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Inventor says new heart catheter will save lives

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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