Background: Critical limb ischemia (CLI) is the clinical manifestation of severe peripheral artery disease presenting as rest pain (RP) and tissue loss (TL). Most studies compare CLI as a homogenous group with claudication with limited database studies specifically studying these differences. We hypothesize that CLI should be stratified into RP and TL because of significant differences in disease severity, comorbidities, and outcomes.
Methods: The American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2016 was reviewed. All patients with a postoperative diagnosis of CLI undergoing femoral to popliteal bypass (FPB) with vein or graft were identified. Patients were stratified into cohorts based on International Classification of Disease (ICD)-9 or ICD-10 codes for RP or TL (gangrene or ulcer). Univariate and multivariate analyses were performed to examine 30-day mortality, morbidity, major amputation, and readmission adjusting for demographics, comorbidities, and procedural details.
Results: There were 5,304 patients. Compared to RP, patients with TL were older (P < 0.0001) and more likely to be dependent (P < 0.0001). TL patients were also more likely to have diabetes (P < 0.0001), congestive heart failure (P < 0.0001), renal failure (P = 0.004), dialysis (P < 0.0001), history of wound infection (P < 0.0001), and sepsis (P < 0.0001). TL patients had higher American Society of Anesthesiologists class (P < 0.0001), were less likely to be transferred from home (P < 0.0001), and more likely to receive an FPB with vein (P = 0.03). Patients with TL had worse perioperative outcomes compared with RP in terms of pneumonia (P = 0.004), unplanned intubation (P = 0.009), cardiac arrest requiring cardiopulmonary resuscitation (P = 0.003), bleeding requiring transfusions (P < 0.0001), sepsis (P < 0.0001), septic shock (P = 0.02), and reoperation (P < 0.0001). TL was associated with significantly higher 30-day morbidity (P < 0.0001), 30-day mortality (P < 0.0001), major amputation (P = 0.0004), and readmission rates (P = 0.005). Patients with TL compared with those with RP also had longer hospital stays (P < 0.0001) and days between operation to discharge (P < 0.0001). TL was independently associated with increased 30-day morbidity (OR: 1.16 [1.00-1.35]) and major amputation (OR: 2.48 [1.29-4.76]) compared with RP.
Conclusions: Patients with RP and TL have drastic differences that impact perioperative mortality and readmissions. TL is an independent predictor of 30-day morbidity and major amputation. The stratification of CLI into RP and TL can provide insight into variations in outcomes and provide a means to quantify the risks associated with the 2 manifestations of the disease.
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