Portal de Periódicos da CAPES

Does vascular surgery cost too much?

2009; Elsevier BV; Volume: 50; Issue: 5 Linguagem: Inglês

10.1016/j.jvs.2009.06.063

1097-6809

G. Patrick Clagett,

Cardiac, Anesthesia and Surgical Outcomes

It has been traditional over the past few years to use the Presidential Address to give an update on Society for Vascular Surgery (SVS) activities – in other words, to provide a “state of the union” address and to tell you what's gone on during my watch. I am going to depart from that tradition for two reasons. The first is that there is a superb treatise on the scope of SVS activities and programs published in the December 2008 issue of the Journal of Vascular Surgery by our past President, Wayne Johnston.1Johnston K.W. The Society for Vascular Surgery – State of the Society, 2008.J Vasc Surg. 2008; 48: 1613-1619Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar I urge you to read this. Wayne outlines SVS programs in the context of strategic initiatives that were determined by the SVS Board of Directors last year. I think that you will be impressed with the multitude of SVS activities that are designed to serve you, the membership. Our councils and their committees are bursting with activity and over 270 SVS members volunteer their time in serving on these committees. I would like to emphasize two themes of Wayne's report. The first is that the SVS is making continued efforts to reach out to the entire vascular community, including international members, vascular technologists, vascular physicians' assistants, nurses, and, most recently, podiatrists. We want to become a diverse and comprehensive organization that represents all in the vascular surgery community. Second, the process for council and committee appointments has been revamped to make this a democratic process. When there are committee vacancies, we send out RFAs asking for your interest in committee assignments, and we appoint on the basis of expertise and availability, not on “who you know.” In my opinion, this process has dramatically strengthened the effectiveness of our SVS committees. So, watch your e-mail for these requests. The second reason for departing from the traditional address is that I have become increasingly concerned about the cost of vascular intervention. I think that this is reaching a crisis state that will have an impact on the way in which we practice. While I am concerned that vascular surgery may cost too much, let me be clear in stating unequivocally that vascular surgeons are the best bargain available when it comes to treating vascular disease. That is because we practice all modalities including medical, endoluminal, and open surgical treatment of vascular disorders. Unlike others, we are not wed to a single approach in treating our patients. This makes vascular surgeons uniquely qualified to determine what are the most effective and the least expensive treatments available. Furthermore, it is better that we make these determinations rather than having a governmental agency or private insurer determine or dictate this for us. There are several looming, external threats driving health care cost concerns. Our economy is in bad shape, we are in a recession, and the federal deficit is ever increasing. Estimates from the Congressional Budget Office project the federal deficit to exceed two trillion dollars for 2009. If you go online to the National Debt Clock, the estimate is over 10 trillion.2US National Debt Clock.http://www.usdebtclock.orgGoogle Scholar The real problem is that health care costs are sky-rocketing and are a major factor in driving the national debt.3Keehan S. Sisko A. Tuffer C. Smith S. Cowan C. Poisal J. et al.Health spending projections through 2017: the baby-boom generation is coming to Medicare.Health Aff. 2008; 27: w145-w155Crossref Scopus (139) Google Scholar Total US health care spending is expected to double to 4.3 trillion dollars by 2017 (Fig 1). Per capita spending will increase from approximately 4000 to 13,000 dollars per person per year over the next decade (Fig 2).Fig 2Per capita spending on health care. Data from Keehan et al, 2008.3Keehan S. Sisko A. Tuffer C. Smith S. Cowan C. Poisal J. et al.Health spending projections through 2017: the baby-boom generation is coming to Medicare.Health Aff. 2008; 27: w145-w155Crossref Scopus (139) Google ScholarView Large Image Figure ViewerDownload Hi-res image Download (PPT) Federal spending for health care, which includes Medicare and Medicaid, is approximately 50% of all health expenditures. Federal funding will also double from 800 billion to a little less than 2 trillion dollars in the next decade. By 2017, Medicare spending is expected to rise to 884 billion dollars and this will be one fifth of all national health care spending.3Keehan S. Sisko A. Tuffer C. Smith S. Cowan C. Poisal J. et al.Health spending projections through 2017: the baby-boom generation is coming to Medicare.Health Aff. 2008; 27: w145-w155Crossref Scopus (139) Google Scholar It is hard to “wrap one's head” around these numbers and it is helpful to look at health care expenditures as a percent of the gross domestic product or the total wealth of our national economy. This is a complicated graph from an influential article that appeared in Health Affairs in 20083Keehan S. Sisko A. Tuffer C. Smith S. Cowan C. Poisal J. et al.Health spending projections through 2017: the baby-boom generation is coming to Medicare.Health Aff. 2008; 27: w145-w155Crossref Scopus (139) Google Scholar (Fig 3). The solid blue line represents the rate of growth in national health care spending. This remains relatively stable at roughly 6% per year. The red line represents the GDP growth rate that has “taken a hit,” with a drop in 2007. The light blue bars show the proportion of the GDP taken by health care spending. Currently, we are at 17% of the GDP and this is expected to rise to about 20% in the next decade. However, I think that these are underestimates because this research was published in 2008, before our economy tanked. Because the red line has decreased even more than shown in the graph, the real percentage of health care spending expressed as a percent of GDP may be much higher. These levels of health care spending are simply not sustainable. Health care costs are eating up a huge proportion of the federal budget. By 2018, Medicare and federal Medicaid costs will consume one third of federal spending (Fig 4). Along with Social Security, these federal expenditures will, by necessity, reduce funding for other prominent, federal entitlement programs. Because entitlement programs have strong grassroots support and congressional advocates, it is predictable that the “entitlement squeeze” will become very political. It is commonly thought that the arrival of baby boomers into the Medicare beneficiary pool will drive a lot of these increasing costs. To some extent that is true, but this is only a modest fraction of projected overall health costs.4Hartman M. Catlin A. Lasman D. Cylus J. Heffler S. US health spending by age, selected years through 2004.Health Aff. 2008; 27: w1-w12Crossref Scopus (64) Google Scholar Of course, this fraction is located squarely in the Medicare pool of patients, and the increase there will have a major impact on future CMS budgets.3Keehan S. Sisko A. Tuffer C. Smith S. Cowan C. Poisal J. et al.Health spending projections through 2017: the baby-boom generation is coming to Medicare.Health Aff. 2008; 27: w145-w155Crossref Scopus (139) Google Scholar As for total health care costs, the major factors driving up the costs are known as “utilization” and “medical prices”3Keehan S. Sisko A. Tuffer C. Smith S. Cowan C. Poisal J. et al.Health spending projections through 2017: the baby-boom generation is coming to Medicare.Health Aff. 2008; 27: w145-w155Crossref Scopus (139) Google Scholar as shown in the red and blue portions of the bars on this graph (Fig 5). Loosely translated, these costs have to do with the way that physicians practice, how they charge, how frequently they admit patients to hospitals, and how they prescribe medicines and use expensive medical devices. These areas will be major targets of health care policy reformers. There is huge variation in health care spending among countries in the civilized world and the United States spends more than any other nation.5Health care spending – UC atlas of global inequality.http://ucatlas.ucsc.edu/spend.phpGoogle Scholar Unfortunately, this does not necessarily translate into better health outcomes. This graph plots per capita spending vs life expectancy (Fig 6). The United States leads the pack in terms of health care spending but enjoys an average life expectancy equivalent to Cuba, which spends a fraction as much on health care. Looking within our own borders, there is huge regional variation in health care spending in the United States. These are data from the Dartmouth Atlas of Health Care 2008,6Wennberg J. Fisher E. Goodman D. Skinner J. Tracking the care of patients with severe chronic illness: The Dartmouth atlas of health care 2008. The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, (NH)2008Google Scholar and they show the ratio of state to national Medicare spending across all states for patients with nine chronically ill conditions, one of which is peripheral vascular disease (Fig 7). The data are adjusted for age, gender, race, illness severity, and other factors that might influence health care utilization. The deep blue and light blue states such as California, New York, and Texas, my own state, are above average and relatively expensive for Medicare compared with grey and green states such as Oklahoma and Iowa. Do higher spending levels result in better outcomes? The resounding answer is no. In numerous studies, Dartmouth health researchers have documented a troubling paradox; higher spending is actually associated with lower quality of care and slightly worse outcomes.6Wennberg J. Fisher E. Goodman D. Skinner J. Tracking the care of patients with severe chronic illness: The Dartmouth atlas of health care 2008. The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, (NH)2008Google Scholar, 7Sirovich B. Gallagher P. Wennberg D. Fisher E. Discretionary decision making by primary care physicians and the cost of US health care.Health Aff. 2008; 27: 813-823Crossref Scopus (198) Google Scholar, 8Fisher E. Bynum J. Skinner J. Slowing the growth of health care costs – lessons from regional variation.N Engl J Med. 2009; 360: 849-852Crossref PubMed Scopus (313) Google Scholar How can this be? This graph plots the number of cardiologists per 100,000 population on the x-axis vs number of visits to cardiologists on the y-axis (Fig 8). More cardiologists beget more visits and referrals with more testing and interventions that may not be helpful, and ultimately may be harmful. In our own specialty, this map shows the rate of aortic aneurysm repair among different regions9Dartmouth – CMS – FDA collaborativeTrends and regional variations in abdominal aortic aneurysm repair.http://www.dartmouthatlas.org/atlases/AAA_report_2006.pdfDate: February 1, 2006Google Scholar (Fig 9). There are some aneurysm “hot spots” around the country, but there are no known differences in the incidence of aortic aneurysms among these regions, and there are no decreased rates of ruptured aneurysms in these areas. In addition, the rate of death from aneurysm is the same, or even slightly higher, than in regions with a comparatively low rate of aneurysm repair. This may simply be due to a higher rate of intervention with attendant morbidity and mortality. These and other variations in CMS expenditures with no improvement in outcomes and, possibly, worse outcomes, are raising tremendous concern among federal health policy makers.10Gawande A. Annals of medicine - The cost conundrum: What a Texas town can teach us about health care The New Yorker.http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawandeDate: June 1, 2009Google Scholar Our new administration has promised health care reform as a centerpiece among their ambitious initiatives (Fig 10). In addition to health care costs, the President has promised to take on the problem of the 47 million US citizens who are uninsured or under-insured and lack access to basic health care. Thus, change is truly on the way, although we do not yet have a clear idea what that change will be. However, rest assured that health care cost containment is a major component. Comparative effectiveness research has been a buzz word among health policy wonks in Washington for the past 5 years or so,11CBO paper Research on the comparative effectiveness of medical treatments: Issues and options for an expanded federal role.http://www.cbo.gov/ftpdocs/88xx/doc8891/12-18-ComparativeEffectiveness.pdfDate: December 2007Google Scholar and this has developed major traction in the Obama administration. Comparative effectiveness research simply compares two treatments with the goal of determining which is most effective.11CBO paper Research on the comparative effectiveness of medical treatments: Issues and options for an expanded federal role.http://www.cbo.gov/ftpdocs/88xx/doc8891/12-18-ComparativeEffectiveness.pdfDate: December 2007Google Scholar, 12Gibbons R. Gardner T. Anderson J. Goldstein L. Meltzer N. Weintraub W. et al.The American Heart Association's principles for comparative effectiveness research – policy statement from the American Heart Association.Circulation. 2009; 119: 2955-2962Crossref PubMed Scopus (35) Google Scholar One may compare medical treatments, medical vs surgical or other interventional treatments, surgical vs catheter-based interventions, or even diagnostic modalities. As many of you know, a significant “chunk” of money, or 1.1 billion dollars from President Obama's multibillion dollar Economic Stimulus Package, is going to the NIH, the Agency for Healthcare Research and Quality, or AHRQ, and the Department of Health and Human Services specifically for comparative effectiveness research. There is even talk of a Comparative Effectiveness Research Institute with legislation introduced by Senator Baucus last year. When I first heard of comparative effectiveness research, my first thought was that this is “rediscovering the wheel”. We have been doing this for years: CREST, NASCET, ACAS, and OVER are just a few examples of trials in the vascular community that are basic “comparative effectiveness research.” But what may be different in these trials and current comparative effectiveness initiatives is the added feature of cost effectiveness analysis.12Gibbons R. Gardner T. Anderson J. Goldstein L. Meltzer N. Weintraub W. et al.The American Heart Association's principles for comparative effectiveness research – policy statement from the American Heart Association.Circulation. 2009; 119: 2955-2962Crossref PubMed Scopus (35) Google Scholar, 13Slutsky J. Atkins D. Chang S. Sharp B. Comparing medical interventions: AHRQ and the effective health care program.J Clin Epidemiol. June 2008; (Sept 30;[Epublication ahead of print].)PubMed Google Scholar There are those who argue that comparative effectiveness research and cost-effectiveness analyses are two separate and distinct disciplines. However, I think that the two are inextricably bound. For example, if one compares two treatments and finds that treatment A is only modestly better than treatment B but costs ten times more, it would seem reasonable to use treatment B for most patients. However, if treatment A is vastly more superior to treatment B, one may be willing to incur the added expense. So, whether explicitly stated or not, comparative effectiveness research has clear economic implications. One of the main reasons the federal government is promoting comparative effectiveness research is the belief that it would reduce variation in practice and, thereby, save money. Research on comparative effectiveness has been integrated into health care systems in other developed countries including Australia, Canada, Britain, France, and Germany. Perhaps the best known is Britain's National Institute for Health and Clinical Excellence that goes by the ironic acronym of “NICE.” NICE is an independent government-funded organization that advises the British National Health Service. It does not sponsor clinical trials or other forms of primary data collection. Instead, it funds meta-analyses of existing research and combines this with cost-effectiveness analyses. Since its inception in 1999, decisions from NICE have generated a great deal of controversy.14Steinbrook R. Saying no isn't NICE – the travails of Britain's National Institute for Health and Clinical Excellence.N Engl J Med. 2008; 359: 19Crossref Scopus (45) Google Scholar Of the 159 decisions handed down by NICE up to 2008, approximately one third have been appealed and a little less than half of these appeals have been upheld. NICE has been variously viewed as a heartless, governmental rationing agency or an honest attempt to prioritize health care with the goal of providing the most effective treatments for greatest number of British citizens at the lowest cost. In February of this year, NICE came out with endovascular aneurysm repair (EVAR) recommendations.15NHSNICE technology appraisal guidance 167 Endovascular stent grafts for the treatment of abdominal aortic aneurysms.http://www.nice.org.uk/nicemedia/pdf/TA167Guidance.pdfDate: February 2009Google Scholar It is notable and laudable that NICE consulted with prominent British vascular surgeons in their deliberations. As I interpret this document, EVAR is recommended for patients who are able to undergo open surgery and is not recommended for “unfit” patients and those with ruptured aneurysms. Thus, these recommendations roughly parallel the findings and conclusions of the UK EVAR 1 and 2 Trials. Many of us in the United States would take exception to these recommendations and would even go as far to say that EVAR has its greatest benefit in patients who cannot tolerate open surgery and those with ruptured aneurysms. Many are concerned that a similar US Comparative Effectiveness Research Institute would mandate treatment decisions and thereby reduce physicians' autonomy.16DeMaria A. Comparative effectiveness research.J Am Coll Cardiol. 2009; 53: 973-975Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar, 17Garber A. Tunis Sean Does comparative-effectiveness research threaten personalized medicine?.N Engl J Med. 2009; 360: 1925-1927Crossref PubMed Scopus (166) Google Scholar At its worst, this is a “one size fits all” mentality that devalues treatment decisions for unusual or special circumstances in which a treatment might be successful even if it is outside of “official guidelines.” The proponents of federal comparative effectiveness research point out that the process will be transparent, scholarly, and persuasive; will involve all stakeholders; and will be designed to promote best practices by gaining the respect of the medical community. In other words, “buy-in” from practicing physicians is necessary for the success of this approach. However, in one document prepared by the Congressional Budget Office, the author states, “To … reduce health care spending in a meaningful way, the results of comparative effectiveness analyses would … have to be used in ways that changed the behavior of doctors … For example, the higher value care identified by comparative effectiveness research could be promoted … through financial incentives – that is, payments to doctors …”.11CBO paper Research on the comparative effectiveness of medical treatments: Issues and options for an expanded federal role.http://www.cbo.gov/ftpdocs/88xx/doc8891/12-18-ComparativeEffectiveness.pdfDate: December 2007Google Scholar I do not know about you, but this sounds to me like coercion akin to “pay for performance.” What is the role of the SVS in all of this? Well, we have some of the tools to carry out comparative effectiveness research. I say some because we are not in the position to sponsor major, randomized clinical trials. However, we have Practice Guidelines and Reporting Standards. Some are published and others are in the pipeline to be published in the Journal of Vascular Surgery. These are important because they provide a framework based on careful, systematic and scholarly analyses that promote best practices. We also have a growing Vascular Registry developed by the SVS Outcomes Committee. The SVS Carotid Registry has been eminently successful and presented an important paper at our annual meeting last year.18Sidawy A. Zwolak R. White R. Simami F. Schermerhorn M. Sicard G. Risk-adjusted 30-day outcomes of carotid stenting and endarterectomy: results from the SVS Vascular Registry.J Vasc Surg. 2009; 49: 71-79Abstract Full Text Full Text PDF PubMed Scopus (151) Google Scholar This, in essence, is a report on comparative effectiveness that compares carotid endarterectomy to carotid angioplasty/stenting. The Outcomes Committee has also partnered with the New England Research Institute in responding to an NIH Challenge Grant on Comparative Effectiveness. The plan is to use SVS carotid registry data in comparing medical vs interventional treatment, including CAS and CEA, in the treatment of asymptomatic carotid stenosis. The Outcomes Committee also has plans to expand the registry to include lower extremity interventions for critical limb ischemia, thoracic dissections and other catastrophic thoracic aortic problems, and, possibly, angioaccess. Prospective registry data are key ingredients in analyzing outcomes as well as costs. I urge you to consider joining SVS Registry modules as they become available. Not only do we have the tools, we have the brain power, talent, and drive to carry out this research. The Clinical Practice Council has developed a Comparative Effectiveness Task Force. They have already produced a “white paper” or position statement that spells out our plans for comparative effectiveness research that will include cost efficacy analyses.19Ad Hoc Task ForceComparative effectiveness and vascular surgery.J Vasc Surg. 2009; (in press).Google Scholar One of their first undertakings will be a systematic review of treatments for intermittent claudication that will focus on outcomes, durability, quality of life, and costs. Medical or exercise therapy compared with intervention will be the main topic. There are at least three, recent randomized on this topic with conflicting conclusions.20Spronk S. Bosch J. den Hoed P. Veen H. Pattynama P. Hunink M. Cost-effectiveness of endovascular revascularization compared to supervised hospital-based exercise training in patients with intermittent claudication: a randomized controlled trial.J Vasc Surg. 2008; 48: 1472-1480Abstract Full Text Full Text PDF PubMed Scopus (92) Google Scholar, 21Greenhalgh R. Belch J. Brown L. Gaines P. Gao L. Reise J. et al.The MIMIC Trial Participants The adjuvant benefit of angioplasty in patients with mild to moderate intermittent claudication (MIMIC) managed by supervised exercise, smoking cessation advice, and best medical therapy: results from two randomized trials for stenotic femoropopliteal and aortoiliac arterial disease.Eur J Vasc Endovasc Surg. 2008; 36: 680-688Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar, 22Spronk S. Bosch J. den Hoed P. Veen H. Pattynama P. Hunink M. Intermittent claudication: clinical effectiveness of endovascular revascularization vs supervised hospital-based exercise training randomized controlled trial.Radiology. 2009; 250: 586-595Crossref PubMed Scopus (109) Google Scholar These and other reports will comprise a data base for a meta-analysis. A recent article from the New York Times has already mentioned this as a target for federal comparative effectiveness research stating, “How do drugs and watchful waiting compare with surgery as a treatment for leg pain that results from blockage of the arteries in the lower legs?”23Pear R. US to compare medical treatments New York Times.http://www.nytimes.com/2009/02/16/health/policy/16health.html?hpGoogle Scholar There are many other areas that we can assess. For example, is EVAR really the best treatment for a relatively healthy person less than 65 years old who may have expected longevity of 20 years or more? Existing data would suggest that EVAR is more expensive, is associated with many more re-interventions, has inferior quality of life, has no survival advantage in the long-term and may, in fact, have poorer long-term survival.24Clagett G.P. EVAR, TEVAR, FEVAR, too far?.Perspectives Vasc Surg Endovasc Ther. 2008; 20: 115-119Crossref PubMed Scopus (12) Google Scholar Other areas in vascular disease treatment ripe for comparative effectiveness research include “endo first” vs distal bypass for critical limb ischemia; medical vs interventional treatment for asymptomatic carotid disease; angioplasty vs bypass for superficial femoral artery disease; IVC filters vs pharmaco-mechanical prophylaxis for patients at high risk for venous thromboembolism, and many others. Why should the Society for Vascular Surgery take on comparative effectiveness research? First, this would be looked on favorably by government agencies such as CMS and, if properly done, might be accepted without further interference. This is a polite way of saying that it is far better that we do it ourselves instead of AHRQ or some other federal agency doing it for us. Second, as mentioned earlier, of all specialty groups treating patients with vascular disease, we are the most unbiased because we practice all modalities; that is, we are not wed to one approach. Thus, we are best positioned of all to do this. Third, we have the expertise and the will to carry out high quality comparative effectiveness research. Finally, these mandates are clearly spelled out in our Mission Statement, to: “Clearly define the role of surgery, endovascular surgery and medical treatment and prevention of vascular disease” and to “Address social, economic, ethical, and legal issues that relate to vascular surgery.” INTEGRITY is our middle name. This is the right thing to do for our membership, for our patients, and for the public. In a memorable SVS Presidential Address in 1994, Norman Hertzer challenged the vascular surgical community to develop mechanisms for formal outcomes assessment.25Hertzer N. Presidential address: outcome assessment in vascular surgery – results mean everything.J Vasc Surg. 1995; 21: 6-15Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar As Norm stated, “Results mean everything”. To this, I would add: compared to what? – and, at what price?