Congenital Heart Disease Clinical Trial
Official title:
Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position: a Comparative Study
Verified date | November 2017 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | June 1, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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: |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann | Brussels |
Lead Sponsor | Collaborator |
---|---|
Pierre Wauthy |
Belgium,
Boethig D, Goerler H, Westhoff-Bleck M, Ono M, Daiber A, Haverich A, Breymann T. Evaluation of 188 consecutive homografts implanted in pulmonary position after 20 years. Eur J Cardiothorac Surg. 2007 Jul;32(1):133-42. Epub 2007 Apr 18. — View Citation
Brown JW, Ruzmetov M, Rodefeld MD, Vijay P, Darragh RK. Valved bovine jugular vein conduits for right ventricular outflow tract reconstruction in children: an attractive alternative to pulmonary homograft. Ann Thorac Surg. 2006 Sep;82(3):909-16. — View Citation
Corno AF, Hurni M, Griffin H, Galal OM, Payot M, Sekarski N, Tozzi P, von Segesser LK. Bovine jugular vein as right ventricle-to-pulmonary artery valved conduit. J Heart Valve Dis. 2002 Mar;11(2):242-7; discussion 248. — View Citation
Corno AF, Mickaily-Huber ES. Comparative computational fluid dynamic study of two distal Contegra conduit anastomoses. Interact Cardiovasc Thorac Surg. 2008 Feb;7(1):1-5. Epub 2007 Sep 28. — View Citation
Fiore AC, Brown JW, Turrentine MW, Ruzmetov M, Huynh D, Hanley S, Rodefeld MD. A bovine jugular vein conduit: a ten-year bi-institutional experience. Ann Thorac Surg. 2011 Jul;92(1):183-90; discussion 190-2. doi: 10.1016/j.athoracsur.2011.02.073. Epub 2011 May 6. — View Citation
Hickey EJ, McCrindle BW, Blackstone EH, Yeh T Jr, Pigula F, Clarke D, Tchervenkov CI, Hawkins J; CHSS Pulmonary Conduit Working Group. Jugular venous valved conduit (Contegra) matches allograft performance in infant truncus arteriosus repair. Eur J Cardiothorac Surg. 2008 May;33(5):890-8. doi: 10.1016/j.ejcts.2007.12.052. Epub 2008 Mar 4. — View Citation
Holmes AA, Co S, Human DG, Leblanc JG, Campbell AI. The Contegra conduit: Late outcomes in right ventricular outflow tract reconstruction. Ann Pediatr Cardiol. 2012 Jan;5(1):27-33. doi: 10.4103/0974-2069.93706. — View Citation
Prior N, Alphonso N, Arnold P, Peart I, Thorburn K, Venugopal P, Corno AF. Bovine jugular vein valved conduit: up to 10 years follow-up. J Thorac Cardiovasc Surg. 2011 Apr;141(4):983-7. doi: 10.1016/j.jtcvs.2010.08.037. Epub 2010 Sep 29. — View Citation
Ross DN, Somerville J. Correction of pulmonary atresia with a homograft aortic valve. Lancet. 1966 Dec 31;2(7479):1446-7. — View Citation
Ross DN. Replacement of aortic and mitral valves with a pulmonary autograft. Lancet. 1967 Nov 4;2(7523):956-8. — View Citation
Shebani SO, McGuirk S, Baghai M, Stickley J, De Giovanni JV, Bu'lock FA, Barron DJ, Brawn WJ. Right ventricular outflow tract reconstruction using Contegra valved conduit: natural history and conduit performance under pressure. Eur J Cardiothorac Surg. 2006 Mar;29(3):397-405. Epub 2006 Jan 24. Erratum in: Eur J Cardiothorac Surg. 2006 Aug;30(2):418.. — View Citation
Urso S, Rega F, Meuris B, Gewillig M, Eyskens B, Daenen W, Heying R, Meyns B. The Contegra conduit in the right ventricular outflow tract is an independent risk factor for graft replacement. Eur J Cardiothorac Surg. 2011 Sep;40(3):603-9. doi: 10.1016/j.ejcts.2010.11.081. Epub 2011 Feb 19. — View Citation
Yong MS, Yim D, d'Udekem Y, Brizard CP, Robertson T, Galati JC, Konstantinov IE. Medium-term outcomes of bovine jugular vein graft and homograft conduits in children. ANZ J Surg. 2015 May;85(5):381-5. doi: 10.1111/ans.13018. Epub 2015 Feb 23. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Age | Age of the child when replacement surgery is performed | 18 years | |
Primary | Length of time between placement surgery and replacement surgery | Length of time between the placement of the homograft/Contegra and its replacement | 18 years | |
Primary | Weight | Weight of the child before replacement surgery | 18 years | |
Primary | Sex | Sex of the child | 18 years | |
Primary | Homograft/contegra position (anatomic/extra anatomic) | Anatomic or extra anatomic position | 18 years | |
Primary | Co-intervention (yes/no) | Presence of another surgical intervention during the homograft/contegra replacement surgery | 18 years | |
Primary | Total duration of intervention | Total duration of the replacement surgery | 18 years | |
Primary | Total duration of extra corporeal circulation | Total duration of extra corporeal circulation during the replacement surgery | 18 years | |
Primary | Aortic clampage duration | Total duration of aortic clampage duration during the replacement surgery | 18 years | |
Primary | Duration of circulatory arrest | Total duration of circulatory arrest during the replacement surgery | 18 years | |
Primary | Presence of perioperatory complications (yes/no) | Presence of perioperatory complications (yes/no) during the replacement surgery | 18 years | |
Primary | PRISM Score | Pediatric Risk of Mortality score, ad defined by the pediatric ICU in post-replacement surgery care | 18 years | |
Primary | Inotropic duration | Inotropic duration in post-replacement surgery care | 18 years | |
Primary | Extubation day | Number of days between the surgery and the extubation in post-replacement surgery care | 18 years | |
Primary | Length of stay in ICU | Number of days in ICU after replacement surgery | 18 years | |
Primary | Length of hospitalisation after replacement surgery | Length of hospitalisation after replacement surgery | 18 years | |
Primary | Cause of death | Cause of death after replacement surgery | 18 years |
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