New Technology the Best Cure?
Treatment of Heart Disease
CABG, PCI and Aortic Valve Replacement
Scope of the Problem of Heart Disease
Ethnic Group
Socioeconomic Factors
Biochemical Factors
Escalating costs associated with new technology for coronary artery disease
CABG cost discussion
Reservations on cost comparisons
Who controls the patient?
Rising costs to patients
Quality of life
Conclusions for CABG and PCI
Aortic valve replacement
Current method of treatment: Surgery or Valvuloplasty
Percutaneous Aortic Valve Replacement
Subapical valve replacement
Patient benefit
Costs and benefits for aortic valve replacement
Conclusion
Annotated Bibliography
References
Bibliography: Note — these are additional articles which I included, which you may wish to delete.
Introduction
Heart disease is the number one cause of death worldwide. Its incidence has grown due to a number of factors: increasing obesity, aging of the population, and better diagnostic techniques which can establish heart disease as the true cause of death. Heart disease’s prevalence in morbidity and mortality, particularly in first-world nations, has resulted in the development of a series of methods to palliate and, in some cases, reduce or eliminate the causes of heart disease.
This paper will explore those methods which have been developed, and their effectiveness in treating heart disease. It will start with an analysis of the types of heart disease, their increases in incidents and some of the proximate causes. It will then deal with technologies which have been developed or perfected to deal with heart disease in two areas: revascularization using PCI, or percutaneous coronary intervention, and CABG, or coronary artery bypass graft surgery. It will then analyze development in aortic valve treatment, including aortic Valvuloplasty, aortic valve replacement surgery, and the newly-emerging minimally-invasive approaches to aortic valve replacement, both surgical and percutaneous.
This author posits that, despite fairly dramatic reductions in heart attack systems and a slight decrease in heart-related deaths in the United States and other first-world countries, the application of technology has had mixed results. This is particularly true when judged against the costs (time of specialists and health care staff) and resources (from capital equipment and medical facilities to medical devices and pharmaceuticals) which have been applied.
The paper finds that cardiac revascularization has added significant costs to the overall healthcare system while providing no benefit in reduced patient mortality, with the exception of primary PCI post-AMI, where PCI offers clear advantages over alternative drug treatments. The main benefit of PCI or CABG has been in morbidity and quality of patient life. There is a clear suggestion in the articles reviewed that the physicians themselves have promoted PCI to the cost of the health care system, and the fact that many diagnosticians can then easily move to a therapeutic operation during the same procedure may provide too big a temptation to add costs to the system.
On the other hand, the author argues that aortic valve replacement surgery may be an area where both patient outcomes and cost to the healthcare system are more in balance. Although the evidence is early on the value of new, minimally invasive techniques, there is clear evidence that costs can be reduced, and that a large number of ‘no option’ patients can avail themselves of these new technologies. Many of these patients face imminent mortality today in the absence of such new technologies.
This paper will conclude with some recommendations based on reflections within the cardiology and general medical community about the right application of medical diagnosis and therapy for the treatment of heart disease. It will also suggest which areas have been more effective in treating heart and vascular disease, and which may be, at the margins, reaching a point of diminishing health returns in regards to morbidity and mortality.
Scope of the Problem of Heart Disease
Heart disease is the number one cause of death in developed countries. When combined with related circulatory illnesses, such as peripheral vascular disease and stroke, heart disease significantly greater in incidence of death than any other illness. Heart disease both causes and is correlated with other conditions, in particular diabetes, obesity, depression and lack of exercise. Other major contributors to heart disease include types of food eaten, stress, and the aging of the population.
This last ’cause’ reveals that heart disease afflicts the aged more than any other population subgroup; as humanity has made progress in combating diseases which claimed lives at an earlier age, such as bacterial infectious disease, heart disease has emerged in the resultant older populations. Finally, an improvement in diagnostic accuracy through additional cardiac markers, such as Troponin, BNP, echocardiography, stress thallium tests and other modalities, have made diagnosis more accurate and more likely to be performed; i.e. The more diagnosis improves, and the more it is applied, the more cases of heart disease will be identified.
There is an additional additive effect which, ironically, is related to our ability to better treat patients after a heart attack. The concept of the ‘golden hour,’ or ‘minutes mean (heart) muscle’ has been inculcated in many industrialized countries, to the extent that emergency crews, emergency rooms and cardiac intensive care stations have been alerted to the need to respond quickly with effective therapy to a suspected AMI. This has led to significant improvements in patient mortality rates post-AMI, but has also led to more patients with heart disease living longer with chronic issues. This has therefore led some patients to continue down the path of cardiac insufficiency for a longer time than would previously have been the case.
The incidence of heart disease varies widely from one country to another and from one ethnic group to another. The United States, for example, has a rate of diagnosis that is three times higher than the average European country. Within the U.S. there are significant differences in the overall rate of heart disease:
Ethnic Group
The highest incidence of heart and circulatory disease is amongst the Pima Indians of the deserts of Arizona. Their rates of obesity, diabetes and heart disease are four times higher than the average American. When all other factors are taken into account, the genetic component is a major causative factor for heart disease.
Blacks and Hispanics have a significantly higher rate of heart disease as well. As with all analyses of causative factors, there is a close correlation between obesity, lack of exercise and Type-2 diabetes in these ethnic groups as well. This could indicate that, because these ethnic groups are more susceptible to these confounding factors, they are therefore more prone to heart and circulatory disease.
Those of South Asian (Indian, Pakistani) and Middle Eastern ethnicity tend to have higher rates of heart disease.
Socioeconomic Factors
Those who are poorer, more depressed and/or older tend to have a higher rate of heart disease than other population subgroups in the U.S.
The rates of heart disease amongst those who are on Medicaid have been shown to be higher than the general population. In addition, there is a greater likelihood that Medicaid patients are less likely to have prophylactic drug treatment (beta blockers, statins, other drugs), as well as less likely to have CABG or PCI.
Biochemical Factors
High cholesterol is associated with higher rates of heart disease, but it is only one of several factors which have been implicated in heart problems. Higher levels of C – reactive protein and Homocysteine have been directly tied to higher rates of heart disease. Both are also associated with inflammation and stress, and both are more common in people who are obese and/or engage in relatively little exercise.
Type-2 diabetes is growing at near-epidemic proportions in the United States, to the point that even 6% of children and teens are estimated to have it at present (this was an almost unknown diagnosis 25 years ago). The mechanisms of Type-2 diabetes are too complex to enter in detail in this paper, but the primary causes are obesity and lack of exercise, which leads to the production of insulin in various places within the body (the omentum, the adrenal glands, the ovaries in women in the case of ovarian cysts, and elsewhere). Type-2 diabetes is typified by an extreme overproduction of insulin and a non-response by cells throughout the body. As a result, high and variable circulating glucose levels are not met by an increase in cellular metabolism, and the effects of uncontrolled or poorly-controlled glucose levels can exhibit the same effects on subjects as with Type-1 diabetic patients who have poor glucose control with insulin injections.
Continued insulin resistance creates the groundwork for Type-2 diabetes, with subsequent circulatory effects, such as thickening of the arteries in the heart and elsewhere throughout the body. When diabetic characteristics are added to other comorbidities which contribute to heart disease risk factors, there is an increasing concern that children and young adults are setting the stage for increases in heart disease rates in future decades.
Escalating costs associated with new technology for coronary artery disease
The question of escalating costs of cardiac and circulatory care is a difficult one to answer directly. Taken in isolation, some of the new, minimally-invasive procedures are less expensive by far, when analyzed on a procedure-by-procedure basis, than previous significant surgical interventions, as demonstrated below:
Procedure
Cost
Estimated duration of ‘cure’
CABG
5-7 years
PCI (percutaneous coronary intervention
3-5 years
Based on the above analysis, it would appear to be clear that a PCI is more cost-effective than CABG procedures. This may not be true when all costs are considered, however. The logic of comparison needs to include additional factors than the ‘cure’ period and the direct procedural costs.
CABG cost discussion
CABG can vary from a simple mammary artery, single bypass to a 3- to 5-vessel bypass graft operation with the use of saphenous vein grafts from the leg. Many of the single-artery bypass operations have been overtaken by PCI in the past few years, as the need to ‘open’ single vessels has been taken in most areas of medical practice. There are some single-artery bypass operations which are necessary for better patient outcomes, however. These include:
Left main disease: the patient outcomes for left main disease are better for mammary artery bypass operations, whereas there are complications which can occur with PCI
Ostial disease: there is a danger that the placement of a stent (or a balloon in the case of POBA — plain, old balloon angioplasty) will be compromised if not done exactly in ostial lesions. These represent approximately 5% of all lesions seen under angiography.
CTO, or Chronic Total Occlusions: These occur in about 35% of patients diagnosed with significant cardiac arterial lesions. Interventionalists are able to penetrate about 50% of these lesions with normal guidewires, “CTO” guidewires, such as the Asahi wire, or with specific devices which have been developed to penetrate CTO’s. That leaves about 20% of patients with complete blockage of one or more arteries; some of those patients are treated medically, as they may be too old or too sick to undergo CABG. In some cases, the collateralization of the arteries is such that the patient can continue without major problems without undergoing a subsequent CABG operation.
Concomitant valvular disease which may require open-chest surgery. In the U.S., there are about 62,000 aortic valve replacement surgeries performed yearly, of which there are an estimated 20-25,000 patients who also receive CABG at the same time. The same is true for CHF patients who undergo mitral valve replacement or repair surgery. It is not uncommon for the cardiac surgeon to perform a “drive-by” CABG as a part of mitral valve repair or replacement.
Recent improvements in less-invasive or ‘minimally’ invasive CABG have given the cardiac surgeon reasonable tools to be able to take back some patients who were earlier lost to PCI procedures. These include mini-throacotamies, which cut only a part of the sternum, and can heal faster, to sub-apical surgery, in which the patient’s sternum is not cut or broken, and the surgeon operates underneath the patient’s sternum to approach the heart from the apex.
Mini-thoracotomy (Medtronic, 2008)
The costs of CABG include significant personnel and institutional charges, while the materials used are relatively minor in the overall cost picture. In a CABG procedure costing $25,000 to $40,000, the primary costs include:
Surgeon, anesthesiologist and medical staff during the operation
Hospital charges, with a stay of about 3-4 days, of which some portion is in the CICU, and some portion in normal in-patient beds, including patient prep room
Some medical devices, costing less than $1,000 (surgical prep tools, mostly)
Operating room charges, which are substantially more expensive than, for example, cath lab charges
Thus in comparing PCI with CABG procedures, the complicating factors can make direct comparison difficult. Patients who undergo CABG tend to have longer improvement times than patients undergoing PCI, but the results can vary significantly from patient to patient. The most common problems with CABG patients with multi-vessel grafts are infection, particularly in the long saphenous-vein extraction portion of the surgery, and stenosis at the anastomatic site. Stenosis occurs in 20-30% of the patients within the first year after surgery, and is generally related to poor technique and/or poor circulation within the media and adventitia of the grafted vessel (which can be pinched off or have poor circulation to begin with). In many cases, this stenotic response can be dealt with using a PCI approach, generally with POBA, and sometimes with a non-DES stent.
If patients’ CABG procedures do not encounter these side-effects, the patient can generally enjoy reduced or eliminated angina pain for five to seven years, at which point a CABG procedures may need to be performed again. In the patient who has developed additional complications, a new CABG procedure may not be indicated; in many such cases, CABG patients will then undergo PCI. If one assumes that the patient who first undergoes CABG is 55 years old and lives another 20 years, the possible costs of cardiac treatment with a beginning CABG could be as follows:
If, on the other hand, the patient undergoes a CABG surgery, lives 20 years, and receives a timely follow-up PCI over the period, the total costs would be as follows:
Primary Coronary Intervention
This section will deal with two types of PCI: post-AMI author acute angioplasty and PCI are related to relieving of angina symptoms and their sequelae.
Post-AMI author angioplasty
The post-AMI author direct procedure involves bringing the patient directly from the emergency room to a waiting cath lab which is equipped to perform both angiography and an angioplasty intervention. This is generally the case in hospitals or cardiac specialty centers with a high volume of patients and the ability to attract physicians and staff which are willing to work a 24-hour schedule (which adds to the cost of the procedure). In this case, the literature is clear that patient outcomes significantly benefit from rapid PCI, with overall reductions in morbidity and mortality as compared to medical (i.e. drug) treatment. Since there is no surgical alternative here, a direct cost comparison need not be done.
The reasons why PCI is so effective have to do with the nature of the arterial blockage. An AMI author is generally caused by a thrombus which is released somewhere in the body and finds its way to a major cardiac artery, causing the artery to completely block off circulation to a major portion of the heart muscle.
While drug treatment, primarily TpA, can help to ‘dissolve’ the clot, there are dangers in using the drugs without subsequent follow-up PCI. The first danger is that the patient may be susceptible to bleeding elsewhere in the body. A major concern is hemorrhagic stroke, which occurs more than 50,000 times in the U.S. per year. This concern has kept the number of patients receiving TpA to less than 10%, despite clear clinical evidence that additional use of TpA could save lives (particularly where there is no primary PCI available).
The second issue with clot-busting drugs is that they may take too long to be effective. That is because the age of the clot, and therefore its composition, may affect how quickly the clot can be reduced by the drug. This is particularly true of the AMI author patient, where there is little circulation at the infarction location (because flow has been inhibited or stopped). If the clot has formed elsewhere in the body, it could be older, and therefore harder to affect with TpA.
A third issue is that clot-busting drugs only affect the thrombi that may be circulating in the bloodstream. They do not directly affect the underlying lesion which may be causing the cardiac blockage.
IVUS and angiography vision of a thrombus pre- and post-stenting (Chen, 2008)
In the above image, one notices that the AMI author patient has a large thrombus which is blocked by soft plaque in image a. Image B. is the same vessel at the lesion site, demonstrating a large amount of soft plaque and thrombus at the vascular blockage (this is an IVUS, or intravascular ultrasound, image). The emplacement of a stent (Image D) both pushes the thrombus into the vessel walls (where it is dissolved) and clears any lesion which may be present. The stent’s struts are visible on D. due to the reflection of ultrasound, while image C. demonstrates an open vessel with removal of the blockage at the lesion site.
In a typical
The other major use of angioplasty is following a diagnosis using angiography, in which case the doctor finds a significant reduction in circulatory ability which has been evinced through one of several non-invasive diagnostic procedures, such as a thallium scan, a cardiac stress test with subsequent echocardiography, a ‘chemical stress test,’ which uses adenosine in order to induce a higher heart rate, or patient symptoms (particularly angina with exercise).
In all these cases, the angiographer is also licensed to perform angioplasty, and the “occulo-stenotic response” is a key factor in a diagnostician/therapeutic MD’s decision to proceed. Although there are a series of tools which can establish actual flow inhibition, they are seldom used. These techniques include:
Flow wire, which directly establishes the flow beyond the lesion. It is generally used in only 1% of cases prior to angioplasty.
IVUS, or Intravascular Ultrasound, which is used in about 8% of cases in the U.S. It is primarily used to judge the type and extent of the lesion, and particularly to establish if there is adequate apposition post-stenting (which is a major cause of acute thrombosis and restenosis)
Pressure wire, which compares aortic pressure to distal arterial pressure. A pressure drop of 75% or greater indicates the need to perform angioplasty, with a 92% flow rate (i.e. 8% or less reduction) regarded as ‘successful’ for POBA, and 95% flow rate for stented lesions.
Although the above procedures are reimbursed, they add time to the procedure and have been demonstrated to reduce the rate of POBA and stenting. In many cases, interventionalists will proceed with an angioplasty even if the above measures indicate that patients are not in need of the procedure (due to the physician’s judgment that the lesion does in fact need to be treated). Insurance companies and other third-party payers have not been able to establish an objective standard other than measurement of the cath images to establish a need for angioplasty, and these quantitative angiography images are generally not well-enough resolved in order to demonstrate the actual extent of the blockage or lesion, nor do they indicate the actual inhibition of flow rate associated with the lesion.
In addition to the above cost analysis, drug-eluting stents have introduced a new set of cost elements which must be considered. Restenosis with non-DES (drug-eluting stents) was in the range of 17-30%, which meant that the patient required a re-intervention in the preponderance of cases within the first year after PCI. The rate of restenosis with DES stents has dropped to 0-3% with comparable (i.e. single-vessel, de novo lesions with no history of treatment in fairly healthy, non-diabetic patients) in clinical studies, and a more-realistic 5-8% in “all-comers” clinical registries. The reasons for the discrepancy are primarily related to interventionalists treating sicker patients:
Multi-vessel disease (which tended to go to the surgeon)
Diabetic patients (who tend to have longer lesions and more lesions)
Longer lesions requiring a ‘full metal jacket.’ In the past, the longer the lesion, the greater the likelihood of restenosis. While this is still true, the lowered rates have increased usage with multiple or long lesions.
Smaller vessels: the average vessel size treated with stents has gone down as sicker patients have been treated.
Multiple stenting: including ‘crush’ and ‘T’ techniques for bifurcated lesions, and stenting at various portions of the vessel.
As more patients have been treated with DES, there have been cost and patient care consequences which have increased cost and concerns. The primary reasons for this have been treatment of more difficult cases, and the consequences for medical treatment of using DES. DES stents offer lower restenosis, on the order of.70 mm per side of the vessel (i.e. 1.4 mm on average on both sides of the vessel), as compared to 1.0-1.25 mm per side of the vessel for non-DES (‘bare metal’) stents. The latter are indicated in vessels of 3.0mm or greater; since approximately 50% of lesions are at that size, this means that patients in this size range should receive non-DES. The facts are different: in the U.S., about 65% of all stents placed are DES, including those in larger vessels.
The overuse of DES leads to cost and clinical drawbacks. From the clinical side, those patients who receive DES stents must take dual anti-platelet therapy for an indeterminate period of time (in most cases, for the rest of their lives). The reason for this is that DES can cause ‘late-stent thrombosis,’ which is the formation of new thrombi at least 30 days after the stent implantation. Those patients who don’t take Plavix have a seven-fold increase in the likelihood of late stent thrombosis, and 40% of those who have such a complication die of a myocardial infarction.
Even those patients who stay with their dual anti-platelet regimen can be forced to abandon their therapy if they are to have subsequent surgery. if, for example, a patient undergoes a subsequent non-related surgery, even a minor arthroplasty, the patient must abandon his/her Plavix for up to two weeks before the surgery. Many patients who have stents implanted are subject to further future surgical intervention, which places them at high risk for a subsequent serious heart attack.
The cost implications of Plavix treatment can add significantly to the cost of total patient treatment. If one adds the yearly cost ($2,000) to the treatment, the costs can rise for the above patient to exceed that of CABG surgery:
In addition to the above, DES stents cost more (and are reimbursed more) than bare metal stents. Since there are more used per case, that also adds to the cost. The cost differentials are as follows:
Stent Type
No./Operation
Cost/Stent
Total Cost/Operation
BMS (bare metal)
DES (drug-eluting)
Note that CMS reimbursement per stent used is $1,000 for BMS and $2,700 for DES. That means that the hospital ‘loses’ $200 per operation for the BMS patient, but $2,700 for the DES patient. That is because CMS only reimburses for the first stent, but not for any additional stents used. In addition, Medicare and other third-party insurers do not cover the use of Plavix, which falls to the patient as a cost.
This cost impact of DES is not felt as significantly by hospitals and physicians as it is by patients because of the way that hospitals and physicians are reimbursed. In general, the physician is reimbursed up to $2,000 per intervention. The hospital receives about $10,000 per angioplasty, plus the independent reimbursement for the stent ($1,000 or $2,700). That means that the hospital receives $11,000 to $12,700, for which it must pay the medical staff and its overhead and cath lab use. The cash contribution to a hospital can be substantial, contributing $2,000 to $5,000 per stented/POBA patient. With about 2 million stenting operations performed in the U.S. each year, that means that hospitals net between $4 and $20 billion in gross contribution to their bottom lines, or $2 to $10 million per hospital per year in cash contribution. Interventional cardiologists can perform up to 15 interventions per day, but generally perform 2-3; their average income per year is nearly $400,000, amongst the highest of the medical profession. Thus the financial incentives for stenting are high, making interventional cardiology one of the major sources of profit for practitioners and health care institutions.
Reservations on cost comparisons
There are several large grains of salt which must be taken with the above cost estimates. In the case of PCI, the rate of restenosis, while smaller, adds about 7% to the ultimate cost of PCI (as there must be 8% re-intervention for various reasons), which amounts to 7% x $12,500, or $875 to each PCI operation. The cost of CABG must also be increased by the percent of ‘re-do’s’, although in this case there are relatively few such operations due to the risks to the patient; exceptions may be if there is another cardiac surgical intervention which may be required, such as a valve repair. Since there can be up to 30% stenosis of vascular grafts in bypass operations, one can assume that PCI must intervene in at least half, or 15% of all CABG’s, in order to use balloon angioplasty to ‘fix’ the anastamosis. This therefore adds 15% x $12,500, or $1,875 to each CABG operation.
The second reservation is longer-term morbidity and mortality. While there is no significant difference in morbidity between the CABG and PCI patients, there is also no significant difference in mortality between patients diagnosed with angiographic stenosis who go untreated as compared to those who are treated. With the exception of percutaneous treatment acutely after an AMI, the clinical evidence demonstrates that patients’ mortality rates are similar.
Direct costs for new devices
The direct costs for new devices in PCI are relatively straightforward. In addition to the stent costs, mentioned above, the following elements add some, although not significant, cost to the procedure:
1. Balloon for pre-dilitation $300
2. Guidewires $100
3. Contrast Media $50
Other costs are incidental to most percutaneous or outpatient procedures, such as cutting sets, introducers and other such elements, which may add another $100 to the procedure. The CMS reimburses the hospital through its general fee for the operation.
Who controls the patient?
The GP, generally within the community, controls the primary patient, and can recommend a referral to a community-based cardiologist if he/she suspects cardiovascular disease. In the case of a suspected heart attack, of course, the patient is brought immediately to the hospital. In cases where the GP has a suspicion of heart disease, he/she will send the patient to the cardiologist.
The cardiologist will generally run non-invasive tests, starting with an ECG, an auscultation and perhaps a cardiac echo (which is growing more common now that the price of echocardiography machines is dipping below $20,000, and the software has become easier to use). The ECG may indicate an anomaly, which will bring the cardiologist to suggest a stress test to determine heart function. In general, these can be a thallium stress test, which is run in the hospital’s nuclear medicine department, or a treadmill stress EKG test, which is run in the cardiologist’s office. Abnormal ST waves or other anomalies can suggest that the cardiologist send the patient to the hospital for a follow-up angiography.
In most cases, whether a patient undergoes a cardiac bypass graft or a percutaneous (stent) operation, he/she will undergo an angiography. Not all physicians who are licensed to do an angiography are also permitted to conduct an angioplasty, but this distinction has been blurred as more diagnostic interventionalists have taken their license for therapeutic treatment.
Since the diagnostician and the therapist are one and the same person, there can be an incentive to move from a diagnostic to a therapeutic exam at the same time. The reimbursement for a diagnostic cath is about $2,000. If further diagnostic work is done, such as pressure wire, flow wire or IVUS, these are reimbursed additionally, at about $300, $400 and $750 apiece, respectively, plus a professional fee to the doctor of about $300. These tests are run relatively infrequently, as they can be time-consuming, and may counterindicate a subsequent POBA or stent placement (a physician would have a difficult time defending his/her decision to proceed to angioplasty if the pressure wire results indicate that it is not needed.
In any event, the physician’s judgment should not be, and in most cases may not be, swayed by other influences. In the event that the interventionalists has a good working relationship with the surgical team, and a surgeon is available to do so, he/she may come into the control room of the cath lab to discuss the patient’s angiogram with the interventionalists in order to determine next steps. In many cases, however, the surgeon is either not available, or the interventionalist-surgeon relationship may not be friendly. In the past, the rules for referral to surgery were relatively rigid: if the patient had a long lesion, multiple vessel involvement or several lesions, small vessels (generally less than 3mm) which nevertheless required revascularization, left main, ostial or chronic total occlusions, the patient was generally closed up (at the femoral site) and scheduled for surgery.
Nowadays the rules are more fluid. With DES, it is now possible for the interventionalist to point to clinical studies supporting the results of diabetic, small-vessel, multi-vessel and other types of patients who, in the past, would not have been stented. Since the interventionalist makes the ultimate decision (many times in concert with the referring community cardiologist), the temptation to stent “while we’re in there” is fairly great.
Rising costs to patients
Health care costs are higher in the U.S. than any other developed country in the world. At 16% of GDP, our healthcare spending takes a much bigger part of the total economy than the next-highest countries: France and Germany, both of which hover around 10%. Since the U.S. GDP per person is much higher than Germany and France, the actual spending per person is much higher:
Relative Spending per Capita in France, Germany and the U.S.
Country
GDP/Head
Healthcare %
Healthcare/Head
US
41.6K
France
35K
Germany
34K (Economist, 2007)
Although many claim that the U.S. has the ‘highest standard of health care in the world,’ the truth is that heart disease rates are higher in the U.S., and overall mortality rates and mean life expectancy is the same in all three countries. What are the reasons for these major differences in healthcare expenditure? Higher numbers of procedures of all types are a clear answer: the U.S. healthcare market is 40% of the global market, which suggests that the number of procedures and/or the price per procedure or pharmaceutical product ordered is higher than elsewhere.
Indeed, the price paid for stents in France and Germany is lower than in the U.S. French prices are negotiated by the national health authority and through a bidding procedure with several Assistance Publique, or public welfare hospitals. These hospitals and the government ministry use the buying power of the country (with 57 million people) to bring French DES prices to about $1,000 less per stent than in the U.S. Germany allows private and public hospitals to negotiate individual stent prices, but it imposes overall tight limits on stent spending. The German Health Ministry has purposely held the total amount of stenting to 1/3 the U.S. level, while it has held the market share of DES to around 40% of the total stent market (as compared to 62% in the U.S.). This dual approach has resulted in German hospitals negotiating the lowest average price in Europe for DES and bare metal stents. The former are about $1,200 less than in the U.S., while the latter are about $300 less than the U.S.
Part of the reason for this price differential is the substantially lower regulatory barrier in Europe as compared to the United States. In general, DES stents achieve approval on the European market 2-3 years earlier than in the U.S. Whereas the FDA may require 1,000 patients with 9- to 12-month follow-up using rigorous diagnostic procedures (second angiography, IVUS, clinical outcomes, including MACE — major adverse clinical events), European approval authorities allow 300-500 patients with 6-month follow-up. AU.S. study and approval therefore requires about 4 years and $20 million, while a European approval requires about 18 months and $5 million. For these reasons, there are many more stent competitors on the European market, and their vigorous competition places a downward pressure on prices.
The U.S., on the other hand, has only 5 main stent suppliers: Boston Scientific, J&J, Medtronic (just introduced in late 2007 after being on the European market since 2005), and Abbott (just introduced in late 2007). Since Johnson & Johnson had the first DES approval in the U.S., they offered the stent at $3,200, and lobbied the CMS heavily in order to achieve reimbursement at $2,700. Unusual to such a product, the CMS approved that level of stent reimbursement two months before the FDA’s approval for sale in the U.S. This demonstrates both J&J’s clout in the marketplace and its ability to defend stent prices three times higher than BMS on the back of strong clinical evidence of reduction in restenosis.
Quality of life
Moving away from stenting vs. CABG, there are several other cardiac procedures that significantly contribute to improvements in morbidity and mortality in patients. These include aortic valve replacement, mitral valve replacement or repair, amelioration of CHF (particularly enlarged ventricle), treatment of PMO’s and LAA (left atrial appendage) and a series of electrical disturbances which may or may not be related to the above. This section will deal with the benefits to quality of life of these procedures, and where the technology stands in reducing morbidity and mortality in these cases.
Conclusions for CABG and PCI
From the above description, one can see that PCI and CABG would not exist at current levels if it weren’t for improvements in patient morbidity. It is clear from the literature that, in most cases, patient mortality is not significantly affected by percutaneous or surgical revascularization in the heart. The reasons for this are complex, and cannot be applied to all patient cases.
In the case of patients who have an AMI author and are close to a facility which offers primary PCI, the improvements in mortality have been clearly demonstrated. Improvements in CABG techniques (lower on-pump time, better anastamosis, mammary artery bypass, ‘minimally-invasive’ CABG) have reduced morbidity and mortality post-surgery, and made it acceptable for many patients.
The key question before choosing either therapy is: what is the value to patient quality of life? If a patient is able to live with less pain and undertake more activities, but nevertheless live no longer than without the intervention, is the procedure ‘worth it’ for the patient and the healthcare system? Most patients, when confronted with the risks and rewards, choose to undergo the procedure. The healthcare system has therefore dedicated an enormous amount of resources to improving patient’s quality of life.
The question of cost of new technology (PCI) versus “old” technology (CABG) demonstrates little cost advantage to either technique. Within the averages presented there are clear cases where a patient would benefit from one procedure more than another: a patient with single-vessel, isolated lesion with no previous history of heart disease and clear angina would be a logical candidate for PCI. On the other hand, a patient with complex multivessel disease would be a better candidate for CABG.
The healthcare system pays for the resulting decisions based on the inputs of the physicians. Since the interventionalist is frequently the diagnostician and the therapeutic doctor, he/she can make the decision to perform an angioplasty and thus increase his/her revenue and costs to the healthcare system. Without a valid, objective feedback system (such as pressure wire), the third-party insurer is left to judge patient need based on the doctor’s report.
Aortic valve replacement
Aortic valve insufficiency and stenosis are both exacerbated by age. It is estimated that about 2% of those over age 75 have aortic valve insufficiency. The main cause is the formation of calcium on the aortic valve leaflets
Aortic valve calcification; not the ‘nodules’ on the leaflets of this bicuspid valve (Pick, 2007)
Aortic valve stenosis can proceed through four stages, with progressively greater impairment of heart function. The greater the stenosis, the more difficulty the aortic valve has in preventing backflow into the left ventricle, and the harder the heart has to work to overcome this deficit. The relationship between degree of aortic leaflet stenosis and heart performance is not linear; rather, the heart continues to grow and pump harder to compensate to a point where it can no longer maintain normal heart function, and heart function drops fairly quickly.
Current method of treatment: Surgery or Valvuloplasty
The current method of choice for patients is open-chest surgery with a replacement of the valve with either a mechanical valve or a pericardial valve (bovine or equine). Whereas the method of choice in the past was a replacement with a mechanical valve due to concerns about longevity, recent advances in tissue valves have resulted in a changeover to the point that animal valves now take 2/3 of the total surgeries. The tissue valves cause less blood cell damage and therefore do not require that the patient take coumarin or warfarin.
Sewing in an animal tissue aortic valve: The heart is accessed through a chest incision (a). The patient’s heart function is replaced by the heart-lung machine. The aorta is cut open to reveal a diseased aortic valve (B), which is then removed. A valve sizer is placed in the opening to determine the size of prosthesis needed -. A prosthetic valve is sutured in place (D and E). (Spivak, 2008)
Valvuloplasty is practiced in a few centers. This procedure allows the physician to expand a large balloon at low pressure to the aortic valve leaflets. Its effects seem to dissipate after 3-6 months, and it is not repeatable.
There are about 62,000 valve replacement surgeries performed in the U.S. each year. There is an additional estimated 30-70,000 U.S. patients who would benefit from the procedure, but are too old or too sick to be able to withstand the surgery. Of those 62,000 aortic valve replacements, about 20,000 are estimated to be ‘drive-by’s’, which means that the surgeon performed the valve replacement while performing other activities on the heart, such as left ventriculoplasty, mitral valve repair/replacement, and/or CABG.
The increasing number of people in the over-75 group will fuel further growth in the number of patients requiring aortic valve replacement. It is estimated that the number of people in that age category will double by 2030, which will mean over 200,000 such candidates for surgery per year (current: 62,000 with surgery and an average 50,000 who do not receive surgery). The medical alternative — watchful waiting — is not an option for patients who are otherwise fairly healthy and would like to continue an acceptable quality of life.
There are two answers emerging with new technology, both of which promise both a lower cost for the healthcare system and better patient outcomes. These include percutaneous aortic valve replacement and sub-apical surgical valve replacement.
Percutaneous Aortic Valve Replacement
Percutaneous aortic valve replacement is currently a very difficult procedure. The PVT valve, offered by Edwards (a major tissue valve supplier) uses a retrograde procedure on a balloon with a catheter which is inserted through the femoral artery. This valve has been used on over 100 patients with mixed success. Changes made by its inventor, Dr. Cribier, have resulted in improvements which have extended the life of the valve and improved patient outcomes. In its current state, perisurgical deaths have decreased. There is concern, however, that the delicate tissue valves are compromised by the crimping and balloon expansion, as well as the concern about endovascular leaks and migration of the stent-based valve.
The Edwards PVT percutaneous balloon-expanded aortic stent valve (Edwards, 2008)
It is expected that the Edwards valve will be approved for use in the U.S. In 2009, and should sell (according to Edwards) for about $12,000. Since it can be performed with a relatively low-trauma interventional procedure, associated hospital and follow-up costs are expected to be low. The cost comparison with the current aortic valve replacement surgery should be compelling:
Unlike the above-explored example of stenting vs. CABG, there should be little difference in valve life: both the surgically-implanted tissue valve and the percutaneous valve are tested and certified with the FDA for 10-year life. One could question the longevity of the PVT valve in actual patient situations — most of the longevity work has been with accelerated bench top testing and with animals. Since most patient life expectancies are less than 10 years, the first-generation PVT valve should meet physician and patient expectations for longevity.
Second-generation aortic valve replacements are coming from other companies in development which have already implanted in humans. These valves should last longer and be easier to implant. Their prices should be in a similar $12,000 range, which will grant similar favorable economics to the above procedure.
Subapical valve replacement subapical approach may help to overcome the gravest concerns about patient outcomes related to aortic surgery: long anesthesia times and long stopped-heart times (as the patients undergoing open-chest operations may be on a ‘stopped heart’ status for over 1 hour). The sequelae to current surgical techniques is a fairly high stroke rate (ministrokes 25-40%, major adverse strokes less than 5%), which can lead to longer-term loss of cognitive ability and some additional morbidity and mortality.
The subapical approach may allow for beating-heart placement of the valve with technologies similar to the valve shown above. The benefits are that the surgeon (rather than the interventionalist) can control the procedure. The costs would be similar to current surgical aortic valve replacement, as the higher medical device costs may be offset by lower CICU and other expenses post-surgery.
Patient benefit
The patients in both examples — subapical and percutaneous valve replacement — benefit from improved morbidity and mortality. One can divide the potential patient population which could benefit from such an operation into three categories:
1. Those who are currently undergoing an open-chest, stopped-heart operation solely for aortic valve replacement (estimate: 42,000 people per year in the U.S.)
2. Those who are currently receiving an aortic valve replacement as the primary surgical goal, but with other operations performed (primarily CABG) during the procedure (assume half of the 20,000 patients per year today).
3. Those patients who receive aortic Valvuloplasty but are only able to see improvement for 3-6 months (1,400 today), and 4. Those patients who are ‘no option’ patients. That is, these patients are stage 3 or stage 4 aortic stenosis or aortic insufficiency patients who are clearly suffering from significant reduction in aortic valve function due to a compromised aortic function, but are too old or too sick, in the surgeon’s opinion, to be able to withstand the rigors of open-chest surgery. Estimates of the number of patients who are in this category range from 30 to 70 thousand per year in the U.S.
Costs and benefits for aortic valve replacement
The above analysis demonstrates that, while the technology is relatively new and unproven, it nevertheless will represent a net benefit to patient outcomes. For those patients where it replaces current surgical techniques, it may cause a reduction of $30,000 per patient for the procedure, or $1.6 billion per year at current volumes, climbing to $3.2 billion by 2030. This assumes that all the patients who currently undergo the surgery would switch to the percutaneous approach. if, however, surgeons were able to retain a number of these patients with the subapical approach, the savings would be less significant.
Such an advance would not stop at those patients who are currently undergoing the open chest procedure. One must assume that some additional number of patients who are currently ‘no option’ would be able to avail themselves of the minimally-invasive replacement device. If one assumes that half, or 25,000 per year, would undergo percutaneous valve replacement. At $30,000 per patient, the total additional procedures would cost the healthcare system $750 million. The net savings, therefore, to the system would be nearly $1 billion. The improvements in patient outcomes (longer life span, improved quality of life) would mean a net gain both financially and for the patients.
There is one potential negative concern: if surgeons remain an important factor in implementing the subapical approach, they could drain some of the savings out of the total procedure. They would need to demonstrate either a more cost-efficient method than that currently, or they would need to demonstrate better patient outcomes. In reality, some patients may benefit from direct surgical intervention (those with particularly difficult aortic roots, or significant calcification, for example), while other patients would be more susceptible to a percutaneous approach.
Conclusion
There are dangers and opportunities for patients and the healthcare system in the introduction of new technology. One can cite, as this paper has done, the dangers of the implementation of a technology in which hospitals and physicians are able to control both the definition of clinical need and the delivery of therapy to the patient. The current incentives from a financial standpoint for both CABG and PCI are relatively biased in favor of more procedures, regardless of patient need (the ‘occulostenotic response’). The benefit to patient morbidity is clear, and patients should be able to enjoy further years of pain-free activity with one or both of the above procedures. One cannot argue that, on average, one procedure is ‘better’ or ‘worse’ than the other, except in particular cases, such as primary PCI after an AMI or in complete occlusion experienced with diffuse disease (which generally requires a CABG intervention).
The literature cited which demonstrates that mortality rates are not reduced has been criticized by the surgical and interventionalist community on the basis of the timing of the data. Most of it was generated at a time when drug-eluting stents were not being used, or, if they were, the experience was not long enough to draw significant conclusions about morbidity or mortality.
The case of aortic valve replacement is a much clearer “win” for new technology. That is because the difference in mortality between operated-upon and non-operated patients can be demonstrated. With 30-70,000 ‘no option’ patients per year, and a growing demographic of those over 75, the evidence is clear that new approaches are needed to be able to reach these patients, and to extend their lives. A cost analysis of the two methods demonstrates that the percutaneous, minimally-invasive approach can offer cost as well as patient outcome benefits as compared to state-of-the-art surgical techniques. The caveat to this conclusion is that one must develop clinical data which demonstrates patient outcomes.
As with stenting and CABG in the preceding example, it is not possible to conduct a double-blind study in order to demonstrate efficacy and safety. Rather, a better analysis and process of technology dissemination needs to be pursued than that which was used in the widespread adoption of stenting and CABG procedures.
Annotated Bibliography
American Heart Association (2007). American Heart Association: Heart Disease and Stroke Statistics – 2007 Update [Electronic version] American Heart Association, 1-40.
The American Heart Association (AHA) is an organization dedicated to the prevention and cure of heart disease. in, American Heart Association: Heart Disease and Stroke Statistics – 2007 Update, Their biostatisticians have compiled data on heart disease and stroke statistics from 2004, incorporating information from several government agencies including, the Centers for Disease Control and prevention/National Center for Health Statistics (CDC/NCHS), Centers for Medicare and Medicaid Services (CMS), and the Health Care Financing Administration (HCFA), along with several prominent peer reviewed journals, such as, the New England Journal of Medicine (NEJM), the Journal of the American College of Cardiology (JACC), and the Journal of the American Medical Association (JAMA). Included in the publication are statistical analysis for populations at risk, associated risk factors, and other valuable data such as, cardiac procedures, prevalence, costs, and morbidity rates throughout the country.
The author has used this information as a premise in the paper to explain the dramatic effects and seriousness of coronary artery disease (CAD), the escalating costs, and to show how the progression of the disease worldwide has expedited the manufacturing of new coronary devices in search of a cure.
Boden, W.E. (2004). Surgery, angioplasty, or medical therapy for symptomatic multivessel coronary artery disease, is there an indisputable winning strategy from evidence-based clinical trials. Journal of the American College of Cardiology, 43, 1752-1754.
In this article, Dr. William Boden, Division of Cardiology, the Henry Low Heart Center at Hartford Hospital, Hartford, CT. discusses the current methods of addressing coronary angina and disease, and uses examples of evidence-based trials to establish a recommendation regarding quantity and quality of life for patients experiencing symptoms. Even though this article had been published prior to the huge domination of drug-eluting stents in invasive cardiology, the premise and information contained in the article are still very accurate in 2007. Dr. Boden addresses the deeper issues of cardiac care by examining the whole patient make-up and not focusing on treating just one of the factors, such as a single coronary blockage. By seeing the entire picture, physicians can assure better outcomes and quality of life for their patients. This article elaborates on the most important entity concerning medical devices – the patient, and the importance of treating the patient for long-term success.
Briguori C. Sarais C. Pagnotta P. Liistro F. Montorfano M. Chieffo a et al. 2002 in-stent restenosis in small coronary arteries: Impact of strut thickness) Briguori, C., Sarais, C., Pagnotta, P., Liistro, F., Montorfano, M., Chieffo, a., et al. (2002). in-stent restenosis in small coronary arteries: Impact of strut thickness [Electronic version] Journal of the American College of Cardiology, 40, 403-409.
Dr. Carlo Briguori (laboratory of Interventional Cardiology, “Vita Salute” University School of Medicine, San Raffaele Hospital, Milan, Italy) and colleagues, report that strut thickness has a prominent effect on restenosis. Dr. Briguori et al. divided bare metal stents into one of two categories: “thin strut” or “thick strut,” and found that patients who received the “thick strut” stents, between March of 1996 and April of 2001, displayed a higher evidence of restenosis than those receiving the “thin strut” stents. Included in this study, the inclusion of one stent in particular, the BX Velocity stent (Cordis, Johnson & Johnson), which was relegated to the thick-strut category and used in 18% of the patients who reported a higher incidence of restenosis. The BX Velocity stent was the “control” stent used against the Sirolimus-eluting stent in early drug-eluting stent trials. This paper illustrates how the differences between drug-eluting stents and bare metal stents were not as significant as originally reported in the RAVEL trial, Morice, M.C., et al., above, and to show how controlled clinical trial information is subject to dissection for supporting or non-supporting evidence.
Cohn, Jay N. (2006). Efficacy and safety in clinical trials in cardiovascular disease. Journal of the American College of Cardiology, 48, 430-433.
Dr. Jay N. Cohn, Cardiovascular Division at the University of Minnesota Medical School, Minneapolis, MN. presents his recommendations for improving clinical trials performed for cardiovascular interventions and their long-term outcomes. Throughout the article, Cohn emphasizes the importance of acknowledging mortality findings into the results, in order to establish a truer picture for cardiologists to base their recommendations for treatment on. The rationale of incorporating true long-term statistics into pre-procedural thought is becoming more popular, especially lately due to the confusion surrounding the safety of drug-eluting stents, as reported above (Kettelkamp, 2004). The importance of this article to the paper is, Cohn’s theory of improving long-term outcomes for patients while cutting unnecessary costs in the process, shows a completely opposite approach to current medical practices in the United States. The author has compared these findings to those of some recent clinical trial data to enforce the hypothesis that there are safer and more efficient treatments available for patients with coronary artery disease as opposed to drug-eluting stents.
Cutlip, D.E., Chauhan, M.S., Baim, D.S., Ho, K.K., Popma, J.J., Carrozza, J.P., et al. (2002). Clinical restenosis after coronary stenting: perspectives from multicenter trials. Journal of the American College of Cardiology, 40, 2082-2089.
Dr. Donald E. Cutlip (Harvard Clinical Research Institute) and colleagues’ analyzed data retrieved from several clinical trials in an attempt to distinguish the differences between angiographic and clinical restenosis rates. Their analysis reported that angiographic restenosis correlates closely with clinical restenosis at six and twelve month intervals. The researchers also found that there was a higher degree of coronary artery restenosis at twelve months than at six months. This information led the researchers to recommend longer evaluations in clinical trials in order to assimilate more accurate findings.
This article includes information regarding several areas important to the paper. The fact that this data was reported prior to the release of drug-eluting stents, serves as a reference regarding clinical outcomes of bare metal stents, restenosis rates, target vessel revascularization (TVR), and target lesion revascularization (TLR). The information is relevant to the paper in that it explains the differences in individual perceptions when diagnosing degrees of stenosis in coronary arteries, and supports Dr. William Boden’s article (below) that not all coronary lesions need to be treated. It will also be used in the paper to elaborate on the impact manufacturers have on using medical devices.
Degertekin, M., Regar, E., Tanabe, K., Smits, P.C., van der Giessen, W.J., Carlier, S.G., et al. (2003). Sirolimus-eluting stent for treatment of complex in-stent restenosis: the first clinical experience [Electronic version] Journal of the American College of Cardiology, 41, 184-189.
Dr. Muzaffer Degertekin (Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands) and colleagues, report their findings on using Sirolimus-eluting stents (SES) to treat “complex in-stent restenosis” in high risk patients. Data surrounding the low incidences of reoccurrence following implantation of the SES in already restenosed standard bare metal stents, allow the authors to conclude from the study that, Sirolimus-eluting stents are an effective means of treating “in-stent” restenosis when properly used. One limitation found in this study was the small number of participants included in the trial, only 16, an incredibly small number considering the possible impact on future outcomes regarding patients and physician practice. Yes, the Sirolimus-eluting stent did in fact perform well, relating to minimal “late-loss,” within the bare metal stent, but, negative events surrounding the target lesion itself place a damper on any positive findings reported in this study. There seems to be a lack of concern regarding the major adverse cardiac events (MACE) that are very prominent in this study. The elaboration on “properly used” does not seem sufficient enough to warrant an approval recommendation from this study for the Sirolimus-eluting stent in any vessel without further evidence. This article exemplifies a loss of focus during this timeframe obtained from the enthusiasm caused by drug-eluting stents. It demonstrates the cultural attitude of trying to find an end-all to coronary disease with just one device. The article helps support the hypothesis by showing that, one; DES are not for every patient, and, two; controlled clinical trials differ greatly from real-world results.
Hannan, E.L., Racz, M.J., Walford, G., Jones, R.H., Ryan, T.J., Bennett, E., et al. (2005). Long-term outcomes of coronary-artery bypass grafting vs. stent implantation [Electronic version] the New England Journal of Medicine, 352, 2174-2183.
In this article, Dr. Edward Hannan and colleagues look at data collected from the state of New York’s cardiac registries to determine which course of action is best when treating coronary artery disease, Coronary artery bypass grafts (CABG) or stenting. Information was collected from January 1, 1997, to December 31, 2000, on a total of 59,314 patients, all of whom had presented with multivessel coronary disease and underwent either CABG (37,212) or stenting (22,102). Results favored CABG over stenting, 7.8% and 27.3% respectively, in all categories including, mortality and restenosis.
The data were reported in the New England Journal of Medicine May 26, 2005, and are the largest and most current information regarding the long-term benefits of CABG over stenting for patients with multivessel coronary disease.
This information elaborates on the “over dissemination” of stents by using these statistics, by showing that evidence-based medicine supports CABG over stenting in patients with multi-vessel disease (more than 1 stenosed artery) is the only proven treatment for patients that fall into that category.
The problem with this study is that it examined data from patients prior to the issuance of drug-eluting stents. Restenosis rates with ‘first-generation’ bare metal stents has been demonstrated in numerous studies (Serruys et al.) to have restenosis rates of 20 to over 30%. “Second generation” stents have been shown to have a restenosis rate of 15 to 20%. In both cases, the patient cohorts were screened to assure single-vessel, single de novo lesions, no diabetes, and no long lesions. One could therefore expect in an “all comers” registry, such as this in New York, would have more complex patients and a greater variation in physician technique, which would account for a higher failure rate than is seen in prospective trials.
Joyner, M., Finn, a.V., Farb, a., Mont, E.K., Kolodgie, F.A., Ladich, E., et al. (2006). Pathology of drug-eluting stents in humans. Journal of the American College of Cardiology, 48, 193-202.
In this article, Dr. Renu Virmani (CVPath, International Registry of Pathology, Gaithersburg, MD.) and colleagues report their findings regarding the first in-human pathological results of drug-eluting and bare metal stents. The authors performed autopsies on 48 individuals who had died of cardiac related issues and had previously received either a drug-eluting (23) or bare metal stent (25). Their findings showed no surprises concerning coronary pathology with the bare metal stents, but found consistent data regarding late healing issues with the drug-eluting stents in relation to stent thrombosis. The authors also found data supporting earlier theories that stent length and placement were large factors associated with stent thrombosis. The authors conclude that antiplatelet therapy should be extended past the initial recommendations (6-9 months) until further knowledge and data is collected regarding drug-eluting stents.
A the author will use the pathology information from this article throughout the paper to elaborate on the current effects of drug-eluting stents on the coronary arteries and future ramifications associated with the lack of knowledge prior to their approval. The effects of trauma caused during coronary intervention to the vessel itself are not new information to the field of cardiology. Drug-eluting stents are designed to inhibit smooth muscle cell proliferation, but do not have any influence on damage to deeper layers of the coronary artery, an assumption made previously by Dr. Peter Berger (above).
These data are supported by other clinical trials in peer-reviewed publications which demonstrate that there is no clear time limit on the amount of time patients should take dual anti-platelet drugs, including Plavix and low-dose aspirin. The rates of late-stent thrombosis appear to be different between the J&J and Boston Scientific stents, but both seem to have a rate of late stent thrombosis in 1.8-2.8% of patients by the 2-year mark, and an increase in late stent thrombosis by 0.5 to 0.6% per year thereafter (out to four years for the J&J stent).
Kettelkamp, R., House, J., Garg, M., Stuart, R.S., Grantham, a., & Spertus, J. (2004). Using the risk of restenosis as a guide to triaging patients between surgical and percutaneous coronary revascularization [Electronic version] Circulation, 110, II-50-II-54.
Dr. Richard Kettelkamp, DO, MHA, and colleagues at the Mid America Heart Institute, Saint Luke’s Hospital, MO. reveal their analyses of a study researching methods for determining risk factors for patients undergoing coronary revascularization. The intent of the article is to provide interventional cardiologist with a tool that provides a means of determining which patients would benefit more from coronary artery bypass graft surgery (CABG) than percutaneous coronary intervention (PCI), based on research suggesting patient undergoing CABG are less likely to have repeat interventions. Kettelkamp et al., offer some theory behind patients undergoing more PCI than CABG by suggesting that many of them are not informed of the evidence showing better long-term benefits for CABG over PCI. This information will be used in the paper to elaborate on how the practice of using drug-eluting stents has further divided interventional cardiologists from thoracic surgeons and evidence-based medicine, in turn, not providing the best possible care for their patients.
Malenka, D.J., Leavitt, B.J., Hearne, M.J., Robb, J.F., Baribeau, Y.R., Ryan, T.J., et al. (2005). Comparing long-term survival of patients with multivessel coronary disease after CABG or PCI: Analysis of BARI-like patients in Northern New England [Electronic version] Circulation, 112, 371-376. This article is a report by David Malenka, M.D., Cardiology, Dartmouth-Hitchcock Medical School, N.H., and colleagues. The purpose of this article is to disseminate information obtained from their research, to patients and physicians that suggest coronary artery bypass graft surgery (CABG) is more beneficial than percutaneous coronary intervention (PCI) with regards to long-term mortality for patients with multivessel coronary disease. The authors report data collected from several clinical trials, all of which report substantial findings favoring the long-term mortality benefits of CABG patients over PC patients. The authors contend that patients receive more complete revascularization with CABG than PCI, allowing for the longer longevity. While this article was presented in 2005, the data was relevant to patients receiving therapy between 1994 and 2001, prior to the release of drug-eluting stents but during a time of >80% stent usage. As of this writing date, this article is the latest study available with regards to CABG vs. PCI. The authors intend to use this information in the paper to show the extent to which medical-based evidence was ignored following the introduction of stents. The use of earlier data on all comers is difficult to apply to today’s experience. Those countries in which DES have been used for longer periods of time, such as Switzerland and Sweden, have conducted studies on a national level which demonstrate that longer-term outcomes with DES and CABG are similar.
Mauri, L., Hsieh, W., Massaro, J.M., Ho, K.K., D’Agostino, R., & Cutlip, D.E. (2007). Stent Thrombosis in Randomized Clinical Trials of Drug-Eluting Stents. The New England Journal of Medicine, 356, 1020-1029.
In this article, Dr. Laura Mauri and colleagues attempt to establish evidence pertinent to the FDA’s recent meeting regarding the safety of drug-eluting stents with regards to recent evidence on stent thrombosis. The authors reviewed a total of eight clinical trials previously performed throughout Europe, Canada, and the United States that used Paclitaxel or Sirolimus coated stents vs. bare metal stents. Incidences of occurrences were rated using definitions established by the Academic Research Consortium (ARC), a committee of international researchers and representatives from manufacturing companies. Using the ARC definitions, the authors reported data suggesting that stent thrombosis occurred at the same rate in drug-eluting stents as in bare metal stents. While the conclusions adopted by the authors was based on a number of different trials involving many subjects (patients), adjudicating the data using different parameters than originally used suggest that the outcomes were preconceived. Information regarding possible reasons for bias is apparent from the beginning of the article where the ARC committee contends that “funding to cover the costs of the meeting was requested and received from each manufacturer.” This information will be used in the paper to demonstrate the possible effects that financial gain and not evidence-based medicine are sometimes the drivers of new technology.
Mintz, G.S., & Weissman, N.J. (2006). Intravascular ultrasound in the drug-eluting stent era. Journal of the American College of Cardiology, 48, 421-429.
Dr. Gary Mintz and Dr. Neil Weissman address the importance of using intravascular ultrasound following stent implantation, especially in patients who present with higher risk of complications, such as, diabetes and complex lesions. The authors report follow-up results from several studies including, the RAVEL and SIRIUS drug-eluting stent trials, in which they conclude moderate differences seen by intravascular ultrasound allow for more complete apposition and sizing than those performed without. This is extremely important today considering the sensitivity regarding stent thrombosis and drug-eluting stents. The author intend to use this information in the paper to elaborate on the differences in physician practices when performing interventional procedures, and how intravascular ultrasound can help eliminate many of these suspected flaws and in turn, allow for safer outcomes for patients.
Morice, M.C., Serruys, P.W., Sousa, J.E., Fajadet, J., Hayashi, E.B., Perin, M., et al. (2002). A randomized comparison of a Sirolimus-eluting stent with a standard stent for coronary revascularization [Electronic version] the New England Journal of Medicine, 346, 1773-1780.
In this article, several prominent interventional cardiologists, from three separate sites across Europe, report their findings from the RAVEL trial (RAndomized study with the Sirolimus-eluting VELocity Balloon Expanding Stent) one of the first major drug-eluting stent trials. This double-blind study focused on the coronary lumen “late loss” differences between coronary stents coated with the drug Sirolimus, and standard bare metal stents. The increasing re-occurrence of restenosis (return blockage) in coronary arteries following PCI with standard bare metal stents was the emphasis behind trialing the new Sirolimus drug-eluting stent, a stent coated with a drug that reduces intimal hyperplasia or “late loss” (proliferation of lymphocytes and smooth muscle cells into the coronary lumen). Dr. Patrick Serruys (Department of Cardiology, Thoraxcenter, Erasmus Medical Center, the Netherlands) and colleagues reported data favoring the Sirolimus-eluting stent, which accounted for an unprecedented -0.01 mm late loss, compared with 0.80 mm for the standard bare metal stent. Data retrieved from the study would show to be very prominent, as the RAVEL Trial became the pivotal trial for drug-eluting stent acceptance in Europe. The author intend to use data from this study to show the phenomenal outcomes of zero percent restenosis reported from this trial, and also to elaborate on the excitement and euphoria generated from this report by showing how drug-eluting stents gained worldly acceptance in a very short timeframe.
While the principal investigator and clinicians were surprised at the very low rate of restenosis, one should note that it was performed on a very select type of patient, with single, de novo, short lesions in patients with no diabetes and no previous angioplasty. As physicians found that lower restenosis allowed them to go into more complex cases, the amounts of restenosis climbed.
Nebeker, J.R., Virmani, R., Bennett, C.L., Hoffman, J.M., Samore, M.H., Alvarez, J., et al. (2006). Hypersensitivity cases associated with drug-eluting coronary stents: A review of available cases from the research on adverse drug events and reports (RADAR) project. Journal of the American College of Cardiology, 47, 175-181.
The authors investigated data collected from the Food and Drug Administration’s (FDA) manufacturer and user device experience center (MAUDE) regarding hypersensitivity issues reported following drug-eluting stent (DES) implantation. A total of 5,781 cases dealing with a variety of issues concerning DES were reported to the FDA since DES was approved in April 2003. Of those cases, 251 of those reported cases contain evidence of hypersensitivity reactions. Following investigations, FDA officials attributed most of the reactions to medications and anti-platelet drugs, and not the stents themselves, except in 17 cases where evidence suggested otherwise, including 4 autopsies. Another probable cause reported by the authors was a reaction to the polymers which coat the stent, and the possibility of small particles possibly breaking loose into the patients system, further investigation on this hypothesis is warranted. The authors conclude that hypersensitive reactions are possible with drug-eluting stents that may be harmful or even fatal.
This article contains early documentation regarding some of the unknown dangers associated with drug-eluting stents, and while the actual numbers of significant events seem very small, the seriousness of the outcomes, provide critical information that cannot be ignored. This information will be used in the paper as another indication for treating each patient individually by reviewing all necessary histories in order to make the right recommendation for treatment.
Pfisterer, M., Brunner-La Rocca, H.P., Buser, P.T., Richenbacher, P., Hunziker, P., Mueller, C., et al. (2006). Late clinical events after Clopidogrel discontinuation may limit the benefit of drug-eluting stents: An observational study of drug-eluting vs. bare-metal stents. Retrieved December 26, 2006 from Journal of the American College of Cardiology web site: http://content.onlinejacc.org/cgi/content/full/j.jacc.2006.10.026v1
Dr. Matthias Pfisterer and colleagues report their findings from the BASKET-LATE (Basel Stent Cost-Effectiveness Trial-Late Thrombotic Event) study performed at the University Hospital in Basel, Switzerland. The study, depicted the relationship of Clopidogrel discontinuation with sub-acute thrombosis (SAT) and describes the long-term effects associated with drug-eluting stents in coronary arteries, and the inability of the artery to heal properly in certain patient subsets thereafter. Dr. Pfisterer et al. report that the healing process, which is purposely delayed by the drug coated stents, accounted for a three times higher risk of cardiac death than bare metal stents following Clopidogrel discontinuation due to SAT. This finding prompted investigators to recommend that longer regimens of Clopidogrel may be necessary for patients who receive a drug-eluting stent, until further evidence is obtained or possibly for the rest of their lives.
This article will be used in the paper to elaborate on the dangers drug-eluting stents cause because of long-term Clopidogrel usage. This also support the hypothesis that not enough long-term data was collected prior to drug-eluting stent approval for use, resulting in an almost certain negligence on the part of the manufacturers through excessive costs and harm to patients.
Serruys, P.W., Kutryk, M.J., & Ong, a.T. (2006). Coronary-artery stents. The New England Journal of Medicine, 354, 483-495.
In this article, Dr. Patrick Serruys (Department of Cardiology, Thoraxcenter, Erasmus Medical Center, the Netherlands) and colleagues give a short, but detailed account, of the history of devices and coronary artery disease. Dr. Serruys et al. retrace the evolution of invasive cardiology, and the need for the different devices from 1964 to 2006. The article differentiates between the pros and cons of coronary devices using published reports from clinical trials that tested the devices.
While the timelines and the history are an excellent reference for coronary artery disease and devices, some of the reported data is misleading in the fact that it is not all reported. At one point, Dr. Serruys et al. report that the BASKET (Basel Stent Kosten Effektivitats Trial) study confirmed superiority of drug-eluting stents over bare metal stents at six months, when in fact data following the six-month period suggested otherwise (see below). This leads the educated reader to assume some bias was used in preparing the article. Throughout the article many different percentages are reported with regards to drug-eluting stents vs. bare metal stents. This information supports Dr. Peter Berger’s theory (above) that all stents are not created equal. The author plan to use information from this article to reference certain historical timelines and to elaborate on the need for more standardization among clinical trials.
Shuchman, M. (2006). Trading restenosis for thrombosis? New questions about drug-eluting stents [Electronic version] the New England Journal of Medicine, 355, 1949-1952.
In this article posted in the New England Journal of Medicine, November 9, 2006, Dr. Miriam Shuchman, Department of Psychiatry at the University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, N.Y. describes reactions from drug-eluting stent manufacturers, physicians, and the Food and Drug Administration (FDA) regarding the rapidly increasing data on the risk of late stent thrombosis associated with drug-eluting stents (DES). Throughout the article, both physicians and company representatives down play the idea of any knowledge about late thrombosis events with DES until the recent FDA request to view data collected from both Boston Scientific (Taxus DES) and Cordis, Johnson and Johnson (Cypher DES). After reviewing the data the FDA agreed that many of the DES were being used off label (in non-FDA-approved indications) and that these patients were at a higher risk for stent thrombosis, resulting in the FDA issuing a statement that drug-eluting stents are “safe and effective when used for the FDA-approved indications.” The article is a further example that drug-eluting stents should have been trialed longer and that more information is necessary before these stents can be considered safe. This article exemplifies the seriousness of “sub-acute thrombosis” (SAT) and will be used in the paper to help elaborate on the complication aspects concerning drug-eluting stents that seemed to be ignored by the FDA prior to their release.
Spaulding, C., Daemen, J., Boersma, E., Cutlip, D.E., & Serruys, P.W. (2007). A pooled analysis of data comparing Sirolimus-eluting stents with bare-metal stents. The New England Journal of Medicine, 356, 989-997.
Dr. Spaulding and colleagues examined data from the RAVEL (RAndomized study with the Sirolimus-eluting VELocity Balloon Expanding Stent) (see above) and SIRIUS trials four years after their completion, and used the Academic Research Consortium (ARC) definitions for stent thrombosis in their analysis. In another example of data collected to influence the FDA panel regarding the safety of drug-eluting stents, as above (Mauri et. Al.), the authors used information obtained from Cordis, Johnson & Johnson (J&J) to elaborate on the four-year mortality ratio between Sirolimus covered stents and bare metal stents. They concluded that there were no differences found between the two stents at the four-year timeline, although the Sirolimus stent group reported 10 episodes of stent thrombosis against 5 for bare metal stents. Again, this information seems to be lacking any pertinent findings that support drug-eluting stents over bare metal stents, and confirms the similarities between the two. The authors also contend that patients used in these studies were “highly selected and are representative of only about 25% of real-world patients currently treated with drug-eluting stents.” The author intend to use this article in the paper to elaborate on the dangers of allowing outside interest, those who stand to gain financially, to become involved in the processes of determining recommendations for medical technology.
Stone, G.W., Moses, J.W., Ellis, S.G., Schofer, J., Dawkins, K.D., Morice, M.C., et al. (2007). Safety and efficacy of sirolimus and paclitaxel-eluting stents. The New England Journal of Medicine, 356, 998-1008.
In this article, Dr. Gregg Stone (Columbia University Medical Center and the Cardiovascular Research Foundation, New York) and colleagues, reviewed data collected from 9 clinical trials submitted by Cordis, Johnson and Johnson manufacturers of the Cypher-drug-eluting stent, and Boston Scientific, manufacturers of the Taxus-drug-eluting stent. Data collected were interpreted for several different end points, including: stent thrombosis, revascularization, and morbidity. The purpose of the research was to determine the long-term safety of drug-eluting stents using clinical trial data that initially approved their use by the FDA. Information obtained was current with new findings that show a higher incidence of stent thrombosis after 1 year than bare metal stents.06 – none. While these data are not significantly different, the mortality rate associated with stent thrombosis increases concerns considerably. The article is important to the paper because the authors used methods consistent with those used during the clinical trials. Unlike the two prior reports submitted to the FDA council in December, 2006, as above (Mauri, L.) and (Spaulding, C.) which took some of the same data but used the ARC (Academy of Research Consortium) methods for determining stent thrombosis, and came away with different results. The method used in this article is relevant to this paper because of the lack of bias evident in the report, and to show the differences in results when changes are made to clinical trial structures.
W.E., O’Rourke, R.A., Teo, K.K., Hartigan, P.M., Maron, D.J., Kostuk, W.J., et al. (2007). Optimal medical therapy with or without PCI for stable coronary disease. The New England Journal of Medicine, 10.1056, Retrieved 03272007, at http://www.nejm.orgIn this most recent article, Dr. William Boden, Division of Cardiology, the Henry Low Heart Center at Hartford Hospital, Hartford, CT. et al. report their current findings from the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) which assessed the differences between patients with known “stable” coronary artery disease who were treated with Percutaneous Coronary Intervention (PCI) and medicines alone. In probably one of the biggest blows to the coronary stent industry, Dr. Boden et al. report documented evidence supporting medicine therapy is as good as intervention for patients presenting with “stable” coronary disease, a condition currently being treated in about 85% of the 1 million patients who undergo stent placement in the United States per year. This trial, which is sure to become a landmark, provides patients and physicians with alternative options other than using controversial devices such as drug-eluting stents with regards to coronary disease management for patient’s not experiencing angina. The importance of this article, particularly to the paper, is the encouragement of physicians to involve every patient into their own treatment for the best possible results. This also allows the physician with more evidence to support non-intervention for those patients looking for a quick fix. The author will also use this article in the paper to elaborate how PCI was initially developed with the intention of relieving angina.
References
American Heart Association (2007). American Heart Association: Heart Disease and Stroke Statistics – 2007 Update [Electronic version] American Heart Association, 1-40.
Boden, W.E. (2004). Surgery, angioplasty, or medical therapy for symptomatic multivessel coronary artery disease, is there an indisputable winning strategy from evidence-based clinical trials. Journal of the American College of Cardiology, 43, 1752-1754.
Boden, W.E., O’Rourke, R.A., Teo, K.K., Hartigan, P.M., Maron, D.J., Kostuk, W.J., et al. (2007). Optimal medical therapy with or without PCI for stable coronary disease. The New England Journal of Medicine, 10.1056,. Retrieved 03272007, at http://www.nejm.org
Briguori, C., Sarais, C., Pagnotta, P., Liistro, F., Montorfano, M., Chieffo, a., et al. (2002). in-stent restenosis in small coronary arteries: Impact of strut thickness [Electronic version] Journal of the American College of Cardiology, 40, 403-409.
Cohn, Jay N. (2006). Efficacy and safety in clinical trials in cardiovascular disease. Journal of the American College of Cardiology, 48, 430-433.
Cutlip, D.E., Chauhan, M.S., Baim, D.S., Ho, K.K., Popma, J.J., Carrozza, J.P., et al. (2002). Clinical restenosis after coronary stenting: perspectives from multicenter trials. Journal of the American College of Cardiology, 40, 2082-2089.
Degertekin, M., Regar, E., Tanabe, K., Smits, P.C., van der Giessen, W.J., Carlier, S.G., et al. (2003). Sirolimus-eluting stent for treatment of complex in-stent restenosis: the first clinical experience [Electronic version] Journal of the American College of Cardiology, 41, 184-189.
Hannan, E.L., Racz, M.J., Walford, G., Jones, R.H., Ryan, T.J., Bennett, E., et al. (2005). Long-term outcomes of coronary-artery bypass grafting vs. stent implantation [Electronic version] the New England Journal of Medicine, 352, 2174-2183.
Joyner, M., Finn, a.V., Farb, a., Mont, E.K., Kolodgie, F.A., Ladich, E., et al. (2006). Pathology of drug-eluting stents in humans. Journal of the American College of Cardiology, 48, 193-202.
Kettelkamp, R., House, J., Garg, M., Stuart, R.S., Grantham, a., & Spertus, J. (2004). Using the risk of restenosis as a guide to triaging patients between surgical and percutaneous coronary revascularization [Electronic version] Circulation, 110, II-50-II-54.
Malenka, D.J., Leavitt, B.J., Hearne, M.J., Robb, J.F., Baribeau, Y.R., Ryan, T.J., et al. (2005). Comparing long-term survival of patients with multivessel coronary disease after CABG or PCI: Analysis of BARI-like patients in Northern New England [Electronic version] Circulation, 112, 371-376.
Mauri, L., Hsieh, W., Massaro, J.M., Ho, K.K., D’Agostino, R., & Cutlip, D.E. (2007). Stent Thrombosis in Randomized Clinical Trials of Drug-Eluting Stents. The New England Journal of Medicine, 356, 1020-1029.
Mintz, G.S., & Weissman, N.J. (2006). Intravascular ultrasound in the drug-eluting stent era. Journal of the American College of Cardiology, 48, 421-429.
Morice, M.C., Serruys, P.W., Sousa, J.E., Fajadet, J., Hayashi, E.B., Perin, M., et al. (2002). A randomized comparison of a Sirolimus-eluting stent with a standard stent for coronary revascularization [Electronic version] the New England Journal of Medicine, 346, 1773-1780.
Nebeker, J.R., Virmani, R., Bennett, C.L., Hoffman, J.M., Samore, M.H., Alvarez, J., et al. (2006). Hypersensitivity cases associated with drug-eluting coronary stents. Journal of the American College of Cardiology, 47, 175-181.
Pfisterer, M., Brunner-La Rocca, H.P., Buser, P.T., Richenbacher, P., Hunziker, P., Mueller, C., et al. (2006). Late clinical events after Clopidogrel discontinuation may limit the benefit of drug-eluting stents: An observational study of drug-eluting vs. bare-metal stents. Retrieved December 26, 2006 from Journal of the American College of Cardiology web site: http://content.onlinejacc.org/cgi/content/full/j.jacc.2006.10.026v1
Serruys, P.W., Kutryk, M.J., & Ong, a.T. (2006). Coronary-artery stents. The New England Journal of Medicine, 354, 483-495.
Shuchman, M. (2006). Trading restenosis for thrombosis? New questions about drug-eluting stents [Electronic version] the New England Journal of Medicine, 355, 1949-1952.
Spaulding, C., Daemen, J., Boersma, E., Cutlip, D.E., & Serruys, P.W. (2007). A pooled analysis of data comparing Sirolimus-eluting stents with bare-metal stents. The New England Journal of Medicine, 356, 989-997.
Stone, G.W., Moses, J.W., Ellis, S.G., Schofer, J., Dawkins, K.D., Morice, M.C., et al. (2007). Safety and efficacy of sirolimus and paclitaxel-eluting stents. The New England Journal of Medicine, 356, 998-1008.
Bibliography: Note — these are additional articles which I included, which you may wish to delete.
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