麻豆传媒

Wise Buy, a 麻豆传媒 series, assesses therapies -- new and old -- to determine if the treatment is not only a wise choice, but also a wise buy.

In an article in The Atlantic in October, the medical ethicist Ezekiel Emanuel, 57, wrote that he hopes to die at 75, when he says he will decline medical procedures that might prolong his life.

Why? Old age, he wrote, "renders many of us, if not disabled, then faltering and declining ... By the time I reach 75, I will have lived a complete life."

Emanuel's article attracted enormous attention, much of it negative. But it underscored an uncomfortable truth: Much of the medical care delivered to our elderly population is futile, costly, and does not extend life. In 2011, for example, . Much of it produced little benefit.

But there are cases where care can help even very elderly people. One example is transcatheter aortic valve replacement (TAVR), which is increasingly being used in older patients.

$67,000 per QALY

In September, researchers reported that TAVR with Medtronic's CoreValve had durable survival benefits at 2 years for extreme-risk aortic stenosis patients and was relatively safe and cost-effective for high-risk patients. The research, presented at the , showed that the projected lifetime incremental cost-effectiveness ratios were about $67,000 per quality-adjusted life-year (QALY).

The authors concluded that lowering the initial hospitalization costs by $2,000 to $4,000 per patient lowered the ratio to less than $50,000, making these "high-value" procedures under the criteria of the American College of Cardiology and the American Heart Association.

Other studies showed that treatment with Edwards Lifesciences' Sapien transcatheter aortic valve implant added years to patients' lives, with less disability than in medically treated patients.

Increasingly, doctors have tried TAVR on very elderly patients -- enough of them that researchers at the Mayo Clinic were able to collect 21 men and 38 women over age 90 for a study.

Thirty-three of these 59 patients had surgical valve replacement, and 26 had transcatheter replacements. In the study, in the , the researchers determined that the Kaplan-Meier survival estimate at 1 year was 81.3% +/- 5.4%, with no difference between the valve replacement group and a matched control group -- less than the risk that had been projected.

The rates of morbidity and mortality were similar with TAVR and surgical AVR. Operative complications occurred in 22 patients, including acute renal failure in seven and stroke in one. Vascular injury occurred in six patients treated with transfemoral SAPIEN valve replacements.

"It's more of a home run when you treat somebody who's 50 than when you treat somebody who's 90," acknowledged , the senior author on the paper. That's because the younger patients stand to gain more years of life, although they could live long enough to require a second valve replacement. Still, with the older patients "you can reset their survival curve to meet a comparable demographic who don't have aortic stenosis," he said.

Mathew noted that new heart valves are coming on the market and under development, and that each new generation is generally better than the previous one. "The technology is moving," he said. There is "a big potential market" for TAVR, he said, even though he doesn't think it's ready to replace surgical valve replacement.

Living Longer and Better

, a cardiologist at the Yale School of Medicine, believes that TAVR is a useful technique, even in very old patients. "There are a lot of areas in medicine where there is a tremendous amount of waste, where we're doing things that provide almost no benefit," he said in an interview. But "here we have a technique that can provide some considerable benefit even if for a relatively short time."

For many people, he said, this is the only medical problem they have, and without treatment, it will kill them. "If you can relieve the stenosis, not only can people live longer, they can live better," he said.

Even so, as TAVR expands to those who are not in clinical trials, it will be important to track what happens, Krumholz said. He praised the FDA for setting up a national registry to track the procedure. That will enable doctors to analyze real-world experience, and it will help prevent aggressive promotion by the makers of the artificial valves. "We want to make sure there is no effort to have people get these procedures before they're at a point that the studies suggest it's appropriate," he said.

CoreValve by Medtronic and the Sapien valve are the only TAVR technologies on the market, and they are approved only for patients at high risk of death from surgical valve replacement. But they "hold huge future growth potential," according to . The analysis also said that CoreValve was largely responsible for a 5% jump in Medtronic's earnings in the most recent quarter.

, director of the division of medical ethics at New York University, said that with TAVR, surgical aortic valve replacement, and other procedures, "age is not and should never be a rigid cutoff. What you're trying to do is use age as a marker to forecast death or other age-related problems. But it's not a reliable marker. There are some healthy 85-year-olds and some unhealthy 10-year-olds."

He said it's important to consider other unrelated health issues in these patients, too. "If you're trying to put a valve into someone with Alzheimer's disease, that's a different argument. Two more years demented is something almost nobody wishes for." And some people might simply refuse a valve and choose to die, Caplan said, and that should be their choice.

The increasing success of TAVR also raises a broader societal question: In a world of scarce resources, should we spend this money on some of our oldest patients?

One More Golf Game?

"Other parts of the world have made other decisions about that, but in the U.S. people want as much as they can," Mathew said. It's important, he said, to include discussion with the family about the patient's support system before decisions are made -- what he called an integrated approach. "It's a complex process, it's a time-consuming process, but we believe the integrated approach -- getting patients' perspectives -- is an important component of the decision making."

Caplan also said that the decision about whether to be treated would depend on many more things than a patient's age. Ezekiel Emanuel's decision to die at 75 is not for everyone. "Some might say there's one more golf game for me, or one more bridge game, or one more grandchild to visit," Caplan said. Once a medical evaluation has been done by doctors, the decision to have a valve replaced should be up to the patient.

"If you have to ration something, you might want the younger person to get the kidney," Caplan said. But if you can make as many aortic valves as needed, the patient should make that choice.

From the American Heart Association:

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