Ignite Creation Date:
2024-05-06 @ 12:57 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01694251
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2012-09-23
Brief Title:
Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography
Sponsor:
Konkuk University Medical Center
Organization:
Konkuk University Medical Center
Study Overview
Official Title:
Determination of Mitral Valve Area After Mitral Valve Repair Surgery for Mitral Stenosis Using 3-dimensional Transesophageal Echocardiography
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MVA
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 TEEs utility for evaluation of MVA
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 TEEs utility for evaluation of MVA
Detailed Description:
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 01-02 mgkg and rocuronium 09 mgkg followed by continuous infusion of remifentanil 05-10 mcgkgmin After tracheal intubation sevoflurane 10 inspired vol and infusion of rocuronium 02 mgkghr 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 220PHT 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
All patients got a single type of MVP Comprehensive Mitral Valve Apparatus Reconstruction consisting of following procedures under moderate hypothermic cardiopulmonary bypass CPB by one cardiac surgeon restoration of a sufficient MV opening with repair of anterior or posterior MV leaflets mitral commissure and chordate and lifting posterior annuloplasty using a flexible ready to use band A Maze operation is additionally performed in patients who associated with Afib
Immediately after the weaning from the CPB and achieving stable hemodynamics mean arterial blood pressure 65 mmHg heart rate 60-90 beats per minute cardiac index 20 Lminm2 MVA-PHT and MVA-3D are determined in the same manner as the baseline data acquisition
The following intraoperative exclusion criteria are applied 1 intraoperative conversion to MV replacement due to insufficient repair procedure 2 the inability to delineate MV opening due to insufficient 3D imaging
Within 7 postoperative days the MVA-CT is determined again for comparison to other methods by an expert cardiac radiologist in the same manner which applied preoperatively
Statistical analyses are conducted using SPSS 180 SPSS Inc Chicago IL USA To assess intra-observer variability the MVAs measured by PHT method and 3D planimetry with TEE are analyzed using intraclass correlation coefficient ICC The comparisons of MVA-PHT MVA-3D and MVA-CT before or after MVP are analysed used a One Way Repeated Measures Analysis of Variance and their pairwise multiple comparisons are performed via the Tukey method The comparisons of the other continuous variables of echocardiographic findings are performed by paired t or Wilcoxon Signed Rank tests The linear regression analysis is used to determine possible correlation between MVA by using each method Data are expressed as mean SD 95 confidence interval CI or median 25-75 and number of the patients A p value less than 005 is considered statistically significant
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 01-02 mgkg and rocuronium 09 mgkg followed by continuous infusion of remifentanil 05-10 mcgkgmin After tracheal intubation sevoflurane 10 inspired vol and infusion of rocuronium 02 mgkghr 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 220PHT 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
All patients got a single type of MVP Comprehensive Mitral Valve Apparatus Reconstruction consisting of following procedures under moderate hypothermic cardiopulmonary bypass CPB by one cardiac surgeon restoration of a sufficient MV opening with repair of anterior or posterior MV leaflets mitral commissure and chordate and lifting posterior annuloplasty using a flexible ready to use band A Maze operation is additionally performed in patients who associated with Afib
Immediately after the weaning from the CPB and achieving stable hemodynamics mean arterial blood pressure 65 mmHg heart rate 60-90 beats per minute cardiac index 20 Lminm2 MVA-PHT and MVA-3D are determined in the same manner as the baseline data acquisition
The following intraoperative exclusion criteria are applied 1 intraoperative conversion to MV replacement due to insufficient repair procedure 2 the inability to delineate MV opening due to insufficient 3D imaging
Within 7 postoperative days the MVA-CT is determined again for comparison to other methods by an expert cardiac radiologist in the same manner which applied preoperatively
Statistical analyses are conducted using SPSS 180 SPSS Inc Chicago IL USA To assess intra-observer variability the MVAs measured by PHT method and 3D planimetry with TEE are analyzed using intraclass correlation coefficient ICC The comparisons of MVA-PHT MVA-3D and MVA-CT before or after MVP are analysed used a One Way Repeated Measures Analysis of Variance and their pairwise multiple comparisons are performed via the Tukey method The comparisons of the other continuous variables of echocardiographic findings are performed by paired t or Wilcoxon Signed Rank tests The linear regression analysis is used to determine possible correlation between MVA by using each method Data are expressed as mean SD 95 confidence interval CI or median 25-75 and number of the patients A p value less than 005 is considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None