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

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 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.