跳至主要内容
临床试验/NCT03048071
NCT03048071已完成不适用

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

Pierre Wauthy1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Length of time between placement surgery and replacement surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Length of time between placement surgery and replacement surgery

时间窗: 18 years

Length of time between the placement of the homograft/Contegra and its replacement

Sex

时间窗: 18 years

Sex of the child

Homograft/contegra position (anatomic/extra anatomic)

时间窗: 18 years

Anatomic or extra anatomic position

Cause of death

时间窗: 18 years

Cause of death after replacement surgery

Age

时间窗: 18 years

Age of the child when replacement surgery is performed

Weight

时间窗: 18 years

Weight of the child before replacement surgery

Co-intervention (yes/no)

时间窗: 18 years

Presence of another surgical intervention during the homograft/contegra replacement surgery

Total duration of intervention

时间窗: 18 years

Total duration of the replacement surgery

Total duration of extra corporeal circulation

时间窗: 18 years

Total duration of extra corporeal circulation during the replacement surgery

Aortic clampage duration

时间窗: 18 years

Total duration of aortic clampage duration during the replacement surgery

Duration of circulatory arrest

时间窗: 18 years

Total duration of circulatory arrest during the replacement surgery

Presence of perioperatory complications (yes/no)

时间窗: 18 years

Presence of perioperatory complications (yes/no) during the replacement surgery

PRISM Score

时间窗: 18 years

Pediatric Risk of Mortality score, ad defined by the pediatric ICU in post-replacement surgery care

Inotropic duration

时间窗: 18 years

Inotropic duration in post-replacement surgery care

Extubation day

时间窗: 18 years

Number of days between the surgery and the extubation in post-replacement surgery care

Length of stay in ICU

时间窗: 18 years

Number of days in ICU after replacement surgery

Length of hospitalisation after replacement surgery

时间窗: 18 years

Length of hospitalisation after replacement surgery

次要结局

未报告次要终点

研究者

发起方
Pierre Wauthy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Wauthy

Head of clinic

Brugmann University Hospital

研究点 (1)

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