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Innovation in Intervention: Perspectives from Industry
Since the beginning of the subspecialty, technological innovations have played a critical role in shaping and defining interventional cardiology as the cutting-edge, transformative field we know today. These developments, resulting from collaborations between the medical community and industry, have brought about substantial advancement in the treatment of patients with CVD, offering less-invasive alternatives and in some cases hope in the fight against disease that would have otherwise been unavailable.
With the new year on the horizon, Cardiology Today’s Intervention interviewed industry leaders to get their thoughts on the decades of progress in interventional cardiology and to take a look at what innovations may further advance the field in the future. The responders included Michael J. Coyle, executive vice president and group president of the cardiac and vascular group, Medtronic; Charles A. Simonton, MD, FACC, FSCAI, divisional vice president, medical affairs, and chief medical officer, Abbott Vascular; and Kevin Ballinger, global president, interventional cardiology at Boston Scientific.
During the past 25 years, what have been the most significant strides in innovation in interventional cardiology?
Michael J. Coyle
Coyle: For most of the last 25 years, interventional cardiology has primarily been about the progress of PCI innovations. Over the last 3 to 4 years, however, what’s been interesting is to see the discussion evolve to include other catheter-based therapies, with transcatheter valves being the first to break the PCI monopoly. The innovations in transcatheter valves we think are really fundamentally important to treating aortic stenosis in patients who otherwise don’t have any good options.
And secondly, over the past 2 years, renal denervation has become a primary discussion point with interventional cardiologists, especially as it relates to the treatment of resistant hypertension, which Medtronic has spearheaded with the Symplicity catheter. We think this patient population could be the single largest set of patients who are currently untreated, since hypertension is the most prevalent of the CVD states.
Simonton: The field of interventional cardiology has rapidly evolved in the past 3 decades. There have been many device-specific innovations, such as the initial introduction of metallic stents in the 1990s, that have had a tremendous, positive impact on patient outcomes. In addition, the investment in developing clinical evidence to support interventional cardiology treatment decisions continues to increase. Abbott has remained at the forefront of these efforts with significant investment in developing clinical evidence, as demonstrated by our SPIRIT and EXCEL programs supporting the Xience family of DES, Absorb program and MitraClip program, most recently including the initiation of the COAPT trial in the United States. One of the most significant advancements has been Abbott’s introduction of Absorb, the world’s first drug-eluting bioresorbable vascular scaffold, a device that dissolves over time. From the early days of interventional cardiology, we hoped to restore blood flow without leaving anything behind. Abbott spent nearly a decade researching materials, engineering process and performing clinical studies to bring this technology to patients. It is now being investigated in the United States in the ABSORB III clinical trial.
Ballinger: Twenty-five years ago, our customers were cardiologists responsible for the care of their patients with new and often unproven technologies. Today, however, we see the continuum of care involving purchasing organizations, Joint Commission on Accreditation of Healthcare Organizations’ standards, highly integrated care, numerous patient touch points and an interventional cardiologist who demands cost-effective technologies that improve patient outcomes and quality of life.
To date, numerous device solutions have been designed and iterated, DES being the most impactful to date. And the investment in DES continues. In 2005 we recognized many physicians were concerned with dual antiplatelet therapy compliance after DES implantation, which led to the investment in our Synergy bioabsorbable program. Development of the Synergy stent system would not have been possible without physician partnership and a collective focus on improving patient outcomes. In fact, we will be the first company to bring the bioabsorable technology to patients in the United States.
What current unmet needs in CVD management do you feel innovations in interventional cardiology will have the greatest impact on in the years ahead?
Coyle: In addition to renal denervation and transcatheter valve technologies, the peripheral business is very focused on drug-eluting balloon technologies. Although our initial datasets target superficial femoral artery (SFA) applications, DEB could also have coronary applications, especially with bifurcation stenting. Also, the cardiac rhythm management business, which has been focused on pacing and ICD therapies, has an application where we are looking at using miniaturized technologies to develop a leadless pacemaker that can be placed into the ventricle with a catheter. So, each of these four areas represents fundamental new growth opportunities for interventional cardiologists and very significant new therapeutic advancements for patients.
Simonton: As the population ages, a growing demand continues to be placed on our health care system. Early interventional approaches that can address unmet needs by providing substantial clinical benefits to patients and economic benefits will have the greatest impact. Some of the areas where there is still significant unmet need include aortic and mitral valve disease, congestive HF, atrial fibrillation and treatment-resistant hypertension. Medical therapy alone is not sufficient in many cases and surgical options are not always possible. All of these diseases represent significant, global health challenges and there is the potential for innovations in the interventional cardiology field to make a positive impact for patients.
Kevin Ballinger
Ballinger: Industry continues to focus on developing less-invasive options for the treatment of CVD by applying our expertise to the entire vascular system, not just the heart. A perfect example is the Vessix renal denervation technology. Recent figures estimate that 1.2 billion people suffer from hypertension, and of those, one in 10 people suffer from medically resistant hypertension. In an effort to bring a remedy to this patient population, a second-generation renal denervation system engineered with the physician and patient in mind was introduced. The familiar over-the-wire-balloon design of the Vessix technology is enabling a short procedure that helps reduce BP to more normal ranges.
A fairly recent emergence has been the collaboration of subspecialties, which has become embodied in the “hybrid OR” approach. In the future, how do you expect this will impact the practice of interventional cardiology and patient care?
Coyle: Three-and-a-half years ago, we put the four CV businesses of Medtronic under a single leadership structure because we saw a lot of the innovation that was taking place between the subspecialties. Transcatheter valves were really the start of this, as the interventional and surgical physicians needed to coordinate with each other to identify appropriate patients and perform the procedure. So that was the lead, but following behind has been mitral valve replacement. With this procedure, collaboration is absolutely critical because you are operating within the heart. We are also seeing the importance of collaboration in AF ablation, left atrial appendage closure and less-invasive CABG procedures, so we think these hybrid OR opportunities are going to pile up in the future. This is a trend we are very excited about at Medtronic because we have very long established ties with each of these physician types and are really in a unique position to bring them together to work together.
Simonton: The effective collaboration of cardiac specialists will ultimately lead to better patient outcomes by integrating different insights and training into the process of making treatment decisions. Although this collaboration may have occurred informally in the past, we are seeing a trend toward more organized heart teams at centers of excellence around the country. Abbott’s EXCEL and COAPT trials are good examples of trials supporting collaboration between cardiac surgeons and interventional cardiologists in evaluating patients with left main disease or mitral regurgitation, respectively. The heart team concept has emerged as the model of choice in treatments such as transcatheter aortic valve replacement and percutaneous mitral valve repair, and this model has been further reinforced by organizations such as CMS in its reimbursement decisions.
Ballinger: Collaboration and a combined approach to patient care are evolving on many fronts. The historic approach of providing a service independent or irrespective of what else is going on in the patient care continuum is a thing of the past. As such, I see the traditional relationship between patient, primary physician and subspecialist coming together with payers and device companies for a unified approach that will provide better outcomes at lower cost. Greater alignment and working more closely together will result in better patient care, greater efficiencies and ultimately take cost out of the system.
Looking ahead, what do you feel the future of innovation will hold in this subspecialty? How will these future innovations improve practice for the clinician?
Coyle: First, I feel future innovations, like many of those I’ve mentioned, will give the field of interventional cardiology entirely new patient populations to serve. As we look at appropriate utilization of therapies giving physicians more opportunities to impact on positive outcomes for appropriate patients, this has to be looked on as a positive from the physician and hospital perspectives. Second, when you perform a catheter-based intervention, you have much lower requirements for infrastructure and training than you do with traditional surgical procedures. We think that from an economic value perspective these therapies will be very attractive, especially when we are trying to drive standard of care usage of proven therapies in emerging markets.
Charles A.
Simonton
Simonton: CVD continues to be the leading cause of death around the world, and although tremendous progress has been made in reducing the global burden of heart disease, there is still more progress to be made. Incremental advances in existing devices can improve outcomes for patients while increasing procedural efficiency, which are important factors in today’s health care environment. Devices that are first-of-their-kind innovations, address clinical treatment gaps and are supported by robust clinical data have the potential to transform CV care. Examples of potential game-changing technologies include TAVR and percutaneous mitral valve repair.
Ballinger: I see tremendous growth in the CV space driven by innovative new therapies. For example, the first-generation TAVR valves represent a significant advancement in the treatment of aortic valve disease. Physicians now have an option to treat patients they could not in the past. There are still areas for innovation in the TAVR space, however, specifically in technology refinement. Our new Lotus Valve is one such example, as it can be controlled during the entire procedure. It also features the unique Adaptive Seal technology, which enables a customized fit for patients to help prevent paravalvular leakage. Additionally, our Watchman left atrial appendage closure device is another growth driver in the new cardiology space. This is an important new treatment option for stroke risk reduction in patients with AF, which has shown superiority over warfarin in clinical trials.
These are just two examples of how industry is bringing meaningful treatment options to physicians and patients.
What final message would you like to leave interventional cardiologists with as we look ahead to the new year?
Coyle: When we look back, almost every technology I’ve brought up — including transcatheter valves, renal denervation and DEB — didn’t exist 25 years ago. Interestingly, we’re going to see presentations on CoreValve data from the High Risk Study and the Symplicity HTN-3 randomized 6-month data on renal denervation sometime this spring; and DEB data for the SFA application by the time we get to mid-calendar year 2014. So we have an exciting array of fundamental trials coming up that will examine how we can impact significant unmet needs using catheter-based therapies.
Simonton: The health care industry is changing at a rapid pace, requiring all key stakeholders — physicians, hospitals and manufacturers — to think differently. Stakeholders must consider the value they bring not only to patients, but also to the system. The interventional cardiology industry has been at the forefront of generating clinical evidence to support treatment decisions that maximize patient clinical outcomes. Those outcomes must now be positioned in light of a rapidly evolving environment, in which both clinical value and economics are important.
Ballinger: Industry will continue to partner with the interventional community to provide new solutions to address unmet clinical needs and help customers expand and grow their practice. We remain deeply rooted in coronary interventions, but we are excited about our work with physicians to advance new treatment options — not just with better technology, but also with a commitment to therapy development. Together, we look forward to advancing cardiology. — by Brian Ellis