Tuesday, July 13, 2010

Remote ICD Interrogation and the Challenges of Telemedicine

This week in Circulation an article was published (before print) about the safety and efficacy of remote monitoring for implantable cardioverter-defibrillator (ICD) follow-up in the industry-sponsored TRUST (Lumos-T Safely RedUuceS RouTine Office Device Follow-up) Trial. This trial randomized 1339 patients in a 2:1 fashion between internet-based “home-monitoring" of patient’s ICD’s and conventional office-based follow-up of ICD’s. While the results of the trial were interesting in regards to ICD follow-up management using the two venues, the trial is even more interesting if one considers the implications of this trial to telemedicine in general.

By way of background, patients with ICD’s are burdened with frequent follow-up to their doctors with guidelines requiring visits very three to six months. With more patients receiving implanted devices that contain more capabilities beyond just pacing and defibrillation (like arrhythmia and fluid-status monitoring), the volume of patients risks outstripping the number of available appointments. Further, it is no secret that device companies would love to reduce their manpower burden for follow-up to reduce their costs since many small doctors offices turn to the device companies for the technical aspects of follow-up support.

Enter home monitoring via the Internet. Using this technology, patients can upload their device data from home, have it reviewed online, and since 90% of device checks require no “actionable” follow-up, forgo a trip to the device clinic if no problems are identified. In fact, the TRUST trial concluded that “Home monitoring is safe and allows more rapid detection of actionable events compared with conventional monitoring in patients with implantable electronic devices.” The authors clearly achieved their stated goals, demonstrating a significant reduction in hospital encounters from 3.8 visits per patient/yr in the control group to 2.1 visits per patient/yr in the intervention group, with no increase in death, stroke, or surgical interventions in patients treated with home monitoring.

What’s not to like, right?

But there are some potential challenges ahead.

For one, in the TRUST trial the decrease in scheduled hospital encounters was partially offset by a significant increase in unscheduled encounters from 0.5 per patient/yr to 0.78 per patient/yr, mostly due to visits following event notifications from the home monitoring device.

Secondly, in his editorial on the study, Dan Matlock, MD from the University of Colorado cautioned that the quality of the TRUST trial fell short in it’s “patient-centeredness” and suggests that “the trial was designed with the belief that multiple follow-up visits are a burden that primarily falls on the providers.” He offers the following cautionary analogy:
A good basis for interpreting the TRUST trial is to draw comparisons with the prostate-specific antigen (PSA) controversy. There was never a debate that the PSA test detects prostate cancer earlier, and the test was widely adopted by the medical community without any evidence of improved outcomes. Finally, after two decades of use, two large, randomized trials studying the effects of PSA screening were published. Only one of the two trials actually demonstrated a benefit, showing a reduction in death from prostate cancer of seven per 10 000 men screened over nine years. This benefit was coupled with an additional 340 diagnoses of prostate cancer, 177 prostatectomies, and 97 radiation therapies. The second trial did not demonstrate any benefit of PSA testing at all. Rather than being a story of saving lives, the story of PSA testing has been one of false positives, frequent biopsies, indolent cancer, patient anxiety, impotence, and incontinence.

Considering the lessons learned from PSA, the TRUST trial leaves some important questions unanswered. Namely, what are the benefits and harms of detecting “actionable events,” and what do patients think of home monitoring?”
It is easy for those of use who are computer-savvy to assume that patients will all leap to home monitoring or telemedicine as their preferred means to address many of their medical concerns. But as the sensitivity for “actionable” items increases thanks to the capabilities of this technology, there is the potential that treatments that ensue adds other unforeseen risks for our patients. For instance, take the example of asymptomatic atrial fibrillation detected by a heart failure patient’s ICD who is already on warfarin: do they really need an immediate cardioversion (and the costs, risks of sedation, and anxiety surrounding the finding) or might the patient have be just as well served by less aggressive conventional follow-up?

Certainly, there appears to be great potential for improved access for care with remote monitoring and telemedicine in our increasingly cost-constrained health care system. Still, doctors and telemedicine developers must assure our recommended treatment strategies that result from improved detection do not conflict with our patients' perspectives, needs and values for their care.



Varma N, Epstein AE, Irimpen A, Schweikert R, Love C, for the TRUST Investigators. "Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up: the Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial." Circulation. 2010;122:325–332.

Matlock DD. "Big Brother Is Watching You - What Do Patients Think About ICD Home Monitoring? Circulation 2010;122:319-321.


Lisa said...

Thanks for this post. I'll keep that in mind. I wrote a post today about a Wall Street Journal article on Long QT Syndrome. Stop by and read it if you'd like.

Pat Craisse said...

With all due respect, your own perspective lacks patient-centeredness (as mine lacks clinician-centeredness) in terms of who has access to this information, i.e. why not send data to the ICD user so that at least some decisions can get made that way? Hugo Campos wrote a very good comment on the patient's perspective on remote monitoring in the ICD User Group: http://icdusergroup.blogspot.com/2010/01/remote-icd-monitoring-where-is-my-pony.html. And at least some EPs (Lesley Saxon, for example) stress that the new remote tech capabilities should make more information available to the USER as well as to the EP and device rep.

Some pacer/ICD users don't care about getting their data, and just feel safer with remote monitoring. But I hope you'd agree it should be an option, not the only choice.