1 Advanced Cardiac & Vascular Amputation Prevention Centers Grand Rapids MI.
2 Division of Interventional Radiology Miami Cardiac and Vascular Institute Miami FL.
J Am Heart Assoc. 2018 Aug 21;7(16):e009724. doi: 10.1161/JAHA.118.009724.
Background The optimal treatment for critical limb ischemia remains controversial owing to conflicting conclusions from previous studies. Methods and Results We obtained administrative claims on Medicare beneficiaries with initial critical limb ischemia diagnosis in 2011. Clinical outcomes and healthcare costs over 4 years were estimated among all patients and by first treatment (endovascular revascularization, surgical revascularization, or major amputation) in unmatched and propensity-score-matched samples. Among 72 199 patients with initial primary critical limb ischemia diagnosis in 2011, survival was 46% (median survival, 3.5 years) and freedom from major amputation was 87%. Among 9942 propensity-score-matched patients (8% rest pain, 26% ulcer, and 66% gangrene), survival was 38% with endovascular revascularization (median survival, 2.7 years), 40% with surgical revascularization (median survival, 2.9 years), and 23% with major amputation (median survival, 1.3 years; P<0.001 for each revascularization procedure versus major amputation). Corresponding major amputation rates were 6.5%, 9.6%, and 10.6%, respectively ( P<0.001 for all pair-wise comparisons). The cost per patient year during follow-up was $49 700, $49 200, and $55 700, respectively ( P<0.001 for each revascularization procedure versus major amputation). Conclusions Long-term survival and cost in critical limb ischemia management is comparable between revascularization techniques, with lower major amputation rates following endovascular revascularization. Primary major amputation results in shorter survival, higher risk of subsequent major amputation, and higher healthcare costs versus revascularization. Results from this observational research may be susceptible to bias because of the influence of unmeasured confounders.
背景 由于先前研究的结论相互矛盾,对于临界肢体缺血的最佳治疗方法仍存在争议。
方法和结果 我们从医疗保险受益人中获得了 2011 年首次确诊为临界肢体缺血的行政索赔数据。在未匹配和倾向评分匹配样本中,对所有患者以及首次治疗(血管内血运重建术、手术血运重建术或主要截肢术)进行了 4 年的临床结果和医疗保健成本估计。在 2011 年首次原发性临界肢体缺血诊断的 72199 例患者中,生存率为 46%(中位生存期 3.5 年),无主要截肢生存率为 87%。在 9942 例倾向评分匹配患者中(8%为静息痛,26%为溃疡,66%为坏疽),血管内血运重建术的生存率为 38%(中位生存期 2.7 年),手术血运重建术的生存率为 40%(中位生存期 2.9 年),主要截肢术的生存率为 23%(中位生存期 1.3 年;每种血运重建术与主要截肢术相比,P<0.001)。相应的主要截肢率分别为 6.5%、9.6%和 10.6%(所有两两比较均 P<0.001)。在随访期间每位患者的年费用分别为 49700 美元、49200 美元和 55700 美元(每种血运重建术与主要截肢术相比,P<0.001)。
结论 在临界肢体缺血管理中,血管重建技术的长期生存率和成本相当,血管内血运重建术的主要截肢率较低。与血管重建术相比,初次主要截肢术导致生存率更短、随后主要截肢术风险更高、医疗保健成本更高。由于未测量的混杂因素的影响,这项观察性研究的结果可能存在偏倚。