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Completed

NCT Number: NCT03048071

Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collection within medical files

Other

Data collection within medical files

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pierre Wauthy

Other

Registry information

Official study title

Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position: a Comparative Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2017
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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