Out-of-Hospital Lower Extremity Intervention in Severe PAD: How the Right Equipment and Devices Support Limb Salvage

Can you tell us about your office-based lab (OBL)?

Liese Redd, Practice Manager: The Center for Vascular Intervention is located in Atlanta, Georgia, and began treating patients just over five and a half years ago. We have one procedure room and a pre and post recovery area with four bays. Almost exclusively, we see limb salvage patients who are suffering with end-stage disease, both arterial and venous. They are coming to us from wound care, have active wounds, and are elderly. Our work is focused on amputation prevention.

The model we have at our center for treating advanced peripheral vascular disease involves decisions around patient identification and risk management, and proactive disease surveillance and management. We hope to get ahead of this horrible end-stage disease that we are seeing so frequently. We recently joined Upperline Health to take what we have on a micro level — a multispecialty limb salvage team — and expand it to a macro level with a nationwide footprint. As part of the partnership with Upperline, we will be building facilities in Florida with additional sites in Georgia, Alabama, Tennessee, Kentucky, Indiana, and California.

Douglas Redd, MD: The hope of our partnership with Upperline Health is being able to move the time point of diagnosis back decades earlier in time where we should be managing patients medically with statins, blood pressure control, and risk reduction, rather than trying a “Hail Mary” procedure in attempt to save a patient from a below-the-knee or above-the-knee amputation.

What procedures are you performing on these advanced disease patients?

Dr. Redd: We treat advanced tibioperoneal and tibiopedal occlusive disease. We also take care of patients with arteriovenous or venous stasus ulcers, so we also perform venous imaging and treatments with endovenous laser therapy and sclerotherapy for venous disease. The majority of our patients are around 70 years old and diabetic. The first visit for a referred patient involves a complete physical and vascular exam. We do outpatient doppler ultrasound studies. These are patients with severely advanced disease that are coming in to see us as a second opinion before below-the-knee amputation, often categorized as desert leg or desert foot. The vast majority of our patients, probably 95%, are accessed with a retrograde pedal approach and the use of a 4 French (Fr) sheath. Femoral access cases for intervention are few and far between, but we use femoral access as necessary. We are using CO2 regularly for patients with renal issues. Every patient on the table receives digital intravascular ultrasound (IVUS) imaging (Philips). We almost exclusively use Philips laser atherectomy followed by plain balloon angioplasty for treatment. Interventions are all angiosome-targeted to the region of the patient’s wound. We perform tibioperoneal/tibiopedal intervention with pedal reconstructions as necessary for patients with ulcerations into the forefoot, for example. For follow-up, we use color doppler ultrasound imaging. We have a superb ultrasonographer, a very good vascular technologist.

Can you share more about the devices you use for diagnostic or interventional treatment?

Dr. Redd: In the cath lab, we have recently upgraded our system from a 9900 OEC C-arm (GE Healthcare) to a motorized C-arm (Philips), which has been critically important for ultrasound-guided pedal access of either the common plantar or dorsalis pedis artery. We start with a small-caliber sheath. Everyone receives IVUS and the vast majority of the patients undergoing an interventional procedure are managed with laser atherectomy. Within the below-the-knee area, the tibioperoneal arteries, we use the Tack Endovascular System (Philips) for tacking down flow-limiting dissections. With the technology and solutions that we have access to through Philips and some of their industry partners, we can perform iliac stenting from a pedal stick and very rarely need femoral access.

Liese: We have the new IntraSight Mobile IVUS System (Philips), and in the near future, we will be getting a Philips Laser System — Nexcimer — which is the newest generation of Philips lasers. In our five years of operation, we have used everything from Jetstream Atherectomy (Boston Scientific) to Diamondback Orbital Atherectomy (CSI), to the Crosser (BD), to Phoenix Mechanical Atherectomy (Philips), and have landed on the use of Philips laser atherectomy nearly exclusively at this point. We have excellent results. Patients are not having any issues with potential showering of micro emboli. We are not seeing any ‘trash foot’ issues from using this platform.

Dr. Redd: We have seen too many instances of distal embolization of micro emboli with rotational atherectomy. The vast majority of patients that we are seeing have a significant calcium burden. I have found that it is possible to avoid the downside of non target embolization of plaque with laser atherectomy and we now use it exclusively. The vast majority of the patients that we are seeing have markedly threatened distal runoffs; a typical patient has a single outflow vessel. Preservation is critical. I find that laser atherectomy allows us to avoid the consequences that we experienced too frequently with rotational or orbital atherectomy.

Liese: Laser atherectomy is elegantly simple to set up. All you have to do once the packaging is opened is plug it in. From the perspective of staff utilization, laser atherectomy is much simpler and much more reliable. You are not using ancillary products to run your system. There is no concern about having any particular wire or tubing, which means no additional ordering or scrambling because something is now backordered.

Dr. Redd: Another advantage to using laser is the catheter itself. It easily tracks over the guidewire. When you are going from a pedal approach, for example, you are often accessing the dorsalis pedis artery. When working up in the anterior tibial artery and going up and over the trifurcation, you often are confronted with a steep transition to the peroneal or posterior tibial. We found that with rotational or orbital atherectomy, when trying to move up and over that trifurcation, the apparatus is just poorly designed or not compliant for this type of transition. We have experienced embolized distal burr tips that have required retrieval. We can avoid all these issues with laser atherectomy. Prior to switching over to the Philips IVUS system, we had a drive shaft-driven IVUS system and experienced significant limitations in trying to get up and over a trifurcation from a pedal approach. We found the flexibility of the Philips laser system and devices to be absolutely fantastic.

Liese: To that point, since rotational atherectomy does not have a rear cutting burr, once we get through a tight lesion, which is very common in our patients, we occasionally would have to fight to get back through the initial opening that was created. This is not an issue with laser atherectomy, which we find to be very compliant in how it moves through the lesion.

Dr. Redd: Pedal access makes the flow and the turnover so much faster in an OBL, where you are trying to do multiple cases in a day. Not having the extended recoveries after a femoral stick is wonderful. Our average time in the procedure room runs between an hour to an hour plus 15 minutes. After 20 minutes of recovery, patients are discharged.

How do IVUS and laser atherectomy work together from the beginning to the end of a case to provide optimal care?

Liese: The Philips IntraSight Mobile IVUS System is user friendly, provides beautiful imaging, and the feedback and the data are invaluable. It is there for the many times when you realize that the ultrasound or the imaging done in clinic, or even the angiography, are not giving you the whole picture of the disease. Being able to see the internal disease process is helpful. From a staff standpoint, it is an easy system to use. You don’t have to hand off anything or handle any sort of sterile drive mechanism. Along with the IntraSight Mobile, we have the separate touchscreen, which is essentially a tablet that can be draped in a sterile fashion and run from the tableside. That is a real win. As mentioned, the majority of our patients are treated with laser atherectomy. We appreciate the simplicity of laser atherectomy; we just plug in, calibrate and go. It is so helpful to have such little downtime in terms of device preparation, both for IVUS and the laser. Those are minutes that a patient is not having undergo sedation or is able to get home more quickly. It is a wonderful time savings and reduced strain on the staff.

Are you using IVUS both pre and post procedure?

Dr. Redd: Yes. Being able to measure the size of the tibials, the superficial femoral artery (SFA), and popliteal arteries with IVUS allows us to more precisely guide our balloon selection for different vessel segments, thus avoiding the complications of dissection, especially in the tibial arteries, where there are few options. IVUS allows you to avoid the complications of vessel rupture, and can minimize the occurrence of dissection or at least limit the extent of the dissection. The last thing an operator in an OBL wants is a complication that requires sending the patient to the hospital for a bailout. For a flow-limiting dissection, we have found that the Tack Endovascular System works well. Post intervention, IVUS allows us to gauge the procedure endpoint and whether we have done enough to have a good revascularization.

Can you describe more of your standardized approach to lower extremity disease?

Dr. Redd: The paradigm that we use is ‘keep it simple’. We start with ultrasound-guided micropuncture access. We use a 4 or 5 Fr Prelude IDeal (Merit Medical) sheath in the foot. Once accessed, we do an initial diagnostic arteriogram. I start with a 21-gauge needle or, depending on the vessel, will use a 24-gauge Angiocath (BD). We start with a V-14 guidewire (Boston Scientific) and place the sheath. Once we get the V-14 up in the artery, we immediately use Philips Digital IVUS and image all the way from the dorsalis or common plantar up into the external iliac. We map out the entirety of the runoff and then direct our attention based on what we find. The vast majority of our patients have tibioperoneal disease. We rarely see an isolated, short SFA stenosis; those patients don’t come to us. We take care of patients with an interrupted wound vessel runoff to the foot. The population we are working in is all limb salvage.

What are the challenges for physicians who would like to start using pedal access?

Dr. Redd: It is important to be familiar with doppler ultrasound imaging. I myself am both holding the probe and accessing the vessel. I don’t have a vascular sonographer scrubbed in and doing ultrasound for me. I have been using ultrasound guidance for 30 years, having trained as a vascular interventional radiologist, and every one of my sticks is image-guided. To become comfortable with pedal access, you will need to accrue a hundred or so cases to obtain experience with the challenges of working inside small vessels. There may be limitations in terms of approaching different anatomy, but ultimately it involves just scrubbing in and doing it. Going to a mini fellowship where a physician can scrub in would be useful. We will be expanding our training program in the future. Spend a week with us in the lab and you will be able to take that skillset back to your home OBL.

Liese: Particularly with end-stage peripheral arterial disease, it is important to understand that patients end up with a lot of aberrant anatomy. There is so much collateralization of the distal arteries that you might think you are in a posterior tibial, for example, but suddenly you are up in the peroneal artery, because of either a collateral or an odd offshoot of the peroneal artery.

Can you share how being in an out-of-hospital setting affects your work?

Liese: There are massive benefits. Our phenomenal staff are like family and this feeling translates into our patient care. Many times, patients say, “I feel like I have not even come to a doctor’s office.” They enjoy coming to see us. If a person is suffering from a threatened limb, we can get them in very quickly. We have CRNAs along with nurse sedation, so we have a very broad coverage for different patient acuities in terms of sedation. We have had hundred-year-old patients on the table. With primary pedal access, we can sit the patients up at a 45-degree angle and adjust their position for comfort. We are able to treat patients who have been declined by other physicians due to their age with very minimal sedation, just local anesthesia. Patients do not have to experience femoral access, and soon after their procedure, they can go home with family and feel much better.

Dr. Redd: We kept the office open throughout the duration of the COVID pandemic. Patients are more comfortable coming to a nice, cozy outpatient lab than checking into a hospital, with registration and the hassles around hospital-based care delivery. It is much more convenient. We are a boutique service, dedicated to limb salvage, and have a large cohort of patients aged 80 to 100 within the southeastern United States.

Liese: Our infection rates are essentially zero. We do not deal with any sort of hospital or community-acquired infections. Patients are not getting bumped because another physician has a more urgent case. We feel we are practicing medicine the way it should be, instead of having to practice within an administrative formula of patient care. For the staff, we don’t work weekends or take late-night calls. We do elective, scheduled cases, with no calls and no weekends. Every single one of our employees has formally worked in a hospital setting.

Dr. Redd: It is a lifestyle choice and it is delightful to have that opportunity. We also offer ongoing long-term follow-up. I see every patient that I have taken to the cath lab back in the clinic at a week, at 6 weeks, or whatever is required. It will be a longitudinal follow-up for their lifetime, which offers continuity of care. I will see the same patients I have taken to the lab for years to come.

Liese: We educate patients that we are now part of their chronic care team. Just like with their nephrologist and their cardiologist, they will see us at least once a year.

Dr. Redd: Another thing about working in an OBL versus a hospital-based lab is that we have to be much more cognizant of our supply and equipment use. Every dollar you don’t spend is a dollar saved. We have a very spartan approach to device and supply utilization. If you are going to succeed financially in operating your own office-based lab, you need to be critically aware of the cost of every wire, your balloon choices, and how you can get an excellent result and not break the bank. We don’t have the pass-through ability that a hospital does in terms of all of those utilized supplies. We have advantageous price structures from our vendors. We have migrated almost exclusively to Philips in terms of IVUS and laser atherectomy.

Liese: We have good results with initial atherectomy and it is effective to use plain balloon angioplasty. There is also the cost of specialty balloons and the fact that you do not have any additional reimbursement for that product, which goes to the conversation about what you have to consider in an outpatient setting because you don’t get the hospital pass-through payments.

How has participating in the Philips SymphonySuite OBL and ASC Solutions program helped your lab?

Liese: First and foremost, all of the people that we work with at Philips are quality individuals. We value the relationships that we have developed with them, and how they have introduced us to other people in the industry and made introductions with other physicians. It is invaluable. We are also participating in the rewards program through SymphonySuite, called the Cadence program, where our utilization of product goes to assist in paying for our capital equipment. The Cadence program allowed us to upgrade our equipment without a big hit to the wallet. Currently, we are paying off our patient monitors that we got sometime last year. Once we pay off our monitors, the Cadence program allows us to bank those rebates. Being able to bring in and upgrade equipment without having to be concerned about the financial burden is fantastic.

As we move forward with Upperline Health, we will be using Philips SymphonySuite’s assistance in designing and building new labs. It is the whole package of having a partner like Philips who can advise on local peculiarities within markets and can help with the identification of appropriate lab sites. Then, as the equipment is being selected, Philips will make sure all the schematics are appropriate for the equipment. Upperline Health has an additional lab close to us that we eventually hope to move to. It is significant that Philips is there to make sure we are actually looking at the proper specifications for a fixed room, make sure that everything is correct in terms of the electronics and the control rooms, and then assist with the lab itself. It’s one thing to have a partner when we know what we are doing, but if you are a physician who is newly entering the market, partnering with Philips SymphonySuite would be incredibly helpful, because Philips will have so many of the answers to questions that essentially someone wouldn’t even know to consider. Philips SymphonySuite is an outstanding program on so many different levels.

We are proud of the team we have built. We now serve our community and understand the often-preached rhetoric by the endovascular community regarding chronic limb-threatening ischemia treatment. We have been able to make the dream a reality. 

This article is supported by Philips OBL and ASC Solutions.

To learn more, please visit Philips.com/SymphonySuite