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Identifying Opportunities and Challenges in Electrophysiology: Interview with Douglas L. Packer, MD, FHRS
On December 14-15, 2010, the Heart Rhythm Society (HRS) held its inaugural research forum to identify opportunities and challenges to advancing electrophysiology research in the United States and abroad. In this feature interview, we speak with Douglas L. Packer, MD, FHRS, President of the Heart Rhythm Society, to learn more about the research forum.
What prompted the creation of a Research Forum?
Every five years, the Heart Rhythm Society has a strategic planning session. It actually takes place over the course of a year, during which a very specific process is utilized to design a 
plan that will guide HRS over the next five years. This was about a year and a half ago, and without getting into the details of the plan, we came up with a mission statement, a vision, very clear goals, and began to elaborate on objectives that would allow us to achieve those goals. Out of the plan came four chief goals. One of them was for the Heart Rhythm Society to become the leader in research in the area of heart rhythm disorders. This may seem like a fairly big goal, but we don’t apologize for it; we recognize that research is very much the number one most important insurance policy for our patients in the future. It’s more important than public options, it’s more important than private options — it ensures patients’ future health and gives guidance to future clinical activities. The Society felt that we had an obligation to act on that mission, to act on that need. We felt that the Society had to step up and pay attention. Now, as you know, HRS has spent a lot of time on health policy. Physicians tend to spend a lot of time on reimbursement issues, regulatory affairs, and even legislative enterprises. Those are important. Those frequently are about the business of medicine or advocacy for the Society, so we don’t step away from those. But I do think we have to spend as much time, effort and expertise on the research side of the society. Now, when I say research, we’re not just talking about basic science, but also translational and clinical research. We believe that the Heart Rhythm Society is the very best suited for shaping that research agenda. We need to move the agenda forward and turn that agenda into research insurance for patients.
Why was it important to include a diverse group of attendees? How were the working groups organized in order to best encourage discussion?
First, there are a number of stakeholders in research, including the National Institutes of Health (NIH), National Heart, Lung and Blood Institute (NHLBI), the American Heart 
Association, and others, including foundations, patient care organizations, patient advocacy groups, and scientists. There are members of government organizations such as the FDA and CMS, and then there are groups like StopAF.org who are all very much concerned about the future, that they also in various ways impact how research is done. Sometimes that is through financial means, and sometimes it’s done through regulatory means. We felt that to be successful in the entire quest, they had to be there. They had to see that this had become very important for us, and that it’s our intention to run with this. Now, HRS has some amazing researchers and scientists, and perhaps more importantly, an amazing group of clinicians who want to be engaged in research. So we needed to bring together representation from that group so that we’ll be much more successful working together than we would be if we were working alone.
You also asked about the work groups. The first part of the meeting featured Dr. Francis Collins, Director of the NIH, and Susan Dentzer, Health Correspondent for PBS and Editor-in-Chief of Health Affairs, who presented us with the broad brushstrokes look at the future. The next morning we worked with Mary Woolley (also from Health Affairs) to look at barriers and obstacles to innovation and research. We then had sessions on the HRS view of overcoming those obstacles. The work groups came out of that latter session. The work groups were designed to take us from ‘here’s what we can do in a broad sense’ to the objectives level — from high-level logistics to bring us right down to low-level logistics and tactics for accomplishing those very issues.
Tell us about your discussion on the current barriers to innovation and implementation from the “PI Perspective” — what were some of the main points addressed?
We built on the comments from Michael Lauer, MD from the NIH and from Bram Zuckerman, MD from the FDA. I talked about the issues apparent in clinical trials. Obviously, one of them is funding. Another aspect, on a local level, is the infrastructure in the EP lab. As you know, EP lab doctors, nurses and technicians are extremely busy. So I presented on a concern about the distraction that all of that is to obtain and maintain our lofty research culture. I talked about some of the issues involved with bringing a higher level of enthusiasm for research studies and a variety of other regulatory issues, for example, the time that it takes a large clinical trial like CABANA to get up and running, the contract issues, how long it takes to get a legal document through, etc. These issues are critical for doing research, but they can be extremely difficult to navigate, and I felt that it was important to simply review what they were and open a dialogue on how to overcome them.
Tell us about some of the sessions that focused on involving patients and their families. What can you tell us about these sessions?
Patients and families are part of the entire equation, of necessity. We didn’t spend that much time focusing, per se, on that topic, although the program as a whole looked at the goal of benefiting patients with better science, discovery, innovation, techniques and, lastly, technologies. Patients and their families are very interested in that. The patient representatives that were there were very much engaged in making sure their voices were heard. A research program is not going to be effective if it doesn’t perform for the patient, and the patient’s voice has to be heard to know their own view on what should be done. That is very critical.
Tell us about HRS.TrialNet, and how soon we could see this available.
One of the major strengths of the Heart Rhythm Society is that we sit at the interface between groups such as basic scientists, translational scientists and clinical researchers. We can talk about science, innovation, or discoveries, but we also have to implement it. The clinical TrialNet is intended to do that — to facilitate the conduct of clinical trials, such that we accomplish the goals that are set before us. Clinical TrialNet is intended to increase the involvement of the clinicians from HRS who want to be involved with research, who have some impediment to that, but given the opportunity would be part of something bigger and better. This will be rolled out over the course of the next 6–12 months. It will start small and will involve 1 or 2 relatively small projects. As the infrastructure at each site is put into place and as the Society assists in the infrastructure, dealing with global IRBs, more global contracts, resource utilization and concept development, we believe that investigators will be able to do just that. So we want to give them the pathway, the capability of getting out there and moving on.
One of the recommendations from the Advancing Research Careers working group was to “create a mentorship network.” Can you tell us more about this?
There should be an excellent mentor at the institution. That mentor guides the fellows through learning the core principles of cardiac electrophysiology and applying them in patients. In some cases, the mentors aid in the development of research capabilities. In other centers, that is less well developed. Certainly after a fellow leaves the nest, they may have no easy access to someone who can lead them along a pathway of clinical investigation. And so the mentor program is doing that: providing critical guidance in very much transitional time frames — when they’re making their transition to practice and transition to independence. So we think that is a necessary part of the overall research effort.
Another interesting recommendation was to “develop research experiences for high school and medical students,” in the Supporting & Funding Research working group. What can you tell us about this?
Well, that is one of the things that came out of one of the work groups. The concern that we have as a Society, and the concern at NIH, NHLBI, and investigational institutes, is a turning away of bright young minds from research activities. So one of the potential mentoring activities that could emerge from this would be for individual investigators in individual cities to be willing to do something truly altruistic. To reach out to high schools, or more importantly to middle schools, to share their enthusiasm and, in turn, engender enthusiasm so that in a formative period, the students would catch the research bug, and carry that through middle school, high school and go on to college.
What steps will the HRS be taking in the coming year to address the working group recommendations from the Research Forum?
The next step is to publish the outcomes, and publish the final word from this forum. That happens first. That will be coming out in HeartRhythm, and will be a very clear clarion call: it will be a call to arms to stand up and work on this research agenda, for all the reasons that I mentioned before. The second step will be another research forum to look at our progress. Third, there are critical funding components that need to come into play. Fourth, the dissemination of the entire agenda, the enthusiasm and the strong sense of urgency. So those things will be brought in that research report format. We will now be sponsoring up to 4 transitional research awards for $50,000 each that will go to young investigators who are making that critical transition from fellowship to independence. This will be supplementary to their ongoing activities where they’ve already demonstrated great promise, and will be intended as seed money. As the funding portion of the research forum moves on, that may increase. So, we have to start small. We have developed existing ideas, infrastructures and capabilities, and then we intend over the next year to build from there to push for this research culture and the quest for science, discovery and innovation.
Do you anticipate holding another research forum next year?
It’s going to be in another 6–12 months. It could be as early as the Heart Rhythm Society meeting in May, or as late as next November. There are the usual logistics that need to fall into place before we can set that time exactly.
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients.
For more information, please visit www.hrsonline.org
plan that will guide HRS over the next five years. This was about a year and a half ago, and without getting into the details of the plan, we came up with a mission statement, a vision, very clear goals, and began to elaborate on objectives that would allow us to achieve those goals. Out of the plan came four chief goals. One of them was for the Heart Rhythm Society to become the leader in research in the area of heart rhythm disorders. This may seem like a fairly big goal, but we don’t apologize for it; we recognize that research is very much the number one most important insurance policy for our patients in the future. It’s more important than public options, it’s more important than private options — it ensures patients’ future health and gives guidance to future clinical activities. The Society felt that we had an obligation to act on that mission, to act on that need. We felt that the Society had to step up and pay attention. Now, as you know, HRS has spent a lot of time on health policy. Physicians tend to spend a lot of time on reimbursement issues, regulatory affairs, and even legislative enterprises. Those are important. Those frequently are about the business of medicine or advocacy for the Society, so we don’t step away from those. But I do think we have to spend as much time, effort and expertise on the research side of the society. Now, when I say research, we’re not just talking about basic science, but also translational and clinical research. We believe that the Heart Rhythm Society is the very best suited for shaping that research agenda. We need to move the agenda forward and turn that agenda into research insurance for patients.
Why was it important to include a diverse group of attendees? How were the working groups organized in order to best encourage discussion?
First, there are a number of stakeholders in research, including the National Institutes of Health (NIH), National Heart, Lung and Blood Institute (NHLBI), the American Heart 
Association, and others, including foundations, patient care organizations, patient advocacy groups, and scientists. There are members of government organizations such as the FDA and CMS, and then there are groups like StopAF.org who are all very much concerned about the future, that they also in various ways impact how research is done. Sometimes that is through financial means, and sometimes it’s done through regulatory means. We felt that to be successful in the entire quest, they had to be there. They had to see that this had become very important for us, and that it’s our intention to run with this. Now, HRS has some amazing researchers and scientists, and perhaps more importantly, an amazing group of clinicians who want to be engaged in research. So we needed to bring together representation from that group so that we’ll be much more successful working together than we would be if we were working alone.
You also asked about the work groups. The first part of the meeting featured Dr. Francis Collins, Director of the NIH, and Susan Dentzer, Health Correspondent for PBS and Editor-in-Chief of Health Affairs, who presented us with the broad brushstrokes look at the future. The next morning we worked with Mary Woolley (also from Health Affairs) to look at barriers and obstacles to innovation and research. We then had sessions on the HRS view of overcoming those obstacles. The work groups came out of that latter session. The work groups were designed to take us from ‘here’s what we can do in a broad sense’ to the objectives level — from high-level logistics to bring us right down to low-level logistics and tactics for accomplishing those very issues.
Tell us about your discussion on the current barriers to innovation and implementation from the “PI Perspective” — what were some of the main points addressed?
We built on the comments from Michael Lauer, MD from the NIH and from Bram Zuckerman, MD from the FDA. I talked about the issues apparent in clinical trials. Obviously, one of them is funding. Another aspect, on a local level, is the infrastructure in the EP lab. As you know, EP lab doctors, nurses and technicians are extremely busy. So I presented on a concern about the distraction that all of that is to obtain and maintain our lofty research culture. I talked about some of the issues involved with bringing a higher level of enthusiasm for research studies and a variety of other regulatory issues, for example, the time that it takes a large clinical trial like CABANA to get up and running, the contract issues, how long it takes to get a legal document through, etc. These issues are critical for doing research, but they can be extremely difficult to navigate, and I felt that it was important to simply review what they were and open a dialogue on how to overcome them.
Tell us about some of the sessions that focused on involving patients and their families. What can you tell us about these sessions?
Patients and families are part of the entire equation, of necessity. We didn’t spend that much time focusing, per se, on that topic, although the program as a whole looked at the goal of benefiting patients with better science, discovery, innovation, techniques and, lastly, technologies. Patients and their families are very interested in that. The patient representatives that were there were very much engaged in making sure their voices were heard. A research program is not going to be effective if it doesn’t perform for the patient, and the patient’s voice has to be heard to know their own view on what should be done. That is very critical.
Tell us about HRS.TrialNet, and how soon we could see this available.
One of the major strengths of the Heart Rhythm Society is that we sit at the interface between groups such as basic scientists, translational scientists and clinical researchers. We can talk about science, innovation, or discoveries, but we also have to implement it. The clinical TrialNet is intended to do that — to facilitate the conduct of clinical trials, such that we accomplish the goals that are set before us. Clinical TrialNet is intended to increase the involvement of the clinicians from HRS who want to be involved with research, who have some impediment to that, but given the opportunity would be part of something bigger and better. This will be rolled out over the course of the next 6–12 months. It will start small and will involve 1 or 2 relatively small projects. As the infrastructure at each site is put into place and as the Society assists in the infrastructure, dealing with global IRBs, more global contracts, resource utilization and concept development, we believe that investigators will be able to do just that. So we want to give them the pathway, the capability of getting out there and moving on.
One of the recommendations from the Advancing Research Careers working group was to “create a mentorship network.” Can you tell us more about this?
There should be an excellent mentor at the institution. That mentor guides the fellows through learning the core principles of cardiac electrophysiology and applying them in patients. In some cases, the mentors aid in the development of research capabilities. In other centers, that is less well developed. Certainly after a fellow leaves the nest, they may have no easy access to someone who can lead them along a pathway of clinical investigation. And so the mentor program is doing that: providing critical guidance in very much transitional time frames — when they’re making their transition to practice and transition to independence. So we think that is a necessary part of the overall research effort.
Another interesting recommendation was to “develop research experiences for high school and medical students,” in the Supporting & Funding Research working group. What can you tell us about this?
Well, that is one of the things that came out of one of the work groups. The concern that we have as a Society, and the concern at NIH, NHLBI, and investigational institutes, is a turning away of bright young minds from research activities. So one of the potential mentoring activities that could emerge from this would be for individual investigators in individual cities to be willing to do something truly altruistic. To reach out to high schools, or more importantly to middle schools, to share their enthusiasm and, in turn, engender enthusiasm so that in a formative period, the students would catch the research bug, and carry that through middle school, high school and go on to college.
What steps will the HRS be taking in the coming year to address the working group recommendations from the Research Forum?
The next step is to publish the outcomes, and publish the final word from this forum. That happens first. That will be coming out in HeartRhythm, and will be a very clear clarion call: it will be a call to arms to stand up and work on this research agenda, for all the reasons that I mentioned before. The second step will be another research forum to look at our progress. Third, there are critical funding components that need to come into play. Fourth, the dissemination of the entire agenda, the enthusiasm and the strong sense of urgency. So those things will be brought in that research report format. We will now be sponsoring up to 4 transitional research awards for $50,000 each that will go to young investigators who are making that critical transition from fellowship to independence. This will be supplementary to their ongoing activities where they’ve already demonstrated great promise, and will be intended as seed money. As the funding portion of the research forum moves on, that may increase. So, we have to start small. We have developed existing ideas, infrastructures and capabilities, and then we intend over the next year to build from there to push for this research culture and the quest for science, discovery and innovation.
Do you anticipate holding another research forum next year?
It’s going to be in another 6–12 months. It could be as early as the Heart Rhythm Society meeting in May, or as late as next November. There are the usual logistics that need to fall into place before we can set that time exactly.
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients.
For more information, please visit www.hrsonline.org
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