As the number of men and women with cardiac disease continues to grow, so too do the clinical indications for pacemakers and automatic implantable cardiac defibrillators. Taken together, there are going to be a lot more people in the near future who are dependent on implanted hardware to keep their hearts working normally. Until relatively recently, the sole form of monitoring of these patients was through regular clinic visits where these devices could be interrogated or unscheduled/emergency visits based on clinical events like shock delivery. While at HIMSS 2010 in Atlanta, I had the opportunity to speak with Tom Schultz at the Interoperability Booth, a space which demonstrates how different innovations could be pieced together to deliver care in new ways. He showed me how the Medtronic CareLink system, working with an electronic health record like Epic and Haiku, could not only notify a physician of a clinical event like AICD shock, but also allow the physician to intervene virtually immediately. And it looks like there is some data, courtesy of the CONNECT trial, showing real clinical benefits from this system. On top of that, there’s even a possibility that physicians will be able to adjust settings on implanted devices remotely.
Here’s how it works now.
Mr. Smith, a gentleman with a dilated cardiomyopathy and dual-chamber pacemaker/AICD, is sitting at home on a Saturday and minding his own business when his heart decides to flip into ventricular fibrillation. His AICD detects the arrhythmia, delivers the life-saving shock, and Mr. Smith goes back into a normal rhythm. Mr. Smith thinks he’s fine and goes back to his daily routine, not realizing that he is in fact at very high risk for further events. His home monitoring device, pictured here, has captured all of these events, including the recent preceding rhythm information, and sends an alarm to the electronic health record of Dr. Jones, the cardiologist.
Dr. Jones happens to be running Epic, for example, and uses Haiku. He has set up an alarm to provide event notification messages to his iPhone when a patient receives an AICD shock. Dr. Jones receives this alarm while at lunch, opens Haiku to remind himself who Mr. Smith is (associated picture of Mr. Smith is pretty nice here), and realizes immediately that this is a guy who needs to be in the hospital now. So, using the one-touch call functionality in Haiku, Dr. Jones calls Mr. Smith at home and asks him to go to the nearest hospital for further evaluation. Dr. Jones then enters a brief note into the electronic health record, sends Mr. Smith’s most recent clinic note to the emergency room, and calls ahead to let them know he is coming. And all of that was done from the restaurant, hopefully in a private place, from his iPhone.
To be perfectly honest, I was really impressed with all of this. Mr. Shultz also pointed out that this remote monitoring system has been IHE certified, meaning it has been extensively testing for interoperability with a number of other systems. In fact, Medtronic, St. Jude, and Boston Scientific have banded together and decided to use a common standard for their respective remote monitoring systems, a decision that runs counter to the typical approach of making everything proprietary in health IT.
What’s particularly exciting about this system is that there is some data backing up its utility from the CONNECT trial. According this article, this randomized prospective study of nearly 2,000 patients demonstrated that the CareLink system reduced time to clinical decision post event – basically, the time from an event to a physician making a care decision – from 22 days in the routine office management group to 5 days for the remote monitoring group. The remote monitoring group also had fewer physician visits, 4 vs. 6, and shorter length of stay in hospitalization, 3 days vs. 4 days. So overall, what this could mean is that remote monitoring does what it was intended – improves response time to clinical events while simultaneously reducing healthcare utilization i.e. routine clinic visits. However, we are certainly wary of the fact that the information currently available is only from Medtronic, so obvious issues of biased reporting need to be evaluating. That being said, we will eagerly await the peer reviewed publication of the data from this trial and report on it when available.
What’s particularly enticing, if just speculation, is the possibility of remote adjustment of implanted devices. Medtronic, in addition to cardiac devices, also makes pain management devices like spinal pumps. What if a physician could remotely increase the baclofen dose of a patient with a spinal cord injury when their symptoms worsen, a patient who may not be able to come into clinic easily? I asked that question at HIMSS at the interoperability booth, and the response was a twinkle in the eye and “no comment.” So we’ll just have to wait and see.