II. Advocating for the Transradial Approach

Why found PAMEAS? I had worked in physician education training for a long time and felt that we needed an organization to represent patients and improve the patient experience. I wanted an organization that could do so, unlike typical patient advocacy groups, by working directly with physicians, other health care providers, industry, regulatory agencies and third-party payors. That is our focus and why we developed the Patient Medical Association, or PAMEAS. I founded the organization back in 2005, and at the time, it was a division of another group I founded called the Endovascular Institute. Initially, I was looking at PAMEAS as a group focusing specifically on interventional-type topics, but then last year we broadened our focus beyond just cardiovascular medicine and incorporated as a separate non-profit corporation. We currently have 9 employees. You mentioned that PAMEAS works with other physicians, healthcare providers, etc. Are those the typical avenues used to promote your causes? We take a pretty broad perspective in our approach to try and improve the patient experience. And by “improving the patient experience,” I mean anything that could increase patient safety and reduce medical errors, as well as subjective things that can help the patient feel more satisfied with their healthcare experience. It is important to address these goals by working with patients to better educate them, as well as patient advocacy groups, like AARP and some of the other organizations out there that exist as a membership of individuals. To improve the patient experience, PAMEAS must also take an active role in physician education. We do reach out and are very aggressive in looking to provide education and training for physicians, as well as ancillary providers like nurses and technologists, in new clinical areas and/or technologies. We work closely with third-party payors, because the insurance industry is obviously a big part of patient satisfaction. We also work with regulatory agencies, particularly with all the pending changes to our healthcare system with the new administration. I have worked in Washington since the early 1990s. It is crucial to work with the National Institute of Health (NIH), Center for Medicaid and Medicare Services (CMS), as well as the Department of Health and Human Services (HHS), in promoting what PAMEAS identifies as causes, so to speak, that can help improve the overall patient experience. PAMEAS is currently promoting transradial access. What are the other topics on which you are focused? The reason we decided to branch off from interventional medicine in 2008 was to incorporate four primary areas of focus, including cardiovascular medicine, diabetes, oncology and then, in general, the topic of healthcare reform, which certainly can cross different clinical areas. Out of all the topics in cardiovascular medicine, why pick transradial access? There are other areas that we are going to be looking at as well — micropuncture techniques, for example. If you look at all fields of medicine right now, one of the areas that has the most rapid expansion and growth, with new clinical processes as well as new technologies, is interventional medicine for cardiologists and vascular surgeons, even to the point of impacting other kinds of surgeons. It highlights the move toward minimally invasive types of procedures in medicine. Within the field of interventional medicine, the reason we are currently looking at transradial access is because it can significantly improve the patient’s percutaneous coronary intervention (PCI) experience through reduced bleeding complications as well as reduced cost. It allows the patient to go through the interventional procedure potentially without an overnight stay. Second, transradial access is not a particular technology that has to be developed where we have to promote one company over another. It’s not something that requires a large amount of money for physicians to adopt. It’s just a training issue. Globally, there is a much higher utilization of transradial access, very successfully, in Europe, Asia and other parts of the world than here in the United States. At PAMEAS, we think that transradial is being held back in the United States mostly due to training reasons and therefore, it’s something we can get behind and help promote. We hope to show significant growth in its utilization in the United States over the next couple of years. How are you working to promote training and what kinds of challenges are you facing? In general, in medicine, there is a fair amount of inertia to doing new things and in promoting new processes. Physicians and healthcare organizations are very busy. One challenge is convincing interventionalists that this is a valuable procedure. There are other logistic-type barriers that will be addressed, certainly, such as billing and coding for transradial procedures. It’s not as familiar to CMS and government organizations as other types of procedures. Appropriate physician reimbursement is also something that we are working to address. At this point, PAMEAS has four types of transradial programs underway. The first one has been funded by an educational grant from Terumo. Within that program, we are focusing on improving and increasing the awareness of transradial access among the clinical community. In that regard, we are planning fifteen dinner programs across the country over the next year or so, in which we bring in subject-matter experts who can talk about clinical and cost experiences, as well as some of the other issues as to why transradial access is something clinicians should be considering. The programs are geared not only for physicians, but also nurses and technologists. We’re also working with Washington — HHS, CMS, and NIH — trying to promote the value of transradial access as a procedure. It should be something that these organizations consider as they think about implementing different healthcare reforms over this coming year related to lowering costs. In the third part of our program, we are working with professional medical societies to try to promote the transradial approach to their members. For example, with the American College of Cardiology (ACC), we are exploring opportunities to collaborate on educational programs, as well as trying to do what we can to encourage the adoption of transradial training within fellowship programs. We are also looking at some potentially collaborative patient education programs with the ACC. We want to do the same thing with the Society for Cardiovascular Angiography & Interventions (SCAI) and some of the other interventional organizations. Finally, we are looking at direct patient awareness education, working with patient advocacy groups as well as developing patient educational materials. In addition, PAMEAS will be sponsoring both a multi-center clinical trial and prospective registry to evaluate the issue of femoral versus radial access. We are also working to develop an overall curriculum of study that can provide hands-on training for physicians interested in learning the transradial approach. It will include lab training, preceptorship training, business model training and clinical case studies available via the internet. We are trying to address not only making people interested in transradial procedures, but also support basic clinical research and go across the spectrum to hands-on preceptorship training. There are physicians that promote the transradial approach in the U.S. What do they have to say in working with your organization? You can’t go very far in a conversation about interventions before physicians start talking about bleeding complications. Bleeding complications for femoral access, which is utilized in 98% or so of all interventional procedures in the United States, have almost become an accepted part of the process. In many clinical trials, researchers do not even report bleeding complications because it’s the de facto reality of doing percutaneous coronary intervention with femoral access. Along with PCI come the concomitant issues with bleeding complications, whether it’s access site or retroperitoneal bleeds, and so on. Physicians who use a radial approach know these significant complications with femoral access are reduced with a radial approach. Many clinicians today say most PCIs and down the road, peripheral interventions, should be done radially, because of the reduced complications as well as the shortened time to ambulation. In many cases, it’s fair to say that you can’t have an outpatient PCI experience unless you use a radial approach, because of the need to watch the patient for post-procedure complications. I think the reason physicians are so excited about radial access is because it’s readily available, you do not have to spend a lot of money or retrofit a lab, and it can address existing bleeding complications with our current interventional procedures. Fewer bleeding complications mean reduced cost. Absolutely. One of the appealing aspects of transradial access is that it doesn’t require a huge, upfront cost. It’s just a matter of personnel training: physician training, nurse training and technologist training, the result of which is that you can potentially greatly reduce the overall cost of a procedure. I believe the government is very interested in looking at ways of decreasing complications, decreasing direct procedure costs and eliminating the need for an overnight DRG for many interventional procedures, for example. Clearly, transradial provides a cost-effective way of pursuing those goals. What do you see as some of the things that need to fall into place before we do have a high percentage of cases done transradially in the U.S.? One of the most important steps is to have a much more aggressive incorporation of transradial training in our fellowship programs. By and large, it’s not included in fellowship training right now. We have the goal of increasing transradial utilization from the 1-3% where it is now, to 20% utilization within the next few years, and that is going to happen with the younger interventionalists. Each year in the United States and Canada, we graduate approximately 250 fellows. They are all looking for jobs and if they can put on their resume that they are capably trained in transradial access, it will make them that much more appealing to practices. The second step involves the government recognizing the value of transradial access and setting up appropriate incentives for its use. The hospital and the DRG structure, as well as the physician reimbursement, for transradial needs to be implemented, so that physicians can start practicing it without fear of actually losing money. I think those two cornerstones can happen in 2009. Right now in the United States there is a confluence of different factors pushing us towards transradial access. Within the next 6-9 months, transradial access will be a significant hot topic at all the interventional meetings: ACC, TCT, etc. Concomitant with that, within this year, I think we will see government regulations in place to account for reimbursement and, toward the latter part of 2009, increased transradial training. I would imagine 2010 and 2011 will bring a tremendous surge in the utilization beyond the 1-3%. 2009 is a working year for us to put together the infrastructure for that. PAMEAS is positioned very importantly right now. We are the only organization that is in fact a patient advocacy organization with direct involvement in physician and ancillary healthcare provider training, and we also sponsor basic clinical research. PAMEAS can play an important role in the coming healthcare reform for cardiovascular medicine, as well as for physicians who are looking at continued training. Industry support of physician training has always been critically important. As we look at healthcare reform in the future, some of that industry support of physician training is going to be more heavily regulated with different guidelines. Organizations like PAMEAS can play a positive role in making sure it is done with a high level of ethical standards, focusing primarily on the goal of improving the patient experience. Dr. Paul Zimnik/PAMEAS can be contacted at zimnik@pameas.org or by phone at (301) 591-1772.

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