Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position

NCT03048071 | Completed

• 1 other identifier: CHUB-Conegra vs homografts
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Contegra; Homograft

Outcome Measures

Primary Outcomes (17)

• Age

  Age of the child when replacement surgery is performed

  18 years

• Length of time between placement surgery and replacement surgery

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

  18 years

• Weight

  Weight of the child before replacement surgery

  18 years

• Sex

  Sex of the child

  18 years

• Homograft/contegra position (anatomic/extra anatomic)

  Anatomic or extra anatomic position

  18 years

• Co-intervention (yes/no)

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

  18 years

• Total duration of intervention

  Total duration of the replacement surgery

  18 years

• Total duration of extra corporeal circulation

  Total duration of extra corporeal circulation during the replacement surgery

  18 years

• Aortic clampage duration

  Total duration of aortic clampage duration during the replacement surgery

  18 years

• Duration of circulatory arrest

  Total duration of circulatory arrest during the replacement surgery

  18 years

• Presence of perioperatory complications (yes/no)

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

  18 years

• PRISM Score

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

  18 years

• Inotropic duration

  Inotropic duration in post-replacement surgery care

  18 years

• Extubation day

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

  18 years

• Length of stay in ICU

  Number of days in ICU after replacement surgery

  18 years

• Length of hospitalisation after replacement surgery

  Length of hospitalisation after replacement surgery

  18 years

• Cause of death

  Cause of death after replacement surgery

  18 years

Study Arms (2)

Homograft in pulmonary position replacement

All patients having had the replacement of an homograft in pulmonary position between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.

Other: Data collection within medical files

Contegra conduct replacement

All patients having had the replacement of a Contegra conduct between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.

Other: Data collection within medical files

Interventions

Data collection within medical files OTHER

Data collection within medical files

Contegra conduct replacement; Homograft in pulmonary position replacement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Pierre Wauthy: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (14)

• Ross DN. Replacement of aortic and mitral valves with a pulmonary autograft. Lancet. 1967 Nov 4;2(7523):956-8. doi: 10.1016/s0140-6736(67)90794-5. No abstract available.

  PMID: 4167516 BACKGROUND

• Ross DN, Somerville J. Correction of pulmonary atresia with a homograft aortic valve. Lancet. 1966 Dec 31;2(7479):1446-7. doi: 10.1016/s0140-6736(66)90600-3. No abstract available.

  PMID: 4163445 BACKGROUND

• 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. doi: 10.1016/j.ejcts.2007.02.025. Epub 2007 Apr 18.

  PMID: 17446081 BACKGROUND

• 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. doi: 10.1016/j.athoracsur.2006.03.008.

  PMID: 16928507 BACKGROUND

• 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.

  PMID: 18313324 BACKGROUND

• 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.

  PMID: 12000167 BACKGROUND

• 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.

  PMID: 21549348 BACKGROUND

• 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.

  PMID: 21339072 BACKGROUND

• 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.

  PMID: 25708132 BACKGROUND

• 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.

  PMID: 20884023 BACKGROUND

• 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. doi: 10.1016/j.ejcts.2005.11.040. Epub 2006 Jan 24.

  PMID: 16439155 BACKGROUND

• 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.

  PMID: 22529597 BACKGROUND

• 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. doi: 10.1510/icvts.2007.162412. Epub 2007 Sep 28.

  PMID: 17905782 BACKGROUND

• Poinot N, Fils JF, Demanet H, Dessy H, Biarent D, Wauthy P. Pulmonary valve replacement after right ventricular outflow tract reconstruction with homograft vs Contegra(R): a case control comparison of mortality and morbidity. J Cardiothorac Surg. 2018 Jan 17;13(1):8. doi: 10.1186/s13019-018-0698-5.

  PMID: 29343297 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nicolas Poinot

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 9, 2017
• Study Start: February 14, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)