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Compelling tale of heart innovation would have benefited from a few more details

Rating

4 Star

Building a Better Valve

Our Review Summary

Henry Kissinger is one of several glowing anecdotes presented in the story.

Henry Kissinger’s experience is one of several positive anecdotes presented in the story.

This article takes an in-depth look at transcatheter aortic valve replacement (TAVR), a method for replacing narrowed valves in patients too sick or old for surgery that is entering common practice. The piece is well-sourced and includes compelling patient stories. It does a nice job of placing TAVR in its proper historical context. However, the piece had an adulatory tone and lacked important details about the benefits, harms, and costs of the procedure. It is disappointing that in such a lengthy report, there is not a single personal example of a less-than-stellar result.

 

Why This Matters

TAVR is an increasingly mainstream option to treat aortic stenosis, a debilitating and eventually fatal condition (usually of old age) for which the only other option has been open heart surgery. This is an important story about how new technology develops in modern health care. But while it details the twists and turns of TAVR’s past, it seems to assume that somehow the future will be smooth sailing.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

We’ll award a Satisfactory here with some reservations. Although the article addresses the cost of the procedure, and in particular of the valve, readers should have been told how the cost compares to conventional surgery, rather than just the bottom line risks for hospitals. Here’s how the story presents it: “It’s a hard proposition when $32,500 goes right out the door to Edwards,” the valve manufacturer, he said. The hospital gets about $40,000 from Medicare, which is fine if there are no complications. But older patients, in their late 80s and 90s, often end up with four-, five- or even seven-day hospital stays. “We could lose $25,000,” he said.”

According to the Healthcare Blue Book, a reasonable charge to the consumer for heart valve surgery is $50,000.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The article mentions several studies and case reports of the benefits of this procedure, but does not share details necessary to evaluate it. The article says “For those who could not have surgery, a valve replacement with TAVR reduced the death rate by 20 percent in the first year.” – 20% from what? Compared to what?

The article also says: “More recent 2015 data from Medtronic indicates that its valve is better than surgery for high-risk patients, resulting in fewer deaths, at least in the first two years. And new data from another large study by Edwards found that patients at intermediate risk did better with the newest version of its valve than would be expected with surgery in the first 30 days, when most deaths occur.”

We would hope to see absolute numbers here, not just percentages. How many fewer deaths compared to surgery? In what way did patients at intermediate risk do better?

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The article mentions several risks of the procedure such as stroke risk and paravalvular leak, but hard numbers are missing. How many patients undergoing TAVR or conventional valve surgery suffer strokes? How common is leakage? All the story provides are generalizations: “There is some question about whether the process of inserting the new valves loosens debris that can cause strokes. One large study found a higher stroke rate in patients receiving valves without surgery compared with those receiving valves with surgery. Another large study did not find this effect. The valves also tend to leak slightly around the edges. New designs are ameliorating this problem, but not solving it.”

We’ll reward the story here for at least mentioning some potential risks. But it is disappointing that such a lengthy report includes only one-sided, glowing patient reviews of TAVR. Why is there not a single account of any patient who suffered a stroke or other serious complication?

To the article’s credit, it also raises the issue of limited evidence about the valves’ durability: “For now, evidence of the procedure’s effectiveness exists only for the sickest patients and there are only five years of data on how long the valves last.”

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The article speaks of TAVR in glowing terms throughout. It mentions a few studies and notes that at least one of them was large and that they were industry-sponsored but does not provide enough further information to allow us to understand the quality of the evidence: Were these randomized trials? How many subjects were involved? The story provides links to the studies, but there simply aren’t enough details in the text to allow for an informed judgement.

Does the story commit disease-mongering?

Not Satisfactory

Aortic stenosis is a serious, sometimes life-threatening condition, but the article hypes the situation:  “aortic valve disease has risen 35 percent, in large part because more people are living long enough to develop it.” then notes that “more than 8,000 Americans die from the disease annually.” Eight thousand deaths seems like a lot in isolation, but readers would have benefitted from being told it is still only about 1 percent of all heart disease deaths in the U.S.

What’s more, while these catheter-inserted valves are approved only for the sickest patients, the articles leads readers to the conclusion that all patients with aortic stenosis would be better off being treated with these relatively new devices, without waiting to see what happens in trials involving healthier patients.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The article features in-depth reporting with plenty of expert testimony — a rarity in health news today and a delight to these reviewers. It might have been nice to include a source who could better explain some of the harms of TAVR.

Does the story compare the new approach with existing alternatives?

Satisfactory

The article does explain that surgery is the alternative, but it would have been helpful to provide more concrete numbers (outcomes, cost) to show how patients fare with surgery vs TAVR. The story would have been better if also told readers about drug treatment for milder cases and that some valves can be repaired, rather than replaced.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story summarizes the approval status of several devices. However, it doesn’t explore important caveats about which patients are eligible for TAVR and implies that all comers who are too sick for surgery are eligible.

Does the story establish the true novelty of the approach?

Satisfactory

This is described nicely — the article goes into depth on the history of the device.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The article certainly goes well beyond any news release.

Total Score: 7 of 10 Satisfactory

Comments (1)

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Gary Schwitzer

June 24, 2015 at 3:35 pm

The piece reviewed above is part of a series appearing in the New York Times this week.
On his Forbes.com blog, Larry Husten wrote:
Fact Check: NY Times Heart Disease Series Gets It Right – Mostly.
http://www.forbes.com/sites/larryhusten/2015/06/24/fact-check-ny-times-heart-disease-series-gets-it-right-mostly/

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