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经股动脉经导管主动脉瓣植入术中完全经皮入路与外科入路的比较:来自多中心注册研究的结果。

Complete percutaneous approach versus surgical access in transfemoral transcatheter aortic valve implantation: results from a multicentre registry.

机构信息

1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland

出版信息

Kardiol Pol. 2018;76(1):202-208. doi: 10.5603/KP.a2017.0205. Epub 2017 Nov 13.

DOI:10.5603/KP.a2017.0205
PMID:29131296
Abstract

BACKGROUND

Although the femoral approach is the most common route utilised in transcatheter aortic valve implantation (TAVI), it still carries a substantial risk of severe bleeding and vascular complications.

AIM

The aim of our study was to compare the safety and efficacy of the complete percutaneous (CPC) approach with surgical cut-down and closure (SCC) in TAVI patients.

METHODS

The study population comprised 683 patients with severe aortic stenosis, who underwent transfemoral TAVI. Bleeding and vascular complications were defined according to the Valve Academic Research Consortium (VARC-2) criteria. Propensity-matched cohorts were created to reduce the potential bias of non-random assignment to the type of vascular access technique (SSC, n = 203 vs. CPC, n = 203).

RESULTS

The rate of minor vascular complications was higher in the CPC cohort (18.2% vs. 9.9%, p = 0.02). There were no differences in major vascular complications or in any type of bleedings between the two groups. Age (odds ratio [OR] 1.044; 95% confidence interval [CI] 1.003-1.09, p = 0.046), preprocedural haemoglobin (OR 0.849; 95% CI 0.760-0.944, p = 0.03), and baseline estimated glomerular filtration rate < 30 mL/min (OR 3.216; 95% CI 1.176-8.741, p = 0.021) were independent predictors of life-threatening/disabling and major bleedings. Diabetes remained the only independent predictor of major vascular complications (OR 1.695; 95% CI 1.014-3.156, p = 0.046).

CONCLUSIONS

In this retrospective analysis both vascular access and closure techniques were associated with a similar risk of severe bleeding and major vascular events. However, these findings should be further confirmed in a multicentre, randomised study.

摘要

背景

尽管股动脉入路是经导管主动脉瓣置换术(TAVI)中最常用的入路,但它仍然存在严重出血和血管并发症的风险。

目的

本研究旨在比较经皮完全入路(CPC)与外科切开缝合(SCC)在 TAVI 患者中的安全性和疗效。

方法

研究人群包括 683 例严重主动脉瓣狭窄患者,均接受经股动脉 TAVI。根据 Valve Academic Research Consortium(VARC-2)标准定义出血和血管并发症。采用倾向性匹配队列研究来减少血管入路技术类型非随机分配的潜在偏倚(SCC,n=203 与 CPC,n=203)。

结果

CPC 组的轻微血管并发症发生率较高(18.2%比 9.9%,p=0.02)。两组之间在主要血管并发症或任何类型的出血方面均无差异。年龄(比值比[OR]1.044;95%置信区间[CI]1.003-1.09,p=0.046)、术前血红蛋白(OR 0.849;95%CI 0.760-0.944,p=0.03)和基线估计肾小球滤过率<30 mL/min(OR 3.216;95%CI 1.176-8.741,p=0.021)是危及生命/致残性和主要出血的独立预测因素。糖尿病仍然是主要血管并发症的唯一独立预测因素(OR 1.695;95%CI 1.014-3.156,p=0.046)。

结论

在这项回顾性分析中,血管入路和闭合技术均与严重出血和主要血管事件的风险相似。然而,这些发现需要在多中心、随机研究中进一步证实。

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