Sept. 7, 2010 -- What doctors say and what patients hear are often quite different, especially when patients are facing surgery or invasive medical procedures. That, in turn raises important questions about whether patients are truly "informed" when they give informed consent.
A group of cardiologists at Baystate Medical Center in Massachusetts explored that communications gap by studying how patients with chronic chest pain (angina), which often limits physical activity, perceived the potential benefits of elective angioplasty to open arteries narrowed by cholesterol-filled plaque.
In a study published in Monday's issue of the Annals of Internal Medicine, they surveyed 153 patients about to have heart specialists examine the insides of their arteries and if needed, perform angioplasty. They also surveyed 10 interventional cardiologists and 17 referring cardiologists.
The research team, led by Dr. Michael B. Rothberg, found that most chronic angina patients overestimated the benefits of angioplasty, even when they had read material provided by their doctors. The survey found 88 percent of the patients believed it would reduce their chances of suffering a heart attack and 75 percent thought that without it, they'd probably have a heart attack within five years. Patients expressed these perceptions even when most of their doctors knew the limitations of angioplasty.
Here is where some confusion may arise: Angioplasty indeed reduces the risk of heart attack and death in patients with acute coronary syndromes, in which plaque suddenly breaks off, blocks an artery and begins starving the heart muscle of oxygen. Acute cases account for the vast majority of the more than 1.2 million angioplasties performed each year.
But for chronic angina patients, angioplasty's benefits are more modest. It relieves chest pain and improves their quality of life for several years.
The study has two major implications. One is that patients may be inadequately informed about many kinds of procedures, and the other is that angioplasty may be described and "sold" by cardiologists.
Patients Need More Info About Angioplasty, Doctors Say
"While the study was done in just one center, it rings true and the message ought to be heeded," said Dr. Mark Hlatky, a professor of health research and policy at Stanford University in Palo Alto, Calif.
Doctors long have debated how to best convey the benefits and limitations of treatments like angioplasty, but as busy doctors see more patients, that cuts into face-to-face time for detailed discussions about precisely what's at stake.
"We need to figure out better ways to inform our patients," said study co-author and interventional cardiologist Dr. Marc J. Schweiger. "What this study tells me is that we have to look further to figure out what works better and what doesn't."
Baystate is already doing that. It's among a dozen medical centers participating in an NIH-funded study of computer-based consent forms that give patients individualized risk profiles before angioplasty. Some of the 1,400 angioplasty patients Baystate hopes to enroll will face angioplasty for an acute heart attack; others for chronic stable angina, said Dr. Aaron Kugelmass, Baystate's chief of cardiology. "To the extent we can tailor a patient's likely benefit and tailor a patient's specific risk, I think that will go a long way toward creating an open dialogue and better dialogue between patents, their family members and physicians."
Dr. Harlan Krumholz, a Yale cardiologist and director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation, has been studying the perception gap for more than a decade. In 2000, he led a study that examined patients' perceptions about elective angioplasty , which found that "the majority of patients" had unrealistic expectations about long-term benefits. This year, he co-authored an article in the Journal of the American Medical Association that proposed addressing this ongoing problem with detailed informed consent documents that spell out details of angioplasty's potential benefits and risks, other medical approaches, the health care team's experience and the costs of the procedure, doctor's fee and required medications.
Patients May Overestimate Angioplasty's Benefit
Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic in Ohio, goes even further. He says the communication role "is best played by a 'gatekeeper,' a primary care physician or general cardiologist that doesn't perform the procedure. When the interventional practitioner who performs the procedure explains the benefits, there is a natural tendency to overstate the benefits. In the words of Mark Twain, 'to a man with a hammer, everything looks like a nail.'"
Other cardiologists contacted by ABC News agreed that the current informed consent procedures can fail.
"Often patients do not absorb all of the information, even when great care is given to discuss the procedure and its expected outcome," said Dr. David Faxon, chief of cardiology at Brigham and Women's Hospital in Boston. "In my view, it is best done in two settings with the physician describing the procedure, its indications, expected outcomes and risks and benefits followed by the same person or another -- often a nurse -- following up to discuss it again to be sure the patient and family understand it and to answer any questions."
When it comes specifically to angioplasty, Dr. Kirk Garratt, director of clinical research of interventional cardiovascular research at Lenox Hill Hospital in New York, says he understands why patients may overestimate potential benefits. "To a layperson, it seems sensible that getting rid of a severe blockage should provide some protection against heart attack. I've had pointed conversations with certain patients over the years, and even when I've gone over things carefully and honestly, some patients simply can't shake the belief that getting rid of a plaque won't prevent a heart attack. It doesn't make sense to them."
Many patients "want to believe that [angioplasty] is life-saving so badly that no consent process would change their minds."
Dr. James N. Slater, an interventional cardiologist at NYU Langone Medical Center in Manhattan, has been there. "Most patients -- including myself in that role -- in my experience tend to overestimate the value of most medical procedures if for no other reason than they are hoping for the best." Stable angina patients often sign consent forms "immediately prior to the procedure and often are nervous and anxious. This coupled with the fact they are given sedation during angioplasty makes it difficult for them to recall what exactly they were told. After such a heroic effort on the part of the patient, maybe it is only natural that they think that Father Time may have been defeated once again."
Surgery Still Best for Some Heart Patients
Dr. Raymond Gibbons, a professor of medicine at the Mayo Clinic in Rochester, Minn., advocates a health system that encourages and reimburses doctors for taking the time to make the decision with the patient. He says some cardiologists may oversell angioplasty because of financial incentives "to grow the business," because angioplasties make money for the hospital and the doctor. But, he says, the problem "is not bad doctors. We have a bad system."
Finally, cardiac surgeons weighing in on the Baystate study had yet another perspective about how angioplasty is presented to patients. Dr. Thoralf Sundt, vice chair of surgery at the Mayo Clinic, noted that in some cases, "the benefits of surgery have been under-played and the benefits of angioplasty overplayed." He added, "Understandably, part of the issue is that no patient really wants surgery."