Evolution of the heart team: Advances in care delivery after 2 decades of TAVR
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One celebrated advance to come from transcatheter aortic valve replacement is the evolution of a multidisciplinary heart team, utilizing skill sets of interventional cardiologists and cardiac surgeons to drive better outcomes for patients.
The joining of specialists from the OR and the cath lab was still novel at the time of the first randomized controlled trials for TAVR, when trial design protocols mandated interventional cardiologists and cardiac surgeons work together to select ideal patients for enrollment, according to Megan Coylewright, MD, MPH, FACC, FSCAI, vice chief of cardiology faculty development and director of the health system’s Structural Heart Program at Erlanger Health System in Tennessee. Since those first procedures in the early 2000s, the “heart team” model has evolved to change the way care is delivered, yet many challenges remain when it comes to including patient goals and preferences in the decision-making process.
Healio spoke with Coylewright about lessons learned from the early TAVR trials, the importance of shared decision-making and the opportunities for true patient engagement.
Healio: Before TAVR, what were the options for patients with severe aortic stenosis, and what was the decision-making process like?
Coylewright: Before TAVR was studied in clinical trials, patients who had aortic stenosis were offered surgical aortic valve replacement. Occasionally, people who were not good surgical candidates would be offered balloon aortic valvuloplasty, which is a procedure that is a temporizing measure, but the aortic stenosis always progressed and returned. There were many patients who had severe aortic stenosis suffering from chest pain and shortness of breath who were not offered therapy, because the risk of surgery at that time was fairly high among older adults.
There was little role for the interventional cardiologist in the decision-making process because we did not have treatment options that were used frequently. Before TAVR was approved in 2011, there was not a field of structural interventional cardiology like there is today. Many interventional cardiologists then were primarily doing coronary work but were also serving as general cardiologists. They were still involved in the care of patients with aortic stenosis. But in general, when patients developed symptoms related to their valve, they were sent to the surgeon. There were not many choices. The choices were to die of this disease or to undergo surgery.
Healio: As TAVR has evolved from 2002 until now, so has the formation of the heart team. What influence has TAVR had on that process?
Coylewright: It began during the clinical trials. When we first developed the trials for balloon-expandable and self-expanding valves, in both trial protocols there was a mandate that interventional cardiologists and cardiac surgeons work together, specifically to choose a patient who would be most likely to benefit from the valve. The heart team was designed to enable enrollment in clinical trials. This is true as well in our prior coronary revascularization trials, where we had the emergence of a heart team even before we started to see this concept in aortic valve stenosis. It was a tool to optimize clinical trial enrollment. It was not necessarily designed from the get-go to be a method of patient engagement. Early on, with both the Edwards Lifesciences valve and the Medtronic valve, there was a mandate that interventional cardiologists and cardiac surgeons both see the patient and give their medical opinion about what treatment was appropriate. This was a breakthrough, because there were few opportunities where interventional cardiologists and cardiac surgeons had to sit down in the same room, at the same time, and discuss patients together. It was a watershed moment; both groups understood that they could teach each other something.
However, this was still not a team approach that was happening at the bedside in clinic. It was happening in a conference room at a distinct time and location from when they met with the patient. It was a technical decision-making process. When TAVR was approved by Medicare, Medicare stated that to have coverage for TAVR, Medicare beneficiaries had to see an interventional cardiologist and, early on, two cardiac surgeons, in person. There was concern from the beginning of “rational dispersion” of therapy.
Later, the Medicare national coverage determination was updated to change the requirement from two to one cardiac surgeon, along with one interventional cardiologist.
The heart team is decision-making between the physicians. The shared decision-making requirement was playing with the idea that decision aids should be utilized with patients and their families, so that they were ready to make informed decisions with their heart team. They opted not to go that far, for a variety of reasons. We continued to work together on a research front as well as a health policy front to figure out how best to include patients and their families in this complex decision-making.
Healio: Two decades in, what has TAVR taught us about patient engagement and health care delivery?
Coylewright: The treatment of aortic stenosis has taught us so much about patient engagement because there are now different options patients think about differently. Patients with different sociodemographic characteristics — gender, race, class, roles they have in within their families and communities — they weigh the risks and benefits differently from one another. Importantly, they weigh them differently from their heart team. One of the things that the treatment of aortic stenosis taught us early on was that our patients were more focused on quality of life than quantity of life. That took physicians by surprise. We had always powered out trials on death. Our earliest patients in the trials for severe aortic stenosis were elderly. They often said, “If I can just have some months or years of quality of life, that would be my goal, rather than lengthening my life. If you are not able to achieve that, I would rather not pursue this.” Some of these patients had so many competing illnesses, that treatment of the valve alone would not improve quality of life. In listening to the patient voices, we learned how we can incorporate what is most important to them and guide them to the therapy that is a good match for their goals and preferences.
We are beginning to accept that truly engaging patients in a shared decision-making process is hard work. It is challenging to meet someone in a short encounter and learn what their goals and preferences are without the use of specially designed decision aids. Some of the work we have been doing at CardioSmart, which is the American College of Cardiology’s patient engagement platform, is to develop and test decision aids designed for patients contemplating these decisions, so their voices can be heard.
Healio: What further changes are needed to put the patient more at the center of their own care?
Coylewright: We must leverage our current systems of care in a way that puts the patient truly at the center. Increasingly, we are comprised of health care teams made up of a variety of CV team members: Physicians, both interventional cardiologists and cardiac surgeons, general cardiologists, imagers, nurse practitioners, physician assistants, nurses, social workers, medical assistants. We need to leverage the skill sets of all the team members to put the patient voice at the center. We still conduct our clinics the same way they were conducted 30 years ago. There is a lot of opportunity to be creative and innovative. It will take focus and research.
One of the projects I am leading with my research partner Nananda Col, MD, MPP, MPH, FACP, a shared decision-making expert, is the development of a patient preference tool for treatment of aortic stenosis. We started this by reaching out to the experts — the patients — who had TAVR or surgical AVR. We asked them, what is most important to you when making the decision about treatment of aortic stenosis? They reflected on the journeys they had been through, and they shared with us what was most important to them. Very little of it matched what physicians said was most important.
There is a lot of room to grow. Now, as we start to work closely with patients, it is fun and interesting to learn how their goals and preferences may be different. We want patients coming to that final decision with informed preferences. That is what we are testing. It is clear that patients need input from their clinician team to make a final decision, yet for patients to express informed preferences, there is work to be done.
If we prepare them beforehand, providing patient education, they can come to the clinical encounter ready to engage in the decision-making with the heart team.
The heart team does not equal patient engagement. It is another step we need to take forward to bridge that gap. Our field of interventional cardiology, and cardiac surgery as well, is well placed to start doing that in the coming years.
For more information:
Megan Coylewright, MD, MPH, FACC, FSCAI, can be reached at megan.coylewright@erlanger.org.
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