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.

中文翻译：

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慢性肢体严重缺血患者在血运重建后随时间推移的健康相关生活质量

客观的

慢性肢体威胁缺血 (CLTI) 会降低预期寿命并损害与健康相关的生活质量 (HR-QOL)。需要血运重建来缓解缺血和挽救肢体。尽管 CLTI 治疗的主要目标是维持 QOL，但关于血运重建后 HR-QOL 随时间变化的信息很少。评估了 CLTI 血运重建后的 HR-QOL 和生存率。

方法

对危重肢体缺血 (SPINACH) 患者的手术重建与周边干预的临床数据库进行了分析，这是一项前瞻性多中心观察性研究。结果指标是根据血管生活质量 (VascuQOL) 问卷和简表 (SF) 36 评估的一般 QOL 的疾病特定 QOL，这些 QOL 在基线和 3、12、24 和 36 个月时进行评估。结果测量是 QOL 相对于基线的变化。最小重要差异（与基线的一半标准偏差）用作改善、恶化和未改变 QOL 的分界点。

结果

三个月时，VascuQOL 的总体 QOL 提高了 61%，SF-36 的总体QOL 提高了大约 40%。然而，这些比例在三年内逐渐下降到 21% - 31%。相比之下，在三年的随访中，死亡患者的比例逐渐增加。多变量分析显示，术前非走动状态与三个月 VascuQOL 和 SF-36 精神成分总结的 QOL 改善呈负相关，而手术重建与这些测量值呈正相关。高龄和肾功能衰竭与 SF-36 精神成分总结和 VascuQOL 在一到三年内的 QOL 改善呈负相关。

结论

血运重建改善了 QOL。然而，不能走动状态的患者与三个月时 QOL 的改善呈负相关，而高龄和肾功能衰竭在血运重建后 1 到 3 年的益处有限。积累 QOL 数据对于血运重建后的 QOL 估计至关重要。术前评估，包括估计的 QOL，对于 CLTI 患者治疗中以患者为导向的结果的共同决策很重要。