Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey.

Decisions to adopt medical devices at the hospital level have consequences for health technology assessment (HTA) on system level and are therefore important to decision makers. Our aim was to investigate the characteristics of organizations and individuals that are more inclined to adopt and utilize cardiovascular devices based on a comprehensive analysis of environmental, organizational, individual, and technological factors and to identify corresponding implications for HTA. Seven random intercept hurdle models were estimated using the data obtained from 1249 surveys completed by members of the European Society of Cardiology. The major findings were that better manufacturer support increased the adoption probability of 'new' devices (i.e. in terms of CE mark approval dates), and that budget pressure increased the adoption probability of 'old' devices. Based on our findings, we suggest investigating the role of manufacturer support in more detail to identify diffusion patterns relevant to HTA on system level, to verify whether it functions as a substitute for medical evidence of new devices, and to receive new insights about its relationship with clinical effectiveness and cost-effectiveness. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

Point-of-care-based protocol with first-line therapy with coagulation factor concentrates is associated with decrease allogenic blood transfusion and costs in cardiovascular surgery: an Italian single-center experience.

BACKGROUND: Transfusion in patients having cardiac surgery has been associated with increased morbidity, mortality, and costs. This analysis assessed the impact of a rotational thromboelastometry (ROTEM®)- and functional platelet assessment (Multiplate®)-based protocol for bleeding management on perioperative outcomes and costs in patients undergoing cardiac surgery. METHODS: This retrospective analysis of the records of all patients who underwent cardiac surgery at the Hesperia Hospital, Modena, Italy, from December 2012 to December 2013 compared outcomes and costs of bleeding management for the two 6-month periods before/after introduction of the ROTEM- and Multiplate-based protocol. Descriptive and correlation analysis were performed as appropriate. Propensity score matching and its correlation analysis were performed. RESULTS: Data from 768 consecutive patients (mean age ~69 years, ~66% male) were included; 50.7% and 49.3% of patients had surgery before and after protocol introduction, respectively. Significantly fewer patients required transfusions of packed red blood cells after the protocol introduction over the 24 hours postsurgery (100 vs. 197 patients; P<0.001) and during ICU stay (134 vs. 221 patients; P<0.001). A significantly greater proportion of patients treated after protocol introduction received prothrombin complex concentrate (31 vs. 16; P<0.05) and fibrinogen concentrate (36 vs. 13; P<0.001). A significantly greater proportion of patients treated after protocol introduction had an ICU stay duration <48 hours (81.5% vs. 71.5%; P<0.001). ROTEM-based bleeding management was associated with a saving of €128,676.23 for the 379 patients undergoing surgery post-protocol introduction (€339.52 per patient). CONCLUSIONS: ROTEM-guided bleeding management in patients undergoing cardiac surgery was cost-effective and associated with an increase of administration of coagulation factor concentrates and a decrease of ICU length of stay.

Reduction in hospital costs and resource consumption associated with the use of advanced topical hemostats during inpatient procedures.

OBJECTIVE: The use of hemostatic agents has increased over time for all surgical procedures. The purpose of this study was to evaluate the newer topical absorbable hemostat products Surgicel * Fibrillar † and Surgicel SNoW ‡ (Surgicel advanced products, abbreviated as SAPs) compared to the older product Surgicel Original (SO) with respect to healthcare resource use and costs in procedures where these hemostats are most commonly used. RESEARCH DESIGN AND METHODS: A retrospective analysis of the Premier hospital database was used to identify adults who underwent brain/cerebral (BC), cardiovascular (CV: valve surgery and coronary artery bypass graft) and carotid endarterectomy (CEA) between January 2011-December 2012. Among these patients, those treated with SAPs were compared to those treated with SO. Propensity score matching (PSM) was used to create comparable groups to evaluate differences between SAPs and SO. MAIN OUTCOME MEASURES: The primary end-points for this study were length of stay (LOS), all-cause total cost, number of intensive care unit (ICU) days, ICU cost, transfusion costs and units, and SO/SAP product units per discharge. RESULTS: Matched PSM created patient cohorts for SO and SAPs were created for BC (n = 758 for both groups), CV (n = 3388 for both groups), and CEA (n = 2041 for both groups) procedures. Patients that received SAPs had a 14-16% lower mean LOS for each procedure compared to SO, as well as 12-18% lower total mean cost per discharge for each procedure (p < 0.02 for all results). Mean ICU costs for SAPs were also lower, with a reduction of 20% for BC and 19% for CV compared to SO (p < 0.01). However, for CEA, there was no statistically significant difference in ICU costs for SAPs compared to SO. CONCLUSIONS: In a retrospective hospital database analysis, the use of SAPs were associated with lower healthcare resource utilization and costs compared to SO.

[Future vascular medicine: inauguration of a cardiovascular hybrid concept]. / Gefäßmedizin von morgen: Vorstellung eines kardiovaskulären Hybrid-Care-Konzepts.

The demographic developments will lead to an exponential increase of cardiovascular diseases. Additionally, technical developments of conservative and invasive treatment modalities will be added to distinguished, organ-orientated therapeutic concepts. This will also require a new orientation of vascular services. This concept implies that specific contents are referred to and contained in partner specialties. Since the heart and vascular system function as an anatomic and functional union, implementation of vascular medicine within cardiovascular centres represents a logical consequence.

Clinical practice, resource utilization, and outcomes of device closure of patent foramen ovale in pediatrics.

BACKGROUND: There are few data on patent foramen ovale closure and its outcome in children. In this study, we evaluated the current clinical practice, resource utilization, and outcome of device closure of patent foramen ovale in children. We hypothesized that patent foramen ovale closure would not result in a demonstrated benefit in children. METHODS: We undertook a prospective survey of all consecutive patients (<20 years) who underwent patent foramen ovale closure in our metropolitan area between 1995 and 2010. Differences in proportions were tested using the chi-square test or Fisher's exact test where appropriate. Differences in group medians were tested using Wilcoxon signed-rank test. RESULTS: A total of 153 patients (104 girls), median age 16 years (range 7-19) were studied. Indications for patent foramen ovale closure included: (1) migraine headache (104; 68%), (2) nonmigraine headache (24; 16%), (3) visual symptoms (110; 72%), (4) transient ischemic attack symptoms (42; 28%), and (5) stroke-like symptom (24; 16%). Patent foramen ovale was closed with an Amplatzer septal occluder in 115 (75%) and a Helex septal occluder in 47 (30%). The mean length of hospital stay was 18 ± 11 hours; the mean hospital charge was $24,126 ± $5808. The median duration of follow-up was 12 months, and 80 patients responded to the study survey. On follow-up, symptoms improved in 143 (93%), of which 29 (19%) had a residual shunt. None of the patient or treatment parameters predicted lack of improvement on follow-up. CONCLUSIONS: Despite the lack of proven benefit, children undergo closure of the patent foramen ovale for a variety of reasons, with the vast majority (92%) of patients reporting significant improvement in their symptoms. However, patent foramen ovale closure is an expensive procedure with serious potential complications. Symptomatic improvement even in the presence of a residual shunt suggests a strong placebo effect.

The costs of heart failure in Poland from the public payer's perspective. Polish programme assessing diagnostic procedures, treatment and costs in patients with heart failure in randomly selected outpatient clinics and hospitals at different levels of care: POLKARD.

BACKGROUND: Heart failure (HF) is a chronic disease of great clinical and economic significance for both the healthcare system and patients themselves. AIM: To determine the consumption of medical resources for treatment and care of HF patients and to estimate the related costs. METHODS: The study involved 400 primary care practices and 396 specialist outpatient clinics, as well as 259 hospitals at all reference levels. The sample was representative and supplemented with patient interview data. Based on the consumption of particular resources and the unit costs of services in 2011, costs of care for HF patients in Poland were estimated. Separate analyses were conducted depending on the stage of the disease (according to NYHA classification I-IV). The public payer's perspective and a one year time horizon were adopted. RESULTS: Direct annual costs of an HF patient's treatment in Poland may range between PLN 3,373.23 and 7,739.49 (2011), the main cost item being hospitalisation. The total costs for the healthcare system could be as high as PLN 1,703 million, which is 3.16% of the National Health Fund's budget (Ex. rate from 05.03.2012: 1 EUR = 4.14 PLN). CONCLUSIONS: The costs of treating heart failure in Poland are high; proper allocation of resources to diagnostic procedures and treatment may contribute to rationalisation of the relevant expenditure.

Health care costs related to out-of-hospital cardiopulmonary arrest in Japan.

OBJECTIVES: Although cost analyses for emergency care are essential, data on costs of care for out-of-hospital cardiopulmonary arrest (OHCA) are scarce. The present study aimed to analyze health care costs related to OHCA using a nationwide administrative database in Japan. METHODS: Using the Diagnosis Procedure Combination database in Japan, we identified OHCA patients who were transported to 779 emergency medical centres between July and December in 2008 and 2009. We assessed patient survival and discharge status, receipt of specific treatments, and costs of in-hospital care. RESULTS: A total of 21,750 OHCA patients were identified. Overall, 59.6% were males, and the average age was 70.3 years. Of them, 1394 (6.4%) resulted in death without attempted resuscitation after hospital arrival (Group A), 14,973 (69.0%) died on admission day despite resuscitation attempts (Group B), 3680 (17.0%) died at ≥2 days after admission despite resuscitation attempts (Group C), 785 (3.6%) survived and were discharged to home (Group D) and 873 (4.0%) survived and discharged to other than home (Group E). The median total costs were $434, $1735, $4869, $28,097 and $31,161 in Groups A to E, respectively. Positive survival status, longer hospital stay and receipt of specific treatments were significant predictors of higher total costs. After adjustment for these factors, higher age was associated with lower costs. CONCLUSIONS: The findings in the present study add further evidence to existing knowledge about healthcare costs related to OHCA.

The economics of cardiovascular disease in the United States.

Cardiovascular disease is the leading cause of death in the United States,and thus its clinical and economic implications are enormous. In an increasingly cost-conscious economic environment, it is important to understand not only the effectiveness of treatments and technologies but also their cost-effectiveness. The authors review and summarize the evidence on cost-effectiveness of surgical versus medical treatments. This evidence should prove useful at the patient bedside as well as assist policymakers and third party payers in deciding what treatments to cover.

More for less: best patient outcomes in a time of financial restraint.

In many countries, expenditure on health care has increased dramatically over recent years. There have been parallel improvements in many indicators of population health, but too many patients continue to be harmed by health care or receive care that is supply-sensitive, ineffective, or poorly aligned with their needs and values. In addition to human costs, this translates into substantial waste of resource. The world has recently faced economic challenges unseen since the great depression of the 1930s. The financial situation of a country can, like a business, be expressed in three sets of accounts: statements of financial position, financial performance, and cash flow. A key test of solvency is the ability to pay debts as they become due (whether from current account or further borrowing). In general, this is a function of public debt, which for many countries has become very high. However, private debt and net financial position are also relevant to a country's financial prospects. Ultimately, borrowing is not sustainable indefinitely and given limited prospects for growth in income in the coming years, most countries will likely need to reduce or at least constrain expenditure on health care. This implies obtaining better value from the resources that are available, and we suggest that the key to this lies in improving the quality of care and, in particular, reducing variation in health care. In the United States, new legislation promoting accountable care organizations may help to do this. Cardiac surgery can be particularly effective in extending patients' lives and in improving the quality of their lives. Our ability to continue to provide cardiac surgery in the face of constrained economic times will depend on engaging more actively in ensuring that what we do is the right thing: that our operations are effective and that they truly meet the needs and values of our patients. It will also depend on doing these operations right the first time.

Could cut-price cardiovascular procedures in India help Europe's hard-pressed health-care systems?

Until recently, travelling to India for a cardiovascular procedure was unheard of, but huge improvements in the quality of medical care available in the subcontinent, and its relative cheapness, have fostered the growth of 'medical tourism' and could impact on health care in Europe, reports Barry Shurlock, PhD.

Progress towards a National Cardiac Procedure Database--development of the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS) and Melbourne Interventional Group (MIG) registries.

Since the call for a National Cardiac Procedures Database in 2001, much work has been accomplished in both cardiac surgery and interventional cardiology in an attempt to establish a unified, systematic approach to data collection, defining a common minimum dataset pertinent to the Australian context, and instituting quality control measures to ensure integrity and privacy of data. In this paper we outline the aims of the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS) and the Melbourne Interventional Group (MIG) registries, and propose a comprehensive set of standardised data elements and their definitions to facilitate transparency in data collection, consistency between these and other data sets, and encourage ongoing peer-review. The aims are to improve outcomes for patients by determining key performance indicators and standards of performance for hospital units, to allow estimation of procedural risks and likelihood of outcomes for patients, and to report outcomes to relevant stake-holders and the public.

[The activities of the Pensa Federal Center of Cardiovascular Surgery of Roszdrav and the issues of its resource support].

The article develops the main aspects of the activities and issues of resource support of the Pensa Federal Center of cardiovascular surgery of Roszdrav. The emphasis is made on the inadequate budget financing and the necessity to increase the regulating scopes of planning of government quota for the high-tech medical care from 881 to 3500 quotas.

Evaluation of hospitalization and follow-up care costs among patients hospitalized with ACS treated with a stent and clopidogrel.

OBJECTIVE: This retrospective claims study was performed to evaluate the initial and subsequent healthcare costs in patients with acute coronary syndrome (ACS) who had been treated with stent placement and clopidogrel following discharge from the hospital. METHOD AND RESULTS: This was a retrospective, administrative claims-based analysis from a large, geographically diverse US managed care plan affiliated with i3 Innovus. Study subjects were commercially insured enrollees, aged > or = 18, who were hospitalized for ACS between 1 January 2000 and 31 December 2004 with a stent placed, and had at least one filled prescription for clopidogrel within 7 days of discharge from the index hospitalization. Of the 9135 subjects included in the cost analysis, 2241 subjects experienced a subsequent event. On average, subjects with a second event incurred $32,495 more in medical costs over 2 years and $39,742 more in medical costs over 3 years versus those who did not have a second event. Excluding ischemic hospitalizations, subjects with a second event incurred $7257 and $9724 more in medical costs than patients without a second event during the 2 and 3 years following discharge from the index hospitalization, respectively. CONCLUSIONS: Significant cost increases were observed among patients who had a subsequent hospitalization for an ischemic event compared to those without a subsequent hospitalization. Cost increases were still present after excluding costs of the ischemic hospitalizations. The findings of this study must be considered within the limitations of database analysis as claims data are collected for the purpose of payment and not research.

Regional collaboration as a model for fostering accountability and transforming health care.

An era of increasing budgetary constraints, misaligned payers and providers, and a competitive system where United States health outcomes are outpaced by less well-funded nations is motivating policy-makers to seek more effective means for promoting cost-effective delivery and accountability. This article illustrates an effective working model of regional collaboration focused on improving health outcomes, containing costs, and making efficient use of resources in cardiovascular surgical care. The Virginia Cardiac Surgery Quality Initiative is a decade-old collaboration of cardiac surgeons and hospital providers in Virginia working to improve outcomes and contain costs by analyzing comparative data, identifying top performers, and replicating best clinical practices on a statewide basis. The group's goals and objectives, along with 2 generations of performance improvement initiatives, are examined. These involve attempts to improve postoperative outcomes and use of tools for decision support and modeling. This work has led the group to espouse a more integrated approach to performance improvement and to formulate principles of a quality-focused payment system. This is one in which collaboration promotes regional accountability to deliver quality care on a cost-effective basis. The Virginia Cardiac Surgery Quality Initiative has attempted to test a global pricing model and has implemented a pay-for-performance program where physicians and hospitals are aligned with common objectives. Although this collaborative approach is a work in progress, authors point out preconditions applicable to other regions and medical specialties. A road map of short-term next steps is needed to create an adaptive payment system tied to the national agenda for reforming the delivery system.