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临床试验/NCT01694251
NCT01694251已完成不适用

Determination of Mitral Valve Area After Mitral Valve Repair Surgery for Mitral Stenosis Using 3-dimensional Transesophageal Echocardiography

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
mitral valve area determined by 3D planimetry

研究概览

简要总结

Even during mitral valve repair procedure (MVP) for severe mitral stenosis (MS), the intraoperative assessment of mitral valve area (MVA) is necessary for evaluating the severity of MS before the repair and excluding residual MS for immediate determination of the success of the repair procedure and postoperative prognosis. For this purpose, several methods have been applied by introperative transesophageal echocardiography (TEE): pressure half-time (PHT) of mitral inflow Doppler and 2-dimensional (2D) planimetry methods have been widely used in clinical practice. However, especially after MVP, the PHT method is usually unreliable because it usually underestimates the MVA due to various intraoperative hemodynamic factors.

The authors hypothesized that the MVA determined by 3D TEE would be more accurate than that by PHT during immediate post-MVP procedure in severe MS patients and comparable to postoperative MVA determined by MDCT. Therefore, the present study determined the MVA by using PHT, 3D planimetry and MDCT before and after the MVP procedure in severe MS patients and analyzed them to evaluate 3D TEE's utility for evaluation of MVA.

详细描述

After obtaining permission of the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea , patients scheduled to undergo elective MVP due to more than moderate MS and left atrial enlargement with or without atrial fibrillation (AFib) signed written informed consent agreements and prospectively participate in the present study.

In addition to the routine transthoracic echocardiographic evaluation, cardiac CT examination is performed in all recruited patients prior to surgery to determine MVA.

Induction of anesthesia and tracheal intubation are performed after the administration of intravenous etomidate 0.1-0.2 mg/kg and rocuronium 0.9 mg/kg followed by continuous infusion of remifentanil (0.5-1.0 mcg/kg/min). After tracheal intubation, sevoflurane (1.0 inspired vol%) and infusion of rocuronium (0.2 mg/kg/hr) are administered for anesthesia maintenance.

After anesthesia induction, pulmonary artery catheter (PAC) is placed in right internal jugular vein into pulmonary artery by pressure guidance and a 3D TEE probe (X-9™, Philips Medical Systems Andover, MA, USA) is inserted for the comprehensive intraoperative TEE examination using a 3D echocardiographic imaging platform (iE33; Philips Medical Systems, Andover, MA, USA). While momentarily turning off the ventilator, three consecutive velocity-time integrals (VTIs) of mitral inflow Doppler scans were obtained by applying the continuous wave Doppler parallel to the mitral inflow Color Doppler signal in the midesophageal long-axis view. In case of AFib, the biggest VTI among the 5 consecutive VTIs of the mitral inflow Doppler was used for determining PHT to detect maximal mitral inflow among irregular heartbeats. Immediately after recording the VTIs, a live 3D zoom "en face" MV view from the left atrium (LA) or left ventricle (LV) perspective is acquired.

As baseline data, MVA is determined by using PHT method (MVA-PHT): PHT of the mitral inflow deceleration slope is determined using stored mitral inflow Doppler VTI and the MVA are automatically calculated assuming MVA = 220/PHT. At the same time, a 2D image of the smallest MVA perpendicular to the mitral inflow at the maximal MV opening was achieved by post-processing including aligning and cropping of the acquired 3D images with an installed software (3DQ™ in Q-lab™, Philips, USA). MVA was determined by circumferential tracing of the leaflet edges of the MV opening in the cropped and reconstructed tomographic image from stored 3D volume image (MVA-3D) (Fig. 1). All MVA measurements were repeated 3 times within a minimal time interval by the same expert cardiac anesthesiologists with the mean value used for analysis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled to undergo elective mitral valve repair surgery
  • more than moderate mitral stenosis
  • left atrial enlargement
  • signed written informed consent agreements

排除标准

  • urgent or emergency case
  • other concurrent valvular surgery
  • patient age < 18 years,
  • reduced left or right ventricular function (ejection fraction < 40%),
  • mitral regurgitation grade more than moderate
  • repeated surgery for cardiac valvular disease

结局指标

主要结局

mitral valve area determined by 3D planimetry

时间窗: within 1 hour after the weaning from CPB

mitral valve area determined by pressure-half time

时间窗: within 1 hour after the weaning from CPB

mital valve area determined by multi-detactor CT scan

时间窗: within 7 days weaning from CPB

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae-Yop Kim, MD PhD

professor of Anesthesiology

Konkuk University Medical Center

研究点 (1)

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