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Experts Warn Expanded Heart Valve Use Risks Patient Safety

In a world full of dizzying innovation, marketing blitzes and conflicts of interest, doctors and patients must decide: how much risk is too much?

By Cat Ferguson Petra Blum / November 26, 2018

Jeanne McArdle was 85 when her doctor said that she needed her heart valve replaced.

Not long before, her best option would have been open-heart surgery, to cut out her valve and sew in an artificial one. McArdle was happy to learn that doctors had recently come up with a new kind of fix: a minimally invasive procedure called transcatheter aortic valve replacement, or TAVR. Instead of surgery, a new valve could be inserted through a small incision and then into the heart on the end of a thin, flexible tube called a catheter. The procedure would be quick and require just a few days of recovery.

“They told me I’d feel like a new woman. I feel like a bionic woman!” McArdle said in a 2016 promotional video shot shortly after the new valve was put in place.

Nearly three years later, she’s still feeling that good, she told the International Consortium of Investigative Journalists. “It was the most wonderful procedure. I didn’t have an ache in my body,” she said.

Aortic stenosis, a narrowed heart valve, is the third most common cardiovascular disease in the Western world. It often develops in old age, when open-surgery can be risky. TAVR has revolutionized treatment of aortic stenosis, extending the lives of hundreds of thousands of patients.

As its popularity has grown, doctors, with the strong encouragement of the manufacturers who make the valves, are using TAVR in younger and healthier patients. It’s common for medical devices to be used for different purposes or in different populations as the science advances, but for TAVR, a critical uncertainty remains: no one knows how long the valve will last.

The companies that make it, the researchers who study it and the doctors who spread its use around the world acknowledge that the TAVR valve’s durability is unknown. A consensus document written by four major heart societies in the U.S. has called for caution in treating patients who might outlive the device by decades.

We have no idea what the durability of those valves is, at all, period. – Dr. Joseph Bavaria

Doctors have told the International Consortium of Investigative Journalists that degradation of the TAVR valve may cause serious problems, including a need for open-heart surgery when patients are older, more frail and at greater risk of death or serious injury. Several studies have suggested that patients who are good candidates for surgical valve replacement have higher mortality rates if they receive a TAVR valve, instead.

At the same time, manufacturers have launched aggressive marketing campaigns targeting doctors, patients and advocacy groups. Both Edwards and Medtronic, the two manufacturers selling TAVR valves in the U.S., are bombarding cardiologists with ads touting their durability, even though there is no strong evidence that the valves last more than five years once implanted.

Groups that claim to advocate for patients survive largely on industry money, and use human interest stories to sell TAVR to patients, politicians, and payers. Mended Hearts, a tax-exempt organization that provides support to hospitalized heart disease patients and their families through a visiting program and other peer-to-peer efforts, took more than a million dollars from pharmaceutical and device companies in 2016, including almost $300,000 from Edwards.

Patients are exposed to marketing campaigns targeting them everywhere, from their internet searches to their support groups, and doctors say patients often ask for or demand TAVR valves.

Edwards projects that the TAVR market will be $5 billion or more a year by 2021, driven by wider use, improved technology and increased “therapy awareness” – more patients asking their doctors about TAVR. Along with other manufacturers, Edwards sought to boost that awareness through patient groups, using them for direct-to-consumer marketing and as an effective tool for lobbying.

Mended Hearts, for instance, brings doctors and patients to explain the TAVR procedure at gatherings of heart disease sufferers, and their members appear in Edwards promotional videos. Mended Hearts members also speak to journalists and policymakers about the benefits of TAVR.

Just in the last few months, industry-backed lobbyists and patient groups have been pressing U.S. regulators to do away with limits on which hospitals can perform the TAVR procedure, and the government has separately agreed to pay for the procedure in a wider variety of patients.

“We have no idea what the durability of those valves is, at all, period,” said Joseph Bavaria, a doctor who co-directs the TAVR program at the University of Pennsylvania, where he is also a professor of surgery.

Bavaria is also chairman of the steering committee for the U.S. TAVR registry, a database of patient information and the outcomes of every TAVR procedure in the country. Many patients having TAVR are now from 65 to 75 years old, “and we don’t have a clue how these things work in those people.”

ICIJ spent the past year examining the medical device industry, its regulators, the doctors who use its products and the patients whose lives are changed — for better and worse — by medical technology. The investigation, known as the Implant Files, has uncovered many examples of devices approved with scant testing and devices allowed to remain on the market too long after their dangers have become clear.

TAVR is relatively early in its lifecycle. It has garnered widespread praise and enthusiasm, turning a previously dire diagnosis into a highly treatable condition. There is no question that it is helping people. Patients want it, and manufacturers want them to have it.

During McArdle’s surgical consultation, her doctors said she was in good shape and could have surgery, she recalled. But she insisted on TAVR. “I didn’t want surgery,” she told ICIJ. “I said, ‘If you have to cut me open, I won’t do it.’”

  • https://www.icij.org/investigations/implant-files/experts-warn-expanded-heart-valve-use-risks-patient-safety/