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Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position

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ClinicalTrials.gov Identifier: NCT03048071
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Pierre Wauthy, Brugmann University Hospital

Brief Summary:

Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used.Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP).

The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. This conduit, however, is not perfect.

Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.


Condition or disease Intervention/treatment
Congenital Heart Disease Other: Data collection within medical files

Detailed Description:

Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used. The technique became particularly popular from the mid-1980s, through the routine use of cryopreservation. Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP). Early failure of homografts is mainly due to early calcifications. Lung homografts are, however, less prone to obstructions and calcifications than aortic homografts but are not readily available, particularly in small sizes (10-18mm).

The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts. For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. It is stored in a glutaraldehyde solution in concentrations sufficient enough to make it non-antigenic, yet low enough to maintain the flexibility of the tissue.This conduit has many advantages: 1) Immediate availability 2) Available size range from 12 to 22mm internal diameter 3) Possibility of adaptation to morphology and easily suturable 4) Good hemodynamics 5) No need for proximal or distal extension 6) lower cost than homograft and 7) non-antigenicity.

This conduit, however, is not perfect. On the one hand, it has no growth potential and therefore risks becoming too small and no longer suitable as the child develops. This problem is particularly encountered in small patients, in whom ducts less than 16mm in diameter have been implanted, and is not specific to the duct in VJB. On the other hand, there is a source of failure specific to the Contegra® prosthesis. These are the stenoses at the level of the distal anastomosis between the duct and the pulmonary artery. Several mechanisms explain this distal stenosis: 1) hypoplasia or distal stenosis of the branches of the pulmonary artery, 2) difference in size between the duct and the pulmonary artery being too important, 3) the surgical technique , 4) immunological and inflammatory reactions, 5) neointimal proliferation, 6) thrombi formation. The most likely cause is multifactorial, with a combination of factors cited above.

Prior et al proposed an operative protocol for reducing the distal stenosis rate. With this protocol distal stenosis has become a rare complication but there are still situations in which the VJB conduit needs to be replaced.

Therefore, whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.


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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position: a Comparative Study
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort Intervention/treatment
Homograft in pulmonary position replacement
All patients having had the replacement of an homograft in pulmonary position between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.
Other: Data collection within medical files
Data collection within medical files

Contegra conduct replacement
All patients having had the replacement of a Contegra conduct between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.
Other: Data collection within medical files
Data collection within medical files




Primary Outcome Measures :
  1. Age [ Time Frame: 18 years ]
    Age of the child when replacement surgery is performed

  2. Length of time between placement surgery and replacement surgery [ Time Frame: 18 years ]
    Length of time between the placement of the homograft/Contegra and its replacement

  3. Weight [ Time Frame: 18 years ]
    Weight of the child before replacement surgery

  4. Sex [ Time Frame: 18 years ]
    Sex of the child

  5. Homograft/contegra position (anatomic/extra anatomic) [ Time Frame: 18 years ]
    Anatomic or extra anatomic position

  6. Co-intervention (yes/no) [ Time Frame: 18 years ]
    Presence of another surgical intervention during the homograft/contegra replacement surgery

  7. Total duration of intervention [ Time Frame: 18 years ]
    Total duration of the replacement surgery

  8. Total duration of extra corporeal circulation [ Time Frame: 18 years ]
    Total duration of extra corporeal circulation during the replacement surgery

  9. Aortic clampage duration [ Time Frame: 18 years ]
    Total duration of aortic clampage duration during the replacement surgery

  10. Duration of circulatory arrest [ Time Frame: 18 years ]
    Total duration of circulatory arrest during the replacement surgery

  11. Presence of perioperatory complications (yes/no) [ Time Frame: 18 years ]
    Presence of perioperatory complications (yes/no) during the replacement surgery

  12. PRISM Score [ Time Frame: 18 years ]
    Pediatric Risk of Mortality score, ad defined by the pediatric ICU in post-replacement surgery care

  13. Inotropic duration [ Time Frame: 18 years ]
    Inotropic duration in post-replacement surgery care

  14. Extubation day [ Time Frame: 18 years ]
    Number of days between the surgery and the extubation in post-replacement surgery care

  15. Length of stay in ICU [ Time Frame: 18 years ]
    Number of days in ICU after replacement surgery

  16. Length of hospitalisation after replacement surgery [ Time Frame: 18 years ]
    Length of hospitalisation after replacement surgery

  17. Cause of death [ Time Frame: 18 years ]
    Cause of death after replacement surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients having had the replacement of a Contegra conduct, or the replacement of an homograft in pulmonary position, between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.
Criteria

Inclusion Criteria:

  • All patients having had the replacement of a Contegra conduct, or the replacement of an homograft in pulmonary position, between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048071


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Pierre Wauthy
Investigators
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Principal Investigator: Nicolas Poinot CHU Brugmann

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pierre Wauthy, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03048071     History of Changes
Other Study ID Numbers: CHUB-Conegra vs homografts
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pierre Wauthy, Brugmann University Hospital:
Contegra
Homograft

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases