CHICAGO — Where do implanted defibrillators go when their people die. Into the grave, mostly.
But James Kirkpatrick, MD, has done a study indicating that even those ICDs that are explanted enter a black hole of absent data because they are seldom interrogated.
During a Sunday morning press conference on “Heart-ware” opening the scientific session of the American Heart Association (Dallas), Kirkpatrick reported on a survey of morticians indicating that the venue of the mortuary offers little chance of explant and interrogation of ICDs — but that it could (and probably should).
The report serves to underline the growing perception that the companies making ICDs have only “guesstimate” data on the actual failure rates of these devices, a charge resulting from the reports concerning failures of devices made by Guidant (Indianapolis) and other manufacturers over the past year and a half.
In an interview with Medical Device Daily following his presentation, Kirkpatrick estimated the number of ICDs explanted from the dead and then interrogated by their manufacturers, as “miniscule” and that there are many more that need such interrogation.
Kirkpatrick, an echocardiologist at the University of Pennsylvania (Philadelphia), and other researchers conducted a survey of a group of morticians and patients to better understand what happens to an ICD at a person’s death — and also what fate for the devices is preferred by those who will eventually die with them implanted.
The researchers interviewed 97 morticians (out of a selected group of 100) and 150 patients, the patients averaging 67 years of age and implanted with an ICD for at least four years, on average
The study found that most of the devices remain in the body at burial. And among the morticians who did explant the devices — with the family’s consent — only three said they had ever returned them to the manufacturer.
If explanted, the devices were most frequently disposed of as “medical waste” (31) or donation “for human use in developing nations” (13). A response of “unknown” was given 24% of the time. Seven reported “Return to next of kin,” 6 reported “Storage in mortuary, 3 reported “Return to hospital where patient died,” and 2 reported donation “for animal use.”
The other major finding from the survey is that the patient respondents said that they would favor — rather overwhelmingly, at 82% — explantation and analysis of their devices at death.
In addition, 79% said they approved of returning the device to its manufacturer for analysis; 72% said they would sign an “advance directive” to this effect; 91% were willing to stipulate that the device could be explanted and donated “to a needy person in a developing country,” and 79% agreed to a donation “for use in pets.”
In his presentation, Kirkpatrick noted this year’s recommendation by the Heart Rhythm Society (Washington) concerning the need to explant and interrogate ICDs in order to promote post-marketing studies.
But he said this recommendation probably has not found its way very broadly to the hospital community, and that the morticians surveyed in the study were unaware of this recommendation.
The findings of the report would suggest the need for legislation to require general device interrogation, perhaps through use of a “Device Living Will” as described by Kirkpatrick in the study. Such a document would authorize “non-invasive analysis and/or retrieval” of the device for analysis.
But following his presentation, Kirkpatrick told MDD that he held out no great hope that mandating the use of such an instrument would achieve the goal, primarily because of difficulties in enforcement.
He said that where similar types of documents have been used, they have only a 24% response rate. “You can’t force people to fill out [this kind of] document,” he said.
The reason, he opined, is that most people aren’t generally too enthusiastic about contemplating a personal demise or mulling over the range of possible details related to it.
He said that the wording of such a document would be crucial, with emphasis on the fate of the device rather than the focus on dying (tricky wording indeed!).
It is relatively easy for a mortician to explant the devices, Kirkpatrick said, pointing out that the survey suggests a general willingness to do so, assuming family approval — fully 87% of the mortician respondents agreed that routine post-mortem device removal and return to manufacturers would be feasible.
Kirkpatrick said that the next step for the research is to develop a form that would be provided to the person implanted with an ICD that would offer a variety of options — this time presented to the patient in an actual clinical setting at the time of implant — to determine their preference among the various options.
In other reports from the “Heartware” press conference.
• Researchers from Brigham and Women’s Hospital (Boston) reported on survey research indicating a large reluctance among heart failure patients with ICDs to turn them off when they are clearly in the end stage of life, even if the devices continue to provide shocks that do not benefit them. The researchers interpreted the responses as an “over-estimation” of the life-saving ability of these devices.
Lynne Stevenson told MDD that patients “way over-estimate the benefit” of ICDs and that the continued shocks greatly reduce quality of life in the final stages of heart failure.
• Education and counseling, beyond that provided in standard hospital release, is useful for reducing the anxiety and depression generally associated with the implant of ICDs, according to a study by researchers at Emory University (Atlanta).
The researchers divided 264 patients into two groups, one receiving usual post-implant follow-up care, the other in which the patients were assigned to receive counseling and intervention during acute post-surgical care and then again two to three months later, by telephone or in a group setting.
At one year post-implant, both groups had reduced depression and anxiety, but the depression scores in the standard follow-up group were twice as high as for those who received the more aggressive intervention, and their anxiety scores also were higher.
• Researchers from the Heart Center, University of Bonn (Bonn, Germany), reported on a study which indicates that the increasing presence of Wi-Fi and Ethernet systems “pose little danger for people with pacemakers and defibrillators.”