Are invasive heart procedures worth the risk?
by Michael Schroeder
After her younger sister had a heart attack, Gilda Povolo returned to her cardiologist, worried she might be next. She had no symptoms — no chest pain or shortness of breath — but risk factors galore, including diabetes, high blood pressure and a family history of heart disease.
Her cardiologist said her second stress test, as he had the first, was a false positive, but Povolo, of Traverse City, Mich., still believed she was at risk. Her persistence, and a recommendation from her primary care doctor to get an angiogram from another cardiologist, eventually landed her on a catheterization table, where the invasive test revealed severe blockages in two arteries. Those were cleared with angioplasty and three stents — mesh tubes — were inserted.
"I think you should always do what your gut is telling you is right," says Povolo, 58 and heart-attack free five years after the procedure.
Questionable data
Millions of Americans have had stents put in since they were invented in the mid-1990s — many, like Povolo, hoping to prevent problems down the road. But research reveals one detail little known by patients: "There's never been any data that's said, 'In stable [coronary artery disease] patients, doing one of these procedures prolongs your life,'" says Dr. Gregory Dehmer, the past president of the Society for Cardiovascular Angiography and Interventions.
Signs you're having a heart attack
Sometimes it's obvious, sudden and intense, but most times not. Heart attacks usually start slowly, with mild pain and discomfort. Call 911 immediately if you notice any of these signs:
• Chest discomfort lasting more than a few minutes or going away and coming back. It can feel like uncomfortable pressure, squeezing, fullness or pain.
• Pain or discomfort in other parts of the upper body - in one or both arms, the back, neck, jaw or stomach.
• Shortness of breath.
• Breaking into a cold sweat, nausea or light-headedness.
• Shortness of breath, nausea, vomiting, and back or jaw pain are more likely to be symptoms for women.
Stable patients are those whose symptoms, such as chest pain, that aren't getting worse. Dr. Judith Hochman, director of the Cardiovascular Clinical Research Center at New York University School of Medicine, puts it another way: "There's no proof that it prevents a heart attack or makes [these patients] live longer."
Neither Dehmer nor Hochman are anti-stent — far from it. Angioplasty, a procedure involving a tiny balloon blown up to smash plaque and open a blocked artery, and stenting — together known as percutaneous coronary intervention (PCI) — have been shown to reduce chest pain, or angina, associated with coronary artery disease.
"A lot of [procedures] are done for symptoms," Hochman says.
Dehmer adds that stents are a lifesaver for some having a heart attack, and, though the circumstance is less dramatic, can save those with severe chest pain from a full-blown heart attack.
More procedures, better care?
But experts who spoke with Angie's List Health say flawed logic, ego and money drive many to do unnecessary procedures.
"The most compelling reason doctors and hospitals overtreat is that most of them are paid for how much care they deliver, not for how well they care for their patients," says Shannon Brownlee, author of the book, "Overtreated."
More procedures doesn't necessarily mean better care. A few years ago, a Dartmouth Institute analysis found EMH Regional Healthcare System in Elyria, Ohio, at the center of a region where Medicare patients underwent angioplasty at the highest rate in the country.
"Since the time of the Dartmouth study, the number of procedures at EMH has been noticeably reduced while still maintaining our high quality outcomes," says spokeswoman Kristen Davis. She attributes that to advances in clinical practice and studies supporting medical therapies as an alternative to angioplasty.
A 2007 Veterans Health Administration study — the largest of its kind testing the benefits of angioplasty and stents in patients with stable heart disease — found these procedures didn't reduce heart attacks, hospitalizations, stroke or death rates.
Heart disease defined
• Angina: chest pain
• Angioplasty: a tiny balloon is blown up to smash plaque and open a blocked artery
• Coronary angiogram, or angiography: X-ray of blood vessels injected with dye to identify blockages. A medical procedure called cardiac catheterization is done in which a catheter is threaded through an artery in the groin or arm and a fluoroscope, a special X-ray viewing instrument, takes pictures of blood flow.
• Coronary arteries: vessels that supply blood to the heart
• Coronary artery bypass graft (CABG) or bypass surgery: Surgeons take a healthy blood vessel from another part of the body to create a detour around the blocked part of the coronary artery.
• Coronary artery disease, or coronary heart disease: Begins when plaque is deposited in a coronary artery, which can cause tiny clots to form, restricting blood flow to the heart and causing symptoms such as angina.
• Myocardial infarction: heart attack — No. 1 killer of men and women in the U.S.
• Percutaneous Coronary Intervention (PCI): typically angioplasty plus stenting
• Stent: a mesh tube inserted to hold open the artery after angioplasty
Those who underwent procedures, took medications and made lifestyle changes, were initially more likely to report relief from chest pain. But when the study was over after five years, those who just took medications and made lifestyle changes were just as likely to report angina relief.
"I think the research has changed practice," says Hochman, noting a decline — though smaller than she expected — in procedures in recent years.
Angioplasty and stents dipped about 17 percent between 2005 and 2008, according to Medicare data. About 1.3 million procedures were done in 2006, according to governmental figures. But an industry analyst says angioplasty is rising and the 2009 stent market will likely exceed 2008.
Dr. Roger J. Laham, an associate professor of medicine at Harvard Medical School and an interventional cardiologist, estimates roughly one in five procedures done today aren't necessary, and that's down from previous years. Others say it's more.
"About half of them, easily, that's a conservative estimate," says Dr. Robert Thompson, a highly rated cardiologist in Seattle, who focuses on prevention.
The mean charge for performing angioplasty and putting in stents is about $50,000. Add in about $100,000 per bypass surgery and a few other procedures and you have a market valued at more than $100 billion.
Evaluating the risks
The problem with using stents when they aren't needed isn't just wasted money, it's unnecessary risk. About one in 140 people who undergo angioplasty and get stents die in the hospital, according to data from the federal Agency for Healthcare Research and Quality. Cardiac catheterization, done for an angiogram to check for blockages, claims one in 130 patients.
Hochman and Laham say some doctors continue to use angioplasty and stents to prevent heart attacks in stable coronary patients even though there's no proof this works. A tiny sub-study of the VHA research suggests it might improve outcomes for some with the most severe heart disease, but findings are inconclusive and more research is needed, Hochman says.
Cardiologists caution against neglecting needed procedures. Dehmer says patients should talk with doctors about their options, including medications. Thompson suggests getting a second opinion from a physician who wouldn't be doing the procedure.
Dr. Nortin M. Hadler, an author, critic of the U.S. health care system and professor of medicine at the University of North Carolina, says if a doctor doesn't have time for a detailed discussion on risks and benefits, move on.
Hadler holds an extremely dim view of heart procedures. Asked what he'd do if he had a heart attack, the physician who's board certified in five specialties says he would take medications, such as blood thinners, but he wouldn't be catheterized or have angioplasty or bypass surgery because of the risks.
"I'm quite certain that that's state of the art, evidence-based care," Hadler says. Based on current, improved heart attack survival rates, he puts his chances of survival at 96 percent, 98 percent if he takes baby aspirin.
"If someone is having a major heart attack and is not comfortable with a procedure that will save their life, I guess that's their business," Dehmer responds, adding that doctors are trained to respect patients' wishes.
Dehmer says he understands the math behind Hadler's argument but calls indiscriminately passing on heart procedures risky.
'A quick fix'
Still, there's some evidence that people who are more informed are less likely to undergo procedures if they can be avoided. Debates about the usefulness of procedures aren't new. Time magazine featured a story on bypass in 1978 with one clinician calling it the most important advancement in medicine in decades and another saying that except for relatively small groups of patients, there was no proof it postponed or prevented death.
Robert Shuck, a 57-year-old from Indianapolis and an Angie's List member, has read a small stack of books since he first had chest pains in 2005. After learning of the risks associated with angiograms, including arterial perforation and the potential the test could lead to unnecessary procedures, he twice declined cardiologists' urging to have one.
The second time a doctor said he needed an angiogram was this summer after his heart started racing and he landed in the ER.
"I'm not one to go to hospitals on a whim." Shuck says. "So that one kind of scared me."
He says he started feeling better shortly after arrival and opted to have an echocardiogram, a non-invasive test that uses sound waves to create a picture of the heart.
Shuck says his angina is stable. He takes baby aspirin and tries to watch what he eats but admits some bad habits, namely smoking. He also sees it as his mission to tell everyone about his experience, and what he's read on angiograms. Shuck concedes most still get the test anyway.
"I'll tell you why," he smiles. "I think Americans just want a quick fix."
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