球囊主动脉瓣成形术的量效关系：来自日本全国多中心注册研究（J-SHD）的连续患者水平数据分析结果。
Volume-outcome relationship in balloon aortic valvuloplasty: results of a consecutive, patient-level data analysis from a Japanese nationwide multicentre registry (J-SHD).
机构信息
Department of Cardiology, Hyogo Prefectural Awaji Medical Center, Sumoto, Japan
Kobe University Hospital Clinical & Translational Research Center, Kobe, Hyogo, Japan.
出版信息
BMJ Open. 2023 Oct 17;13(10):e073597. doi: 10.1136/bmjopen-2023-073597.
OBJECTIVE
Transcatheter balloon aortic valvuloplasty (BAV) remains an important alternative treatment for severe, symptomatic aortic stenosis. With increasing numbers of BAVs being performed, the need for large-scale volume-outcome relationship assessments has become evident. Here, we aimed to explain such relationships by analysing consecutive, patient-level BAV data recorded in a prospective Japanese nationwide multicentre registry.
DESIGN
Prospective study.
SETTING
Data of 1920 BAVs performed in 200 Japanese hospitals from January 2015 to December 2019.
PARTICIPANTS
The mean patient age was 85 years, and 36.9% of procedures involved male patients.
METHODS
The efficacy of BAV was assessed by reducing the mean transaortic valve gradient after the procedure. We also assessed in-hospital complication rates, including in-hospital death, bleeding, urgent surgery, distal embolism, vessel rupture and contrast-induced nephropathy. Based on the distribution of case volume (median 20, IQR 10-46), we divided the patients into high-volume (≥20) and low-volume (<20) groups. In-hospital complication risk was assessed with adjustment by logistic regression modelling.
RESULTS
Indications for BAV included palliative/destination (44.2%), bridge to transcatheter aortic valve replacement (34.5%), bridge to surgical aortic valve replacement (7.4%) and salvage (9.7%). Reduction of the mean transaortic valve gradient was similar between the high-volume and low-volume groups (20 mm Hg vs 20 mm Hg, p=0.12). The proportion of in-hospital complications during BAV was 4.2%, and the incidence of complications showed no difference between the high-volume and low-volume groups (4.2% vs 4.1%, p=1.00). Rather than hospital volume, salvage procedure was an independent predictor of in-hospital complications (OR, 4.04; 95% CI, 2.03 to 8.06; p<0.001).
CONCLUSION
The current study demonstrated that procedural outcomes of BAV were largely independent of its institutional volume.
目的
经导管主动脉瓣球囊成形术（BAV）仍然是严重症状性主动脉瓣狭窄的重要替代治疗方法。随着 BAV 数量的增加，需要进行大规模的量效关系评估。在这里，我们旨在通过分析连续的、以患者为基础的 BAV 数据来解释这种关系，这些数据是在一个前瞻性的日本全国多中心登记处记录的。
设计
前瞻性研究。
设置
2015 年 1 月至 2019 年 12 月期间，200 家日本医院进行的 1920 例 BAV 的患者数据。
参与者
患者的平均年龄为 85 岁，36.9%的手术为男性。
方法
通过降低术后平均跨主动脉瓣梯度来评估 BAV 的疗效。我们还评估了住院期间的并发症发生率，包括住院期间死亡、出血、紧急手术、远端栓塞、血管破裂和造影剂肾病。根据病例量的分布（中位数 20，IQR 10-46），我们将患者分为高容量（≥20）和低容量（<20）组。使用逻辑回归模型进行调整后，评估住院期间并发症的风险。
结果
BAV 的适应证包括姑息/终末期（44.2%）、经导管主动脉瓣置换术桥接（34.5%）、外科主动脉瓣置换术桥接（7.4%）和抢救（9.7%）。高容量组和低容量组的平均跨主动脉瓣梯度降低相似（20mmHg 对 20mmHg，p=0.12）。BAV 期间的住院并发症比例为 4.2%，高容量组和低容量组的并发症发生率无差异（4.2%对 4.1%，p=1.00）。与医院容量相比，抢救手术是住院并发症的独立预测因素（OR，4.04；95%CI，2.03 至 8.06；p<0.001）。
结论
本研究表明，BAV 的手术结果在很大程度上与其机构容量无关。
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