Jaclyn Chomsky, DNP, Valve Clinic Coordinator: Valley Hospital is a 452-bed community hospital. We are staffed by all attendings and more than half of the cardiology groups are employed by Valley. In 2015, we did 37 TAVR cases. In 2016, we did 74 cases. Dr. John Goncalves became the Surgical Director of the TAVR program in July 2016. In 2017, we did 156 cases. You can see our growth as we went from 37 TAVRs in 2015 to 156 TAVR cases last year.
John A. Goncalves, MD, FACS, FAAC, Director of Cardiac Surgery and Surgical Director, TAVR Program: For 2018, we are projected to do between 225-250 TAVRs. Our projections show us continuing on a steady growth path. Valley is a community hospital with a focus on research, which can be rare for a community hospital and differentiates us significantly. We are part of the Cleveland Clinic affiliation for cardiovascular disease. The dedication to research at Valley is significant. We have one of the only tissue banks in the entire region, and obtain and store tissue for multiple research projects, including cardiovascular and cancer projects, in conjunction with the University of Pennsylvania and Columbia University. In addition, we do clinical research at our center. Our electrophysiology (EP) colleagues have multiple, ongoing clinical trials. The TAVR program is part of the Medstar low-risk TAVR trial (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis). We are also part of a clinical trial looking at the use of novel oral anticoagulants (NOACS) versus coumadin for TAVR patients with atrial fibrillation. Valley is not just a community hospital; we differentiate ourselves by staying on the cutting edge and taking on clinical research, and along with tissue banking, we are involved in bench research as well.
Can you tell us about your heart team?
Dr. Goncalves: It is primarily two interventionalists (Dr. Tom Cocke and Dr. Sean Wilson) and me. We also have one interventionalist from a private group, Dr. Navin Budhwani, who helped start the program.
Jaclyn Chomsky, DNP: Dr. Goncalves’ experience has helped us immensely. Patients do ask, how many cases has he done? When I can easily say, over 1200 TAVRs, patients find it comforting. Dr. Wilson also started MitraClip (Abbott Vascular) procedures at Valley and does WATCHMAN left atrial appendage closure (Boston Scientific) with electrophysiologist Dr. Suneet Mittal. Dr. Wilson has been making a big effort to grow the MitraClip and WATCHMAN programs, so that hopefully in the future we can have a mitral platform as well. Our outcomes are very good. Dr. Cocke’s experience is something I quote to patients as well. We get a lot of referrals because he joined our team. His experience puts patients and referring physicians at ease. Dr. Cocke also does all of the structural heart procedures. He is a part of the WATCHMAN program and does atrial septal defect (ASD)/patent foramen ovale (PFO) closures as well.
Sean Wilson, MD: I have been part of the valve program now for four years. With Dr. Goncalves and Dr. Cocke joining the program in 2016, there has been tremendous growth. We have grown from a very small program to a flourishing program. It has been a dramatic transformation. When I started, they were still doing surgical cut downs, every patient was being intubated, and they were putting in a lot of Swans. We have transformed, following best practice standards and a minimalist approach. It has led to a great benefit to our patients and the recognition by our referring doctors of the good care we can deliver at a community hospital.
Thomas P. Cocke, MD, FACC: Our rapid growth is a combination of various factors. It is the expanded indication from the FDA, it is combining the experience of three physicians from several different program backgrounds, and really, it is the growing acceptance among the cardiology community that transcatheter devices are not a niche technology for the 90-year-old who can’t have anything else — this is actually appropriate technology for the great majority of aortic stenosis patients.
Dr. Goncalves: The TAVR program at Valley started out slow, which is appropriate. Valley does things slowly and methodically with an emphasis on quality. For a TAVR program to be successful, you not only need the surgeons’ buy-in, but you need the surgeons to be active participants in the program. One of the things that the whole team had to adapt to when I got here was not only that I was at the table, but I was doing the procedures. I think the cath lab staff was surprised to be handing AL1 catheters and wires to a surgeon. Now we are all viewed as team members and partners, and they value my suggestions and I value their suggestions, and we have an open communication in the room. Surgeons have to view TAVR as an extension of, and new model for, cardiac surgery. It is a new model with the cardiac surgeon and interventionalist working together with true hybrid skill sets. We are headed towards transcatheter mitral valve and tricuspid valve procedures, and minimally invasive surgical revascularizations in conjunction with percutaneous coronary intervention (PCI). If surgeons view cardiac surgery as in the midst of an evolution and they embrace it, then they will be part of the program and the program will succeed. Otherwise, you are in an environment where cardiac surgery is trying to hold on to their volume, and interventionalists are trying to push things in a different direction, yet they need cardiac surgical backup, then there is infighting…you can’t have that. We have been successful because a whole different mindset came into play. This patient needs an aortic valve, but let’s consider, are they a TAVR candidate? Why are we going straight to the operating room? I am a surgeon, I love to operate, but the intermediate risk data for TAVR is clear. Now we are in a low risk trial. We are going to rapidly approach a time where patients will be given both options, and it is going to be their choice, under a shared decision-making model. Shared decision-making not only means a team approach with the valve coordinator, anesthesia, cardiac surgery, interventional, EP, the cath lab team, and the OR team, but the patient is also included in this collaborative model. Many people have that instinct or mindset that they “don’t want their chest cracked”. But that may not be the right way for the patient to be thinking about things, so it is our role to educate them. Surgeons have to be an active participant in the process.
How many TAVR procedure rooms do you have?
Dr. Goncalves: We have two rooms: one is in the cath lab and one is a hybrid operating room (OR), but we don’t have the two rooms on the same day. It would be great if we had both rooms and could lateral back and forth, and decrease our downtime between cases, because then we would easily be able to do 4, if not 5, cases a day. When I arrived, doing two cases in a day was a big deal. Jackie would have scheduling nightmares. Now we easily do three cases in a day. The turnaround time is good. We can be done by 2:00 pm on average, but will finish 3 cases by 3:30 or 4:00 pm at the latest.
What is your algorithm for selecting devices?
Dr. Goncalves: First we look at the patient and the computed tomography (CT) scan. I have equal fondness for a CoreValve Evolut valve (Medtronic) and for a Sapien valve (Edwards Lifesciences). I don’t have any biases for one over the other. We look at it anatomically. If the vasculature is an issue, and we are dealing with small and/or calcified vessels, then we lean towards an Evolut. Although the Sapien device has the 14 French (Fr) expandable sheath for the smaller valves, it is not a true 14 French system. So if we are dealing with small blood vessels and want to maintain a femoral access approach, then we will probably lean towards Evolut. If the left ventricular outflow tract (LVOT) is densely calcified and extends down the aortic-mitral curtain, being contiguous with mitral annular calcification, those patients with a balloon-expandable device are at a high risk for annular rupture. For those patients, we would lean toward an Evolut, again, as a self-expanding device, in order to minimize that risk. When we look at these scenarios, it roughly equals out 50-50. It is actually unfair to Evolut, because we tend to select out the riskier patients for the Evolut device. If they have worse calcification and worse peripheral vessels, I tend to use Evolut. Other scenarios include valve-in-valve; if someone has a degraded bioprosthetic valve, I like Evolut in that scenario to maintain the effective orifice area (EOA). Putting a Sapien device inside of a valve has been done often enough, but with a CoreValve, you maintain better gradients.
Were there certain aspects of the program that were targeted for improvement?
Dr. Cocke: We, as a team, when we came together, were very firm on the need to change a program that had worked on the basis of general anesthesia and cut down vascular access to a program that was very heavily monitored anesthesia care — not general anesthesia — and very heavily percutaneous access, rather than vascular cut down. We still do alternative access when needed, but the great bulk of the patients get monitored anesthesia care and a fully percutaneous procedure. That is something we as a team agreed upon early on and we were very focused on showing the staff that a quality procedure could be done much less invasively, with both a shortened procedure time and greater patient comfort.
Dr. Wilson: We moved away from Swans, we implemented early mobilization — different programs like that helped. The attention and level of care we give to our patients also helped — they really value this. A lot of our patients, if they are in the hospital, will stop by at the valve center just to say hi. Jackie and Lenka are there to give an update on how they are doing. It’s created a big family, which has been a very nice thing. We are a thorough, cohesive team, including the cath lab nurses and technologists, OR nurses and techs, nurses in the floor in cardiac surgery, and nurses in the floor in cardiac stepdown. We all feel great ownership for the patients. I say that as someone who came from a larger centers where you didn’t necessarily have that sense. It is an aspect of Valley Hospital that I enjoy.
Jaclyn Chomsky, DNP: Patients always say, “I’m a name, not a number.”
When I go to coordinators’ conferences, the thing every valve coordinator and TAVR program struggle with the most is having everyone being able to come together as a heart team. So, how do you get 4 physicians in a room at the same time? (It’s a running joke, like, how do you change a light bulb?) When Dr. Goncalves came on board, he fixed that issue instantly. He demanded we have 1 day a week for valve clinic, which is now Thursday. Our valve clinic day involves a heart team meeting before valve clinic, where we review all of our cases. We decide, at that meeting, what valve we are going to put in the patient, what size, and what approach we are going to do, along with discussing bailout options. If I have any complicated patients that I need to bring up to the physicians beforehand or if I want to do screening before they come into valve clinic, I will bring those patients up during this meeting. If we have any post procedure issues, such as perhaps a patient’s echo didn’t look good, I will ask them to look at it. I have all these physicians in a room, and so I jam-pack every single thing I need to talk to them about into that hour. To keep everyone straight, I have my own system where I have every patient in a table that will also have their echo and anything outstanding on the CT. If someone has a calcium nodule or something, then I have it in a particular section to remind me, so I can bring it up during this meeting. After meeting, we go into our day. We have 6 time slots available, depending on the day. I am lucky to have other nurse practitioners to do the H&Ps. Dr. Cocke, Dr. Wilson, and Dr. Goncalves will all meet the patient at the same time, go through the process, and explain the procedure to the patient. The patients love it, because they get to meet everybody. Surgeon consult is done on pre-admission testing days. Dr. Mariano Brizzio or Dr. Alex Zapolanski will meet the patients. I see the patient afterwards, will go over everything that they didn’t understand, and explain to them what screening they will need to have done, if they will need a cath, etc. I give them my card and tell them to call me with any questions.
How did the program change with Dr. Goncalves’ arrival to lead the program?
Jaclyn Chomsky, DNP: Before that, I was scattered, seeing patients any day of the week. I was seeing every single surgical patient. I was not a very happy valve coordinator. Once Dr. Goncalves joined the program, the change was huge. The question now is, tell me why this patient shouldn’t have TAVR, not why they can. Obviously, depending on the age of the patient, surgical still is a requirement. Once intermediate risk came into play, it has been easier for us.
Dr. Goncalves: We provided education about TAVR to our referring physicians, our hospital-based primary care providers, and cardiologists, sharing that we have this option for their patients. We shared outcomes, expectations, and the experience of our operators. The referrals continue to grow, and I see them growing even more within the next year or two.
What changes were necessary to accommodate such dramatic growth?
Dr. Goncalves: Administration played a significant role, because of the resources involved. It’s one thing to do 30 cases a year, which is 2-3/month. You can find the time in the cath lab or hybrid OR for that sort of volume. But now we are taking up an entire lab in the cath lab for a day or two a week, or taking up the hybrid OR for a day, so it required a lot of help from administration, including cath lab administration, OR administration, and the overall administration for the cardiovascular service line.
Lenka Mysliwiec, Nurse Practitioner & Valve Clinic Coordinator: The cath lab trained more staff and we are considering promoting one of our technologists to lead tech for structural heart. The OR allocated dedicated block time for the hybrid OR. The service line projected the growth and budgeted accordingly. The valve center added a valve coordinator and an office coordinator due to the increase in volume.
Was there a certain metrics you were focused on?
Jaclyn Chomsky, DNP: Our length of stay is on average 2.5 days, so when explaining things to the patient, I say they will spend 2 to 3 days in the hospital. The ICU stay depends on their pacemaker wire — at our hospital, we have to keep patients with a wire in the ICU. After the ICU, patients go to the floor, and the next day they will go home. The patients are aggressively ambulated, as long as there is nothing complicated with the patient. We are lucky to have inpatient cardiac rehab that will walk and work with all of our patients. Depending on where they live, we refer all of our patients post procedure to either our cardiac rehab program or an outside cardiac rehab program.
As you worked to develop the program, how was industry involved?
Dr. Goncalves: The companies were helpful as we sought to build unity. When a new person comes on board, especially a surgeon in the cath lab, you need some team-building. It takes a number of cases to gain people’s trust, but before you get there, you need a sense of the team and the companies were helpful in doing some sponsored events, lecture series, and talks, where we could have an educational meeting, but share food or drink at the same time. It goes a long way to sit down with someone you work with on a day-to-day basis, and find out about their kids and family.
Jaclyn Chomsky, DNP: Industry supplied educational support, such as handouts for patients, and they have programs for coordinators. We are actually going to a Medtronic valve clinic coordinators program in February. I get access to other coordinators that are going through the same struggles I am — monster, growing programs that the same level of staff is supporting. Industry has assisted us in figuring out how to sustain and grow these programs, as well as providing reimbursement education to keep us current. The Healthcare Economic Managers have also come in and helped educate our coding teams — they have been a huge support.
Dr. Goncalves: Medtronic and Edwards have programs that not only are trying to increase outreach to referring physicians, but also to try to capture more of the patients who are already undergoing testing in your institution. There are many patients who have echocardiograms that show moderate to severe aortic stenosis, moderate to severe aortic insufficiency, and moderate to severe mitral regurgitation, who aren’t referred to a valve center. Maybe it was a primary care doctor who ordered the echo while a patient was in-house and then there is no cardiology follow-up. Reaching out to these physicians is something that, after having a recent administrative meeting, we are going to start pushing ahead on. Perhaps a patient had disease on echo, but wasn’t referred, and now we are reaching out and educating that physician as to current indications. You don’t want to step on toes, but at the same time, you want to let the physician know of our program, that we have resources, two valve coordinators, a valve center, and that we can monitor your patient alongside you and if need be, recommend therapy. Both of our industry partners have programs aimed at getting over that initial difficult relationship between the valve center and potentially referring physicians, and letting them see that we are a resource and a partner. We will see more referrals, but also we will be sending more patients to our cardiology colleagues, for example, who perhaps weren’t seeing this patient undergoing an echo requested by their primary care doctor.
Dr. Cocke: Within our valve clinic, we routinely see people that are, in effect, self-referred, and that has been a result of the growing understanding within the public that transcatheter technology is widely available. Industry has been very helpful in terms of the outreach we do, both within the medical community within the hospital, as well as in the broader, general public. It is not always easy for individual programs to do the kind of broad outreach and marketing that industry can do, and that, in turn, feeds the local programs.
Do you have advice for other programs looking to grow their TAVR program?
Jaclyn Chomsky, DNP: Start with a good heart team that meets consistently. It means I have confidence to ensure patients are going to get the best possible care and that the physicians are all communicating with each other. All four of them are in a room, sometimes not agreeing with each other, but that is the best care, for me. I think that has really made the difference with our program, as far as having a dedicated day, and knowing that every Thursday, we are going to have valve clinic and conference. If we don’t, then we always make it an alternate day.
Dr. Goncalves: Our procedure days are expanding, because we typically can’t get all the cases done in just one day a week. We meet in the ICU the morning after, or on the floor, at either 7 or 7:30 am, with the entire team. Our valve coordinators, the primary operators, our intensivist, and our advanced practice personnel, either nurse practitioners or physician assistants, to go over each case. This is a multidisciplinary team, and if we round in a fractured manner, then it becomes too disjointed. I would come by and say, take out the pacer, start a beta blocker, and somebody else will come by and say, no, I want to leave the pacer in. Instead, we meet together and set a unified plan. Obviously, clinical scenarios can occur later in the day that may necessitate a change in plan, but at least going into the day, we have the same plan. If the clinical scenario changes, we will get the communication from the floor or from the intensivist, and they will ask us what we would like to do. Rounding more as a team, going over the cases together, and communication are key and have helped significantly. You need to put together interventional cardiologists that truly have an interest in this program, not just somebody who primarily does PCI, but wants to do a valve now and then. That is not the person you want to work with. You have to have a surgeon in the program. I don’t think you need to seek out someone who has already built a large program and has a large body of experience, but you have to have surgical partners who believe in the technology and believe that it is part of the evolution of cardiac surgery. Otherwise you are just going to have silos — the surgeons in one silo, the interventionalists in another silo, and your program is going to be in a vicious cycle of shooting itself in the foot.
Dr. Wilson: Be open to change and other people’s opinions. It’s like a marriage, because these programs are all multidisciplinary. You need people who are willing to listen to you and you have to be willing to listen to them, and compromise, all with the goal of best patient outcomes. Be humble and flexible enough to realize that sometimes your decision may not be the best. Hopefully, the people around you will sometimes realize that as well about themselves. Never stop refining your program.
Any final thoughts?
Dr. Goncalves: Our CEO, Audrey Meyers, had a vision several years ago, recognizing how cardiac surgery is evolving. We now have approval and a certificate of need (CON) from the state of New Jersey to build a new hospital. At present, we have a single hybrid OR and enough space, but there are neurosurgeons, vascular surgeons, cardiac surgeons, the TAVR team, and interventional radiologists all vying for the hybrid OR. Fortunately, we can do a lot of our work in the cath lab, but the new hospital is right in line with the future of cardiac surgery and with cardiovascular medicine as a team approach. We will have several dedicated hybrid operating rooms and advanced cath labs juxtaposed to the hybrid OR, so that we all share a common core. It will make the flow of patient care run more smoothly — if we need more materials, we don’t need to run to the OR or run to the cath lab. We value a team approach not only in the office, where we are seeing patients together, but in the design of our new hospital, which will also reflect and encourage a team approach.
Disclosure: Dr. Goncalves reports he is a proctor for Medtronic and Edwards Lifesciences. Jaclyn Chomsky reports she is a faculty advisor for Medtronic. Dr. Cocke and Dr. Wilson report no conflicts of interest regarding the content herein.
The authors can be contacted via Jaclyn Chomsky, DNP, at firstname.lastname@example.org