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Though it may improve symptoms, minimally invasive heart valve surgery is not without risks

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2 Star

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Less-invasive heart valve replacement tied to better quality of life

Our Review Summary

This story reports a meta-analysis of 20 studies that measured functional and quality-of-life outcomes for patients who underwent a minimally-invasive procedure called transcatheter aortic valve replacement, or TAVR, to fix a narrowing of the aortic valve.

The story spells out several study limitations and included multiple expert perspectives. But, it may have confused readers because in several places it used medical terminology that relates to blood vessel surgery, not heart valve surgery. And, by not discussing risks or costs of the surgery, the story could leave readers with the impression that the surgery is low-risk and cheaper than alternatives.

 

Why This Matters

Aortic stenosis, a condition that decreases blood flow from the heart, occurs in about 2% of people over 65 years, according to the U.S. National Library of Medicine. In the last decade the introduction of minimally invasive TAVR procedures — which involve inserting a replacement valve in place of the damaged one via a catheter — have provided a treatment option for patients at high risk for open-heart surgery due to advanced age or other medical conditions.

Selection criteria for the procedure is expected to broaden to treat lower risk groups, according to the authors of this analysis, who say their review “provides evidence that benefits for functional capacity and (health-related quality of life) have been maintained.”

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There’s no mention of the cost. TAVR procedures averaged $55,136 in 2013, 8.4% higher than open-heart surgery, according to research covered by MedPage Today. TAVr procedures are more expensive due to the high cost of the device.

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

Not Satisfactory

While it can be difficult to report on a complex synthesis of data, more numbers were needed to give readers a sense of the scale of improvements patients experienced.

The story says after patients “could walk significantly further in six-minute walking tests used to assess their functional capacity. On average, they added almost 42 meters (138 feet) to their performance before” the procedure. But, according to the study appendix, this 6-minute walk statistic was based on only 4 studies and, more importantly, was not considered a clinically important difference.

The story also also says patients “reported clinically meaningful improvements in their quality of life and their ability to complete daily tasks after surgery.” But there is no data to explain how that was measured.

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

Not Satisfactory

The story portrays this procedure as minimally invasive and less risky than traditional surgery, but does not describe any risks.

Although TAVR is considered to be lower risk than surgeries that cut open the heart, it’s long-term durability is unknown because the procedure has only been approved in the U.S since 2011.

Minimally invasive TAVR is still risky. The rate of death within 30 days ranges from 1 to 4%, for example, and it increases the risk of a stroke or heart attack, in addition to other potential vascular and valvular complications, according to UpToDate.com.

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

Satisfactory

This is a strong point of the story, which says:

Overall, the current analysis included 2,775 patients from a total of 20 previously published studies on outcomes for this type of surgery. Participants were 82 years old, on average, and they were typically considered high-risk surgical patients due to either advanced age or other medical issues.

The smaller studies in the analysis ranged in size from 36 to 484 patients, and most of them followed patients for as long as six to 12 months after surgery. One limitation of the current analysis is that many of these smaller studies were not controlled experiments designed to prove whether or how transcatheter aortic valve replacement might improve quality of life, lead study author Nicola Straiton of the University of Sydney and colleagues note in Age and Ageing.

Does the story commit disease-mongering?

Satisfactory

No disease-mongering here. However, the story doesn’t give any idea of how common this condition is–which would have been helpful to include.

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

Not Satisfactory

The story quotes two experts who weren’t involved in the analysis, which is good. However, both have received payments from companies that make heart valves, according to CMS’ Open Payments search tool. Those connections were not disclosed in the story.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story discusses alternatives this way:

People who don’t get this type of minimally invasive surgery may instead get a more invasive procedure that involves surgeons cutting open the chest to repair a damaged valve.

Surgeons may also perform what’s known as angioplasty, which uses a catheter to insert a tiny balloon and inflate it to open the valve; sometimes surgeons will also insert a stent, or tiny wire mesh cage, to keep the artery propped open.

While this is an attempt to explain the other type of surgery, it uses terms that apply to heart vessel surgery, not valve surgery (“angioplasty,” and “keep the artery propped open.”)

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

Not Satisfactory

The story doesn’t discuss how widely available these procedure are.

Does the story establish the true novelty of the approach?

Satisfactory

The story helpfully quotes outside experts who say the analysis supports the idea that transcatheter aortic valve replacement can help ease symptoms and be a viable option even for elderly patients who tend to be at high risk for surgery.

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

Satisfactory

The story does not appear to rely on a news release.

Total Score: 4 of 10 Satisfactory

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