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经导管主动脉瓣置换术在射血分数较低的患者中是一种安全的选择:来自意大利经导管球囊扩张瓣膜置换术登记研究(ITER)的结果。

Transapical aortic valve replacement is a safe option in patients with poor left ventricular ejection fraction: results from the Italian Transcatheter Balloon-Expandable Registry (ITER).

机构信息

Division of Cardiac Surgery, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.

Department of Surgical Sciences, Città della Salute e della Scienza, Molinette, University of Turin, Turin, Italy.

出版信息

Eur J Cardiothorac Surg. 2017 Nov 1;52(5):874-880. doi: 10.1093/ejcts/ezx227.

Abstract

OBJECTIVES

The most commonly used accesses for transcatheter aortic valve implantation (TAVI) are the transfemoral (TF-TAVI) and the transapical (TA-TAVI) ones. There are concerns about TA-TAVI use in patients with reduced left ventricular ejection fraction (LVEF). The aim of this retrospective multicentre study was to compare the outcomes of TA-TAVI and TF-TAVI in patients with poor LVEF.

METHODS

Patients with LVEF ≤35% were included in the analysis. Data were obtained from the Italian Transcatheter Balloon-Expandable Registry (ITER), which enrolled patients undergoing TAVI with the Sapien bioprosthesis in 33 national centres. Patients were divided into 2 groups according to the access: TA or TF. A multivariable logistic regression analysis was performed in order to evaluate whether the type of approach (TA and TF) has an impact on outcomes.

RESULTS

Between 2007 and 2012, 1882 patients were enrolled in the Registry. LVEF ≤35% was found in 208 (11.1%) patients. TA-TAVI and TF-TAVI were performed in 69 (33.2%) and 139 (66.8%) patients, respectively. Overall 30-day mortality was 11.6% and 7.9% in TA and TF patients, respectively (P = 0.45). Overall Kaplan-Meier survival was significantly higher in the TF-TAVI group (log rank: P = 0.003). Age [odds ratio (OR) 1.066, P = 0.016], creatinine (OR: 2.301, P < 0.001), preoperative permanent pacemaker (OR: 4.662, P = 0.035) and TA approach (OR: 2.577, P = 0.006) were identified as independent predictors of overall mortality at follow-up. However, the TA approach resulted an independent variable of mortality only 3 years after TAVI.

CONCLUSIONS

TAVI yields good results in patients with depressed LVEF. Age, preoperative creatinine and preoperative pacemaker are independently associated with mortality. The TA access is associated with mortality only after 3 years of follow-up, thus probably reflecting a worse general clinical status of these patients.

摘要

目的

经导管主动脉瓣植入术(TAVI)最常用的入路是经股(TF-TAVI)和经心尖(TA-TAVI)。TA-TAVI 在心衰射血分数(LVEF)降低的患者中使用存在顾虑。本回顾性多中心研究的目的是比较 LVEF 降低患者中 TA-TAVI 和 TF-TAVI 的结局。

方法

本分析纳入 LVEF≤35%的患者。数据来自意大利经导管球囊扩张瓣膜植入注册研究(ITER),该研究纳入了 33 个国家中心 3313 名接受 Sapien 生物瓣 TAVI 的患者。患者根据入路分为两组:TA 或 TF。采用多变量逻辑回归分析评估方法(TA 和 TF)是否对结局有影响。

结果

2007 年至 2012 年,登记处共纳入 1882 例患者。LVEF≤35%的患者有 208 例(11.1%)。TA-TAVI 和 TF-TAVI 分别在 69 例(33.2%)和 139 例(66.8%)患者中进行。TA 和 TF 组 30 天死亡率分别为 11.6%和 7.9%(P=0.45)。总体 Kaplan-Meier 生存曲线显示 TF-TAVI 组明显更高(对数秩检验:P=0.003)。年龄[比值比(OR)1.066,P=0.016]、肌酐(OR:2.301,P<0.001)、术前永久起搏器(OR:4.662,P=0.035)和 TA 入路(OR:2.577,P=0.006)是随访期间全因死亡率的独立预测因素。然而,TA 入路仅在 TAVI 后 3 年是死亡率的独立变量。

结论

TAVI 在心衰射血分数降低的患者中取得了良好的结果。年龄、术前肌酐和术前起搏器与死亡率独立相关。TA 入路仅在随访 3 年后与死亡率相关,可能反映了这些患者的一般临床状况较差。

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