January 28, 2021

Impact of COVID-19 on CLTI Outcomes Evaluated

January 28, 2021—In a recent study of the impact of COVID-19 on outcomes in patients with chronic limb-threatening ischemia (CLTI) or diabetic foot infection (DFI), investigators found that patients treated during the pandemic had significantly delayed presentation with features of sepsis and worse primary patency and freedom from major adverse limb events (MALEs). The study by Zayed and Musajee et al was published online ahead of print in the Annals of Surgery.

Key Findings

Time from onset of symptoms to clinical presentation was significantly longer during the pandemic compared to the same period in 2019; however, time from presentation to intervention was significantly shorter.
Undergoing treatment during the pandemic was an independent predictor of worse primary patency and freedom from MALE.
AFS and limb salvage rates at 90 days were worse during the pandemic.

The investigators compared outcomes of patients with CLTI and DFI during the COVID-19 pandemic (period 2, March 15, 2020-May 30, 2020) and during the same period the previous year (period 1, March 15, 2019-May 30, 2019). Using a prospective database, data were collected on patient demographics, comorbidities, medications, nature of presentation, time between onset of symptoms to presentation, time from presentation to intervention, type of intervention, complications, and minor and major amputations. Laboratory results on admission and discharge, as well as procedural data including Rutherford stage (pre- and postintervention) and GLASS (Global Limb Anatomic Staging System) classification were also collected.

Primary outcome measures were amputation-free survival (AFS) and limb salvage rates. Secondary outcomes included time between onset of symptoms to presentation, time between presentation and intervention, freedom from clinically driven reintervention (CDR) in patients who underwent revascularization, freedom from MALE, and freedom from major adverse cardiovascular events.

A total of 234 patients were admitted for urgent or emergency intervention (139 in period 1 and 95 in period 2). Comorbidities were comparable between the two groups, with the exception of smoking and hypercholesterolemia, and patients were well matched regarding Rutherford stage (P = .25), anatomic level of arterial disease (P = .19), and overall GLASS classification (P = .38). There was no significant difference in radiographic evidence of osteomyelitis or gas in the soft tissues on presentation; however, white blood cell counts and C-reactive protein levels were significantly higher in patients treated in period 2 as compared with those in period 1 (P = .0014 and P = .004, respectively).

As compared with the period 1 group, the time from onset of symptoms to presentation was significantly longer for the period 2 group (median, 31 [range, 1-105] days vs 27 [range, 0-78] days; P = .017); however, time from presentation to intervention was significantly shorter (median, 3 [range, 0-61] days vs 5 [range, 0-65] days; P = .013).

Using Kaplan-Meier analysis to compare period 1 versus period 2, AFS at 90 days was 80% and 87% (P = .016), respectively, and limb salvage was 64% vs 72% (P = .41), respectively, in patients who underwent revascularization. Primary patency was significantly better in period 1 compared with period 2 (88% vs 60%; P = .003). Freedom from CDR and freedom from MALE were significantly worse in the period 2 group (83% vs 67% for period 1; P = .037 and 60% vs 46% for period 1; P = .034). A higher white blood cell count on admission (P = .018) and treatment during period (P = .003) were independent predictors of worse primary patency. Overall survival at 90 days was 85% in the period 1 group and 92% in the period 2 group (P = .41). Of note, five patients in the period 2 group tested positive for COVID-19.

Patients with CLTI and DFI in the period 2 group were more likely to have a significantly delayed presentation with raised inflammatory markers and had significantly worse freedom from CDR and freedom from MALE, according to the investigators. However, despite this delay in presentation, patients received treatment quicker, which could be attributed to the fact that capacity had been freed up due to the cancellation of elective procedures. Given these results, the investigators noted that it may be beneficial to establish COVID-19–protected pathways to care during any future COVID-19 waves to reduce perioperative complications in this high-risk cohort of patients.

ENDOVASCULAR TODAY ASKS…

We asked lead authors Hany Zayed, MD, and Mustafa Musajee, MMed, from Guy's and St Thomas' NHS Foundation Trust in London, United Kingdom, to expand on the results of the study:

What do the results of your study suggest about how to facilitate care of CLTI patients during future waves?

Previous studies have shown that patients with CLTI and DFI should be treated in a timely manner to avoid limb amputation and death. In this study, we noted that these patients continued to constitute the majority of the vascular workload during the pandemic. We also noted that these patients had significantly longer delays to access the necessary care during the pandemic compared to the same period the year before. It is therefore paramount to ensure that these patients who need time-critical limb- and life-saving interventions have rapid access to the necessary multidisciplinary expertise and adequate treatments. This involves maintaining fully functional urgent and emergency vascular services, including secure access to theatre facilities with endovascular capabilities during future pandemics. This would allow for adequate and timely interventions on these high-risk patients in order to achieve satisfactory AFS and limb salvage rates.

You noted in the discussion that restricted access to outpatient support may have contributed to the worse freedom from MALE in period 2. In your opinion, how can access to outpatient support be bridged despite the ongoing pandemic?

In the United Kingdom, the vascular service operates in a vascular hub-and-spoke model. The pandemic resulted in severe pressures on the outpatient services in the spoke hospitals and in the community due to either staff redeployment or sickness. This could be potentially addressed by adopting innovative approaches such as the virtual multidisciplinary foot clinics to support the patients in the spoke hospitals or in the community settings. This will facilitate timely reviews of patients and expedite their treatment as needed. Additionally, the establishment of one-stop “hot” clinics in the hub with access to same-day imaging facilities could be a useful option. These “hot” clinics could be used as a safety net accepting referrals from health care professionals in the community or spoke clinics if the local capacity gets overwhelmed. These alternative routes should be designed as COVID-19–free pathways to minimize the risk of infection in these fragile patients.

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