This story reports on the use of customized stents and 3-D mapping to treat abdominal aortic aneurysms, which are enlargements of the lower part of the aorta, the major blood vessel that supplies blood to the body.
The story provides no data to back up the claim that this procedure reduces complications, saves more lives, and results in quicker recoveries compared with stent procedures that don’t have these features. It also doesn’t mention how much this technology costs and engages in disease-mongering.
In the U.S., medical devices may be used in patients before anyone knows if they’re safe or effective. Too often, news stories on new devices leave out this reality. In this case, this story focuses more on one patient’s harrowing story, and high-tech buzzwords like “personalized” medicine and “3-D printing.” The reader won’t come away informed about the benefits, risks, costs and alternatives.
There’s no discussion of how much this procedure costs or whether it’s covered by insurance, and no comparison with stent procedures that don’t include the 3D printing and customized fit.
Actual data is nowhere to be found to back up the assertion that this technique saves lives and results in quicker recoveries than other treatments, and it’s not clear what the procedure is being compared to. Instead, there’s one patient anecdote with an unsubstantiated statement that her condition “nearly killed her.”
Ideally, the story should have made clear what data, if any, compares these customized stents to standard stents.
There’s no mention of potential risks associated with this procedure or any stent insertions for abdominal aortic aneurysms. Further, there’s no discussion of whether the procedures and devices involved have undergone safety trials.
There’s no discussion of the quality of evidence to support this procedure. Was there a randomized clinical trial? It doesn’t say.
The story is rife with fear-mongering. The video states that 200,000 patients have abdominal aortic aneurysms and calls it a “death sentence” and a “ticking time bomb.” The printed version said it is “a hidden, often deadly heart condition with no clear known cause” and “can be immediately life-threatening if it grows large enough to rupture. The chance of survival when it ruptures is less than 10 percent.”
The story doesn’t make it clear how many people with this condition are really at risk of dying. According to the CDC, aortic aneurysms were the primary cause of 9,863 deaths in 2014 and a contributing cause of at least 17,215 deaths in the U.S. in 2009.
According to the Mayo Clinic, “Some aneurysms will never rupture. Many start small and stay small, although many expand over time. Others expand quickly. Predicting how fast an abdominal aortic aneurysm may enlarge is difficult.”
The article also doesn’t mention risk factors, which include tobacco use, family history, hypertension, and prolonged alcohol use.
It’s also unclear why the story calls abdominal aortic aneurysm a “heart” condition; it’s a vascular condition, meaning a condition affecting the body’s system of arteries and vessels.
One of the sources, Gustavo Oderich, MD, has reported being a consultant for Cook Medical and W. L. Gore, both makers of endovascular grafts. The story did not disclose this.
The story isn’t always clear about whether it’s comparing the 3D technique with open surgery or with stent procedures that do not use the technology. In any case, there’s no data to make the safety and effectiveness distinctions clear.
The story says “doctors sometimes use a stent to repair the aorta, but it doesn’t always work since the aneurysms are often in places where a stent can’t fit. And even if the stent does fit, patients often undergo a long, painful recovery.” It says, “Using a minimally invasive endoscopic vascular surgical technique, patient recovery times are quicker.”
The story also does not make it clear that not every case requires surgery. According to the Mayo Clinic, “Depending on the size and the rate at which your abdominal aortic aneurysm is growing, treatment may vary from watchful waiting to emergency surgery. Once an abdominal aortic aneurysm is found, doctors will closely monitor it so that surgery can be planned if it’s necessary. Emergency surgery for a ruptured abdominal aortic aneurysm can be risky.”
The story states: “So far doctors at Mayo Clinic have done this personalized procedure on more than 450 patients. They are now training doctors nationally.” It’s not clear how many doctors are being trained.
Also, we’re assuming they’re referring to the 3-D printing aspect of this procedure. But regarding the endoscopic procedure, it’s not clear how widely available it is. It’s also not clear if this custom-printed device is still being tested in clinical trials.
The story explains that the approach allows a surgical team to “create an individualized model of the patient’s aorta.”
“Each anatomy of the patient is different and that’s the problem, that’s why we need stents that are actually specific for the patient,” it quotes vascular surgeon Dr. Gustavo Oderich, MD, saying. “The 3-D prints are used to rehearse the operation. We can anticipate challenges by practicing the procedure beforehand.”
The story does not appear to be based on a news release.