Ponukumati Aravind S, Columbo Jesse A, Jarmel Isabel, Mulley Albert G, Suckow Bjoern D, Goodney Philip P, Scali Salvatore T, Stone David H
Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Geisel School of Medicine at Dartmouth, The Dartmouth Institute for Health Policy and Clinical Practice, Hanover, NH.
Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Geisel School of Medicine at Dartmouth, The Dartmouth Institute for Health Policy and Clinical Practice, Hanover, NH; Department of Surgery, Geisel School of Medicine at Dartmouth, Hanover, NH.
J Vasc Surg. 2025 Jun;81(6):1430-1439.e8. doi: 10.1016/j.jvs.2025.01.215. Epub 2025 Feb 4.
The growing prevalence of diabetes and concomitant peripheral arterial disease (DM/PAD) has led to an increase in patients at risk for adverse limb events in current practice. Despite a widespread perception that minor amputation may result in both limb salvage and preserved functionality, the natural history of minor amputations remains unknown. Thus, we sought to quantify the rates of subsequent major amputation and survival among DM/PAD patients with any prior minor amputation.
We performed a retrospective cohort study using US Medicare claims from 2007 to 2019. We included patients with DM/PAD based on International Classification of Diseases, 9th and 10th editions, diagnosis codes. We excluded patients lacking continuous fee-for-service coverage or with incomplete demographic data. The primary exposure was prior minor (below-ankle) amputation. The primary outcome was major (above-ankle) amputation. Statistical analyses were performed using the Kaplan-Meier method and Cox proportional hazards modeling.
We identified 12,257,174 patients (age 73 ± 11 years; 48% male; 76% White) with DM/PAD. Of these patients, 2.2% (n = 274,225) underwent prior minor amputation. Patients with prior minor amputation were more likely to be male (63% vs 47%; P < .0001), Black non-Hispanic (17% vs 13%; P < .0001), and rural (25% vs 21%; P < .0001) than those without prior minor amputation. The 5-year Kaplan-Meier cumulative incidence of major amputation was 27% (n = 58,613) of patients with prior minor amputation, compared with 1.4% (n = 129,872) of patients without prior minor amputation. After risk-adjustment, patients with prior minor amputations were 6.1-fold more likely to require a subsequent major amputation (hazard ratio, 6.11; 95% confidence interval, 6.04-6.18) compared with those without prior minor amputations.
This contemporary claims-based analysis demonstrates that approximately 25% of Medicare beneficiaries with DM/PAD and prior minor amputation will necessitate a major amputation within 5 years. Prior minor amputation carries a risk of major amputation comparable with de novo tissue loss and is a stronger predictor than any demographic or socioeconomic exposure. These results help to inform both clinical decision-making and anticipated real-world outcomes among those at greatest risk for limb loss.
在当前临床实践中，糖尿病和伴发的外周动脉疾病（DM/PAD）的患病率不断上升，导致发生肢体不良事件风险的患者数量增加。尽管人们普遍认为小截肢术可能既能挽救肢体又能保留功能，但小截肢术的自然病程仍不明确。因此，我们试图量化既往有过小截肢术的DM/PAD患者后续大截肢术的发生率和生存率。
我们使用2007年至2019年美国医疗保险理赔数据进行了一项回顾性队列研究。我们根据国际疾病分类第9版和第10版诊断编码纳入DM/PAD患者。我们排除了缺乏连续的按服务付费保险覆盖或人口统计学数据不完整的患者。主要暴露因素是既往小（踝关节以下）截肢术。主要结局是大（踝关节以上）截肢术。使用Kaplan-Meier方法和Cox比例风险模型进行统计分析。
我们确定了12257174例DM/PAD患者（年龄73±11岁；48%为男性；76%为白人）。在这些患者中，2.2%（n = 274225）曾接受过小截肢术。与未接受过小截肢术的患者相比，接受过小截肢术的患者更可能为男性（63%对47%；P <.0001）、非西班牙裔黑人（17%对13%；P <.0001）以及居住在农村地区（25%对21%；P <.0001）。既往接受过小截肢术患者的大截肢术5年Kaplan-Meier累积发生率为27%（n = 58613），而未接受过小截肢术患者为1.4%（n = 129872）。经过风险调整后，既往接受过小截肢术的患者需要后续大截肢术的可能性是未接受过小截肢术患者的6.1倍（风险比，6.11；95%置信区间，6.04 - 6.18）。
这项基于当代理赔数据的分析表明，约25%患有DM/PAD且既往接受过小截肢术的医疗保险受益人将在5年内需要进行大截肢术。既往小截肢术具有与新发组织缺失相当的大截肢术风险，并且是比任何人口统计学或社会经济因素更强的预测指标。这些结果有助于为肢体丧失风险最高人群的临床决策和预期的实际结局提供参考。
