John C. Wang, MD, MSc, FACC, FSCAI
How does a virtual valve clinic differ from a traditional valve clinic?
The traditional valve clinic associated with TAVR programs is a clinic that patients visit in order to be seen by members of the heart team. After they are seen by members of the team, patients are sent for all of their respective testing. They will then return to the clinic. The information is compiled, usually in a separate meeting, and patients are scheduled for their procedure. The problem with this type of model is that it is very inefficient and is centered primarily around the team’s convenience, not necessarily the patient’s convenience. The patient has to make multiple visits back and forth. The national average for the length of time it takes from a patient being referred for a TAVR procedure to the implant is about 7 weeks. Our concept is very simple. We decided to bring the valve clinic to the patient. Every workup starts with a heart catheterization. If a referring doctor calls and says, “I have a patient with aortic stenosis. We did an echocardiogram. It’s severe. They’re symptomatic. I’d like to refer them,” the first thing we do is set up the patient for a right and left heart catheterization. On the day of the catheterization, we meet with the patient and explain what to expect. After performing the catheterization, one of our surgeons sees the patient that afternoon and does the surgical consult. Now the patient has been seen by an interventional cardiologist, had their heart catheterization, and had their surgical consult. If their creatinine is normal, we have them spend the night under an extended-stay observation status, and the next morning, we order the TAVR computed tomography (CT) scan. In <24 hours, we have done the entire workup for TAVR. At that point, patients are scheduled to come back for their procedure, typically the following week. Instead of having a brick and mortar clinic, where the patient, as an outpatient, has to first come in and meet the team, the concept of a virtual valve clinic means we do the entire workup on the date of the catheterization procedure, with the TAVR CT the following morning.
Can you describe more about the patient pathway?
Patients for a TAVR predominantly come through the cath lab. We have educated our referring physicians that if they have a patient that has severe aortic stenosis, usually diagnosed by transthoracic echocardiography in the outpatient setting, that they should call us and have the patient referred for a heart catheterization, because that is how our intake process works. It starts with the catheterization being done along with an explanation of what the expectations are, the cardiac surgery consult that afternoon, and then the overnight stay, with the TAVR CT taking place the next morning. Some patients come to us who have already had their heart catheterization, and in those situations, they bypass the heart catheterization step, and just come, meet our surgeons, and get the TAVR CT the same day. The third avenue would be via a consult with cardiac surgery. Patients deemed potentially good surgical candidates saw one of our cardiac surgeons and our cardiac surgeons call to let us know, “Actually, I think this patient is a better TAVR candidate,” and we have a discussion. Depending on what workup has been done, we will fit them into our process. The TAVR virtual valve clinic that I described is what the vast majority, perhaps 90%, of our patients go through. But, of course, there are situations where people have had different parts of their workup already done, and we adapt accordingly.
How does the virtual valve clinic shape the heart team approach?
The virtual valve clinic does not replace the heart team, nor does it replace the heart team meeting. The meeting, though, is done in real time, as information becomes available from our valve coordinators. After the heart catheterization, the interventional cardiologist is the one contacting the cardiac surgeon for the consult, and we give them a sign-out as to what to expect about this patient. They do their consult, come back, and discuss the patient with us. We have a meeting right then and there about what we think, and the vast majority of time, it is fairly straightforward that TAVR is the right approach for our patients. The results of the patient’s CT scan with 3-dimensional reconstruction come back the next day. If there is something unusual, for example, very challenging femoral access indicating we may need to look for alternative access, our valve coordinator will bring that to both the surgeon and interventionalist’s attention immediately, so that we can make decisions as to the proper approach. There is no need to wait for a follow-up appointment to make those decisions, which would then slow the process. The advantage of our system is in our very close-knit team. We have 3 cardiac surgeons and 3 interventionalists, all co-localized in our basement-level location. Our valve coordinator is also housed in the same location and she has been working with me as my research coordinator for 16 years. This dynamic allows us to communicate together continuously throughout the day so we can still maintain a heart team approach, but essentially on the fly, as information becomes available, versus having to schedule set days, which are really convenient for the doctor, not the patient. If you think about it from their perspective, our patients have been diagnosed with a tight aortic valve that is leading them to have symptoms, and one of their physicians has probably expressed to them that there is a 50% mortality within two years if nothing is done. Imagine what that is like for the patient, knowing that it could be almost two months until they can get their valve fixed. For patients to go through a traditional valve clinic means a lot of steps and different trips for the patient. It is a process that is not centered around the patient, but around the efficiencies of the workflow for the physician. Our concept is to bring the process back to the patient.
Has the pandemic affected your ability to treat severe aortic stenosis patients?
We’ve had a relatively low census of COVID patients. We still have cardiac surgery coverage and interventional cardiology coverage every day. One of the advantages of our virtual valve clinic is that we don’t have a very large backlog of patients. On average, we have about enough patients to fill two weeks of TAVR work, which, doing approximately 5 per week, would be about 10 patients at any one point. When this pandemic arrived and the state and our hospital mandated that we stop elective procedures, we had about 10 TAVR patients waiting to be treated who had already been worked up. Since we didn’t have a large backlog and these certainly are not elective procedures, we actually got them done in just over one week’s time. Thankfully, we don’t have 7 weeks’ worth of TAVR patients that are waiting for their procedure because the efficiencies of our processes. Subsequent to that, we have not been restricted on performing TAVRs on very unstable patients, inpatients, etc. Fortunately, the vast majority of our patients have been fairly stable. Our valve coordinator calls the patients waiting to be worked up on a weekly basis to make sure that they are stable and not having symptoms. We told our referring physicians that, if at any point, they feel that their patient is not safe to wait, refer them, and we can get them worked up very quickly. The reason we feel comfortable having these patients waiting right now is because from the time a patient is referred, we can schedule the heart catheterization for the next day. They can have the complete workup within 24 hours, and we could even implant later the same week. Due to the speed of our process, I feel comforted that some of these patients can be waiting until we are in less of a pandemic situation. It is a complicated decision process as to whether TAVR can be done during this pandemic and it has to be individualized to particular hospitals. Certainly, I don’t think that TAVR is going to be a high priority in a hospital that is overrun with COVID patients. But if you are in a location where you have a very few number of COVID patients isolated into one unit, that will change the threshold as to how aggressive you can be in getting your TAVR patients done. Regardless, the pandemic has not affected our ability to treat what we consider emergent or urgent TAVR patients.
How are you defining emergent patients?
Patients that are highly symptomatic. We have not been taking those with a single episode of angina or those with a past admission for heart failure, but who are now clinically stable. But those patients with progressive, worsening heart failure or who have been admitted with heart failure symptoms, or those who present with true syncope, are all warranted to be done.
How have you incorporated changes to TAVR evaluations and staffing issues per the CMS interim final rule?
One of the interim rule changes is the fact that patients don’t need to have a face-to-face meeting with either a cardiac surgeon or interventional cardiologist. Potentially, it can be done by video conference or phone call. Certainly having that option during this pandemic is going to be of help, but, in our program, it will primarily be of help on the back end, when we do our follow-ups after the TAVR procedure. We can check on patients in a few weeks with a video conference call or a telephone call versus an actual office visit, just to minimize their exposure to being in the hospital. CMS also made the rule that because of staffing constraints, programs can have whoever is qualified be the operator. Thus far, we’ve not had to deviate from our interventional cardiologist and cardiac surgeon, but having that flexibility certainly is important during this time.
Can you describe some key elements to put in place if another hospital would like to implement a virtual valve clinic model?
Implementing a virtual valve clinic model will require a meeting with the heart team and an agreement by all members to trial it, and I do encourage facilities to trial it. You wouldn’t necessarily want to replace the traditional heart team meeting for more complex patients that may require more formal discussion with other members of the team. But for the vast majority of TAVR patients, this is not the case. It is almost unnecessary to fill your heart team meeting during the week with cases that are going to be straightforward. In trialing the virtual valve clinic model, start with the straightforward cases, and try and streamline the process for those patients. It is also important to implement a pre-brief meeting before the procedure, the same day, with every member involved. It doesn’t have to be longer than 5 minutes. Since the inception of our program, we have never once deviated from having a pre-brief meeting. Everybody involved comes together in a conference room where we present that patient on a PowerPoint and discuss any last-minute issues, just to make sure we are on the same page. It is critically important because with a virtual valve clinic, we are constantly dealing with multiple different patients, CT scans, surgical consults, and a lot of moving pieces. We refocus everyone for 5 minutes right before the procedure to make sure we all know what we are doing. I don’t believe it adds time; I actually think it is more efficient and saves time in the long run.
Many heart teams are trying to figure out how to implement efficiencies similar to what you have described while in the middle of the pandemic. Do you have any words of encouragement for them?
Try it one time, on one patient, and prove to yourself it will work. The next time there is a TAVR patient, meet with your team first to tell everybody what the expectations are, and give it a trial. Start with the right and left heart catheterization. Afterwards, call your cardiac surgeon. Have the surgeon see the patient. Discuss amongst yourselves, based on whether or not you think this would be a good TAVR candidate, of course, without the CT yet. Get the CT the next morning. Have the valve coordinator load the CT up, and you are going to realize that, in under 24 hours, you have actually been able to explain the procedure to the patient, and have the patient undergo a right and left heart catheterization, a cardiac surgery consult, and a CT scan. You have the information back and are actually ready to schedule this patient. It sounds so simple to do, but medicine is a fairly conservative field that is rooted in tradition and is sometimes very resistant to change. People ask, “Why do we do things this way?” and you don’t really question why we do things a certain way. I’ve even heard the response, “Well, this is the way we’ve always done it.” This is one of those examples. It is re-evaluating the whole paradigm. Once you try it and realize that this is going to work, then you’re off and running. I have outlined what happens in 90% of the cases, but are you going to have patients that have an elevated creatinine? You won’t want to do the CT scan the next morning. Of course, that’s going to happen. Do the heart catheterization, have the surgeon see them, do whatever other testing you feel is necessary to do, whether that be carotids or pulmonary function tests, if necessary, or repeating the echo if it was a poor quality echo. Bring the patient back the following week for the CT scan, with some pre-CT hydration. Then, the following week, you can set them up for their TAVR. Even in that worst-case scenario of renal insufficiency, the process is now at 2 weeks, not 7 weeks. It is very doable. Programs just to have to give it a try.
Are there any procedural efficiencies you have adopted that other TAVR programs might want to consider?
We have employed a minimalist approach during the TAVR procedure. Uncomplicated procedures are 30 minutes, skin to skin, from the time we lidocaine to the time we close everything and leave the room. Of course, some TAVRs are very complex, but, for the most part, if the procedure is uncomplicated, that is the timeframe. Many programs talk about conscious sedation, which we do, and limiting TEE use and primarily using transthoracic echocardiogram, and of course, we do that as well. We have found other opportunities that we believe have brought our program to the next level of efficiency. One is not having anesthesia place an arterial line, which we feel is unnecessary and takes a lot of time. We place a left radial sheath and then place a pigtail catheter in the ascending aorta with the radial sheath, which becomes our contralateral access. We only have one large-bore access, where we are doing our TAVR, and the contralateral femoral is untouched. Having anesthesia look at our monitor and see the central aortic pressure serves the same function, and it saves a lot of time on the front end with anesthesia not having to fuss with getting in an arterial line. In addition, we realized that we had as many vascular complication rates in the contralateral femoral as in the primary access femoral site, which makes a lot of sense, because you choose the best side to put in a large sheath for the TAVR. Typically, the other side is more diseased. By doing the other arterial access via a radial approach, you have virtually eliminated a potential vascular access complication site. We also do not place a neckline in these patients if they have no underlying conduction abnormalities. With the SAPIEN 3 Ultra valve (Edwards Lifesciences), the pacemaker rates are extremely low in our institution, below 5%.
Is there anything else programs should consider when implementing a virtual valve clinic approach?
This approach does not replace the heart team discussion. Heart team discussions are happening continuously throughout the day about particular patients, between cardiac surgeons, interventionalists, and the valve coordinator. We just don’t formalize them all and do them one hour, one day a week. Good communication between the valve coordinator, the cardiac surgeon, and the interventionalist is critical. Pair that with the efficiencies we described and the critically important pre-brief to get everybody on the same page. Those are the elements that are the most important.
Dr. John Wang can be contacted at firstname.lastname@example.org