“I have said that the soul is no more than the body. And I say that the body is not more than the soul.” — Whitman in 1855
“Medicine is flying blind. Thousands of medical journal articles are published every month on potential new treatments and diagnostic tests. Precious few of them measure how well doctors are doing in the real world, outside of controlled trials—what they are doing right, what they are doing wrong and what they are forgetting to do entirely. No wonder our medical system wastes billions of dollars a year,” writes Mathew Herper of Forbes magazine.
Last week, The Outlook published a detailed article on angioplasties in our hospitals and their hazards. Most of it was about the cost of stents and their misuse and abuse. Little did the writer, or even the interview that followed, touch upon the crucial point—the coronary angiogram, the villain of the piece.
I had written about it and have been doing so even before some of the leading American researchers, like Harlan Krumholz, came on the scene. The only area where angioplasty has a proven track record is immediately after (minutes after) a heart attack, if the heart attack-related coronary artery is the blocked culprit with an added clot blocking the vessel.
For heart attack patients, Dr Krumholz picked ‘door to balloon time’—how fast the patient is treated upon arrival at the hospital. Hospitals that are doing badly on this measure can’t blame it on how long the ambulance took to get there. Angioplasty is done to make money by frightening patients and their relatives that there are blocks in the coronary arteries. Almost every living human being, including children, has one, two or even three vessel blocks. This was shown so elegantly in the post-mortem angiograms done on 205 American young soldiers shot dead in Vietnam and Korean wars.
So, almost all our angioplasties are done unnecessarily. The epicardial vessel blocks (shown to patients and relatives to frighten them) do not usually critically restrict heart muscle blood flow which takes place through collateral vessels (nature’s bypass) and the perforating coronary vessels dilation (coronary reserve) when needed in young healthy individuals. This process is well oiled in nature, called pre-conditioning, helping patients to get over the blocks.
In addition, if the doctor studies the FFR (flow fraction ratio) across a block, almost 90% of the so-called critical blocks become benign and need to be left alone. No hospital, to my knowledge in India, does FFR studies, although they do all and sundry tests to collect money from patients. If one has a two-camera angiogram facility, where all the so-called blocks are simultaneously viewed from two angles at 90 degrees to each other, even the 90% block might just be only 10% block from another angle. No hospital has that facility either, as it will cut down their angioplasty indications to less than 20%! How can they show a profit to their shareholders?
They all follow the Wall Street greed! In essence, the only indication for angioplasty is immediately after a heart attack, if the vessel blocked is the one causing the heart attack. Exertional angina (most patients have that) is no indication for angioplasty. Medical treatment is better. Lifestyle change is the basis of all coronary artery disease treatment. Asymptomatic patients have no indication for angioplasty at all. Do understand that coronary artery blocks are not synonymous with coronary artery disease.
Therefore, the only way to curb angioplasties, and the attendant exorbitant costs to patients and the exchequer, is to ban routine angiograms to diagnose coronary artery disease. Way back in 1991, the Harvard group of Professor Bernard Lown had shown that a moratorium on coronary angiography alone can save patients from greedy cardiologists.
A paper in Journal of the American Medical Association began a debate in the UK to cut down on cardiac centres there, to save money for the NHS and the lives for their patients. Tom Treasure, an aggressive cardiac surgeon, made a plea in The Lancet. The scientific role for angiogram is only when the patient’s clinical assessment demands either an angioplasty or bypass surgery for relief of chest pain just to know where to plumb. Legislations to control the cost of stents will not do any good to patients who are now being exploited through unnecessary angiograms for diagnosing coronary artery disease.
The government must legislate to have outcome audits of all such procedures; only then will we make cardiologists practise scientific cardiology, nothing else. For big corporations, the idea that ‘you can’t manage it if you can’t measure it’ is an old chestnut. General Electric, Toyota and other companies have had data-driven quality improvement efforts, for years. But medicine—supposedly a more scientific profession—has been slow to measure itself. Dr Krumholz has been one of a handful of pioneers behind the scenes pushing to do this.
There are many other reasons to work on banning diagnostic angiograms in asymptomatic patients faster.
“Knowledge,” said Karl Popper “advances NOT by repeating known facts, but by refuting false dogmas.” One cannot agree more. Modern medicine abounds in dogmas: many of them have not been scientifically audited. Science is change. Every single hypothesis is true until refuted by new knowledge. Knowledge today, in the medical field, is replaced by information, resulting in doctors relying only on information and not wisdom. The so-called evidence-based medicine really is evidence burdened.
Medical muddling seems to be a profitable business. New tests, new devices and new drugs pour into this arena on an unprecedented scale.
It is time to audit all the technologies used in patient-care, just as we have placebo-controlled trials for drugs before releasing them for human use. Even in the case of drugs, in some rare instances, release of drugs for patient use before they are audited by such trials had resulted in major damage resulting in their withdrawal from the market. It stands to reason that we should debate the issue of auditing untested technologies like angiograms that get into the arena of patient-care.
Starting with some of the audits just completed, we could move on to other areas. Many of the unmeasured physiological effects of in-dwelling catheters come to mind first. The Swan-Ganz catheter was introduced without appropriate validating studies to compare with identical groups without the catheter. This catheter, by itself, could be an adverse factor for many critically ill patients. ( Spodick DH, ‘Uncritical critical care’, British Medical Journal, The Swan-Ganz catheter. 1999; 115: 857-858)
In an observational study by AF Connors and colleagues showed that in critically ill patients, after adjusting for selection bias, the catheter was associated with increased mortality and increased utilisation of resources.
Extrapolating another study done in Worcester, ED Robin estimated that around 15,000 unnecessary deaths could have occurred in 1984 alone and his paper goes on to estimate a total of nearly 100,000 excess deaths in the US since 1975 due to the catheter. Following these studies, there was a justifiable demand for a moratorium on the use of the catheter until further prospective controlled studies cleared the mist. Understandably, strong opinions were expressed against the demand for a moratorium, but the opinion, unfortunately, ignored some of the very valid data in the field.
Coronary artery surgery is the next popular surgical procedure crying for proper audit. There was a demand for audit in this area way back in the early 1970s. Indeed, all new surgical procedures are better audited by controlled studies before being routinely performed in practice There was hardly any substantial change in this area even as recently as 1997. (Hegde BM, “Coronary Artery Revascularisation - Time for reappraisal” Proceedings of the Royal College of Physicians Edinburgh, 1997)
More recently, an audit showed ethically unacceptable results of overuse of both bypass and angioplasty in the immediate post myocardial infarction scenario. (“Use of cardiac procedures and outcomes in elderly patients in the US and Canada”, New England Journal of Medicine, 1997: 336; 1500-5.)
Writing a very balanced editorial in the same issue, Harlan Krumholz from Yale laments: “In a fee-for-service system, cardiac procedures generated billions of dollars in revenues each year. A high volume of procedures brought prestige and financial rewards to hospitals, physicians and the vendors of medical equipment.”