, further emphasis on cost containment and decreased readmissions for patients undergoing a ventricular assist device is essential to the viability of such therapy in the era of value-based health care delivery.


Subject(s)
Heart Transplantation/mortality , Heart-Assist Devices/statistics & numerical data , Patient Readmission/statistics & numerical data , Female , Health Care Costs , Heart Transplantation/economics , Heart-Assist Devices/economics , Humans , Male , Middle Aged , Patient Readmission/economics , Postoperative Complications/epidemiology , Retrospective Studies , United States/epidemiology , Utilization Review
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