Implants and other new technologies—including smartphone apps and over-the-counter monitors—are testing the very definition of medical records - Amy Dockser Marcus and Christopher Weaver


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Atrial fibrillation, a condition affecting three million to six million Americans, is caused by irregular contractions of the heart and results in an increased risk of stroke and death. Over the past two decades, cardiologists have increasingly treated it with a procedure called catheter ablation, in which small plastic catheters are used to create scars in the damaged heart tissue to prevent the aberrant electrical signals from spreading. Many have touted catheter ablation, which can cost well above $20,000, as a “cure” for atrial fibrillation.

Yet a new randomized controlled trial, the gold standard of clinical research, has produced disappointing results. The study, called the Cabana trial, found that the procedure was no more effective than much cheaper medications at reducing mortality, cardiac arrest, major bleeding and stroke.

These results come on the back of another prominent trial published last year, which showed that stents used to relieve blockages in patients with stable chest pain provided no benefit over medications.

In the furor over the Cabana results, which have been presented at a scientific conference but not yet published, many have argued that the underlying data suggests that catheter ablation does help some people. But a different kind of study will be needed to confirm that. The fact is that years after catheter ablation hit the market, we shouldn’t have this many questions about it.

The bar for approval of medical devices is too low. There is no reason we shouldn’t require, as we almost always do for drugs, a randomized placebo-controlled trial showing improvements in “hard” outcomes like mortality before approving them.

Unfortunately, the United States may soon make it even easier for medical devices to reach the patient’s bedside. The Food and Drug Administration is considering requiring less upfront research and instead adding increased oversight after a device has been introduced into the market. The argument is that this will spur technological innovation and perhaps help terminally ill patients. However, loosening regulations could extract a steep cost from patients and the health system.

Recently, an employee from a company that makes a small heart pump called Impella emailed me asking how the use of this device could be increased: “How would you approach a physician to adopt this therapy?”

The Impella has been placed in more than 50,000 patients’ hearts, though we still have no randomized controlled trial data on its efficacy. Each device costs roughly $25,000. I replied, “I think a device such as an Impella will always be underutilized until there is a randomized controlled trial which shows improvements in hard clinical outcomes.” Was the company interested in doing an RCT, I asked.

I never heard back.

After a device has reached the market, companies have little incentive to do a high-quality trial. Why risk a study showing that your device’s benefit doesn’t exceed its harms when cardiologists are already implanting it?

Physicians have become major drivers of the overuse of devices and procedures like these. Doctors are rewarded on a fee-for-service basis, meaning the more that they do, the more they are paid.

This is especially true of doctors performing procedures such as catheter ablation. Last year, five cardiologists at Ohio State University made almost $2 million (twice what the Buckeyes’ president made).

In this environment, despite their best intentions, physicians cannot be expected to be completely disinterested stewards for their patients.

Some argue that regulations are making it too hard for good ideas to come to fruition. But if anything, over time I have become warier of “good ideas.”

The F.D.A. recently approved a new kind of stent to relieve blockages. These stents would dissolve in about three years, the theory being that patients would prefer this to having metal placed inside them. And indeed they started showing up in clinics demanding these vanishing stents.

But longer-term studies showed that while these stents were disappearing, many were disappearing into blood clots, causing an increased risk of heart attacks compared with conventional stents. The manufacturer quickly shut down the program.

It is much more difficult to study the efficacy of devices than that of drugs, because the former involves invasive procedures. It’s one thing to give patients a placebo pill to swallow; it’s much harder to pretend to implant a stent. But these so-called sham procedures are necessary if we’re going to find out whether devices work, especially for treating symptoms that are susceptible to the placebo effect.

We know what lax regulations can do. Europe’s historically loose regulatory environment exposed so many patients to harm from devices like exploding stomach balloons and deadly breast implants that regulators there have done a complete turnaround, moving toward very strict criteria.

A perfect storm of conflicted physicians, loose regulations and a culture that celebrates shiny, expensive and invasive treatments has led to the fetishization of medical devices. But if the F.D.A. won’t act, change is still possible.

The most important lever protecting patients and the economy from wasteful devices and procedures is manned by the same hand that signs the checks — insurance companies. Even if the F.D.A. approves a device, insurers can stop paying or reduce how much they pay for it. The Centers for Medicare and Medicaid Services, for example, has recently proposed reducing reimbursements for the Impella.

Transforming how doctors and hospitals are paid, from a fee-for-service model to a system in which payments are tied to the health of the patient, would also discourage the use of devices of questionable efficacy. Devising such alternate payment models was part of the mandate of the Affordable Care Act. However, progress in transitioning to these payments has been slow, and most health care continues to be paid for by quantity rather than quality.

In the meantime, we need the F.D.A. to do its job and ensure that devices that can careen patients and the health care system toward bankruptcy are actually making people healthier.

Source: Haider Warraich, Don’t Put That in My Heart Until You’re Sure It Really Works, The New York Times, May 20, 2018.

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Last Updated : Thursday, January 28, 2021