Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048071
• Other study ID #: CHUB-Conegra vs homografts
• Status: Completed
• Phase: N/A
• First received: February 2, 2017
• Last updated: November 20, 2017
• Start date: February 14, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: November 2017
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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:

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

Intervention

Other:
• Data collection within medical files
Data collection within medical files

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

References & Publications (13)

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

Outcome

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