TRANSACTIONS OF THE AMERICAN CLINICAL AND CLIMATOLOGICAL ASSOCIATION, VOL. 126, 2015
PROJECT MY HEART YOUR HEART: AN IDEA WHOSE TIME HAS COME KIM A. EAGLE, MD, and (by invitation) THOMAS C. CRAWFORD, MD, and TIMIR BAMAN, MD ANN ARBOR, MI
ABSTRACT It is estimated that nearly 1 million patients in low-income countries die every year from bradyarrhythmias coupled with no access to a pacemaker. At the same time, it is estimated that tens of thousands of used devices could be harvested from hospitals, funeral homes, and crematories in wealthy nations if such a practice was legal and proven to be safe and efficacious. Project My Heart Your Heart is a collaborative, multinational effort with a goal of making pacemaker recycling a reality. Since its inception 4 years ago, the project has studied beliefs and attitudes of this idea among patients, pacemaker recipients, funeral home directors, and arrhythmia specialists. The project has explored the safety and efficacy of this practice in several small pilot studies. Nearly 15,000 used devices have been received and evaluated. Efforts to fully define optimal methods for sterilization and device processing have progressed positively. Safe, effective pacemaker recycling is possible and is generally supported by the public, patients, and cardiovascular specialists. An ongoing dialogue with the FDA will hopefully lead to a large pivotal study in five countries which will definitively establish this practice including optimal strategies for device removal, interrogation, sterilization, handling, implantation, and follow-up at charitable pacemaker facilities servicing low income patients throughout the world.
INTRODUCTION It is estimated that nearly 1 million patients in low-income countries die every year from bradyarrhythmias coupled with no access to a pacemaker (1). With a growing burden of cardiovascular disease in these very Correspondence and reprint requests: Kim. A. Eagle, MD, Division of Cardiovascular Medicine, Department of Internal Medicine and the Samuel and Jean Frankel Cardiovascular Center, University of Michigan Health System, 1500 East Medical Center Drive, SPC 5853, Ann Arbor, MI 481105-5853, E-mail: [email protected]. Supported by the Frankel Cardiovascular Center (University of Michigan), the Hewlett Foundation, the Mardigian Foundation, and gifts from Mr and Mrs Sheldon Davis and Mr and Mrs Craig Sincock. Potential Conflicts of Interest: None disclosed.
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same countries, the gulf between the bradyarrhythmic treatment available and unmet need is only expected to grow (2). Accordingly, it is perfectly appropriate to consider the option of pacemaker recycling as a viable solution to address this unmet need. Currently it is known that tens of thousands of used devices could be harvested from hospitals, funeral homes, and crematories in wealthy nations if such a practice was legal and proven to be safe and efficacious (3). METHODS Project My Heart Your Heart is a collaborative, multinational effort which has a goal of making pacemaker recycling a reality (1–3). During the past 5 years, the project has addressed various aspects of this possibility and this report is a reflection of that work. To make the case for device reuse, the Project My Heart Your Heart team sought to understand beliefs and attitudes of patients, individuals from the general population, funeral home directors, and arrhythmia specialists. The methods surrounding each of these surveys are noted in the references. In addition, making the case for device reuse requires an assessment of device availability which is addressed in the results section. Finally, a successful effort in pacemaker reuse will require ongoing evidence of the safety and efficacy of device reuse (3). RESULTS When we surveyed both patients from the general population as well as patients receiving pacemakers, there was an overwhelming majority who supported the notion of providing a pacemaker or implantable car-
FIG. 1. Population opinions.
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dioverter defibrillator (ICD) from a loved one if that device would be used for someone in another country who otherwise could not afford a new one (Figure 1) (4). When we surveyed 90 funeral home directors, we determined that 84% discard pacemakers in waste or store them with no intended purpose, and just 4% of those surveyed return the pacemaker to the manufacturer (4). When we asked the question “would you support a central independent organization to regulate device distribution back to manufacturers,” 81% said yes, and 89% said they would be willing to donate the device to a charitable organization if given the opportunity (4). When one looks at data regarding post-mortem removal, it is widely known that pacemakers and devices must be extracted before an individual is cremated after death. It is estimated that nearly 50% of all deaths in the United States by the year 2025 will be followed by cremation. This means that there is an ever-enlarging pool of potential devices that are being automatically removed at funeral homes and crematories after a person has passed.
FIG. 2. (A, B) Battery longevity study at the University of Michigan.
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Finally, when we surveyed arrhythmia specialists about pacemaker reuse, 86% indicated it would be appropriate to use devices from deceased patients (5). Eighty-eight percent indicated that this was an appropriate strategy assuming good battery life, and 83% indicated a willingness to actually implant a device if this was legal. The next question we asked was whether there is evidence for a reasonable pool of usable devices. Figure 2A shows an analysis of battery longevity in devices that have been explanted at our medical center. In this study, we evaluated 326 consecutive devices that were returned for consideration of reuse. Of these, 133 or 41% were removed for reasons other than end of battery life. When we looked for devices with ⬎50% battery life, 74% of these 133 devices had an extended battery life available (6) (Figure 2B). During a period of 5 years, Project My Heart Your Heart has received pacemaker donations from virtually every state in the country. Figure 3 shows the state of origin for 12,736 devices received by the Project My Heart Your Heart team. With no concerted efforts to reach all funeral homes and crematories, our experience suggests that thousands of usable devices are available. The next question is what is the current evidence favoring pacemaker safety and efficacy. In a meta-analysis, we were able to show that reutilized pacemakers are not at a higher risk of infection when compared to new device implants (7) (Figure 4). This was based on an analysis of more than 6,000 devices studied in the past (7). However, pacemaker reuse is associated with a higher risk of device malfunction which in studies of 2,200 patients has been in the range of 5% (Figure 5). We believe that this may well relate to issues with the set screws and the header which, if not carefully removed and properly cleaned, re-evaluated and tested,
FIG. 3. Pacemaker donations in the United States from 2009 to 2014.
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FIG. 4. Pacemaker meta-analysis. Forest plot of odds ratios of patients developing an infection after implantation of re-used pacemakers versus implantation of new pacemakers.
FIG. 5. Pacemaker meta-analysis.
can lead to device malfunction. We have previously published a small series of 12 patients suggesting that outcomes from pacemaker reuse with appropriate selection of devices and subjects can be excellent (1). Based on this work as well as other activities, we have created a product handling work flow that we believe represents a reasonable model for how pacemaker recycling can be systematized (Figures 6A and 6B). In addition, we have articulated what we believe is the appropriate vision for used pacemaker use through identification of a center of excellence, appropriate involvement of funeral homes and crematories, the involvement of non-profit charitable organizations, the involvement of low-income country device implantation centers, and the appropriate role for legal counsel and the FDA in a process of oversight (2) (Figure 7). DISCUSSION Pacemaker recycling was a reality in a number of countries in years past. For a variety of reasons, the practice fell out of favor and has not
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FIG. 6. (A, B) Product handling workflow for Project My Heart Your Heart.
been supported in a public way for nearly 2 decades. However, based on our early experiences, we believe that pacemaker recycling offers a remarkable opportunity to prevent death from bradyarrhythmias in a number of low-income countries throughout the world. As noted in this publication, the general notion of pacemaker recycling is widely supported by the general public, individuals receiving devices, individuals who run funeral homes, and even arrhythmia physicians who implant pacemakers and defibrillators. Furthermore, the evidence supporting the argument that this can be performed safely and effectively is continuing
164
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FIG. 7. Flowchart showing our vision for used pacemaker use through identification of a center of excellence, appropriate involvement of funeral homes and crematories, the involvement of non-profit charitable organizations, the involvement of low-income country device implantation centers, and the appropriate role for legal counsel and the FDA.
to build. Accordingly, we believe that in the future this should become a common reality. Given the fact that used pacemakers currently reside in buckets and boxes in crematories and funeral homes throughout the world while individuals living in low-income countries are simultaneously denied the opportunity for health because of lack of a pacemaker, someone must bridge this gap. Project My Heart Your Heart is a large collaborative which is endeavoring to do just this. ACKNOWLEDGMENTS We would like to acknowledge Mr. Jay Snell, who has provided key expertise in the development of the product handling workflow.
REFERENCES 1. Baman TS, Romero A, Kirkpatrick JN, et al. Safety and efficacy of pacemaker reuse in underdeveloped nations: a case series. J Am Coll Cardiol 2009;54:1557– 8. 2. Baman TS, Kirkpatrick JN, Romero J, et al. Pacemaker reutilization: an initiative to alleviate the burden of symptomatic bradyarrhythmia in impoverished nations around the world. Circulation 2010;122:1649 –56.
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3. Kirkpatrick JN, Papini C, Baman TS, et al. Reuse of pacemakers and defibrillators in developing countries: logistical, legal, and ethical barriers and solutions. Heart Rhythm 2010;7:1623–7. 4. Gakenheimer L, Lange DC, Romero J, et al. Societal views of pacemaker reutilization for those with untreated symptomatic bradycardia in underserved nations. J Interv Card Electrophysiol 2011;30:261– 6. 5. Kumbhani DJ, Steg PG, Cannon CP, et al. Statin therapy and long-term adverse limb outcomes in patients with peripheral artery disease: insights from the REACH registry. Eur Heart J 2014; [Epub ahead of print]. 6. Baman TS, Crawford T, Sovitch P, et al. Feasibility of postmortem device acquisition for potential reuse in underserved nations. Heart Rhythm 2012;9:211– 4. 7. Baman TS, Meier P, Romero J, et al. Safety of pacemaker reutilization: a metaanalysis with implications for underserved nations. Circ Arrhythm Electrophysiol 2011;4:318 –23.
DISCUSSION Gotto, New York: Many years ago when I was at Baylor, starting in the 70s, there was a young cardiologist who trained with us, Federico Alfaro. He had watched a young 17-year-old boy die in front of his eyes in Guatemala with heart block because he didn’t have a pacemaker. He began forming a pacemaker bank. Then the chair of medicine who preceded me in Baylor, Dr Henry MacIntosh, took this on with a zeal and enthusiasm that kept him going for a long time. They formed Heartbeat International. When I was on the Board of Medtronic, Dr MacIntosh was constantly lobbying me to try to get more pacemakers. What is the relationship of your organization to Heartbeat International or to others? Are you working together? Eagle, Ann Arbor: Dr MacIntosh formed Heartbeat International. They use new devices that have been expired on the shelf, and those are supplied by manufacturers. Currently they can offer 500 to 1,000 devices per year. They have about 15 clinics in the world that they work with. Tom Crawford who is leading our program is now on their board. We are trying to work in close collaboration with them. The thing is there are over 100,000 used devices harvested in this country every year. So the scale that we can reach in terms of human life is much greater if we join forces. And this is not even to mention countries in Europe, Japan, etc, who also have a large resource. But we have to band together. Our first foray with Heartbeat International 5 years ago was that they didn’t really want to talk to us much, because they were worried that the manufacturers that sponsored them would be very uneasy with this notion. But as the years have gone on we have become much more collaborative. I feel optimistic that working together we can do more. Dr MacIntosh was a giant in this field, and I want to honor him for sure. Glassroth, Chicago: I have two brief questions. First, having provided the pacemaker to a patient, do you have any ongoing commitment to providing replacements, batteries, so forth, down the line as those become needed? Eagle, Ann Arbor: We go to every place that we implant. One of our team members goes there to make sure that we are comfortable with the quality, safety, and the ability to track. Actually we have used Heartbeat International’s standard operating procedures to establish that. We have an online database that allows the investigators anywhere to put their patient in, so that if there is a device recall or something like that, we can attempt to reach them and give them another device. But that is a very important part of our work, so thank you for asking that question. Glassroth, Chicago: The second question relates to other organizations that provide
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medical devices, not pacemakers; dialysis machines come to mind. Are you working or interacting with any of those groups in any way? Eagle, Ann Arbor: So that is a key part of the work; we need to work with organizations that are already doing this. They know the countries, they know the leaders, they know the people. For this pilot we have chosen World Medical Relief which is in Detroit. It is the second largest supplier of used medical supplies in the world; started by a single housewife during the Korean conflict in 1955 who saw Korean orphans on TV not getting medications and decided to do something about it. We work with World Medical Relief to go to the 135 countries in various hospitals they are working with to find the first wave of where we can go. Around the world we are going to need to do this. There are folks that are very expert in this, and we need to work with them in partnerships. Calkins, Baltimore: What has the response been from manufacturers of devices? I am sure you have had interactions with them. How have you managed to get funding for this effort? It is a herculean task, and I would be interested in your path. I assume the NIH is not funding your research in this, so I would love to hear what you have done to make this possible. Eagle, Ann Arbor: Let’s start with the manufacturers. It’s been mixed. BIOTRONIK has been willing to donate new leads for our trial. I was on the front page of the Minnesota Star — not in a good way. The Vice President of Medtronic was talking about our work and said, “Dr Eagle doesn’t understand that our devices are made for single use.” So we have seen everything in between. I have written to the presidents of the major manufacturers. Most of the time I am ignored, but some of them are beginning to understand that the world need is so large that we should probably do this. And it can be done safely and effectively if we do it right. The second question is funding. The Frankel Cardiovascular Center gave us a startup grant of $50,000 and it just so happens that one of my patients was vice president of a pacemaker company. He has decided to donate as much as 1 million dollars of his resources because he believes so strongly that this must happen. So he is helping us as we move along, particularly like flying physicians to other countries to help set up pacemaker labs and things like that. Rice, Providence: Have you considered offering this to people of limited means in the United States? Eagle, Ann Arbor: So the answer to your question is that would be very difficult to do in the current climate. The need is so large outside of the United States, and I think it is rare that a patient in the United States dies for lack of a pacemaker. I actually think it is currently a rare patient and one can usually find a charitable hospital that will do this. So we haven’t. Of course for manufacturers this represents perhaps the greatest threat. Alpert, Tucson: When I first came here 21 years ago as chair of medicine, I had very good friends that I helped train back in Boston and Venezuela. Of course they had a huge indigent population that cannot afford the private hospitals, and they said to us, “Can you send us your used catheters and you know, we throw away hundreds of thousands of pieces of equipment every single month?” I said, “Sure what a great idea.” You can imagine the backlash — from the hospital, from the group practice, from the industry. I was almost afraid to go home at night: am I going to have rocks thrown through the window? There was a huge negative feeling, and the same thing about using it on indigent patients in the US. Of course what they said, “Hey all there has to be is one HIV case you know and it will be a hundred million dollars down the drain.” So I applaud what you are doing and I think it is fabulous, and I am glad you finally were able to at least partly break the barrier. Eagle, Ann Arbor: We are on our way, thank you Joe.
PROJECT MY HEART YOUR HEART: AN IDEA WHOSE TIME HAS COME KIM A. EAGLE, MD, and (by invitation) THOMAS C. CRAWFORD, MD, and TIMIR BAMAN, MD ANN ARBOR, MI
ABSTRACT It is estimated that nearly 1 million patients in low-income countries die every year from bradyarrhythmias coupled with no access to a pacemaker. At the same time, it is estimated that tens of thousands of used devices could be harvested from hospitals, funeral homes, and crematories in wealthy nations if such a practice was legal and proven to be safe and efficacious. Project My Heart Your Heart is a collaborative, multinational effort with a goal of making pacemaker recycling a reality. Since its inception 4 years ago, the project has studied beliefs and attitudes of this idea among patients, pacemaker recipients, funeral home directors, and arrhythmia specialists. The project has explored the safety and efficacy of this practice in several small pilot studies. Nearly 15,000 used devices have been received and evaluated. Efforts to fully define optimal methods for sterilization and device processing have progressed positively. Safe, effective pacemaker recycling is possible and is generally supported by the public, patients, and cardiovascular specialists. An ongoing dialogue with the FDA will hopefully lead to a large pivotal study in five countries which will definitively establish this practice including optimal strategies for device removal, interrogation, sterilization, handling, implantation, and follow-up at charitable pacemaker facilities servicing low income patients throughout the world.
INTRODUCTION It is estimated that nearly 1 million patients in low-income countries die every year from bradyarrhythmias coupled with no access to a pacemaker (1). With a growing burden of cardiovascular disease in these very Correspondence and reprint requests: Kim. A. Eagle, MD, Division of Cardiovascular Medicine, Department of Internal Medicine and the Samuel and Jean Frankel Cardiovascular Center, University of Michigan Health System, 1500 East Medical Center Drive, SPC 5853, Ann Arbor, MI 481105-5853, E-mail: [email protected]. Supported by the Frankel Cardiovascular Center (University of Michigan), the Hewlett Foundation, the Mardigian Foundation, and gifts from Mr and Mrs Sheldon Davis and Mr and Mrs Craig Sincock. Potential Conflicts of Interest: None disclosed.
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same countries, the gulf between the bradyarrhythmic treatment available and unmet need is only expected to grow (2). Accordingly, it is perfectly appropriate to consider the option of pacemaker recycling as a viable solution to address this unmet need. Currently it is known that tens of thousands of used devices could be harvested from hospitals, funeral homes, and crematories in wealthy nations if such a practice was legal and proven to be safe and efficacious (3). METHODS Project My Heart Your Heart is a collaborative, multinational effort which has a goal of making pacemaker recycling a reality (1–3). During the past 5 years, the project has addressed various aspects of this possibility and this report is a reflection of that work. To make the case for device reuse, the Project My Heart Your Heart team sought to understand beliefs and attitudes of patients, individuals from the general population, funeral home directors, and arrhythmia specialists. The methods surrounding each of these surveys are noted in the references. In addition, making the case for device reuse requires an assessment of device availability which is addressed in the results section. Finally, a successful effort in pacemaker reuse will require ongoing evidence of the safety and efficacy of device reuse (3). RESULTS When we surveyed both patients from the general population as well as patients receiving pacemakers, there was an overwhelming majority who supported the notion of providing a pacemaker or implantable car-
FIG. 1. Population opinions.
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dioverter defibrillator (ICD) from a loved one if that device would be used for someone in another country who otherwise could not afford a new one (Figure 1) (4). When we surveyed 90 funeral home directors, we determined that 84% discard pacemakers in waste or store them with no intended purpose, and just 4% of those surveyed return the pacemaker to the manufacturer (4). When we asked the question “would you support a central independent organization to regulate device distribution back to manufacturers,” 81% said yes, and 89% said they would be willing to donate the device to a charitable organization if given the opportunity (4). When one looks at data regarding post-mortem removal, it is widely known that pacemakers and devices must be extracted before an individual is cremated after death. It is estimated that nearly 50% of all deaths in the United States by the year 2025 will be followed by cremation. This means that there is an ever-enlarging pool of potential devices that are being automatically removed at funeral homes and crematories after a person has passed.
FIG. 2. (A, B) Battery longevity study at the University of Michigan.
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Finally, when we surveyed arrhythmia specialists about pacemaker reuse, 86% indicated it would be appropriate to use devices from deceased patients (5). Eighty-eight percent indicated that this was an appropriate strategy assuming good battery life, and 83% indicated a willingness to actually implant a device if this was legal. The next question we asked was whether there is evidence for a reasonable pool of usable devices. Figure 2A shows an analysis of battery longevity in devices that have been explanted at our medical center. In this study, we evaluated 326 consecutive devices that were returned for consideration of reuse. Of these, 133 or 41% were removed for reasons other than end of battery life. When we looked for devices with ⬎50% battery life, 74% of these 133 devices had an extended battery life available (6) (Figure 2B). During a period of 5 years, Project My Heart Your Heart has received pacemaker donations from virtually every state in the country. Figure 3 shows the state of origin for 12,736 devices received by the Project My Heart Your Heart team. With no concerted efforts to reach all funeral homes and crematories, our experience suggests that thousands of usable devices are available. The next question is what is the current evidence favoring pacemaker safety and efficacy. In a meta-analysis, we were able to show that reutilized pacemakers are not at a higher risk of infection when compared to new device implants (7) (Figure 4). This was based on an analysis of more than 6,000 devices studied in the past (7). However, pacemaker reuse is associated with a higher risk of device malfunction which in studies of 2,200 patients has been in the range of 5% (Figure 5). We believe that this may well relate to issues with the set screws and the header which, if not carefully removed and properly cleaned, re-evaluated and tested,
FIG. 3. Pacemaker donations in the United States from 2009 to 2014.
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FIG. 4. Pacemaker meta-analysis. Forest plot of odds ratios of patients developing an infection after implantation of re-used pacemakers versus implantation of new pacemakers.
FIG. 5. Pacemaker meta-analysis.
can lead to device malfunction. We have previously published a small series of 12 patients suggesting that outcomes from pacemaker reuse with appropriate selection of devices and subjects can be excellent (1). Based on this work as well as other activities, we have created a product handling work flow that we believe represents a reasonable model for how pacemaker recycling can be systematized (Figures 6A and 6B). In addition, we have articulated what we believe is the appropriate vision for used pacemaker use through identification of a center of excellence, appropriate involvement of funeral homes and crematories, the involvement of non-profit charitable organizations, the involvement of low-income country device implantation centers, and the appropriate role for legal counsel and the FDA in a process of oversight (2) (Figure 7). DISCUSSION Pacemaker recycling was a reality in a number of countries in years past. For a variety of reasons, the practice fell out of favor and has not
PROJECT MY HEART YOUR HEART
163
FIG. 6. (A, B) Product handling workflow for Project My Heart Your Heart.
been supported in a public way for nearly 2 decades. However, based on our early experiences, we believe that pacemaker recycling offers a remarkable opportunity to prevent death from bradyarrhythmias in a number of low-income countries throughout the world. As noted in this publication, the general notion of pacemaker recycling is widely supported by the general public, individuals receiving devices, individuals who run funeral homes, and even arrhythmia physicians who implant pacemakers and defibrillators. Furthermore, the evidence supporting the argument that this can be performed safely and effectively is continuing
164
KIM A. EAGLE ET AL
FIG. 7. Flowchart showing our vision for used pacemaker use through identification of a center of excellence, appropriate involvement of funeral homes and crematories, the involvement of non-profit charitable organizations, the involvement of low-income country device implantation centers, and the appropriate role for legal counsel and the FDA.
to build. Accordingly, we believe that in the future this should become a common reality. Given the fact that used pacemakers currently reside in buckets and boxes in crematories and funeral homes throughout the world while individuals living in low-income countries are simultaneously denied the opportunity for health because of lack of a pacemaker, someone must bridge this gap. Project My Heart Your Heart is a large collaborative which is endeavoring to do just this. ACKNOWLEDGMENTS We would like to acknowledge Mr. Jay Snell, who has provided key expertise in the development of the product handling workflow.
REFERENCES 1. Baman TS, Romero A, Kirkpatrick JN, et al. Safety and efficacy of pacemaker reuse in underdeveloped nations: a case series. J Am Coll Cardiol 2009;54:1557– 8. 2. Baman TS, Kirkpatrick JN, Romero J, et al. Pacemaker reutilization: an initiative to alleviate the burden of symptomatic bradyarrhythmia in impoverished nations around the world. Circulation 2010;122:1649 –56.
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3. Kirkpatrick JN, Papini C, Baman TS, et al. Reuse of pacemakers and defibrillators in developing countries: logistical, legal, and ethical barriers and solutions. Heart Rhythm 2010;7:1623–7. 4. Gakenheimer L, Lange DC, Romero J, et al. Societal views of pacemaker reutilization for those with untreated symptomatic bradycardia in underserved nations. J Interv Card Electrophysiol 2011;30:261– 6. 5. Kumbhani DJ, Steg PG, Cannon CP, et al. Statin therapy and long-term adverse limb outcomes in patients with peripheral artery disease: insights from the REACH registry. Eur Heart J 2014; [Epub ahead of print]. 6. Baman TS, Crawford T, Sovitch P, et al. Feasibility of postmortem device acquisition for potential reuse in underserved nations. Heart Rhythm 2012;9:211– 4. 7. Baman TS, Meier P, Romero J, et al. Safety of pacemaker reutilization: a metaanalysis with implications for underserved nations. Circ Arrhythm Electrophysiol 2011;4:318 –23.
DISCUSSION Gotto, New York: Many years ago when I was at Baylor, starting in the 70s, there was a young cardiologist who trained with us, Federico Alfaro. He had watched a young 17-year-old boy die in front of his eyes in Guatemala with heart block because he didn’t have a pacemaker. He began forming a pacemaker bank. Then the chair of medicine who preceded me in Baylor, Dr Henry MacIntosh, took this on with a zeal and enthusiasm that kept him going for a long time. They formed Heartbeat International. When I was on the Board of Medtronic, Dr MacIntosh was constantly lobbying me to try to get more pacemakers. What is the relationship of your organization to Heartbeat International or to others? Are you working together? Eagle, Ann Arbor: Dr MacIntosh formed Heartbeat International. They use new devices that have been expired on the shelf, and those are supplied by manufacturers. Currently they can offer 500 to 1,000 devices per year. They have about 15 clinics in the world that they work with. Tom Crawford who is leading our program is now on their board. We are trying to work in close collaboration with them. The thing is there are over 100,000 used devices harvested in this country every year. So the scale that we can reach in terms of human life is much greater if we join forces. And this is not even to mention countries in Europe, Japan, etc, who also have a large resource. But we have to band together. Our first foray with Heartbeat International 5 years ago was that they didn’t really want to talk to us much, because they were worried that the manufacturers that sponsored them would be very uneasy with this notion. But as the years have gone on we have become much more collaborative. I feel optimistic that working together we can do more. Dr MacIntosh was a giant in this field, and I want to honor him for sure. Glassroth, Chicago: I have two brief questions. First, having provided the pacemaker to a patient, do you have any ongoing commitment to providing replacements, batteries, so forth, down the line as those become needed? Eagle, Ann Arbor: We go to every place that we implant. One of our team members goes there to make sure that we are comfortable with the quality, safety, and the ability to track. Actually we have used Heartbeat International’s standard operating procedures to establish that. We have an online database that allows the investigators anywhere to put their patient in, so that if there is a device recall or something like that, we can attempt to reach them and give them another device. But that is a very important part of our work, so thank you for asking that question. Glassroth, Chicago: The second question relates to other organizations that provide
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medical devices, not pacemakers; dialysis machines come to mind. Are you working or interacting with any of those groups in any way? Eagle, Ann Arbor: So that is a key part of the work; we need to work with organizations that are already doing this. They know the countries, they know the leaders, they know the people. For this pilot we have chosen World Medical Relief which is in Detroit. It is the second largest supplier of used medical supplies in the world; started by a single housewife during the Korean conflict in 1955 who saw Korean orphans on TV not getting medications and decided to do something about it. We work with World Medical Relief to go to the 135 countries in various hospitals they are working with to find the first wave of where we can go. Around the world we are going to need to do this. There are folks that are very expert in this, and we need to work with them in partnerships. Calkins, Baltimore: What has the response been from manufacturers of devices? I am sure you have had interactions with them. How have you managed to get funding for this effort? It is a herculean task, and I would be interested in your path. I assume the NIH is not funding your research in this, so I would love to hear what you have done to make this possible. Eagle, Ann Arbor: Let’s start with the manufacturers. It’s been mixed. BIOTRONIK has been willing to donate new leads for our trial. I was on the front page of the Minnesota Star — not in a good way. The Vice President of Medtronic was talking about our work and said, “Dr Eagle doesn’t understand that our devices are made for single use.” So we have seen everything in between. I have written to the presidents of the major manufacturers. Most of the time I am ignored, but some of them are beginning to understand that the world need is so large that we should probably do this. And it can be done safely and effectively if we do it right. The second question is funding. The Frankel Cardiovascular Center gave us a startup grant of $50,000 and it just so happens that one of my patients was vice president of a pacemaker company. He has decided to donate as much as 1 million dollars of his resources because he believes so strongly that this must happen. So he is helping us as we move along, particularly like flying physicians to other countries to help set up pacemaker labs and things like that. Rice, Providence: Have you considered offering this to people of limited means in the United States? Eagle, Ann Arbor: So the answer to your question is that would be very difficult to do in the current climate. The need is so large outside of the United States, and I think it is rare that a patient in the United States dies for lack of a pacemaker. I actually think it is currently a rare patient and one can usually find a charitable hospital that will do this. So we haven’t. Of course for manufacturers this represents perhaps the greatest threat. Alpert, Tucson: When I first came here 21 years ago as chair of medicine, I had very good friends that I helped train back in Boston and Venezuela. Of course they had a huge indigent population that cannot afford the private hospitals, and they said to us, “Can you send us your used catheters and you know, we throw away hundreds of thousands of pieces of equipment every single month?” I said, “Sure what a great idea.” You can imagine the backlash — from the hospital, from the group practice, from the industry. I was almost afraid to go home at night: am I going to have rocks thrown through the window? There was a huge negative feeling, and the same thing about using it on indigent patients in the US. Of course what they said, “Hey all there has to be is one HIV case you know and it will be a hundred million dollars down the drain.” So I applaud what you are doing and I think it is fabulous, and I am glad you finally were able to at least partly break the barrier. Eagle, Ann Arbor: We are on our way, thank you Joe.
