- Email: [email protected]
Economics of ventricular assist devices: European view
SESSION 5 :
ECONOMICS OF DEVICES
Economics of Ventricular Assist Devices: European View Friedhelm Beyersdorf, MD Department of Cardiovascular Surgery, Albert-Ludwigs University, Freiburg, Germany
Among the treatment options for congestive heart failure, ventricular assist devices (VADs) are an emerging new technology, which may serve as a realistic therapeutic option once the complication rate is reduced. Whereas these devices were used in the past almost exclusively as a bridge to transplant, today permanent VAD and fullimplantable VAD are considered for destination therapy. It is therefore necessary to compare this treatment mo-
dality with other current strategies with regard to not only current survival, quality of life, and complication metrics but also relative costs between treatments. Comparable studies evaluating treatment costs are rare and future research must focus on theses issues because of the demands of permanent cost containment. (Ann Thorac Surg 2001;71:S192– 4) © 2001 by The Society of Thoracic Surgeons
C
ing may provide possible treatment options in the future. The 1-year survival rate for patients in class IV HF, however, is still only 40% to 50% [6]. This rate could be improved by cardiac surgical treatments. However, cardiac transplantation is available for only a small number of patients (approximately 500 cardiac transplantations per year in Germany). Although other new surgical techniques, for example, left ventricular reduction surgery (RESTORE trial) are being evaluated in international prospective studies, VADs are currently the only widely recognized treatment option for bridging patients to transplantation and possible destination therapy [7]. In this report, current available information is given concerning the economics associated with VAD in Europe.
ardiovascular disease is the leading cause of mortality in the western world and accounts for 40% of annual deaths [1]. Heart failure (HF) affects between 3 and 4 million Americans [2, 3] and is expected to reach 5.7 million by the year 2030. In addition, the World Health Organization proposes that by the year 2025 cardiovascular disorders will be the most frequent diseases worldwide. The increase in HF incidence is multifactorial. One reason is the successful treatment and reduction in mortality of cardiovascular diseases in younger age groups, a development that eventually leads to progressive myocyte loss, decrease of ejection fraction, and the development of HF later in life. In addition, the population of the western world is aging rapidly; the population aged 85 years or older is expected to more than triple between 1980 and 2030, and will be nearly sevenfold larger by 2050 [1]. The incidence of HF is expected to increase exponentially reaching 31% in men and 28% in women between the ages of 85 and 95 years (Fig 1). This increase in HF is also ref1ected by the fact that HF is the leading diagnosis-related group (DRG) among elderly patients [4]. The economic burden of HF is considerable: it has been estimated that in 1991 $5.5 billion was spent on HF in the United States, a1most double the expenditure for cancer and myocardial infarction [5] (Fig 2). Medical strategies are constantly being improved for the treatment of HF. Current treatment options for endstage HF include medical treatment, cardiac transplantation, ventricular assist devices (VADs), cardiomyopathy, high-risk conventional operations, and left ventricular reduction surgery. Procedures involving tissue engineerPresented at the Fifth International Conference on Circulatory Support Devices for Severe Cardiac Failure, New York, NY, Sept 15–17, 2000. Address reprint requests to Dr Beyersdorf, Department of Cardiovascular Surgery, University Hospital Freiburg, Hugstetterstrasse 55, D-79106 Freiburg, Germany; e-mail: [email protected].
© 2001 by The Society of Thoracic Surgeons Published by Elsevier Science Inc
Expenditures for Heart Failure The costs for HF include hospital care (which alone accounts for two-thirds of the total costs), outpatient care, medications, laboratory tests, procedures, and transplantations. Costs from lost work time are not usually included [1]. It was estimated that in the United States in 1991, health care costs due to HF were in the range of 5.4% (US $38.1 billion) of the total health care expenditure (approx. US $700 billion) [1]. In the United Kingdom, costs for HF represents 1.1% of the total National Health Service expenditure.
Costs of Left Ventricular Assist Device Implantation Data on the costs associated with LVAD implantation are rare and differ considerably depending on the device used, length of hospital stay, country-specific payment, number of patients included, and nature of the underlying disease. Moskowitz and colleagues [8] reported the average actual total costs for an LVAD patient (inpatient and outpatient combined) to be US $210,132 over an 0003-4975/01/$20.00 PII S0003-4975(00)02617-5
Ann Thorac Surg 2001;71:S192– 4
CIRCULATORY SUPPORT BEYERSDORF ECONOMICS OF VAD: EUROPEAN VIEW
S193
Fig 1. Incidence of heart failure by age and sex from Framingham. (Reproduced from Kannel WB, Ho K, Thom T. Changing epidemiological features of cardiac failure. Br Heart J 1994;72[Suppl 2]:S3–9. With permission from the BMJ Publishing Group.)
average period of 9.5 months. Several other studies reported costs for LVAD treatment ranging from US $186.131 to $435.133 [9 –12]. Left ventricular assist device costs for these reports include initial hospitalization, readmissions, and outpatient costs. The initial hospitalization accounts for approximately two-thirds of total costs, followed by costs for intensive care unit and diagnostic tests [8].
Reimbursement Reimbursement differs considerably in Europe, related to different health care models used in the different countries. The predominantly public system (Beverage model)
Fig 2. Health Care Financing Administration (HCFA) expenditure on heart failure compared with that for cancer and myocardial infarction, according to Medicare in 1991. (Reproduced with permission from O’Connell JB, Bristow MR. Economic impact of heart failure in the United States: time for a different approach. J Heart Lung Transplant 1994;13:S107–12.)
Fig 3. Bridge to recovery in a 2-month-old infant with ejection fraction ⬍ 0.10 and severe congenital aortic stenosis after successful valve repair. (A) During left ventricular assist support and (B) 2 months later at home.
is used in the United Kingdom, Italy, Spain, Sweden, Denmark, Norway, Finland, and Canada. This highly centralized system has a public taxation, uses predominantly public providers (hospitals and ambulatory care), and requires low copayment. In France, Germany, Austria, Switzerland, Belgium, Holland, and Japan, a mixture of private and public systems (Bismarck model) is used. This system includes a contribution based on salaries, offers private and public providers, and is based mainly on a solidarity principal. It has cost containment and is supposed to avoid explicit rationing measures, except a list of prohibited pharmaceutics and a restriction of some high-cost technology equipment (Joseph A, personal communication, 1999).
S194
CIRCULATORY SUPPORT BEYERSDORF ECONOMICS OF VAD: EUROPEAN VIEW
These different systems may explain the great variety of reimbursement schedules in Europe and even the different policies within a given country. The reimbursement policy for LVADs differs in Germany from region to region. In some centers, DRGs were tested in pilot projects. In most of the other centers, agreements with the local health insurance companies were made to implant a certain number of VADs per year, which are included in the clinic budget. In France, case-lump sums (“Fallpauschale”) do not exist. Every clinic has an annual budget, which might include the costs for VADs. Italy is the only country in which a case-lump sum for VADs exist. Per clinic LIT 96.750.000 (approximately US $60,000) are being reimbursed for implantation. In addition, a daily reimbursement of approximately US $600 and complication-lump sum (re-thoracotomy for bleeding, etc) of approximately US $6,500 is being paid. These costs are fixed by the government and are equivalent to the reimbursement for heart transplantation. These reimbursements, however, can be modified locally to a certain extent (90% to 110%). These case-lump sums are used for all LVADs and biventricular VADs, regardless of the costs for the different systems.
Comment Data on the economics of LVAD treatment are rare. As the number of HF patients is increasing, the costeffectiveness of LVAD treatment has been scrutinized and a comparison with other treatment modalities has been offered. Left ventricular assist device technology will evolve in the future, leading toward less invasive implantation techniques, modified surface materials, and fully implantable devices. It is hoped that these advance will result in fewer complications (bleeding, thrombosis, infection) and readmission rates and shorter initial hospital stays. In the near future, the emerging LVAD technology must prove itself superior to medical treatment for the treatment of end-stage HF. Novel surgical techniques
Ann Thorac Surg 2001;71:S192– 4
must be evaluated using the measures of survival, quality of life, and costs.
References 1. Robbins MA, O’Connell JB. Economic impact of heart failure in management of end-stage heart disease. In: Rose EA, Stevenson LW. Management of end-stage heart disease. Philadelphia: Lippincott-Raven, 1998:3–11. 2. Ho KK, Pinsky JL, Kannel WB, Levy D. The epidemiology of heart failure: the Framingham Study. J Am Coll Cardiol 1993;22(Suppl A):6A–13A. 3. Schocken DD, Arrieta MI, Leaverton PE, Ross EA. Prevalence and mortality rate of congestive heart failure in the United States. J Am Coll Cardiol 1992;20:301– 6. 4. Yusuf S, Garg R, Held P, Corlin R. The need for a large randomized trial to evaluate the effects of digitalis on morbidity and mortality in congestive heart failure. Am J Cardiol 1992;69:64G–70G. 5. O’Connell JB, Bristow MR. Economic impact of heart failure in the United States: time for a different approach. J Heart Lung Transplant 1994;13:S107–12. 6. The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325:293–302. 7. Rose EA, Moskowitz AJ, Packer M, et al. The REMATCH trial: rationale, design, and end points. Randomized evaluation of mechanical assistance for the treatment of congestive heart failure. Ann Thorac Surg 1999;67:723–30. 8. Moskowitz AJ, Williams DL, Tiemey A, Levitan RG, Zivin J, Gelijns AC. Economic consideration of left ventricular assist device implantation. In: Goldstein PJ, Oz MC, eds. Cardiac assist devices. Armonk, NY: Futura, 2000:183–92. 9. Swartz M, Reedy J, Lohmann D, et al. Cost and reimbursement rates for investigational circulatory support. ASAIO Trans 1991;37:549–52. 10. Mehta S, Aufiero T, Pae W, et al. Mechanical ventricular assistance: an economical and effective means of treating end-stage heart disease. Ann Thorac Surg 1995;60:284–91. 11. Cloy M, Myers T, Stutts L, et al. Hospital charges for conventional therapy versus left ventricular assist system therapy in heart transplant patients. ASAIO Trans 1995;41: M535–9. 12. Gelijns AC, Richards AF, Williams DL, Oz MC, Oliveira J, Moskowitz AJ. Evolving costs of long-term left ventricular assist device implantation. Ann Thorac Surg 1997;64; 1312–9.
ECONOMICS OF DEVICES
Economics of Ventricular Assist Devices: European View Friedhelm Beyersdorf, MD Department of Cardiovascular Surgery, Albert-Ludwigs University, Freiburg, Germany
Among the treatment options for congestive heart failure, ventricular assist devices (VADs) are an emerging new technology, which may serve as a realistic therapeutic option once the complication rate is reduced. Whereas these devices were used in the past almost exclusively as a bridge to transplant, today permanent VAD and fullimplantable VAD are considered for destination therapy. It is therefore necessary to compare this treatment mo-
dality with other current strategies with regard to not only current survival, quality of life, and complication metrics but also relative costs between treatments. Comparable studies evaluating treatment costs are rare and future research must focus on theses issues because of the demands of permanent cost containment. (Ann Thorac Surg 2001;71:S192– 4) © 2001 by The Society of Thoracic Surgeons
C
ing may provide possible treatment options in the future. The 1-year survival rate for patients in class IV HF, however, is still only 40% to 50% [6]. This rate could be improved by cardiac surgical treatments. However, cardiac transplantation is available for only a small number of patients (approximately 500 cardiac transplantations per year in Germany). Although other new surgical techniques, for example, left ventricular reduction surgery (RESTORE trial) are being evaluated in international prospective studies, VADs are currently the only widely recognized treatment option for bridging patients to transplantation and possible destination therapy [7]. In this report, current available information is given concerning the economics associated with VAD in Europe.
ardiovascular disease is the leading cause of mortality in the western world and accounts for 40% of annual deaths [1]. Heart failure (HF) affects between 3 and 4 million Americans [2, 3] and is expected to reach 5.7 million by the year 2030. In addition, the World Health Organization proposes that by the year 2025 cardiovascular disorders will be the most frequent diseases worldwide. The increase in HF incidence is multifactorial. One reason is the successful treatment and reduction in mortality of cardiovascular diseases in younger age groups, a development that eventually leads to progressive myocyte loss, decrease of ejection fraction, and the development of HF later in life. In addition, the population of the western world is aging rapidly; the population aged 85 years or older is expected to more than triple between 1980 and 2030, and will be nearly sevenfold larger by 2050 [1]. The incidence of HF is expected to increase exponentially reaching 31% in men and 28% in women between the ages of 85 and 95 years (Fig 1). This increase in HF is also ref1ected by the fact that HF is the leading diagnosis-related group (DRG) among elderly patients [4]. The economic burden of HF is considerable: it has been estimated that in 1991 $5.5 billion was spent on HF in the United States, a1most double the expenditure for cancer and myocardial infarction [5] (Fig 2). Medical strategies are constantly being improved for the treatment of HF. Current treatment options for endstage HF include medical treatment, cardiac transplantation, ventricular assist devices (VADs), cardiomyopathy, high-risk conventional operations, and left ventricular reduction surgery. Procedures involving tissue engineerPresented at the Fifth International Conference on Circulatory Support Devices for Severe Cardiac Failure, New York, NY, Sept 15–17, 2000. Address reprint requests to Dr Beyersdorf, Department of Cardiovascular Surgery, University Hospital Freiburg, Hugstetterstrasse 55, D-79106 Freiburg, Germany; e-mail: [email protected].
© 2001 by The Society of Thoracic Surgeons Published by Elsevier Science Inc
Expenditures for Heart Failure The costs for HF include hospital care (which alone accounts for two-thirds of the total costs), outpatient care, medications, laboratory tests, procedures, and transplantations. Costs from lost work time are not usually included [1]. It was estimated that in the United States in 1991, health care costs due to HF were in the range of 5.4% (US $38.1 billion) of the total health care expenditure (approx. US $700 billion) [1]. In the United Kingdom, costs for HF represents 1.1% of the total National Health Service expenditure.
Costs of Left Ventricular Assist Device Implantation Data on the costs associated with LVAD implantation are rare and differ considerably depending on the device used, length of hospital stay, country-specific payment, number of patients included, and nature of the underlying disease. Moskowitz and colleagues [8] reported the average actual total costs for an LVAD patient (inpatient and outpatient combined) to be US $210,132 over an 0003-4975/01/$20.00 PII S0003-4975(00)02617-5
Ann Thorac Surg 2001;71:S192– 4
CIRCULATORY SUPPORT BEYERSDORF ECONOMICS OF VAD: EUROPEAN VIEW
S193
Fig 1. Incidence of heart failure by age and sex from Framingham. (Reproduced from Kannel WB, Ho K, Thom T. Changing epidemiological features of cardiac failure. Br Heart J 1994;72[Suppl 2]:S3–9. With permission from the BMJ Publishing Group.)
average period of 9.5 months. Several other studies reported costs for LVAD treatment ranging from US $186.131 to $435.133 [9 –12]. Left ventricular assist device costs for these reports include initial hospitalization, readmissions, and outpatient costs. The initial hospitalization accounts for approximately two-thirds of total costs, followed by costs for intensive care unit and diagnostic tests [8].
Reimbursement Reimbursement differs considerably in Europe, related to different health care models used in the different countries. The predominantly public system (Beverage model)
Fig 2. Health Care Financing Administration (HCFA) expenditure on heart failure compared with that for cancer and myocardial infarction, according to Medicare in 1991. (Reproduced with permission from O’Connell JB, Bristow MR. Economic impact of heart failure in the United States: time for a different approach. J Heart Lung Transplant 1994;13:S107–12.)
Fig 3. Bridge to recovery in a 2-month-old infant with ejection fraction ⬍ 0.10 and severe congenital aortic stenosis after successful valve repair. (A) During left ventricular assist support and (B) 2 months later at home.
is used in the United Kingdom, Italy, Spain, Sweden, Denmark, Norway, Finland, and Canada. This highly centralized system has a public taxation, uses predominantly public providers (hospitals and ambulatory care), and requires low copayment. In France, Germany, Austria, Switzerland, Belgium, Holland, and Japan, a mixture of private and public systems (Bismarck model) is used. This system includes a contribution based on salaries, offers private and public providers, and is based mainly on a solidarity principal. It has cost containment and is supposed to avoid explicit rationing measures, except a list of prohibited pharmaceutics and a restriction of some high-cost technology equipment (Joseph A, personal communication, 1999).
S194
CIRCULATORY SUPPORT BEYERSDORF ECONOMICS OF VAD: EUROPEAN VIEW
These different systems may explain the great variety of reimbursement schedules in Europe and even the different policies within a given country. The reimbursement policy for LVADs differs in Germany from region to region. In some centers, DRGs were tested in pilot projects. In most of the other centers, agreements with the local health insurance companies were made to implant a certain number of VADs per year, which are included in the clinic budget. In France, case-lump sums (“Fallpauschale”) do not exist. Every clinic has an annual budget, which might include the costs for VADs. Italy is the only country in which a case-lump sum for VADs exist. Per clinic LIT 96.750.000 (approximately US $60,000) are being reimbursed for implantation. In addition, a daily reimbursement of approximately US $600 and complication-lump sum (re-thoracotomy for bleeding, etc) of approximately US $6,500 is being paid. These costs are fixed by the government and are equivalent to the reimbursement for heart transplantation. These reimbursements, however, can be modified locally to a certain extent (90% to 110%). These case-lump sums are used for all LVADs and biventricular VADs, regardless of the costs for the different systems.
Comment Data on the economics of LVAD treatment are rare. As the number of HF patients is increasing, the costeffectiveness of LVAD treatment has been scrutinized and a comparison with other treatment modalities has been offered. Left ventricular assist device technology will evolve in the future, leading toward less invasive implantation techniques, modified surface materials, and fully implantable devices. It is hoped that these advance will result in fewer complications (bleeding, thrombosis, infection) and readmission rates and shorter initial hospital stays. In the near future, the emerging LVAD technology must prove itself superior to medical treatment for the treatment of end-stage HF. Novel surgical techniques
Ann Thorac Surg 2001;71:S192– 4
must be evaluated using the measures of survival, quality of life, and costs.
References 1. Robbins MA, O’Connell JB. Economic impact of heart failure in management of end-stage heart disease. In: Rose EA, Stevenson LW. Management of end-stage heart disease. Philadelphia: Lippincott-Raven, 1998:3–11. 2. Ho KK, Pinsky JL, Kannel WB, Levy D. The epidemiology of heart failure: the Framingham Study. J Am Coll Cardiol 1993;22(Suppl A):6A–13A. 3. Schocken DD, Arrieta MI, Leaverton PE, Ross EA. Prevalence and mortality rate of congestive heart failure in the United States. J Am Coll Cardiol 1992;20:301– 6. 4. Yusuf S, Garg R, Held P, Corlin R. The need for a large randomized trial to evaluate the effects of digitalis on morbidity and mortality in congestive heart failure. Am J Cardiol 1992;69:64G–70G. 5. O’Connell JB, Bristow MR. Economic impact of heart failure in the United States: time for a different approach. J Heart Lung Transplant 1994;13:S107–12. 6. The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325:293–302. 7. Rose EA, Moskowitz AJ, Packer M, et al. The REMATCH trial: rationale, design, and end points. Randomized evaluation of mechanical assistance for the treatment of congestive heart failure. Ann Thorac Surg 1999;67:723–30. 8. Moskowitz AJ, Williams DL, Tiemey A, Levitan RG, Zivin J, Gelijns AC. Economic consideration of left ventricular assist device implantation. In: Goldstein PJ, Oz MC, eds. Cardiac assist devices. Armonk, NY: Futura, 2000:183–92. 9. Swartz M, Reedy J, Lohmann D, et al. Cost and reimbursement rates for investigational circulatory support. ASAIO Trans 1991;37:549–52. 10. Mehta S, Aufiero T, Pae W, et al. Mechanical ventricular assistance: an economical and effective means of treating end-stage heart disease. Ann Thorac Surg 1995;60:284–91. 11. Cloy M, Myers T, Stutts L, et al. Hospital charges for conventional therapy versus left ventricular assist system therapy in heart transplant patients. ASAIO Trans 1995;41: M535–9. 12. Gelijns AC, Richards AF, Williams DL, Oz MC, Oliveira J, Moskowitz AJ. Evolving costs of long-term left ventricular assist device implantation. Ann Thorac Surg 1997;64; 1312–9.