Hot Topics in Today’s EP Lab<br />

What are your thoughts about non-EPs implanting ICDs? Do you train such individuals? What about dealing with device recalls? New York Presbyterian Hospital, Columbia University, New York, April 2007: Device recalls: We ve instituted more frequent follow-ups in this population and followed the manufacturers guidelines for recall. Each patient was assessed individually by the attending physician involved, and those patients deemed pacer-dependent or high risk for frequent ICD treatment underwent explantation and replacement of the pulse generators. Hershey Medical Center s Penn State Heart & Vascular Institute, Hershey, Pennsylvania, March 2007: Non-EPs implanting ICDs: To implant an ICD takes skill and dexterity. Many non-EPs can learn the skill of implantation; however, implanting an ICD is only a small facet of patient care. What about programming, setting proper parameters, and administering appropriate anti-arrhythmic therapy? To me, it is continuity of care if my electrophysiologist implants the device and is there more follow-up care if needed. Therefore, we do not train non-EPs for ICD implants. Device recalls: In the past few years, recalled devices have been troublesome. We usually followed the vendor s recommendation on each separate recall. We notified the patients, gave them our recommendation, and let them decide. University of Pennsylvania (Penn Presbyterian Medical Center), Philadelphia, Pennsylvania, February 2007: Non-EPs implanting ICDs: We do not train those individuals. I believe that the device companies will do whatever it takes to sell more devices. Having non-EPs implant ICDs would absolutely benefit the device companies. However, I think the device companies will implement preset modes that will allow non-EPs to program the devices safely and effectively. I do believe that EPs are definitely more knowledgeable when it comes down to managing difficult patients. The question is, how will you know what patient will be the difficult one? As with any new changes, I think initially there may be some issues if non-EPs implant ICDs. As long as those issues are minor and are not life-threatening, I think we will see non-EPs implanting ICDs. However, I do not think this will happen soon. One of the things that will keep this from happening in the near future is the recent defibrillator recalls; these recalls have put the companies under the microscope as of late. Until this settles down, I don't expect any major changes from the device companies. Device recalls: We explanted certain devices. It has been a very difficult situation for all of us. Patients today are more informed due to the abundance of media sources available. We carefully discuss the situation and options with patients and referring physicians. We try to answer as many questions as possible. We strictly adhere to the published guidelines. Some physicians avoid putting in devices that are from companies that have had major recalls; their rationale is that they can avoid dealing with the problem completely if they do not implant those devices. Many of the doctors also report spending most of their clinic time discussing the recent recalls. Spending time discussing the recalls can limit the time that physicians and patients can discuss their clinical issues. Nebraska Heart Hospital, Lincoln, Nebraska, December 2006: Non-EPs implanting ICDs: We have several cardiologists and cardiovascular surgeons who routinely implant pacemakers, and would consider training them to implant ICDs. However, at this time, we have no plans to train non-EP physicians for implanting ICDs and biventricular devices. Device recalls: Our vendors have been very generous in offering our physicians the freedom to choose what is best for patients when a device has been recalled. We have electively replaced most of these devices in our practice. Huntsville Hospital, Huntsville, Alabama, November 2006: Non-EPs implanting ICDs: We feel that in locations where EP physicians are available they should be performing the implants. We would be willing to train individuals under appropriate circumstances; however, in general, currently designed scenarios emphasizing brief hands-off training do little to actually advance competency. Device recalls: We approach these on a case-by-case basis. Oregon Heart & Vascular Institute, Eugene, Oregon, September 2006: Non-EPs implanting ICDs: This is of course a very controversial issue. We did train one such individual, a very skilled implanter in a neighboring town, for where there is no electrophysiologist available, and he has done well. One of our general cardiologists here also implants BiVs pacemakers, but not ICDs. Generally speaking, I think it is reasonable for non-EPs to implant ICDs, if certain conditions are met, primarily with respect to training, and perhaps more importantly, follow-up. My suspicion is that most of the problems associated with non-EPs implanting ICDs are related to appropriate patient selection and follow-up, rather than technical aspects of the implantations themselves. Device recalls: We have been conservative in our management of these; generally speaking, if the mode of failure of the device is thought to be loss of pacing output, in patients who are pacemaker-dependent, we have replaced these devices. In patients who are not pacemaker-dependent, we generally just follow up with them a little bit more closely. For ICDs, if the mode of failure is lack of shock output, we have replaced these if patients have required frequent shocks; however, if that was not the case, we have sometimes simply monitored these patients more closely. Basically, we have taken an individualized approach and tried to balance the risks of device replacement (in particular, infection), with the risks of leaving the old device implanted. Robert Wood Johnson University Hospital, New Brunswick, New Jersey, July 2006: Device recalls: Each recall is specifically addressed by the Cath Lab Administration, Risk Management, Materials Management, Senior Management and physicians. The decision to replace a device is specifically left up to the patient s electrophysiologist. Carolinas Medical Center, Charlotte, North Carolina, June 2006: Non-EPs implanting ICDs: EP cardiologists perform the majority of implants. Our thoracic surgeons collaborate with the EP cardiologists with sub-pectoral and epicardial implants and lead extractions. One of our general cardiologists developed an interest in pacemakers and ICDs during his training. He passed the HRS exam and was mentored by his EP colleagues. This individual now has privileges to implant devices, and does so with great success. Device recalls: The cath labs and Materials Management Administrations along with the physicians are notified by the company of the recall details. The appropriate assessment is performed and decisions are made regarding the course of action to be taken. Overlake Hospital Medical Center, Bellevue, Washington, March 2006: Device recalls: The two major device recalls in the last year have been taxing on our material, finance, and compliance departments. Separate charge master entries had to be created to indicate replacements without cost. Recently, the CMS FB modifier has been added to signify replacement items. Beginning in April, we will add Condition Code 49 or 50 to differentiate between early replacement and recall replacement. UCLA Cardiac Arrhythmia Center, Los Angeles, California, February 2006: Non-EPs implanting ICDs: We support the HRS guidelines on this issue. However, we have not received any requests from non-EPs for training. Device recalls: One at at time! We have had to weigh the risks versus benefits on a case-by-case basis.