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Posts Tagged ‘angioplasty’

Effectively treating atherosclerosis without angioplasty or bypass

Posted by Colin Rose on September 17, 2008

Below is a example of the issues involved in treating chronic coronary atherosclerosis presented by an intelligent patient who asked questions about treatment and did not accept the mainstream opinion without good evidence.

The vast majority of patients with chronic coronary artery atherosclerosis can be treated as the patient described here. Most cardiologists still believe the profitable myth that heart attacks can be prevented by “treating” those blockages seen on a coronary angiogram. We now have good evidence that such blockages are composed of older, harder plaques that are less likely to rupture and cause a sudden total blockage and a heart attack. Angioplasty, stent or not, and coronary bypass are PALLIATIVE procedures indicated only for intractable symptoms related to decreased coronary blood flow reserve.

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From ProCor

From the patient’s perspective: Effectively treating heart disease through diet, exercise, lifestyle and medication

In the late 1960s, Professor G. S. H. Lock was engaged in the development of the artificial heart to address cardiac conditions for which other alternatives were not available. Forty years later he writes, “Today it is difficult to argue that technological intervention on such a scale is really necessary on a routine basis. Even intervention through angioplasty and the insertion of a stent may offer little more than temporary relief.”

In this article, adapted from a longer feature in The Lown Forum, Professor Lock shares his experiences as a cardiac patient and his observations on the use of medical technology in cardiovascular care. The Lown Forum is a publication of the Lown Cardiovascular Research Foundation; ProCor is one of its programs.

Vikas Saini
President, Lown Cardiovascular Research Foundation
 
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From the patient’s perspective: Effectively treating heart disease through diet, exercise, lifestyle and medication

G.S.H. Lock, Professor Emeritus and former Dean of Interdisciplinary Studies, University of Alberta, Edmonton, Alberta, Canada

My story begins, as it often does, with the onset of mysterious chest pains. My family physician immediately diagnosed it as angina, meriting further investigation. After numerous tests on treadmills and in machines whose operations are still a mystery to me, I was confirmed as a high-risk patient with a plumbing problem, usually described as coronary arterial occlusion. An angiogram was recommended and scheduled within two weeks. However, this seemingly routine procedure created a special problem for me because three of my colleagues had failed to recover from that very procedure. With apprehension, I listened to the consulting physician explain that the risk of complication was minimal (about 1%). I asked if there was an alternative. I shall never forget his answer: “Death.”

Needless to say, I was not reassured by this response from a very able doctor who was obviously bound by prescribed procedure. Even though he was careful enough to prescribe appropriate medication while I waited for the angiogram procedure, I sought a second opinion, at another hospital. This proved to be an equal waste of time. The physician simply described the use of angiography as a “no brainer” because he viewed it as the natural prelude to intervention. No other possibility was even considered.

These experiences led me to conduct my own extensive research on heart disease, its diagnosis, and treatment. The majority of cardiologists seem to favor intervention, with all of the technology that accompanies, if not drives, it. I, however, could not support such an approach except in emergencies or when surgery was clearly the only means by which a patient’s life could be improved if not saved. Through the Lown Cardiovascular Center I was able to confirm that a healthy minority of cardiologists are not interventionists, but believe instead that in the majority of cases, heart disease may be treated more effectively using medical therapy with its four components: diet, exercise, lifestyle, and medication.

At first glance, I thought that each of these would prove to be distasteful – something that would destroy the quality of life – but I found instead the very opposite.

Luckily for me, my wife is an excellent cook – dare I say chef? – and has developed the standard Mediterranean diet into such a variety of dishes that I eat better now than I did two years ago. This alone took my cholesterol level down well below the established safe limit.

Exercise, too, has improved my quality of life. My cardiologist at the Lown Center, Dr. Vinch, is himself and athlete and he reminded me that the heart is a muscle that needs to be nourished and exercised like any other muscle. Under his guidance, I began various walking exercises. At first, using a nitroglycerine spray to decrease the resistance of the peripheral vascular system, I took my daily walks in the river valley where I live. Gradually, the walks became longer and steeper. Today, I can briskly walk up and out of the river valley and then jog up 12 flights of stairs without any angina, and without using the nitroglycerine. 

Clinical Encounter 
Date Posted: 9 April 2008

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Medical Devices – No Controlled Trials

Posted by Colin Rose on July 24, 2008

“I’m not allowed to prescribe one pill unless it has gone through years of trials,” said Dr. Colin Rose, a Montreal cardiologist. “Why can they license these [devices] — which can be just as dangerous — with no controlled trials? What is the difference?


MEDICAL IMPLANTS
BY TOM BLACKWELL
National Post
24 Jul 2008

Late in the 1990s, Health Canada licensed a new artificial lens, the latest in an innovative generation of implants for treating cataracts. Made from a foldable material, it could be inserted in the eye with a smaller incision than usual and less-invasive surgery. It did not matter, under the department’s rules, that the device had been tested on relatively few people before being approved.

As thousands of the newly licensed lenses were installed worldwide, however, doctors started noticing a serious defect with many of the implants: they were turning opaque inside patients, and in some cases had to be removed with a much more complex operation through the individual’s temple.

“ The ophthalmologists were petrified,” said Dr. Pierre Blais, a former Health Canada official who now does consulting work on medical devices for insurance companies. “They said, ‘We can’t trust these [regulatory] agencies. We have to do our own trials.’ ”

But the eye implant case was no exception. Health Canada routinely approves surgical devices after limited — or no — study on humans, far less evidence than is required for the certification of prescription drugs. And now some experts are raising serious concerns about the process.

The number of devices being inserted into Canadians’ bodies is soaring, and there is no doubt many work wonders: saving patients’ eyesight, relieving debilitating joint pain or preventing lethal heart irregularities.

In a recent article, however, several prominent obstetricians and gynecologists accuse Health Canada of failing in its ethical duty to protect patients, and call on the regulator to impose the same kind of strict approval criteria for devices as for drugs.

“Most people assume that … any surgical device licensed in Canada must be safe for human use,” notes the paper, co-authored by the president of the Society of Obstetricians and Gynaecologists of Canada. “As things currently stand, this assumption is not justified.” The paper, published in the society’s scientific journal, cites Health Canada’s approval in 2006 of a new surgical implant to combat female incontinence. At the time, the device had never been tested on a single person. Within a year, though, the freshly approved “vaginal tape” had been permanently installed in more than 1,000 Canadian women.

Individual case reports have so far been generally positive, but a clinical trial proving they are safe and effective has yet to take place. Concerns reach beyond gynecology. A trial published last year found that angioplasty — a widely hailed procedure that uses a tiny balloon to clear harmful plaque from clogged arteries — did no better than much cheaper, intensive drug treatment and exercise to treat stable heart patients. The device had been used for years on about 40,000 Canadians annually, most of them stable.

“I’m not allowed to prescribe one pill unless it has gone through years of trials,” said Dr. Colin Rose, a Montreal cardiologist. “Why can they license these [devices] — which can be just as dangerous — with no controlled trials? What is the difference?”

Other doctors and the industry, though, argue that requiring devices to be extensively studied before approval would be impractical and hamper important innovation. With changes and improvements constantly being introduced, devices have a much shorter shelf life than drugs, meaning companies could not recoup the tremendous investment needed to conduct pricey clinical trials, they say.

“It would be great to have a perfect system that makes sure we understand what the benefits and risks are of everything,” said Dr. David Urbach, a Toronto surgeon who has studied how new surgical techniques are adopted. “But if it took 10 or 15 years to bring a device to market, you’d never use any devices, because they’d be obsolete. We still use drugs, antibiotics, developed 50, 60 years ago. We don’t use devices from even 10 years ago.”

Paul Duschene, a Health Canada spokesman, said the department submits devices to a “robust” approval process, including demands for information showing they are safe and effective. But devices do not need to be vetted the same way drugs do because “the hazards and risks posed to the patient are much different with a medical device,” he said.

Health Canada divides devices into four classes, depending on how much risk they pose to patients. The higher the class, the more evidence is required of a product’s safety and efficacy. Those considered to be incremental modifications of earlier products require less proof.

Class three — which includes gynecological implants such as the vaginal tape, and artificial hip replacements — and class four, including pacemakers and other heart devices, are the most controversial. The vaginal tape was approved based on lab tests and studies on animals, said the paper by the gynecology group.

Another, similar tape approved with no human studies a few years earlier caused considerable problems, frequently eroding inside bodies and triggering infection, said Dr. Sue Ross, a University of Calgary scientist and one of the paper’s authors.

Similar problems occurred with a sling used to reconstruct the uterine cavity in women who had had hysterectomies. The device was meant to prevent collapse of the cavity, but the mesh straps at the core of it would often deteriorate after a couple of years, causing abscesses and other problems, Dr. Blais said. He said the foldable lens — one version of a concept that has generally proven successful — was likely implanted in about 1,000 Canadians, many of them in Alberta, before being recalled.

Then there were heart valves coated with silver, an innovation meant to avoid infection but not tested widely in patients before being licensed in about 1997. As the device was widely distributed, doctors discovered the silver coating sometimes impeded proper melding of the valve with natural tissue, leading to leaks that may have killed some patients, Dr. Blais said. They were later recalled and are now the subject of class-action lawsuits.

In contrast to devices, drugs are regulated in a separate system that requires them to be studied on hundreds of people in a series of clinical trials, which compare the new product against a control group of patients taking a placebo or other treatment.

But Dr. Martin McKneally, a retired surgeon and bio-ethicist at the University of Toronto, argues that clinical trials cannot be carried out for devices when they are first introduced, since the products’ impact differs depending on how it is used by individual doctors, and techniques are honed over time. He believes the key is to adequately inform patients that the implant or other device they are about to receive is novel and has been tested on only a handful of other people.

“You have to learn in patients and keep modifying as you go along,” Dr. McKneally said. “The fact we have such excellent devices is a credit … in part to the patients.”

Even Dr. Blais, once fired and later reinstated over his outspoken comments while at Health Canada, said it may be unrealistic to expect the government to demand extensive clinical trials be done on surgical devices, except those with the highest risk.

It would be more practical for the regulator to simply be up front about the limited vetting that devices undergo before being licensed, and let patients decide if they will accept the risk, he said.

As it stands, Health Canada’s approval of devices “is a licence to test out an idea on somebody else, if possible at government cost,” Dr. Blais said. “What is happening now is we are becoming a nation of uninformed and unremunerated laboratory rats.”

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COURAGE demolishes the myth of the “widow maker” and the “time bomb” but does not use optimal medical therapy

Posted by Colin Rose on March 26, 2007

For 30 years since the development of a balloon-tipped catheter to dilate coronary arteries, now known as PCI (percutaneous coronary intervention), it has been revealed truth from “experts”, most of whom paid their mortgages by doing PCI’s, that all significant coronary narrowings should be dilated to prevent a heart attack. In spite of overwhelming evidence that heart attacks are caused by rupture or early, unstable, non-obstructive plaques, most cardiologists still believe that heart attacks (sudden complete blockage of a coronary artery) occur at the site of the largest plaques. Patients are shown angiograms and told they have a “widow maker” or are “sitting on a time bomb”. I refused to do angioplasties until there was some proof for this superficial but very lucrative theory. Again, it turns out I was right. Even in patients with major narrowings and symptoms, PCI does not prolong life or prevent heart attacks. Chronic symptoms were slightly more improved in the PCI group but most medically-treated patients had symptom improvement just with pills.

 

Legal Addictions

The COURAGE type subject

All cardiologists give lip service to the necessity for lifestyle change as the ultimate cure for atherosclerosis, but in this study there was no attempt at lifestyle change. Most patients were overweight or obese, gained weight over the five year study. 20% smoked and did not stop. While the authors claim to using “optimal” medical therapy, they did not even try significantly changing lifestyle, the obvious cause of the patients’ atherosclerosis. No doubt even better results that could have been obtained with just lifestyle change, without pills or PCI, as Dean Ornish showed many years ago.

If you want an explanation for why, except for a feeble attempt to raise HDL by exercise, NO attempt was made to change lifestyle meaningfully before using statins or PCI you need look no further than the source of funding and the disclosure statements of the authors. Those who recieve substantial income from drug dealers are not keen on proving that cost-free lifestyle change alone will do the same or better than expensive drugs.

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Now, why has it taken 30 years to finally prove the futility of PCI in patients with stable or stabilized coronary disease? Unlike new drugs, there are no rules and no government agency mandating that surgical procedures have to undergo clinical trials before being done on the general population. Any surgeon can develop some operation that seems superfically rational and he and his colleagues can do many thousands of those operations, costing millions or billions of dollars and risking many lives until someone gets around to actually testing it to see if the outcome is really as advertised.

Doctors profess to want to practice “evidence-based medicine” but when change negatively affects bank accounts habits change very slowly if at all. Angioplasty in stable CAD can always be rationalized by the classic, “my patient is different than those in the controlled trial”. We can predict that angioplasties in patients with stable CAD will not decline significantly until most of those trained in the procedure have retired. The system could save a lot of money by giving each of them $one million and a house in Mexico to retire to.

Posted in angioplasty, atherosclerosis, coronary artery disease, diet, drugs, professionalism, statins | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 1 Comment »