I am providing the link to an article in MobiHealthNews with little commentary. The article can be found at: http://mobihealthnews.com/5797/nhs-wireless-health-needs-standards-interoperability/. My one comment is that it appears that his objectives for tele-medicine are similar to my own: provide medical care that keeps patients out of hospital and nursing homes.
The article is an interview with George MacGinnis who is with the Assistive Technology Programme at the NHS Connecting for Health in the UK. He was interviewed by MobiHealthNews at the Mobile Healthcare Industry Summit in London. I think it is well worth taking the time to read this interview. In addition, MobiHealthNews has included a video of the interview.
Thursday, December 17, 2009
Tuesday, December 15, 2009
Revamping the Revenue Generation Model in the Medical Device Industry
My fourth posting on this blog on 29 September 2009 was part of a multi-part examination of Medtronic's remote programming patent (US Patent # 7,565,197 that was granted in 21 July 2009). I suggested that the patent patent implied two directions in the development of medical devices:
Today, physicians, hospitals and device manufacturers receive the bulk of their payment when a device is implanted or replaced. Thus, the current business model of device manufacturers relies on primarily on product such as an ICD or CRT and leads.
However, the Medtronic patent suggests the possibility, maybe even the likelihood of strategic shift from a product to a licensing business model. This would suggest a business similar to software companies who charge a flat or yearly fee for the use of software. Instead of a replacement, the patient receives a software upgrade and the device company receives payment for the software upgrade. This is one step removed from a pure product to a service-oriented model, but it still treats the software as a product. Nevertheless, it provides flexibility to the medical device company in that revenue comes less tied to the sale of objects, and more tied to the services provided to the customer.
An even more innovative approach and more in-line with a service-oriented business model would be to have the software redefine the capabilities of the device itself while implanted in the patient. For example, upgrade an ICD to a CRT-D by changing software. I do not know the technical, implantation or leads-related issues of doing this, however, from a software standpoint, there should be nothing stopping a device manufacturer who has taken the common hardware design approach.
A pure service-oriented model would change on the basis for the services provided. Since I'm a technologist and not an MBA who has worked in the device industry for decades, I cannot define all the possible revenue-producing services medical devices with remote monitoring and remote programming could provide device companies. I can say that the services that medical device companies can provide medical care providers and their patients is becoming less and less tied to the devices themselves. So a more service-oriented perspective in the medical device industry seems warranted.
It seems apparent that for medical device companies to expand their services and patient-care and management capabilities with information-based services over the communications infrastructure, they are going to have to change the way they receive revenue. The current business model and means of generating revenue does not provide incentives to companies to expand into information based services given the current product-based revenue model currently in use. I suspect that in a relatively short time, Medtronic will propose a new revenue model. I shall be watching for the signs.
- The development of a single, common hardware platform based on a generalized processor, similar to TI's low power processor. (Add urls).
- Medtronic device capabilities would be defined primarily by software. Furthermore, the patent defines a capability for software to be downloaded to a device, thus defining the capability for updating the software on the device.
Today, physicians, hospitals and device manufacturers receive the bulk of their payment when a device is implanted or replaced. Thus, the current business model of device manufacturers relies on primarily on product such as an ICD or CRT and leads.
However, the Medtronic patent suggests the possibility, maybe even the likelihood of strategic shift from a product to a licensing business model. This would suggest a business similar to software companies who charge a flat or yearly fee for the use of software. Instead of a replacement, the patient receives a software upgrade and the device company receives payment for the software upgrade. This is one step removed from a pure product to a service-oriented model, but it still treats the software as a product. Nevertheless, it provides flexibility to the medical device company in that revenue comes less tied to the sale of objects, and more tied to the services provided to the customer.
An even more innovative approach and more in-line with a service-oriented business model would be to have the software redefine the capabilities of the device itself while implanted in the patient. For example, upgrade an ICD to a CRT-D by changing software. I do not know the technical, implantation or leads-related issues of doing this, however, from a software standpoint, there should be nothing stopping a device manufacturer who has taken the common hardware design approach.
A pure service-oriented model would change on the basis for the services provided. Since I'm a technologist and not an MBA who has worked in the device industry for decades, I cannot define all the possible revenue-producing services medical devices with remote monitoring and remote programming could provide device companies. I can say that the services that medical device companies can provide medical care providers and their patients is becoming less and less tied to the devices themselves. So a more service-oriented perspective in the medical device industry seems warranted.
It seems apparent that for medical device companies to expand their services and patient-care and management capabilities with information-based services over the communications infrastructure, they are going to have to change the way they receive revenue. The current business model and means of generating revenue does not provide incentives to companies to expand into information based services given the current product-based revenue model currently in use. I suspect that in a relatively short time, Medtronic will propose a new revenue model. I shall be watching for the signs.
Sunday, December 13, 2009
Essay: Economical Medicine
To my readers: I have been engaged in high-priority activities for my current client and have unfortunately neglected this blog. I plan on publishing a flurry of articles from now to the end of this year. Furthermore, I am re-initiating my review of patents and patent applications.
Preface
In this essay I discuss some of my observations regarding the US medical system. I discuss what I consider could be the impact of remote monitoring technology on US medical practice.
I hope that people outside of the United States read my blog. I provide my perspective as one US citizen about the US culture and medical practice. I hope that others may chime in, and provide their perspectives regarding the US medical system, their own medical systems (if citizens of another country) and provided me with their perspectives.
I argue that remote monitoring can provide high quality health care at a lower cost. Remote monitoring provides lower cost health care primarily by keeping people out of the hospitals. As a result, the huge infrastructure devoted to hospital will likely whither. Hospitals will always have a place, but they'll become smaller and targeted to providing critical services such as trauma care, critical care and post-operative recovery. People will spend less time in the hospitals, but physicians and automated care-givers will be able to monitor patients where ever they are located - mostly, away from the hospital.
But before I discuss my views on remote monitoring and it's place in economical medicine, I discuss my concepts of economical medicine.
Economical Medicine
My home is Chicago, Illinois, and over the last few years, I have seen a spat of new hospital construction. Admittedly, there are areas where there are too few hospital beds and services. I have been astonished by the amount of recent construction. It seems that the hospital are competing with each other to see who can provide the newest, most up to date hospital. Furthermore, many of these same hospitals purchase the most expensive scanning equipment available and build large testing laboratories.
The United States provides some of the worst and the best medical treatment available in the industrialized world. If you want something extra-ordinary performed, come to the US. Where the US fails is providing mundane care to the majority of its populace. Our outcomes for the extraordinary are fabled, but the US ranks 37 in the WHO health care rankings behind countries such as Costa Rica, Columbia, Dominica, besides the obvious ones such as France, Switzerland, Austria, Italy, etc.
A landmark study published in 2000 showed that the US has the most expensive health care system in the world based on per capita and total expenditures as a percentage of gross domestic product.
In 1998 the US spent $4,178 per person on health care in 1998. The study median was $1,783 and the closest competitor was Switzerland at $2,794. US spending as a percentage of gross national product was 13.6 percent. The countries closest were Germany (10.6%) and Switzerland (10.4%). And things since 1998 have only gotten more expensive in the US to the point where the US care costs have reached crisis proportions.
Yet in the midst of an attempt to repair the US crisis, members of the US Congress, including nearly every member of the Republican party, have demonized any attempt to make the cost of health care more reasonable. Particularly, when the costs of US health continued to increase at a pace that would eventually drastically lower the standard of living of the majority of Americans. Why is this?
The roots of the opposition are clearly political and rooted in the economic interests of primarily the US health insurance companies. Health insurance companies nearly own and operate many members of the House and Senate on matters of health care. And these health care companies decided to declare war against any and especially a strong public insurance option - e. g., anything close to Medicare for the rest of us. However, there is cultural resistance as well.
Culturally, Americans are profligate. We are a non-economical culture and that believes itself to have no limits. Our sense of limitlessness is our greatest strength and weakness, and it has been running out of control for a long time.
Americans build roads and cars instead of building trains and tracks. We built muscle cars with large and powerful engines for decades instead of fuel-saving vehicles. We built suburbs along our superhighways and commute long distances to work in vehicles that consume excessive amount of fuel. We built large houses and houses with little insulation that consume excessive amounts of fuel to heat and excessive amounts of electricity to cool and light. Growing up in this culture, my sense is that many Americans construe excess with the good life. That need not be case.
We have a medical system that costs too much, delivers too little, places undue burdens on it's practitioners such as malpractice insurance costs and excessive paperwork. In addition it has been perceived by a wide variety of players as a way to make massive, excessive amounts of money. Getting fairly paid for a medical service, product or drug is a good thing. Excessive payments can corrupt or bankrupt an entire system.
Lower Cost Does Not Necessarily Equal Lower Quality
Over the past several decades we have be privy to a revolution, a revolution in ubiquity of computer power. Compare the cost of an 1984 Apple Macintosh or a 1984 PC with one today. The costs are either comparable or lower, but the computational power has skyrocketed from then to now. Everything in the computational and communications sphere has increased while the cost has decreased. Supercomputers and supercomputer availability, rare in the 1980s and early 1990s, has exploded in the last decade. Sophisticated hand held computers with voice and data capabilities that dwarf the powers of 1990's desktop computer are available for hundreds of dollars.
Remote Monitoring
Remote monitoring is a minor outgrowth of the computing and data communications revolution. It makes some use of the continuing computer and telecommunications developments, but so far, relatively little. However, the potential is there as well as the interest in spreading the capabilities of the computing and communications revolution to the medical community. In fact, I believe that many computer scientists and engineers consider medicine one of the last frontiers to thoroughly swept-up in this revolution.
Medicine by nature is a conservative discipline. It deals with people's lives. In the US there's the added problem of the legal profession and malpractice insurance companies breathing down a physician's neck.
I believe that the medical industry finally fully leverages the capabilities of the computer and communications revolution, medical costs will be lowered, people will spend either no or little time in hospitals. Physicians will have the capability of tuning the dosages of medication in real time. Sophisticated computer systems that have made use supercomputer models will be able to determine the medical status of a patient in real time or near real time. These systems will be able to determine if a patient is showing signs of a pending medical crisis and requires intervention before the crisis appears.
All this can be available to the citizenry at a cost that would surprise you. This is the ounce of prevention on a grand scale.
I shall continue to discuss economical medicine in future articles and how leveraging the computational and communications revolution will contribute to providing better medical care at a lower cost.
Preface
In this essay I discuss some of my observations regarding the US medical system. I discuss what I consider could be the impact of remote monitoring technology on US medical practice.
I hope that people outside of the United States read my blog. I provide my perspective as one US citizen about the US culture and medical practice. I hope that others may chime in, and provide their perspectives regarding the US medical system, their own medical systems (if citizens of another country) and provided me with their perspectives.
I argue that remote monitoring can provide high quality health care at a lower cost. Remote monitoring provides lower cost health care primarily by keeping people out of the hospitals. As a result, the huge infrastructure devoted to hospital will likely whither. Hospitals will always have a place, but they'll become smaller and targeted to providing critical services such as trauma care, critical care and post-operative recovery. People will spend less time in the hospitals, but physicians and automated care-givers will be able to monitor patients where ever they are located - mostly, away from the hospital.
But before I discuss my views on remote monitoring and it's place in economical medicine, I discuss my concepts of economical medicine.
Economical Medicine
My home is Chicago, Illinois, and over the last few years, I have seen a spat of new hospital construction. Admittedly, there are areas where there are too few hospital beds and services. I have been astonished by the amount of recent construction. It seems that the hospital are competing with each other to see who can provide the newest, most up to date hospital. Furthermore, many of these same hospitals purchase the most expensive scanning equipment available and build large testing laboratories.
The United States provides some of the worst and the best medical treatment available in the industrialized world. If you want something extra-ordinary performed, come to the US. Where the US fails is providing mundane care to the majority of its populace. Our outcomes for the extraordinary are fabled, but the US ranks 37 in the WHO health care rankings behind countries such as Costa Rica, Columbia, Dominica, besides the obvious ones such as France, Switzerland, Austria, Italy, etc.
A landmark study published in 2000 showed that the US has the most expensive health care system in the world based on per capita and total expenditures as a percentage of gross domestic product.
In 1998 the US spent $4,178 per person on health care in 1998. The study median was $1,783 and the closest competitor was Switzerland at $2,794. US spending as a percentage of gross national product was 13.6 percent. The countries closest were Germany (10.6%) and Switzerland (10.4%). And things since 1998 have only gotten more expensive in the US to the point where the US care costs have reached crisis proportions.
Yet in the midst of an attempt to repair the US crisis, members of the US Congress, including nearly every member of the Republican party, have demonized any attempt to make the cost of health care more reasonable. Particularly, when the costs of US health continued to increase at a pace that would eventually drastically lower the standard of living of the majority of Americans. Why is this?
The roots of the opposition are clearly political and rooted in the economic interests of primarily the US health insurance companies. Health insurance companies nearly own and operate many members of the House and Senate on matters of health care. And these health care companies decided to declare war against any and especially a strong public insurance option - e. g., anything close to Medicare for the rest of us. However, there is cultural resistance as well.
Culturally, Americans are profligate. We are a non-economical culture and that believes itself to have no limits. Our sense of limitlessness is our greatest strength and weakness, and it has been running out of control for a long time.
Americans build roads and cars instead of building trains and tracks. We built muscle cars with large and powerful engines for decades instead of fuel-saving vehicles. We built suburbs along our superhighways and commute long distances to work in vehicles that consume excessive amount of fuel. We built large houses and houses with little insulation that consume excessive amounts of fuel to heat and excessive amounts of electricity to cool and light. Growing up in this culture, my sense is that many Americans construe excess with the good life. That need not be case.
We have a medical system that costs too much, delivers too little, places undue burdens on it's practitioners such as malpractice insurance costs and excessive paperwork. In addition it has been perceived by a wide variety of players as a way to make massive, excessive amounts of money. Getting fairly paid for a medical service, product or drug is a good thing. Excessive payments can corrupt or bankrupt an entire system.
Lower Cost Does Not Necessarily Equal Lower Quality
Over the past several decades we have be privy to a revolution, a revolution in ubiquity of computer power. Compare the cost of an 1984 Apple Macintosh or a 1984 PC with one today. The costs are either comparable or lower, but the computational power has skyrocketed from then to now. Everything in the computational and communications sphere has increased while the cost has decreased. Supercomputers and supercomputer availability, rare in the 1980s and early 1990s, has exploded in the last decade. Sophisticated hand held computers with voice and data capabilities that dwarf the powers of 1990's desktop computer are available for hundreds of dollars.
Remote Monitoring
Remote monitoring is a minor outgrowth of the computing and data communications revolution. It makes some use of the continuing computer and telecommunications developments, but so far, relatively little. However, the potential is there as well as the interest in spreading the capabilities of the computing and communications revolution to the medical community. In fact, I believe that many computer scientists and engineers consider medicine one of the last frontiers to thoroughly swept-up in this revolution.
Medicine by nature is a conservative discipline. It deals with people's lives. In the US there's the added problem of the legal profession and malpractice insurance companies breathing down a physician's neck.
I believe that the medical industry finally fully leverages the capabilities of the computer and communications revolution, medical costs will be lowered, people will spend either no or little time in hospitals. Physicians will have the capability of tuning the dosages of medication in real time. Sophisticated computer systems that have made use supercomputer models will be able to determine the medical status of a patient in real time or near real time. These systems will be able to determine if a patient is showing signs of a pending medical crisis and requires intervention before the crisis appears.
All this can be available to the citizenry at a cost that would surprise you. This is the ounce of prevention on a grand scale.
I shall continue to discuss economical medicine in future articles and how leveraging the computational and communications revolution will contribute to providing better medical care at a lower cost.
Tuesday, December 1, 2009
Biotronik TRUST Studies: Reprinted Abstracts and Commentary
What follows are published abstracts of the Biotronik studies that provided evidence that Home Monitoring can substitute for quarterly check-ups for ICD patients. That care of ICD patients can be just as effective with one per year in-clinic check-ups instead of the normal three month in-clinic check-ups. This was supported primarily by 2008 study.
The 2009 study is a logical follow-up to the 2008 study. This study provided evidence that the Biotronik remote monitoring (Home Monitoring) system can provide early-warning notifications of significant cardiac events faster and more effectively than quarterly, in-clinic visits. This study has wider implications. It provides evidence that remote monitoring can provide the kind of care that at one time could only be provided in hospitals. Furthermore, it demonstrates the kind of capability necessary to provide the kind of early warning that can keep specific, targeted populations out of hospital, thus providing more economical and more desirable health care.
These studies are reprinted with permission from Biotronik. (I have no affiliation with Biotronik.)
2008 Study
Evaluation of Efficacy and Safety of Remote Monitoring for ICD Follow-Up:
The TRUST Trial
Authors: Niraj Varma, Cleveland Clinic, Cleveland, OH; Andrew Epstein UAB Medical Center, Birmingham, AL; , Univ of Alabama Birmingham Medical Center, Birmingham, AL; Robert Schweikert Cleveland Clinic, Cleveland, OH; , Akron Medical Center, Akron, OH; Charles Love, Davis Heart and Lung Research Institute, Columbus, OH; Jay Shah, Carolina Cardiology Associates, Rock Hill, SC; Anand Irimpen; Tulane University Medical Center, New Orleans, LA
Background: Remote monitoring (RM) of ICDs may provide daily, automatic device and patient status data and cardiac event notifications. TRUST tested the hypothesis that RM was safe and effective for ICD follow-up for 1 year in a prospective, randomized controlled clinical trial.
Methods: 1282 patients were randomized 2:1 to RM or to conventional (RM disabled) groups.Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. In the RM arm, RM was used before office visits (OVs) at 3 and 15 months. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. Conventional patients were evaluated with OVs only. Follow up was “actionable” if system reprogramming/revision or change in anti-arrhythmic therapy occurred. Scheduled and unscheduled OVs (including responses to event notifications in RM) were quantified for each individual patient per year (pt yr) of follow up. Incidence of death, strokes and surgical interventions (morbidity) was tracked in both groups.
Results: RM and conventional patients were similar in age (63.3 ± 12.9 vs 64.1 ± 12.0 yrs, p = 0.30), gender (71.9% vs 72.4% male, p =; 0.89), pathology (LVEF 29.1 ± 10.8% vs 28.6 ± 9.8%, p = 0.47;coronary artery disease 64.5% vs 71.4%, p = 0.02), medications (Beta blockers 79.5% vs 75.9%, ACE inhibitors 42.4% vs 46.8%, ARBs 7.8% vs 9.9%, p = NS), indication (primary prevention 72.3% vs 74.2%, p = 0.50), and dual chamber implants (57.9% vs 57.0%, p = 0.76). RM reduced scheduled OVs by 54% and total OVs by 42% without affecting morbidity. Event notifications were managed using RM alone in 92% of cases. Of the remainder resulting in unscheduled OVs, 52.2% were actionable. RM improved adherence to follow-up.
Conclusions: TRUST demonstrated that remote monitoring is safe, decreases the need for in-office visits, provides early detection of significant problems, and improves ICD surveillance without increasing unscheduled office visits. In conclusion, remote monitoring is a safe alternative to conventional care.
2009 Study
EARLY DETECTION OF ICD EVENTS USING REMOTE
MONITORING: THE TRUST TRIAL
Authors: Niraj Varma, MD, FRCP, Andrew Epstein, MD, Anand Irimpen, MD, Robert Schweikert, MD, Jay Shah, MD, Lori Gibson, DVM and Charles Love, MD. Cleveland Clinic, Cleveland, OH, University of Alabama Birmingham Medical Center, Birmingham, AL, Tulane University Medical Center, New Orleans, LA, Akron Medical Center, Akron, OH, Carolina Cardiology, Rock Hill, SC, Biotronik, Inc., Lake Oswego, OR, Davis Heart & Lung Research Institute, Columbus, OH
Introduction: ICDs have extensive self-monitoring capability with diagnostic data available at interrogation. Remote Monitoring (RM) may facilitate data access but this has not been tested. The secondary endpoint of the TRUST trial tested the hypothesis that RM with automatic daily surveillance can provide rapid notification thereby facilitating prompt physician evaluation.
Methods: 1312 patients were randomized 2:1 to RM or to conventional (C) groups. Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. RM was used before office visits (OVs) at 3 and 15 months in RM group. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. C patients were evaluated with OVs only. Unscheduled checks between these time points were tracked. The hypothesis was tested by determining time elapsed from first event occurrence in each patient to physician evaluation.
Conclusions: Remote monitoring with automatic daily surveillance provides rapid detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling early physician evaluation.
Commentary
2008 Study
Of significant interest would be morbidity rate. The remote monitoring group showed a .9% higher death rate than the conventional group. This result was also nonsignificant. The nonsignificant difference appears to be expected outcome. Demonstrating a negative - or no difference - is always a concern in research because of the logical problem in demonstrating that something did not happen or that there are no difference between the groups.
I have an additional concern with respect to the unbalanced design. Unbalanced designs have lower power of your statistical power - that is, the ability to reject the null hypothesis - than balanced designs. And that would be of concern in study where the expected outcome is no difference. However, the numbers are extremely large that should off-set the reduction in statistical power created by the unbalanced design. Since I do not have the raw data, I cannot be sure. Nevertheless, this seems reasonable.
The remote monitoring group did have a slightly higher rate of unscheduled appointments - .6 per year in the RM group and .5 in the conventional group; and the actionable percentage was .7% higher in the RM group. The differences could be considered marginally significant with a p = .104. If I understand the circumstances correctly, it seems reasonable that remotely monitored patients would have a higher rate of unscheduled appointments. Remote monitoring should have the capability of earlier detection of arrhythmic events. Thus a detected cardiac event would trigger the patient's to request that the patient come to the clinic as soon as possible thus an unscheduled appointment would be registered. One might expect remotely monitored patients would have appointments that are more demand or situation based than regular, scheduled appointments.
In spite of this difficulties of this design, the conclusions of this study seem reasonable in that the remotely monitored patients who received in-clinic check-ups once per year had similar outcomes to those who receives conventional care with four in-clinic visits per year.
A point of interest. No comparisons were made between Biotronik and remote monitoring systems provided by other companies such as Medtronic, St. Jude Medical or Boston Scientific. I understand the difficulties and roadblocks in the attempt to assess whether the other systems would be just as effective. However, Biotronik effectively side-stepped the issue by comparing their home monitoring system against conventional care thus avoiding comparisons with other remote monitoring systems. Biotronik focused on effectiveness against conventional care and in this case they were successful.
2009 Study
As a study to show the effectiveness of remote monitoring, I believe this study is more effective. First, it's a better design in that the expected outcome is to reject the null hypothesis - that is, to find a significant difference. Second, there is a clear case made by the findings that remote monitoring leads to earlier discovery of an adverse event. One truism in medicine, particularly when it comes to cardiac events, is the earlier the discovery, the better the outcome. Another thing, ICD patients have been identified as a vulnerable population and rapid reports of adverse events within this population are particularly welcome.
In theory, over time patients remotely monitored should show better outcomes than those who are not. The data in these two studies does not show that. However, data from other studies are starting to demonstrate that remotely monitored patients are less likely to be admitted to the hospital. This is a new area of technology and more research is required. However, the trends are favorable for remote monitoring.
In this study, the Biotronik remote monitoring system reported arrhythmic events. The data reported was not early warning or predictive. The capability to collect predictive data would increase the value of remote monitoring. Predictive data would allow the clinic (or computer system) following the patient to intervene before the adverse event occurs. In this study, this was not the case.
The 2009 study is a logical follow-up to the 2008 study. This study provided evidence that the Biotronik remote monitoring (Home Monitoring) system can provide early-warning notifications of significant cardiac events faster and more effectively than quarterly, in-clinic visits. This study has wider implications. It provides evidence that remote monitoring can provide the kind of care that at one time could only be provided in hospitals. Furthermore, it demonstrates the kind of capability necessary to provide the kind of early warning that can keep specific, targeted populations out of hospital, thus providing more economical and more desirable health care.
These studies are reprinted with permission from Biotronik. (I have no affiliation with Biotronik.)
2008 Study
Evaluation of Efficacy and Safety of Remote Monitoring for ICD Follow-Up:
The TRUST Trial
Authors: Niraj Varma, Cleveland Clinic, Cleveland, OH; Andrew Epstein UAB Medical Center, Birmingham, AL; , Univ of Alabama Birmingham Medical Center, Birmingham, AL; Robert Schweikert Cleveland Clinic, Cleveland, OH; , Akron Medical Center, Akron, OH; Charles Love, Davis Heart and Lung Research Institute, Columbus, OH; Jay Shah, Carolina Cardiology Associates, Rock Hill, SC; Anand Irimpen; Tulane University Medical Center, New Orleans, LA
Background: Remote monitoring (RM) of ICDs may provide daily, automatic device and patient status data and cardiac event notifications. TRUST tested the hypothesis that RM was safe and effective for ICD follow-up for 1 year in a prospective, randomized controlled clinical trial.
Methods: 1282 patients were randomized 2:1 to RM or to conventional (RM disabled) groups.Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. In the RM arm, RM was used before office visits (OVs) at 3 and 15 months. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. Conventional patients were evaluated with OVs only. Follow up was “actionable” if system reprogramming/revision or change in anti-arrhythmic therapy occurred. Scheduled and unscheduled OVs (including responses to event notifications in RM) were quantified for each individual patient per year (pt yr) of follow up. Incidence of death, strokes and surgical interventions (morbidity) was tracked in both groups.
Results: RM and conventional patients were similar in age (63.3 ± 12.9 vs 64.1 ± 12.0 yrs, p = 0.30), gender (71.9% vs 72.4% male, p =; 0.89), pathology (LVEF 29.1 ± 10.8% vs 28.6 ± 9.8%, p = 0.47;coronary artery disease 64.5% vs 71.4%, p = 0.02), medications (Beta blockers 79.5% vs 75.9%, ACE inhibitors 42.4% vs 46.8%, ARBs 7.8% vs 9.9%, p = NS), indication (primary prevention 72.3% vs 74.2%, p = 0.50), and dual chamber implants (57.9% vs 57.0%, p = 0.76). RM reduced scheduled OVs by 54% and total OVs by 42% without affecting morbidity. Event notifications were managed using RM alone in 92% of cases. Of the remainder resulting in unscheduled OVs, 52.2% were actionable. RM improved adherence to follow-up.
2009 Study
EARLY DETECTION OF ICD EVENTS USING REMOTE
MONITORING: THE TRUST TRIAL
Authors: Niraj Varma, MD, FRCP, Andrew Epstein, MD, Anand Irimpen, MD, Robert Schweikert, MD, Jay Shah, MD, Lori Gibson, DVM and Charles Love, MD. Cleveland Clinic, Cleveland, OH, University of Alabama Birmingham Medical Center, Birmingham, AL, Tulane University Medical Center, New Orleans, LA, Akron Medical Center, Akron, OH, Carolina Cardiology, Rock Hill, SC, Biotronik, Inc., Lake Oswego, OR, Davis Heart & Lung Research Institute, Columbus, OH
Introduction: ICDs have extensive self-monitoring capability with diagnostic data available at interrogation. Remote Monitoring (RM) may facilitate data access but this has not been tested. The secondary endpoint of the TRUST trial tested the hypothesis that RM with automatic daily surveillance can provide rapid notification thereby facilitating prompt physician evaluation.
Methods: 1312 patients were randomized 2:1 to RM or to conventional (C) groups. Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. RM was used before office visits (OVs) at 3 and 15 months in RM group. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. C patients were evaluated with OVs only. Unscheduled checks between these time points were tracked. The hypothesis was tested by determining time elapsed from first event occurrence in each patient to physician evaluation.
Results: RM and C patients were similar (age 63 ±13 vs 64 ±12 yrs; gender 72 vs 73% male, NYHA class II 56 vs 61%, pathology LVEF 29 ±11 vs 28 ± 10%; CAD 65 vs 72%, amiodarone 14 vs 14%, primary prevention indication 72 vs 74%, and DDD implants 58 vs 57%). Median time to evaluation was < 3 days in RM compared to < 30 days in C (p < 0.001) for all arrhythmic events (figure) including silent episodes eg AF. System (lead/ generator) problems were infrequent (20 events in RM +C).
Conclusions: Remote monitoring with automatic daily surveillance provides rapid detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling early physician evaluation.
Commentary
2008 Study
Of significant interest would be morbidity rate. The remote monitoring group showed a .9% higher death rate than the conventional group. This result was also nonsignificant. The nonsignificant difference appears to be expected outcome. Demonstrating a negative - or no difference - is always a concern in research because of the logical problem in demonstrating that something did not happen or that there are no difference between the groups.
I have an additional concern with respect to the unbalanced design. Unbalanced designs have lower power of your statistical power - that is, the ability to reject the null hypothesis - than balanced designs. And that would be of concern in study where the expected outcome is no difference. However, the numbers are extremely large that should off-set the reduction in statistical power created by the unbalanced design. Since I do not have the raw data, I cannot be sure. Nevertheless, this seems reasonable.
The remote monitoring group did have a slightly higher rate of unscheduled appointments - .6 per year in the RM group and .5 in the conventional group; and the actionable percentage was .7% higher in the RM group. The differences could be considered marginally significant with a p = .104. If I understand the circumstances correctly, it seems reasonable that remotely monitored patients would have a higher rate of unscheduled appointments. Remote monitoring should have the capability of earlier detection of arrhythmic events. Thus a detected cardiac event would trigger the patient's to request that the patient come to the clinic as soon as possible thus an unscheduled appointment would be registered. One might expect remotely monitored patients would have appointments that are more demand or situation based than regular, scheduled appointments.
In spite of this difficulties of this design, the conclusions of this study seem reasonable in that the remotely monitored patients who received in-clinic check-ups once per year had similar outcomes to those who receives conventional care with four in-clinic visits per year.
A point of interest. No comparisons were made between Biotronik and remote monitoring systems provided by other companies such as Medtronic, St. Jude Medical or Boston Scientific. I understand the difficulties and roadblocks in the attempt to assess whether the other systems would be just as effective. However, Biotronik effectively side-stepped the issue by comparing their home monitoring system against conventional care thus avoiding comparisons with other remote monitoring systems. Biotronik focused on effectiveness against conventional care and in this case they were successful.
2009 Study
As a study to show the effectiveness of remote monitoring, I believe this study is more effective. First, it's a better design in that the expected outcome is to reject the null hypothesis - that is, to find a significant difference. Second, there is a clear case made by the findings that remote monitoring leads to earlier discovery of an adverse event. One truism in medicine, particularly when it comes to cardiac events, is the earlier the discovery, the better the outcome. Another thing, ICD patients have been identified as a vulnerable population and rapid reports of adverse events within this population are particularly welcome.
In theory, over time patients remotely monitored should show better outcomes than those who are not. The data in these two studies does not show that. However, data from other studies are starting to demonstrate that remotely monitored patients are less likely to be admitted to the hospital. This is a new area of technology and more research is required. However, the trends are favorable for remote monitoring.
In this study, the Biotronik remote monitoring system reported arrhythmic events. The data reported was not early warning or predictive. The capability to collect predictive data would increase the value of remote monitoring. Predictive data would allow the clinic (or computer system) following the patient to intervene before the adverse event occurs. In this study, this was not the case.
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