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Posts Tagged ‘heart surgery’

Heart surgery 2nd opinion center

Posted by medconsumers on September 22, 2009

For years, we have been reporting the overuse of the coronary artery-opening procedure called angioplasty, aka percutaneous coronary intervention. About one million people in the U.S. undergo this procedure annually; despite the fact that well-designed clinical trials proved that many are in non-emergency situations and can be treated just as effectively with the multiple drug therapy. These are the same drugs, by the way, that most people will be told to take after they’ve had an angioplasty. The procedure, done in non-emergency situations, has a death rate of at least 0.63%.

Lown Cardiovascular Center, Brookline, Massachusetts is the place to go if you want a second opinion about the necessity of angioplasty or coronary bypass surgery. Long-time readers may recognize the name of cardiologist Thomas Graboys, MD, of the Lown Cardiovascular Center, who was frequently quoted in HealthFacts over the years, expressing concern that angioplasty had become a cash cow for many hospitals. In one memorable interview, he said that many symptomless people are scared into undergoing angioplasty after “failing” a stress test and told they are sitting on a “time bomb.” Such people, he said, could have been safely treated with daily aspirin and avoided the procedure.

Dr. Graboys, professor of medicine at Harvard Medical School, first came to our attention in 1992 when he co-authored a seminal study showing that angioplasty can be safely deferred in many people who have been told that the procedure is urgently needed. This and many other studies he co-authored over the years led him to recommend a second opinion when a cardiac catheterization is advised because this diagnostic procedure puts people on the proverbial conveyer belt to having an angioplasty or coronary bypass surgery. Sadly, Dr. Graboys is no longer with the Lown Cardiovascular Center. He was forced into premature retirement in 2006 due to Parkinson’s disease and dementia. He wrote a book about the experience called Life in the Balance.

Visit the Lown Cardiovascular Center Web site to see what a second opinion involves and to read the bios of the six cardiologists on the staff and no cardiovascular surgeons. Let us know if there’s a similar center in your area.

Maryann Napoli,Center for Medical Consumers(c)

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Most Recent New York State Reports on Cardiac Surgery Outcomes

Posted by medconsumers on July 1, 2009

Percutaneous Coronary Interventions (PCI) in New York State
New York State Department of Health 2004-2006. The per-hospital, per-surgeon rate of PCI, aka angioplasty, coronary-artery-opening procedures, performed in New York State hospitals from 2004 through 2006.
July 2009 Read the full report.

Adult Cardiac Surgery in New York State
New York State Department of Health 2004-2006. The per-hospital, per surgeon rate of coronary artery bypass graft surgery and cardiac valve procedures performed in New York State hospitals from 2004 through 2006. Read the full report.

Posted in Heart, heart surgery, surgery | Tagged: , , , | Comments Off

Drug-Coated Stent No Riskier Than Bare-Metal Stent, But…

Posted by medconsumers on June 1, 2009

Drug-coated stents, intended to keep coronary arteries from closing up again, have been under suspicion for causing harm to people years after they had an artery-opening procedure. In earlier studies, the powerful drugs used to coat the tiny wire-mesh cylinders known as stents, were linked to a slightly higher rate of death and potentially fatal blood clots. A new study of Swedish people who were implanted with either a bare-metal stent or a drug-coated stent appears to exonerate the latter.

While this is good news for people who already had a drug-coated stent implanted, it should not distract from the fact that too many Americans continue to undergo artery-opening procedures for non-emergency heart conditions that can be just as successfully treated with drugs alone.

The Swedish study was led by Stefan K. James, MD, Uppsala University Hospital, and published last month in The New England Journal of Medicine. It is based on the information reported to a nationwide registry of all people in Sweden implanted with either a bare-metal or drug-coated stent between 2003 and 2006 (nearly 48,000). Registry studies represent real-world care; whereas clinical trials are likely to deliver what is thought of as exceptionally good care, i.e., highly experienced surgeons at academic teaching hospitals operating on patients with the best prognoses.

The Swedish study found that the 1- to 5-year results from the registry patients were the same, regardless of the type of stent implanted. There was only one advantage to the drug-coated stent. The treated artery is less likely to become constricted again (restenosis). This advantage, however, was slim. Dr. James and colleagues described it this way, “The rate of restenosis at one year was low for both types of stents and was 1.5 percentage points lower with drug-coated stents than with the bare-metal stents.”
Dr. James was asked by e-mail who is an appropriate candidate for a stent, given the fact that researchers now know that a constricted artery does not indicate the location of a future heart attack. “You are correct,” he responded. “The use of the drug-coated stent should be reserved for patients at high risk for restenosis, such as diabetics.” Dr. James explained that there is also a role for drug-coated stents for people with long and very narrow constrictions, less than 3mm in diameter, in the coronary arteries.

The Swedish study illustrates the importance of following people for years after a surgical procedure to see how they fare. Earlier research from the Swedish registry, also published in The New England Journal of Medicine, indicated that people implanted with drug-coated stents had a 30% higher mortality rate. This landmark study, published in 2005, alerted doctors for the first time that the drugs used to coat the stents were causing a slightly increased risk of death and potentially fatal blood clots. It generated attention around the world and many cardiovascular surgeons changed their practice accordingly. Now surgeons start their patients on Plavix prior to surgery and continue the drug long after implantation of a drug-coated stent.

Bottom Line: Stents were first introduced to stop the high rate of restenosis that occurred after a coronary artery-opening procedure, also known as angioplasty. When it was discovered that tissue growth around the implanted stent also caused restenosis, the drug-coated stent was introduced. Some stents are coated with paclitaxel, an anti-cancer drug that has anti-inflammatory effects and others with sirolimus, an immunosuppressive drug. When the 2005 Swedish registry study indicated that the drugs used to coat the stent increased the risk of dangerous blood clots, Plavix, was introduced into the mix. Plavix (generic name: clopidogrel), heavily promoted on TV, has its own risks, primarily stomach or intestinal bleeding and ulcers of the stomach or intestines.

For decades, people have been told that large constrictions in the coronary artery signal future heart attacks which must be prevented by an immediate artery-opening procedure called angioplasty. This hypothesis was disproved 3 years ago by two landmark trials.  Many, if not most, of the one million or so Americans who undergo angioplasty each year (with or without stents) can be treated just as successfully with the same multiple-drug regimen advised for just about everyone after angioplasty.

The exception: People in the midst of a heart attack are appropriate candidates for angioplasty. Unfortunately, about one-third of all heart attack patients do not receive artery-opening treatment within the recommended 12 hours after the first symptoms of a heart attack.

More Information About the Two Landmark Trials:
Heart attack patients who did not receive the recommended treatment in time are represented in the federally-funded Occluded Artery Trial (OAT). This trial, published in 2006 in The New England Journal of Medicine, randomly assigned people who were in stable condition 3 to 28 days after a heart attack to have either an artery-opening procedure with stenting plus multiple-drug therapy or multiple-drug therapy alone. After 3 to 5 years, the people given multiple-drug therapy alone did just as well as the people who underwent an artery-opening procedure plus drugs.

The OAT found no benefit to opening a blocked artery after the heart attack patient is stabilized. The procedure “should be reserved only for certain patients such as those who are unstable or continue to have chest pain following a heart attack,” according to an OAT researcher. See 2006 press release.

In 2007, another landmark trial, known as COURAGE [Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation], produced results similar to those of OAT for people with stable heart disease. The people in this trial had angina (average 10 episodes a week) for about two years before they entered the trial; most had hypertension, over one-third had had a heart attack.  In short, they were at very high risk and were highly symptomatic for a long time prior to the start of this trial.  A five-year follow-up showed that those who were randomly assigned to have angioplasty had the same risk of heart attack and death as those who were randomly assigned to multiple drug therapy.

Maryann Napoli, Center for Medical Consumers© June 2009

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Most Recent New York State Report on Angioplasty Outcomes

Posted by medconsumers on February 1, 2008

Percutaneous Coronary Interventions (PCI) in New York State
New York State Department of Health 2003-2005
February 2008

Read the full report.

Posted in Heart, surgery | Tagged: , | Comments Off

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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