TAVR and the Structural Heart Program at the Prairie Heart Institute

When did Prairie Heart Institute begin transcatheter aortic valve replacement (TAVR)?

We started doing commercial cases on January 12, 2012 and joined the PARTNER trial (Sapien, Edwards Lifesciences) in March 2012. Since that time, we have been part of the PARTNER program, including PARTNER 2, an intermediate risk trial, and we will be joining the PARTNER 3 trial, which will look at low-risk patients. We also are involved in research with Direct Flow Medical’s valve and the Boston Scientific Lotus valve. Since January 12, 2012, we have done over 350 TAVR cases. As part of the structural heart program, we also do MitraClip (Abbott Vascular), although at a much lower volume. There aren’t as many of the mitral valve cases, because of the relatively rigid guidelines for MitraClip. Our structural heart program also offers treatment of atrial septal defect (ASD), patent foramen ovale (PFO), ventricular septal defect (VSD), patent ductus arteriosus (PDAs), and paravalvular leaks, as well as abdominal aortic and thoracic aneurysms.

Do you work in a hybrid lab?

We are planning to purchase a dedicated hybrid lab, but we currently work in modified cath labs or modified OR circumstances. There are two cath labs in which we do structural heart cases, along with an operating room with a fixed imaging system. These are the three rooms where we do TAVR.

When you implement the hybrid lab, are you planning to build a new lab or modify an existing one?

One of the cath labs where we currently do TAVR will be taken down to the studs. We will retrofit it to OR specifications, so it can be used either as an OR or a cath lab.

Does your TAVR program draw staff from both the OR and cath lab?

We do use both OR and cath lab staff for each case, and over the last two months, we have gone through a redesign process, looking at workflow and staffing needs. We have cross-trained the cath lab staff with some OR skills and the OR staff with cath lab skills so we can begin to more efficiently use people in the room. Since we started doing TAVR very early on, it brought a more traditional model of how TAVR should be done, and frankly, involved many more people than is probably necessary three years later. So now we are streamlining and working to lean down our TAVR program.

Does that include a move towards a more minimal approach?

We have been doing minimally invasive procedures for about a year now. Some programs use a minimally invasive approach as their default approach and then essentially you have to come up with a reason why you want to use general anesthesia. I can’t say that ours is minimally invasive as a default. We look at each case individually and make a decision as to whether we are going to do it as minimally invasive or use general anesthesia, whether the patient requires a transesophageal echocardiogram (TEE), and so on. There is a checklist. We review the cases in advance with anesthesia and come up with a plan. As it stands now, between 40-50% of our TAVRs are done without general anesthesia. Still, anesthesia is involved in giving conscious or deep sedation. Even some of the general anesthesia cases are done without TEE to also reduce resources. 

You would use thoracic echo in those cases?

Yes, we would use thoracic echo as necessary.

How do surgeons and interventionalists work together in the TAVR program?

We work together collaboratively regarding the workup, decision-making, and in terms of the program itself. There is a formal valve clinic where patients see a cardiologist, a surgeon, and have the majority of their testing done in one day. For patients coming from a distance, typically we will keep them overnight and then do a cath or computed tomography (CT) scan the next day. During the workup, interventionalists will work with the surgeons, not side by side, but usually in the same facility or on the same day. TAVR days are Tuesdays and Thursdays, and there is a formal meeting every Tuesday and Thursday morning, where the cases for the day are presented and upcoming cases are also presented. At a minimum, we will have one surgeon at that meeting along with other interested cardiologists. On many occasions, we will have two surgeons present. All patients being presented have already been seen by two surgeons. We tell patients that their case will be discussed in our multidisciplinary team and that we will arrive at a group decision regarding the recommended treatment, whether it is surgery or TAVR. It has been a mindset change. In the past, the surgeons might have felt a need to talk a patient into one thing or another, or present all the options. Today there is a different focus when a patient sees our surgeon in clinic: what is the surgical risk? A formal treatment decision is going to be made by a group, not by any one individual. Finally, of course, when we do the TAVR procedure, there is always a surgeon and a cardiologist working together as a team. Typically we alternate front end/back end in terms of the valve implantation. On the first case, the surgeon may be on the front end of the valve and on the second case, the surgeon might be on the back end of the valve. Our surgeons want to be engaged in the procedure, and we have taught them how to puncture an artery, how to do Perclose, how to cross the valve, do valvuloplasty, and so on. Since 90%+ of the procedures are done transfemorally, the surgeons are as involved as they want to be, and they have learned the basic skills. Early on, we had a large transapical experience, and then converted to transaortic, and now, by virtue of the size of the catheters, we are at 90% transfemoral. We have looked for transcaval cases to perform; but because we have also adopted the subclavian approach (about 5% of our cases are now subclavian), we have not yet found the need to do any transcaval. There are advantages to the transaortic approach, but in our 350+ cases, we have not found the need to do it. We have found the subclavian approach useful both with the Medtronic CoreValve and Sapien valve.

How are you dividing your use of the Sapien and CoreValve?

Most of the research studies randomize against CoreValve, so that decision has been made for us. Typically, for the commercial cases, we have used Sapien. As it stands now, we’re involved in several registries, but the only study currently randomizing in our lab is the Direct Flow Medical valve, and my understanding is that they are planning on opening that up to allow both the CoreValve and the Sapien valve. Rather than pick an arbitrary number, I would say that we want to maintain proficiency with both valves. We feel like there are certain cases where there is potentially an advantage to one valve or the other. At this point in time, the majority of commercial cases are done with Sapien, but we have done a fair number of CoreValve EVOLUTs as well. 

What about preparing patients for discharge?

We are very attuned to Post-Acute Care Transfer (PACT) policy — to the expected length of stay for these patients and the ramifications of PACT, which subtracts payment for the hospital if post discharge resources are invoked before a specified length of stay is reached. As part of our valve meeting, we will determine the expected length of stay, and start to plan for the discharge almost from the first day. We will talk about an expected date of discharge with the family when they come in, so that there are no surprises. Often, particularly with commercial patients, these are older patients and they need resources. We have found, schedule-wise, that the Tuesday patients are not as problematic as the Thursday patients, because the Tuesday patients are usually ready to go home on a Thursday or a Friday. The Thursday patients are usually ready to go home on a Sunday. We need to have everything teed up for a discharge on a Sunday vs during a weekday, to make sure all i’s are dotted and t’s are crossed. 

Are your valve coordinators following the patient through this process and helping with discharge?

Yes. We have an RN valve clinic coordinator, one additional RN, and an LPN. One of the valve clinic staff follows the patient through their course of treatment. We have pre-specified order sets. A nurse practitioner (NP) will also see a number of these patients. This has been an evolving role. Currently, our NP is divided with other responsibilities and so can’t dedicate herself as much to TAVR patients, so we are looking at hiring a full-time nurse practitioner in addition to the RNs, who see the patients in the outpatient clinic and follow the patient through their stay. 

What do you envision as the role for the NP?

The NP will see patients collaboratively with physicians in the valve clinic. New patients and follow-up patients see the physician and the surgeon. When we have a full-time NP, I would see transitioning some of the follow-up care in the hospital to the NP rather than to the valve clinic coordinator. It will allow the valve clinic coordinators to focus on triaging patients — ordering the testing. We run our TAVR program efficiently and pride ourselves on the fact that if somebody called us up with an urgent patient, that patient could be done within a week. A large number of patients come from out of our immediate area, because Springfield is not a large city. We developed a system where patients only make two trips to Springfield: one for the valve clinic visit and one for the procedure. That’s all patients need to anticipate before getting their valve.

What is the geographic range of your program?

We actually took our first 100 cases and mapped out where all the patients come from. We get patients from south of I-80, which is the dividing highway between Chicagoland and the rest of Illinois. So our patients come from south of I-80 down through all the Illinois borders: Indiana, Iowa, Kentucky, and Missouri. And, on occasion, we receive patients from other TAVR programs. We were doing valve-in-valve early on and would get referrals from other TAVR sites — this was before commercial release of valve-in-valve. The program has also evolved to doing valve-in-valve in mitral and also, on one occasion now, a double valve. This was a recent case placing two Sapien 3 valves in both a native aortic and mitral valve, for an inoperable 72-year-old female patient.

How is that patient doing now?

She has some other health challenges that will require aggressive therapy, but she is doing extraordinarily well from a cardiac standpoint. 

Are there any particular considerations that you have adopted in dealing with geriatric patients, such as avoiding opiates?

Early on, we discovered that when we gave opiates to patients they often had all sorts of issues, such as urinary retention, constipation, or confusion. There were a couple of respiratory embarrassments. Our pharmacy did not have IV acetaminophen; it had specifically been taken off, so we had to go through an elaborate committee process to get IV acetaminophen reintroduced to the hospital in order to allow for non-opiate use of analgesics. We also worked with both anesthesia and the pharmacy committee to develop protocols for our minimalist approach. We don’t use any narcotics during the minimalist approach; in fact, we try to avoid using a lot of Versed during the minimalist approach as well. With the current generation of valves, many valve procedures now take less than 45 minutes, so we also try to avoid putting Foley catheters into the men. Patients are sitting up within a few hours of the procedure.

What do you see as the future of the TAVR program?

There are many more programs than when we started, including a second TAVR program in Springfield. Naturally, there is going to be increased competition locally and regionally as other programs mature. That being said, the pie will likely get bigger for everyone. We don’t know the results of the intermediate risk randomized trials, but if those trials demonstrate at least equivalence in terms of surgery vs transcatheter valves, we will need much more in the way of resources for TAVR. Within our local community, all the cardiac surgeons are involved in a TAVR program one way or another. We have 4 interventional cardiologists involved in our TAVR program, and at the other hospital, there are 2 interventional cardiologists. If TAVR evolves, as it has in Europe, to even include a lower-risk cohort, then instead of 18,000 TAVRs/year, it is likely that number will double. It will also prompt the question as to whether CMS will have to modify the national coverage decision in terms of what is required for hospitals to offer TAVR. Will it be mandatory that a hospital doing TAVR have a certain expertise with high-risk surgical valves, if it turns out that the majority of cases won’t be high-risk surgical valves? 

Can you share your experience in treating mitral valve disease?

The majority of these patients have mitral regurgitation and there is a subset of patients that have significant stenotic mitral disease. Our double valve patient had mitral stenosis in combination with aortic stenosis. As it turns out, given sufficient calcium in the mitral valvular structure, you can seat a Sapien valve in that location. MitraClip is a very good device, but as the coverage decision is written, it has a very narrow application, at least in the United States, meaning degenerative mitral valve and mitral regurgitation. The anatomical requirements also restrict its use. If we come to the point where functional mitral regurgitation is an approved use, then use of the MitraClip would expand. The majority of mitral regurgitation, however, is outside of the realm of the MitraClip. Companies are developing valves specifically designed to fit into the mitral valve orifice, which has its own design characteristics distinct from the aortic valve. Over the next five years, if that area evolves, it will mean a greater number of patients that could be appropriate for a transcatheter approach rather than a surgical approach. Recently, the Sapien valve has been approved for use in the pulmonic circuit. People are also working very hard on tricuspid applications, either through some form of annular modification with sutures or potentially even a tricuspid valve. In all these locations, if a valve is present in that location, the current generation valve can always be used. I wouldn’t say it could be done on a routine basis, but the same day as we did our native mitral valve application for the patient who had both an aortic and mitral valve stenosis, we did a mitral valve in a degenerated, severely regurgitant prosthetic mitral valve. We do see those applications not infrequently in the mitral and tricuspid position. Potentially over the next 5 to 10 years, we will see not just an increase in the aortic valve patients, but a significant increase in the application of all these technologies for other valves. 

What has been the impact of the ability to do valve-in-valve?

Just having TAVR has changed how we view implanting valves in patients. The downside to a bioprosthetic valve has always been that in 10 to 15 years, patients are likely to need another open heart surgery. For younger patients, if they only want to have one operation, it requires placement of a mechanical valve, but that patient then has to take Coumadin for the next 15-30 years. Having TAVR available has changed the paradigm such that a large number of these patients now get a bioprosthetic valve, with the expectation that they can always get a transcatheter valve when that bioprosthetic valve fails. How many times are you going to do valve-in-valve? This is not yet known. Orifice area is lost every time a valve is placed in a valve, and it can’t be done ad infinitum. But it certainly has changed how we look at patients. We pay more attention to getting the biggest valve possible in place for that first procedure. Certainly when you put a 21 mm valve in, it will not create as effective an orifice as putting in a 23 mm valve. A large number of patients over the last 10-15 years have had valve replacement, increasingly with bioprosthetic valves, and we are going to start seeing those patients come back. Prior to TAVR, these patients may have been operated on or potentially not offered anything if they are elderly. In any one community, there are a significant number of patients who have had valve replacement. The majority of those valve replacements today are bioprosthetic valves and we will increasingly start to see them as a routine part of our practice. Not as much as with native aortic stenosis, but certainly in any TAVR program, on a regular basis, you will be considering a valve-in-valve. 

We aren’t just looking at the very elderly anymore.

Absolutely, and we are now considering long-term strategy when placing a valve in these patients. For instance, currently there is no indication for any valve for a bicuspid valve, but it can be done and we have done it. A bicuspid valve is more than just the bicuspid valve — it is the associated aortopathy. You can fix the bicuspid aortic valve, but what do you do about the aortopathy? What would be the plan if you fix the aortic valve, but 5 or 10 years from now, if the aorta is 5 cm or 4.5 cm, what would be the surgical approach to the bicuspid aortic valve if you had a CoreValve in place, where that valve is actually reaching all the way up into the aorta vs a Sapien? There is a shift in how we approach patients with all of these structural heart/valvular problems. That is the beauty of having a valve team. Often the surgeons ask us questions and we ask the surgeons surgical questions: how would you approach this? If we put in a particular kind of valve, how would you take it out? What is the surgical remedy 5 or 10 years from now if surgery is needed? Does this preclude a patient from having a remedy done surgically in 5 or 10 years? The questions have become much more detailed and far reaching, rather than only thinking about putting in a valve now. You need to think about what we would do for this patient in 5 to 10 years if this valve fails. 

Any final thoughts?

The most remarkable and unique thing about our program is that it has been a fairly successful, robust, and innovative program in a city of relatively small size and in a non-academic institution with private practitioners. Much of our success speaks to outreach and finding patients. It is important to go out to where the patients are with your program. We have created a model of off-site valve clinics in communities that are remote from us, where we will work with local practitioners. We take practitioners from our own institution and go to their institution, and create a local valve clinic. In these local clinics, we can tell patients, the only time you need to come to Springfield is for your valve implant, because we can do the entire workup collaboratively with your cardiologist on site. 

Are these remote hospitals part of your hospital system?

Interestingly enough, it is a different hospital system. Our group has a very big group in Carbondale (a few hours south of Springfield) that is in a different hospital system. This system does have an open-heart program, but doesn’t do high-risk surgical valves. We have set up a valve clinic in the Carbondale community with our cardiologists and essentially replicate the workup in its entirety, and then the visit to Springfield is just for the valve.

Disclosure: Dr. Gregory Mishkel reports having received either consulting, proctoring, and/or speaking fees from Edwards, Medtronic, and Boston Scientific.

Dr. Mishkel can be contacted at gmishkel@prairieheart.com