Questions About a Popular Heart Procedure

Posted on March 25, 2014 by ECR Louisville in Blog

 

Our great-great-grandparents probably didn’t have to think much about the way the heart’s aortic valve slowly stiffens and narrows over decades, a condition called aortic stenosis. Most of them died before they could experience its distressing symptoms — shortness of breath, chest pain, fatigue, fainting.

Now, an estimated quarter of a million older adults get that diagnosis annually. When the stenosis becomes severe, they have to grapple with their medical options, a decision becoming steadily more complicated.

“There’s no real medical therapy for this” – no drug, that is – “because it’s a mechanical problem,” said Dr. Harlan Krumholz, a professor of medicine at Yale University. For decades, the standard treatment has been aortic valve replacement surgery: opening the chest and stopping the heart to replace the malfunctioning valve.

“That used to be the only treatment that improved symptoms and survival,” said Dr. Dae Hyun Kim, a gerontologist at Beth Israel Deaconess Medical Center in Boston. Once older people develop symptoms, about half die within two years. Surgery drastically reduces that risk.

Still, it is such a big operation that about a third of elderly patients either decide to avoid it or are warned they won’t survive it. Dr. Krumholz, senior author of a recent article in The Journal of the American Medical Association looking at the surgery’s growing use and declining mortality risk, calls it “a technique that’s been around for decades, that’s getting better, but that is traumatic.”

 

Enter a newcomer, transcatheter aortic valve replacement. T.A.V.R., as it is known, involves a catheter, usually inserted through the groin, that delivers a new valve without a big incision and sometimes without general anesthesia. The Food and Drug Administration approved it in 2011 for patients whose aortic stenosis is considered inoperable, then in 2012 for the larger group of patients deemed “high risk” (an expansion skeptics call “indication creep”).

It sounded like a big step forward. “Here was this new, sexy-sounding procedure that had a huge amount of press,” said Dr. Torrey Simons, a palliative care specialist at Stanford University who has been analyzing the operation’s cost-effectiveness.

If you watch television in New York, you might have seen ads for NewYork-Presbyterian Hospital in which lively older women testified to their happy experiences with T.A.V.R. “No stitches, no pain and in three days, I was home,” an 83-year-old announces. “Unbelievable.”

She was particularly lucky, perhaps. Appearing in the same issue of JAMA with Dr. Krumholz’s article was a review of the first 7,710 procedures reported to a national T.A.V.R. registry. The study reported that the median hospital stay was six days, two of them in intensive care.

Moreover, patients who opt for the transcatheter procedure face complications that in some cases outweigh those of traditional surgery. The most sobering is stroke: Data from a subset of the registry shows that within 30 days, 2.8 percent of T.A.V.R. patients (median age 84) had had a stroke, 2.5 percent needed to begin kidney dialysis, and 7.6 percent had died, about half of noncardiac causes. After a year, all those measures were higher. Some T.A.V.R. patients need pacemakers or sustain blood vessel damage. A minority see no meaningful improvement in their condition.

“It’s still a relatively new technique, and there’s still a learning curve,” Dr. Krumholz said.

Traditional aortic valve replacement surgery has a lower stroke risk, and its 30-day mortality rate – 4.2 percent in 2011, according to the JAMA study, a review of 12 years of Medicare records – is lower than that reported to the T.A.V.R. registry. But most patients require longer hospitalizations – a risk in itself to vulnerable older people, which almost by definition these are – and longer recoveries.

In both cases, the procedure corrects problems with a single organ. Most patients in their 80s and 90s have multiple chronic diseases. “Fixing one abnormality out of many may not make a huge difference to a patient,” Dr. Kim cautioned. “It doesn’t necessarily translate to better long-term outcomes or a better life.”

He and his colleagues recently reviewed 62 T.A.V.R. studies. Many were small and of questionable quality, the team found. They concluded that while most patients with aortic stenosis had reduced symptoms and better physical functioning after the procedure,improvements in general health and on psychological measures were modest. Moreover, some medical centers – about 250 now offer T.A.V.R. – have better results than others.

“I’m very concerned that we’re subjecting a lot of people to a procedure that sounds like it makes so much sense before we have all the data,” Dr. Simons said.

How are patients faced with these choices – assuming they are surgical candidates and have a choice – supposed to understand the trade-offs? (If you or a family member has undergone treatment for aortic stenosis, please tell us about it below.)

Naftali Zvi Frankel knows firsthand how bewildering the decision can be. His grandfather, who received a diagnosis of severe aortic stenosis last year, was eligible to join a clinical trial at a New York hospital. (Mr. Frankel declined to say which.) It would randomly assign him to receive conventional aortic valve surgery or T.A.V.R. “The phrasing used was ‘non-inferior,’ ” Mr. Frankel told me, meaning that one option was no worse than the other.

Was that true? Mr. Frankel, a research fellow at the Institute for Advanced Talmudic Studies in New York, told his grandfather he would find out. For more than a month he researched online, poring over medical journals. He even submitted a Freedom of Information Act request to the state Department of Health to try to learn which surgeons and hospitals had the best outcomes. “These facts should be available to the consumer,” Mr. Frankel said.

Writing about this experience in JAMA Internal Medicine, he noted that patients get “an idealized vision of T.A.V.R.” but not much information about its risks. His grandfather eventually decided on conventional surgery, recovered well and is living at home in Queens.

But how many people can undertake that depth of research? Most will have to rely on carefully questioning their cardiologists and seeking second opinions. Perhaps most important, they will have to consider their own values as they approach the end of their lives.

“There are no certainties,” Dr. Krumholz said. Each option involves risks – as does aortic stenosis itself, of course. “This is medicine in the modern age,” he said.


About The Author:

Paula Span is the author of “When the Time Comes: Families With Aging Parents Share Their Struggles and Solutions.”

http://newoldage.blogs.nytimes.com/2014/03/12/a-popular-heart-procedure-under-fire/