Leadership Forum: Looking into the 2011 Crystal Ball

Reimbursement changes, healthcare reform, comparative-effectiveness research, conflicts of interest, accountable care organizations and a workforce shortage—these are some of the topics that our Leadership Forum participants put forth as challenges—with perhaps some hidden opportunities—for the coming year.

The Participants are:
Larry S. Dean, MD, President of the Society for Cardiovascular Angiography and Interventions (SCAI) and Director of the University of Washington Regional Heart Center in Seattle, Wash.Clyde W. Yancy, MD, Immediate Past President of the American Heart Association (AHA) and Medical Director and Chief of Cardiothoracic Transplantation at Baylor Heart and Vascular Institute in DallasDouglas L. Packer, MD, President of the Heart Rhythm Society (HRS) and Director of the Heart Rhythm Services at Mayo Clinic in Rochester, Minn.Jack Lewin, MD, CEO of the American College of Cardiology (ACC)

Q. What are at least two major challenges in cardiovascular medicine going forward in 2011?

Lewin: One of the big issues for cardiovascular medicine is how the delivery system will change and whether or not there will be a continued movement toward employment of cardiologists by hospitals. A second challenge—which may be ancillary to the first—is whether or not private practice for cardiology will remain viable.

Another challenge will be designing accountable care organizations [ACOs], which can be analogous to Bigfoot: We think we know what they are, but nobody has really ever seen one. Congress points to existing integrated systems such as Geisinger Health System, Kaiser Permanente and Intermountain Healthcare. ACOs that work well tend to have physician governance structures, like the Mayo Clinic, Cleveland Clinic and Geisinger. We will have to ensure that the federal definition of ACOs will help move the non-integrated majority of U.S. caregivers into a better delivery system.

Dean: The biggest challenge is trying to anticipate what will happen with healthcare reform. There has already been a considerable impact over the last couple years from the rationing down of payments—both for imaging and basic cardiology services. And these changes occurred before healthcare reform. In 2011, we have to position ourselves so we can respond to changes coming from healthcare legislation. It’s a difficult challenge because of the uncertainty. ACOs and medical homes appear to be the future for primary care physicians, for example, but we don’t know the impact of those on cardiology.

Packer: The biggest challenge for practitioners and societies is to stay on track regarding the mission of putting patients first. We have to continue to promote research, education and optimal health policies. There has been a shift where we are increasingly dealing with the process of medicine—reimbursement and regulatory issues, for example—rather than patient care. We have to continue to highlight our core mission and values.

Yancy: Cardiovascular medicine will indeed be challenged in 2011, but there will be major opportunities as well. The first challenge will be managing the dynamics of payment reform—notice, I didn’t say healthcare reform; and second, understanding issues of manpower. The real opportunity for us is to embrace and pursue a very new direction in cardiovascular medicine—and that is prevention. The burden of disease is so major that unless we all work collaboratively, no healthcare reform system will work; we must  capture the specialized arena of prevention.

Q. What manpower issues will impact 2011?

Packer: Cardiology fellows are worried about the increasing workload, which may worsen before it improves, if 40 million previously uninsured Americans enter into the healthcare arena. Fellows need to see our efforts to improve efficiency, quality and performance, as well as how we can continue to deliver quality care with limited resources.

There needs to be a continued understanding that quality is more than effectiveness outcomes—more than the ablation success rate or the sudden death rate, for example. Quality is about safety, process, structure and efficiency. With potential workforce challenges, we need to focus more on defining quality metrics in a measurable way, thereby, using those data to improve overall performance and patient care.   

Lewin: New research, technologies and scientific breakthroughs will continue to make cardiology one of the most exciting fields. However, the length of time it takes to train a cardiologist is daunting. We currently don’t have enough fellowship spots to meet the needs of patients who will be entering the system.

Once again, however, we have to go back to the issue of preserving private practices that serve most of rural, suburban and inner city America. Not everybody can be in a large group practice or an integrated system. Therefore, we are very concerned about how to deal with the increased demand for cardiovascular services in the future.

Yancy: The beauty is knowing that we have navigated so many transitions as physicians that we can afford to be bullish and believe that this too will pass. Yet, we also have to create intriguing alignments, such as larger groups and a different distribution of work. ACOs are something that can be done in a right way. Rather than fear them, let’s help create them, so that we preserve the practice of medicine as we’ve known it, while taking advantage of economies of scale and efficiencies that occur by bringing hospital systems, outpatient offices and practitioners under the one umbrella.

We also can gain efficiency by using EHRs more intelligently, namely, coupled with clinical decision support systems that are rooted in evidence-based medicine. With that, the EHR transitions from being a static repository to a dynamic tool. With it, we can redistribute the workload of available manpower in a more reasonable manner, allowing us to be responsive to an evolving external environment.

Dean: Unfortunately, if you discourage people from going into cardiology, or any subspecialty, the long-term effects can be quite damaging. Reimbursement changes already have had an impact on cardiology fellows seeking jobs. Practices are being very conservative about overextending themselves. And cardiology fellows do not want the traditional heavy workloads. They are seeking to integrate a better lifestyle with their profession. Who then will pick up the slack? Practices and departments have to be creative with existing faculty and staff, or hire extra people to fill in gaps. In addition, resident hours will be restricted starting July 2011, further straining resources.

There is tremendous emphasis on primary care right now. If you increase the number of people by some 40 million who need access to primary care, you will need more primary care physicians, but you also will need more cardiologists. Where will subspecialty medicine, and cardiology in particularly, wind up with respect to how the government views specialty care versus primary care? Presently, it’s very uncertain.

Q. How will the debate on physician-industry relationships play out next year?

Lewin: The pendulum has swung too far to one side and we’re in danger of being in regulatory overkill. Innovations in cardiology have contributed to an overall 30 percent reduction in morbidity and mortality over the last decade. Much of that happens through relationships with industry. The government is not leading the way in innovation. Instead, the path is led by the private sector, working collaboratively with cardiologists.

The ACC has been very transparent about its relationships with industry. If someone doesn’t report a conflict of interest, he or she will be prohibited for a year from presenting at our meetings or participating on our committees.

Dean: SCAI has implemented similar policies as the ACC regarding disclosures of potential conflicts of interest. We also are developing an ethics document for interventional cardiologists and are researching the development of a mechanism to ensure the completion of disclosures in CME programs. It’s a challenge because there is not a central clearinghouse for such information. Relationships with industry are necessary, which makes it extremely important in 2011 to continue to inform the dialogue, especially regarding the mainstream press, which tends to focus on a few negative examples.

Yancy: Many class I guideline recommendations have emerged from randomized controlled trials that were supported by industry. We have to be cognizant of that, but not all alignments are good. Occasionally, whether intended or unintended, opinions are compromised, which makes the data look less genuine to the external community. We must work together to understand how best to have a relationship with industry. What constitutes conflict is a complex discussion and not having a clear-cut definition can be frustrating for practitioners, investigators, authors and editors. However, there is much less variance than just a few years ago.

For example, for every ACC/AHA guideline or statement, 50 percent of the writing committee, along with the chair, must be free of any relationships. We can’t exclude every relationship, and many people have appropriate relationships, but we must  manage them wisely.

Packer: In 2011, patients, the media and practitioners hopefully will have a better understanding of clinicians’ relationships with industry, and the proper role for that interaction. Great strides have been made in the past year, which will continue. Even though there might be more scrutiny, there is improved disclosure.

Q. Data from national registries have begun to mature. What influence can we expect from these in the coming year?

Yancy: Registries have become powerful tools and will increasingly become more important as we enter the era of real-time comparative-effectiveness research. They are important to understand what’s happening to large groups of patients who have similar characteristics and are treated in similar ways. An example is a study by Cohen and colleagues who found that hospitals enrolled in the AHA Get with the Guidelines–CAD program actually improved treatment of MI for all patients over a five-year period, regardless of race or ethnicity. In fact, differences in care by race or ethnicity at baseline were reduced or eliminated [Circulation 2010;121:2294-2301]. These are the only real data that demonstrate the ability to narrow and/or eliminate disparate care—and these findings came from a registry. Registries help us focus on quality and process, and their results can be quite informative.

Lewin: Registries will help standardize best practices, similar to the way ACOs will gather providers under one umbrella. We need the non-integrated world to become at least clinically integrated and that can happen by combining the registries that cover both inpatient and outpatient care. These provide venues for hospitals and doctors to collaborate on quality improvement and be rewarded financially. If we systematically improve quality in a transparent manner, there is a chance that this new kind of U.S. healthcare system could be a model for rest of the world.

Packer: The NCDR-ICD continues to collect information about device implantation. The HRS recently published the fourth year report on the registry. While this registry is excellent for examining safety and appropriate utilization, it’s more difficult to review the device effectiveness and outcomes. The SAFARI registry is just getting underway, and will tell us about ablation safety. However, monitoring for recurrent atrial fibrillation is difficult. For data on long-term outcomes, effectiveness and cost, we rely on trials, such as CABANA, which had positive results for radiofrequency ablation, or STOP-AF, which had positive results for cryo-balloon ablation. Together, registries and trials will continue to inform revisions of consensus documents on quality, appropriateness, outcomes and patient selection.

Q. Can you point to recent studies that will strongly influence practice in2011?

Dean: The most recent and exciting study, from an interventional perspective, is the PARTNER trial, which evaluated the Sapien valve from Edwards Lifesciences, and found that TAVI is a safe and effective alternative in patients with aortic stenosis who are not surgical candidates. PARTNER also found that patients’ quality of life improved substantially at one month, with further improvements at six and 12 months. Those data were just released in November at the AHA meeting.

Another area of research involves appropriate dosing of clopidogrel, as well as ways to identify poor responders of the drug. Recently reported data from the GRAVITAS trial found that a higher dose of clopidogrel did not seem to improve outcomes for poor responders.  

Packer: Some basic science studies this year looked at ion channel abnormalities that have a genetic basis. While we still need more information to make this relevant for practice, the HRS is working on guidelines for the application of genetic information.

We have translational studies being conducted on device and ablation techniques, such as using different ablation energy forms and measuring their impact, as well as how best to guide the ablation process. These translational studies will be more applicable over the next year.

The National Heart, Lung and Blood Institute recently convened two working groups regarding research. One group made recommendations about comparative-effectiveness research and how to obtain information quicker than it would otherwise take via large clinical trials. That study will be released next year. The second group published a paper last year that identified opportunities to advance research on the prevention of atrial fibrillation [Circulation 2009;119:606-618]. Both of these reports summarize important issues and make a clarion call for the kind of research needed to have an impact on practice.

Yancy: There have been a couple game changers in 2010, and in late 2009. First, the revolutionary changes in our understanding of the natural history of atrial fibrillation, along with more techniques and technologies to achieve successful ablation. Second, more data are emerging attesting to the benefit of our focus on quality. The Agency for Healthcare Research and Quality published a paper in October, for example, that found a 49 percent reduction in the risk of death in patients hospitalized with heart failure between 2000 and 2007 [HCUP Statistical Brief #98]. That is huge. While there is therapy that modifies the natural history of heart failure, we also have to recognize that the quality of care has improved. A third game changer is the increasing evidence that left ventricular assist devices improve long-term heart failure care.

Whether the challenges are in payment reform, manpower or incorporating new research into clinical practice, the work we need to do is to embrace the adventure and make that the calling card for cardiovascular medicine.