Worse quality of life for many despite ‘miracle’ TAVR heart procedure

Worse quality of life for many despite ‘miracle’ TAVR heart procedure

More than sixteen years ago, Gary Schwitzer wrote about the seven words you shouldn’t use in medical news. One of those words is “miracle.”

The term is still commonly used and abused to describe the impact of new medical treatments — for example in a news release we reviewed last week about cancer immunotherapy.

The term “miracle” has also been applied to a relatively new heart disease treatment called transcatheter aortic valve replacement (TAVR). It’s a less invasive alternative to open heart surgery for patients with damaged heart valves who would be at increased risk with standard surgery. These types of patients tend to be older — in their 70s, 80s, and even 90s — and have other health conditions that make them worse candidates for open heart surgery.

Patients attesting to miracle outcomes with TAVR are not hard to find in news stories on the Internet.

But a new study suggests that such stories may have served to build unrealistic patient expectations about the procedure.

More patients with ‘severe’ problems after TAVR

A piece on the cardiology news site TCTMD headlined “TAVR: Miracle for Some, but No Improvements in Quality of Life for Others” reports on the study, which looked at quality of life outcomes in 2,288 TAVR patients who underwent two different versions of the procedure. Quality of life scores improved in the study cohort overall after 12 months, and the number of patients reporting “no problems” increased for some measures such as mobility and the ability to do usual activities. So it’s clear that for some patients, this procedure has substantial benefits that some might even perceive as “miraculous.”

But that’s not the whole story — not even close to it.

As the piece cautions, “Many patients in both groups reported a worsening of their quality of life, especially in terms of pain/discomfort and depression/anxiety.” That decline is captured in the following graphic, in which the red bars represent the change in the percentage of patients who reported “severe complaints”  after a year with either of the two versions of the procedure — the transvascular (TAVR-TV; panel A) or transapical (TAVR-TA; panel B) approach.



Dr. Philippe Généreux, who is quoted in the piece, says:

“The bottom line is, if you’re not too sick or don’t have too many comborbidities … you have a chance to improve your quality of life. On the other hand, if you’re too sick already and you’re extreme risk and have other comorbidities such as frailty and other organ failure, your chance to improve your quality of life is extremely low [with TAVR].”

And that’s a problem, he adds, “especially with the family and the relatives who believe that you are going to fix everything and all the symptoms they have.”

Généreux reported financial relationships with Edwards Lifesciences, a device company, and the study itself was funded by a number of different device companies.

Where are the miracle stories coming from?

The impact that incomplete, imbalanced news reports have on patients and their families is a recurring theme in our work. These reports serve to stoke false hope that can lead to bad decisions and disappointment.

A lot of the miracle news coverage about TAVR seems to have its origins in promotional efforts by hospitals that offer the procedure.

For example this (possibly sponsored) piece in SuburbanLife magazine from Philadelphia, headlined “A Miracle Cure,” that talks exclusively to physicians at St. Mary Medical Center, “the first hospital in Bucks County to offer TAVR.”

Or this poignant video from Michigan Health, headlined “What they did to me was a miracle,” that profiles an 89-year-old D-Day survivor who received TAVR and the Michigan Health physician who made it possible.

It’s a heartwarming personal story and the patient is entitled to his belief that the treatment was “a miracle.” But we expect the health system to provide some context when it puts that miracle quote in its headline – context such as the data we presented above. Without that, the video feels like slick marketing from the data-free zone.

A physician calls for changes in hospital self-promotion

Not all physicians may realize it, but some are aware that these miracle patients are not representative of the broader experience with TAVR. At least one has openly decried the misleading use of these stories in hospital advertisements.

Eric Beam, MD, writing at KevinMD.com about a commercial he heard for a local hospital, calls the patients in these stories “outliers, selected to boast of the miracles the hospital is capable of. They do not represent the aggregate patient experience — nor are they meant to — and they do little to assist potential patients in making informed decisions about their care.”

What a customer really wants to know, and deserves to know, are the results for the average patient. How many 90 year olds have successful TAVRs at your hospital? What’s the readmission rate? What’s the one-year mortality? Five-year?

Evidence would suggest that things aren’t as rosy as this one commercial makes them out to be. Make no mistake: Performing a TAVR on a 90 year old is relatively safe, but it is not without risk. Strokes occur at twice the rate of those undergoing open surgery, and data shows that one in four TAVR patients die within a year, and more than one in three die before two years. Clearly, this is too much information to convey in a 30-second radio spot. But it is crucial knowledge for anyone considering such a major procedure.

The questions Beam wants answered are very similar to those we highlight in our 10 criteria. This is must-have information for journalists and news release writers to include in their writing about medical tests and treatments.

Beam goes even further, suggesting that hospitals should be held to a higher standard in any promotional activity, including advertisements.

He wants more evidence, fewer miracles.

“Perhaps if medicine approached self-promotion with data-driven realism rather than inspiring anecdotes, patients would be better informed, less frustrated and, ultimately, less afraid,” he says.

Can I get an “amen”?

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