Clinical Trial: Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary:

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 fro
Sponsor: Konkuk University Medical Center

Current Primary Outcome:

  • mitral valve area determined by 3D planimetry [ Time Frame: within 1 hour after the weaning from CPB ]
  • mitral valve area determined by pressure-half time [ Time Frame: within 1 hour after the weaning from CPB ]
  • mital valve area determined by multi-detactor CT scan [ Time Frame: within 7 days weaning from CPB ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Konkuk University Medical Center

Dates:
Date Received: September 23, 2012
Date Started: December 2011
Date Completion:
Last Updated: September 23, 2012
Last Verified: September 2012