Health Related Quality of Life Over Time After Revascularisation in Patients With Chronic Limb Threatening Ischaemia.

ABSTRACT

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) decreases life expectancy and impairs health related quality of life (HR-QOL). Revascularisation is needed to relieve ischaemia and salvage limbs. Although a major goal of CLTI treatment is maintaining QOL, little information is available about changes of HR-QOL over time after revascularisation. HR-QOL with survival after revascularisation for CLTI was assessed. METHODS: The clinical database of the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH), a prospective multicentre observational study, was analysed. Outcome measures were disease specific QOL per the Vascular Quality of Life (VascuQOL) questionnaire and the Short Form (SF) 36 evaluated generic QOL, which were assessed at baseline and three, 12, 24, and 36 months. The outcome measure was change of QOL from baseline. The minimally important difference (half a standard deviation from baseline) was used as the cut off point for improved, worsened, and unchanged QOL. RESULTS: Overall QOL was improved in 61% of patients for the VascuQOL and approximately 40% for the SF-36 component summaries at three months. However, these proportion gradually decreased to 21% - 31% at three years. In contrast, the proportion of deceased patients gradually increased over the three year follow up. Multivariable analysis revealed that pre-operative non-ambulatory status was inversely associated with improved QOL for the three month VascuQOL and SF-36 mental component summary, and surgical reconstruction was positively associated with these measurements. Advanced age and renal failure were inversely associated with improved QOL for the SF-36 mental component summary and VascuQOL at one to three years. CONCLUSION: Revascularisation improved QOL. However, patients with non-ambulatory status exhibited a negative association with improved QOL at three months, and advanced age and renal failure limited benefits one to three years after revascularisation. Accumulating QOL data will be essential for post-revascularisation QOL estimation. Pre-operative assessment, including estimated QOL, is important in shared decision making for patient oriented outcomes in the treatment of CLTI patients.