Can you tell us about the Amputation Prevention Center at Rose Medical Center?
Sameer Mehta, MD: Three years ago, we developed a dedicated critical limb ischemia program and opened the Amputation Prevention Center. It is an actual physical structure with 6 exam rooms and 2 hyperbaric oxygen chambers, and is located in an office building that is adjacent to Rose Medical Center. Rather than a standard wound care center, the Amputation Prevention Center is designed specifically around patients with threatened limbs at risk for amputation. The whole center is designed around amputation prevention and is multidisciplinary, with interventional cardiologists, vascular surgeons, a general surgeon, infectious disease specialists, podiatrists, other wound care specialists, hyperbaric medicine specialists, and dermatologists, all supporting our patients. Dr. Richard O’Brien is the hyperbaric oxygen (HBO) medical director.
I am the co-director of the Amputation Prevention Center, along with podiatrist Dr. Eric Jaakola, and I direct the vascular aspect of the center.
Andrew Burke, Lab Supervisor: Previously, the vascular program was divided amongst the OR and the cath lab. Now, even though procedures are performed in the same locations, the Amputation Prevention Center better unifies the whole program.
Heather Harris, Cardiovascular Director: Jennifer Urbonas, the director of the Amputation Prevention Center, is easy to work with, and will do anything she can to help the program. Her leadership in working with the cath lab, staff, and Dr. Mehta is also why I think the Center has been successful.
What inspired you to start the Amputation Prevention Center?
Dr. Mehta: We have seen a proliferation of wound care centers, but still felt there was a lack specifically for the patients with diabetic wounds and critical limb ischemia. If you look at national numbers, the rate and prevalence of amputations, from the actual data, are still quite harrowingly high. Amputations are growing at alarming rates, and as diabetes and hypertension go up and up, we are amputating more and more patients. Many of these patients have atherosclerotic vascular disease that is inhibiting or limiting their ability to heal. Supported by our hospital, we took the opportunity to help influence our community’s limb salvage rate. The vast majority of patients we see have wounds. Our hope is that if somebody sees a wound and feels it is potentially bad, that they send this patient to the Amputation Prevention Center, rather than undergoing what is the usual delay of a month or three months of standard wound care without vascular assessment. Many of our patients do come very early in the wound care stage. We have defined protocols of vascular screening so that when values are abnormal, it auto-triggers a consultation with a vascular specialist.
Where are your patients coming from?
Dr. Mehta: Eighty percent are referrals from physicians and about 20 percent are direct patient referrals, where patients have either searched “amputation” online or they have been told they need an amputation. There are the occasional patients that actually require amputations for non-vascular causes; however, for most patients (and I hesitate in saying this), I do feel it is malpractice not to have a vascular evaluation before amputation.
What results have you seen in the past two years since the Amputation Prevention Center has opened?
Dr. Mehta: We have a very high wound healing rate, with 96% of wounds healed within 60 days (median time to heal is 36 days). Our major amputation rates have also been exceptionally low at <5%.
How have you handled the integration of different disciplines of care into the Amputation Prevention Center?
Dr. Mehta: There have been challenges. Some of the providers who take care of wound care in their own outpatient practices had to give up a little bit of their own outpatient practice after seeing that our multidisciplinary approach has been more effective. That actually happened pretty quickly. The other challenge has been to navigate the crossover field of who does vascular interventions. The relationships at our center, primarily between the vascular surgeons and myself, an interventional cardiologist, have been very collegial. There is an understanding that we both carry different skill sets into the field. There is a lot of misconception that when you say “we’re doing limb salvage” that this means 4- and 5-hour long cases on very sick people. What we have actually found, with the more cases we do, is that the vast majority of cases actually take between 1 to 2 hours and move very smoothly, despite the patient being so sick.
Why do you think cases are going so quickly?
Dr. Mehta: From the cardiologist standpoint, there is a big difference between doing peripheral vascular disease interventions and doing limb salvage. I think for people who might dabble in the field a bit, the cases can be very long. Familiarity with various techniques and the ability to do retrograde or pedal access has sped up our case volume and our success rate a great deal. I think it is a result of both the physician and the staff really dedicating themselves to learning, getting the appropriate tools, and mastering the appropriate techniques to make things more efficient.
Can you tell us about your access, and some of the devices and equipment you use?
Dr. Mehta: We do contralateral, antegrade femoral access, brachial and radial access, if appropriate, as well as a fair amount of pedal access. By default, every patient that is brought to the lab is prepped from either an upper extremity or femoral access, and pedal access, which, from the standpoint of efficiency, saves 20 minutes up front, if, in the middle of the case, the operator decides that now we have to do pedal access. We are adaptive to most common access points. We use ultrasound-guided access now for every case. We probably switched to that approach about a year ago. We think it helps us with access, but also in determining the ability for using closure devices. We also use micropuncture access in over 90% of patients. Our hospital has been very supportive regarding devices. We have a full array of balloons, including scoring balloons and two drug-coated balloons, a full array of self-expanding, balloon-expandable, and covered stents, and have three different atherectomy catheters available. We are not pigeonholed into having to do things a certain way because we only have device Y and not device X. As we do more, and have found new things that may help our patients, our administration has been very prompt and supportive about allowing us access to new technology.
Could you provide an example of a typical patient and their path through the center?
Dr. Mehta: I will share what I’m doing this Friday. Our patient X was seen as a first referral for a non-healing wound on the dorsal of his foot. All patients undergo immediate vascular screening and his was grossly abnormal. Between myself and my nurse practitioner, we do have dedicated clinic hours, but also we are able to see patients ad hoc while they are at the Amputation Prevention Center. This patient was seen by the podiatrist who also examined him and found no pedal pulses. I was in the cath lab at that time, so my nurse practitioner went down and did a full consultation on the patient. She didn’t find any pedal pulses and agreed that the patient had severe peripheral vascular disease. He is now scheduled for an angiogram this Friday. This is what we are aiming for — early detection and early screening.
What does the initial vascular screening involve?
Dr. Mehta: We use segmental skin perfusion pressure (SPP) for vascular screening (SensiLase, Väsamed). SPP checks macro and micro vascularity of the patient. Our feeling is that although there is not yet published data, SPP is more accurate than using an ankle-brachial index (ABI) for screening. We use an SPP level of <50 to prompt a vascular consultation. I wasn’t aware of this technology before it was employed by the Center, but now after becoming aware of it, I use it a lot more. Anecdotally, I find it is much more accurate than any other vascular screening.
Can you tell us about any training that was required?
Andrew: Industry has helped, but the staff is very experienced. Most of the staff at this hospital, especially the technologists, have been in the field for ten years or more. We have all worked with Dr. Mehta for 5-10 years since he has been coming to Rose Medical Center, so the transition with the cath lab staff went very smoothly.
Heather: The cath lab staff don’t work in the Amputation Prevention Center; they have their own staff. At Rose, we do a monthly case conference where most of the cath lab staff and the staff from the Amputation Prevention Center come together and review cases, discuss the patients, and what treatments were performed. Everyone can see what happened from the beginning, how Dr. Mehta worked on the patient, and what the outcome is. It helps the group work together, because everyone involved is seeing the patients at different points of treatment.
How are these cases in terms of the lab setup?
Andrew: It was a little adjustment period, but as you get going, you learn better what you need. The other staff would help bring in equipment. We don’t keep everything in the room; we wait until we know if we are going to need it, such as the laser, which is a large piece of equipment that we don’t bring in until we know we are going to use it. The laser has a 10- to 15-minute setup time, but everyone works together very well, which is helpful.
Heather: The lab staff likes new procedures, and likes to learn and be involved in new things. Rose Medical Center is building three new cath labs, and part of the reason for that is we have a really engaged staff. When our doctors want to try a new procedure, the staff is always on board and as Dr. Mehta noted, Rose Medical Center will send staff for training or to conferences so they can continue to learn and be up to date on the latest studies and information. Half our battle is that we have an incredible staff that want to do that and we have really great doctors that work very well together. You don’t see that at every lab. At Rose, I think it is a true testament to why things keep going well, and why we want to do more and different interventions.
Your three new labs will be in the same location?
Heather: Yes. We will close down the two cath labs we have in order to open three brand-new labs. In the next few months, they will be up and running.
Did the work of the Amputation Prevention Center help grow your volume?
Heather: Yes. We have also employed our own physicians and are hiring new physicians. Much of that has really helped the volume at Rose. We are trying to become a cardiac center of excellence and are working on different accreditations. Vascular procedures have been one reason the lab continues to grow, month after month.
Andrew: All of our rooms are capable of anesthesia, because with sick patients, they sometimes have a hard time lying still in a two-hour case. We can have anesthesia come in and make them comfortable and relaxed. Probably 20 to 30% of our patients have anesthesia, but it is also available on an as-needed basis. If we are assessing the patient and the nursing staff or the physician thinks that the patient needs it, we make a phone call, anesthesia comes over that day, and the case is done the same day. The case is never delayed or postponed for that reason. Anesthesia is very accommodating.
Is the Amputation Prevention Center involved in teaching?
Dr. Mehta: In the next few months, we will start teaching courses at our center specifically designed around patients with critical limb ischemia. We are working with industry to get that up and running.
Can you tell us about patient education?
Dr. Mehta: There are three aspects. First is wound prevention, further wound prevention, and foot care — chronic podiatric visits, if patients with chronically poor flow need the podiatrist to trim their toenails, etc. The second and biggest is smoking cessation, and showing patients that ongoing smoking increases the risk of amputation nine-fold, a profound increase. The third is both education for patients as well as other providers that critical limb ischemia is not necessarily a one-stop treatment. These patients often require repeat intervention before they heal, because below-knee patency rates are so fairly low across the board if we are looking out a year. We schedule patients fairly regularly for follow-up — at the most, every 4-6 weeks until their wound heals, so we can repeatedly assess vascular patency in the office, and then even after they are discharged with a healed wound, I will see patients in my private office yearly as a check-in, to make sure nothing new has arisen.
Is medication adherence an important aspect?
Dr. Mehta: Yes, and for me, the addition of working with advanced practice providers has helped, because we have been able to address medication adherence with more than one provider, every visit or every other visit. Often I’ll switch out with my nurse practitioner, Maggie Bast. Maggie and I can approach the patient somewhat differently and from different angles.
What do you see going forward for your center and the field as a whole?
Dr. Mehta: From our standpoint, we’d like to see more community awareness and growth of our Center, because we are dedicated to the process. From a field standpoint, there is a lot of ongoing research and data as the field tries to improve below-knee patency rates for vascular interventions. We have greatly improved patency rates for what we do above the knee, but below the knee, we are still troubled. My hope is that in the next five years, we figure out a more durable approach to peripheral vascular disease below the knee.
Are patients arriving with accompanying coronary artery disease?
Dr. Mehta: It is a mix. Up to a third of these patients will have significant coronary disease, often not previously recognized, because these patients tend not to be ambulatory and don’t exercise to the point where they get angina. Because this is a systemic disease, we also see patients where it is the opposite, where we took care of their heart attack, and found out they had wounds and hadn’t seen anybody.
Do you have advice for other facilities who might want to start up an Amputation Prevention Center?
Dr. Mehta: Treating critical limb ischemia isn’t something to dabble in — and this goes to everybody working in the field. When we look at our wound care specialists and our podiatrists, this is a big part, if not the vast majority of, their practice. They have said, we want to become wound specialists. Our cath lab staff has taken time out of their lives to go to various courses around the country, with hospital support, to get extra training and bring that knowledge back to the Center. From an interventional standpoint, treating critical limb ischemia patients is a very hard thing to do if you are going to do a case a month of limb salvage. It’s going to be long. This has to be a passion and a big part of life that is dedicated to this subfield.
What do you think turned you in that direction?
Dr. Mehta: Community need. I was trained to do vascular interventions, but there wasn’t, at the time I trained, a lot of limb salvage or below-the-knee work being done. Over the first few years I was in practice, I realized there was a void, despite being in a big city, in the treatment of critical limb ischemia. It was what the patients and community needed.