TAVR and COVID Corner: Preparing for the TAVR Journey Ahead and Enhancing Communication Through the Patient Care Pathway

06/30/2020

Can you tell us about your practice and current situation?

Benjamin Galper, MD: I am the director of the structural heart disease program for the Mid-Atlantic Permanente Medical Group. We are a large, regional network, covering patients from Maryland, Washington, D.C., and Northern Virginia affiliated with Kaiser of the Mid-Atlantic States, with close to one million members. We have a focused structural heart program where we perform all our cases in one hub, and we take referrals from throughout the network. A lot of our work is done through telemedicine. In mid-March, when it was clear COVID was going to be an issue across the country, we started reviewing our TAVR patients to figure out how we can safely manage these high-risk patients. We reviewed our TAVR patient list with our structural heart team and we grouped patients into red, yellow, and green. Patients that were red, we determined could not wait and needed to undergo TAVR, no matter what. Yellow were ones that we really worried about, who had worsening symptoms, but were stable. Green were stable patients who had mild symptoms. We decided we were going to try to get through all the red patients in the second and third week in March, and then monitor the other ones closely. The governor issued an order, which was reasonable, to halt all elective procedures around mid March. We performed a number of TAVRs during March and April for patients who developed heart failure from aortic stenosis and were admitted to the hospital, as well as patients who were in the “yellow” intermediate category, but were becoming more symptomatic. Now that the ban on elective procedures was recently lifted in my area, we are starting to go back to normal in terms of TAVR. The key to ensuring that our patients remain safe during this time has been close coordination and keeping tabs on each of our patients. Aortic stenosis patients can get sick very easily. When they do get sick, sometimes there is no turning back, because once they fall off that cliff, they can move into irreversible heart failure and even die. We have to keep a close eye on them and weigh the risks of COVID with the risks of waiting to perform TAVR before it is too late.

James McCabe, MD: I am an interventional cardiologist and cath lab director at the University of Washington. The University of Washington is a quaternary care center that covers about a quarter of the land mass of the United States, so a fairly large territory. We have a robust program that also draws from a large area that includes Alaska, Idaho, Northern Oregon, some parts of Wyoming, and Montana. Of course, there are multiple TAVR centers between us and a lot of those outlying areas, but certainly in terms of the more complicated, higher risk, and more frail patients, we tend to get a lot of those patients. In the context of COVID, however, TAVR and the word elective don’t always go exactly together. We had some internal discussions about what elective means. TAVR has very good mortality data and while there are certainly patients who can wait months, if not longer, it is not as truly elective as many procedures are. It is important to contextualize these discussions around how every community is doing. In Seattle, we were early to the party with COVID, but it didn’t stay that long. We were not overrun in the same way that some regions of the East Coast seem to be. And while there were concerns and limitations, there was never a moment where we didn’t have enough PPE. As a result, we actually took a more aggressive stance in terms of proceeding with our TAVR patients on the basis that we had sufficient PPE and aortic stenosis is a highly morbid condition. Furthermore, TAVR in 2020 is fairly resource-light, because the patients are staying for 24 hours and we put some other structures in place. Every patient who came in for a procedure during this time got COVID testing, because they are interacting with anesthesia and there is a possibility that an aerosolizing process could happen if they needed to be bag-masked, if CPR was required, or if they needed to be intubated. Every single person, irrespective of their symptom status, was tested for COVID before coming in. With those kinds of conditions in place and with those caveats, we were able to keep a pretty brisk TAVR program going during this time, and we felt that was best. We did have discussions with minimally symptomatic patients who said, “You know, I’d rather wait.” We were able to talk with them on a routine basis, give them some anticipatory guidance and talk about triggers that might prompt another call. By and large, however, for people who were truly symptomatic, we were moving forward.

Benjamin Galper, MD: To follow up on two points from Dr. McCabe, I think it is important to think about where you and your hospital are in terms of the COVID pandemic. First, not only in following case counts, but second, to determine what you can safely handle. Do you have enough PPE? Can you test patients? It took us a little while to ramp up, but we became able to test every single patient that came in for a procedure, which was reassuring to patients and to staff. We bulked up our PPE, so we felt comfortable moving forward. Every hospital has to look closely at your structural heart program and discuss with your hospital administration what is reasonable to do right now, especially because a lot of aortic stenosis patients can’t wait a long time for their TAVR. If you’re not doing what we call fast-track TAVR or minimally invasive TAVR, now is the time to be thinking about not having patients go to the ICU and not using general anesthesia for TAVR. TAVR, in this day and age, for 95% of patients really should be a 24-hour hospital stay, with the use of conscious sedation, minimal resources, and no central line. We don’t want patients in the ICU right now. We need ICU beds for COVID patients and we don’t want to take up those beds if our patients don’t need it. Now is the time to be thinking about those kind of things if you’re not already doing so as a program.

How are you discussing risk-stratifying aortic stenosis patients?

Benjamin Galper, MD: Severe symptomatic aortic stenosis is a very serious diagnosis, which carries a mortality of up to 50% at one to two years. Once you are symptomatic with aortic stenosis, we know you need to move forward with valve replacement and do it as soon as possible, but there is a spectrum. We looked at patients who were at highest risk and determined that patients who had a recent drop in their ejection fraction, patients who had recent syncope, a recent admission for heart failure, or rapid progression in symptoms, those are the patients that can’t wait. If we had to wait even a week or two, something terrible could happen to these patients. Those are the patients we put in the category that we need to move forward and do TAVR no matter what. Then there’s a gray zone. Those patients who are symptomatic, have shortness of breath or chest pain when they walk, especially if symptoms are progressing, they probably can’t wait as long either. Then there are those patients who have the diagnosis, have been doing fine for six months to a year, but are mainly asymptomatic. These patients can wait. We communicated our plan with our hospital administration to perform TAVR on the highest risk patients and then as we get through those, to move to those patients at lower risk. Convincing patients that it’s safe to come in is important and can be a challenge as well. That has taken a lot of direct reassurance from us letting them know that, “We are testing everyone, we have all the PPE equipment we need, we’re going to minimize your exposure as much as possible, and that if we wait on this, your risk of dying or something very serious happening to you is much higher than your risk of contracting COVID.”

James McCabe, MD: We are seeing a lot more people with shortness of breath who were told “just stay home,” and they are not seeking an evaluation. What ends up happening is that they are landing on our doorstep with these massive complications or very late sequelae of all sorts of cardiovascular conditions, whether aortic stenosis or just riding out a heart attack and now experiencing a structural complication from that. We probably want a mulligan on our public messaging. It was likely not the best public health message, and while it made sense at the time, at least within our community, the rates of cardiovascular complications and late sequelae from cardiovascular disease are not trivial. We have been trying to get out there to say, we understand that it is a scary time to leave your house and to come to the hospital. People feel like the hospital is the last place they want to go. But we should recognize there are COVID-dedicated units, and COVID-dedicated pathways and processes in the hallways. Everyone is getting screened and the hospitals are probably a lot safer than, say, going to a grocery store. I can’t confirm that, but at least in terms of the process of how things are being screened and checked, our hospital is more rigorous. Absolutely there were patients who were nervous about coming in and there are patients who continue to be nervous. As long as we’re able to communicate with them regularly, as long as they understand the things to be on the lookout for, then I think we can feel okay about that. But by and large, we have treated our sickest patients. In fact, during this time, we have seen a bit of an uptake in hospital-to-hospital transfer for inpatient TAVRs. Other patients are presenting with advanced heart failure in the setting of aortic stenosis, and we have always prided ourselves on being able to go from presentation to TAVR within 24 to 36 hours, and we are continuing to do that.

Can you share some of your physical setup and how patients are being contacted?

James McCabe, MD: We are a hospital-based practice. Our clinic and our offices, as well as our treatment areas, are all within a hospital system. There is symptom screening at the entrance to the hospital. For the procedural spaces, there are actual COVID tests. The people who are most nervous, actually, are the ones who are uncomfortable with the current guidelines around family, meaning a lack of family attendance in the hospital. And right now, unfortunately, hospital recommendations, at least at our hospital, are that family can come in the pre-procedural area and the immediate post-procedure area, but they can’t stay with the patient. There are some patients who are nervous about that. “Should anything go wrong, what would happen? And how would I communicate with my family?” It’s a very real concern. We want to respect the process and incorporate shared decision making. It is important to have a conversation with the patient to make sure they have the information necessary to make the best decision for them, but also that the patient’s input is absolutely respected during this entire process. But by and large, as Dr. Galper mentioned, we are advocates of a minimalist pathway for TAVR. Once patients understand that they are going to be able to see their loved one immediately after the procedure, before they go up to telemetry unit, and then will be in the hospital for a very short amount of time, going home the next day, it is reassuring to them. In terms of who is reaching out to patients, we have a valve clinic coordinator, a couple of nurses and advanced practice providers, and it is a rotation based on who is available that day and who knows the patient best.

Benjamin Galper, MD: We have outpatient offices not attached to the hospital. Our structural heart coordinator reaches out to our patients and their families every week to check on how they are doing. I have been talking to a number of concerned patients as well. We have not been seeing a lot of people in the clinic at all. We are doing nearly everything virtually because of COVID. In fact, I’ve done a couple of video visits with concerned patients and their families who are in different locations, all conferenced together. I have found it to be an amazing experience, because we don’t generally get to meet the entire support network of these patients when they have to come into the office or the hospital. It has been nice to be able to do that. It has been reassuring to the families when we actually talk face-to-face via video. There are still some patients that are reluctant. We are calling them every few days, trying to get them to come in, and reassure them it will be okay.

Can you share more about your use of telehealth?

Benjamin Galper, MD: Nearly 90% of our visits have become virtual, mainly to support social distancing during the COVID-19 situation. Patients have loved it, particularly video visits, and we’ve had really high satisfaction with virtual visits from patients. I understand that. They don’t have to leave their house, especially the elderly. They can sit on their couch and they can still talk to me face-to-face on video. I like it, too. It is nice to see the patients in their own element, to see the pictures they have on their wall, to see what their house is like, to meet the whole family. It is not as artificial an encounter as sitting in a sterile doctor’s office. There’s no question this is going to continue.

How are you communicating with your referring physicians?

Benjamin Galper, MD: Our network includes all of the primary care doctors and cardiologists from the Mid-Atlantic Permanente Medical Group. As a result, we already have a built-in system where every note I write and every communication I have with patients is part of the same medical record system as our primary care physicians. We have been communicating with our referrers since COVID started, telling them, “We’re really worried about your patient. We’re going to reach out to them, but if you hear anything, actually anything, please let us know.” Already there were two patients in the last month where the primary care doctor alerted us and said, “Hey, this person is really much more short of breath,” or, “This person does not sound good to me.” We got them in and performed their TAVR within a few days of hearing from their doctor. Something that has been augmented by this whole experience is the importance of communication both with patients and our colleagues, because we’re not seeing each other in-person anymore. Making sure that we are staying on top of things and that we are all on the same page has been important.

How frequently have you interacted with your administration and what are their concerns?

Benjamin Galper, MD: There has been a lot of coordination with hospital administration. In the very beginning, we had almost daily interaction in terms of, “What is our PPE status? What is our COVID bed status?” I was having almost daily discussions with our hospital CMO about each case I was going to do. Our conversations were always focused on making sure we were doing what was best for the patient, making sure we were all on the same page, and minimizing the risk to the patients and staff. There were daily conference calls about COVID, but they are becoming a little less frequent, as thankfully things are improving here. The regular contact between the structural heart program and the hospital administration has only built up our relationship, as we have clearly shown we are helping our patients and doing it in a safe way. Everyone at this point knows our program is well established, aortic stenosis patients are sick, and we perform these procedures because it saves their lives.

James McCabe, MD: We are a university hospital system, so there are lots and lots of layers to this onion. As the cath lab director, early on, we created a scheme for who was going to be treated during this time. It was broader than just TAVR. For some of those procedures, we said, “The whole program is going forward.” In other situations it was, “Well, if you meet these XYZ criteria, we’ll proceed.” We developed that with consensus amongst our group, and then it was passed forward to the administration, who were okay with it. They wanted to understand what we were doing, but we developed the safety parameters and we got their buy-in. I do think actually closing down was probably less difficult than this process of trying to open up, because there is the feeling that we need a graduated or tiered opening. Finding the gray zones to slowly open up those procedures that have been closed is probably a little more in the weeds. It has meant more of an active discussion for the opening process than it was in the closing process.

Are you anticipating a surge of procedures as you open back up?

Benjamin Galper, MD: There are lots of unknowns. There will be more than one phase of COVID even if we are careful, and likely a surge in cases as we open up. But that being said, we have to treat these patients, because if we don’t, bad things will happen to them. It is more a matter of anticipation and planning in advance, making sure that we always have enough PPE, that we are assessing our ICU bed situation regularly, and that we have enough tests for patients. One of the issues early on was that hospitals didn’t have any surplus. Now we want to make sure we have enough PPE, so when the surge does happen, we still can treat these patients safely. We learned a lot. Dr. McCabe mentioned having COVID units at the University of Washington and we also have units that are solely for COVID patients. Making sure you can sequester structural heart patients, and that they don’t get exposed and infected, is extremely important. We have to assume there is going to be another phase of COVID, be prepared to deal with it, and continue working through it. I don’t think we want to or will be able to shut down again for a long period of time for procedures like TAVR, as these patients are at a high risk of complications if they are forced to wait longer for their procedures.

James McCabe, MD: Dr. Galper brings up a good point, which is that there probably will be ebbs and flows in the larger context of the infectious patterns with coronavirus. Everyone is anticipating a surge in cardiovascular patients, and there is probably going to be some backlog, depending on what you have or haven’t been doing during this time. I actually am anticipating a bit of a slowdown in the few weeks to come, because I don’t think our referral network has been seeing a ton of patients in the clinic, and I think that there is going to be a lag before cardiology offices and clinics pick back up and start seeing these patients again. Once they see them, these patients are referred into specialists like Dr. Galper or myself. I do think we will see somewhat of an uptick in acute presentations due to this lag, as people come out from their homes, try to be more active, and realize they can’t be. In our center that backlog is actually not going to be very big. I expect we are going to see a little bit of a downturn perhaps in the next few weeks, and then hopefully things will pick back up. But of course, time will tell.

Dr. McCabe, you talked about how more discussion is going to be necessary in opening back up. What type of questions are you working to address?

James McCabe, MD: Hospitals obviously are feeling a lot of stress these days. Their numbers don’t look great and their economics aren’t perfect, by any stretch. There is enthusiasm for revenue-generating procedures to come back online. Now, that sounds somewhat crass, but you’ve got to keep the lights on. By the same token, there is enthusiasm about getting back to doing the things that we love doing and caring for the patients we love caring for, and trying to get them feeling better. No one is quite ready to say, “Well, that whole COVID thing is done, period and paragraph. Let’s just start back up again.” There are still some concerns about having effective PPE, and having space in the ICUs, and having all the things necessary to be able to be nimble in our response to whatever recurrence there might be in virus rates. So, we’re being asked to open partially, and from my perspective, the best way to open is to create schemes where it’s not, “I want to treat Ms. Jones today and Mr. Ralph three weeks from now.” It’s, “We want to take care of everyone who meets X, Y, and Z criteria now. People who have A, B, and C, can wait.” Trying to match those schemes to the volume that hospitals want in order to open while also retaining that flexibility has been the biggest challenge. I think closing down was probably less difficult than this process of trying to open up, because there’s this feeling that we need a graduated or sort of tiered opening, which is probably more difficult to figure out than knowing how you turn the spigot off.

Based on everything that we have learned from the pandemic, what are you taking forward in terms of learning, should we have another surge?

Benjamin Galper, MD: Now that we have had this experience, we know how to prepare for it. We need to ensure we have enough material, like PPE, tests, beds, and staffing in order to take care of these patients, and plan for any possible COVID surges in advance. The first inclination when it started was, “Let’s minimize staff, get as many people out of the hospital, and minimize exposure. Take the cath lab staff and put them in other places to take care of COVID patients.” As Dr. McCabe said, it’s hard to bring that back now, as we are going back to normal. We need to have a plan in place that still preserves the normal function of a cath lab unit, but does it in a safe manner. The other thing is really prioritizing patients. You can always prioritize patients based on symptoms, but we need to have a good scheme in place to figure out who we are going to do first and why, and make sure everyone is aware of the plans. The telemedicine effort has been very helpful. We will need to utilize telemedicine more for our patients, and be set up to continue to communicate virtually with our patients in the future.

As the pandemic eases, will it change how you communicate with referring physicians?

James McCabe, MD: We have continued to work with our referrers in the same fashion we always have. It was certainly not business as usual for the last number of months, but a lot of patients were being treated, and I was continuing to call referrers on a daily or near-daily basis while we were treating their patients. When you call to say, “Hey, Mr. So-and-So got treated,” it is an opportunity to check in with them and see how their practice is going, where their head is at, what their stressors are, and so forth. And just have a chat as normal people being nervous together in an unknown time.

Benjamin Galper, MD: I agree. We are spread throughout the mid-Atlantic region, so we are really communicating through the medical record and by talking on the phone. We have continued to do that, if not more so. For patients we were concerned about, I’ve been talking to the referring cardiologist more often than usual, to communicate that we are keeping an eye on their patient. I think it has been very helpful to have multiple people and teams looking out for these really sick people right now.

We know so many patients are concerned about coming in for routine appointments, as well as treatment. Are you doing any proactive communications to patients in general about the importance of coming in for appointments, continuing to watch symptoms, and getting treatment?

Benjamin Galper, MD: We have been calling these patients regularly. We are calling them up and trying to schedule, and saying, “It’s going to be safe, you’re going to be tested for COVID, and we have the equipment we need to protect you. You’ll be in our hospital no more than 24 hours, and this is certainly safer than waiting and having something bad happen to your heart.” Our organization, the Mid-Atlantic Permanente Medical Group, has also been working, particularly in cardiology, to encourage patients and let them know that we are here to treat their heart. Just because COVID is here, it doesn’t mean we’re not here to take care of your heart. We’ve been sending communications on Twitter for patients, to make it clear that your heart still matters in COVID and that now is not the time to ignore your chest pain, to ignore your shortness of breath. Now more than ever, you need to come in. We’ll take care of you and do it safely.

James McCabe, MD: In our center, we have not sent out a newsletter or email blasts direct to patients, or anything along those lines. We’ve simply been speaking with the patients with whom we already have touchpoints. What I am hoping to see and what we are trying to communicate is a more broad, almost a public health messaging, that needs to unravel a bit of what was said earlier about being sure to just stay home and try not to infect anybody else. One of the lessons we will likely carry forward should this come back to the fore, is to message a little bit differently about what is safe and what is not safe, and whether or not it is a good idea to just stay home and ride it out. I think that will be different in the next go-around.