Dun Chen, Weaver M Libby, Bose Sanuja, McDermott Katherine M, Deery Sarah E, Black James H, Siracuse Jeffrey J, Columbo Jesse, Hicks Caitlin W
Department of Biomedical Informatics and Data Science, The Johns Hopkins University School of Medicine, Baltimore, MD; Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD.
Division of Vascular and Endovascular Surgery, University of Virginia, Charlottesville, VA.
Ann Vasc Surg. 2025 Oct;119:14-28. doi: 10.1016/j.avsg.2025.04.116. Epub 2025 Apr 29.
The efficacy of intravascular ultrasound (IVUS) for improving outcomes of peripheral vascular interventions (PVIs) has not been well studied. We aimed to evaluate the association of IVUS with long-term outcomes in patients undergoing PVI for claudication.
We conducted a two-cohort study using data from 100% of Medicare fee-for-service claims (2018-2022) and the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network (VISION; 2016-2019). For both cohorts, we identified all patients who underwent an index (first-time) femoropopliteal PVI for claudication, excluding patients with chronic limb-threatening ischemia (CLTI) and acute limb ischemia. We compared IVUS use over time and by procedure type and setting. We used multivariable Cox proportional hazards models to assess the associations of IVUS with repeat PVI, conversion to CLTI, and amputation. For the Medicare cohort, adjustments were made for baseline patient characteristics, while for the VISION cohort, additional adjustments were made for detailed anatomic factors. All models were clustered by physician.
In the Medicare dataset, 69,092 patients (median age 74 years; 40.5% female; 12.1% non-Hispanic Black) underwent an index femoropopliteal PVI for claudication, of whom 22.1% (N = 15,253) received IVUS. In the VISION dataset, 6,722 patients (median age 72 years; 38.7% female; 11.6% non-Hispanic Black) underwent an index femoropopliteal PVI for claudication, of whom 3.8% (N = 254) received IVUS. The mean follow-up time for both cohorts was 2.7 years. For both the Medicare and VISION cohorts, IVUS use significantly increased over time, particularly in ambulatory surgery center/office-based laboratory settings and in conjunction with atherectomy procedures (P < 0.001). In the Medicare cohort, IVUS use was associated with a higher hazard of repeat PVI (adjusted hazard ratio [aHR] 1.07, 95% CI 1.02-1.12) and progression to CLTI (aHR 1.11, 95% CI 1.03-1.20) after adjustment compared to PVI without IVUS. In the VISION cohort, there were no significant differences in outcomes between IVUS and non-IVUS cases (all, P > 0.05).
The use of IVUS for the treatment of claudication is rapidly increasing, without clear benefits in outcomes. The role of IVUS in treating claudication deserves further investigation.
血管内超声(IVUS)改善外周血管介入治疗(PVI)结局的疗效尚未得到充分研究。我们旨在评估IVUS与因间歇性跛行接受PVI患者的长期结局之间的关联。
我们进行了一项双队列研究,使用了100%的医疗保险按服务收费索赔数据(2018 - 2022年)以及血管质量倡议血管植入监测与介入结局网络(VISION;2016 - 2019年)的数据。对于这两个队列,我们确定了所有因间歇性跛行接受初次(首次)股腘动脉PVI的患者,排除慢性肢体威胁性缺血(CLTI)和急性肢体缺血患者。我们比较了IVUS随时间、手术类型和手术地点的使用情况。我们使用多变量Cox比例风险模型评估IVUS与重复PVI、转为CLTI以及截肢之间的关联。对于医疗保险队列,对基线患者特征进行了调整,而对于VISION队列,还对详细的解剖因素进行了额外调整。所有模型均按医生进行聚类。
在医疗保险数据集中,69092例患者(中位年龄74岁;40.5%为女性;12.1%为非西班牙裔黑人)因间歇性跛行接受了初次股腘动脉PVI,其中22.1%(N = 15253)接受了IVUS。在VISION数据集中,6722例患者(中位年龄72岁;38.7%为女性;11.6%为非西班牙裔黑人)因间歇性跛行接受了初次股腘动脉PVI,其中3.8%(N = 254)接受了IVUS。两个队列的平均随访时间均为2.7年。对于医疗保险和VISION队列,IVUS的使用随时间显著增加,尤其是在门诊手术中心/基于办公室的实验室环境中以及与旋切术联合使用时(P < 0.001)。在医疗保险队列中,与未使用IVUS的PVI相比,使用IVUS与重复PVI的更高风险(调整后风险比[aHR] 1.07,95% CI 1.02 - 1.12)以及进展为CLTI(aHR 1.11,95% CI 1.03 - 1.20)相关。在VISION队列中,IVUS组和非IVUS组的结局无显著差异(所有P > 0.05)。
IVUS用于治疗间歇性跛行的使用正在迅速增加,但在结局方面没有明显益处。IVUS在治疗间歇性跛行中的作用值得进一步研究。