Relationship between WIfI stage and quality of life at revascularization in the BEST-CLI trial

Jeffrey J. Siracuse, Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA. Electronic address: Jeffrey.Siracuse@bmc.org.
Vincent L. Rowe, Division of Vascular Surgery and Endovascular Therapy, University of Southern California, Los Angeles, CA.
Matthew T. Menard, Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Kenneth Rosenfield, Section of Vascular Medicine and Intervention, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Michael S. Conte, Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA.
Richard Powell, Division of Vascular and Endovascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
Leonardo C. Clavijo, Division of Cardiology, French Hospital Medical Center, San Luis Obispo, CA.
Kristina A. Giles, Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME.
Taye H. Hamza, HealthCore, Watertown, MA.
Max Van Over, HealthCore, Watertown, MA.
Mark Cziraky, HealthCore, Watertown, MA.
Christopher J. White, Department of Cardiology, Ochsner Clinical School, University of Queensland, Brisbane, QLD, Australia; Department of Cardiology, The John Ochsner Heart and Vascular Institute, New Orleans, LA.
Michael B. Strong, Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Alik Farber, Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA.

Abstract

OBJECTIVE: The WIfI (Wound, Ischemia, foot Infection) stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with the risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which can be multifactorial. We hypothesized that the severity of the limb threat (WIfI stage) would be associated with poor HRQoL among patients with CLTI presenting for revascularization. METHODS: The dataset of the BEST-CLI (best endovascular versus best surgical therapy in patients with CLTI) trial, a prospective, randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessments at patient enrollment. The HRQoL assessments included (1) Vascular Quality of Life; (2) 12-item short form survey (SF-12), containing the utility index score (short-form six-dimension R2 utility index, incorporating physical, emotional, and mental well-being) and mental and physical components; and (3) the EQ-5D. Multivariable regression analysis was used to identify the independent associations with the baseline HRQoL assessments. RESULTS: A total of 1568 patients with complete WIfI data were analyzed, of whom 71.5% were men. The WIfI distribution was 35.5% with stage 4, 29.6% with stage 3, 28.6% with stage 2, and 6.3% with stage 1. Patients presenting with WIfI stage 4, compared with stage 1 to 3, were more often men (74.9% vs 69.6%) and current smokers (25.4% vs. 17.6%), had had end-stage renal disease (13.3% vs 8.5%) and diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had had higher median morbidity scores (4 vs 3; P < .05 for all). On multivariable analysis, WIfI stage 4, compared with stage 1 to 3, was associated with lower SF-12 mental component scale scores (estimate, -2.43; 95% confidence interval, -3.73 to -1.13; P < .001) and short-form six-dimension R2 utility index scores (estimate, -0.02; 95% confidence interval, -0.03 to 0.001; P = .04). The WIfI stage was not independently associated with the baseline Vascular Quality of Life, SF-12 physical component scale, or EQ-5D assessments. CONCLUSIONS: WIfI stage was independently associated with poorer quality of life because of mental, rather than physical, health for patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with the greatest limb impairment.