Welcome! In my prepared remarks, I would like to address three themes that have occupied much of my thinking—and that of our Board—over the past several months. These are Opportunity, Challenge, and Leadership. I apologize beforehand for trying to step out of my comfort zone as a card-carrying clinical cardiologist.
It’s a very exciting time for cardiovascular medicine and science. But, we sometimes lose track of the progress we’ve made, what with the mounting pressures we face daily in our efforts to deliver care, teach, and do research. But it’s really remarkable to think of how far we’ve come in such a short a period of time in areas like the delivery of transcatheter therapies for structural heart disease and cardiac rhythm disorders; in the search for new disease-modifying treatments for heart failure and acute coronary syndromes; in the understanding of the genetic underpinnings of cardiovascular disease; and in the application of increasingly refined imaging techniques for cardiovascular diagnosis and prognosis. We are also poised to do much more— PCSK-9 inhibitors may soon find their way into clinical practice, while bioengineering feats, and 3-D printers are opening new doors.
The era of relatively inexpensive genome analysis and “Big Data” is upon us. Wireless technologies, biosensors, social media, and video streaming are already transforming the clinical landscape. Just this week we learned that more than 11,000 people signed up overnight to participate in a cardiovascular study at Stanford after Apple released a new iPhone application. Efforts to increase the speed at which the efficacy and safety of new discoveries are rigorously established have led to calls for new trial designs and a re-examination of the utility of observational studies and registries. “Big simple trials” are envisioned, supported by public-private partnerships, academia, and patients. Network biology has entered the main stream. The promise of Precision Medicine even recently found its way into the President’s 2015 State of the Union Address and legislation currently being discussed in Congress. The possibilities really do seem endless!
One question to ask, however, is whether we have the systems in place, organizational flexibility, and what I call the societal tolerance, to allow for the practical implementation of these marvelous scientific advances? How do we best enable a successful future focused on improving the cardiovascular health and lives of our patients? How do we deliver on the value proposition we espouse and upon which we are, or will be, judged?
Let me touch on just a few of the challenges we face. Stagnant funding for medical research in the United States hangs over most conversations and threatens our ability not only to generate new knowledge and innovate, but also to support the careers of an entire generation of young investigators. The potential impact of reduced funding on the broader economy, so much of which depends on medical research and clinical care, cannot be ignored. Experts from across the spectrum of academia, government, private foundations, industry, think tanks and payers, have invested significant time and energy in discussing this problem; thus far without a clear path forward. The public too seems quite skeptical. Perhaps we over-promised with early predictions that deciphering the human genome would lead to cures for a variety of diseases.
Funding for medical research comprises less than 5 percent of total US health care expenditures. Health services research, or implementation science, accounts for less than 0.5 percent of the total. Maybe it’s conceptually easier to invest in the study of orphan diseases or cancers that lend themselves to genetic finger printing, than such chronic, multi-dimensional problems as atherosclerosis and hypertension.
We live in a world of oftentimes myopic, short-term expectations, quarterly reports, and less tolerance for exploration, for discovery, and, yes, even for failure. The path from early stage conceptualization to targeted drug delivery is enormously lengthy—and extraordinarily expensive. Given current trends, and without significant re-investment, many have predicted that the United States will relinquish its historical position as the global leader in biomedical research within the next decade. All of us—academic researchers, trainees, practitioners, and most importantly, patients— are affected by this trend. All share in the responsibility to arrest or reverse it, to avoid a near term future in which we fail to advance beyond the present. On a more clinical level, think of the consistent criticism targeted at practice guidelines, so many recommendations of which lack an adequate evidence base. How can we fix this problem?
Professional societies like ours operate at the interface between science and clinical care. As such, we can and should play a more active role by reminding ourselves and others that the patient comes first. We need a way to break through the inertia, develop bolder solutions to the funding crisis, and set national priorities. Some have started to suggest crowd funding. I learned recently of the Harrington Discovery Institute at Case Western and its innovative, hybrid approach to helping scientists from all over the country gain access to the vital resources necessary to accelerate their discoveries into clinical trials and eventually into patient care.
Recent calls to revise, or even eliminate, Medicare funding for some aspects of post-graduate medical education may also have enormous, unintended consequences for the multi-specialty care of an aging population with a high prevalence of cardiovascular disease. Estimates of the magnitude of the future deficit in the supply of medical specialists are admittedly flawed. There is also no doubt but that the more efficient utilization of the multi-disciplinary members of the cardiovascular care team can help address any workforce shortage. But leadership gaps will remain and should be filled by those with the requisite knowledge, training, and experience to integrate complex information from disparate sources, design care plans, and counsel patients to enable shared decision-making. We know, for example, that cardiovascular physician specialists provide added value in the care of patients with acute coronary syndromes and heart failure. The nation’s primary care needs should not be under-estimated, yet decisions that could imperil high quality specialty care are problematic and could be self-defeating. We should also avoid the temptation to pit one professional society against another and keep the focus on the patient and our commitment to the public health.
A third, and somewhat more ominous challenge, deals with trying to reduce the crushing burden of what at times seems to be the unrestrained, external regulation of clinical care, research, and training. This trend, if left unchecked, threatens to stifle creativity and force lock-step adherence to well-intentioned policies, many of which do not have an evidence base to substantiate their effectiveness.
How much time is currently spent by clinicians performing mandated tasks that do not improve the patient experience? Four hours of ambulatory clinical work easily translates into more than an hour of “paper” work. Many wonder whether some of our EHRs will solve problems related to billing and compliance at the expense of capturing clinical reasoning and improving care. I also worry that we are at risk of losing the narrative insights of our master clinicians—the pearls of wisdom that cannot be captured in a drop down menu—or an RVU-based compensation system-- yet these are often the essence of both the art and science of medicine.
The cost of supporting the infrastructure required for research has also become unwieldy. One of Dr. Loscalzo’s recent Circulation editorials pointed out that nearly 40 percent of an NIH funded researcher’s time is consumed by fulfilling regulatory tasks. Although several factors have contributed to this trend towards hyper-regulation, our society has developed a tendency to attach the inappropriate or harmful actions of a handful of clinicians or researchers to entire communities of individuals; we are all painted with a broad brush of suspicion and distrust. Have we reached a tipping point in our relationship with patients and the public beyond which only blunt, “one size fits all,” administrative or legislative solutions can be invoked to achieve “best practices”? There are broader, societal implications here. If we are unable to balance the relationship between regulation and quality we will only delay progress and be distracted from our mission. We need to regain our footing, while demonstrating to our patients and the public the highest standards of professionalism and competence. I believe we have come to learn both the burden and the responsibility of self-regulation. I’m you’d agree that we could do better, while we work to rebalance this equation.
TAVR, A Success Story
Winston Churchill once said: “A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty.” Let’s look beyond these challenges and seize the opportunities before us. Innovation requires creativity, problem solving, hard work, determination, vision and leadership. It means thinking “outside the box,” testing and retesting new hypotheses, asking questions and being comfortable with the unknown. Where would we be if the early pioneers of cardiac surgery did not have the freedom to experiment or the strength to fail? The pathway from innovation to implementation is a team sport. There are several examples to cite, but perhaps the TAVR story, now no longer new, deserves special emphasis. TAVR started as a transformative technology that began with an idea many dismissed; gained momentum through iterative device modifications pioneered by industry; earned a growing sense of feasibility with animal and early human studies; achieved U.S. Food and Drug Administration approval after reporting of a pivotal, randomized clinical trial; expanded to additional clinical sites in the United States that met quality standards; and rapidly matured to the point that legitimate questions have surfaced regarding appropriate utilization and best practices for shared decision-making between patients and multi-disciplinary clinician heart teams. The multi-stakeholder STS/ACC TVT Registry is a terrific example of the combined strength of professional societies, government regulators, payers, and industry in evaluating new device performance, patient outcomes, quality, and safety. As we have also seen, registries of this type can serve as platforms for the more efficient performance of prospective randomized clinical trials.
The central objective behind the development of TAVR was to bring the life-altering and life-saving benefits of aortic valve replacement to prohibitive- or high-surgical risk patients with aortic stenosis. We now find ourselves studying the use of TAVR in intermediate-surgical risk patients and discussions have turned to a near term future in which it may perhaps be offered to low-surgical risk patients. Technological breakthroughs in the field of TAVR presage similar advances in the treatment of other types of structural heart disease. Implementation science and outcomes research, with a patient-centric focus, must keep pace and provide rigorous assessment of efficacy, comparative effectiveness, safety, cost, and value, lest we discover again that interventions that initially dazzle become the recommended standard long before their limitations are realized.
Leadership and Responsibility
In closing I’d like to get back to the topic of leadership. The TAVR example is instructive for its focus on the patient, the principle that guides our actions. We also should not lose site of the altruistic ideal that initially drew many (should I say all of us) to careers in medicine. We have all learned from the leadership of some of the giants in our field—Paul Dudley White, MD, Eugene Braunwald, MD, and Valentin Fuster, MD. How can we respond to their motivating influence? How can we not also be inspired by the work of our colleagues who place themselves in harm’s way to deliver care to the world’s most vulnerable populations—in places like Haiti, Rwanda, Nepal and our inner cities? I think we have an extraordinary opportunity to lead by our actions, in partnership with our patients, in a time that appears devoid of compromise and in a place where community interests are often subordinated to individual rights.
The operative word here is action, for the clock is ticking and the time allotted to us is limited. Some problems are clearly easier to solve than others. Realism is always in high demand. It’s easy to think, at times, that we operate in a vacuum. But we live in a world of chaos, terrorism, climate change, pollution, dwindling resources, intolerance and inequality. There is a bigger picture confronting us, and thus a greater responsibility. The College has been out in front on many issues; we have much more to offer as the stewards of cardiovascular care. Over the next three days, as you learn of the most recent advances in our field, connect with colleagues, and envision opportunity, I hope you can also take a step away from the daily challenges you face and think more broadly of the leadership role we can play collectively to make a difference in the lives of our patients and the communities we serve.
Patrick T. O’Gara, MD, FACC