Tuesday, February 14, 2012

The Riata ICD Lead Recall: Two Perspectives

Robert Hauser, MD published a perspective piece in the New England Journal of Medicine today entitled "Here We Go Again — Another Failure of Postmarketing Device Surveillance." In the piece, he offers these suggestions on how to detect these failures earlier:
Opportunities have emerged for automated tools to prospectively monitor multicenter device databases for early, low-frequency adverse events and to compare suspect devices with established products that have been shown to be reliable.(4) The goal is a postmarketing surveillance system that not only detects device problems early but also accumulates the data needed to guide patient care. Until such a system exists, St. Jude Medical should initiate a study with these attributes for recalled Riata and Riata ST leads and for the currently marketed Durata leads. Indeed, all manufacturers should conduct postmarketing studies of this type for marketed class III devices that sustain or support life.

It has been 3 years since the FDA launched the Sentinel Initiative, as Congress, in 2007, directed it to do.(5) The intent of this new system is to supplement the current passive adverse-event reporting with an active, real-time network capable of identifying any safety or efficacy issues soon after a new drug or device is marketed and then communicating the information in a timely manner to health care providers and the public. Creating such a system is an ambitious undertaking, and the initiative aims to gather electronic health data from 100 million people by the end of 2012. Formidable challenges lie ahead, such as setting priorities, developing analytic tools, and deciding when and how to alert the public if a safety signal is detected. Thus, we are years away from a fully operational Sentinel Network.
Jay Schloss, MD offers another thoughtful perspective on this issue in his guest post over on Cardiobrief:
It is worth noting that all high impact device failures in the cardiac rhythm device industry have occurred well after device approval. In most cases, failures have been rare events occurring many years after these devices became clinically available. The industry is littered with high profile device failures, some of which serve now as footnotes or memories from the more gray haired members of the EP community: Medtronic polyurethane pacing leads, Ventitex Cadence ICDs, and Telectronics Accufix pacing leads were all devices that failed well after they had been introduced to the market. It was through case reports from concerned doctors – not the FDA — that these problems were brought to light.

Trying to absolutely prevent the failure of medical devices through the FDA approval process would be challenging to say the least. This would require an anticipation of the potential failure mechanism before the fact to design a study that would detect said defect. Moreover, the number of patients and length of study for these trials would be daunting, impractical and quite likely prohibitively expensive.

Hauser’s call to enforce a robust active postmarket surveillance system would allow ongoing innovation and appropriately timed approval of new technology. With the ability to carefully monitor a large population of approved devices “in the field,” sentinel failures could be detected and acted upon as they occur. With public reporting of these events, doctors could draw their own conclusion of whether to keep implanting these devices and prospective studies could then be designed promptly to determine the scope of the problem. That would be a system that protects patients while still allowing innovation.
Neither author mentions how their approaches might be funded. Nor is there a clear consensus on how to determine a threshold for sounding a recall (or "advisory"). Should it be announced before a root cause of the problem is known or suspected, or after? Pulling a recall trigger too early before a root cause of the defect is identified leaves doctors and patients completely in the dark about how to manage these complicated situations. These issues are still debated today.

What is clear, though, is that the efforts to prevent such widespread recalls continue and doctors (as shown by these two perspectives) remain eager to participate in the process.



Anonymous said...

In the late '80s, NASPE (HRS) and the Cleveland Clinic organized an all day program to consider a plan proposed by Dr Bruce Wilkoff to organize a national lead registry. Industry largely agreed to fund the registry and each company would have access to the data on their products. A physician review board would oversee the registry and, most importantly, standardized definitions would have been developed on what and how to measure lead performance. There was great consensus among physicians, industry and even the FDA staffers in attendance that this could and should be done. The plan however never got out of a NASPE committee organized to make it happen. Most of what was agreed to at the Cleveland Clinic meeting became the framework for the Medtronic prospective lead registry (System Longevity Study) and the FDA's proposed, mandated long term lead monitoring requirement. The latter was never fully implemented by the FDA however because, lacking an industry wide, standardized registry, the FDA was left to negotiate a registry program with each individual company. Think how valuable the registry would be today if it had been implemented 25years ago.

Anonymous said...

Despite St. Judes claims, they don't have the most robust monitoring system. I think Medtronic used Carelink to predict Fidelis survival and that data preceeded the mentioned longevity study in showing the problem. Maybe the Riata/Durata failure mechanism won't show up on Merlin but they don't seem to be trying to help us or exploring that. with so many patients on remote management systems manufacturers should be able to easily report and contribute collective lead performance.

Anonymous said...

I appreciate your follow-up on this issue. I'm an ICD user (with a Durata lead) who's seen these articles and read the St. Jude response to the orignial NEJM article. Like a lot of other ICD users signed up in the last two or three years, I'm a primary prevention person who was persuaded that an ICD was the responsible choice -- for me, my family, etc. -- without any emphasis, if mention, of a) "this is a lifetime choice" and b) if your device malfunctions, which it well might, you'll be physically blown across the room and, afterwards, by the way, you'll deal with the psychological consequences all by yourself. What I mean is that faith in technology really does collide with reality for ICD users. God bless us all -- I only hope I can get rid of the rotten ICD if it doesn't work.