Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients with severe MR due to the prolapse of both leaflets in the context of Barlow's disease submitted to EE repair via a video-assisted right minithoracotomy (minithoracotomy group) and patients with Barlow's disease treated with surgical mitral repair with the EE technique through a conventional median sternotomy (sternotomy group).
The diagnosis of Barlow's disease was made during a preoperative transoesophageal echocardiographic (TEE) examination and confirmed by the surgeon's direct assessment of the valve. All patients had excessive leaflet tissue, annular dilatation and bileaflet prolapse. Cases with a forme fruste of Barlow's disease were excluded.
Description
Inclusion Criteria:
Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011
Exclusion Criteria:
Age inferior to 18 years
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MT-Right
|
Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
|
|
Sternotomy
|
Longitudinal resection of the sternum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac Death
Time Frame: 12 years
|
The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk
|
12 years
|
|
Severe MR
Time Frame: 12 years
|
The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk
|
12 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MICETE-BBL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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