Posted on 02/01/2005 7:45:22 AM PST by neverdem
In a sharp change from current policy, an influential medical advisory group is recommending that all men ages 65 to 75 who have ever smoked have an ultrasound screening test to see if they are developing a condition that could kill them in minutes by bursting a major artery in the abdomen.
The group, the United States Preventive Services Task Force, is an independent panel of medical experts that advises the federal Agency for Healthcare Research and Quality. Its recommendations help set government policy and are generally followed by primary care doctors.
The task force last looked at the condition, abdominal aortic aneurysms, in 1996 and concluded that there was insufficient evidence that a screening test would save lives. But now, it said, four large clinical trials have provided the evidence it needs, at least for those most at risk.
Finding aneurysms early, with a scan that can cost $350 to $400, and repairing them with an operation that can cost $15,000 to $20,000 if there are no complications, can cut the death rate by a third. Although the surgery can itself cause death, the risk that a large aneurysm will suddenly rupture and kill the patient is greater, the group said.
The condition kills at least 9,000 people a year in the United States. With screening, "the science comes down to saying this is worth doing," said Dr. Ned Calonge, chairman of the task force and chief medical officer of the Colorado Department of Public Health and Environment.
"We think our recommendation will translate into physicians incorporating screening into their practice," said Dr. Calonge, who does not screen for or repair aneurysms nor determine payments for health care, and said he has no conflicts of interest in making the recommendation.
The recommendation affects about 9.8 million Americans, the 70 percent of the nation's 14 million men ages 65 to 75 who are smokers or have ever smoked. The task force defined the group to include any man who had smoked at least 100 cigarettes in his life.
The test was not recommended for women because they are at much lower risk of developing the aneurysms.
The task force estimated that for every 500 men who meet its criteria and are screened, one death would be prevented over five years. In comparison, the only test for colorectal cancer that was evaluated in a randomized controlled trial, the fecal occult blood test, requires that 1,374 people be screened to prevent one death over five years.
"This is huge," said Dr. Frank A. Lederle of the University of Minnesota and the Minneapolis Veterans Affairs Medical Center, who reviewed the clinical trial data for the task force. "A major test for a major disease - it just doesn't come along very often."
Almost no one is screened now for abdominal aortic aneurysms, vascular surgeons say. Medical researchers suspect the true death rate is higher than 9,000 a year because often the swift deaths are attributed to a heart attack or stroke.
"If it ruptures, you're dead," Dr. Lederle said. Most bleed to death so quickly that they never make it to the hospital. And half of those who do make it to the hospital do not survive.
The review of the trial data on abdominal aortic aneurysms, along with the task force's recommendations, is published today in the Annals of Internal Medicine.
An abdominal aortic aneurysm is a small weakened area of the aorta, the large artery that carries blood from the heart and winds down along the spinal cord to the abdomen. Over the years, the weak spot slowly balloons and eventually bursts. There are no symptoms as the aneurysm grows. But once it reaches five and a half centimeters, or a little over two inches, in diameter, it may burst at any moment. That is the time to repair it, medical researchers say, explaining that smaller aneurysms posed too little danger to be worth the risk of operating on them.
Of course, finding small aneurysms also leads to a screening dilemma: patients will discover that they have a time bomb in their body but will have to wait and monitor it before getting it fixed. Still, vascular surgeons say, that is far better than the current situation, in which most aneurysms are not found until they rupture and the few that are discovered earlier are found by accident.
"Frequently we end up with someone who has back pain and gets a CT scan or an M.R.I. of the back," said Dr. Samuel Money, the chief of vascular surgery at the Ochsner Clinic Foundation in New Orleans. The doctor, he said, looks at the scan and says, "Holy smoke, you have a 6.2-centimeter aneurysm."
The task force limited its recommendations to men aged 65 to 75 who have smoked because rupture is rare in people under age 65 and is at least three times as likely in people who have smoked. The condition is about four times as common in men as in women. Anyone with a family member who had an aneurysm is at increased risk. High blood pressure is a more minor contributor to risk and cholesterol does not seem to make much difference, researchers say.
After 75, the life expectancy is considered too short and the operation too risky.
The group recommended neither for nor against screening men ages 65 to 75 who never smoked. Those men should consult their doctors, it said. Women, however, should not be screened, the task force said, because it is much less likely that they will have a ruptured aneurysm and, if they do, the rupture usually occurs in their 80's.
Screening can be costly. It usually involves a complete ultrasound scan of the abdomen, at $350 to $400. There also are quick ultrasound tests that cost about $50 to $100. If they show an aneurysm, patients are referred for a more complete test to confirm the diagnosis.
Medicare does not pay for preventive medicine unless Congress requires it. But vascular surgeons say the new recommendation should give Congress an impetus to make screening for the aneurysms, like screening for colon and breast cancer, part of Medicare's benefits.
Lobbying for Medicare coverage has been intense, said Dr. Robert Zwolak, professor of surgery at Dartmouth Medical School. Dr. Zwolak lobbies Congress as chairman of the National Aneurysm Alliance, a group of doctors, professional societies and companies. But, he said, one holdup has been the Preventive Services Task Force, which, until now, had not recommended screening.
"I would say that in two-thirds of the offices I visit, they ask, 'What does the task force say?' " Dr. Zwolak said.
Now, he says, he expects Congress will pass a bill requiring Medicare to pay for screening.
"It's just wonderful what the task force has done," Dr. Zwolak said.
His main concern, shared by his colleague Dr. Jack L. Cronenwett, the chief of vascular surgery at Dartmouth-Hitchcock Medical Center, is that the recommendations do not go far enough. Women with a family history of the aneurysms and who have smoked have the same risk as a nonsmoking man, Dr. Cronenwett said.
"If Medicare bases a coverage decision on the recommendations, a woman could have three brothers with aneurysms and she could be a smoker and she still wouldn't get reimbursement," Dr. Cronenwett said.
Medicare does pay for the repair of aneurysms by either of two methods.
One involves opening the abdomen and replacing the damaged area with a synthetic tubing. In the other method, endovascular repair, a doctor threads a catheter through the groin to the aneurysm and relines the damaged section of blood vessel from the inside, inserting a segment of synthetic material.
About 4 percent of surgery patients die. The death rate from putting in an endovascular graft is about 1.5 percent. But researchers worry that those grafts may not provide lasting results and are awaiting data from large clinical trials comparing the two methods.
"Some of us think the long-term benefits of grafts are not proven," said Dr. Lederle, an internist who is directing one of the clinical trials and takes no money from the industry. But grafts, he said, are a huge market, widely promoted. "This has created tension in the field," he added.
Dr. Calonge of the task force said the question for insurers was going to be whether to pay for the screening. He knows that world well, he says, because until a few years ago he was the chief of preventive medicine for the Kaiser Permanente health care company in Colorado and had to decide whether new tests and services should be provided.
"People don't sit down and say: 'Here's $60,000. I want a year of life,' " he said. "What you end up doing is to say, what's the cost of the program and how does that affect what I charge and does it help or hurt in the marketplace?"
The task force's role was a bit different, he said. "Cost does not enter into the task force's recommendations," Dr. Calonge said. "We're looking for a balance of harm to potential risk. You will have the benefit in terms of lives saved and years given back to those men."
But for insurers the question is a bit different, Dr. Calonge said, "They will say, 'At what cost and can we afford this?' "
That there $300 quote is MSRP - good for the next 20 minutes only. Don't walk out, I won't give you this good a deal again. Mediwhat? I thought you just walked in off the street...
Let's correct your math. That 14 million initial scan is for an at risk group that covers 11 years (65-75.) So each following year about 1.27 million people would enter the at-risk group and be scanned. 9000 deaths/year divided by 1.27 million is a .71% chance of dying from this problem, or about 1 in 141 people. Still not the most impressive odds, but I think worth a medicare reimbursement of $87.94.
Thanks for sharing! I'll keep you in my prayers.
A measurement of 5.0 centimeters is what vascular surgeons consider the "let's fix it" point. Below that diameter, especially at 2.7 centimeters, they would have recommended monitoring it.
We are very sorry we didn't have the first and successful operation............ Two things I would suggest, are: ask doctors for copies of your tests, they're yours and you have a right to copies of them and more important, ask your doctor how many times he has performed the surgery he is suggesting.
You have to remember though, that in a new procedure or with new inventions, nobody has done very many of them and the problem may lie in the new procedures or with new inventions themselves and not how the surgeon performed the procedure.
Maybe the new procedure or the new invention will revolutionize how medicine is practiced and it will turn out to be the greatest thing since sliced bread.
Maybe the new procedure or the new invention will have all sorts of unforeseen complications and later be abandoned as an idea than did not pan out.
The invention of new drugs goes through the same cycle:
1. Good initial outcomes result in newspaper headlines proclaiming a "Miracle Drug". Interests groups accuse the FDA of dragging its feet in the approval process of the wonderful stuff.
2. Bad side effects begin to be discovered in a certain percentage of users and newspaper headlines proclaim a "Killer Drug". Interest groups accuse the FDA of dragging its feet in the banning of that rat poison.
3. The good and the bad are weighed and drug is either totally banned or used in the future with caution or for certain special cases where it may provide a special benefit although it is known to have risks.
In a surgical procedure, for example, one surgery may result in a much higher failure rate down the road but may be much less invasive than the tried and true procedure that a relatively young patient may tolerate well but that a patient with other medical problems may not survive getting off the operating table.
So, a healthy 50 year old ( "a good surgical risk" ) would get the more reliable and more invasive operation and a 75 year old with heart problems ( "a bad surgical risk" ) would be encouraged to get the less reliable but less invasive operation.
For the record, this is a sterling example of a case in which preventive care increases health care costs. Just remember that the next time some legislator wants more of you money for preventive care that he says will lower costs.
Yes, this is true, but if we were aware of the problem when it was 2.7 (the primary never told us) we would have more time to research and make a better decision under less stress.
So, a healthy 50 year old ( "a good surgical risk" ) would get the more reliable and more invasive operation and a 75 year old with heart problems ( "a bad surgical risk" ) would be encouraged to get the less reliable but less invasive operation.
They told us just the opposite, his age could mean the more invasive surgery, yet decided to go ahead with the newer one because he has no other health issues. Life at 75 leaves at the most, 10 or 15 years of quality of life left, if one is lucky. We would have rather that than taking a chance by being a guinea pig on a new surgery.
We do not blame the doctor for the error, and in no way do we hold him liable, we were disappointed to be informed at the last minute (day before) in the change of procedure. Even in consul, when the first surgery went wrong he admitted the bad decision of changing the his plan.
If you are a good surgical risk, then always follow the dictum:
"Never volunteer to be the guinea pig for the latest new procedure unless you have run out of other options."
I don't think we would have any doubts if we had time to explore it more, which we would have, had we known about the aneurysm in the first MRI.
I guess you are arguing that the operation should not have taken place. OK. Ultimately, that decision is up to the patient: they must weigh the risk of death from the aneurysm vs death from the corrective procedure.
In the alternative case (no surgery) the cost is certainly lower. And if the aneurysm never bursts, it is lower forever.
Of course, if the aneurysm does burst, the cost of the corrective procedure is higher (emergency basis), the risk associated with the procedure are still the same (this patient would likely have had the same complication) and the patient might just as likely be dead because of the time criticality of effecting the repair.
What impacts (negatively) the cost of health care is the likelhood that a large number of unnecessary operations would occur (aneurysms detected that would have never burst.) But this data is not revealed by this study. It is not clear just how many patients in the risk group (or any group, for that matter) have detectable aneurysms that would never burst.
So I ask you: would you forego the operation?
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