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Planning and Developing a Successful TAVR Program at Maine Medical Center: Economic, Program, and Procedural Considerations
Overview
TAVR patients require the highest levels of management and attention from a team of healthcare providers — not just from a single physician, but an entire multi-disciplinary team that itself must be adequately supported by the hospital system (imaging tests and coordination of information). Improving systemic practice and management will standardize care for all patients with aortic stenosis who are considered for transcatheter aortic valve replacement (TAVR) or open aortic valve surgery.
CEE CME/CE 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 provides the latest evidence-based data and science for learning 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 improve patient care.
This activity is for those who have not implemented a TAVR program. It is crucial to have multi-disciplinary and administrative backing before TAVR implementation to achieve optimal TAVR program success.
Using an experienced, successful TAVR center (Maine Heart Center) as a model, their experience can advise readers who are beginning a TAVR program how to navigate the key stakeholders who need to be involved with TAVR program implantation. The results and goals of the shared experience will help guide learners to understand what to expect and where to direct their energies most efficiently.
This system-based practice demonstrates awareness of a responsibility to larger context and systems of healthcare. Readers need to be able to call on system resources to provide optimal care (by coordinating care across sites or serving as the primary case manager when care involves multiple specialties, professions, or sites).
Learning Objectives
By the end of this article, participants should be able to:
- Identify key stakeholders at their facility who should be involved in a TAVR program startup.
- Define likely impacts on scheduling, services, and resources at their facility once a TAVR program is implemented.
- Describe the importance of the ‘halo effect’ in financially supporting the resources required for a TAVR program.
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.
CME/CE Disclosure to the Readers
A review has been conducted by the CEE CME 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.
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/CE-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/CE Accreditation for this article expires on November 30, 2014.
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Capacity constraints and process inefficiencies can have deleterious effects on a transcatheter
aortic valve replacement (TAVR) program. In order to achieve optimal results, both these areas must be addressed. To achieve efficient and productive processes, as with any new procedure such as TAVR, there must be a culture of collaboration between departments. As Cath Lab Digest talks with key members of the successful TAVR program at the Maine Medical Center, a tertiary referral hospital, we will focus on the pre, peri and post procedure processes that lead to the most efficient care of the patient, as well as the importance of collaboration and communication among various departments.
I. David W. Butzel, MD, FACC,
co-director of the TAVR program at the Maine Heart Valve Center of Maine Medical Center.
Dr. Butzel, how did you position the Maine Medical Center TAVR program when it was first begun, and what level of support did you get from key department heads?
It is crucial to get both buy in from administration and resources before even starting a TAVR program. The head of our cardiac division and director of the cardiac cath lab, Dr. Bud Kellett, and our vice president of cardiac services, Tim Kafer, worked with the highest levels of the Maine Medical Center administration and finance. Initial discussions focused on communicating that Maine Medical Center had a wonderful opportunity to be early out of the gate in developing a unique program. TAVR already appeared to have a promising future, based on the data coming out of Europe. We also stressed the presumed halo effect, meaning that the presence of a TAVR program would recruit additional procedures such as computed angiography tomography (CAT) scans, coronary catheterizations and interventions, and ultimately, more open aortic valve surgeries. The increase in open-heart surgeries brings much of the financial benefit from a good TAVR program.
What is the current status of the program?
The Maine Medical Center TAVR program began in April 2012 and has been active for approximately a year and a half. Over 500 patients have been screened, and as of this date, we have performed 53 TAVR procedures. The program has exploded in growth. As an example, we have had 20 TAVR referrals in just the past two weeks.
How did you find the process of coming together with the different specialties involved in a TAVR program?
We have always had a positive working relationship with the heart surgeons and we now work together quite intensely. It has brought our relationship to a completely different level.
Have you had to adjust your estimates of what you needed as the program has developed?
Yes. The resources required to schedule necessary tests, arrange team meetings, and guide the patient through very complicated decision-making are enormous. The work up for these patients is extraordinarily complicated. TAVR is for patients who are not appropriate candidates for open surgery, but the procedure is still risky and complicated. Patients must be efficiently evaluated, with good communication. The thought processes and documentation arising out of patient encounters needs to reach a very high level, and it is crucial to maintain an extremely detailed database for each patient.
I would also stress the importance of having a TAVR team coordinator of high ability, both in of terms of energy and intellect. The ability to talk people through emotional and complicated decisions is critical. Claire Berg, our TAVR and research nurse coordinator, spends thousands of hours on the phone gently talking patients through very complicated issues.
Did you begin the program with dedicated clinic space?
No, but as we moved forward and became busier, we requested and planned a dedicated clinic space, which is currently under construction.
Can you describe how patients are evaluated?
In the beginning, we avoided asking patients to go through the testing process unless we knew the patient was a good candidate for TAVR, since these patients are elderly and often sick. Now that our program has more experience, we will sometimes review a chart from original correspondence in order to decide whether a patient should be evaluated. Geographic distance has also become a factor, because an 89-year-old may be traveling with six family members for several hours in order to reach our center. To increase efficiency, these patients might get much of their testing done on their initial visit.
Evaluating a patient for surgery or TAVR is usually done in our clinic. Patients are seen by a multidisciplinary team, which includes an interventionalist, a surgeon, and an echo cardiologist. We will have prescreened the patient’s data and will know, on paper, the way we are leaning. It may be that upon meeting the patient, their data and what we call the ‘eyeball test’ will differ. On paper, a patient may appear to be well suited for surgery, but a meeting can reveal that the patient is deconditioned, with an appearance much older than the stated age, making them a much poorer surgical candidate.
The decision that takes the most time is whether to perform a TAVR and how to perform it. We evaluate the type of access, whether to protect the left main, and whether the patient will require full support, as well as reviewing any peripheral vascular disease, strokes, liver problems, and/or abnormal creatinine levels. Transesophageal echo can reveal additional concerns such as an atheroma in the aorta or little strands hanging off of valves. For TAVR, every little thing that isn’t exactly in line is a risk for a complication.
How are you measuring the success of your program?
We measure 30-day and one-year outcomes. In order to evaluate clinical outcomes, we look at aortic insufficiency via echocardiogram. We also track procedure volume and growth rate.
The financial aspect of the program has been positive, mostly due to an increase in open aortic valve surgeries. Physicians who never would have considered a patient to be an open candidate now send these patients for evaluation, and a certain number can undergo traditional open surgery. Other aspects of the halo effect include an increase in ordered CT scans, pulmonary function tests, diagnostic catheterizations, and stents, performed as part of getting patients prepped for surgery.
What are your hopes for the future?
We want to run at the highest level possible. Growing a medium-size program to a bigger program requires, first, that you find patients, which we have not found to be a problem. Second, it involves setting a balance between the resources that are given to the TAVR group versus the amount of time and commitment it takes to do a good job. Appropriate patient selection and having the right people in place to perform the procedure are what drives outcomes, and these decisions take time. Programs have to be careful not to grow too quickly. If you grow too quickly, you outstrip your resources. If you try to make decisions quickly, you can get burned. It is important to sit down and very carefully go through every single piece of paper and every single test with your own eyes. There are numerous small details in our patients’ past medical histories and in the results of their testing. We don’t just read the report, but look at the raw data itself. It takes that level of scrutiny to arrive at an appropriate patient choice.
II. Claire M. Berg, MS, RN, CCRC, Maine Heart Valve Center Coordinator, Maine Medical Center.
Tell us about how you transitioned into the role of a TAVR program coordinator.
Prior to my current role, I had worked as a research coordinator for twenty years, coordinating clinical trials in cardiology, including some valve device studies. I became the TAVR coordinator because of my skill set related to valve devices. Our program volume has now grown to the point that we are hiring an additional coordinator, so that ultimately we will have 1.5 full-time TAVR coordinators.
Being a TAVR coordinator is a role similar to what people might call a ‘patient navigator.’ It involves navigating patients through very complex evaluation processes, multiple care providers, and multiple institutions, if consults are required, and then through specialty exams prior to the procedure. I am in touch with patients constantly in order to guide them through a complex system.
You are a touchstone for the physicians as well.
A TAVR coordinator is the central point person for all communication. Referrals come directly to me and I speak with the outside referral physicians. I keep a running spreadsheet of all patients, noting where they are in the process of being evaluated and what needs to be done next, so I am very much an information gatekeeper. I also maintain data regarding the number of clinic visits, number of patients screened, and number of CT scans associated with the clinic. Periodically, I will share this data with Tim Kafer, our VP of cardiac services, and Dr. Marco Diaz, who works on a pro forma for the TAVR program.
How many days per month are procedures scheduled?
When we first began our TAVR program, Maine Medical Center had a hybrid OR that was already very much in demand, particularly for vascular surgery. Two Wednesdays each month were designated for TAVR procedures. Effective September 2013, we now have three dedicated TAVR days per month in the hybrid OR, due to our volume growth. Maine Medical Center will also be undertaking a hospital construction project in the near future to expand OR capacity, and included in that project will be a second hybrid OR.
Can you tell us more about the team that assists the physicians in a TAVR case?
Right from the beginning, the OR selected a dedicated team of OR staff and the cath lab also selected a dedicated team of cath lab staff. These individuals are always involved in each case.
Within each scheduled day, how many TAVR cases can be done?
Typically, two cases, but we are able to easily do three cases. We have to be very cognizant of staff needs. Since it is a dedicated staff, other people can’t be pulled in for relief, so we need to be careful not to put the team in the OR wearing lead for 12 hours straight. We worked closely with our OR clinical leader, Kathy Black, regarding the appropriate timing for three cases in one day, and decided if there are three transapical cases, it is possible. We begin at 7am and are done before 3pm. There is the understanding that if one of the cases runs into complications, the third case would be canceled, but we haven’t yet had to do so.
The hybrid room is under OR management?
Yes, it is in the OR suite. The second hybrid OR Maine Medical Center will be building will also be under OR management.
How many physicians are involved with the TAVR team?
Currently, there are three cardiothoracic surgeons, three interventional cardiologists, two echo cardiologists, and three anesthesiologists. We have been careful about not bringing too many people on board, because volume makes a big difference in your ability to do these complicated procedures. Two surgeons and two interventionalists are present for most cases, whether transapical or transfemoral.
What was it like for the selected OR and cath lab staff to transition together into a TAVR team?
I observe in the control room for at least part of the case. It seems to me that the transition has worked extremely well. When we began, there was a great deal of training involving both departments. We included all of the technical staff in kick-off meetings. After the first case, we had lunch in a conference room for the entire crew to celebrate. The hope was that everyone would feel like an important member of the team. From my perspective, this approach has worked well.
What needs do you see for those involved in managing the program?
Until now, we have not had dedicated clinic space, which has been a challenge. Effective October 1st, Maine Medical Center began renovating a wing for our TAVR clinic, some combined cardiology clinics, the heart failure clinic, and the general cardiology clinic. We will now have dedicated clinic space with a receptionist and a medical assistant. These ancillary resources, which will include secretarial support, are critical in order for us to continue to grow and maintain our high standards of care.
How are you measuring the success of the program as it goes forward?
We enter our data into the Society of Thoracic Surgeons/American College of Cardiology’s transcatheter valve therapy (TVT) registry and are involved in many aspects of research. Maine Medical Center will be examining risk factors that might lead to the anticipation of pacemaker placement. We are also going to be involved in a research trial through Albert Einstein to look at the safety culture of the OR team.
Any final thoughts?
It has been extremely rewarding to see patients come back at one month. So many of them look transformed and many come back saying, I can breathe now, I feel so much better. They are so grateful. It is very gratifying.
III. Kathleen Black, RN, OR Clinical Manager Cardiac/Thoracic Vascular Transplant and Endovascular, Maine Heart Valve Center.
Can you tell us about your position with the TAVR program and in the hospital?
I am the point person for the staff, surgeons, and equipment, making sure that ‘wheels in to wheels out,’ everything goes well. I book patients and take care of everything having to do with the operative services field.
What are some of the things that you find challenging about the TAVR procedures that you are hosting in the hybrid OR?
It is challenging to sequence patients properly. Three TAVR procedures can be done in one day, if the cases are transapical. We try to schedule the transapicals back to back in order to be as efficient as possible. Perhaps the biggest challenge is evaluating how sick these patients are, whether everything has been done up front, and finding out whether there anything we need to do the day of the procedure. From the OR standpoint, on the day of the procedure, there is very little to be done, with exception of the block. We try to front load the labs and get as much information as possible. We make every effort to meet our 6:50am room time.
In the OR setting, only anesthesia needs to be done the day of the procedure?
Besides the block, there isn’t anything routinely done, unless something pops up when anesthesia sees the patient the night before. The TAVR clinic is done first thing in the morning as a regroup to make sure they are headed down the right path, but from an OR standpoint, the patients are already well prepared.
How easy is it to hit 6:50am for an on-time start?
All cardiac patients hit the door at 6:50 and we begin within 5 minutes of that time. Most days we are on time. We make an incision within 45 minutes of our in-room time.
What about room turnover between patients?
Typically, we have very quick turnovers for our cardiac patients. We are wheels out to wheels in with the next patient in about 30-40 minutes. The procedure itself is probably two hours.
What kinds of things help keep your turnover time so short?
The case cart is completely packed with everything necessary for the next case. We have enough turnover help that the patient has been sent for far in advance. They are in our holding area ready to go, with their block already placed. We try to have the block placed in advance with all of our cardiac cases, because otherwise it lengthens the turnover time. The patient is transported to the holding room as soon as possible. We minimize having to move items multiple times in order to increase efficiencies.
How does the team keep their energy level up?
We have a dedicated team that rotates within the room on a given day. We don’t want anyone to suffer a back injury due to wearing lead. The team is in lead for 10 hours a day and it ends up taking its toll, because we now do TAVRs 3 out of 4 Wednesdays. If we are not cutting on the third patient by 2 o’clock in the afternoon, we put the third case off to another day. We are trying to be aware of burnout factors, outside lives, and the importance of keeping the team focused and dedicated. If we go in with the attitude of no matter what we are going to do three cases, even if we get out at 9 o’clock at night, staff will become disengaged. We frequently do three TAVR cases a day. If we have three on the schedule, reach 2pm and are not ready to cut on the third case, it prompts an evaluation of our efficiencies. Missing that cutoff may also be the result of a patient-related issue. Our main focus is outstanding and safe patient care.
How are cancellations the day of the procedure prevented, perhaps due to an unexpected fever or urinary tract infection?
The TAVR clinic does a significant amount of work up front to make sure that these patients are well prepared. The patient will be worked up several days in advance. Sometimes the patient will be brought in a one or two days prior to the procedure to make sure that any comorbidities are dealt with in advance, versus the night before.
Are patients admitted the day before the procedure?
Yes, the majority of patients are admitted the day prior to the procedure. There are some patients that come into our ambulatory surgery unit, which is located right next to the OR, but probably the majority of our patients come in the night before.
Is there anything you would like to highlight about your work or team?
It is important to have a small, dedicated team. A small group is more efficient. It allows us to do three cases in a day, multiple cases in the course of the month, and cuts down on turnover time. It also leads to increased effective communication among team members. Cardiac surgery has a very small team of eight nurses and eight technologists, and the cath lab is probably similar. It is efficient and cohesive. Everyone knows their role and what they are supposed to do. It allows us to achieve the ‘wheels in to wheels out’ efficiency, a model everybody strives for.
Was there any history prior to the TAVR program where the cath lab and OR worked as closely together?
Maine Medical Center has a pediatric cardiac program, and every so often, the OR would perform a pediatrics case with the cath lab staff or vice versa. This type of collaboration was minimal, but we worked well together when it occurred. Today, the cath lab and OR have a great relationship. No one brings in anyone new unless that person has undergone the orientation, knows how the TAVR program runs, and their specific role. The TAVR team works well together. I have been impressed, because sometimes people prefer to remain in their silos. It is not like that here; we have a great team dedicated to the patients under their care. The TAVR program gives many of these patients a second chance at life.
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