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Adding Value with TAVR at the Oklahoma Heart Institute
Note: In order to complete this educational activity, please visit the website to answer questions and obtain your certificate:
https://www.cathlabdigest.com/TAVRprogramOH
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Overview
This module will provide advice from an experienced, successful TAVR center (Oklahoma Heart Institute) to readers who are beginning a TAVR program, and link data tracking and describe the nature of team involvement necessary for the care of this patient population. The results and protocols shared by this experienced TAVR program can help guide others as to what to expect, resources required, and where to direct energies most efficiently.
As facilities are deciding whether to invest in new TAVR technologies and then seek to maintain support for those technologies once established, hospitals often look to ensure that the service line provides some combination of strategic, clinical and financial benefit. The purpose of this article is to describe processes to comprehensively track, monitor and understand the overall financial impact of TAVR from a hospital perspective. This process is sometimes referred to as program economics or the halo effect, and involves quantifying the incremental screening tests and interventions that are attributable to the TAVR program. In this article, we talk to a TAVR program director about how patients are directed through the screening process, and how data about patient care is tracked at their facility for clinical and financial review.
CEE CME/CEU Accreditation and Designation
The Center of Excellence in Education (CEE) designates this live activity for a maximum of ONE (1) AMA PRA Category 1 Credit (s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This credit may also be applied to the CMA Certification in Continuing Medical Education.
This educational activity has been planned and implemented in accordance with the Institute for Medical Quality and the California Medical Association’s CME Accreditation Standards (IMQ/CMA).
This module is additionally accredited for RNs and other licensed healthcare providers for ONE (1) CE by California Board of Registered Nursing and California EMT-P ~ Pre-Hospital Provider.
Documentation of awarded credit is provided for registered learners in exchange for completed post test and activity evaluations included in the modules.
Target Audience
This journal-based activity is designed for interventional cardiologists, radiologists, clinical cardiologists, vascular medicine specialists, cardiac and vascular surgeons, nurse practitioners, cath lab technologists, and other health care professionals with a special interest in the field of interventional and vascular medicine.
Needs Statement
CEE reviews and our activities provide the latest best practice, evidence-based data and science that physicians require to improve patient outcomes.
Activity Goals
The overall goal of this activity is to improve knowledge and competence by the target audience implementing a TAVR program whose ultimate goal is to improved patient care.
This activity is for those who have not implemented a TAVR program and who want to implement protocols with a consistent multidisciplinary team, track metrics, create a detail-oriented screening process, and a focus on post procedure resources that are used to avoid readmission.
Learning Objectives
Upon completion of this article, participants should be able to:
- Describe the importance of the ‘halo effect’ in financially supporting the resources required for a TAVR program.
- Define scope, type and method of data collection regarding patients in the program, and its importance.
- List the types of screening that TAVR patients are most likely to receive, and possible pathways through the TAVR program to treatment (whether TAVR or other treatment).
CME/CEU Disclosure to the Readers
A review has been conducted by the CEE CME/CEU Committee that includes evaluation of objectives, content, faculty qualifications, and commercial supporters (i.e. pharma companies, instrument or device manufacturers) to comply with, and ensure the Institute for Medical Quality (IMQ)/California Medical Association (CMA) and Accreditation Council for Continuing Medical Education (ACCME) standards are met.
In accordance with the standards of commercial support of the IMQ/CME and ACCME, all speakers are asked to disclose any real or apparent conflicts of interest, which may have a direct bearing on the subject matter they will be presenting in this article.
It is the policy of The Center of Excellence in Education to ensure balance, independence, objectivity, and scientific rigor in all of its sponsored educational activities. Commercial support from industry does not influence educational content, faculty selection, and/or faculty presentations, and does not compromise the scientific integrity of the educational activity.
Discussion of off-label product usage and/or off-label product use during live cases is made at the sole discretion of the faculty. Off-label product discussion and usage are not endorsed by The Center of Excellence in Education.
Authors, faculty and planners participating in continuing medical education activities sponsored by The Center of Excellence in Education are required to disclose to the activity audience any real or apparent conflicts of interest related to the content of their presentations. Faculty not complying with this policy are not permitted to participate in this activity.
All authors and planners have disclosed that they have no relevant conflicts of interest and forms are on file for review.
Successful completion of this activity requires a completed post-test and evaluation. You will then print your CME/CE Certificate from the website.
For any CME/CEU-related inquiry, please contact donnaconrad@shasta.com
Activity Sponsorship
This article is sponsored by The Center of Excellence In Education and the educational partner HMP Communications.
Program Support
This article is funded through an educational grant through a commercial supporter. The Center of Excellence in Education ensures that its activities are educational and meet the needs of the target audience.
This educational activity is developed without influence from commercial supporters.
This educational activity is supported by an educational grant from Edwards Lifesciences in accordance with industry standards.
Disclaimer
This article does not endorse any commercial products.
CME/CEU accreditation for this article expires on March 31, 2015.
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Can you tell us about your institution and transcatheter aortic valve replacement (TAVR) program?
Oklahoma Heart Institute is part of the Hillcrest Healthcare system, located in Tulsa, Oklahoma.
We are a full-service cardiology practice and heart hospital, and began performing TAVR in May 2012 with great success.
Oklahoma Heart Institute was the first center to offer TAVR in Tulsa and northeast Oklahoma, and is the highest volume TAVR program in the region. We are happy to have had the opportunity to help 60 patients thus far with this therapy.
How many interventionalists and surgeons are involved with the TAVR program?
There are two interventional cardiologists, including myself and Dr. Wayne Leimbach, Jr., and two cardiothoracic surgeons, Dr. Paul Kempe and Dr. Michael Phillips. Anna Richardson, LPN, serves as the valve coordinator. Dr. Victor Cheng serves as our imaging specialist — he performs and interprets all of the cardiac and vascular computed tomography scans (CTs) performed as part of the TAVR evaluation, as well as the intraprocedural transesophageal echocardiograms.
Do you use dedicated staff?
We do have a dedicated team, made up of cath lab and operating room (OR) staff. Any time we do a TAVR or other valve procedure, including valvuloplasty, the same team works with us in the hybrid lab. It helps tremendously, because hybrid procedures require specialized equipment and techniques. It is helpful to have dedicated staff that is familiar with that set up and tools. It makes everything smooth and consistent.
Did you have a hybrid lab in place prior to the TAVR program beginning?
No, it was constructed prior to the program starting. The construction was completed and the hybrid cath lab opened in April 2012.
As a hybrid cath lab, is it under cath lab management?
Yes. It is actually physically located in the cath lab and is under cath lab management. Our hybrid lab is a dedicated and purpose-built lab that was built from the ground up to support TAVR and other complex hybrid procedures.
What other procedures take place in the lab?
In addition to TAVR, we perform endovascular aortic repair, and complex valvuloplasties and structural heart procedures in this lab. Our electrophysiology partners perform lead extractions in the hybrid cath lab. Occasionally, we will perform hybrid surgical/interventional procedures (other than TAVR) with the surgeons in the hybrid lab as well. We are also planning to launch a large-bore deep vein thrombosis/pulmonary embolism aspiration program utilizing the AngioVac (AngioDynamics/Vortex Medical) device in the hybrid lab.
Are there designated days for TAVR procedures?
We try to do all our TAVRs on Tuesdays. It is a day where we have structured the schedules of the interventionalists and the surgeons such that we are all together in the hybrid cath lab, rather than being in clinic or in other roles.
Do you have a dedicated clinic space?
We are remodeling a space on the first floor of our office building with the goal of having the TAVR program interventionalists and cardiac surgeons in the same location. It will permit us to see our patients at the same time and in the same space. For our older patients, it is also easier on them if they can avoid traveling up and down elevators.
Our ancillary staff includes nurses working with the surgeons and the interventionalist, as well as medical assistants that are working with us in the clinic. We have also recently brought on a dedicated mid-level provider (advanced practice nurse – clinical nurse specialist) to help us coordinate care in our multidisciplinary Valve Center.
What is the process of evaluating a patient for TAVR?
Typically a referral is made by another cardiologist or by a primary care physician. The patient has an initial visit to the clinic, and we explore their symptoms and review any outside information they bring along with them, including testing that may have been done in the past. An initial determination is made regarding whether this patient has severe aortic stenosis and whether it is symptomatic. Assessment of independence, quality of life and frailty is also performed at this initial visit. If the patient has other significant co-morbidities, we also carefully consider issues around futility of aortic valve intervention. Then we begin the process of evaluation, which usually includes echocardiography to confirm severe aortic stenosis (if not already done), followed by a cardiac catheterization to evaluate for coronary disease and further evaluate the aortic stenosis. During this process, the patient will also be seen by our colleagues in cardiac surgery, often the same day as their testing or shortly thereafter, in order to get a surgical opinion on their aortic valve disease. Before the patient is considered a candidate for TAVR, the Centers for Medicare and Medicaid requires two surgeons to independently evaluate the patient and deem them high risk for surgical AVR. TAVR is currently only approved for severe symptomatic aortic stenosis in high-risk patients. We try to have patients visit both our surgeons on the same day, but in some cases, the visits happen on separate days. Once these basic steps have occurred, if we determine that the patient has severe symptomatic aortic stenosis and the patient is high risk for surgical aortic valve repair/replacement, then we typically proceed with a CT angiogram to evaluate the native aortic valve and annulus for transcatheter heart valve sizing purposes. We also use CT to evaluate whether there is adequate access from a transfemoral route or whether an alternative approach like transpical or transaortic TAVR is required. Additional testing, including pulmonary function testing and carotid ultrasonography, may also be performed, depending on the clinical picture. Following this, the patient can then be considered for TAVR if all the criteria are met, the CT scan shows a valve of the appropriate size can be placed, and an approach has been determined. The whole TAVR team meets regularly before we proceed with any case, including the surgeons, the interventionalists, our valve coordinator, and a non-invasive imaging cardiologist. The team discusses every case in a multidisciplinary fashion. We review all the data that has been collected and make a final decision: whether this patient is a candidate for a transfemoral, transapical, or transaortic TAVR, or that this patient is better suited to surgical AVR, or that this patient is not a candidate for either form of therapy and should be treated medically. After this final meeting, we proceed with whatever plan is agreed upon by the whole team.
What is the role of the valve coordinator?
Our valve coordinator, Anna Richardson, LPN, is involved with the patient throughout the evaluation. Beginning with the patient’s first visit, she will see them along with the physicians, and is the point of contact for the patient and family. TAVR patients are generally older individuals, often with multiple family members that bring them to their appointments and testing, and who are their points of contact. Our valve coordinator helps to coordinate with the patient and their family. There is a great deal of behind-the-scenes work involving phone calls, instructions, ongoing education, and explanations about why a test is happening on a particular day or why the patient is seeing another physician to discuss a particular issue. There are often many social factors that are uncovered as the evaluation proceeds, and the valve coordinator is very useful in bringing those to the table when we have our final multidisciplinary meeting.
If a patient requires a percutaneous coronary intervention (PCI), is it done prior to the actual TAVR procedure or is it possible to do during the TAVR procedure?
We tend to take it on a case-by-case basis. Often patients have both coronary and valvular disease such as aortic stenosis. How we proceed is based on the patient’s clinical features. If they have symptoms to suggest that their coronary disease is playing a role in addition to their severe aortic stenosis, we will typically treat their coronary disease first with PCI before TAVR. On the other hand, if a patient has severe coronary disease, but it appears their severe aortic stenosis is the bigger culprit in their clinical presentation, then we will treat the aortic stenosis first and may treat the coronary disease later, if needed. If the disease is not amenable to PCI before or during the TAVR, sometimes we will do a hybrid procedure combining a coronary revascularization via a surgical route at the same time as the TAVR.
What has been the impact of the TAVR program on Oklahoma Heart Institute?
TAVR is a resource-intensive procedure, both on the physician and hospital level as well as on the inventory/supply cost level. It requires a great deal of manpower from highly trained people whose time is worth a great deal. The equipment itself is also very expensive, including the replacement aortic valve, which is not surprising, because so much research and effort has gone into developing, testing and trialing the valve and leading to its approval. Yet, despite all the issues that make TAVR an expensive procedure, it has been found to be very cost-effective. Investigators have studied the effects of TAVR on patients, looking at factors like rehospitalization for heart failure, quality of life, and so on, and found it to be a cost-effective therapy. That is why TAVR is an approved therapy. However, at the same time, any institution that starts a TAVR program can undergo financial strain, because of up-front costs and resource utilization. This is important, because in the real world, any institution performing procedures has to remain financially viable. Patient care and patient outcomes come first, but an institution still has to be financially viable to continue to provide patient care and service.
Since the cost of the TAVR procedure can be roughly equivalent to the payment that the institution receives for the procedure (i.e., the DRG; depending on geographic location), we must sometimes look beyond the dollars and cents resulting from each procedure reimbursement, and explore other factors. One is the incremental effect of having a TAVR program beyond a case-by-case procedural reimbursement, sometimes referred to as the ‘halo effect.’ The halo effect encompasses the upstream and downstream effects of having a TAVR program. This includes referrals of patients that may have otherwise not come to your facility, whether or not those patients receive TAVR or not in the end. It includes incremental services rendered as part of the evaluation for TAVR, including imaging studies such as echocardiography, CT angiography, and cardiac catheterization. In some cases, the halo effect may encompass other procedures such as PCI, peripheral vascular intervention, valvuloplasty procedures, or even surgical aortic valve replacement or other surgical therapies for cardiac and vascular diseases. In addition, there are consultations with various physicians on the TAVR team, including the interventional cardiologist and the cardiac surgeon. That is the halo effect, in a nutshell.
Is there one particular test or procedure that has proven to make up the bulk of the halo effect at your institution?
Not necessarily. In general, just being able to offer a service that may not be readily available at other places adds value to the program and to the institution.
How many patients have you screened for TAVR since the program opened, and how many ended up receiving a TAVR or surgical AVR?
To date, we have screened > 100 patients for TAVR. Of these, 60 have received TAVR and > 15 have received surgical AVR. The remainder were felt to be inappropriate for either TAVR or surgical AVR, due to clinical and/or anatomic factors (a number of these patients are in need of a transcatheter valve of a diameter larger than what is currently commercially available). If surgical AVR is recommended by the multidisciplinary valve team, it most often takes place at Oklahoma Heart Institute, as most referrals are internal to our healthcare system or from facilities that do not offer high-risk aortic valve replacement.
How many patients usually arrive with certain testing already performed?
I would estimate that a minority (<20%) of patients arrive with comprehensive testing already completed. Certainly, most patients arrive with an echocardiogram that has been used to make the diagnosis of severe aortic stenosis, but little, if any testing, has typically been completed beyond this. This has to do with our referral patterns, with most patients arriving to us from primary care providers and other non-cardiology providers. Testing is only repeated if felt to be outdated or if there has been a clinical change in the patient’s course.
Can you talk about the relationship with the referring physician? How much are they invested in the screening process?
We endeavor to be as engaged with referring physicians as possible. Certainly, pre-procedural testing such as echocardiography and cardiac catheterization is sometimes performed by our referring physicians and we welcome this. We have also reached out to key referring providers to join and scrub with us in our hybrid lab when the TAVR procedure takes place on their patient. Beyond this, we are very active in education through symposia, talks, and dinners in order to further educate our referring providers on TAVR.
How are you collecting and utilizing patient data?
All TAVR data collection and analysis requires maintenance of records and charts, and ideally, electronic records that can be easily queried to get data. It is helpful to have a database or spreadsheet that can be populated with key data points. Then someone needs to analyze the data. It can be someone from the TAVR team, like the valve coordinator, if their role and job permits, or it can be someone on the business side of the hospital or practice. The person in this role will analyze the data and come up with benchmarks, metrics and an idea of the program impact from a business aspect. Clearly, these data can and should also be evaluated for clinical outcomes as well.
Initially, we chose to collect data retrospectively. Every patient we see in our valve clinic and our TAVR clinic was followed. On a quarterly basis, we would perform a retrospective analysis to plot that patient’s clinical course, from the first day we met them all the way to the TAVR or other endpoint (surgical valve, etc.). Of course, some patients go on to have a surgical valve or different surgery/procedure. The analysis included all clinical visits, and all other testing and procedures that were done. It allowed us to determine, over that quarter, the impact of having a TAVR program.
After some experience with retrospective data management, we found that a more useful way to collect and analyze data — and we have moved toward this — is to do it prospectively. Retrospective data capture means you run the risk of not fully capturing the data, whereas if you do it prospectively in a deliberate manner, i.e., every time a patient is seen, this risk is reduced. Tracking data prospectively also means collection and analysis is cleaner, more efficient, and easier in the end. It takes more work up front, but in the end, saves time and person hours. Currently, our valve coordinator inputs data, I do some of it myself, and we also have employees in our practice, on the business side, that have helped us, especially initially. Once a patient is seen for the first time, their data is input into the database and then, as the evaluation of that patient unfolds, the latest information is entered.
What specific data do you track?
Along with all the basic demographic information like patient name, date of birth, age, and gender, we track referring physician, date of visit, date of subsequent visits, type of visit and with what physician. That is clearly important. We also track downstream services, which include:
- Visits with other physicians.
- Cardiac imaging studies. TAVR is highly dependent on pre-procedural imaging, and this includes echocardiography, both transthoracic and/or transesophageal if needed, CT-based imaging of the aortic valve, femoral vessels, and aorta, and of course, left and right heart cardiac catheterization.
- Interventional procedures such as PCI, or lower extremity or vascular interventions.
- Valvuloplasty and surgical aortic valve replacement. In many cases, patients will undergo valvuloplasty before a TAVR. Sometimes it ends up that the patient is not a candidate for TAVR, but will have a valvuloplasty or surgical valve.
- Clinical outcomes: length of stay after procedure, change in heart failure class, change in quality of life scores, stroke, rehospitalization, death.
- Echocardiographic outcomes: left ventricular function, aortic valve gradient, aortic valve area.
How does administration at your facility support the TAVR program?
We have a very good relationship with our administration. They are highly supportive of the program, but they are also very keen and sharp, and want to see that, as with any investment, that there is a good return — meaning that our TAVR program is feasible and viable. Analyzing the incremental benefit of having a program beyond case-by-case reimbursement is important to them. Having support to gather and understand this data is important to us as well as our administrators. It is mutually beneficial for us and for any program to be able to characterize this information objectively so that it can be studied and defined. We will regularly gather the clinical data endpoints, along with data on visits and testing, and turn it over to our hospital and practice administration so they can analyze it for the financial information.
Certainly as we progress and gain experience, it is easier to understand the data and see what variables are important, but it remains complex, because the patients themselves are complex. In many cases, the patient outcome is unknown until we are at least partway through the evaluation process.
What feedback do you receive from your administration?
As physicians, we tend to stay away from financial analysis, because our primary role is to make sure patients get the best care. In general, I just like to know that whatever metric the administration is looking at in order to keep our program strong and viable is being met. We like to be analytical and keep our administration informed with what they need. We want our administration to be able to demonstrate to their and our satisfaction that the program is not only clinically strong and meaningful, but also financially viable.
We already know clinically that TAVR is a highly meaningful and life-changing therapy. It is here to stay, and this is also supported by the literature. On a day-to-day basis, we see the impact that TAVR has on our patients. There is no question that it has a very important clinical role. We have also begun to appreciate the positive impact that the TAVR program has had on our institution and hospital as a whole.
Dr. Kamran Muhammad can be contacted at Kamran.muhammad@oklahomaheart.org
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In order to complete this educational activity, please visit the website to answer questions and obtain your certificate:
https://www.cathlabdigest.com/TAVRprogramOH
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Check out the previous two articles in Cath Lab Digest's TAVR CME/CEU series:
From November 2013: "Planning and Developing a Successful TAVR Program at Maine Medical Center: Economic, Program, and Procedural Considerations"
From December 2013: "Focusing on Each Patient: TAVR Care Protocols at Long Island Jewish Medical Center"
