NorthShore University Health System
Trial participation is part of the culture at this integrated hospital system, where the first US MitraClip procedure was performed in 2003.
The NorthShore University Health System, headquartered in Evanston, IL, is an integrated six-hospital network. Within its multidisciplinary cardiovascular institute are more than 75 cardiovascular and vascular physicians, as well as advanced practice nurses (APNs) and physician assistants (PAs).
Cath Lab Forum spoke with interventional cardiologist Mark J. Ricciardi, MD, senior clinical nurse manager Johnny Driscoll, BSN, RN, and director of interventional services Beena Thomas, BSN, RN, MHA.
Tell us about your interventional services and operational style.
Driscoll: Within the system, five of the hospitals have active cath labs. Two of the new affiliate hospitals run several labs and function largely independently of our “legacy” hospitals. Of the remaining three legacy cath labs, two do outpatient and inpatient 5 days a week, and one does urgent cases only with a busy STEMI volume. Basically, what we do is we run about five to six rooms a day. There might be two rooms at one hospital and four rooms at another, or some other combination depending on our needs. At least two of the total rooms will usually be EP, consisting of ablations and devices. What’s nice is that we staff in the room, but also our prep and recovery area, so patients are getting ready for procedures with our nurses. Since 2019, we have had a greater emphasis on same-day discharge procedures and we've really done very well with that both from a safety standpoint as well as the convenience of our patients being able to go home.
Ricciardi: Like many healthcare systems, we have evolved over the years through partnerships and acquisitions of hospitals. Our main legacy hospital, Evanston Hospital, has been involved in many early transcatheter valve trials, including pivotal TAVR trials and early feasibility mitral valve replacement studies. In fact, the first MitraClip (Abbott) procedure in the United States was performed at Evanston Hospital in 2003, and TAVR has been part of the armamentarium here for almost 15 years. We maintain a busy transcatheter valve program and are active in the investigation of how these therapies are applied to an ever-increasing number of patients. In the past few years, we have also committed to a robust CTO and complex high risk and indicated PCI (CHIP) intervention program, as well as left atrial appendage occlusion. How NorthShore’s academic culture translates to the newer hospitals in our system will be integral to our growth and success and is fascinating to navigate. As cath lab folks, that has meant putting an emphasis on an institutional culture with a single set of priorities for standards and outcomes. As we integrate and evolve, we are also working on how to operationalize procedures at differing sites and referrals within systems for specialty care.
Do you have dedicated staff for specific procedures, and do they travel between your different locations?
Ricciardi: We have some of the staff travel between the hospitals and some are just at one hospital. With the addition of hospitals with cath lab expertise to the system, it becomes more complex. I think many people in the field can identify with the fact that it’s always a work in progress in terms of whether individual hospital staff remain independent; and whether true expertise can exist at multiple sites. It really comes down to resources and how to maximize patient outcomes.
Driscoll: Everyone on our legacy hospital staff can do a general cath procedure and take call, but we have a group of roughly 10 people who are trained specifically in EP, and another group of 10 or 12 that comprise our dedicated structural heart intervention staff. Lastly, we have a smaller group of go-to staff for complex interventions and out-of-the-ordinary cases. So, staff will travel depending on which hospitals those rooms are located in that week.
Thomas: One thing I think is very important is that our leadership team provides a clarity and transparency to people from the time of hiring about our unique multi-hospital system concept and how it works. It’s important that they understand that it’s a little different than working for a system where there is just one hospital involved.
How do you approach the incorporation of new procedures and devices?
Ricciardi: Sometimes we educate the staff even before the attendings because getting them very comfortable with a new approach allows the docs to also be comfortable. We definitely have found this to be the case with things such as the Impella (Abiomed) device. Last year, we introduced TAVR to one of our hospitals. Staff education was key, as it involved having staff travel to our main hospital to observe and learn and bring that expertise back with them. We also had our expert staff travel to the newer site; all the while maintaining operations at the main Evanston hospital.
Driscoll: We put a lot of effort into planning and implementing structural heart procedures at that hospital over a period of months in 2019. It involved a lot of pieces of the hospital coming together, from anesthesia to ICU and the step-down unit, to nurse education, nursing administration, and cardiac imaging. We were fortunate that everyone was supportive and did their part to help because they all knew this was an important step forward for us and for our patients.
What are some of the strengths of your team for clinical trial participation and what trials have you been involved in?
Driscoll: We have a great clinical trial department, especially for cardiology, with whom we work very closely, as do our APNs and our nurse coordinators. The research team really is very detailed and good at communicating with our scheduling team. It’s seamless for the most part, and our staff are not only used to doing research cases, they’re interested in learning more, and in helping with the research part of it.
Ricciardi: Participation in clinical trials is an important part of our culture here. The cath lab staff and the research coordinating staff are all familiar faces to each other and work well with each other. In terms of the actual trials, we are participating in or have just completed several TAVR trials using balloon-expandable valves in differing surgical risk groups, TAVR in patients with low ejection fraction, asymptomatic severe AS, and valve-in-valve TAVR. On the mitral side, we’ve been involved in mitral repair device trials (both annuloplasty and leaflet repair) and registries assessing the newest iterations of existing edge-to-edge repair devices. In the tricuspid space, we are very involved in tricuspid valve repair trials. Nonvalve trials have focused on heart failure with preserved ejection fraction (using a novel intra-atrial shunt device) and mechanical circulatory support for anterior STEMI and for high-risk PCI.
How has COVID-19 impacted cath lab operations, patients, and staff?
Ricciardi: Like many other healthcare systems, nonurgent procedures were put on hold around mid-March to minimize hospital and staff resource use. We went through a process of categorizing patients based on the immediacy of their need for intervention. Trying to predict who may not survive if their procedure was delayed was onerous. Often troubling and difficult for us was that we needed to carefully consider if putting off someone’s procedure would have the negative effect of them having to be hospitalized. The last thing that we, or anyone, wanted was to hospitalize a patient in the middle of a pandemic for non-pandemic-related illness. So, it required a careful case-by-case assessment. Because we are a multi-hospital system, we were able to put all of our COVID-19 patients in one of our hospitals, which happened to be a newer facility with an excellent airflow system. That allowed the ERs, ORs, and ICUs of the other hospitals to care for non-COVID patients in a seminormal capacity. It wasn’t perfect because PPE use was an issue, as was staffing. We also experienced what many others did around the country in terms of a downtick in the number of patients presenting with NSTEMI and STEMI—partly a function of fear on the part of patients to come to the hospital.
Driscoll: It was a hard time for all of us, and protocols kept changing, but the staff were amazing. Some of them were asked to relocate to other areas, and others volunteered to do so. It was a time when everyone was needed not only to handle the immediate situation, but to plan how we were going to resume nonurgent cases in a way that was safe for everyone. Collectively, we were able to bounce things off of each other and see what worked or didn’t work in terms of scheduling and documentation. Another big issue was making sure that we were as standardized as we could be across the system, especially with anesthesia providers between departments, because those were a little restricted for a while. It really came down to how best to use our resources to get the job done.
Thomas: Johnny [Driscoll] was doing conference calls constantly with staff to keep the lines of communication open and make sure that they were getting all the information that they wanted and needed. He also spent hours going to different sites to talk to people in person. He was really one of the people that others looked to because he was saying, ‘We can do it if we do it together,’ and that attitude transferred to the staff and helped them get through it. Then, when we finally started opening back up, it was a great feeling, because we all knew that we had so many patients who had been waiting for months for their procedures.
Driscoll: Yes, we did, and our volume was way higher than expected right off the bat, which I think goes to show the importance of the high degree of planning that took place in order to get us to that point where we could safely reopen and meet current needs.
Are there things that you’ve learned from the COVID-19 experience that you think may be useful going forward?
Driscoll: I think probably the same-day discharges is a big one. We were able to start planning this and doing it prior to COVID, but the pandemic increased its importance both to us and to patients. It’s why we’re still going strong with our cases now and we don’t depend on inpatient beds at all. We’re basically able to continue chugging along because we're sending so many patients home safely, but it was a huge team effort to get to this point.
Ricciardi: I think we learned that when you pull together and show people that you care about their safety it benefits everyone and it grows trust. We saw our staff rally and work as a team during some really tough moments. I do wonder, though, what the long-term effects may be on all of us when this is said and done. Some people say there may be hesitation to go into healthcare fields and that it could be long-lasting. I do worry about the effects on people who were new to the profession when all of this started. But with these struggles I remain confident that we will all be stronger, and the docs and staff will come out of this better suited to take on challenges that lie ahead.