In the essay, he reviews two opposing views on the industry handling of this recall, one published as a perspective piece in the New England Journal of Medicine by Robert Hauser, MD, and the other, a rebuttal piece published by St. Jude Medical's Chief Medical Officer and Senior Vice President of Clinical Affairs, Mark D. Carlson, MD. The article reviews the engineering changes made to the Riata line of leads in its evolution to the Durata defibrillator leads and expresses clear concerns about disclosure of all available information regarding lead characteristics to implanting physicians.
This piece is a must-read for electrophysiologists and industry personnel involved in the care of these complicated patients. Schloss concludes:
Anyone who has been in the business of cardiac rhythm management has struggled with the problems of device failures. Because most of these only occur years after FDA approval, having a system for early detection of excess or unique failures is critical.Go now. Read it all. You will learn something.
Industry response to these failures is also critical. Clear, honest acknowledgement of the problem is essential. We also need quick action to define the scope of the problem and create an action plan. These measures go a long way to maintaining the confidence of everyone involved, including, but not limited to, physicians, hospitals, patients, and the investment community.
Every time we, the implanting physicians, implant a medical device, we are taking a measured risk that must be outweighed by its benefits. Understanding this true risk, especially in newer devices, is extremely difficult. By becoming a student of the engineering process of these devices, we can become better equipped to make good decisions for our patients.
We are only now learning the scope of the problem with Riata and Riata ST. The lead mechanical failures and externalizations of this lead may only first occur four to five years after implant. Since Durata leads are only now approaching that interval, it is not surprising that we have not seen many troubling signals with this lead. It remains to be seen what the future holds. Until we have longer experience and collect more data, it us up to individual doctors to educate themselves with available clinical and engineering data so they are equipped to make good decisions.
PS: John Mandrola, MD, a co-editor of Dr. Schloss's piece, also offers an excellent overview of concerns that confront electrophysiologists regarding the Riata/Riata ST lead recall over at theHeart.org.