Physiologic Data Strengthens the Heart Team Concept at East Carolina Heart Institute

Multidisciplinary decision-making is gaining traction in many areas of cardiovascular medicine, including aortic and mitral valve disease, and ischemic heart disease. The multidisciplinary approach facilitates selecting the optimal treatment option for each patient, every time.

In stable ischemic heart disease (SIHD), for example, the treatment options consist of medical therapy, or revascularization with either  percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG). The premise is that a multidisciplinary team of specialists can together better analyze and interpret the available diagnostic evidence, and put into context the clinical condition of the patient. Then, the patient-centered individual preferences can be determined through shared decision-making with the patient. Through this process, the most optimal joint treatment strategy recommendation for patients with stable coronary artery disease can be determined for each patient. However, this approach, coined the ‘heart team,’ has not yet been widely implemented in the United States. 

What is the heart team concept?  

At East Carolina Heart Institute, we view the heart team concept as an alignment of perspective of the cardiologist, the heart surgeon and the vascular surgeon, looking at an individual patient in a collaborative and disciplined manner to determine the best course of treatment for that individual. A group of specialists dialoguing with a patient-centered focus is likely to arrive at a superior patient decision rather than individual specialists viewing options primarily through the lens of their particular specialty.  

More widely accepted in Europe, the heart team concept is just beginning to gain momentum in the U.S. Initial interest in the heart team approach for ischemic heart disease decision-making was first generated by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial. In that study of advanced coronary artery disease, all eligible patients were screened and a mandated consultation between cardiologists and surgeons was built into the protocol. The group formalized the idea of an interventional cardiologist and cardiac surgeon closely collaborating in assessing and managing patients with complex coronary artery disease who required revascularization.

The heart team approach was incorporated into the European Society of Cardiology’s 2011 revascularization guidelines and subsequently has become the first recommendation in the American College of Cardiology/American Heart Association guidelines for PCI and CABG. These guidelines suggest collaborative input from a surgeon, an interventional cardiologist, and a general cardiologist.

Similar heart team collaborations have been developed for percutaneous mitral valve surgery, and for percutaneous aortic procedures (TAVR). Additionally, as the importance of physiology in stable ischemic heart disease becomes more established, new diagnostic technologies will continue to be worked into the heart team approach for SIHD, established by and based on SYNTAX.   

Forming the heart team at East Carolina Heart Institute

In 2007, a new Department of Cardiovascular Sciences at East Carolina Heart Institute was designed around the fledgling concept of a heart team. The founding clinicians viewed the new department as a critically important opportunity to develop the organizational and process governance to achieve a level of integration that was being talked about, but not yet achieved. With the overarching mantra of highly collaborative cardiac decision-making, we recruited Ramesh Daggubati, MD, and Ashesh N. Buch, MD, innovators who viewed and approached cardiac protocols with a penchant different from the traditional surgery versus interventional cardiology. 

This new governance required realigning the former Division of Cardiothoracic and Vascular Surgery, moved from its traditional academic home in the Department of Surgery, and moving the Division of Cardiology out of the Department of Medicine.  The Brody School of Medicine at East Carolina University combined both departments together into the new Department of Cardiovascular Sciences, in the East Carolina Heart Institute facilities. This re-organization resulted in a new identity for the faculty that embraced the foundation of collegiality and commonality that helped facilitate the heart team approach. Further, the reorganization removed many of the traditional departmental and academic obstacles — financial, organizational, and accountability reporting structures — from the mix. Most importantly, the Department of Cardiovascular Sciences creates the opportunity for all providers to operate from the same aligned agenda, which paradoxically was what they wanted to do anyway, but couldn’t. The heart team concept could also move forward while minimizing current turf wars over what could (but not always should) be done, and who could do it.     

From these foundational changes came the evolutionary physiologic approach to evaluating ischemic heart disease. With a new environment populated with interventional cardiologists, cardiologists and surgeons, the discussion regarding ischemic heart disease is a completely different framework where anatomy is no longer the epitome of decision-making; rather, the crux becomes ischemia and its quantification, and improved patient outcomes.  

Other departmental changes have resulted in a highly efficient process for patients and clinicians. Patients can be seen on the same day by a cardiologist, by a cardiac surgeon, and by a vascular surgeon, and a team approach is implemented in their management. It is more time effective for the patient, engenders great patient satisfaction, and in the long run, a collaborative approach to these patients will provide the best outcomes. And though initially a lengthier process on the provider side of the equation, the superior patient management decisions that ensue ultimately result in reduced costs.  

Migrating anatomic decision making to physiology

When ischemic heart disease was suspected, non-interventional cardiologists used to send patients to the cath lab for a coronary angiogram. The patient would then be classified by the anatomic construct of disease: 1-, 2-, or 3-vessel disease and the location of the lesions. This anatomic construct was, for years, the basis of the decision of who would go to PCI and who would go to bypass surgery; medical therapy was an option of last resort when intervention couldn’t be accomplished.

The documentation of the importance of optimal medical therapy, and transition from anatomy-based intervention to functionally based intervention are having an enormous impact on cardiovascular medicine. Making therapeutic decisions about intervention on what is seen without an assessment of the physiological aspects of blood flow (throughput, pressure, etc.) as part of the diagnosis, has been documented as resulting in suboptimal patient outcomes. In other words, it is not just the static anatomy that requires assessment, but also the degree of ischemia indications, in order to determine optimal treatment outcomes. For example, it has been common for interventional cardiologists or cardiac surgeons to see additional anatomic narrowings that seemingly required intervention, performed on the spot. Physiologic data can reveal that a decision to intervene on the additional narrowing might not be necessary or warranted. For both CABG and PCI, the need for physiologic data is prompting cath labs to evaluate lesion functionality with fractional flow reserve (FFR).  

Fractional flow reserve (FFR) technology at the apex of change

For the past decade, randomized studies of physiologic data acquired in the cath lab have been persistently changing concepts of stable ischemic heart disease, in collaboration with other randomized trials of optimal medical therapy.  Technologies like FFR are important because they work with the anatomy data from the cath to create a functional anatomy construct for intervention in patients who fail optimal medical therapy. FFR is a functional measurement that analyzes pressure and flow parameters from inside of the vessel. It is used at the time of cardiac cath. FFR has transformed revascularization by bringing the concept of functionality to the evaluation of coronary anatomy and obstruction within the coronary vessels. This reproducible measurement provides physicians with specific clinical guidance to aid appropriate treatment.

Four years ago, at the East Carolina Heart Institute, we didn’t use FFR. The International ISCHEMIA trial (ischemiatrial.org) has revolutionized our thinking about revascularization and stable ischemic heart disease. The concept and data from FFR has conceptually changed our clinical practices for both PCI and CABG. We think about surgical revascularization differently now than we did three or four years ago.  In addition, we have been doing intraoperative imaging to assess the physiologic response of bypass grafting and document it in real time. In off-pump surgical revascularization, we can actually demonstrate how much the regional myocardial perfusion changes at the time of surgery as a result of bypass grafting.

We realized that what we were measuring in the operating room with our imaging technology was the relief of the ischemia that was being identified by FFR in the cath lab. The more we work through the fundamental physiology of evaluation of blood flow and perfusion that have been going on in the cath lab for the last 20 years, the more we realize that there are very real parallels in the operating room.

Physiological data such as FFR, when coupled with anatomy data, will give an indication of which vessels need to be intervened upon with PCI, and perhaps with coronary bypass grafting; this is still a matter of debate in cardiac surgery. It is interesting to note that the per-graft response to revascularization based on the degree of anatomic stenosis mirrors the data in the FAME trial. Using a surgical threshold of 70% or greater stenosis as a trigger for anatomic-based revascularization, 20-22% of the grafts that are placed and widely patent angiographically in the operating room don’t have any improvement in myocardial perfusion. In the FAME trial, 20% of the anatomic stenoses between 70-90% were anatomic but not functional, and would not be expected to be associated with a change in myocardial perfusion with grafting. Further, our preliminary data comparing FFR and the magnitude of the FFR decrement at the time of cardiac catherization mirrors what we measure as the relief of ischemia in the operating room very closely. This suggests that we need to learn much more about the physiologic response to coronary bypass grafting, and that, like PCI revascularization, the key may well be in the underlying physiologic correlates that seem to be present in both intervention circumstances.  

I think that we are going to see an increasing stream of data from the cath lab that will help improve our technical decision-making and outcome evaluation in the operating room. Documenting these physiologic conditions preoperatively, and then confirming the resolution of the physiologic aberrations at surgery, should result in more optimal coronary artery revascularization procedure, with better outcomes.

The heart team and FFR in practice

FFR plays an important role at the East Carolina Heart Institute by identifying so-called intermediate lesions that are seen on coronary arteriography, where we can’t be exactly sure how severe those particular obstructions are. In the past, we always used our eyes to guess as to how significant a lesion may be, and made decisions to intervene or not based on those decisions. We now know from FFR data that lesions that appear to be significant may not be and those that do not appear to be significant may indeed be so. So it is our belief that FFR will play a significant role in guiding the decision process to a percutaneous intervention, medical therapy, or surgery.

The heart team concept is particularly valuable when decisions related to revascularization are uncertain. The physiologic data provides important and sometimes new, additional information to this decision-making process. Patients are managed by gathering interventional, diagnostic, and therapeutic colleagues together to evaluate the films. If the intervention decision remains unclear, the patient might go back to the cath lab, not for a repeat diagnostic procedure, but to determine lesion functionality. At East Carolina Heart Institute, these processes are becoming more frequent and standardized as the surgical community becomes more convinced that functionality is critical to decision-making. Clearly, the interventional cardiologists are beginning to think about surgical patients the same way they think about patients who are candidates for PCI, and as a result, are proactively doing FFR on patients they believe will be a difficult call for surgeons. That is a really important transition and one that wouldn’t necessarily occur outside of a truly integrated heart team. It demonstrates that all heart team providers are beginning to think the same way about revascularization, and using the same framework regarding revascularization and stable ischemic heart disease.

The quality outcomes and healthcare financial benefits of FFR-guided revascularization for PCI have been demonstrated by the FAME 1, FAME 2 and DEFER studies. This strategy may also be applicable to CABG, but there are many unknowns yet to be determined. The only way to make these determinations is to be operating on patients where the functional anatomy is known, and the response to revascularization is evaluated at the time of CABG. What we can agree on in the heart team, is that it is critical that we know the anatomy and the hemodynamics of that anatomy to provide the best recommendation to the patient for their immediate and long-term healthcare needs. We need to know that we are placing a stent for the right reason or doing a coronary bypass graft for an appropriate indication. It remains to be determined that if we do those things for hemodynamically significant lesions in CABG, the patient will have an improved long-term outcome. However, if we continue to do things that are unnecessary, the patient, as well as the healthcare system, will be exposed to risk and expense.

Heart team concept – a surgeon’s perspective

From a surgeon’s standpoint, the primary benefit of the heart team and FFR is to aid in certainty regarding the severity of the lesion in any of the coronary artery distributions. The truly critical lesions can be grafted with arterial conduits, thus assuring the best long-term patency and the best long-term patient outcome. The non-critical lesions should not be grafted if they can be managed medically. 

The SYNTAX and FREEDOM trials both demonstrated better long-term outcomes of survival and freedom from MI with CABG as compared to PCI. Surgeons have argued for years that large-scale observational studies have demonstrated these better long-term outcomes, and now seminal randomized clinical trials have shown the same findings. However, the reason for the increased survival and freedom from MI are at present unknown. Because both SYNTAX and FREEDOM were trials where the intervention was based on anatomy in both arms, anatomy cannot be the explanation for these late outcomes. These late outcomes must, in some way, reflect the underlying physiologic results from CABG, but not PCI. The only way to determine whether this is true is to assess these physiologic outcomes before, during, and after the interventions. Our CABG data suggests, for example, that a “perfusion safety net” is created by multiple-vessel bypass grafting, particularly if the SIHD process has created the opportunity for this excess perfusion to be shared around the heart where it is needed most. The key to unraveling this process is dependent upon knowing the functional anatomy prior to CABG, as determined by FFR. 

Because of the heart team, surgeons work with interventional cardiologist colleagues in a number of ways. We always have a surgeon available to come to the cath lab when needed to provide collegial help. We collaborate to discuss and engage in the evolution of our merging knowledge bases. We share East Carolina Heart Institute clinical cardiovascular information system cardiology and cardiac surgery data, through conferences and sidebar discussions, and through case presentation conferences. It is critical that each cohort develops an understanding of developments in each area, because we recognize fundamentally that percutaneous revascularization and surgical revascularization are both forms of revascularization in the context of stable ischemic heart disease.

Heart team concept – an interventional cardiologist’s perspective

For an interventionalist, the primary value of the heart team and FFR is, first, in aiding and clarifying diagnosis. The pressure wire helps determine, with a high level of certainty, that what we see on the angiogram is bad enough to cause angina or ischemia. Second, it aids in determining what type of revascularization therapy to provide; in other words, how are we going to improve the blood supply to this patient? We generally have two options – stenting or surgery. How we decide to proceed can be heavily influenced by FFR data.

There is very good data to emphasize the fact that using FFR will clarify angiographic interpretation. According to the RIPCORD study, use of FFR changes decision-making 26% of the time.¹ In another study by Sant’Anna et al², it is 48% of the time.  

When you use FFR, you will change your diagnosis, you will change your management a quarter to 50% of the time, and that is quite significant. And it proves the point that angiography is incredibly limiting and has limited applicability outside certain patient populations.

In our practice, we discuss the pros and cons of bypass surgery versus PCI with the surgical team. We get together and look at the angiogram. We determine what is limiting the patient’s symptoms, what are their co-morbidities, what are the real risks of PCI, and what are the risks of surgery. It is a matter of determining the risk benefits of both and deciding collectively what is the best method of treatment.

Clinical benefit of the heart team concept

Expanding on the heart team concept, we are not just concerned with the dialogue between an interventional cardiologist and a surgeon; we are designing what we can do in both environments to benefit the other. Adopting mechanisms to generate the functional anatomic construct in the cath lab for patients that we know are going to surgery based on the initial diagnostic cath is an example of that level of cooperation. That information is going to be beneficial in knowing how to optimize surgical revascularization down the road. This type of cooperation is only possible with a team comprised of like-minded individuals who have a shared interest in the best patient outcome and the right processes in place. We have moved from an operational group, a heart team, to a group of professionals that are truly starting to think the same way about stable ischemic heart disease revascularization. This collaboration results in more sophisticated, superior decision-making for revascularization strategy with regards to our complex patients. 

Patient benefit from the heart team concept

Implicit in the heart team process is the placement of the patient at the center of the decision-making process. An Institute of Medicine publication, “Best Care at Lower Cost: the Path to Continuously Learning Health Care in America,”³ provides a roadmap for achieving an ideal health paradigm based on continuous learning, focused on the individual patient. Patients benefit from improved quality of care and a better healthcare experience through the team approach. Quality of care means giving patients the right care at the right time, minimizing complications, and maximizing their long-term benefit from that care. The better and more efficiently surgeons and interventionalists work together, the more that translates into seamless, high-quality results and lower healthcare costs for patients.   

As well, patients have the confidence that their physicians are working together collaboratively, and using all the tools and resources available in order for the patient to benefit.

Economic benefit of the heart team concept

The Institute of Medicine report cites that as much as one third of healthcare dollars in the U.S. are wasted through inefficient, unnecessary, or illegal spending.³ In the current healthcare environment, we are faced with increasing downward pressures on cost associated with healthcare reform, including electronic health records, meaningful use, additional personnel required to comply with the Affordable Care Act, and an increasingly tough regulatory environment.

Other studies have demonstrated that the introduction, expansion, and diffusion of new technologies are credited with having the single largest effect on the growth of healthcare spending. Importantly, there are considerable data that demonstrate the heart team approach will reduce costs and at the same time improve quality. 

These economic concerns need to be addressed by building a healthcare team that focuses on which patients should have which treatment at which time, based on appropriate guidelines and protocols, all while avoiding unnecessary procedures and costs. The physiologic assessment of patients with SIHD with FFR and FFR-guided intervention has been demonstrated to improve outcomes while reducing healthcare expenditures.

The technologies that produce new and important information will help guide clinicians to do the right procedure and in the long run, result in the least expensive approach to care. By using physiology-guided revascularization, you will end up treating only vessels that actually require treatment. Patients will receive more appropriate care, and you will avoid unnecessary stents or bypasses, which may help reduce length of stay and reduce morbidity. The right procedure, for the right patient, at the right time, is the best economic approach. Readmissions will be less, recurrent interventions will be less, and long-term results will be maximized.

Advice for adopting a heart team model

The heart team model must be based on a group of clinicians who share a like vision for organization, for governance, for patient-centric care, and for placing the patient at the center of quality of care decisions. The primary focus must be on identifying the right team members, and then, on the right team leadership. The team members will need to change existing care patterns slightly, and will need to make time in the week to get together and review and discuss cases and practices. Collecting and analyzing clinical data is critically important, but it also must be transparently shared and used for planning quality improvement strategies. Finally, the members of the heart team must share with the hospital system the financial outcomes from this hard, persistent, and diligent work that improves outcomes and reduces costs.  

Conclusion

We see the heart team concept at the core of cardiac science in the future. Collaboration among the disciplines and concentrating on a functional anatomic roadmap on every patient will result in more sophisticated, superior decision-making, with improved patient outcomes and an economic benefit for the hospital.

Disclosure: Dr. Ferguson reports no conflicts of interest regarding the content herein.

Dr. Bruce Ferguson can be contacted at fergusont@ecu.edu.

References

1. European Society of Cardiology. EuroPCR press releases. Available online at https://www.escardio.org/about/press/press-releases/pr-13/Pages/europcr-day2.aspx#coronary. Accessed December 12, 2013.
2. Sant’Anna FM, Silva EE, Batista LA, Ventura FM, Barrozo CA, Pijls NH. Influence of routine assessment of fractional flow reserve on decision making during coronary interventions. Am J Cardiol. 2007 Feb 15; 99(4): 504-508.
3. Institute of Medicine of the National Academies. Best care at lower cost: the path to continuously learning health care in America. Released September 6, 2012. Available online at https://www.iom.edu/Reports/2012/Best-Care-at-Lower-Cost-The-Path-to-Continuously-Learning-Health-Care-in-America.aspx. Accessed December 12, 2013.