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Posts Tagged ‘surgery’

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Healthy Ovaries Should Not Be Removed

Posted by medconsumers on May 5, 2009

For about 50 years, gynecologists have been recommending the surgical removal of healthy ovaries in women who undergo a hysterectomy for reasons unrelated to cancer. The advice is based on the fact that ovarian cancer is difficult to diagnose until it is advanced, as well as a blatant disregard for the usefulness of the ovaries once a woman has all the children she wants.

A new study shows that this longstanding practice causes two health improvements (fewer cases of ovarian and breast cancers), but more harms (an increased risk of death from all causes, fatal and non-fatal heart disease, and lung cancer). In other words, the women who kept their ovaries lived longer.

The findings are based on data from nearly 30,000 participants of the famed Nurses’ Health Study who had a hysterectomy for benign disease. More than half had a hysterectomy with bilateral oophorectomy (removal of both ovaries); and 44% had a hysterectomy with ovarian conservation. The participants periodically filled out an extensive questionnaire about their health status and were followed over a 24-year period. Results were published this month in the journal Obstetrics & Gynecology.

The women who fared the worst were those who had a bilateral oophorectomy before the age of 50 years and did not go on estrogen replacement therapy. They had an increased risk of all-cause mortality, heart disease, and stroke. “With an approximate 35-year life span after surgery,” estimated the authors, “one additional death would be expected for every nine oophorectomies performed. In no age group was oophorectomy associated with increased survival,”

The authors noted that ovarian cancer is rare. About 1% of American women will die of ovarian cancer.

Maryann Napoli, Center for Medical Consumers© May 2009

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Fosamax-Induced Osteonecrosis of the Jaw More Common Than Previously Thought

Posted by medconsumers on March 1, 2009

Dentists have been in the forefront of identifying a severe complication of Fosamax, the osteoporosis drug widely prescribed to prevent fractures. The January issue of the Journal of the American Dental Association published a study describing a significant risk of osteonecrosis of the jaw from even oral use of Fosamax. Until this small study of 208 dental patients was published, jaw osteonecrosis was thought to be rare and limited to people with cancer who received large doses of Fosamax intravenously to treat bone metastases.

Dental School Patients Studied

In this study conducted at the University of Southern California School of Dentistry, 4% of the dental patients taking oral Fosamax had osteonecrosis of the jaw. All had suffered dental trauma—either a tooth extraction or ill-fitting dentures that resulted in jawbone exposure; all were women, average age 73 years, who had been taking the drug for 12 months or longer. Osteonecrosis is defined as “the presence of exposed bone in the mouth, which fails to heal after appropriate intervention over a period of six or eight weeks.”

Parish P. Sedghizadeh, DDS, and colleagues at the USC School of Dentistry found no cases of osteonecrosis of the jaw among their 4,384 dental patients not taking Fosamax who underwent tooth extraction. Fosamax was the first and most aggressively promoted of all drugs in a class called bisphosphonates, which also includes Actonel, Boniva, Aredia, Zometa and Bonefos.

4% Risk is Not Rare

Sedghizadeh and colleagues say their findings contradict Merck’s claim that jaw osteonecrosis is a rare side effect of its drug. “We have been told that the risk with oral bisphosphates is negligible, but 4% is not negligible,” said Dr. Sedghizadeh. (The benefit of Fosamax could also be described as rare because the drug reduces the risk of hip fracture from 2% to 1%, as demonstrated in premarketing trials.) Prior to receiving FDA approval, Fosamax was tested in trials that lasted only three to five years. Ever since this drug first came on the market in 1996, the unanswered question has been: How long can people safely take Fosamax—or any one of other bisphosphonates, which are known to suppress bone turnover.

Drugs Have a Long Half-Life

This warning came from the USC Dental School research team: Bisphosphonates have half-lives of ten years or more, and people taking the drug orally may ultimately reach the same high dose level as that given intravenously to treat bone metastases in cancer patients. Sedghizadeh and colleagues also explained that because bisphosphonates stay in the bone for a long time, the risk of osteonecrosis remains even after people go off the drugs. The half-life of a drug describes how long it takes for half of it to be eliminated from the bloodstream.

The USC study is not the last word on the frequency of osteonecrosis of the jaw in people taking bisphosphonates. A much larger study is needed; ideally, one that takes place in many dental schools. Researchers at other institutions are trying to determine the prevalence of osteonecrosis of the jaw in cancer patients treated with bisphosphonates for cancer metastases. In the journal Bone, Dr. I.R. Reid, University of Auckland, estimated that it is 5% among people with myeloma, breast cancer or prostate cancer.

What to do

Thirteen years after Fosamax was launched, severe adverse effects have been showing up that may not be as rare as the public has been led to believe. Last year, the FDA reported that all bisphosphonates carry the risk of severe and sometimes incapacitating musculoskeletal pain. And case reports in several medical journals describe an unusual type of severe fracture of the femur associated with bisphosphonate use. In 2007 an increase in serious cases of atrial fibrillation was reported in people given the relatively new once-a-year bisphosphonate injection for fracture prevention (Zometa).

Osteonecrosis Treatments

As for osteoporosis of the jaw, more information is needed about how to prevent and treat it successfully—if that’s possible. Sedghizadeh and colleagues at USC Dental School did not have too much to offer on this topic. They advise unnamed alternate treatment options be considered for “nonnecessary extractions;” reducing the amount of the bacteria with a chlorhexidine rinse for those who must undergo a procedure; and daily antibiotics for those with denture trauma. For the exposed bone that fails to heal, the researchers name a procedure called “mucosal coverage.”

University of New Zealand’s Dr. Reid put it more succinctly “Management focuses on prevention, treatment of infection and cessation of bisphosphonate. The role of surgery is unclear.”

For more information: Read my 2008 article about Fosamax and this 2008 article about Evista. For an overview of how the definition of osteoporosis was expanded by the pharmaceutical industry: read “The marketing of osteoporosis: how a risk factor became a disease,” which appeared in the April 2009 issue of the American Journal of Nursing.

Maryann Napoli, Center for Medical Consumers©

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Alternatives to Open Breast Biopsies

Posted by medconsumers on February 1, 2009

Excessive Use of Open Breast Biopsies: An Interview

Too many U.S. women are having the more drastic, more expensive open biopsy once a mammogram detects an abnormality, according to a new study conducted at one academic medical center. This is diagnostic overkill given the facts that 80% of all such breast abnormalities eventually prove to be benign and that minimally invasive needle biopsy techniques have been available for years.

Overuse of the open biopsy means that women’s health is unnecessarily compromised because the procedure can have serious complications. The development of scar tissue, for example, may inhibit the diagnosis of a future breast cancer. Incredibly, 1.6 million breast biopsies are performed yearly in the U.S. If this study is representative of the rest of the country, nearly 40% are open biopsies.

“Where’s the Outrage?” asked surgeon Melvin J. Silverstein, MD. In the editorial that accompanied the new study, he reminded readers that the women’s movement of the mid-1970s eventually put an end to the drastic one-step diagnosis/treatment procedure. Up to that era, women with a breast lump had to sign a consent form before going under anesthesia, allowing their surgeons to determine malignancy on the basis of a quick frozen biopsy and to do an immediate radical mastectomy when results showed cancer. (Years later, the frozen-section biopsy was acknowledged to be unreliable.)

Now there’s another pressing need for advocacy, says Dr. Silverstein, Director of the Breast Program at Hoag Memorial Hospital Presbyterian, Newport Beach, California, and professor of surgery at the Keck School of Medicine, University of Southern California. He is interviewed by Maryann Napoli, Center for Medical Consumers.

MN: A shockingly high 40% of the breast biopsies done at one Manhattan teaching hospital were open (excisional) biopsies, according to the new study, conducted by Emily M. Clarke-Pearson, MD, and colleagues at Beth Israel Medical Center and Columbia University Medical Center (January 2009, Journal of the American College of Surgeons). How can a woman tell whether she truly requires an open biopsy?

MJS: She needs to know that well over 90% of all breast abnormalities can be biopsied with a needle. Very few people need an open biopsy. For example, if the abnormality is in an extremely difficult place, such as right on the chest wall, a needle biopsy may not be possible. Another possibility is that the patient may not be able to lie on her abdomen thereby making stereotactic biopsy nearly impossible. More and more, needle biopsies are being done with ultrasound guidance and they’re much easier.

MN: You were appalled to learn that so many women in this study with palpable or mammography-detected abnormalities were going straight to the operating room for diagnostic open surgical breast biopsy. What is the typical scenario?

MJS: If the radiologist has control of the patient and the radiologist is an interventionalist—that is, one who knows how to put needles in, then he or she will do a needle biopsy*. But the radiologists often do not control the patients in the U.S. The patients “belong” to the referring doctor. Many breast centers won’t do a mammogram without a doctor’s prescription. In general, a patient goes to a radiologist with a doctor’s prescription that says “bilateral mammography”. If an abnormality is found, the radiologist typically calls the referring doctor, and most of the time, he or she will say, “go ahead and do the biopsy.” But often that referring doctor is a surgeon, and he or she will do an open surgical biopsy because they do not know how to do a needle biopsy.

MN: Breast biopsies are so lucrative., I assume there’s a turf war between the radiologists and the surgeons.

MJS: Yes, when the needle biopsy came along in the early 1990s, the radiologists captured the market, and the surgeons didn’t care. But as time went on, the surgeons said, “I used to do 280 biopsies a year, but now I’m not doing any because the radiologists do them all. I’d better learn.” So the American Society of Breast Surgeons formed, mainly to teach surgeons how to do ultrasound-guided biopsies and stereotactic biopsies. Now there are probably 3,000-4,000 surgeons in U.S. who are competent to do needle biopsies, but there also [another] 30,000 surgeons who do open breast biopsies because they don’t know how to do needle biopsies. It comes down to this: If I don’t know how to do a needle biopsy, then I either have to send the patient to someone who does or do an open biopsy myself.

MN: And the cost differences?

MJS: I used to do 225 open biopsies a year for diagnosis and now I do only two or three a year. An open biopsy in New York City is probably $2,000 to $3,000 [just the surgeon’s fee]. If I lived there, I would have given up $600,000 in billing fees**. So you can understand the motivation. A lot of surgeons now know how to do needle biopsies and those who know how will do it. Open biopsy costs rise to $5,000 to $7,000 once you include the operating room fee and the anesthesia, which can be either local or general. A needle biopsy in New York City is about $2,000. In a smaller city, it will probably be between $1,000 and $1,500.

MN: There are plenty of downsides to the open biopsy besides the expense.

MJS: I’m a professor of surgery. I get a lot of referred patients and half have already had open surgical biopsies. Many times the incision was done in wrong place, and it compromises what I’m going to do, or the margins are not done well because the biopsy was done simply as a diagnostic procedure, not as a therapeutic procedure.. On the other hand, when I get a patient who has had a needle biopsy, nothing has been compromised. Studies have shown that in competent hands, the needle biopsy is just as accurate as the open biopsy.

MN: And many inconveniences are avoided.

MJS: Yes, when a woman has a needle biopsy, she is in and out in one or two hours. She doesn’t need someone to drive her home; she can go to work; she can lift things. When she has an open biopsy, the wound has to heal. She has to be careful of what she does for a few days or a week.

MN: You seemed to be counting on consumer advocacy to change doctors’ practices.

MJS: Yes, the study was done at Beth Israel Hospital, an academic medical center where the work should be top of the line and it’s in New York City, which has some of the most demanding consumers of medicine in the world. And yet nearly 40% were getting open biopsies [in 2007]—that’s outrageous. Once women all over America know about this, that number will drop precipitously.

MN: Your editorial and the study are circulating on the Internet among breast cancer advocates.

MJS: Remember about 10 or 15 years ago, there was a new procedure called sentinel node biopsy. Instead of doing a full axillary node dissection [removal of 20 or so nodes near the armpit], the surgeon could remove only one or two lymph nodes. And surgeons said, “We don’t know if it works.” And you know what happened? Women heard about it and they demanded it. And if the surgeon didn’t offer it, she came down the street to me. The surgeons were losing their patients so they learned how to do it. Now everyone does it.

*Dr. Silverstein said that the term needle biopsy refers to several different minimally invasive techniques including core biopsy, vacuum-assisted biopsy, ultrasound-assisted biopsy (most common and easiest to perform) and the MRI-assisted biopsy (most difficult and least common).

** Billing fee is different from what the physician actually receives. According to one New York City breast surgeon, Medicare and many insurance companies will reimburse only 20% of the billing fee.

Maryann Napoli, Center for Medical Consumers© February 2009

More on Breast Biopsy
One co-author of the breast biopsy study is Susan K. Boolbol, MD, Chief, Appel-Venet Comprehensive Breast Service and Director, Breast Surgery Fellowship, Beth Israel Medical Center, New York City. In a telephone interview Dr. Boolbol was asked whether her study is representative of care in the rest of the country.

SKB: Yes, I do think so. First, keep in mind that the overwhelming majority of breast abnormalities are benign and the introduction of new needle biopsy techniques means that women do not have to go the operating room for diagnosis any more.

MN: But your study was done at one teaching hospital. Do we know how women are treated in the real world?

SKB: When you look at our study, you will see that we have three separate sets of physicians. First, the academic breast surgeons like me; second, the breast surgeons in private practice who don’t work for the hospital, but perform surgery there; and third, the general surgeons who do all types of surgery, including breast surgery.

MN: It does provide a window into what’s going on in the real world. During the seven-month study period, the academic breast surgeons did only 10% of their breast biopsies as open biopsies; compared with the breast surgeons in private practice (35%) and general surgeons (37%).

SKB: Another study showed that the majority of women with breast cancer in New York State are not operated on by breast surgeons. That could be true of the rest of the country. Educating women is the whole issue raised by our study. [If told they should have an open biopsy] they need to ask the question: Is there another way to do the biopsy? Women should know that the operating room is for treatment, not diagnosis.

Note: Read this 2010 update on this topic: “Breast biopsy: one type is much safer.”

Maryann Napoli, Center for Medical Consumers©

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Arthroscopic Surgery for Knee Arthritis

Posted by medconsumers on October 1, 2008

Arthroscopic surgery is no better than conservative treatment for people with knee osteoarthritis. This was shown in a 2002 clinical trial, and now a new trial has produced the same result. Will it change anything? Will people be told that surgery provides no advantage over drug treatment and physical therapy? Are there any exceptions?

These are just a few of the questions raised by two studies published in The New England Journal of Medicine. The backstory for their findings are the advances in fiberoptics and instrumentation that have made knee procedures much easier and safer to perform than an open-incision operation. And advances in imaging, specifically MRI scans, can mislead doctors into seeing a tear in the knee cartilage as reason enough to perform surgery for someone with knee pain. Add the lack of any requirement for scientific proof that an operation is effective before it becomes widespread. And what Americans get as a result is a lot of unnecessary knee surgery.

Sometimes referred to as “keyhole surgery,” arthroscopic surgery involves a small incision in the knee, which is inflated with fluid under pressure with a pump. This allows the surgeon to work through an arthroscope, flushing out material (lavage), such as cartilage fragments, and scraping the rough surfaces of the arthritic knee joint to remove debris (debridement).

The new trial randomly assigned 178 men and women to receive the operation or conservative treatment alone. All were treated at a sport medicine clinic at the University of Western Ontario, Canada; all had moderate-to-severe osteoarthritis of the knee. All, including those assigned to surgery, received 12 weeks of physical therapy, drug therapy advice, and were free to try any other non-surgical treatments, such as lubricant or steroid injections.

At two years of follow-up, the Canadian researchers concluded, “The people assigned to arthroscopic surgery were no more likely to improve with respect to physical function, pain, or health-related quality of life than were those assigned to the control group [no surgery].” The Canadian Institutes of Health Research funded this trial.

Its findings should settle a controversy that followed a 2002 American trial that also found knee surgery offered no advantage over the usual non-surgical care. Although many people experienced symptom relief after knee surgery, some orthopedic surgeons had long suspected that the operation did not work. In one of a few clinical trials to show that surgery can have a placebo effect, researchers at the Veterans Affairs Medical Center, Houston, TX, randomly assigned 165 men with knee arthritis to receive either knee surgery or a sham procedure.

Those assigned to the sham procedure were taken to the operating room, lightly sedated and given an incision similar to the one made during arthroscopic surgery. This allowed all participants to remain unaware of their actual treatment until two years later—after they had had their symptoms and knee function regularly assessed. Those given the sham procedure had the same level of pain relief and physical function as those given surgery. Whether this study led to a decline in knee surgery is unknown because there is no national system for keeping track.

Predictably, many orthopedic surgeons rejected the 2002 findings, charging that the trial was flawed. For example, only one surgeon had performed all the operations and the participants were all men who were older than the typical knee surgery patient. The Canadian trial was designed specifically to overcome these and other criticisms.

MRI of the Knee

Another study published in the same issue of The New England Journal of Medicine found that a tear in the knee cartilage is present on a MRI scan of most middle-aged and elderly people who have no knee symptoms. This finding has major implications because doctors often order magnetic resonance imaging for people with knee pain of unknown cause. And when a tear in the knee cartilage (meniscus) is found, it is often assumed to be the cause, especially in people with knee osteoarthritis. Repair of the meniscus, which is the small portion of the cartilage that helps stabilize the knee, is a common reason for arthroscopic knee surgery. (About 80% of the people in the Canadian trial had degenerative meniscal tears.)

The MRI study participants were living in Framingham, Massachusetts, when they were randomly selected from census data and random-digit telephone dialing. MRI scans were performed on the right knee of 991 male and female participants. All were asked to fill out questionnaires about possible knee symptoms. Of the participants who reported “knee pain, aching or stiffness on most days,” 63% had meniscal tears on the MRI. Of those who reported no knee problems, 60% showed meniscal tears on the MRI.

In an editorial that accompanied this MRI study and the Canadian trial, Robert G. Marx, MD, observed that the latter had excluded people with large meniscal tears from participation because there still is a role for knee surgery for this injury. In a telephone interview, Dr. Marx, an orthopedic surgeon at New York City’s Hospital for Special Surgery, was asked how a “large” meniscal tear is determined and how the consumer would know whether it is large enough to warrant surgery. “It’s not so simple,” he responded. “It is determined by the surgeon who takes all variables into consideration, such as the patient’s history, the physical exam, the x-ray and the MRI before recommending surgery.”

A co-author of the Canadian trial, Brian G. Feagan, MD, University of Western Ontario, strongly disagreed with Dr. Marx’s diagnostic advice but was in total agreement that large meniscal tears require surgery. “Large meniscal tears are not difficult to diagnose with a physical examination because the patient will have substantial locking of the knee,” said Dr. Feagan in a telephone interview. “It is usually seen in younger people with sports injuries and you you don’t need an MRI scan. No one would deny that surgery is effective for people with locking of the knee due to a large meniscal tear, but the vast majority of people do not have large tears, they get meniscal tearing, which is actually meniscal degeneration.”

Referring to the MRI study, which was published along with his arthroscopic surgery trial, Dr. Feagan emphasized, “That study showed that there is no correlation between those small tears seen on an MRI scan and clinical symptoms, so it doesn’t make sense to repair them because they don’t cause any symptoms in the first place.”

Asked for the take-home message of his study, Dr. Feagan replied, “The majority of the patients with mild to moderate osteoarthritis of the knee will do reasonably well with drug therapy and physiotherapy. And total knee joint replacement is excellent for people with severe disease.”

Maryann Napoli, Center for Medical Consumers ©

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Hip and Knee Replacement: Low Rate of Repeat Surgery

Posted by medconsumers on October 1, 2008

Hip & Knee-Replacement Surgery: Need for Reoperation within Three Years is Extremely Low

People facing hip- or knee-replacement surgery might want to know whether there’s a success rate that can be checked beforehand. The National Joint Registry for England and Wales has provided just such information. It differs from the type of information generated by clinical trials, most of which take place in academic medical centers. The latter represents surgery performed under the best of circumstances, whereas registries provide information about surgery as it is performed in the real world.

In this case, the real world is England’s National Health Service between 2003 and 2006 when more than 150,000 people underwent hip or knee replacement. Nokuthaba Sibanda and colleagues of the London School of Hygiene and Tropical Medicine used the National Joint Registry to determine the rates of revision, or reoperation, within the first three years after surgery. Their findings were reassuring because the need for revision was low for both procedures. Overall, one in 75 people required revisions within three years of surgery.

Partial Replacement

When the researchers broke things down according to age, gender and different types of operative techniques, they found that those who underwent a newer technique called hip resurfacing were more likely to need another operation than people whose hips were fully replaced and cemented (3% vs. 0.9%).

Similarly, people who underwent unicondylar knee replacement, which replaces only half of the knee joint, also did not fare as well as the people whose knee joints were fully replaced. (For both unicondylar knee replacement and hip resurfacing, only the diseased parts of the joint are replaced, if the damage is limited to one component of the joint.) The revision rates were slightly higher for women who underwent unicondylar or hip resurfacing procedures. Additionally, the need for revision after knee replacement “strongly decreased with age.”

Sibanda and colleagues concluded that hip resurfacing should be performed only in men and unicondylar knee replacement only in elderly people. This conclusion was challenged soon after the study was published in the Public Library of Science Medicine, a peer-reviewed open-access online medical journal.

Conclusion Challenged

The conclusion that people fare worse after hip resurfacing and unicondylar knee replacement was called “misleading” and “erroneous” by Justin P. Cobb, professor of orthopaedic surgery, Imperial College, London. In a letter to the editor of the British Medical Journal, which had published a short report about the registry data analysis, Professor Cobb cites two studies to support his contention that partial replacement procedures provide better results.

The lower rate of complications after unicondylar knee replacement was established nearly 10 years ago with data from the Swedish registry, wrote Professor Cobb, “Total replacement is not more successful, just harder to revise.” There is a substantial group of people who not entirely happy with their total knee replacement result, he explained, “yet they choose not to undergo reoperation because revision of a total knee is a huge undertaking, while revising a partial knee [unicondylar] is a relatively simple affair.”

In response to an e-mail request for more explanations, Professor Cobb wrote that the registry analysis implies that any reoperation is equivalent to failure. “Of course any reoperation is an event best avoided, but the type of reoperation and the function following it are essential pieces of information,” he wrote. “Given the choice of lumpectomy or mastectomy, most women would accept a risk of one in 30 of having a second operation, if that meant a 29 out of 30 chance of saving a breast. So it is with partial knee replacement. If there’s a one in 30 chance of having your entire knee cut out and replaced, but a 29 in 30 chance of saving two-thirds of the joint and all the ligaments, then most would choose the conservative option.”

And what about hip resurfacing? “There does appear to be a higher failure rate for resurfacing among women,” responded Professor Cobb, “but the causes of that failure are still far from certain, and function following the more conservative operation of hip resurfacing does appear to be superior to that experienced when the entire hip is excised.”

Maryann Napoli, Center for Medical Consumers ©

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Hernia Surgery

Posted by medconsumers on February 1, 2007

Hernia Surgery vs “Wait and See”

Surgeons typically tell their hernia patients, even those without symptoms, that they risk dire complications if they do not have it repaired. But hernia surgery itself, though generally safe and effective, also poses long-term risks of hernia recurrence, pain, and discomfort. An unusual clinical trial, published in the January 18, 2006 issue of the Journal of the American Medical Association, compared immediate surgery with a “wait and see” approach. It showed that the surgical repair of a hernia can be safely delayed or avoided completely.

The 720 men who participated in the trial had either minimal or no symptoms of an inguinal hernia. This type of hernia occurs when part of the intestine or abdominal tissue protrudes through a weak point in the muscles of the groin. The much-feared consequence of avoiding surgery is the possibility of a strangulated hernia. The hernia could become trapped and that might cut off the blood supply to the hernia and cause bowel obstruction and life-threatening conditions like gangrene and peritonitis.

The research team led by Robert J. Fitzgibbons, Jr., MD, Creighton University, Omaha, designed the trial to assess both the harms of delaying surgery, as well as the harms of hernia surgery itself. The 720 study participants were randomly assigned to receive either surgery or watchful waiting. The latter involved check-ups at six-month intervals.

Only one man in the watchful-waiting group had experienced acute hernia incarceration without strangulation (at two years) and another had acute incarceration with bowel obstruction at four years. As for the risks of hernia surgery, three men who had surgical repair experienced a life-threatening complication. Other less-severe postoperative complications like urinary tract infections occurred in 22% of the men.

As with the back surgery trial described on the previous page, the hernia study had many crossovers in both directions. Some study participants (23%) assigned to the watchful-waiting group decided to undergo hernia surgery. And 17% of the men assigned to surgery decided to join the watchful-waiting group.

Dr. Fitzgibbons, Jr., and colleagues concluded that watchful waiting is a safe option for men with minimal or no symptoms of an inguinal hernia. And if they choose to delay surgery until their symptoms interfere with everyday activities, they have no greater risk of operative complications than those who choose to undergo immediate hernia surgery.

Maryann Napoli, Center for Medical Consumers ©
February 2007

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Back surgery compared to non-surgical treatment

Posted by medconsumers on January 1, 2007

Back Surgery Compared to Non-Surgical Treatment

People with severe back pain due to a ruptured disk usually recover whether they have surgery or decide to wait it out, though an operation brings immediate pain relief. And contrary to what many people are told by their surgeons, avoiding surgery does not result in nerve damage. These findings are from a large clinical trial published in November in the Journal of the American Medical Association.

Many back surgeons criticized this trial before it began because they were convinced of disk surgery’s benefit. Some refused to refer their patients to a trial they saw as unethical because surgery would be withheld from some study participants, a necessary component to a study intended to randomly assign half to non-surgical treatment.

But the research team led by James N. Weinstein, DO, Dartmouth Medical School, had these justifications for going ahead: 1) ruptured disks are often seen on the CT or MRI scans of people without any back symptoms and these scans also show that untreated ruptured disks can regress in time; 2) the rate of disk surgery in some regions of the U.S. is 15 times higher than that of other regions and other Western countries, thus raising suspicion that many disk operations are unnecessary.

The clinical trial went forward despite surgeons’ objections, and 2,000 people were treated at one of 13 U.S. spine clinics. All had scan-confirmed disk herniation and the persistent back and leg pain of sciatica for at least six weeks. Some of the participants agreed to be assigned randomly to receive either back surgery or non-surgical therapy (physical therapy and counseling and anti-inflammatory painkillers). Other participants, however, wanted to choose their own treatment, and they formed the basis of a separate trial called an observational study.

The results did not identify one treatment as superior to the other because so many study participants “crossed-over.” Only 50% of the people assigned to undergo surgery actually had the operation, and 30% of those assigned to non-surgical therapies decided to have the operation.

A co-author of the observational study Richard A. Deyo, MD, Professor of Medicine and of Health Services, University of Washington, Seattle, was asked for the take-home message of both trials. “Most people got better, regardless of whether they had surgery. Surgery typically offered faster relief, but by two to four years, people are the same whether or not they had surgery,” he responded in a telephone interview. Surgery can be avoided, if the pain is tolerable and the patient is “risk averse,” he explained, referring to the small but definite risks of surgery, such as nerve injury, scarring, and anesthesia mishaps.

The risks of surgery, though small, are greater than any risk of the wait-and-see approach, he continued. “Many people have the impression they will become paralyzed or [suffer] permanent muscle weakness if they delay, but patients needn’t worry.”

Will the new findings reverse back surgeons’ opinions? “This study replicates a trial done in Norway 30 years ago with much the same results,” said Dr. Deyo, noting that many American back surgeons could be unaware of this trial. “It might bring some surgeons up to date,” he said, answering the question of whether the findings will reduce the country’s high number of herniated disk operations, estimated to be 300,000 yearly.

“But it’s spinal fusion surgery that is now the most controversial,” said Dr. Deyo, referring to another back surgery now done in excess. “It has exploded [in growth] over the last decade, and there is no evidence for it.” There are huge financial interests involved in terms of equipment, hospitals, and physicians, explained Dr. Deyo, and the circumstances for which the operation may be warranted, such as spondylolisthesis (vertebrae out of alignment), spinal fracture, and cancer metastasis to the spine—are all uncommon.

Maryann Napoli, Center for Medical Consumers ©
January 2007

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Drug-eluting Stent

Posted by medconsumers on October 1, 2006

A Failed Solution to an Iatrogenic Problem

The long-term safety of drug-releasing stents implanted during angioplasty has been called into question. These tiny wire-mesh tubes emitting low doses of a powerful drug are now the predominant means of propping open a constricted coronary artery in the U.S and many other countries. Called drug-eluting stents by their makers, they show a slightly increased mortality and a higher rate of serious adverse events in longer follow-ups of trials in which participants were implanted with either a drug-eluting or an uncoated stent.

This was announced at the World Congress of Cardiology 2006 held last month in Barcelona, Spain and reported worldwide by UPI and other wire services. The findings have huge implications for the estimated 800,000 Americans who have had a drug-eluting stent implanted and for the multi-billion dollar business that artery-opening has become.

At the Barcelona meeting cardiologist Salim Yusuf, MD, McMaster University, Hamilton, Ontario, gave “a thundering indictment” of artery-opening procedures, according to the cardiology Web site, www.theHeart.org. “The whole field of angioplasty has been led astray by a preoccupation with restenosis [re-narrowing of the artery after angioplasty], for which study after study has shown no prognostic value. We’re chasing problems that are iatrogenic that naturally would not exist in people. We’ve had a perverse financial incentive on the practice of cardiology. It is time to stop and reevaluate.” (That angioplasty* and bypass surgery are not very effective in preventing future heart attacks was explored in the April 2006 HealthFacts “Dramatic Rise in Cardiac Procedures, But No Drop in Heart Attack Rate.)

Dr. Yusuf’s point was lost in the ensuing media coverage of the serious adverse events that showed up in the longer follow-ups—two to four years—of people given drug-eluting stents in clinical trials that compared them with people given uncoated stents. All were company-sponsored trials by Boston Scientific (Taxus stent) or Johnson & Johnson (Cypher stent).

Two separate analyses of the combined results of these trials were described at the Barcelona meeting by Edoardo Camenzind, MD, University Hospital in Geneva, and Alain J. Nordmann, MD, University Hospital, Basel, Switzerland. “What we saw in the long term was more deaths and MIs [heart attacks] in the groups with the first-generation drug-eluting stents,” said Dr. Carmenzind.

Dr. Nordmann’s analysis showed that the people implanted with a drug-eluting stent did better at one year, but there was “a trend toward increased mortality” with drug-eluting stents at up to four years of follow-up. People implanted with a Cypher stent fared worse than those with a Taxus stent in this analysis. They had a higher rate of non-cardiac mortality and serious adverse events than the people with a Taxus stent. Within two days of the Barcelona meeting, Boston Scientific and Johnson & Johnson each released results of one trial claiming safety for its stent and advantages over the uncoated stent. This hasty release of data was, no doubt, intended to counter the negative press from Barcelona.

Shortly thereafter, Boston Scientific did an about-face. The company announced by way of The Wall Street Journal that its Taxus stent does in fact show a slightly higher rate of “late stent thrombosis [potentially fatal blood clots].” The announcement was based on the company’s own reanalysis of its trials. Stent thrombosis should not come as news to Johnson & Johnson because the FDA sent a warning letter to doctors about it months after the Cypher stent was approved in 2003. The following year, Boston Scientific had to recall 99,200 stent systems because of a defect that made it hard, in some cases, to deflate the balloon used to implant the stent. The defect was linked to three deaths and 47 serious injuries.

Stents were introduced after studies showed that about 40% of the coronary arteries close up again (restenosis) in the 6-12 months after angioplasty. This procedure involves the threading of a catheter to the constricted section of a coronary artery and then inflating a balloon at the tip of the catheter to compress the plaque or fatty deposits against the lining of the artery. The introduction of stents, mounted on the balloon catheter, was the intended solution to restenosis. Once the balloon is inflated, the stent expands and is pressed permanently into the inner wall of the constricted portion of the artery.

But physicians found that tissue growth around the stent caused restenosis. Drug-eluting stents were developed to prevent this problem. The Taxus stent emits paclitaxel, an anti-cancer drug that has anti-inflammatory effects. The Cypher stent emits sirolimus, an immunosuppressive drug. These stents reduce but do not eliminate the possibility of restenosis. Once implanted, people go on anti-clotting drugs (aspirin, Plavix) for the rest of their lives.

Bottom Line: Though constricted coronary arteries are not the cause of future heart attacks (as outlined in April 2006 HealthFacts), a lucrative industry has built up around opening them. Because restenosis is common after angioplasty, drug-eluting stents were approved by the FDA in 2003 to reduce the risk. Approval was based on company-sponsored trials that lasted 6-24 months and an agreement that participants will continue to be followed to five years. The companies did not have to prove that their stents were better than drugs in reducing heart attacks. Instead, they merely had to prove drug-eluting stents are better than uncoated stents in avoiding restenosis. Longer follow-up data from these trials formed the basis of two new analyses that found potentially fatal blood clots are not as rare as previously thought. These analyses, however, remain to be confirmed as they have not yet been published.

In his role as discussant at the Barcelona meeting, Dr. Yusuf, the Canadian cardiologist who delivered the thundering indictment of his profession, summarized the situation: “With about six million of these procedures done [worldwide], isn’t it a terrible indictment of our system that we don’t know the safety of these things?”

What to do:

  • If you have had a stent (or other type of medical device) implanted, get the name of the manufacturer, the type of stent, and model number. Keep this information in your personal records in case a defect is reported in the future.
  • If you had a drug-eluting stent implanted, consult your cardiologist about the need for anti-clotting drugs and the danger of stopping them. Last year the FDA issued a warning that it had received an unspecified number of reports of heart attack, stent thrombosis, and death that occurred in people “who received a drug-eluting stent and then stopped taking their antiplatelet [anti-clotting] medication prematurely.” Some were told by their practitioners to stop the medication prior to undergoing a surgical or dental procedure, others stopped on their own.
  • Web casts from the September 2-5 Barcelona meeting can be accessed at the World Congress of Cardiology www.worldcardio2006.org.

*Angioplasty is lifesaving for those who receive the procedure while in the midst of a heart attack.

Maryann Napoli, Center for Medical Consumers ©
October 2006

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Drug-emitting stents a failed solution to an iatrogenic problem

Posted by medconsumers on September 1, 2006

The long-term safety of drug-releasing stents implanted during angioplasty has been called into question. These tiny wire-mesh tubes emitting low doses of a powerful drug are now the predominant means of propping open a constricted coronary artery in the U.S and many other countries. Called drug-eluting stents by their makers, they show a slightly increased mortality and a higher rate of serious adverse events in longer follow-ups of trials in which participants were implanted with either a drug-eluting or an uncoated stent.

This was announced at the World Congress of Cardiology 2006 held last month in Barcelona, Spain and reported worldwide by UPI and other wire services. The findings have huge implications for the estimated 800,000 Americans who have had a drug-eluting stent implanted and for the multi-billion dollar business that artery-opening has become.

At the Barcelona meeting cardiologist Salim Yusuf, MD, McMaster University, Hamilton, Ontario, gave “a thundering indictment” of artery-opening procedures, according to the cardiology Web site, www.theHeart.org. “The whole field of angioplasty has been led astray by a preoccupation with restenosis [re-narrowing of the artery after angioplasty], for which study after study has shown no prognostic value. We’re chasing problems that are iatrogenic that naturally would not exist in people. We’ve had a perverse financial incentive on the practice of cardiology. It is time to stop and reevaluate.” (That angioplasty * and bypass surgery are not very effective in preventing future heart attacks was explored in the April 2006  “Dramatic Rise in Cardiac Procedures, But No Drop in Heart Attack Rate.”)

Dr. Yusuf’s point was lost in the ensuing media coverage of the serious adverse events that showed up in the longer follow-ups–two to four years–of people given drug-eluting stents in clinical trials that compared them with people given uncoated stents. All were company-sponsored trials by Boston Scientific (Taxus stent) or Johnson & Johnson (Cypher stent).

Two separate analyses of the combined results of these trials were described at the Barcelona meeting by Edoardo Camenzind, MD, University Hospital in Geneva, and Alain J. Nordmann, MD, University Hospital, Basel, Switzerland. “What we saw in the long term was more deaths and MIs [heart attacks] in the groups with the first-generation drug-eluting stents,” said Dr. Carmenzind.

Dr. Nordmann’s analysis showed that the people implanted with a drug-eluting stent did better at one year, but there was “a trend toward increased mortality” with drug-eluting stents at up to four years of follow-up. People implanted with a Cypher stent fared worse than those with a Taxus stent in this analysis. They had a higher rate of non-cardiac mortality and serious adverse events than the people with a Taxus stent. Within two days of the Barcelona meeting, Boston Scientific and Johnson & Johnson each released results of one trial claiming safety for its stent and advantages over the uncoated stent. This hasty release of data was, no doubt, intended to counter the negative press from Barcelona.

Shortly thereafter, Boston Scientific did an about-face. The company announced by way of The Wall Street Journal that its Taxus stent does in fact show a slightly higher rate of “late stent thrombosis [potentially fatal blood clots].” The announcement was based on the company’s own reanalysis of its trials. Stent thrombosis should not come as news to Johnson & Johnson because the FDA sent a warning letter to doctors about it months after the Cypher stent was approved in 2003. The following year, Boston Scientific had to recall 99,200 stent systems because of a defect that made it hard, in some cases, to deflate the balloon used to implant the stent. The defect was linked to three deaths and 47 serious injuries.

Stents were introduced after studies showed that about 40% of the coronary arteries close up again (restenosis) in the 6-12 months after angioplasty. This procedure involves the threading of a catheter to the constricted section of a coronary artery and then inflating a balloon at the tip of the catheter to compress the plaque or fatty deposits against the lining of the artery. The introduction of stents, mounted on the balloon catheter, was the intended solution to restenosis. Once the balloon is inflated, the stent expands and is pressed permanently into the inner wall of the constricted portion of the artery.

But physicians found that tissue growth around the stent caused restenosis. Drug-eluting stents were developed to prevent this problem. The Taxus stent emits paclitaxel, an anti-cancer drug that has anti-inflammatory effects. The Cypher stent emits sirolimus, an immunosuppressive drug. These stents reduce but do not eliminate the possibility of restenosis. Once implanted, people go on anticlotting drugs (aspirin, Plavix) for the rest of their lives.

Bottom Line: Though constricted coronary arteries are not the cause of future heart attacks (as outlined in April 2006 HealthFacts), a lucrative industry has built up around opening them. Because restenosis is common after angioplasty, drug-eluting stents were approved by the FDA in 2003 to reduce the risk. Approval was based on company-sponsored trials that lasted 6-24 months and an agreement that participants will continue to be followed to five years. The companies did not have to prove that their stents were better than drugs in reducing heart attacks. Instead, they merely had to prove drug-eluting stents are better than uncoated stents in avoiding restenosis. Longer follow-up data from these trials formed the basis of two new analyses that found potentially fatal blood clots are not as rare as previously thought. These analyses, however, remain to be confirmed as they have not yet been published.

Maryann Napoli, Center for Medical Consumers© October 2006

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Angioplasty: No Effect on Future Heart Attack

Posted by medconsumers on April 1, 2006

Dramatic Rise in Cardiac Procedures, But Heart Attack Rate Stays Constant

Over the last 10 to 15 years there has been a dramatic increase in cardiac procedures in the U.S. and Canada. Coronary artery bypass surgery and artery-opening procedures are intended to restore blood flow to the heart in order to prevent heart attacks. One might reasonably expect each country’s rate of heart attack to show an equally dramatic decline. But the heart attack rate stayed relatively constant in both countries. The findings came from two studies, one in the U.S. and one in Canada, published in the January 24 issue of the journal Circulation. They appear to validate the longstanding, but widely ignored, research indicating that today’s cardiac surgeons are still operating on an outmoded understanding of heart disease.

Each country’s study drew on claims data from its publicly funded Medicare program to determine the cardiac procedure rate. Medicare in the U.S. primarily covers people age 65 and over, while Medicare in Canada covers everyone, though the study looked solely at adults in Ontario. At the start of the study period, Canada’s rate of cardiac procedures was lower than that of the U.S., but both countries showed similar massive increases. The researchers determined the heart attack rate by looking at the claims submitted by people hospitalized for a heart attack during a 15-year period in the U.S. study and a 10-year period in the Canadian study.

“There are a couple of different messages for consumers in our study,” said F. Lee Lucas, PhD, Center for Outcomes Research and Evaluation, Maine Medical Center, the lead author of the American study. “The increased rates [of bypass surgery and artery-opening procedures] over time likely mean that doctors are quicker to intervene for milder and milder symptoms, particularly in white men,” she noted in a telephone interview. Dr. Lucas explained that the data collected in her study did not allow conclusions to be drawn regarding the percentage that might have been unnecessary.

David Waters, MD, who was not involved in either study, was less reticent about their implications. “We can assume that that these procedures are not influencing the heart attack rate, and some may be unnecessary,” he said in a telephone interview. Dr. Waters is chief of cardiology at San Francisco General Hospital and professor of medicine at University of California, San Francisco.

The two studies also indicate that an outmoded understanding of heart disease still dominates the way it is treated. According to the so-called new view of heart disease, a major constriction in the coronary artery is not where a future heart attack will occur. “There’s lots of data to show that opening a narrowed artery will not reduce your chances of having a heart attack,” said Dr. Waters, citing the one exception. “If, however, a person is having a heart attack, and that person has an artery-opening procedure while having the heart attack, there is good evidence that this will reduce the risk of dying of that heart attack.” In other words, the procedure will have no effect on future heart attacks.

The old model for the development of a heart attack is based on heart disease as a plumbing problem. The metaphor, which is still served up to the public to explain heart attacks, goes like this: A coronary artery slowly becomes narrowed with plaque in much the same way a pipe becomes corroded with rust and other gunk. In time, the artery becomes so constricted that blood flow to the heart is eventually shut off with a blood clot.

New Mechanism for a Heart Attack

The new understanding of heart disease is far more complex and is based on the observation that the vast majority of heart attacks do not occur in the portion of the artery that is most obstructed. Instead, most heart attacks occur where plaque breaks off and a clot forms over the area that can abruptly stop blood flow to the heart. In this scenario, the plaque is soft, symptomless, and would not be seen as an obstruction to blood flow. Heart disease is an inflammatory process by which the coronary arteries are subjected to a constant cycle of irritation, injury, healing and reinjury that makes the plaque likely to rupture. The solutions are the standard prevention advice: stop smoking, and take drugs to reduce clotting, inflammation, blood pressure and cholesterol.

If the new view of heart disease has been around for more than a dozen years, why hasn’t this changed the way it is treated? Do heart surgeons know about it? “The interventional cardiologists know about it, but they ignore it,” answered cardiologist Thomas Graboys, MD, in a telephone interview. “A new breed of over-trained cardiologists has now flooded into the community,” said Dr. Graboys, professor of medicine at Harvard Medical School and president of the Lown Foundation. It is no longer the large urban-based academic medical centers that come overstocked with interventional cardiologists. They have now come to the community hospital near you. And there is a strong financial incentive for them to look for constricted arteries and open them. “Economics drive the train,” said Dr. Graboys. “The starting salary of an interventional cardiologist is $300,000-400,000 a year, and for one that has been in practice three years, it is $500,000 to $600,000.”

Dr. Waters also sees money as the driving force. “If you have chest pain and the cardiologist you see does coronary angiography (see sidebar below) and that pays for his kids to go to college; well, are you are more likely to wind up with that procedure?” He advises, “Get a second opinion from a cardiologist who is not in the same building, the same group, or the same hospital as the first opinion cardiologist.” Dr. Waters also suggests that people give careful thought to the type of cardiologist chosen for a second opinion. There are, he explained, regular cardiologists who prescribe drugs; interventional cardiologists who do cardiac catheterizations, artery-opening procedures and stenting; and cardiovascular surgeons who perform coronary bypass surgery. The received opinion will likely mirror the doctor’s area of expertise.

The number of people undergoing artery-opening procedures continues to rise not only because they are huge money-makers but they are also very effective at relieving the severe chest pain of angina, which is a common symptom of heart disease. They are virtually useless, however, in stopping the progress of the disease itself. “The public is looking for a magic bullet,” observed Dr. Graboys, who offered this advice to people who are not in an acute situation. “Go to a non-hospital-based doctor in the community. A well-trained internist can take care of the lion’s share of people with coronary heart disease. The vast majority of people do well on medication—cholesterol-lowering drugs, antihypertensives, low-dose aspirin.”

Still, clogged arteries cannot be good. Won’t they eventually close off? “The body performs its own bypass,” explained Dr. Graboys, describing what is often seen during cardiac catheterizations. “The body forms new blood vessels around the constricted area, thus restoring blood flow.”

Dr. Graboys knows whereof he speaks; he is a cardiologist at the Lown Cardiovascular Center in Brookline, Massachusetts, a second opinion consultation center affiliated with Brigham and Women’s Hospital. For over two decades, the Center has helped many people avoid unnecessary surgery. Long before others made this connection, Dr. Graboys began to see the stress test and cardiac catheterization—two diagnostic procedures—as somewhat akin to a conveyer belt that funnels people to an artery-opening procedure or bypass surgery. A constricted artery is discovered, often several (not at all unusual in anyone over age 55), and the person goes on to what doctors call “a cascade of interventions”. In fact, the odds are so high that a cardiac catheterization will set people on to this course of events that Dr. Graboys advises a second opinion before agreeing to it.

A second opinion is all the more important given that Dr. Lucas, the lead author of the American study, said her data suggest that the threshold for deciding who is a candidate for an artery-opening procedure has been lowered over time. “Rates of bypass surgery have leveled off. This is due to the fact that bypass surgery is clearly the more invasive procedure requiring prolonged anesthesia and use of a heart/lung machine, etc., but with artery-opening procedures you’ve got the person in the cath lab, and you’ve got that catheter in there already; it’s tempting to go ahead and do the procedure, so the threshold for performing the procedure might be lower than it would be for bypass surgery,” Dr. Lucas explained. “Many people who have had it done firmly believe that it saved their lives, but the benefit of most procedures is [solely] control of symptoms.”

What does all this mean to the average older person who suspects that one day he or she might wind up in an emergency room with chest pains? To Dr. Waters, the people who show up in the emergency room with severe chest pain are the ones most likely to require an artery-opening procedure. “The person I worry about is the person who goes to the doctor with a vague symptom and finds himself with a doctor who is not skilled at distinguishing the important symptoms of a heart disease from other symptoms.”

Asked for an example of a vague symptom that an unskilled physician might mistakenly identify as heart-related: “I was recently playing catch with my dog and now have shoulder pain,” he responded, suggesting that this could be enough to start the cascade of interventions. It is, in fact, common for symptom-free people to be told to have a stress test and this alone can start the cascade.

The cascade may be worth it, if all these cardiac procedures were lifesaving, but so far proof is lacking. “There is no evidence to show that artery-opening procedures will prolong life,” said Dr. Graboys, citing the exception of a person in the midst of a heart attack. “Although these procedures are good at alleviating the heart-related chest pain called angina, so too are drugs and lifestyle changes.” Dr. Graboys continued, “Data show that people with angina can be treated successfully with medicines and lifestyle changes like stress reduction, regular exercise, smoking cessation, and treatment of risk factors like high cholesterol and high blood pressure.”

For more information on different types of angioplasty, see below.

The U.S. study led by F.L. Lucas, PhD, was supported in part by a grant from the National Institute of Aging. The Canadian study led by David A. Alter, MD, PhD, was supported in part by a grant by the Heart and Stroke Foundation of Canada.

Maryann Napoli, Center for Medical Consumers ©
April, 2006


Cardiac Procedures Explained

Cardiac catheterization is a general term for a group of procedures involving a thin tube (catheter) inserted into a blood vessel in the groin or arm. The catheter is threaded up to the coronary arteries andpositioned either in the chambers of the heart or at the arteries supplying the heart. Once the catheter is in place, the doctor can inject a special dye or fluid that is visible by x-ray. This produces motion x-ray pictures called an angiogram, which are used to diagnosed the health of the coronary arteries. Other names for cardiac catheterization are coronary angiography and coronary arteriography.

This diagnostic technique becomes therapeutic once the doctor decides to widen a constricted artery in another procedure called angioplasty. This can be done in several ways. The plaque can be pressed against the walls of a constricted artery with an inflated balloon at the tip of the catheter. In the currently most popular version of angioplasty, tiny wire cages called stents are used to destroy the obstruction and keep the constricted artery open. In the new study by Dr. Lucas and colleagues, artery-opening procedures were grouped under the name of percutaneous coronary interventions.

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