Roundtable Discussion: COVID-19 and Lower Extremity Revascularization
How the onset of COVID-19 has affected patient selection, resources, staffing, and safety.
Even with guidance from societies and institutions, deciding whether a patient needs urgent below-the-knee (BTK) revascularization remains challenging in some cases. How have you decided where to draw that line, and which patients pose the most challenging decisions? Have there been any legal/governmental restraints in your region that influence your practice?
Dr. Gray: Our driving principle is a very pragmatic one: In the physician’s estimation, if the patient’s condition would materially deteriorate as a result of a delay in treatment of more than a few weeks, then we will bring that patient in for the procedure. Most, if not all, of these patients will have high-risk features for COVID-19, so that is not a stratifier, and most anatomies (but not all) will get an attempt at revascularization, so this again is a weak stratifier. We believe that any risk to the patient from coming to the hospital (which should be small given the precautions in place) should be considerably outweighed by the benefit of revascularization. Moreover, if we plan well, these patients can generally be discharged home on the same day, thus not further straining hospital resources. In my region, there really haven’t been any external constraints otherwise.
Dr. Gallagher: Our institution canceled all elective cases; however, throughout the pandemic, we have continued to treat patients with severe rest pain and tissue loss who are at risk of limb loss. We also perform all urgent limb ischemia cases that come in through the emergency department or as a transfer from other institutions in Michigan that have shut down or don’t have capacity or expertise.
Dr. Madassery: The majority of my outpatient practice is with critical limb ischemia (CLI) patients. Most are in wound care management, with some needing minor amputations and other treatments. I believe these patients are on the urgent scale of the many diseases we treat. We all know that delayed management and care of these patients leads to significant increase in the severity of their comorbidities and potential mortality. Therefore, I have continued to intervene on my limb salvage patients. One issue that has to be taken into consideration is whether it is prudent to have them undergo anesthesia if absolutely needed, due to the increased risk of underlying COVID-19 transmission during intubation. For me, if patients are in need of limb salvage, the necessity of evaluation and intervention is still warranted.
We are following the recommendations from our mayoral and gubernatorial offices regarding being selective of patients brought in for procedures and ensuring physicians deem their procedure as urgent. In general, I have found that while many patients are more than happy to hold off on their elective procedures, my CLI patients desire to still have their revascularization procedures performed because they understand the importance.
Dr. N’Dandu: To work within the restrictions instituted while still providing necessary care to our patient population, we have implemented tri-weekly meetings between the physicians, nurse practitioners, and department directors. Intensive care unit (ICU) patients with multiple preexisting comorbidities and a positive COVID-19 result are assessed at times on an hourly basis based on clinical presentation and acute decompensation. All outpatient cases are screened for COVID-19. If a decision is made to proceed with treatment, we document the clinical indications for each case, ensuring that we clearly state that delaying care will possibly lead to preventable limb loss.
Dr. Neville: When the crisis first hit, our system ratcheted things back in anticipation of the need for resources for the anticipated COVID-19 crisis moving forward, performing only emergent cases. Right away, we came up with a tiered system that included four levels: emergent (eg, septic limb); urgent, which should be done within 48 hours to 2 weeks (eg, CLI-related symptoms such as rest pain, tissue loss, gangrene); patients who could delay treatment for 4 to 6 weeks; and patients who could delay treatment for up to 3 months. This system was implemented prior to the society recommendations, although it dovetailed very well with the both the American College of Surgeons and the Society for Vascular Surgery guidelines. Tweaks were made, mostly related to dialysis rather than CLI. COVID-19 has not affected our decisions surrounding who to revascularize, who to treat with wound care, and what type of revascularization to perform.
Regarding legal/governmental restraints, our governor initially mandated that only emergent cases be performed, which I think was more of a resource utilization issue. I’ve had to make the case regarding treatment of CLI patients to our administrators, and some tier 2 cases have been undertaken with the argument that they might require more resources if we’d waited.
Dr. Patrone: CLI is the second-leading cause of death after lung cancer.1 Most CLI patients are diabetic and have diseased BTK vessels. In my institution, all patients with progressing tissue loss and lower limb ischemia have been treated, and we will continue doing this in the future. In patients with stable tissue loss and no signs of infection, revascularization has been put on hold and they are undergoing a strict follow-up. No legal/governmental restrictions are influencing our practice. Our diabetic foot clinic is running every day in the hospital, which has been reserved for “clean” patients.
During the period of COVID-19–related restrictions, has there been any change in your decision-making as to whether a patient in urgent need of revascularization should undergo an endovascular procedure rather than open bypass?
Dr. Gallagher: No, my indications for best treatment, which involve considerations such as patient comorbidities, location of disease, and conduit, have remained unchanged during the COVID-19 pandemic.
Dr. N’Dandu: COVID-19 has strengthened our multidisciplinary approach to CLI patients. We work very closely with interventional cardiology, interventional radiology, and vascular surgery. Thus far during the pandemic, we have treated every patient with an endovascular approach. Operating room (OR) availability has been significantly reduced, and we are all redeployed to different departments but are available to address any urgent needs that present. Urgent peripheral cases and CLI patients with progressing wounds are triaged prior to coming in, pretested, and placed in a special waiting area removed from the COVID-19 patient care areas. Interventions are performed using tibiopedal arterial minimally invasive and radial approaches, which allows patients to be discharged home the same day to minimize further risk of exposure. Revascularization strategies are discussed in advance to shorten case time. We use femoral nerve blocks with minimal conscious sedation, which in turn allows the patient to be discharged home the same day. Same-day discharges have reduced the use of beds to accommodate COVID-19 patients.
Dr. Madassery: The pandemic has not changed my approach to managing peripheral vascular disease with CLI, especially when deciding between endovascular versus surgical revascularization. If the patient is better suited for surgical revascularization, I send them immediately to my surgical colleagues who are also still revascularizing patients who need it. For patients with claudication, we are dealing with those patients with virtual visits, medical management, and follow-ups and reserving revascularization for a later time, if warranted clinically.
Dr. Neville: Our decision-making has not changed. We’re still revascularizing patients the way we think is best. What has changed is how to handle these patients in terms of testing, if they are COVID-19–positive, and their perioperative care. Currently, we are not routinely testing for COVID-19, but we are selectively testing based on an algorithm including recognized clinical criteria if the patient has symptoms such as cough, fever, or malaise. If this is the case, we would wait for the results to come back before making a decision to intervene or move forward using appropriate personal protective equipment (PPE).
Dr. Patrone: No, there has not been a change in our decision-making. Most of these patients are treated endovascularly anyway.
Dr. Ellozy: There are a number of factors that come into play when deciding between open and endovascular revascularization for an urgent indication in the current environment. The patient population that we’re treating is probably the most vulnerable to coronavirus infection. If a patient is coming in from home with urgent need of revascularization, there is a real concern that they would get exposed and possibly infected during their hospitalization. Anything that would shorten the period of exposure is potentially beneficial. There is also a concern for intubating a COVID-19–positive patient for surgery and the likelihood of being able to extubate them.
The patient’s disposition after hospitalization is also a consideration in terms of risk of exposure to coronavirus. It would certainly be better to send them home rather than to an acute rehabilitation center or long-term facility. There is clearly a benefit for a less invasive approach with a shorter hospital length of stay. If there is the possibility of treating a patient endovascularly and getting them through their acute issue, we can consider a more durable solution such as a distal bypass once the worst of the pandemic is over.
Dr. Gray: Because we generally have taken an endovascular-first approach even before COVID-19, there really hasn’t been much of a change. Surgical bypass is obviously effective assuming adequate conduit availability, but given the longer length of stay for bypass, it makes sense to preferentially offer an endovascular approach in a resource-constrained (nursing, PPE, etc) environment during the COVID-19 pandemic.
If you have encountered patients with both severe BTK disease and COVID-19, how was this scenario managed?
Dr. N’Dandu: Patients are triaged on a clinical status and emergent basis. COVID-19 patients are restricted to a dedicated procedure room where a locked supply of proper PPE is available for both staff and patients. Patient care is clustered for safety, and patients are given N95 masks to prevent the possibility of spreading the virus. Closed-circuit patients on ventilators are required to have in-line suctioning in place, and all noninvasive ventilated patients have a viral filter attached at all times.
Dr. Patrone: One patient scheduled for long superficial femoral artery recanalization (necrotic tip of the first toe) was swabbed due to a cough and found to be positive for COVID-19 despite being clinically well. Because the patient was in his early 80s, affected by multiple comorbidities, required general anesthesia, and did not have extensive tissue loss/threatened limb, we decided to wait 2 more weeks before swabbing him again and eventually proceeding with treatment to minimize the risks of postprocedural complications, as agreed with the anesthesia team.
Dr. Neville: Interestingly, to my knowledge, we haven’t had to intervene on a COVID-19–positive CLI patient. However, we have treated COVID-19–positive patients with acute limb ischemia who have had arterial thrombotic events.
Dr. Gallagher: We have continued to treat these patients if they have severe rest pain/tissue loss in the same fashion as prior to the pandemic.
Dr. Madassery: We test every patient who comes to our procedural platform for COVID-19, and as of late-April, none of the revascularization patients I have intervened on have been positive with the virus. They are all also screened for any symptoms or sick contacts. That being said, we do not know if they could be potentially false negative from the test or not presenting with enough viral load to be positive. If they were positive, depending on their clinical situation, I would determine to intervene or not.
What measures have your team put in place to ensure its own safety despite challenges in keeping sufficient PPE on hand?
Dr. Ellozy: Initially when the pandemic struck New York City in early to mid-March, we made adjustments to our call schedule. We went to a weekend model where one person would be on call for the entire group. The call was a week at a time. Vascular surgery was felt by the Department of Surgery to be an essential service, as vascular emergencies would continue to come in. Initially, we were protected from being redeployed to other duties outside of the purview of vascular surgery. However, the situation evolved fairly rapidly. As the demand on the system increased, two of our partners were redeployed to the ICU and three of us continued with full-time vascular coverage.
Soon after the start of the pandemic, we were tasked with creating a line service. The goal was to provide 24/7 coverage and to decant some of the work for the intensivists in the hospital. We structured our call for the line service as separate from our vascular call, and we included some of our partners who have a full-time vein practice and are not on the general vascular call. There is one senior surgery resident covering the line service and they carry the pager. The attending coverage during the day from 6:00 AM to 6:00 PM is by the vascular surgery service. The coverage at night is by the in-house acute care surgeons. This has been a relatively successful model. At the peak, we were probably putting in 20 lines a day, but at this point, the number has gone down somewhat.
In terms of PPE, we’ve been reusing the N95 masks but otherwise have sufficient PPE. We are practicing social distancing, or perhaps more accurately physical distancing, to limit our own risk of infecting each other. We have a daily Zoom meeting for the division to check in and make sure there are no issues. Our office staff are working from home, and we’ve embraced telemedicine for follow-up of our patients.
For the OR setup, we’ve had to make adjustments because many of our ORs were converted to ICUs to handle the overflow of COVID-19 patients. We are using one of the neurointerventional suites as our angio suite. We have set up anterooms for intubation, which are separate from the main OR. The institution has come up with specific guidelines for donning and doffing PPE as well as a workflow for transporting and intubating COVID-19 patients.
Dr. Gray: We have designated one lab and one electrophysiology room for COVID-19 cases only. We have “platooned” our cath lab staff wherever possible, both as an acknowledgment that there is not as much elective work to do and also to keep teams of staff healthy in case of inadvertent exposure. Other sites in our region had to completely shut their labs early in the course of the COVID-19 pandemic because most staff had been exposed to a patient who was not previously identified as having COVID-19, and we wanted to avoid this fate. Fortunately, we have not had a PPE issue with surgical masks, and like many institutions, we are resterilizing N95 masks.
Dr. Patrone: We are trying to minimize the presence of unnecessary staff in the hospital, and we have stopped all nonelective cases. Our meetings are conducted with chairs 2 m apart. Some of the nursing staff have been reassigned to support intensive therapy unit needs/bereavement.
Dr. Gallagher: We have moved to a Lombardy model where we are splitting teams. We have also designated two of our ORs as COVID-19 OR rooms, and thus, all patients that have not been ruled COVID-19–negative are treated in these negative-pressure rooms.
Dr. Madassery: As an interventional radiology service line, we have a variety of disease processes we manage; therefore, we still have a moderate volume of procedures we perform daily. Therefore, we have instituted methods to keep all staff members and trainees on a periodic rotation of doing procedures and available as backup to limit exposure to the virus. At Rush, our hospital system has done an excellent job of maintaining adequate PPE for us and keeping us abreast daily of the system-wide virus situation. Some changes have been reduced anesthesia teams and keeping all anesthesia cases in one procedure room, which is important because those cases present patients and staff with the highest virus transmission risks. All positive patients or “patients under investigation” are treated with proper N95s, face shields/goggles, and donning/doffing techniques.
Dr. N’Dandu: Our department designated one specific COVID-19 room with the same call team on for the entire week to limit multistaff risk of exposure. PPE has been carefully distributed by the same designated staff member to prevent misuse or loss of essential PPE. All equipment has been removed from the COVID-19–designated room and is brought in on a case-by-case need. Each case has one designated staff member to be a runner for supplies to minimize the risk of cross-contamination. The COVID-19 room sterilization process, which all team members partake in, includes hourly wipe downs, clear communication between the staff about contamination or precautions, and environmental department and light treatments between patients. A checks-and-balances system has been set up whereby each staff member has a buddy who triple-checks that all PPE is in place and appropriately fitted before each case.
Dr. Neville: Many of our ORs and ICUs have been converted to negative pressure rooms to care for COVID-19 patients. Our health system actually expended quite a bit of resources and has taken a fairly significant financial stake in outfitting and reoutfitting our facility for COVID-19 in terms of capability and staffing. Staff has been retrained. Our vascular unit has been dedicated to COVID-19 patients, so our vascular cases have been moved to a different unit. The safety of the staff in these settings is critical, and as mentioned previously, we have developed a tiered system for treatment, so hopefully we’re not exposing people to nonurgent exposures. We have specific strategies and protocols for both the COVID-19–positive patient and the patient under investigation, which includes testing and the use of PPE. For patients taken to the OR for intubation, we have a dedicated intubation team of anesthesiologists who are not considered at high risk for COVID-19.
Have you encountered any device or drug shortfalls as a result of reps not having physical presence in your facility? How is this scenario being mitigated?
Dr. Patrone: No, we have been using an automatic reordering system called H-track for the past 2 years, so we haven’t encountered any problems with product availability.
Dr. Ellozy: Luckily, we have not encountered any device shortfalls during the current pandemic. I think this may be partially related to the fact that our case volume has decreased significantly. Although the device reps are not physically present, they are available.
Dr. Gray: The supply of endovascular devices has not been an issue—we don’t have difficulty sourcing them, and we are not using as many!
Dr. N’Dandu: Effective planning for future scheduled cases and communication on possible devices or education needs are addressed in advance between physicians, the charge nurse, lead tech, and reps. A drop-off system has been implemented, and a clean COVID-19–free area for equipment and supplies has been created. We use virtual calls during cases where clinical expertise on products is needed during this time when reps cannot be physically available.
Dr. Madassery: We have not experienced any shortfalls thus far. We have excellent relationships and communication between the physicians and our industry partners, as well as with supply chain and platform managers to keep our equipment adequately stocked. Many reps periodically make sure we have everything we need, which also keeps things in check for us.
Dr. Gallagher: No, I have not had trouble reaching the reps, who are able to get ahold of devices.
How is your practice preparing for the likelihood of a surge of cases once restrictions are lightened? Are you expecting these cases to be more severe on average due to the need to delay nonurgent cases?
Dr. Gallagher: We have already begun to see patients who have waited to be seen for their CLI/limb ischemia symptoms. They are presenting with more severe disease, and we are treating them as expeditiously as possible.
Dr. Madassery: We are aware there will likely be a surge of patients needing elective procedures scheduled when the crisis resolves. As it is, our schedulers have been tentatively scheduling patients for after the current expected stay-at-home orders from the regional governing bodies. We are fortunate to have a large number of interventional suites, and I believe we will be able to take on the volume of patients requiring intervention. There may be some delays based on what the patient or referring physician may anticipate; however, we will address all patients requiring care in a prioritized manner.
Dr. Neville: There are three parts to this answer: telemedicine, systems-wide utilization, and appropriate triage. We are now embracing telemedicine wholeheartedly, especially for the initial visit. I think that telemedicine is now here to stay, one of the positive developments that has come out of this crisis and maybe pushing us forward where we should have been. Telemedicine will give us the opportunity to triage more people and interact with more people from remote areas. As a result, we have designed protocols for when they should be seen, such as getting a vascular lab study on-site.
To manage the demand, we will have to look across our health care system to optimally use all the resources in the system. Another positive thing may be a look at the resources across health care systems to determine the capacity to handle the influx of patients.
Once mandates are relaxed, we will have to determine a triage system for patients, which would likely be similar to the tier system I mentioned previously. We are going to have to push our outpatient initiatives for care delivery.
Dr. N’Dandu: The staff has been staggered to prevent the potential for burnout in the anticipated upcoming case surge. To provide the best care for our patients during this time, our team has been medically managing symptoms and following patients closely with virtual visits. We have seen several patients present with more severe cases of CLI because they were afraid to come to the hospital, and we are constantly reassuring patients that we will safely take care of them.
Dr. Gray: A great question, the answer to which really won’t be known for a while. Intuitively, the deferment of known cases (of all types) and the lack of reporting of critical symptoms by patients concerned that a trip to the hospital is tantamount to vacationing in a leper colony would almost certainly lead to a sicker and more complex set of challenges for patients and treating physicians alike once restrictions are relaxed. Of note, in Europe, where they are a little ahead of us in reopening, they have noticed a reluctance of patients to come to the hospital. I would not be surprised if the same phenomenon occurring here will blunt whatever increased caseload we otherwise might anticipate. For the patients’ sake, I hope not. We are currently in the process of developing direct patient communications that will help educate patients as to the precautions being taken at our facilities around COVID-19 and the importance for them to have continued medical care.
Dr. Patrone: We expect to have a big backlog of nonurgent vascular patients. We potentiated our hot clinic, spreading the message to all the local general practitioners, and the patients can be directly referred without passing through the accident and emergency department. We think that this helps alleviate patient worry about reaching the hospital to get an urgent vascular opinion. Based on the cardiology and neurologic data that show 40% fewer events registered during this pandemic,2 we are sure that many CLI patients are also probably not keen on coming to the hospital to be seen because of the potential contamination risk. The isolation and lack of physical contact with family members and carers is also a potential threat for their symptoms to progress. Thus, we may face a peak of patients presenting with Rutherford 6 symptoms once the lockdown is over.
1. American Cancer Society. Cancer statistics center. https://cancerstatisticscenter.cancer.org/?_ga=2.39975970.1231753458.1537645337-1450708034.1537467257#!/. Accessed April 27, 2020.
2. Garcia S, Albaghdadi MS, Meraj PM, et al. Reduction in ST-segment elevation cardiac catheterization laboratory activations in the United States during COVID-19 pandemic [published online April 9, 2020]. J Am Coll Cardiol.