TAVR at the UHS Structural Heart and Valve Center

You built a transcatheter aortic valve replacement (TAVR) program from the ground up. Can you share some of your history and the challenges you faced?

I started working at UHS Wilson Medical Center in Johnson City, New York, in July 2014. I was hired as a new director of the structural heart division. A TAVR program had been discussed for quite some time, but the hospital didn’t have the properties in place that are required to launch a full-fledged quality program. I came on board as one of the first graduating fellows from a structural heart disease fellowship at Henry Ford Hospital in Detroit, Michigan. I was fortunate to train with incredibly talented faculty, including the world-renowned Dr. William O’Neill. It was a huge honor to work alongside someone so experienced and well regarded in the structural heart community. I owe much of my early career development to Dr. O’Neill and his colleagues.

How have you been able to transform your training experience into medical practice?

You bring up an excellent point, which is the ability to translate the training experiences we gather over the course of fellowship into real-world practice success. It is something we don’t talk about much during fellowship. We do discuss job selection and “getting a good fit” in your ultimate position, but not much is said about how to take what you have learned in fellowship and translate it into quality patient care and success in your practice. There are challenges we experience in practice that we aren’t confronted with during fellowship; mainly, budget restrictions, hospital executive decisions regarding utilization of resources, and group dynamics. Newly graduated fellows face these aspects very quickly, especially with service line development such as building a TAVR program. You learn very quickly how difficult it can be to navigate. The key is to describe the new service in terms of the needs of the community and the patients of that community. In the case of TAVR, we saw a huge unmet need, and that generated a lot of excitement to drive us forward. Whenever you are starting something new, it really speaks a new language to the physicians, to the staff, to the administrators, and to the executives. It does place significant stress on the system. But, with good, cohesive efforts, I feel that you can make a huge impact and provide new services that help in a very positive way. You can impact not just the cardiac care of the patients in your community, but also the overall medical care of the patients in your community. 

Can you tell us a little bit about your community?

Johnson City is part of the Binghamton metropolitan area located in upstate New York, a 3-hour drive northwest of New York City. We have a catchment area of approximately 300,000 people. Several notable businesses, such as IBM, Dick’s Sporting Goods, and Valvoline, got their start in the Binghamton area. Our current employment base is still oriented towards technology and defense manufacturing (IBM, Lockheed Martin, BAE Systems). Like many other similarly sized communities in upstate New York, education (Binghamton University) and healthcare (United Health Services, Lourdes Hospital) are rapidly developing sectors in the regional economy. We are fortunate to be surrounded by nationally recognized university medical centers. Albany Medical Center is two hours to the northeast. Strong Memorial Hospital in Rochester University is three hours to the west, and Columbia Presbyterian is under three hours away. All institutions have provided us with very valuable support. We therefore have several options if confronted with patient complexities that we are not able to take care of here.

Can you share more about the startup of the program?

The structural heart program was present only in concept, so we essentially started from ground zero. It was a rewarding experience. Our first challenge was infrastructure. The first wave of TAVR programs were developed under the auspices of the PARTNER and the CoreValve Pivotal trials. These handpicked programs across the country received a great deal of support and direction on how to start a TAVR program, including patient selection, team building, and procedural training. They paved the way by establishing the safety and feasibility of the TAVR procedure. Now it is up to the community hospitals to follow suit. The challenge is to develop the infrastructure within your institution to complete a patient workup from beginning to end. The backbone of a successful TAVR program is a functional valve clinic run by a valve clinic coordinator and staffed by specially trained cardiologists and cardiac surgeons. The imaging component is extremely critical, so we collaborated with our radiology department on a computed tomography (CT) protocol specific for TAVR planning. Our radiologists and imaging cardiologists received special training to analyze scans with regards to vascular access and valve size selection. Then there is the training of nursing and cath lab staff that will be involved in the care of these patients perioperatively. Finally, Edwards Lifesciences and Medtronic were instrumental in supplying both on site and off site training for implanting physicians, in order for them to feel comfortable with this new technology and to yield consistent, reproducible outcomes. 

What was your community’s reaction to the new program?

TAVR is a breakthrough technology that has changed the lives of hundreds of thousands of people. Having said that, we know that there is a gradual uptake until a new therapy becomes part of accepted practice in the community. Early on, there was still doubt in the minds of many providers regarding how these valves are going to hold up, are they durable, how much are they going to leak, what is the stroke rate and will patients require repeat operation. There were a lot of questions. For someone like myself, who was trained in an environment where these procedures are done regularly, TAVR is very well accepted, but when you go to smaller communities, physicians are not familiar with these procedures. It is important for people believe in the new technology. We have gone out to the community, to physicians’ offices, talking to cardiologists and primary care physicians about this new procedure. We share the patient experience, the patient selection process, which patients will gain the most from this procedure, the workup involved, how the procedure is performed, what to expect during their hospital stay, how long they are expected to stay in the hospital, what their follow-up is after the procedure is completed, and what medications they need to be on. Slowly but surely, we gained enough steam, enough of a backing from the referring physicians and the cardiologist community, who decided, we trust this program, and we will trust the program with our patients. Gaining the trust of our referral base was crucial to the success of the program. We have seen such a heartwarming response to this program. We routinely receive positive feedback telling us over and over again, “I’m so happy that you are here! I’m so happy that we have this available in our community” so our patients don’t have to travel far.

What resources did you begin with, in terms of space and equipment? 

Our biggest initial hurdle was finding a suitable cath lab or operating room for the TAVR procedure. I came from a large university hospital with all the latest, greatest technology, with CT overlay technology to guide valve deployment, and the newest fluoro camera, and a huge hybrid cath lab room with a dedicated team, and a dedicated anesthesiologist. In a small community, resources are more limited. Initially, we felt there was no way we could do this procedure within our current cath lab, expecting to have to wait to purchase a new camera and renovate the whole layout, which is a huge project. Yet we found we could use the lab we already had in place, after making some modifications such as air ventilation, anesthesia workstation, booms with OR gases, and space to accommodate cardiopulmonary bypass equipment. We used a conventional single plane floor-mounted C-arm with a 6-inch image intensifier (GE Healthcare Innova 2000), which had been in use since 2000, so certainly nothing fancy! Well, we have actually been able to perform over 70 cases in this lab. Space or image quality was never an issue, and everything went very, very well. We are now renovating the hybrid cath lab to include expanded control room space, a sterile scrub room, and a brand-new ceiling-mounted Philips Allura 20-inch flat panel with an integrated 56-inch color display. So we are certainly looking forward to that as our program continues to expand to more complex procedures such as paravalvular leak repair and MitraClip (Abbott Vascular).  

One unique piece of equipment you have been using is a mobile c-arm.

Yes, and that was one of the really exciting moments where we were able to think outside the box. We researched and found a new type of flat panel, mobile c-arm camera. They are already in use in Europe; one is called Cios Alpha, made by Siemens, the other one is made by Ziehm Imaging, a German company. These are very high energy, portable,  liquid-cooled c-arms,  providing phenomenal image quality. The mobile c-arm unit can be moved from room to room; it can be moved away from the surgical field during alternative TAVR access. A ceiling-mounted fluoro camera is fixed; whereas the mobile c-arm is so versatile. We have more flexibility in scheduling and room availability. The mobile c-arm is used by multiple operators in the operating room of their choice. Our vascular surgeons are using it, our heart surgeons are using it, and our TAVR team is using it. During the construction phase of our renovation, we don’t have access to another hybrid cath lab. The portable C-arm allows us to perform TAVRs right in our operating room, the same space where we perform open-heart surgery. A mobile c-arm is a new concept for us in the United States. We are doing a pilot study to look at outcomes of the mobile vs fixed c-arm. So far, we have seen no impact in fluoro time, x-ray dose is actually less, procedural success is equal, and patient length of stay and clinical outcomes are, from our preliminary results, quite comparable. Using the mobile c-arm allows us to continue to do TAVR procedures while our lab is being renovated. While this approach may not become mainstream, is has certainly proved to be a valuable bridging tool for us during the renovation project.

Can you discuss the use of anesthesia and echocardiography for your TAVR procedures?

We started doing our TAVR procedures under general anesthesia like most other programs. At the time in 2014, that was, by and large, in the U.S. at least, the anesthesia of choice for most programs. We have started to shift away from that rather quickly. We have had very good success with general anesthesia, though it does carry significant morbidity in the elderly such as respiratory suppression, altered mentation, and urinary retention. Sometimes this translated into a longer length of stay. Today, for most of our patients, the preferred anesthesia is moderate sedation. We go with a rapid triage of these patients through their procedure; to obviate the associated infection and urinary retention risk, we don’t insert a Foley, certainly not for men and for most women as well. We don’t utilize a Swan for these patients unless they are at high risk for hemodynamic instability. We insert a radial arterial line and use conscious sedation. We often use transthoracic echo imaging rather than transesophageal echocardiography (TEE). General anesthesia, TEE, and pulmonary artery (PA) catheter use remains at the discretion of the TAVR team and if we felt we needed additional imaging or a more controlled setting, we would not hesitate. Our length of stay has really come down and most of our patients will go home within 2 days. Obviously in certain cases where patients need a longer recovery time, we manage them in the hospital until they are ready for discharge.

What is your interaction with the surgeons?

We are fortunate here to have two phenomenal surgeons, Kenneth Wong, MD, and Bashar Yousuf, MD, both of whom have served our community for 25-30 years. They have a ton of experience, they are wonderful surgeons, they are great with their patients, they are very highly skilled, and they have embraced this new technology. There was a little bit of skepticism initially about the durability of the valve and the degree of paravalvular leak. With the newer generations of the valve, we have addressed these concerns. Our surgeons have participated from the onset in select patients that are deemed high risk or inoperable. We follow the formal FDA recommendations very closely, offering this procedure only to those patients who are deemed high risk or inoperable. We work very closely in a team atmosphere. A lot of times it is a two-way street in terms of referrals. If I see a patient who is low to moderate risk, then I send that individual to one of our surgeons, and in a similar fashion, if our surgeon will see a patient that they feel is too high risk for surgery, then they will send that individual for a TAVR evaluation. We have a lot of trust, we have a lot of mutual respect, and we work together in the patient’s best interest. We select the best procedure for that individual, regardless of who sees the patient first.

Now the focus is turning to intermediate risk patients.

The data presented at this year’s American College of Cardiology Scientific Sessions was very promising. The FDA is currently reviewing the data from the PARTNER II intermediate cohort. We should find out by the end of the calendar year 2016 or the beginning of 2017 whether this technology can be applied to intermediate risk patients. Certainly that is where things are headed. At our institution, we have not yet selected patients who are moderate risk, but I will say that a lot of patients who are in the intermediate risk category are very interested in this procedure. It will be something our program and many programs have to discuss: are we ready to expand this technology to patients who are at moderate risk? The main concern is the longevity of the valve, and re-accessing the coronary arteries when performing this valve replacement in younger individuals who may later require coronary interventions. Certainly the TAVR procedure is one of the great medical breakthroughs of this century, and not going away, but becoming bigger and bigger with time. 

What has been the financial impact of adding TAVR to your hospital?

There is a lot of upfront investment that needs to be done. The use of our preexisting hybrid lab and our traditional camera permitted us to launch a program with a reasonable upfront cost. We actually launched very quickly; in just under six months from the time that I started, we were able to do our first procedure. The concerns were mainly that the valve currently is very expensive and the procedure itself is not a moneymaker per se. We all know and are aware of that. However, there is a powerful halo effect. That is the upstream and downstream effect of taking care of these complex patients that can be quite financially feasible for an organization our size as well as for most organizations participating in TAVR. As you follow a patient’s voyage through the TAVR procedure, there are cardiology office visits, echocardiograms, a heart catheterization, CT scan, etc., all of which are performed to prepare the patient for the procedure. In essence, a TAVR program may not be lucrative for the hospital, but provides a necessary service to the community and is vital to the health of a tertiary cardiac program.

Describe other services your program provides and your future direction.

We have developed a same-day PCI program that has been very well received at our institution. Using an evidence-based protocol, stable patients are discharged home 6 hours after uncomplicated PCI. One of the nice things about this program is that we provide patients with their first 90 days of antiplatelet therapy at the bedside — we have learned that the pharmacy is the last place a patient wants to stop on their way home from the hospital. Patients receive a follow-up phone call the next day and are seen by their cardiology provider within two weeks. Our patient feedback has been very positive. We have also developed a program for percutaneous left ventricular assist therapy using Impella (Abiomed) for high-risk PCI and cardiogenic shock. We also perform ASD/PFO closure, mitral valvuloplasty and paravalvular leak closure. In the future, we hope to develop transcatheter mitral valve repair and left atrial appendage occlusion.  

Can you tell us about your TAVR coordinator?

Our TAVR and valve clinic coordinator, Kara Mucilli, has done a phenomenal job for us (see sidebar). A valve clinic coordinator is crucial for the success of a TAVR program. He or she is the contact person for the family and the patient, and educates them about the procedure and what it is going to be like to be evaluated for the procedure, what they can expect the day of the procedure, and afterwards. There are many questions that patients have that physicians themselves might not always be available to answer. Kara has really helped to grow the program.

Any final thoughts?

In cardiology, we are seeing so many new technologies and so many exciting breakthroughs. It is like we are being given keys to a luxury sports car — but, in order to best serve our patient needs, we first need to make sure we know how to drive it. This is a very interesting and exciting time to practice. We are able to offer so many new technologies to our patients. It is the physician’s responsibility to not only know about these technologies, but also to know how to select the correct patients for the use of these technologies. 

Disclosure: Dr. Alon Yarkoni reports no conflicts of interest regarding the content herein. He can be contacted at Alon_Yarkoni@uhs.org