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Ann Thorac Surg 2004;77:2151-2156
© 2004 The Society of Thoracic Surgeons

Original article: cardiovascular

Right ventricular outflow tract reconstruction with the Contegra bovine jugular vein conduit: a word of caution

Andreas R. Tiete, MDa*, Jörg S. Sachweh, MDa, Ulrich Roemer, MDb, Rainer Kozlik-Feldmann, MDb, Bruno Reichart, MDa, Sabine H. Daebritz, MDa

a Department of Cardiac Surgery, University Hospital Großhadern, Munich, Germany
b Department of Pediatric Cardiology, University Hospital Großhadern, Munich, Germany

Accepted for publication December 10, 2003.

* Address reprint requests to Dr Tiete, Department of Cardiac Surgery, University Hospital Großhadern, Marchioninistr. 15, 81377 Munich, Germany
e-mail: atiete{at}med.uni-muenchen.de


   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Comment
 References
 
BACKGROUND: Since introduction in 1999, pulmonary valve replacement in pediatric patients with the Contegra conduit (Medtronic Inc, Minneapolis, MN) has gained widespread application with increasing enthusiasm. However, unexpected graft related adverse effects may occur.

METHODS: Between April 2001 and December 2002, 29 patients (20 male; mean age, 3.39 ± 3.66 years; range, 0.01 to 13.0 years; mean weight, 11.62 ± 8.73 kg) underwent right ventricular outflow tract reconstruction with the Contegra conduit. Seventeen patients underwent primary repair, 8 had prior homografts, and 4 had other previous operations.

RESULTS: There were no deaths. Three early graft related complications were observed. In two infants (age, 1.8 and 3.5 months; weight, 3.6 and 3.8 kg, respectively) thrombus formation at the conduit valve was detected 2 weeks postoperatively. Under anticoagulation with low-molecular-weight heparin, thrombi resolved completely in both patients. One patient (4.5 months, 4.43 kg) developed severe regurgitation due to a fibrous layer covering the inner conduit wall and required conduit exchange 3 weeks postoperatively. After a mean follow-up time of 10.2 ± 6.4 months all patients are in good clinical condition. However, one patient with systemic right ventricular pressure developed pseudoaneurysm at both graft insertion sites and is scheduled for reoperation. Two other patients underwent balloon dilation. Freedom from reoperation and intervention at 1 year is 89.4%. With regard to regurgitation and conduit stenosis all other conduits perform well.

CONCLUSIONS: Contegra conduits are an alternative to homografts for right ventricular outflow tract reconstruction. However, there is a risk of thrombus formation in small infants so that prophylactic anticoagulation may be necessary. Patients with systemic right ventricular pressure require close observation as pseudoaneurysm formation has been observed.


   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Comment
 References
 
In pediatric cardiac surgery, valved conduits are used in a variety of congenital heart defects for establishment of a continuity from the right ventricle (RV) to the pulmonary artery. First introduced by Ross and Somerville in 1966 [1], homografts became the conduits of choice and are still considered the gold standard for right ventricular outflow tract (RVOT) reconstruction since they have a superior event-free survival compared to porcine valved conduits [2–4]. Nevertheless, homografts are far from being the ideal device for RVOT reconstruction. Particularly in young recipients, homografts show early calcification and degeneration [5–11]. Development and progression of homograft insufficiency is common and not innocuous [12, 13]. With regard to the limited durability of homografts, the Contegra bovine jugular vein conduit (Medtronic Inc, Minneapolis, MN) was introduced as an alternative in 1999 and has gained widespread application with increasing enthusiasm. The Contegra conduit consists of a bovine jugular vein with an incorporated trileaflet valve. The conduit tissue is extremely pliable and offers optimal conditions for surgical handling. Moreover, the proximal tubular segment allows the construction of the proximal anastomosis to the RV without additional material. Experience with the use of this new device has been recently published [14, 15]. We present our experience and the observation of unexpected adverse effects with the Contegra conduit in 29 pediatric patients.


   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Comment
 References
 
Patient characteristics
Between April 2001 and December 2002, 29 pediatric patients (20 male) underwent RVOT reconstruction with the Contegra bovine jugular vein conduit at our institution. Mean age was 3.39 ± 3.66 years (0.01 to 13.0 years, median 1.88 years), mean body weight was 11.6 kg ± 8.7 kg (3.0 to 37 kg, median 10.0 kg) with 6 patients weighing less than 4 kg. Primary diagnoses were pulmonary atresia with ventricular septal defect and major aorto-pulmonary collateral arteries (PA/VSD/MAPCAs, n = 7), tetralogy of Fallot (TOF, n = 4), pulmonary atresia with VSD and persistent ductus arteriosus or modified Blalock-Taussig (BT) shunt (PA/VSD with PDA/BT shunt, n = 3), truncus arteriosus communis (TAC, n = 5), transposition of the great arteries with VSD and pulmonary stenosis (TGA/VSD/PS, n = 4), double outlet right ventricle (DORV, n = 3), heterotaxia, atrioventricular septal defect (AVSD), complex DORV (n = 1), and aortic stenosis (AS, n = 1).

In 17 patients the Contegra conduit was implanted at primary repair. Twelve patients required the implantation of a valved conduit for a failing RVOT patch reconstruction (n = 4) or for degeneration of a homograft (n = 8). Four of the 8 patients with homograft degeneration had had previous palliations (BT shunt, n = 2), RVOT patch -reconstruction (n = 1), or both (n = 1) before homograft implantation. Seven patients had undergone previous interventions (aortic valve [n = 1], pulmonary valve [n = 4], or homograft dilation [n = 1], coil embolization of MAPCAs [n = 1]).

Surgical technique
All patients with primary repair and implantation of the Contegra conduit were operated using standard cardiopulmonary bypass techniques, moderate or deep hypothermia, and cardioplegic arrest induced by crystalloid cardioplegia (Bretschneider). Due to the natural high profile character of the conduit valve, the conduit was distally always cut just above the commissures of the valve to keep it as short as possible for placement between the right ventricle and the pulmonary bifurcation. The proximal anastomosis to the right ventricle was performed using the proximal tubular extension of the conduit. The proximal segment was tailored in an oval-shaped manner to create a smooth right ventricular outflow. In the redo procedures the RVOT patches or degenerated homografts were completely removed and the Contegra conduit was implanted as described above. In 7 of 12 patients with conduit replacement, surgery was performed in a beating heart technique. Six patients with conduit replacement underwent additional reconstruction of the central pulmonary arteries. The majority of implanted conduits were small (12 mm, n = 10; 14 mm, n = 5), but larger conduits were also used (16 mm, n = 8; 18 mm, n = 5; 22 mm, n = 1). In most of the patients, there was a deviation of the implanted conduit size from the natural valve size. A minor positive conduit size deviation was favored in children and adolescents to reduce the reoperation rate for conduit outgrowth. In very young recipients a major positive conduit size deviation was unavoidable as the smallest available size is 12 mm (Fig 1).



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  		Fig 1. Deviation of conduit size from natural valve size in percentage (means ± 95% confidence interval). Deviation in size was greatest in very young patients receiving the smallest available conduit (12 mm).

 
Data acquisition
Data were recorded prospectively. The patients were regularly followed up at our institution or by pediatric cardiologists. Transthoracic Doppler echocardiography was performed before discharge and every 3 to 6 months postoperatively with special attention to valve function and RVOT obstruction. Conduit regurgitation was graded from 0 to 4 (grade 0 = no regurgitation, grade 1 = trace, grade 2 = mild, grade 3 = moderate, and grade 4 = severe regurgiation). Conduit gradients were classified as transvalvular or at the site of the distal anastomosis.

Statistical analysis
Data are presented as mean ± standard deviation, range, and median where appropriate. The Wilcoxon-Mann-Whitney test was applied to compare nonpaired groups. A p value less than or equal to 0.05 was considered significant. Freedom from conduit related reoperation or reintervention was calculated by means of the Kaplan-Meier method. All statistical analyses were performed with SPSS 11.0 for Windows (SPSS Inc., Chicago, IL).


   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Comment
 References
 
Operative results
There were no operative deaths. Operative complications included bleeding (n = 2), cerebral infarction in the area supplied by the left medial cerebral artery resulting in a minor neurologic deficit (n = 1), sepsis (n = 2), reintubation (n = 2), pericardial and pleural effusion requiring drainage (1 each), and pneumothorax requiring chest tube insertion (n = 1). A 7-year-old patient with DORV, severe pulmonary stenosis, and hypoplastic pulmonary artery branches needed extracorporeal membrane oxygenation for right ventricular dysfunction for 3 days.

There were three early Contegra conduit related adverse events. In two patients thrombus formation at the conduit valve leaflets was detected by routine echocardiography on the 13th and 15th postoperative day after PA/VSD and TAC repair, respectively (Fig 2). The patients were 3.5 and 1.8 months old, weight was 3.6 and 3.8 kg. Both had 12-mm conduits with corresponding z-score of + 2.6 each. Anticoagulation was performed with low-molecular-weight heparin (Fragmin) with an antifactor Xa plasma level of 0.5 IU/l. In both patients the thrombus resolved completely. Prophylactic anticoagulant therapy was continued with aspirin (10 mg/d) after discharge until a weight increase to 5 to 6 kg. There was one reoperation in a 4.5-months-old girl, weight 4.3 kg, with complete repair of PA/VSD/MAPCAs with a 12-mm Contegra conduit (z-score + 1.9) and factor V Leiden mutation. Echocardiography showed a severe conduit regurgitation on the 20th postoperative day with deteriorating RV function. Right ventricular to left ventricular (RV/LV) pressure ratio was 0.7. Cardiac catheterization revealed severe stenosis of the origin of one unifocalized MAPCA. Reoperation was performed on the 39th postoperative day with patch augmentation of the origin of the MAPCA and exchange of the Contegra conduit. The inner conduit wall was completely covered with a fibrinous layer that fixed the valve leaflets to the wall. The membrane could be peeled off easily from the conduit wall and from the totally intact valve leaflets.



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  		Fig 2. Floating thrombus (arrow) adjacent to the conduit valve in a 3.5-months-old patient with PA/VSD 13 days postrepair with a relatively oversized Contegra conduit (12-mm, z-score deviation from native pulmonary valve + 2.6). (PA/VSD = pulmonary atresia with ventricular septal defect.)

 
Follow-up
Mean follow-up was 10.2 ± 6.4 months (0.4 to 25 months) and is complete. There were no late deaths. One 2-months-old girl with PA/VSD required epimyocardial pacemaker implantation on the 31st postoperative day for intermittent AV-bloc.

There was one conduit related complication in a 4.6-year-old boy with TOF, s.p. multiple interventional procedures on the left pulmonary artery resulting in an occlusion and status post fenestrated VSD closure and RVOT reconstruction first with a homograft, then with an 18-mm Contegra conduit. Seven months postoperatively, echocardiography detected a fluid accumulation around the Contegra conduit that was confirmed by magnetic resonance imaging (MRI) (Fig 3). Drainage inserted under computed tomographic (CT) imaging revealed an unspecific inflammatory fluid. In further follow-up, the fluid accumulation increased in size in echocardiography. Seven months later pseudoaneurysm formation with blood inflow at the proximal and outflow at the distal anastomosis was seen in echocardiography. The findings were confirmed by MR imaging and the patient is scheduled for reoperation.



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  		Fig 3. Pseudoaneurysm formation (arrows) at both insertion sites of an 18-mm Contegra conduit leading to blood flow around the conduit in a 4.6-year-old boy (TOF, status post multiple previous interventional and surgical procedures, fenestrated VSD closure, and RVOT reconstruction with homograft implantation, status post homograft replacement with a Contegra conduit). (RVOT = right ventricular outflow tract; TOF = tetralogy of Fallot; VSD = ventricular septal defect.)

 
With regard to the echocardiographic assessment of the conduit function at follow-up, there was no gradient across the conduit valve in 17 patients (58.6%). Eleven patients (38%) had a gradient less than or equal to 30 mm Hg; one had a gradient of 40 mm Hg. Four patients had an increase of a conduit gradient less than 20 mm Hg and 2 patients less than 40 mm Hg, first observed 6 to 12 months after implantation. There was no evidence that mean conduit gradients increase with time (Fig 4). There was no significant correlation between age (≤ 6 months) or small graft size (≤ 14 mm) and development of a conduit gradient (p = 0.95 and 0.32). With regard to a gradient at the distal anastomosis, 21 patients (72.4%) had no gradient and 6 patients (20.7%) less than or equal to 40 mm Hg. Two patients (6.9%) had a distal gradient of 50 and 60 mm Hg, respectively. Two patients underwent balloon dilation. In one patient with PA/VSD a gradient of 28 mm Hg at the origin of the left pulmonary artery was relieved 10 months postoperatively. One patient with heterotaxia, AVSD and complex DORV developed a pressure gradient at the distal anastomosis of 53 mm Hg 13 months postoperatively. The conduit valve itself did not have a gradient. Dilation was not successful and the patient is scheduled for conduit exchange. In all other patients gradients at the distal anastomosis were measurable directly after surgery in echocardiography. There was no evidence that these gradients increased with time (Fig 4). There was no significant correlation between younger age (≤ 6 months) or small graft size (≤ 14 mm) and a gradient at the distal anastomosis after implantation (p = 0.93 and 0.78) and at last follow-up (p = 0.84 and 0.48). It is of note that these gradients might be overestimated by echocardiography due to a turbulent flow.



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  		Fig 4. Conduit gradients and gradients at the distal anastomoses over time. Mean gradients remain constant; there was no tendency to increase with time.

 
Valve insufficiency was zero in 5 patients (17.2%), trace to mild in 23 (79.4%) patients, and moderate in one patient (3.4%). Conduit insufficiency did not increase in 20 patients (69%), 8 patients (27.6%) had an increase of one grade (n = 7) or two grades (n = 1), and one patient had a decrease of regurgitation.

There was no echocardiographic evidence for device related pathologic lesions such as calcification or leaflet destruction. Freedom from reoperation and intervention at 1 year is 89.4% (Fig 5). At follow-up, all patients are in good clinical condition. Cardiac function was NYHA class I or II in all patients except one with PA/VSD/MAPCAs.



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  		Fig 5. Actuarial freedom from reoperation or intervention on the Contegra conduit.

 

   Comment
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
References
 
Homografts have been used for the repair of a variety of complex congenital heart defects, since their introduction by Ross and Somerville in 1966 [1]. Due to superior event-free survival compared to porcine valve conduits because of refinements in harvesting, cryopreservation, and distribution [3, 16], the homograft became the gold standard for RVOT reconstruction in pediatric patients despite early calcification and degeneration particularly in this patient group. Young recipient age and small homograft size were determined as risk factors for homograft survival in major studies [6–8, 10, 11]. Moreover, pulmonary insufficiency after RVOT reconstruction is not innocuous [17]. Several studies noted rapid occurrence and progression of significant homograft insufficiency [12, 13, 18]. This is of major impact particularly in patients with high pulmonary artery pressure or resistance [13]. Chan and colleagues [12] reported homograft regurgitation in 100% of their patients (median age, 37.5 months) and a progression of more than two grades in 35% after a median follow-up of 28.5 months. Their data predicted that up to 50% of patients operated on before 18 months of age will have severe regurgitation 15 months postoperatively [12].

The limited durability and availability of homografts in young patients support the search for an alternative device for RVOT reconstruction [19, 20]. Besides, due to expanding indications for early repair of congenital heart defects and early Ross procedures, there is an increasing demand for small conduits for RVOT reconstruction [21]. In 1999 the Contegra bovine jugular vein conduit was introduced both to overcome the mismatch between homograft demand and supply and to increase longevity. The resistance of the Contegra conduit to calcification implanted in juvenile sheep, was recently reported by Herijgers and colleagues [22]. First clinical short-term and mid-term results are encouraging and cause increasing enthusiasm [14, 15].

The results of our series of 29 patients compare favorably with the series of Breymann and colleagues [14] and Bové and colleagues [15]. With regard to echocardiographic outcome the conduit valve function is good. However, echocardiograpic findings evaluating regurgitation are subjective and conduit gradients depend on cardiac output at the time of examination. In our series, the incidence of remarkable conduit stenosis or severe conduit regurgitation was low. Pressure gradients across the conduit valves were zero or insignificant (≤ 30 mm Hg) in 28 (96.6%) patients. Echocardiographic gradients observed at the distal anastomosis in 8 patients were attributed to the mismatch between conduit size (minimum 12 mm) and the recipient pulmonary artery branches. However, an exact localization of the site of a detected gradient in echocardiography is often limited by the small distance between the conduit valve and the pulmonary artery bifurcation. In our series, two patients required interventional balloon dilation of a stenosis at the distal anastomosis. In contrast to the reported early onset and progression of homograft insufficiency [12, 13, 18], the majority of the Contegra conduits had only trace or mild conduit insufficiency without a tendency to increase in follow-up. Apart from the good conduit performance we observed four conduit related adverse effects. In two small patients with relatively big conduits, thrombus formation was detected early postoperatively necessitating anticoagulant therapy. The thrombus formation is most likely due to the mismatch in valve sizes causing a relatively low blood flow and an incomplete valve leaflet motion. As there are no smaller conduits than 12 mm, small patients with a 12-mm Contegra conduit are anticoagulated with heparin during their hospital stay followed by aspirin (10 mg/d) after discharge until they gain a weight of 5 to 6 kg. Since the introduction of this regimen we have not observed any other case of conduit valve thrombosis. Thrombus formation in a Contegra conduit for RVOT reconstruction has not been reported so far. Recently Schoof and colleagues [23] reported thrombosis of Contegra conduits (2 nonvalved, 1 valved) implanted as extracardiac conduits for Fontan circulation completion. They attributed the increased thrombogenicity to a lack of endothelial resurfacing and an inflammatory response to the glutaraldehyde as well as to the great cytotoxic surface area of the conduit. However, flow characteristics of a Fontan conduit are different from a RVOT conduit. Nevertheless, the observation of conduit thrombosis in a slow nonpulsatile blood flow may compare partly with our observation of thrombus formation in oversized RVOT conduits with a pulsatile but relatively slow blood flow and incomplete valve function.

There was one reoperation for severe regurgitation of a 12-mm Contegra conduit. The valve dysfunction was caused by fibrous peel, not by leaflet destruction, which most likely has been caused primarily by thrombus formation. To our knowledge this phenomenon has not been reported previously and it is questionable whether this observation remains an isolated case in a patient with factor V Leiden mutation with an increased susceptibility to thrombosis.

Pseudoaneurysm formation in coherence with Contegra conduit implantation has also not been reported so far. We observered a pseudoaneurysm under systemic RV pressure a few months after implantation, which might be due to a decreased resistance of the conduit wall to high pressure in combination with a perivascular unspecific inflammatory reaction. This is of major importance as several patients with RVOT reconstructions have elevated or systemic RV pressures. Further investigation is necessary to assess whether our observation is a single, nonconduit related, complication or whether Contegra conduits should not be implanted in expected high RV pressures.

To sum up, the Contegra conduit shows good midterm results with regard to regurgitation and conduit stenosis. It is a valuable alternative to homografts for reconstruction of the RVOT with advantages particularly with regard to the development of conduit valve insufficiency. However, experience with this new device is still limited and unexpected adverse events may occur. The conduit seems to have a certain thrombogenicity. Therefore, in small patients with a greater mismatch between conduit size and normal valve size, prophylactic anticoagulation is recommended. Due to the initially good overall performance, the Contegra bovine jugular vein conduit has become our preferred device for RVOT reconstruction.


   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 

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  7. Forbess J.M., Ashish S.S., St. Louis J.D., Jaggers J.J., Ungerleider R.M. Cryopreserved homografts in the pulmonary position: determinants of durability. Ann Thorac Surg 2001;71:54-60.[Abstract/Free Full Text]
  8. Twedell J.S., Pelech A.N., Frommelt P.C., et al. Factors affecting longevity of homograft valves used in right ventricular outflow tract reconstruction for congenital heart disease. Circulation 2000;102(Suppl III):130-135.
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  10. Stark J., Bull C., Stajevic M., Jothi M., Elliot M., de Leval M. Fate of subpulmonary homograft conduits: determinants of late homograft failure. J Thorac Cardiovasc Surg 1998;115:506-516.[Abstract/Free Full Text]
  11. Yankah A.C., Alexi-Meskhishvili V., Wenig Y., Schorn K., Lange P.E., Hetzer R. Accelerated degeneration of allografts in the first two years of life. Ann Thorac Surg 1995;60:S71-77.
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  13. Baskett R.J., Ross D.B., Nanton M.A., Murphy D.A. Factors in the early failure of cryopreserved homograft pulmonary valves in children: preserved immunogenicity?. J Thorac Cardiovasc Surg 1996;112:1170-1179.[Abstract/Free Full Text]
  14. Breymann T., Thies W.R., Boethig D., Goerg R., Blanz U., Koerfer R. Bovine valved venous xenografts for RVOT reconstruction: results after 71 implants. Eur J Cardiothorac Surg 2002;21:703-710.[Abstract/Free Full Text]
  15. Bové T., Demanet H., Wauthy P., et al. Early results of valved bovine jugular vein conduit versus bicuspid homograft for right ventricular outflow tract reconstruction. Ann Thorac Surg 2002;74:536-541.[Abstract/Free Full Text]
  16. Homann M., Haehnel J.C., Mendler N., et al. Reconstruction of the RVOT with valved biological conduits: 25 years experience with allografts and xenografts. Eur J Cardiothorac Surg 2000;17:624-630.[Abstract/Free Full Text]
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  20. Marianeschi S.M., Iacona G.M., Seddio F., et al. Shelhigh no-react porcine pulmonic valve conduit. a new alternative to the homograft. Ann Thorac Surg 2001;71:619-623.[Abstract/Free Full Text]
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