In this edition of Conversations with Experts, Spencer B. King, III, MD, is joined by Craig Thompson, MD, to discuss hot topics in complex interventions, technological innovations, and areas still needing improvement. Dr. Thompson was recently appointed senior vice president and chief medical officer of interventional cardiology at Boston Scientific, and previously served as director of invasive cardiology and vascular medicine at Yale New Haven Hospital and associate professor of medicine at Yale University School of Medicine.

Spencer B. King, III, MD: Craig, you have recently moved from Yale to Boston Scientific—I think that transition puts you in a good position to talk about the subject of complex PCI. I wanted to start off by asking you for your perspective about some of the "hot topics" surrounding complex coronary disease today.

Dr. Thompson: In the big picture, I think the cardiology community will see more expansion into treating patients who we perhaps haven't treated as frequently in the past. Often these are the patients most in need and derive greatest benefit of interventional care. Chronic total occlusion is a very hot topic, as is treating resistant lesions, calcification, bifurcation, and multivessel disease. Lesion assessment in the current era—be it pressure wire, intravascular ultrasound, or optical coherence tomography—brings us back to our roots of using physiology to drive care.

When it comes to complex disease, these adjunctive techniques that investigate the lesions further are another tool to help us to detect multivessel disease, and manage this more intelligently. I think as we move forward as a community, we'll continue to expand our opportunities for lesion assessment, for lesion treatment, and to close the durability gap between PCI and surgical bypass procedures.

Dr. King: One surprising element regarding interventions is that the transradial approach hasn't taken off as much as we would have expected in the United States. Do you think there has been hesitancy in adopting the transradial approach in the very complex lesions? Perhaps people who are not experienced with transradial access may prefer to stick with the simpler femoral route, but have you seen a shift toward attempting very complex lesions with the radial approach in the United States?

Dr. Thompson: I do think that there will be increased uptake in addressing very complex disease using the radial approach. Historically, the underlying technologies were less suited for transradial complex PCI and education and technique was not well disseminated. Currently, at Boston Scientific, we are creating more educational opportunities and programs to help physicians and health care teams provide very cost-effective, efficient, and high-quality care within all spectrums of coronary disease, from simple to complex.

There are always opportunities for improvement, and we are supporting device innovation to allow health care providers to better approach those patients with complex lesions.

Dr. King: In addition to looking to improve bleeding complications, patient outcomes, and so forth with radial access, we are also in an era of cost-containment and economic impact of high-tech procedures. Do you think this is an issue in training operators with the transradial approach? Would better dissemination of information about this approach be helpful to practitioners and medical systems in terms of controlling cost?

Dr. Thompson: Cost containment is certainly a very important goal, and one means of accomplishing that is related to one of the factors you just mentioned: the reduction in bleeding complications. One of the major factors in prolonging hospitalization and increasing expenditure is vascular access-related complications; the transradial approach has been effective in reducing these types of complications. When operators gain expertise in transradial intervention, the procedures are generally not prolonged and there isn't excessive equipment utilization. It is generally possible to achieve a very successful and clinically-effective outcome using the transradial technique.

Dr. King: Craig, I chair the New York State Cardiac Advisory Board, and in data over the past several years we have seen the volume of elective PCI dropping—about 8% each year for the last several years. Do you see this drop continuing, or what is your projection for the "PCI market," if you will?

Dr. Thompson: In the United States I think there will probably be a bit of a rebound. I expect the market to experience a relatively flat, slow growth. I don't anticipate it necessarily going either direction very rapidly, but I do think that there will probably be some degree of accelerated growth worldwide outside of the United States.

Dr. King: Could you define what you consider to be "complex" procedures? What do you see on the development landscape in terms of equipment and technology to improve operators' success with these cases?

Dr. Thompson: A generic definition of "complex" procedures includes procedures that require more technology and technique than one wire, one balloon, and one guide catheter per case. So, in my mind, complex lesions might span total occlusions, heavily calcified or resistant lesions that require rotational atherectomy, bifurcations, and multivessel disease.

Dr. King: And, of course, the more complicated anatomy is what dissuades operators from even taking on these types of cases. One of the options that I don't think occurs to operators who are not comfortable handling these interventional procedures is referral to another, more expert operator who is comfortable dealing with those kinds of very difficult cases.

Now, in your current position, what is being done to further clinical research to cope with complex PCI?

Dr. Thompson: At Boston Scientific, we are making an effort to support a variety of research projects for people who have the skillset and a passion to investigate. These investigators need funding support, and we provide "investigator-sponsored research grants" for that purpose.

For instance, we're financially supporting a registry in the United States called the OPEN Chronic Total Occlusion study, which is planning to evaluate outcomes in 1,000 patients in multiple US cities using currently available technologies and techniques. This will aid in answering a number of questions, including quality of life, substantial Clincial endpoints, and cost and resource utilization.

We're supporting a study called CONSISTENT CTO overseas that is using IVUS-OCT at baseline and at follow-up to evaluate how people heal using available techniques and state-of-the-art technology in chronic total occlusion and to better define the outcomes scientifically. We're also supporting registries to evaluate utilization of rotational atherectomy in resistant lesions and adjunctive imaging to name a few.

We're certainly leveraging our educational division for creating programs that can help operators and health care teams better deliver care with didactics, simulation, live cases, proctoring, in a number of different areas: chronic total occlusions, transradial intervention, interventional ultrasound in resistant lesions, rotational atherectomy, etc.

Complex PCI is, again, a passion of mine and of Boston Scientific as well. The number of patients who require procedures in this category is significant, and they are really inadequately treated by any other modalities—whether that is PCI, medical therapy, or surgery. Those are patients who are very much in need of a better solution.

Dr. King: It seems like what we are really in need of are head-to-head comparisons of the efficacy of the different options for treating chronic total occlusions, but a great deal of the research in registries has dealt more with answering questions about procedure. Some also compare successful opening of the CTO to failure to open or electing not to open. Are there any randomized trials on the drawing board to compare attempted PCI versus deferred PCI for CTO?

Dr. Thompson: There are a couple happening right now: the European CTO Club is performing a randomized trial with a design similar to what you described and the Deliver CTO randomized trial in South Korea is comparing PCI versus medical therapy. If these trials have high enough successful revascularization rates and truly reflect the general CTO population, I think they can contribute to our understanding and provide therapeutic insight.

Certainly, many people are going to be interested in understanding hard endpoints in registries. We want to answer questions like, "Can we affect mortality? Can we reduce spontaneous myocardial infarction by opening these vessels, or at least diminish the severity?" We have several data sets suggesting that is the case, but until you perform adequate randomized trials, it is difficult to know with certainty. This is really true for all complex PCIs, not just total occlusions. Over the years, research in these areas has been limited because of the difficulties in running such a randomized study, including the selection and participation of a variety of institutions that need to be able to deliver high-quality, technically successful clinical results.

Dr. King: Another problem that has been pointed out recently is the fact that many of the studies use subjective endpoints. The goal is largely to relieve symptoms and angina, and the interpretation of results is always going to be difficult when we are relying on subjective endpoints.

Dr. Thompson: I absolutely agree, and I think this goes back to the original coronary artery surgery studies. It will always be difficult to get true answers from randomization for complex patients who are perceived as high-risk. We may gain some answers and some valuable information in that subgroup of patients, but we haven't really answered the question of whether reducing significant ischemic burden can improve on hard endpoints. Randomized clinical trials for stable coronary disease comparing medical and/or revascularization strategies have consistently been limited by enrollment bias toward less severe patients.

These are very difficult trials to run, which is the reason that we have to take data from multiple sources—this is true whether we're collecting data for trials, registries, real-world marketing, or databases. We're tasked with aggregating all those data and using our best judgment to determine where this information leads us.

Dr. King: Because of your position, you can give us a unique view from inside industry. At Boston Scientific, what are you doing to support the treatment of complex PCI in the future?

Dr. Thompson: One of our goals as a company is to continue to adapt to changing needs over time. Over the course of my professional lifetime, we've really witnessed a shift in the delivery of health care, from total physician autonomy and collaborative doctor-patient relationships to transitioning the decision and clinical care tree. Now, health care decisions are driven by a variety of other stakeholders as well—from hospitals to health care systems to professional societies—who are very much engaged in the process.

As a company that has historically been a medical product company, one of the things Boston Scientific is making a concerted effort to do is differentiate and to provide comprehensive solutions. In a broader respect, we view ourselves in the present and in the future as a solutions-based company, with the goal of streamlining health care processes and delivery, to improve patient care and the public health in a cost-effective manner.

Because we are advantaged by having a differentiated suite of technical solutions and educational solutions around various aspects of complex PCI, another project is pulling these elements together into a common source for research, education, and development. We call this the "Master the Cross" program. This program combines aspects of our portfolio and expertise that we've built over the years, all addressing some of these conundrums we've discussed today.

This program will serve as an umbrella for all these training and educational aspects, bringing them together in a single offering, rather than having to access this material through several compartmentalized approaches. So, at Boston Scientific, we're covering device development, training and education, to supporting these efforts with appropriately-tailored clinical research.

Dr. King: You mentioned that there's been a shift from the autonomous doctor to health care organizations in terms of health care decision making. I'm very hopeful that industry will continue to involve the doctors—the ones in the trenches performing these procedures—as part of that development team.

Dr. Thompson: Well, I think while the customer may be the physician or the health care system, our ultimate "consumer" is always the patient. If all of the stakeholders—whether industry, physicians, health care organization, societies, or government—remember who the end-user is, we will all be better off. It's all about the patient; that principle has never changed.

Dr. King: Craig, thanks for joining us, and providing this different perspective for us. It was great having you visit with us.

This material was sponsored by Boston Scientific Corporation.