Thursday, April 12, 2012

When Medical Device Children Behave Badly

The St. Jude-MDT smackdown on the Riata lead performance continues. (For some background, here's my original post).  

After seeking a retraction of Robert Hauser, MD's paper that identified 22 deaths from the Riata lead in the Heart Rhythm Journal,  St. Jude's attempt to secure the retraction of the peer-reviewed paper that was released electronically is rebuffed by the journal's editor, Doug Zipes, MD: 

“I have no knowledge of their data and therefore cannot accept a statement from them to contravene the results from the peer review process,” Zipes said.

Next, St. Jude offers their side of the causes of the deaths in a letter from their medical director.  This letter was helpful but still leaves questions regarding the leads' long-term reliability.   

And then St. Jude issues yet another press release that displays 377 deaths from Medtronic's Sprint Quatro lead on their website.  The reader is left to wonder why.  It's almost like a scene from Keeping Up With the Kardashains, where they just can't stop their incredulous foot stomping.

St. Jude acknowledged years ago there there were problems with this class of defibrillator leads.  To those of us in practice, it is not suprising there are problems with these same leads now.  If fact, we continue to find new clinical challenges when managing these leads.  We are concerned about at least one case report (to be presented at HRS this year) of device defibrillation failure from multiple high voltage shocks supposedly delivered through a high voltage lead impedance of 0 ohms.  Why St. Jude continues to suggest that their pulled Riata leads really aren't as bad as claimed seems incongruous with their professed need to recall them.

Electrophysiologists and patients need more credible information about the likelihood of failure of these leads and ways to follow patients to prevent further deaths.  New softare upgrades to provide eaarly warning alerts, registries, or updated recommendations regarding the routine follow-up of these leads would be welcomed.

What we don't need are more media temper tantrums.  This problem is hard enough without having to endure the spin.


1 comment:

Anonymous said...

Amen. I remember when I was told by a St. Rep that their perforations were the result of physician implant technique while the quietly pulled the lead from the market and replaced it. Now they are playing a blame game and trying to distract people from their problems by pointing out other companies past problems. I have stopped using St. Jude -- I just don't trust them.