Our patients live with the fallout of a device recall

In the last several weeks there has been much discussion concerning the St. Jude Medical Riata lead Class I recall.  Prior to the Riata , there was the Medtronic Sprint Fidelis lead recall.  Prior to Fidelis, there were multiple recalls involving Guidant (now Boston Scientific) devices.  The common thread to all of these recalls is our patients.  Our device patients have endured all of these events.  How exactly does the recall of an implanted device affect those that we work so hard to care for?

I blogged earlier about the recall and how we should focus on the patient and not the device industry.  I was really fortunate to be contacted via social media by several device patients from all over the country.  I received very pointed feedback about my blog posting.  It is abundantly clear to me that we, as clinicians, have a poor understanding of just how our patients may react to recalls and advisories.  Our patients are well informed, sophisticated and web savvy.  Our patients want and deserve answers–from us, from industry and from the medical system as a whole.  Our patients deserve access to the same data that we, their providers, have access to.   Our patients trust the system, trust the device to protect them from sudden cardiac death, and trust us to give them the very best care available.  My discussions with the patients who responded to my blog post via social media outlets were quite sobering and I believe will make me a better electrophysiology (EP) physician in the long run.  I write this blog in the hopes that I can share some of these insights with my colleagues across the country.

In response to a recall, Expert Consensus Committees are often formed.  Industry begins to self evaluate and leverage the event with their competitors in the market.  The FDA takes a look at just how devices are approved–all in an effort to reduce future adverse events.  Although EP clinicians have worked feverishly to determine the best way to handle the recalled devices and leads during these events, very little has been done to examine the ways in which these recalls affect the psychological health of our patients.  From the outset, the implantation of a cardiac device has an immeasurable psychological affect on patients.  Dr Sam Sears, a brilliant colleague of mine in North Carolina has extensively studied the psychosocial impacts of ICD therapy.  The implantation of a device is a significant event in the lives of our patients.  In one review in Clinical Cardiology in 1999, 13-38% of patients with an ICD were found to have clinically relevant diagnosable anxiety (excessive worry, psychological arousal). Depression was seen at rates similar to other cardiac populations.  Often these patients (particularly primary prevention patients) are making a choice between fear of a disease and its complications (including death) and fear of a procedure that may result in post implant complications, shocks, device malfunctions–all causing stress and anxiety.

A study published in Pacing and Clinical Electrophysiology in 2008 examined these specific psychological impacts of recalls.  In this study, 61 recall patients were compared to 41 controls with HADS (Hospital Anxiety and Depression Score) and a Quality of Life Measure.  Not unexpectedly in this analysis, the patients with a class 1 recall had a lower quality of life as compared to control and both groups had a reduced trust in the medical system.  However, not all patients respond the same way to recalls.  Those with prior negative experiences such as inappropriate shocks, tended to have a more negative response.  In another study in the American Journal of Cardiology, the response to recall was evaluated and found that risks for poor psychological response to recall with increased anxiety included age<50, prior shock, and female gender.

So, recalls are a big deal.  They are a big deal to the FDA, to physicians and to industry.  Most importantly they are a big deal to patients.  Our patients live with the fallout of the recall.  Patients have measurable psychological responses to recalls–as should we all.  The key to successfully navigating the recall mess is communication.  A plan for recall action should be in place prior to implant.  This should be discussed with the patient and family from the very beginning.  Just as implementing a “shock plan” for my patients in my clinic helps to empower them to deal with the ICD shock in a calm, controlled and prepared way–making a Recall plan just makes good sense.  During the recall, there may be some solace in the fact that the patient and his provider have discussed the possibility of an advisory and have a plan in place to deal with it before it happens.  With data there is power.  ICD patients should have access to all available data. Period.

It all goes back to what makes us good doctors in the first place — care, compassion and above all communication during times of illness (or recall). Through communication and engagement, we all become better at what we do, and in the end, provide better care for our patients.

Kevin R. Campbell is a cardiac electrophysiologist who blogs at his self-titled site, Dr. Kevin R. Campbell, MD.

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  • http://twitter.com/JjrkCh Joleen Chambers

    Thank you for posting on this topic.  On April 27 and 28 FDA is conducting a public meeting with the Orthopaedic and Rehabilitation Medical Devices panel to discuss the metal-on-metal hip implants that fail early.  I hope that doctors will come and stand with harmed patients. See my blog http://fida-advocate.blogspot.com/  What doctors can do is partner with patients to pass updated federal public policy legislation that protects patients by reducing the number of failed devices that reach the market.  Patients with failed devices did trust the system, but the system failed.  They live in medical and legal purgatory so depression and anxiety are clinically engineered and a normal human reaction to medically induced traumatic stress.  To change the system,  doctors/hospitals must demand that purchase of an implanted device includes independent post-market data collection that is accessible to the consumer and researchers.  This would be a safety check for the industry.  Patients know that reliable clinical studies of implants are nearly impossible to provide.  Be honest with them.  If their best option is to be a guinea pig, tell them.  Remove the false promise of FDA ‘approval’.  Patients want to be cared for if a device fails.  They do not want an ugly court battle, but currently they are placed in direct opposition to their caregivers when an adverse event occurs and the legal system is not an antidote.  Working together for more transparency and accountability of the device industry will heal the patient/doctor schism. 

  • http://twitter.com/DrKevinCampbell Dr. Kevin Campbell

    This post was authored by me, Dr Kevin R. Campbell, it is incorrectly attributed to an author Dr Kevin Bernstein.  Likely a typo.

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