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Inventor says new heart catheter will save lives

 

If all goes well for award-winning Plainfield inventor Matt Reavill, his new device will help save lives, decrease health care costs — and employ disabled veterans to boot.

 

Reavill won a prestigious contest in London late last year called the OmniCompete Health Pitch Battlefield, whose independent judges said his invention is a simple way to catheterize the heart. It reduces risks to an “absolute minimum” by moving the catheter insertion to the arm, the judges said, replacing a complex wire-guided procedure through the neck, which is typically used to monitor the heart during a hospital stay for very ill patients.

 

 

His breakthrough was also chosen by hospital-based clinical experts to participate in the 2010 Innovation Celebration, a national program run by Premier, a hospital-owned group purchasing organization. Premier Chief Operating Officer Mike Alkire says the products selected have the potential to improve safety and quality while cutting the cost of health care.

 

Reavill plans to hire 13 to 20 disabled vets to get the production off the ground — with the goal of hiring up to 18,000 if the device goes national. He recently procured a bank loan agreement and is hoping the award recognition and hospitals’ willingness to try the catheter will attract a venture capitalist.

 

Called the ReavillMED CV, the Food and Drug Administration-cleared device includes a catheter called a PICC line, IV tubing that sheathes it to provide sterility, and a transducer that can directly measure blood pressure to help determine needed fluid levels. The catheter is inserted into the arm and travels to the heart within 20 to 30 seconds via the bloodstream. Traditional heart catheterization through a vein in the neck can take 20 minutes or longer.

 

Reavill likes to say it’s “stupidly simple” because the individual parts have been around for decades, but no one had thought of this particular configuration before.

 

“It’s old technologies put together in a different way to enable established medical treatments to be done earlier,” Reavill says.

 

It remains to be seen whether that saved time will result in saved lives. But because it’s self-contained, the catheter theoretically should provide little margin for contamination that can lead to infection. It can be inserted in a nonsterile environment such as an emergency room.

 

In 1994, Reavill says, his father survived a complicated angioplasty with a high mortality rate, only to die three weeks later of a staph infection that was caused by a central line catheter inserted into his heart through a neck vein.

 

A venous heart catheter inserted through the neck, the traditional approach, requires painstaking preparation of the insertion area and a “pseudo-operative field,” says Dr. Andrew Dennis, attending surgeon at Stroger Hospital’s trauma and burn units and a clinical researcher.

 

Dennis believes the ReavillMED CV shows a “tremendous amount of promise,” and he wants to test the first 50 catheters Reavill can provide. If the device lives up to expectations, the hospital will probably use it in patient resuscitation, Dennis said. He also plans to research whether quicker central venous catheterization improves patient resuscitation efforts.

 

Dennis adds that the catheter could prove useful in patients with sepsis, or blood poisoning, which strikes about 750,000 Americans every year. Of those, between 28 and 50 percent die, according to the National Institute of General Medical Sciences.

 

“Once a person presents with septic shock, the catheter is an early aid that can guide the way a patient is managed,” Dennis says. “You get an objective number and it becomes less art, less gestalt and more evidence-based.”

 

Southern Illinois Healthcare, a three-hospital system that is considering use of Reavill’s catheter, has a team of specially trained nurses who install catheters in the neck, says Dr. James Miller, chief medical officer. The nurses have a success rate in the “high 90s,” Miller says, but “very few” hospitals have devoted the time or resources to create the discipline.

 

Reavill says he may be proudest of his intention to hire disabled veterans in southern Illinois, a hard-hit region economically. He plans to bear the cost of any prostheses the veterans need to work on the catheters.

 

Reavill grew up on a pig farm in Robinson, in southeastern Illinois, and attended Southern Illinois University, which is supporting the development of the device.

 

“My wife’s family is from southern Illinois, too, so it’s home,” Reavill says.

Rating

2 Star

Inventor says new heart catheter will save lives

Our Review Summary

We understand that a newspaper would find it interesting to report on the human interest angle of someone who grew up on a pig farm who won an award for his invention and who hopes to hire disabled veterans to work on his invention.

But a health story – so categorized by the Chicago Tribune – that includes claims about saving lives, reducing risks to an absolute minimum, and decreasing health care costs – needs to provide some evidence to back up such claims.

This story didn’t deliver that evidence.  It was an impressive job of cheerleading, though.

 

Why This Matters

The compelling human interest angle of the story shouldn’t deceive any reader into thinking that this “breakthrough” approach can do what the story claims it can do.  Maybe it can.  But we urge journalists to take a more evidence-based approach to such claims – even in a human interest story and certainly in one in the health section.

The use of a peripherally-inserted catheter to measure central venous pressures is not new and has been studied for more than a decade (see Crit Care Med 2000 Vol. 28, No. 12).  While some would argue that using the arm as an access site is preferable, there are no studies to back up that claim. It might be easier to do and not require the skill level of a neck insertion but the catheter ends up in the same place and shares all of the liabilities of any central venous catheter. (By the way, central venous pressure measurement catheters end up in a blood vessel and not in the heart as described in the story.)

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There is no discussion of how much the “breakthrough” approach will cost.

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

Not Satisfactory

The story states that the catheter:

  • “will save lives” (it says this in two places but later says “It remains to be seen whether (it) will result in saved lives.”)
  • may “decrease health care costs”
  • “reduce risks to an absolute minimum”

But there isn’t one piece of data – of evidence – presented in the entire 718-word story.  That’s not a short story these days – so there was plenty of space afforded.

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

Not Satisfactory

There was no discussion of harms in the story. Placing a catheter into the central circulation and measuring pressure is not without the potential for harm.  Although the risk of a catastrophic rare neck artery puncture may be avoided with the use of the arm approach, the risks of misplacement and infection may not be reduced.

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

Not Satisfactory

There was no discussion of evidence – yet the story provides a clue about why.

Late in the story, a doctor is quoted saying that “he wants to test the first 50 catheters” that the inventor can provide.

Does that mean there’s no clinical evidence yet? For an approach that the story says “will save lives…decrease health care costs…reduce risks to an absolute minimum” ???

In reality, the device was approved by the FDA under the assumption that it is not all that different from existing devices commercially available.

Does the story commit disease-mongering?

Not Applicable

Not applicable.  There wasn’t really any specific discussion of any condition.

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

Satisfactory

The story at least turns to two physicians who are considering use of the catheter at their hospitals.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Venous heart catheters are mentioned – but no meaningful comparison was made with the new approach – again, because no evidence was provided. It is actually somewhat disingenuous to claim superiority of a new device that was approved by the FDA under a 510K premarket approval process – which is predicated on the assumption that the device is not significantly different than existing devices already on the market.

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

Not Satisfactory

Not clearly explained.  Is anyone using this catheter clinically right now?

Does the story establish the true novelty of the approach?

Not Satisfactory

Peripherally-inserted central venous catheters for drug and fluid delivery as well as pressure management is not a new concept. This wasn’t discussed at all in the story.  While there may be advantages to the use of the arm for access, there are also potential disadvantages.  While controversial, some studies have suggested that many patients in shock would benefit from a pulmonary artery catheter (usually inserted in a neck vein) that allows doctors to have a better understanding of a patient’s blood volume and performance of the heart.  While a pulmonary artery catheter takes time and skill to place and interpret, the debate about which approach is best is ongoing.  This story didn’t reflect the debate – making the inventor’s approach seem like a slam dunk.

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

Satisfactory

Because other sources were quoted, it does not appear that the story relied solely on a news release.

 

Total Score: 2 of 9 Satisfactory

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