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经导管主动脉瓣置入术患者中血管内超声评估天然瓣膜指标的准确性:初步结果

Accuracy of Intravascular Ultrasound Evaluation for the Assessment of Native Valve Measures in Patients Undergoing TAVI: Preliminary Results.

作者信息

de Cillis Emanuela, Dachille Annamaria, Giardinelli Francesco, Acquaviva Tommaso, Bortone Alessandro Santo

机构信息

Institute of Cardiac Surgery, University of Bari, Bari, Italy.

出版信息

Surg Technol Int. 2016 Oct 26;29:201-206.

Abstract

INTRODUCTION

Transcatheter aortic valve implantation (TAVI) technique represents a real revolution in the field of interventional cardiology and medicine, in particular for the treatment of severe aortic valve stenosis in elderly patients or in patients when the periprocedural risk for the traditional surgical option is considered too high, as an alternative to the traditional aortic valve replacement. Although experience on the valves of the last generation is still limited in terms of time, the data currently available are definitely moving in the direction of a minimum hospital mortality (1%) as well as a drastic reduction in the incidence of complications when compared to the devices of the previous generation. Finally, the evolution of specified materials of the newest generation have greatly enhanced safety and efficacy of TAVI procedures in the last years. In order to ensure the selection of the most appropriate valve and the success of the procedure, the role of cardiac imaging (computed tomography scan evaluation and angiography) is crucial. These examinations require the use of contrast medium in patients suffering from renal dysfunction at the baseline. The need for fluoroscopy and angiography using contrast agents to aid positioning of the valve may lead to contrast-induced nephropathy (CIN) as one form or one etiology of acute kidney injury (AKI), which is associated with increased morbidity and mortality. The aim of our study is to investigate the accuracy of intravascular ultrasound (IVUS-a technique which does not need contrast) for the assessment of native valve measures in patients undergoing TAVI by comparing values obtained with IVUS to those ones previously obtained in the same patients with computed tomography (CT) scans.

MATERIAL AND METHODS

We enrolled 25 consecutive patients (10 males, average age 81.3±5,1 years) who underwent TAVI with femoral access in our Cardiac Surgery Cath-Lab (University of Bari) from January to October 2015 (Logistic EuroSCORE 21.6±15.4%; STS score mortality 20.9±14.9%). Each patient scheduled for TAVI underwent coronary angiography and high resolution angio-CT in order to obtain a complete evaluation (diameters, perimeters, and areas at annulus level, -3mm level, +15mm level, height of coronary ostia, shape, and conformation of left ventricle outflow tract, conformation, and calcifications of aortic and ileo-femoral axis) to choose the most suitable prosthetic aortic valve for each patient. In all patients, during the procedure (before the prosthetic valve implantation), we executed a manual IVUS pullback (from left ventricle outflow tract to ascending aorta) by using a 7F IVUS probe (Volcano Corporation, San Diego, CA). On the recorded IVUS pullback, a second operator (who did not know the values obtained by CT measurements) identified the aortic annulus and, at this level, measured: minimum and maximum diameter; perimeter; derived perimeter, and area. The t-student test has been used to compare the averages of these IVUS values to the CT ones. A p value< 0.05 was considered as statistically significant.

RESULTS

Independently from the kind and size of implanted prosthetic valve, no statistical differences were found when the averages of all considered parameters (obtained both with CT and IVUS) were compared. The following are the results obtained: minimum diameter (CT: 19,62mm±1,10 vs. IVUS: 19,55mm±1,40; p=0.41); maximum diameter (CT: 24,73mm±2,42 vs. IVUS: 25,9mm±1,80; p=0.08); perimeter (CT: 72,05mm±4,36 vs. IVUS: 73,32mm±6,09; p=0.164); derived perimeter (CT: 22,94mm±1,40 vs. IVUS: 23,32mm ± 1,95; p=0,198); and area (CT: 3,99cm2 ±0,97 vs. IVUS: 4,06 cm2 ± 0,47; p=0,073) (Figs. 1-3).

CONCLUSIONS

These preliminary data suggest accurate IVUS measures when compared to CT in the evaluation of valve parameters considered (minimum and maximum diameters, area, perimeter, and derived perimeter at the annulus level). In order to confirm these findings and to give them statistical significance, it will be necessary to increase the sample size.

摘要

引言

经导管主动脉瓣植入术(TAVI)技术代表了介入心脏病学和医学领域的一场真正革命,特别是对于老年患者或传统手术选择的围手术期风险被认为过高的患者,作为传统主动脉瓣置换术的替代方法,用于治疗严重主动脉瓣狭窄。尽管就时间而言,关于上一代瓣膜的经验仍然有限,但目前可用的数据肯定朝着最低医院死亡率(1%)以及与上一代设备相比并发症发生率大幅降低的方向发展。最后,近年来最新一代特定材料的发展极大地提高了TAVI手术的安全性和有效性。为了确保选择最合适的瓣膜并确保手术成功,心脏成像(计算机断层扫描评估和血管造影)的作用至关重要。这些检查需要在基线时对肾功能不全的患者使用造影剂。使用造影剂进行荧光透视和血管造影以辅助瓣膜定位的需求可能导致造影剂肾病(CIN),作为急性肾损伤(AKI)的一种形式或病因,这与发病率和死亡率增加相关。我们研究的目的是通过比较血管内超声(IVUS,一种不需要造影剂的技术)与之前在同一患者中通过计算机断层扫描(CT)获得的值,来研究IVUS在评估接受TAVI患者的天然瓣膜尺寸方面的准确性。

材料与方法

我们纳入了2015年1月至10月在我们的心脏外科导管实验室(巴里大学)通过股动脉途径接受TAVI的25例连续患者(10例男性,平均年龄81.3±5.1岁)(逻辑欧洲评分21.6±15.4%;胸外科医师协会评分死亡率20.9±14.9%)。每位计划接受TAVI的患者均接受冠状动脉造影和高分辨率血管CT检查,以获得完整评估(瓣环水平、-3mm水平、+15mm水平的直径、周长和面积、冠状动脉开口高度、左心室流出道的形状和结构、主动脉和髂股轴的结构及钙化情况),为每位患者选择最合适的人工主动脉瓣。在所有患者中,在手术过程中(人工瓣膜植入前),我们使用7F IVUS探头(Volcano Corporation, San Diego, CA)进行手动IVUS回撤(从左心室流出道到升主动脉)。在记录的IVUS回撤图像上,另一名操作人员(不知道CT测量获得的值)识别主动脉瓣环,并在此水平测量:最小和最大直径;周长;衍生周长和面积。使用t检验比较这些IVUS值与CT值的平均值。p值<0.05被认为具有统计学意义。

结果

无论植入的人工瓣膜的类型和大小如何,比较所有考虑参数(通过CT和IVUS获得)的平均值时均未发现统计学差异。以下是获得的结果:最小直径(CT:19.62mm±1.10 vs. IVUS:19.55mm±1.40;p = 0.41);最大直径(CT:24.73mm±2.42 vs. IVUS:25.9mm±1.80;p = 0.08);周长(CT:72.05mm±4.36 vs. IVUS:73.32mm±6.09;p = 0.164);衍生周长(CT:22.94mm±1.40 vs. IVUS:23.32mm ± 1.95;p = 0.198);面积(CT:3.99cm² ±0.97 vs. IVUS:4.06 cm² ± 0.47;p = 0.073)(图1 - 3)。

结论

这些初步数据表明,与CT相比,IVUS在评估所考虑的瓣膜参数(瓣环水平的最小和最大直径、面积、周长和衍生周长)时测量准确。为了证实这些发现并使其具有统计学意义,有必要增加样本量。

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