Monthly Archives: April 2012

The Importance of Pre-Procedure Discussions: Communication Between Patient and Physician and the Development of a Device Management Plan

Much has been written about the positive benefits of communication between patient and physician. Today, in the increasingly time-pressured medical work environment, physicians are pushed to see more patients in less time. Patients are moved thru clinics as if on an assembly line. There are fewer opportunities for conversation and many patients and providers never really get to know each other on a “human” and interpersonal level. Care often suffers due to the fact that the patient and provider are unable to really connect. The connection that develops when patient and clinician are afforded the ability to spend adequate time in consultation leads to a collaborative approach to disease management. Sadly, this is lacking in medicine today.

I recently blogged about the psychological effects of ICD recalls. In that blog I mentioned my use of Shock and Recall Plans with my patients in an effort to ease anxiety when these events do inevitably happen. I was fortunate enough to have comments and questions concerning these plans left by several highly engaged readers (some of which are ICD patients). This blog entry is in response to those inquiries. Much of my “plans” have been inspired by Dr Sam Sears who has done pioneering work in this arena.

Those of us who perform invasive procedures as a routine part of our practice are quite accustomed to having the obligatory “informed consent” conversations with our patients. There are legal and national standards for these conversations as well as institution-specific requirements. We must explain the procedure to the patient in words he or she can understand, we must explain the alternatives to the procedure and carefully go over the possible complications. After this discussion is completed, we must have the patient sign a legal document that verifies their understanding of the procedure they have just agreed to. Is this type of discussion applicable to any procedure? Is this discussion adequate? Is this truly informed consent? I would argue “No”. I would put forward the fact that we must go a step further, we must individualize consent and we must have discussions that address specific concerns that may be attributable to a particular procedure such as ICD implantation. For me, a key component in this discussion is to develop a Shock and Recall Plan.

What is a shock plan? Quite simply, a “shock plan” is a procedure that the patient and physician create to address what to do in the event of an ICD shock. A “recall plan” is a similar construct. In Circulation in 2005, Dr Sears et al. published a guideline for responding to shocks and developed a suggested plan. The plan consists of several parts:

1. Patient education: The patient should know as much as possible about their device. Access to data is paramount.

2. Data Control: Patient needs to have all relevant data in one place –device name and serial number, physician name and number, after hours on call numbers, list of medications and medical problems. ALL in one PLACE. Give a duplicate copy of this information to a friend or family member as well.

3. Action plan: This plan should be rehearsed and discussed with family. The Shock plan should be developed collaboratively. An example of a plan of action may be: Receive a shock > Feel fine > Call MD or transmit remote report OR Receive shock > Experiencing chest pain, SOB or other symptoms > Call 911 and seek medical attention. These plans may be individualized and reflect the particular needs of the patient. In addition, coping strategies for dealing with shocks can be discussed and rehearsed. These may include breath work, positive thinking and certainly post shock debriefing

A recall plan has very similar structure. Dr Sears published a manuscript in Circulation in 2009 addressing the Recall plan. Again, the plan is patient specific but centers on Patient education, Access to and control of relevant data, and development of coping strategies to deal with the anxiety related to a device advisory.

The key component in any of these plans is communication. Although not always easy and certainly not always an adequate dialogue, I try to spend time discussing these issues with my patients prior to implantation. Along with explaining the procedure and the possible complications associated with device implantation, I discuss the implications of living with an implanted device-namely shocks and recalls. During these discussions, we focus on the significant life saving benefits of device therapy as well as the downside of shock and recall. When shocks and recalls occur, we revisit these discussions in clinic and remind patients that knowledge and preparedness bring empowerment.

As an Electrophysiologist, I am fortunate to be in a position to provide potentially life saving therapy to my patients. However, with this privilege comes much responsibility. Part of the duty of any physician who performs procedures is to ensure that the patient is fully aware of the risks, benefits and alternatives to any invasive intervention. To meet regulatory requirements, we must provide informed consent at a minimum. To ensure that our patients are able to function at the highest possible levels post operatively, we must also spend time developing strategies to deal with the device implant long term. Communication between physician and patient is of paramount importance. The key to coping with shocks and recalls is simple. Knowledge, Access to Data, and Developing a Plan.

References: (These are “Patient Pages” and can be downloaded and copies placed in your ICD clinic or used in Patient support groups)

How to Respond to an Implantable Cardioverter-Defibrillator Shock Samuel F. Sears, Jr, Julie B. Shea and Jamie B. Conti Circulation 2005, 111:e380-e382

How to Respond to an Implantable Cardioverter-Defibrillator Recall Kari B. Kirian, Samuel F. Sears and Julie B. Shea Circulation 2009;119;e189

Psychological Impact of ICD Recalls: With Data there is Power, With Communication there is Healing

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 this week 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 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 by Sears, et al published 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 by Undavia and Mehta, et al 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 by Sears et al, 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).

Many thanks to the wonderful patients who have reached out to me and commented on my last blog post.  Because of you and your engagement, I was moved to write this follow up posting.  Through communication and engagement, we all become better at what we do, and in the end, provide better care for our patients.

Putting the Patient at the Center of the Device Recall

As most of the EP community is aware, device and lead recalls are a reality in today’s EP practice. In the last 5 years, both Medtronic and St Jude medical have had significant lead failure issues. The public responses to these recalls have been varied and quite different. As physicians who care for device patients, we must learn to quickly sort through the rhetoric put forth in the New York Times and other media outlets and focus on what is most important–our patients. Certainly, for-profit companies are going to have strategies for handling the “business” aspect of the recalls and we as clinicians must not be distracted by any of the battles we may see in the press. Our job is to provide superior care for our patients. We must analyze the available data and collaborate with industry and the FDA to determine what actions must be taken to keep our patients safe in face of lead or device recalls or advisories.

Recalls and advisories may affect our patients in many ways. Certainly there is the obvious direct biologic and medical risks and complications associated with a particular advisory. However, there is a great deal beyond the concrete medical complications. There is a growing body of published medical literature that examines the psychosocial and emotional effects of device therapy. One of my colleagues, Dr Sam Sears is one of the most well published in this arena. We must consider the emotional and psychosocial effects that these recalls and advisories may have on our patients. Many of these issues may need to be addressed with counseling sessions, support groups and psychotherapy. We must not underestimate the impact that emotional stressors can have on our patient’s overall health.

So, we know that recalls and advisories are a reality. We know that different industry leaders are going to have different responses and that the press is going to sensationalize the stories. The industry response is likely what the particular CEO or executive leadership team feels is in the best interest of their company and their shareholders. To us as physicians caring for patients, that response should not even be relevant. WE must respond in a way that puts our patients first. WE must address both the immediate medical issues as well as the potential longer lasting emotional and psychological needs in a patient-centered manner. WE must put the patient at the center of any device recall and let the guys in the suits on wall street manage their company and their own recall response.