Hybrid Labs: Considerations Before Moving Forward

Author(s): 

Cath Lab Digest talks with Larry S. Dean, MD, FACC, FAHA, FSCAI, Professor of Medicine and Surgery, Director, UW Regional Heart Center, University of Washington Medical Center, Seattle, Washington. Dr. Dean is also the president of the Society for Cardiovascular Angiography & Interventions (SCAI).

Is your facility working to create a hybrid lab?
  Yes, the hybrid suites at the University of Washington Medical Center are now in the planning stages. We have two major hospitals in our system. Our other hospital is further along in the process, but still has not opened their hybrid lab.

What have you learned about the process thus far?
  There is a great deal that drives the development of a hybrid suite. The critical first step is to determine what procedures will be done in the room. Then you can decide who the stakeholders are. Is it cardiovascular surgery and cardiology? Cardiovascular surgery, cardiology and vascular surgery? Cardiology, interventional radiology and vascular surgery? The list can go on and on. Depending on your institution, you may also want to include electrophysiology and/or pediatric interventional cardiology. During the American College of Cardiology meeting this year, I spoke with someone who had a hybrid lab started by a vascular surgeon. The lab was designed to his specifications and his needs, and it really wasn’t used by anybody else. Clearly, the first thing is to get the right stakeholders together. Anesthesia, obviously, needs to be involved. The operating rooms would potentially have to be involved as well, depending on where you site the lab. Is the room going to be in operating room space? Is it going to be in a cath lab space? Is it going to be in some new tower? Staff needs to be involved, which might include nursing and technical staff, both from the cath labs and the operating room, and perfusionists, among others. There is an entire range of people that need to be involved at some point in the planning stages, particularly with the design, or you will wind up with a room that doesn’t meet anyone’s needs.

How did you determine what procedures are going to be performed in your hybrid rooms?
  Part of it has arisen from our experience in doing percutaneous aortic valve insertion through the PARTNER trial. This is a trial looking at percutaneous insertion of an aortic valve (we say ‘insertion’ instead of ‘replacement,’ because you don’t take the old valve out). There are two percutaneous approaches, one through the femoral artery and the other through the thorax, via a mini thoracotomy, which is much more a surgical procedure. That procedure, by its very nature, brings in the cardiovascular surgeons. They have been intimately involved in the whole process since the very beginning, and it was a natural occurrence that we would have our cardiovascular surgeons involved in any kind of discussion around a hybrid procedure room.
  We are trying to avoid the term ‘operating room.’ The room may be located in an operating room space in some facilities and in a cath lab space in other facilities. Regardless, we are trying to keep it generic or ‘non-denominational,’ so everybody feels ownership, and have been calling it a ‘hybrid procedure room’ and not a ‘hybrid operating room.’ Currently, we are doing percutaneous aortic valve insertion within a cath lab space that is not perfectly designed for this type of procedure. Since our cardiovascular surgeons have been involved since the beginning, along with anesthesia and perfusionists, it has been relatively easy for us to turn to hybrid procedure room planning. We are now having additional conversations with electrophysiology. Our EP docs do some procedures in the operating room — laser lead extractions, for example — that could also be done in hybrid procedure room. Having a cardiovascular service line made it easier for us to come together and plan, simply because of our structure.
Our sister institution is also creating a hybrid room. At that institution, it is going to be in the operating room area. The process is being driven primarily by vascular surgery, although cardiovascular surgery is involved as well. Cardiology has not been involved at this point, because our sister hospital doesn’t do cardiovascular surgery, being located 5 miles from our main campus. While the planning process is being driven by slightly different people at our sister facility, it is essentially the same approach.
  At our facility, we are also having conversations with pediatric cardiologists who are not on site, but do adult cases in our facility. They are part of the heart center, so they will be involved, but not as a first-line stakeholder, because they just don’t do that kind of volume. The other people we will have a conversation with are our interventional radiologists, to offer the facility and some insight if they so desire. They are not really part of the heart center, so it’s a bit of a different conversation. We at least will extend a hand to our radiology colleagues to see if they are interested in helping with the planning.
  One of my concerns, however, as we start identifying the stakeholders, is that the list quickly gets long. If the hybrid room is successful, how are we going to handle different procedures in one room? Should we also be looking for a second space? The procedures are complicated, and by their very nature, take longer to do, so a successful hybrid procedure room can fill up quickly. The greater the number of stakeholders involved, the more potential utilization will occur. It is important to start thinking about the next step if the room is indeed successful.

What about square footage requirements?
  It’s a space hog, to be honest. Hybrid procedure rooms are huge, much larger than ORs or cath labs. If the room is going to be multi-specialty, then you have to consider all the different specialties and their needs: anesthesia, perfusion, cardiovascular surgery, and so on. Because of all the equipment that needs to be put in, there needs to be very careful planning so that it all plays well together.
  Once you decide who is going to be involved, then you can decide what kind of equipment you need. Many different people need to have a conversation around what needs to go in the rooms and what is necessary for people to practice. The great fear is that you design something that nobody wants to use — the perfect room, that everybody looks at and says, “It’s not perfect for me; I’m not going to use it.”
  We are looking in the 1200-square-foot range, which is significantly larger than any cath lab and certainly larger than operating rooms as well. It’s a big piece of real estate. State agencies must weigh in as well, and at least in Washington state, there’s no such thing as a hybrid procedure room or a hybrid OR, so the state is simply calling it an OR.

What about implementing operating room standards?
  Air exchange, tiling, the ceiling, sterile corridors and access, etc., all need to be considered. If the room is in the operating room environment, it’s relatively simple, because it is already in that same environment, but if you put it in the cath lab area, it may be more challenging.
  What’s a hybrid procedure, anyway? Is it where you do an open operation at the same time that part of it is done closed? Vanderbilt University in Tennessee, for example, has been doing combined procedures where they do the whole thing at once. Do you do a percutaneous procedure one time and an the open procedure another time? How much are you going to use the hybrid procedure room as an actual operating room? If you are going to use it a lot as an operating room, then it might need to go in an operating room area, just for utilization. If you are going to use it for true combined procedures, and sometimes as an operating room, then you maybe you need to site it someplace else, or maybe call it a cath lab. There are several issues surrounding where you put the room and what you call it. Then, when you go to the state, you have to anticipate what the state is going to call it. If you say you are going to do operations in the room, then, at least in the state of Washington, they are going to call it an operating room and you will have to meet those standards.

What kind of timeline are you estimating to completion?
  Unfortunately, we don’t have the luxury of having shelled space that we can move into or of building a space that we can design ourselves into, so we are going into previously used space. Clearly, going into previously used space is something that most hospitals will be doing, because most facilities are not building new space or don’t have a shelled area. When you are looking for more space, somebody has to move. You have to find somewhere for them to go and there is due diligence that must be performed. Considering everything, if we were up and running in a year, I would be happy, but a more realistic estimate is probably 18 months.

What was the response of your stakeholders when they were approached about creating a hybrid procedure room?
  Since we work together already within the cardiovascular service line, they have actually been quite interested in this whole concept.
  At our sister hospital, they were doing combined procedures. Vascular surgeons were combining endographs in the thoracic aorta with some more elegant open procedures with our cardiovascular surgeons. They have also been involved in the PARTNER trial, so the surgeons were on board from the very beginning. The EP doctors see the value of having certain things they do in the operating room in a set up they’re more familiar with. The hybrid will have a little bit of everything that will hopefully make everyone comfortable. If you are a cardiologist and go to an OR to do something, then you feel a little out of your environment. If you are a surgeon and you go to the cath lab, you feel a little uncomfortable. The hybrid therefore makes people more comfortable in a working environment similar to both.

It’s interesting that there can be different focuses for hybrid suites because that means two different facilities, despite being close, may not compete with each other.
  Right. It depends a great deal on who is at the table, there is no doubt about that. It is important to make sure that you have thought about what you are going to do in the room. Make sure you have the participants involved, because otherwise you’ll wind up with a white elephant, and the only person who is going to use it will be the person who designed it, or the group that designed it. They can call it whatever they want to, but it won’t be a real hybrid facility.

What about management of the room(s)?
  We haven’t discussed this issue in-depth at our facility yet. Again, it would be a reason to bring all the stakeholders together. It will have a great deal to do with where the facility is sited. If it’s sited in an operating room, then clearly it is going to have to function within the operating room environment. The management of the operating room area would obviously have basic control. It would be a bad idea to have control and management of the space by some other entity that is not part of the area. I think that would be a problem. Let’s say you put it in a cath lab space. Well, you still need to interact with the operating rooms because of some of the staffing that has to occur if you decide to do an open procedure. You have to have a good working relationship between departments and a structure that allows conversations between the operating room and the cath lab, depending on where it is sited. I think you do need a bit of a blended model, but the day-to-day operations have to blend in with wherever the room is physically located.

What about incorporating robotic equipment?
  We haven’t had that conversation, although we do have robotics here. I think that robotics have been more broadly accepted by other specialties, like urology and maybe gyn. There are some robotics going on in cardiovascular surgery, but I don’t see a huge wholesale run to it. I don’t think it will be an integral piece. Clearly, if you are going to put robotics in, you will need a bigger room. We’re not planning to do it, but it is something to think about. You may have someone in your institution that is a big cardiovascular robotics person. If so, get them on board, but here, at least, it is not a strong part of cardiovascular surgical practice.

As technology develops, as things get smaller, maybe hybrid procedures won’t require surgical involvement.
  That’s always a possibility, but I actually see more synergy. I don’t think cardiovascular surgery is going to be replaced by purely percutaneous approaches. For example, I think that the multi-vessel bypass operation should perhaps be less multi-vessel. Maybe what we should do is use an arterial conduit like the left internal mammary artery (LIMA) graft to the left anterior descending artery (LAD) and stents for the other vessels. There is no study to prove it, but stents might be a good alternative to vein grafts. Another example is cardiac resynchronization therapy. Much of that has to be done through the coronary sinus. The anatomy of the coronary sinus is highly variable, so sometimes it is difficult to get leads in the right place. If you know where to put the lead and it is not in an accessible area of the coronary sinus, you can do a mini-thoracotomy to place the lead in the right place on the left ventricle. It is externalized into the pacemaker, done by electrophysiology docs. Another area is a combined Maze procedure, with some kind of percutaneous afib ablation. There are definitely areas where interventionalists have difficulty, and combining a surgical with a non-surgical approach might be not only easier, but best for patient outcomes. It’s an area ripe for research. Not to say that there won’t be improvements and we may change in 10 years to something different. It could all become percutaneous, and if that’s the case, then you’ll need to re-tool your workforce so that the people who are doing open procedures are now doing percutaneous procedures. There are examples of cardiovascular and vascular surgeons doing percutaneous procedures.

Any final thoughts?
  Having a service line approach has truly benefited our planning process. We have been working with our cardiovascular surgeons for years. They see things slightly differently sometimes than we do, but nonetheless the conversations are being had. It’s not like all of a sudden we had to initiate a relationship. Everyone is part of the Regional Heart Center, our CV service line, so it’s not like we are trying to go out and work with 7 private cardiology groups, 3 surgical groups, 3 anesthesia groups, and so forth. If that were the case, it could get even more complicated, very quickly. Ultimately, however, there is no one size fits all. Plans need to be adapted to the institution and the people involved.

Dr. Larry Dean can be contacted at lsdean@u.washington.edu.

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