Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00173186
Collaborator
(none)
411
1
217
1.9

Study Details

Study Description

Brief Summary

The major risk factors of aortic valve replacement in three outlet types VSD after surgical repair were the severity of preoperative AR and older operation age. For those patients with less than moderate degree AR preoperatively, AR progressed rarely and all in those with aortic valvar and subvalvar anomalies.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Progression of aortic regurgitation (AR) in repaired outlet (juxta-arterial, muscular outlet and perimembranous outlet) ventricular septal defect (VSD) remains unclear.

    From 1987 to 2002, 411 patients with complete follow-up after repair of outlet VSD constituted the study population. Study end point was aortic valve replacement or mortality.

    Aortic valve replacement was performed in seventeen patients (4.1%), in whom logistic regression showed only the severity of preoperative AR and age at VSD repair as the predictors. After excluding the eleven patients with endocarditis from analysis, there were 377 patients with none to mild AR (Group I) and 23 with moderate to severe AR (Group II) preoperatively. Total follow-up was 2,230 person-years. After VSD repair, the 5- and 10-year freedom from aortic valve replacement in Group I was 100%, and in Group II 50.2%. In Group II, ten patients received aortic valve replacement and 8 underwent valvuloplasty with VSD repair. One patient needed valve replacement four years later. Age at VSD repair was the predictor for aortic valve replacement. In Group I, AR progressed in four patients (1.2%, two juxta-arterial and two perimembranous outlet) 3.5 to 7.9 years later and was associated with aortic valvar or subvalvar anomalies. The event-free curves in three outlet types VSD showed no differences.

    Although AR progressed rarely (probably not in muscular outlet type) in repaired outlet types VSD with none to mild preoperative AR, in the presence of aortic valvar or subvalvar anomalies, early surgical repair of the VSD is still warranted.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
    Study Start Date :
    Jan 1, 1987
    Study Completion Date :
    Feb 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      0 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • ventricular septal defect patients receiving total repair from Jan, 1987 to Dec, 2002.

      • follow up more than 1 year after operation

      Exclusion Criteria:
      • complex cardiac lesions

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Pediatrics, National Taiwan University Hospital Taipei Taiwan 100

      Sponsors and Collaborators

      • National Taiwan University Hospital

      Investigators

      • Study Chair: Mei-Hwan Wu, MD, PhD, National Taiwan University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00173186
      Other Study ID Numbers:
      • 9461700517
      First Posted:
      Sep 15, 2005
      Last Update Posted:
      Sep 15, 2005
      Last Verified:
      Jun 1, 2005

      Study Results

      No Results Posted as of Sep 15, 2005