Archives for November 8, 2003

Stapler Scapegoated in Death

Stapler cited in gastric bypass death

DURING THE course of a standard laparoscopic gastric bypass surgery, a widely utilized staple gun apparently malfunctioned, leading to a significant complication, Brigham and Women’s Chief Medical Officer Andy Whittemore said in statement released by the hospital. The relationship of that complication and her ultimate death remains at present unclear.
(the patient), a 37-year-old woman from Lawrence, Massachusetts, died two days after the Oct. 21 surgery, which involved reducing the size of her stomach.
While the cause of death has not been established, the hospital is working with the family to fully understand all issues bearing on her outcome, the hospital said in the statement.

Hmmm. The article doesn’t say when the ‘stapler malfunction’ was recognized, but it seems odd they’re pushing it so hard as the cause of the patients’ death.

I’m not a surgeon, and I’m fortunate in that there are very few super-fancy medical devices used to directly treat my patients, so I don’t have to worry a lot about how to recover from gadget malfunctions.

As I recall from my surgical intern days, a GIA (GastroIntestinal Anastomosis) stapler is an alternative to a hand-sewn anastomosis; the stapler does it quickly, with a nice, pretty row of staples, and it’s quick; a hand-sewn connection requires more time. I’ll let surgeons educate us as to which has the higher complication rate (Cut-to-Cure, that’s your bait). (Aside: I know one surgeon whose practice is largely gastric bypasses, and even laparoscopically does hand-sewn anastamoses. Quickly.)

Seems that this hospital is working hard to pin the blame on the hardware, but the surgeon is ultimately responsible. Captain of the ship doctrine, and all that. The only time that there should be some shared blame is when the equipment malfunction cannot be discerned until later.

This blame-shifting is unseemly. I think if my company sold GIAs it’d be a hell of a long time before Brigham & Women’s got any of my hardware.

Plaque Reducing Drug

“Liquid Drano&reg for the arteries”
In this MSNBC story, there’s a promising report of a very preliminary study of a drug that shrinks cholesterol plaques:

In the study, 36 patients who had had heart attacks or severe chest pain received weekly intravenous infusions of the substance for five weeks. Eleven patients received dummy treatments.
At six weeks, imaging tests showed the patients receiving the synthetic protein had a visible 4 percent reduction in plaque buildup in their coronary arteries. There was no significant change in the placebo group.

The study was funded by Esperion Therapeutics Inc. of Ann Arbor, Mich., a small biotechnology company that makes the product.

Espersions’ website says they have 4 different engineered molecules in testing, so it’s not clear which one worked in this study.

A 4% reduction in a plaque may not seem like much, but that’s a big change over 5 weeks. It’ll be interesting to see whether a longer-term treatment changes the rate of plaque reduction.

Also, the unintended consequences will need evaluation, as well. The cholesterol is transported to the liver ‘for elimination’, which is normally how it’s done. However, rapidly sending this much cholesterol to the liver could have interesting side-effects, like an increase in gallstone formation, for one thing.

But, this is an interesting breakthrough. Let’s hope it pans out.

Some business evals of Esperion: Forbes and Yahoo.