The Impact of the SARS-CoV-2 Pandemic on the Management of Chronic Limb-Threatening Ischemia and Wound Care
Authors: Vickie R. Driver DPM, MS, FACFAS, FAAWC, Kara S. Couch MS, CRNP, CWCN-AP, FAAWC, Kristen A. Eckert MPhil, Gary Gibbons MD, Lorena Henderson APRN, MSN, FNP-C, John Lantis MD, Eric Lullove DPM, Paul Michael MD FSCAI, Richard F. Neville MD FACS, Lee C. Ruotsi MD, ABWMS, CWS-P, UHM, Robert J. Snyder DPM, MBA, MSc, CWSP, FFPM RCPS (Glasgow), Fadi Saab MD, FASE, FSCAI, FACC, Marissa J. Carter PhD, MA
In the wake of the coronavirus pandemic, the Critical Limb Ischemia Global Society aims to develop improved clinical guidance that will inform better care standards to reduce tissue loss and amputations during and following the new SARS-CoV-2 era. This will include developing standards of practice, improve gaps in care, and design improved research protocols to study new chronic limb-threatening ischemia treatment and diagnostic options. Following a round table discussion that identified hypotheses and suppositions the wound care community had during the SARS-CoV-2 pandemic, the CLI Global Society undertook a critical review of literature using PubMed to confirm or rebut these hypotheses, identify knowledge gaps, and analyze the findings in terms of what in wound care has changed due to the pandemic and what wound care providers need to do differently as a result of these changes. Evidence was graded using the Oxford Centre for Evidence-Based Medicine scheme. The majority of hypotheses and related suppositions were confirmed, but there is noticeable heterogeneity, so the experiences reported herein are not universal for wound care providers and centers. Moreover, the effects of the dynamic pandemic vary over time in geographic areas. Wound care will unlikely return to pre-pandemic practices. Importantly, Levels 2–5 evidence reveals a paradigm shift in wound care towards a hybrid telemedicine and home healthcare model to keep patients at home to minimize the number of in-person visits at clinics and hospitalizations, with the exception of severe cases such as chronic limb-threatening ischemia. The use of telemedicine and home care will likely continue and improve in the post-pandemic era.
BKA: below-knee amputation
CDS: clinical decision support
CLI: critical limb ischemia
CLTI: chronic limb-threatening ischemia
CMS: The Centers for Medicare and Medicaid Services
DFU: diabetic foot ulcer
EMR: electronic medical record
ER: emergency room
ICU: intensive care unit
OR: operating room
PI: pressure injury
PAD: peripheral arterial disease
PPE: personal protective equipment
RCT: randomized controlled trial
SARS-CoV-2: severe acute respiratory syndrome coronavirus 2
WCWW: Wound Care Center Without Walls
WIfI: wound, ischemia, and foot infection
Chronic limb-threatening ischemia (CLTI) is a devastating condition found in 6.5 million patients in the United States, Japan, and Europe. The terminology change from the term critical limb ischemia (CLI) towards CLTI is to distinguish between CLI, which implies that there are minimum threshold values for impaired perfusion, and CLTI, which recognizes that the impaired perfusion occurs on a continuum. Previously, CLI, included hemodynamic data such as an ankle brachial index (ABI) of ≤ 0.3, absolute ankle pressure < 50 mmHg, a toe pressure < 30 mmHg, and toe brachial index < 0.3. The ABI can be falsely elevated in patients with diabetes; consequently, the original definition of CLI presented at an International Vascular Symposium in 1982 specifically excluded diabetics.
CLTI is the end stage of peripheral arterial disease (e.g., Rutherford Category 4–6 or Fontaine Class III and IV; peripheral arterial disease [PAD]) and is a clinical syndrome characterized by rest pain, gangrene, and ischemic ulceration and associated with limb loss and increased mortality. It is important to distinguish CLTI, a progressive and insidious process developing over weeks to months, from acute limb ischemia, typically occurring within 0–14 days and usually due to embolus or thrombosis. With diabetes, CLTI may present with ulceration and gangrene and no claudication or rest pain history. Revascularization is required to restore blood flow to the limb, and up to 75% of patients are indicated for endovascular therapy, but amputation rates remain unsettlingly high, with as many as 20% of patients requiring an amputation at 1 year. The mortality risk following diagnosis is 24% at 1 year and 60% at 5 years. Poor outcomes compound the reduced quality of life and high pain experienced by patients with CLTI, with 25% dead at 1 year and more than 60% dead at 5 years. Among European patients, male sex, obesity, the 65–67 year age group, and having high cholesterol and triglycerides have been found to be associated with a CLTI diagnosis.15 Amputation rates due to CLTI are disproportionately higher among racial and ethnic minorities. A univariate model was developed based on data collected from 88,346 White patients (7.2% of whom had a below-knee amputation [BKA]) and 23,115 Black patients (12.3% of whom had a BKA). Among both racial groups, 6465 patients also identified as Hispanic. Univariate analysis revealed that black race (odds ratio 1.93, 95% CI 1.84–2.03) and Hispanic ethnicity (odds ratio 1.62, 95% CI 1.51–1.73) had a significantly higher risk of having a BKA compared to the White reference group (p < 0.001). The financial costs of CLTI may be as high as $12 billion a year among Medicare patients.
Under normal circumstances, managing CLTI and preventing limb loss is extremely challenging. In addition to CLTI management, a multidisciplinary team approach can offer an intensive prevention strategy (that includes patient education, foot care, and therapeutic footwear) to avoid a significant number of amputations. The multidisciplinary team is part of the global transition from clinic-centred to patient-centric health care in chronic diseases that require involvement of multiple specialties. At the end of the 20th century, collaboration between vascular surgery and podiatry demonstrated economic benefit.
Since March 2020, health systems have been overburdened by the SARS-CoV-2 pandemic, with wound care sometimes being a casualty of lockdowns that deemed these potentially limb-preserving services to be ‘nonessential’. As of 21 October 2021, there have been more than 242 million confirmed global diagnoses of coronavirus and at least 4.9 million known global deaths. Yet the uncalculated toll of the SARS-CoV-2 pandemic on wound care may not be known for years to come, and a ‘pandemic within a pandemic’ is foreboding, with healthcare providers worried over future increases in mortality rates and amputations as a result of wound care centres closing, services being disrupted, and patients staying home and avoiding medical attention (and risk of SARS-CoV-2 infection).
Given the uncertainty over when the pandemic will end, the CLI Global Society Wound Care Committee began an important dialogue to understand the impact of SARS-CoV-2 pandemic on the CLTI population, especially with tissue loss, and analyze the available evidence regarding impact of the pandemic. Since health care will likely never return to prepandemic practices, the CLI Global Society aims to develop improved clinical guidance that will both inform better care standards to reduce tissue loss during the new SARS-CoV-2 era, develop standards of practice, improve gaps in care, and design improved research protocols to study new CLTI treatment and diagnostic options. Following a round table discussion that identified hypotheses and suppositions the wound care community had during the SARS-CoV-2 pandemic, the CLI Global Society Wound Care Committee undertook a critical review of literature to confirm or rebut these hypotheses, identify knowledge gaps, and analyse the findings in terms of what in wound care has changed due to the pandemic and what wound care providers need to do differently as a result of these changes.
Materials And Methods
The CLI Global Society Wound Care Committee organized a round table discussion on the likely impact of the pandemic on CLTI patients on 6 January 2021. The discussion was distilled into hypotheses and ancillary suppositions grouped by the following subjects: SARS-CoV-2 status, amputations, pressure injuries (PIs), patient visit frequency (outpatient wound care centres/clinics), telemedicine, and home health care.
A literature search was carried out on PubMed using the search string: (COVID impact) AND [(chronic limb-threatening ischemia) OR (critical limb ischemia) OR (ischemia) OR (amputations) OR (pressure wounds) OR (pressure injuries) OR (pressure ulcers) OR (wound care) OR (diabetic wounds) OR (diabetic ulcers) OR (outpatient services) OR (home healthcare) OR (telemedicine)] AND [(COVID-19) AND ((chronic limb-threatening ischemia) OR (critical limb ischemia) OR (ischemia) OR (amputations) OR (pressure wounds) OR (‘pressure wounds’ pressure injuries) OR (‘pressure injuries’ pressure ulcers) OR (‘pressure ulcers’) OR (wound care) OR (‘wound care’) OR (diabetic wounds) OR (diabetic ulcers) OR (outpatient services) OR (home health care) OR (telemedicine))].
We screened article abstracts for their relevance to CLTI, tissue loss, and/or wound care, and we included general articles about changes made to health care or other areas of medicine during the pandemic that could still be applicable to CLTI and wound care. Few articles were returned from our initial search that were relevant to the impact of COVID on home healthcare; therefore, we did a separate, more generalized search using the terms: home AND healthcare, for articles published since 2020, which then returned articles relevant to the pandemic.
We chose studies or papers mainly on content related to a hypothesis or supposition. Where there were choices, we focused on higher level of evidence studies (e.g., a full-length published cross-sectional study versus published correspondence or a research letter, or editorial). Pre-print articles not indexed on PubMed were not included. Each paper or study was rated according to the Oxford Centre for Evidence-Based Medicine scheme (Center for Evidence-Based Medicine – OCEBM Levels of Evidence) but was not assessed further.
Results, Discussion, Open Research, References
View complete publication including Results, Discussion, Open Research, and References by following the link below.
Wiley Online Library – Wound Repair and Regeneration / Volume 30, Issue 1: https://onlinelibrary.wiley.com/doi/full/10.1111/wrr.12975