Medical Device Daily Executive Editor
SAN FRANCISCO — First, some things we already know: that more and more electronic devices are being implanted in humans; that they are being implanted in broader populations of patients; and that these devices are becoming increasingly more complex.
These facts, though basic, have many implications, some of the most important — perhaps the most important — being addressed at the multi-buildinged Moscone Convention Center during this week's annual scientific sessions of the Heart Rhythm Society (HRS; Washington). In particular, how do you best manage these devices?
Or to sum up — as Bruce Wilkoff, MD, did — "It's not buying the car, it's driving it that makes the difference."
In first-day activities, the society rolled out recommendations concerning management and follow-up of what it broadly termed cardiovascular implantable electronic devices (CIEDs).
Wilkoff, chair of the Health Policy Committee of HRS and director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic, presented the guidance on CIEDs and emphasized a clear gap in post-implant device management of them.
"We have spent a lot of time understanding the reasons to implant these devices — most of our energy in getting them in," he said. "But we have spent very little time on safety and monitoring of those devices over time."
And he said that while monitoring of these implantable devices has been going on for some time, it hasn't been "codified in a universal way." The new guidance is an attempt at doing this.
Wilkoff said there were "about" 1.78 million implantations of CIEDs in 2007. But he noted that the document is an attempt to address the 5.86 million "follow-up events" after implantation.
He acknowledged these numbers as "estimates," but said that they "give you an idea of how important this [issue] is."
Besides the raw numbers of follow-up events, he said that they come attached to an extreme breadth of information, along with a variety of emerging issues related to the handling of data and data security. (See sidebar for the range of topics addressed.)
"Until now," Wilkoff said, "there has been little guidance for practicing physicians, hospitals, regulatory agencies and insurance agencies to provide the medically appropriate level of care for patients [implanted with these devices]."
And the HRS statement discussing the guidance emphasized the need for this management "from the time of implantation until explanation or the patient's death."
The consensus statement was a joint development effort by HRS and the European Heart Rhythm Association (EHRA; Sophia Antipolis, France ), along with participation from several other U.S. and international cardiovascular groups.
HRS said this broad input was important for dissemination of the guidelines, and said that all participants "agreed that device monitoring should be handled by professionals specially trained in the field."
Additionally, it issued "a call-to-action for the device industry, healthcare institutions and physician practices to provide the necessary infrastructure that will ensure patient care is safe and effective."
Wilkoff emphasized the growing complexity of device monitoring, saying that this effort needs to be expanded to "patient monitoring," because including "all levels of the healthy and unhealthy, young and old, sedentary and active. This is a very diverse population and a rapidly changing field because there's this sort of invasion of high-tech which the promise of improving health, but a little scary and a little complex."
"We need to know how to use these things appropriately," he said. "It's not enough to see that it works — you have to tell this to the patients and their families."
He described these devices as "essentially implantable computers with antennas that communicate information," and termed the antenna "a friendly spy inside the patient's body."
He called the communicated data "very personal — you have to know how to manage that information well."
Wilkoff and others presenting the guidance emphasized the importance of using advanced, remote systems to improve monitoring for better care but pointed to (here's a surprise!) the need for reimbursement that pushes this type of device management forward.
"Unfortunately," Wilkoff said, "we've ignored the need to adequately fund ... the ongoing maintenance of the patient and their device. It's not appropriate to just put it in and not provide for the follow-up." Doing this, he said, should be a "moral contract made by the doctor, the nurse, government, [and] regulators."
Wilkoff has been leading the effort over the past two years to win new codes for such follow-up, and he expressed optimism that the appropriate codes would be developed, but acknowledged: "Unfortunately, I can give you only limited details because this is in process."
Saying that the guidance offers a new "benchmark" for CIED management, Panos Vardas, MD, PhD, of Heraklinion University Hospital (Heraklinion-Crete, Greece), defined its main goals as increasing "the length and quality of the patient's life [and] appropriate monitoring of device therapy ... [for] fewer interruptions by hospital admissions and operative interventions."
But Vardas said that the hurdles for developing the necessary registry systems for tracking implantable electronic devices and pushing forward the necessary reimbursement policies is even more difficult in Europe than in the U.S., given the 17 different healthcare systems.
Finally, Wilkoff pointed to end-of-life considerations.
"There's the emotional issue — what happens when the person [implanted with an electronic device] will die for another reason. They may have the desire to withdraw therapy, or the perception that the device is going to do something adverse during the dying process. Is it possible to adjust [the device] to the appropriate situation? What are the considerations, how to handle the logistics under such circumstances? These are important but largely unsaid in the past. Now we have a complete discussion of what some of the most important considerations might be."
Tomorrow in MDD: smaller patients needing electronic implants and the need for training.