key: cord-299124-g70v4crs
authors: Lancaster, Elizabeth M.; Wu, Bian; Iannuzzi, James; Oskowitz, Adam; Gasper, Warren; Vartanian, Shant; Wick, Elizabeth; Hiramoto, Jade; Eichler, Charles; Lobo, Errol; Reyzelman, Alexander; Reilly, Linda; Sosa, Julie A.; Conte, Michael S.
title: Impact of the COVID-19 pandemic on an academic vascular practice and a multi-disciplinary limb preservation program
date: 2020-09-12
journal: J Vasc Surg
DOI: 10.1016/j.jvs.2020.08.132
sha: 
doc_id: 299124
cord_uid: g70v4crs

With the aggressive resource conservation necessary to face the COVID-19 pandemic, vascular surgeons face unique challenges to managing the health of their high-risk patients. Early analysis of patient outcomes following pandemic-related practice changes suggest that patients with chronic limb threatening ischemia (CLTI) have been presenting with more severe foot infections and are more likely to require major limb amputation compared to 6 months prior. As our society and health care system adapt to the new changes required in the post-COVID era, it is critical that we pay special attention to the most vulnerable subsets of patients with vascular disease, particularly those with CLTI and limited access to care.

The outbreak of a novel strain of coronavirus, (SAR-CoV-2) 1, 2 , in December 2019 resulted in 14 restructuring of the delivery of health care in the United States, both to preserve resources for 15 anticipated large volumes of patients critically ill with COVID-19, and to mitigate disease 16 spread. As a consequence, patient care classified as non-urgent at the outset of the pandemic was 17 deferred and in-person outpatient physician interaction was largely replaced. These changes pose 18 particular challenges to the care of patients with chronic limb threatening ischemia (CLTI) 19

because of the risk of clinical deterioration, the importance of physical examination in patient 20 assessment, and the need for hemodynamic and imaging studies to direct treatment. The Division of Vascular Surgery, housed within the UCSF Department of Surgery, is comprised 7 of 9 full time faculty, 3 clinical fellows, and 5 advanced practice providers, with 6 8 general/vascular surgery residents and 2-6 medical students rotating on service at any time. 9

Faculty, fellows, and residents provide care for vascular patients at the main UCSF campus as 10 well as two partner hospitals; the San Francisco Veteran Affairs (SFVA) Medical Center and 11

Zuckerberg San Francisco General Hospital (ZSFG, a safety net/community hospital). In (Table I) . Patients with CLTI with gangrene, major tissue 4 loss, advanced ischemia or infection (WIfI [Wound Ischemia foot Infection] stage 4) were 5 categorized as Tier 3 (the most urgent cases) and given scheduling priority, while those with rest 6 pain or a minor ulcer were Tier 2B and scheduled pending operating room availability. Tier 1 7 and 2A cases were deferred until adequate resources were secured and in accordance with local 8 public health guidelines. 9

Using this triage system, the overall case volume within the Division of Vascular Surgery 11 decreased by 46% from baseline in the first week, then by 74% from baseline for the following 12 two weeks. Since April 22nd, when non-urgent cases (including Tier 2A and some Tier 1 cases) 13

were allowed to be selectively added back to the surgical schedule, case volume has increased to 14 approximately 80% of baseline at our main hospital ( Figure 1A ). At the main University 15

Hospital the proportion of cases performed for lower extremity revascularization (lower 16 extremity bypass or endovascular interventions) increased from 31% of total operative volume at 17 baseline to 42% of operative volume from March 15-May 16, 2020, however the absolute 18 number of limb revascularization cases were similar between the two intervals. 19 20 While all of our hospitals (UCSF, SF VA Medical Center, and ZSFG) were swift and effective in 21 reducing case volumes initially, each has had a different experience in resuming non-urgent 22 surgical care. For instance, at the VA Medical Center, case scheduling protocols are guided by 23 regional and national leadership teams, rather that institutional leadership, as is seen at UCSF. 1

This has led to a much slower resumption of operative cases at the VA, as demonstrated in 2 Figure 1A . instructed to cancel or convert to telehealth all appointments that did not absolutely require 7 inpatient visits. In addition, public health messaging instructed citizens to delay "non-essential" 8 medical visits during the high-risk period. Providers prioritized in-person clinic visits for patients 9 with advanced lower extremity peripheral artery disease (PAD) with concern for CLTI (e.g. new 10 tissue loss), given that physical examination and vascular studies are essential for evaluation. 11

Patients in need of dialysis access, particularly with prior failed access, also were seen in person, 12 as were post-operative patients requiring physical examination. Patients with foot wounds 13 requiring ongoing wound care were still seen by the podiatry team in our Limb Preservation 14

Clinic. Those with aneurysmal and carotid disease, particularly when asymptomatic, were 15 encouraged to have necessary imaging performed locally and were seen virtually to obtain a 16 focused history. All routine surveillance visits were otherwise deferred for three months. Family 17 members were not allowed to accompany patients to clinic visits unless deemed medically 18 necessary and with special clearance. 19 20 Compared to standard clinic patient volumes, in-person visits across all three care sites were 21 reduced by 84% within two weeks, and 70% of visits were conducted by phone or video. 22

Vascular lab volume decreased in parallel by 75% across all three sites ( Figure 1B ). Since the 23 J o u r n a l P r e -p r o o f beginning of shelter in place orders, the proportion of lower extremity arterial duplex and 1 toe/ankle pressures performed by the vascular lab has remained relatively stable, however 61% 2 of studies performed during this period were in the inpatient setting, compared to only 34% prior 3 to the pandemic. Because assessing wounds through a video stream is challenging, if not 4 impossible, there has been a persistent rate of in-person clinic visits for patients in the Limb 5

Preservation Program, although still decreased by more than 40% from baseline ( Figure 1C) . 6

This was a combination of decline in new referrals as well as established patients not showing, 7

cancelling, or rescheduling their follow-up visits. 8 9 Like many specialties, we have continued to work to find the best way to resume outpatient care; 10 balancing the needs for in-person patient visits and patient/provider safety. We have 11

implemented social distancing policies in our clinic and continue to operate at a reduced capacity 12 to ensure these policies can be enforced. Currently our visits remain approximately 30-50% 13 virtual and at 50-70% of our normal pre-pandemic volume. 14

To evaluate the early effects of the pandemic on patients with CLTI, we compared the WIfI 17 staging for all CLTI patients admitted to our main university hospital from March 15, 2020 18 through May 15, 2020 to a baseline cohort from 6 months prior (September 1, 2019 through 19

October 31, 2019). Additionally, we determined the overall number of amputations performed at 20 our main university hospital and the SF VA Medical Center for the same time periods. This 21 investigation was approved by the UCSF Institutional Review Board. 22

patients, particularly those with PAD, have issues with poor compliance, and studies have shown 1 that intensified center-based care provided by a vascular medicine group can improve outcomes. 4 2

In addition to deleterious effects from delaying diagnoses/operations, it is possible that deferring 3 clinic visits could affect patient compliance with important medical therapies and lifestyle 4 interventions, leading to compromised outcomes. We are concerned that this may be especially 5 true with regards to patients with CLTI that require regular in-person evaluation and frequent 6 interventions to prevent adverse outcomes such as major limb amputation. 5-7 7 8 Our results align with other early studies demonstrating increased amputation rates and 9

peripheral artery disease severity in the setting of the COVID-19 pandemic. 8, 9 Recent 10 publications outside of vascular surgery suggest we are not alone in our observation of negative 11 pandemic-related effects. A recent study found that weekly rates of hospitalization for acute 12 myocardial infarction decreased by 48% during the pandemic, suggesting that emergent patient 13 needs are likely not being addressed. 10 In addition, numerous studies have found an increase in 14 diabetic foot wounds and complications since the onset of the pandemic. 11, 12 15 16

We hypothesize the observed increase in major amputation is due to delayed presentation and 17 changes in regular surveillance mechanisms caused by both limited hospital capacity as well as 18 patient reluctance to travel and interact with the health care system. We did not experience an 19 inability to admit CLTI patients requiring hospital-level care during this period, nor was there a 20 lack of access to the operating room for high priority limb revascularization procedures. Notably, While further research is needed to understand the root causes of these differential outcomes and 7 identify the optimal ways to address them, it is clear that more attention (and outreach) must be 8 paid to patients with severe PAD. Virtual clinic appointments and telehealth remain an effective 9 care option for a subset of our patients, particularly those with aortic aneurysms or carotid artery 10 stenosis, however there is a more limited role for virtual appointments in the Limb Preservation 11

Clinic and for patients with limited technology resources. Attempting to maintain care for some 12 of the most vulnerable patients, the Limb Preservation podiatry fellow has been assessing 13 patient-sent digital images of wounds to triage and provide guidance on when patients need to be 14 seen in clinic or evaluated urgently. In addition, UCSF Health is taking proactive measures to 15 encourage patients with high risk conditions to seek care when appropriate and needed. This 16 includes reassurance about safety measures, phone and video follow-up targeting high risk 17 patients, and direct communications with referring providers about the reopening of services. 18

Finally, the adaptations being made during the pandemic present opportunity to improve care 19 delivery and resource utilization in CLTI that may be accelerated. For example, adaptation and 20 implementation of recently developed remote limb monitoring tools such as biosensors 13 and 21 "Smart Socks" 14 represent methods for providing safe and effective care for patient with CLTI 22 amidst the drastic changes in health care necessitated by the COVID-19 pandemic. The field 23 would benefit by testing and improving specific remote monitoring and telehealth tools 1 applicable to patients with limited access to care and who are at risk for limb loss. 2 3

Despite challenges unique to the vascular surgery patient population, coordinated efforts based 5 on best available evidence allowed for rapid modification of care pathways across a tertiary care, 6 multi-hospital academic vascular surgery practice during a pandemic. As our society and health 7

care system adapts to the new changes required in the COVID era, it is critical that we pay 8 special attention to the many vulnerable subsets of the vascular surgery population, particularly 9 those with CLTI and limited access to care. The recent acute increase in major amputations we 10 have witnessed is a concerning trend that requires a strategic response from each practice, health 11 system and public health sector. Further study is needed to understand the underlying causes and 12 the most effective ways to mitigate negative outcomes now and prevent them in the future. J o u r n a l P r e -p r o o f Above knee amputation 1 4

Trans-metatarsal amputation 10 7 Other minor amputation 10 13 Major:minor amputation ratio 0.3* 0.7* * Statistically significant difference between pre-COVID and post-COVID (p<0.05) OR, operating room; CLTI, chronic limb threatening ischemia;

J o u r n a l P r e -p r o o f

Understanding of COVID-19 based on current 16 evidence

Center-based patient care enhances survival of elderly patients suffering from peripheral arterial 2 disease

Outcomes of neuroischemic wounds treated by a multidisciplinary amputation prevention 5 service

Society 7 for Vascular Surgery limb stage and patient risk correlate with outcomes in an amputation 8 prevention program

Determinants of midterm functional outcomes, wound healing, and resources used in a hospital-11 based limb preservation program

An increased severity of peripheral arterial disease in the COVID-19

Impact of the COVID-19 lock down strategy on vascular surgery practice: more major 16 amputations than usual

Pandemic and the Incidence of Acute Myocardial Infarction

Affects the Delivery of Care for Patients With Diabetic Foot Ulcers. Diabetes Care

Diabetic Foot Problems During the COVID-19 Pandemic in a Tertiary Care Center: The 2 Emergency Among the Emergencies. Diabetes Care

Tissue-Integrating Oxygen Sensors: Continuous Tracking of Tissue Hypoxia

Fiber-Based Smart Textile (Smart Socks) to Manage Biomechanical Risk Factors Associated

With Diabetic Foot Amputation