Flatlined

Unnecessary Procedures

Many of the most expensive and common procedures in medicine are of unproven value in many of the patients who receive them. The investigators at the Dartmouth Institute for Health Policy and Clinical Practice (the group that established the spending variations in different regions of the US) has divided surgeries into those that are always indicated when they are performed and preference-sensitive surgeries whose usage depends on the opinion of the surgeon and the wishes of the patient.

The hallmark of preference-sensitive surgeries is that, while the procedures are always valuable in some group of patients, their value in other groups of patients is untested and unknown. Preference-sensitive procedures have another characteristic--extreme variation in the frequency of their performance among hospital referral regions. Procedures that are always indicated, such as surgical repair of hip fractures and removal of colon cancer, vary in frequency by a factor of two among regions. But the performance of preference-sensitive surgeries such as heart bypass operations, knee and hip replacements, surgery for vascular problems of the legs, and prostate surgery, among others, vary in the rates of performance among regions in the US by factors of four to twelve times in 2003.(1) If there are best practices for these procedures, no one knows what they are.

I examined the costs of hospitalization in the US in 2005 and found that the classes of procedures the Dartmouth Atlas’s investigators consider to be preference-sensitive accounted for 18.3 percent of the total charges of hospitalization for all causes, and these are not the only such procedures in medicine. An estimate based upon a review of the medical literature and the cost of preference sensitive surgery is that a minimum of 6 of hospital spending in the US is for surgery that could be unnecessary or might be unwanted if the patients and the doctors had full information.

In the absence of definite information about who benefits from a procedure and who does not, doctors rely on their own experience and judgment in whom to perform preference-sensitive procedures. Such conclusions can be colored by self-interest, limited by personal experience, and complicated by an inherently unorganized lack of big-picture information, including a lack of understanding of the natural history of a problem without the treatment in question. And sometimes surgeons in a community just decide to get very busy.

I came to understand the power of the tone or attitude I used in presenting facts to patients who were scared, hurting, and vulnerable. I learned that for all but a few patients, the tone I used in presenting a surgical decision determined whether they would agree to it or not. If I seemed reticent, patients rarely opted for surgery. If I seemed decisive, they may have been reluctant at first, but they usually agreed to undergo the recommended procedure. The patients who were unaffected by my tone were not only scared and hurting but also suspicious and confused, often having trolled the Internet and talked to myriad doctors. In a discussion with a surgical friend about what surgeons tell patients he remarked on their plight by saying, “Why, I could convince a patient that I should cut his head off and he would not know the difference.” This is not such an exaggeration as you might think.

A Common Procedure of Doubtful Value

The coronary arteries are blood vessels the size of a pencil that feed blood to the beating heart. Blockages in the coronary arteries become known to the patient in two ways: occurrence of a heart attack or the occurrence of chest pain, called angina. Twenty years ago the only way to treat such blockages was by open-heart surgery, called coronary artery bypass surgery. In 1992 as many blockages of coronary arteries were being treated by new catheter techniques as were being treated by coronary artery bypass surgery because the newer procedure was far less invasive and safer. By 1996 the number of bypass surgeries began to fall as this major surgery was replaced by catheter procedures.(2)

Catheter techniques cost one-third less than coronary artery bypass surgery and do not carry many of the risks of open heart surgery, but they do not keep the blocked arteries open as long as surgical bypasses. (3) To accomplish the procedures, a catheter is inserted in an artery in the groin and threaded up through the internal blood vessels under x-ray guidance until the tip of the catheter enters the coronary arteries. Devices on the end of the catheter are used to either dilate the blocked artery in the heart or place a stent to hold it open.

Heart trouble presents itself in one of three ways: a sudden cardiac arrest, a heart attack or stable angina (chest pain on exertion that is relieved when a person sits down to rest). The cause of stable angina is that as the heart works harder, it requires more blood. Blockages in the coronary arteries limit the heart’s blood supply. When a person rests, the heart is also at rest and the chest pain goes away because the blood supply, while limited, is adequate. There are medications that can manage the pain of angina. There are medications and diets that can reverse heart disease over a period of several years so that the symptoms of angina go away.

There is no debate in cardiology that either a catheter procedure or coronary artery bypass surgery is beneficial in patients who have just had, are having, or are about to have a heart attack, if such treatment is quickly provided. On the other hand, for over ten years the use of catheter procedures in patients with stable angina has been in question.

A number of randomized clinical trials (half the patients being treated with surgery and half medically) compared the effectiveness of diet, exercise, and drugs that lower cholesterol with the use of surgical or catheter procedures for stable angina. These studies all used much less rigorous and effective medical management than is available now. This comparatively weak medical management should have given catheter procedures the advantage, but none of the studies showed that the procedures decreased the risk of heart attack or death.(4) Catheter procedures relieved angina faster than weak medical management, the procedure’s only potential benefit.

One would have thought that the invention of a procedure that is one-third less expensive than coronary artery bypass surgery would have reduced the cost of treating heart disease. If medicine was like the car industry, where new technology lowers cost, it would have. Although the incidence of more expensive heart bypass procedures decreased, the overall cost of treating heart patients has gone up, not down.(5)

I examined data from hospital admissions for heart catheter procedures from 1996, when catheter procedures were well-developed and widely deployed, through 2005. I divided hospital admissions into two categories: catheter procedures for patients admitted to the hospital having a heart attack or about to have a heart attack (proven benefit) and catheter procedures for patients admitted with stable chest pain (marginal benefit).

Figure 1 shows the number of US hospital admissions for both types of patients. Since 1993, the number of catheter procedures performed for stable angina has remained at double the number performed for heart attacks, suggesting that the indications for performance have changed little over a long period of time, despite a long series of publications showing that catheter procedures for stable angina have no effect on the long term rate of heart attack. Keep in mind that this procedure in 2005 had the widest regional variation in its rate of performance—ten fold. Cardiologists in some regions used very different indications for performing the procedure than in others. This graph illustrates the reason why new technology that is less expensive and more effective than older technology increases the cost of medical care rather than decreasing it.

Figure 1 Number of US Hospital Admissions with Coronary Catheter Procedures

Source: Author’s compilation of data from Agency for Healthcare Research and Quality’s Hospital Cost and Utilization Project (HCUP), Nationwide Inpatient Sample.

On March 27, 2007 a group of investigators funded by the Veterans Administration published a study of 2,287 patients with stable angina from heart disease. They compared aggressive medical management plus the most advanced catheter procedures available against aggressive medical management alone. Like all previous studies the investigators found no difference in the future rate of heart attack and death.(6) But in this study, catheter procedures were not much better than modern medical management in decreasing the symptoms of angina. Catheter procedures decreased the percentage of patients with symptoms of angina by thirteen percent in the first year and less than that by the third year. By five years there was no difference in the rate of angina between the two groups.

The trial’s results have been criticized as representing a subset of patients with relatively mild coronary artery disease and, therefore, they cannot be applied to the majority of patients with stable angina. There are doubtless groups of patients with stable angina who are suitable for this procedure, such as those with debilitating symptoms who have failed symptom relief with medical management or who are not compliant with medication. (7)(8) However, it is not clear how many of these patients there are and it is not likely they are the majority of those who undergo the procedure. I doubt that anyone who objectively examines the available information would conclude that anywhere near 500,000 patients a year benefit from this procedure.

This procedure is not without risk. The complication rate of its performance is a 0.4-4.9 percent rate of heart attack and 0.4-1.9 percent chance of death.(9) Patients have the right to know exactly what the likelihood is that they will benefit substantially from the procedure, benefit only marginally, or not benefit at all. Not only do we not have the information needed to tell them, we do not have the means of being certain that this information would get to the patients if we had it.

According to the Washington Post, the cost of each of the catheter procedures is $50,000. (10) In 2005, 484, 308 catheter procedures of marginal benefit were performed and at $50,000 a procedure the total cost was $25 billion dollars. The State Children’s Health Insurance Program (SCHIP) is similar to Medicaid and provides health insurance for poor children. In 2007 the program only had enough federally-allocated money to cover about seventy percent of eligible children, leaving two to three million uninsured children eligible children not enrolled in the program. The cost to the federal government of insuring those missing children plus all eligible children for one year, the cost of the entire program, is about $12 billion. A bill to fully fund this program was vetoed by the George W. Bush twice. The bill failed to pass the House and the Senate with a veto-proof majority in 2007 primarily because of the cost.

How is it right that so much money was wasted on procedures of marginal value while there was not enough money to insure poor children? Medical waste in the form of unnecessary procedures is an issue of justice as well as being a disservice to those who undergo them.

  1. James N.Weinstein, Kristen K. Bronner, Tamara Shawver Morgan, et al., “Trends and Geographic Variations in Major Surgery for Degenerative Diseases of the Hip, Knee, and Spine,” Health Affairs Web Exclusive, October 7, 2004.
  2. "Coronary Revascularization: Coronary Artery Bypass Grafting and Percutaneous Coronary Interventions,” Dartmouth Atlas of Health Care: Studies of Surgical Variation, Cardiac Surgery Report. 2005.
  3. Mark A. Hlatky, William J. Rogers, Iain Johnstone, et al., “Medical Care Costs and Quality of Life after Randomization to Coronary Angioplasty or Coronary Bypass Surgery. Bypass Angioplasty Revascularization Investigation (BARI) Investigators,” New England Journal of Medicine 336, no. 2 (January 9, 1997): 92-99.
  4. David T. Nash, “The Case for Medical Treatment in Chronic Stable Coronary Artery Disease,” Archives of Internal Medicine 165, no. 22 (December 12, 2005): 2587-2589.
  5. Jonathan Skinner, Douglas Staiger, and Elliott Fisher, “Is Technological Change in Medicine Always Worth It? The Case of Acute Myocardial Infarction”, Health Aff (Millwood). 2006 ; 25(2): w34–w47.
  6. William E. Boden, Robert A. O’Rourke, Koon K. Teo, “Optimal Medical Therapy with or without PCI for Stable Coronary Disease,” New England Journal of Medicine 356, no. 15 (April 12, 2007): 1503-1516.
  7. Leslee J. Shaw, Daniel S. Berman, David J Maron et al, Optimal Medical Therapy With or Without Percutaneous Coronary Intervention to Reduce Ischemic Burden Results From the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) Trial Nuclear Substudy, Circulation, March 11, 2008, 1283-1291.
  8. George A. Diamond and Sanjay Kaul, COURAGE under fire: on the management of stable coronary disease. Journal of the American College of Cardiology, 2007 Oct 16;50(16):1604-9
  9. ACC/AHA/SCAI Practice Guidelines, February 21, 2006 Circulation 2006;113;e166-e286
  10. Rob Stein, “Heart Attack Study Casts Doubt on Routine Use of Angioplasty,” Washington Post, March 27, 2007.