Mitral Valve Repair SurgeryMVANCT01694251
Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography
An observational study of Mitral Valve Repair Surgery, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Repair Surgery
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mitral valve repair mitral stenosis
Who may be able to join
- patients scheduled to undergo elective mitral valve repair surgery
- more than moderate mitral stenosis
- left atrial enlargement
- signed written informed consent agreements
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Mitral Valve Area After Mitral Valve Repair Surgery for Mitral Stenosis Using 3-dimensional Transesophageal Echocardiography
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.
Read the 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 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.
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 > 2.0 L/min/m2), 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 18.0 (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 0.05 is considered statistically significant.
- Conditions
- Mitral Valve Repair Surgery
- Keywords
- mitral valve area, pressure half time, 3 dimensional transesophageal echocardiography, computed tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
mitral valve area determined by 3D planimetry
Measured: within 1 hour after the weaning from CPB
mitral valve area determined by pressure-half time
Measured: within 1 hour after the weaning from CPB
mital valve area determined by multi-detactor CT scan
Measured: within 7 days weaning from CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve Repair SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-Yop Kim, MD PhD, Principal investigator, Konkuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694251
- Sponsor's protocol ID
- KUH1160027
- Acronym
- MVA
- Status last verified
- Sep 2012
- First submitted
- 23 Sep 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Mitral Valve Area After Mitral Valve Repair Surgery for Mitral Stenosis Using 3-dimensional Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT01694251
- Acronym / sponsor ID
- MVA / KUH1160027
- Conditions
- Mitral Valve Repair Surgery
- Keywords
- mitral valve area, pressure half time, 3 dimensional transesophageal echocardiography, computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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.
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 > 2.0 L/min/m2), 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 18.0 (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 0.05 is considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mitral valve repair mitral stenosis
Key inclusion criteria (4 listed)
- patients scheduled to undergo elective mitral valve repair surgery
- more than moderate mitral stenosis
- left atrial enlargement
- signed written informed consent agreements
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
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Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
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PRIMARY Ancillary Substudy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Yop Kim, MD PhD principal investigator
Konkuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Repair Surgery, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mitral valve area determined by 3D planimetry (time frame: within 1 hour after the weaning from CPB). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.