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Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03048071
Enrollment
84
Registered
2017-02-09
Start date
2017-02-14
Completion date
2017-06-01
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Contegra, Homograft

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.

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.

Interventions

OTHERData collection within medical files

Data collection within medical files

Sponsors

Pierre Wauthy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cause of death18 yearsCause of death after replacement surgery
Age18 yearsAge of the child when replacement surgery is performed
Length of time between placement surgery and replacement surgery18 yearsLength of time between the placement of the homograft/Contegra and its replacement
Weight18 yearsWeight of the child before replacement surgery
Sex18 yearsSex of the child
Homograft/contegra position (anatomic/extra anatomic)18 yearsAnatomic or extra anatomic position
Co-intervention (yes/no)18 yearsPresence of another surgical intervention during the homograft/contegra replacement surgery
Total duration of intervention18 yearsTotal duration of the replacement surgery
Total duration of extra corporeal circulation18 yearsTotal duration of extra corporeal circulation during the replacement surgery
Aortic clampage duration18 yearsTotal duration of aortic clampage duration during the replacement surgery
Duration of circulatory arrest18 yearsTotal duration of circulatory arrest during the replacement surgery
Presence of perioperatory complications (yes/no)18 yearsPresence of perioperatory complications (yes/no) during the replacement surgery
PRISM Score18 yearsPediatric Risk of Mortality score, ad defined by the pediatric ICU in post-replacement surgery care
Length of hospitalisation after replacement surgery18 yearsLength of hospitalisation after replacement surgery
Inotropic duration18 yearsInotropic duration in post-replacement surgery care
Extubation day18 yearsNumber of days between the surgery and the extubation in post-replacement surgery care
Length of stay in ICU18 yearsNumber of days in ICU after replacement surgery

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026