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血管内治疗慢性闭塞性下肢动脉疾病的机构量和初步结果:来自日本全国登记处的报告。

Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry.

机构信息

Department of Cardiology, Nagoya Heart Center, Nagoya, Japan.

Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.

出版信息

J Endovasc Ther. 2024 Oct;31(5):975-983. doi: 10.1177/15266028231161242. Epub 2023 Mar 19.

Abstract

PURPOSE

Chronic total occlusion (CTO) remains as a major target for endovascular treatment (EVT) in improving symptomatic lower-extremity artery disease (LEAD). However, despite the technical demand and learning curve for the procedure, volume-outcome relationship of EVT targeted for CTO in symptomatic LEAD remains unclear.

MATERIALS AND METHODS

Data were obtained from a nationwide registry for EVT procedures limited to the Japanese Association of Cardiovascular Intervention and Therapeutics between January 2018 and December 2020 from 660 cardiovascular centers in Japan. In total, 96 099 patients underwent EVT for symptomatic LEAD, and 41 900 (43.6%) underwent CTO-targeted EVTs during the study period. Institutional volume was classified into quartiles. The association of institutional volumes with short-term outcomes was explored using the generalized linear mixed model using a logit link function, in which, interinstitution variability was used as a random effect.

RESULTS

The median institutional volume for all EVT cases per quartile was 29, 68, 125, and 299 cases/year for the first, second, third, and fourth quartiles, respectively. With each model analysis, the adjusted odds ratios (ORs) for technical success were significantly lower in patients who underwent EVT in institutions within the first quartile (<52 cases/year) than in the other quartiles ( < .01, respectively). On the contrary, the adjusted ORs for procedural complications were significantly higher in the first and second quartiles than in the third and fourth quartiles ( < .01, respectively).

CONCLUSION

In contemporary Japanese EVT practice, a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions.

CLINICAL IMPACT

EVT for CTO lesions is still challenging for clinicians because of difficulties of wire/devise crossing or high procedural complications rate. Our study demonstrated that a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. In contemporary Japanese practice, a higher institutional experience has better impacts on short-term clinical outcomes. Future research should determine the relationship between institutional volume and long-term clinical outcomes.

摘要

目的

慢性完全闭塞(CTO)仍然是改善症状性下肢动脉疾病(LEAD)的血管内治疗(EVT)的主要目标。然而,尽管该手术具有技术需求和学习曲线,但针对症状性 LEAD 中的 CTO 的 EVT 的量效关系仍不清楚。

材料和方法

数据来自于 2018 年 1 月至 2020 年 12 月期间在日本心血管介入治疗协会(Japanese Association of Cardiovascular Intervention and Therapeutics)的限制下,来自日本 660 个心血管中心的全国性 EVT 手术登记处。共有 96099 例患者因症状性 LEAD 接受 EVT 治疗,在研究期间,41900 例(43.6%)接受了 CTO 靶向 EVT。机构容量分为四分位数。使用广义线性混合模型,采用对数链接函数,使用机构间变异性作为随机效应,探讨机构容量与短期结果的关系。

结果

所有 EVT 病例的中位数机构容量分别为第一、二、三、四分位数的 29、68、125 和 299 例/年。在每个模型分析中,与其他四分位数相比,在第一四分位数(<52 例/年)接受 EVT 的患者的技术成功率的调整优势比(OR)明显较低(<.01,分别)。相反,第一和第二四分位数的调整 OR 与第三和第四四分位数相比,手术并发症的发生率明显更高(<.01,分别)。

结论

在当代日本 EVT 实践中,在涉及 CTO 病变的症状性 LEAD 患者中,较高的机构容量而不是操作人员的容量与更高的技术成功率和较低的手术并发症率相关。

临床意义

由于导丝/器械交叉的困难或较高的手术并发症发生率,CTO 病变的 EVT 对临床医生仍然具有挑战性。我们的研究表明,在涉及 CTO 病变的症状性 LEAD 患者中,较高的机构容量而不是操作人员的容量与更高的技术成功率和较低的手术并发症率相关。在当代日本实践中,较高的机构经验对短期临床结果有更好的影响。未来的研究应确定机构数量与长期临床结果之间的关系。

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