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Eur J Cardiothorac Surg 2002;21:703-710
© 2002 Elsevier Science NL
a Department of Thoracic and Cardiovascular Surgery, Heart-Center North-Rhine Westfalia, Ruhr University of Bochum, Bad Oeynhausen, Germany
b Department of Pediatric Cardiology, Heart-Center North-Rhine Westfalia, Ruhr University of Bochum, Bad Oeynhausen, Germany
Received 18 September 2001; received in revised form 6 December 2001; accepted 14 January 2002.
* Corresponding author. Tel.: +49-5731-971912; fax: +49-5731-972020
e-mail: tbreymann{at}hdz-nrw.de
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Abstract |
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 Top Abstract 1. Introduction2. Patients and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Key Words: Pulmonary valved conduit • Contegra® bovine jugular vein graft • Homograft • Xenograft • Right ventricular outflow tract reconstruction
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1. Introduction |
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TopAbstract1. Introduction2. Patients and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Porcine xenografts perform worse than homografts with respect to all durability parameters such as early calcification and stenosis of the valve, incompetence, pannus and graft tissue stiffness [6–8].
To overcome these limitations, the Contegra® conduit, a totally integrated valved conduit, has been developed. It consists of a bovine jugular vein with a naturally integrated valve in it. Only venous valves consisting of three leaflets with natural sinuses are made available for clinical purposes. Abundant material on both sides of the valve allows enhanced implantation techniques. The Contegra® conduit is treated by a buffered low pressure glutaraldehyde fixation. No additional anticalcification treatment is used. The conduits are available in sizes from 12 to 22 mm. They are also available with rings as reinforcement. We used only the ringless conduits because we consider pliability as one of the big advantages of this material. The Medtronic product is CE-certified. In the USA, a clinical trial aimed at the approval of Federal Drug Administration (FDA) is in progress. Due to shortage of small homografts for infants and after disappointing experiences with porcine aortic xenografts at our institution, we decided in May 1999 to implant the Contegra® bovine valved conduit within a controlled study. The study included only patients requiring an RVOT reconstruction. This report presents the results of our first 71 Contegra® conduits implanted in pediatric patients and compares them with the results of our homograft and porcine Tissuemed® aortic xenograft conduit implantations.
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2. Patients and methods |
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TopAbstract1. Introduction2. Patients and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Conduits of 12, 14, 16, 18, 20, and 22 mm were implanted in 30, 12, seven, five, eight, and nine patients, respectively. The majority of the conduits were 12 and 14 mm in diameter. No ring-reinforced conduit was implanted.
2.3. Statistical analysis
Statistical analysis was performed with SPSS 10.0 (SPSS Inc., Chicago). Means are given with 95% confidence intervals of their mean value or standard deviation, as indicated. Survival and event-free time estimates were calculated with the Kaplan–Meier method and compared by log rank test. P values of <0.05 were considered significant. Linear regression was used to estimate the relationship between RV/LV ratio and the degree of Contegra® incompetence. Early death was defined as death within 30 days after the operation.
2.4. Echo examinations
The patients were examined before discharge and every 3 months postoperatively and the examination included a standardised colour Doppler examination at each interval. We determined separate gradients: (a) at valve level, measured with pulsed wave (PW) Doppler, (b) at distal of the valve, measured with continuous wave (CW) Doppler, calculated with the simplified Bernoulli equation Vpa2x4 for gradients <15 mmHg and with the complete Bernoulli equation (Vpa2-Vv2)x4 for higher gradients, where Vpa is the CW Doppler-measured velocity over the whole RVOT and Vv the PW Doppler-measured velocity at conduit valve level.
2.5. Surgical techniques
Surgical technique varied according to the different initial situation.
2.5.1. Primary repair (25 patients)
Some of the most complex malformations have been operated under circulatory arrest while others have been operated in low flow and myocardial protection by crystalloid cardioplegia (Bretschneider). A major attempt has been made to locate the conduit valve as close as possible to the native pulmonary bifurcation to avoid squeezing and distortion of the valve by closure of the sternum. In addition, this made it easier to implant the high profile type venous valve. We tried to position the conduit in such a way as to avoid conduit laceration at the next sternotomy (for conduit replacement). The connection to the subpulmonary ventricle was easily done by a simple running suture using the proximal tubular extension of the conduit without the need of any additional homologous or foreign material. The conduit was cut down in all cases in a S-shaped manner to fit against the ventriculotomy. In four patients with pulmonary atresia, VSD and MAPCAs, primary repair was performed by a median sternotomy. In those patients, the distal part of the conduit was extensively used to augment the central part of the reconstructed pulmonary arteries. The conduit was incised longitudinally from the distal end to the level of the commissures of the conduit valve. Then two flaps were tailored to be long enough to reach both lung hili. Due to the great elasticity of this new material, there was no kinking.
2.5.2. Conduit replacement (22 patients)
Patients of this group were revised in mild hypothermia after singular venous atrial cannulation, regardless to the underlying disease (5xTOF, 8xDORV, 4xTAC, 1xTGA+VSD+PS).
If necessary, a right pulmonary artery plasty was carried out in short intermittent aortic cross clamping and aortic transsection. In all other cases, the operation was performed without myocardial ischemia but ventricular fibrillation or beating heart. The degenerated homografts (n=8), porcine xenografts (n=11) or Dacron tubes (n=3) were entirely removed. The continuity between RVOT and pulmonary arteries was then achieved by a Contegra® conduit as described above.
Additional foreign material was never needed. We found that Contegra® conduits simplified the procedure very much.
2.5.3. Failed repairs
Twenty-four patients with previous palliations or repairs had to be reoperated: 17 RVOT patches (11 transannular, six not transannular), five aortopulmonary shunts; two patients with a Taussig Bing malformation and previous Kawashima procedures. The operative method is like the one used for conduit replacement.
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3. Results |
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TopAbstract1. Introduction2. Patients and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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3.1. Device related adverse events
During the whole follow-up, there occurred no device-specific complication like calcification or degeneration of the conduit tubes or valves. The reasons for reoperation or death were related to the underlying disease in each case. The Contegra® graft itself was never the reason of any adverse event.
3.2. Mortality
There were five early (7%) and one late death. The reason for early death was postoperative myocardial failure in three cases (two TAC IV (pulmonary atresia+VSD+MAPCAs), one with a weight of 2.4 kg with a very rare complex malformation), one sepsis, one intractable junctional tachycardia. A further patient with TOF and absent pulmonary valve syndrome died 6 months postoperatively due to pulmonary artery ectasia, repeated bronchial obstructive crises, and chronic infection. Echocardiographic assessment demonstrated perfect conduit function and technical correctness of the performed procedures in each case.
3.3. Reoperations
There were seven reoperations. Within the primarily repaired group, two residual VSDs had to be reoperated after 8 weeks and 4 months, respectively. Three patients with repaired TAC A2 and one with repaired TOF developed restenoses at the origin of the pulmonary branch arteries after 1, 2, 4, and 12 months with pressure gradients of more than 80 mmHg. They underwent plastic augmentation. One of the patients with TOF and absent pulmonary valve underwent a reduction plasty of the right pulmonary artery 2 months after repair. The ectatic right pulmonary artery was considered to compress the right main bronchus significantly. She was the one who died late. In each case, inspection of the conduit revealed a pliable, non-calcified tissue and the valve itself appeared morphologically as newly implanted.
3.4. Echocardiographic analyses of the Contegra® conduit function
3.4.1. Pulmonary artery stenosis
During the whole follow-up, there was no pressure gradient detectable across the conduit valve in 35 patients (49%). The maximal transvalvular peak gradients of 25–32 mmHg were measured in seven patients (10%); these gradients showed no tendency to increase over time (Fig. 1
).
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3.4.2. Contegra® valve incompetence
During the whole follow-up, there was no valvular incompetence at all detectable in 20 patients (28%). A trivial to mild incompetence was seen in 32 patients (45%). Nineteen patients (27%) presented with a moderate pulmonary incompetence which decreased spontaneously to mild or trivial values in 14 cases during the follow-up (Fig. 2 ). Up to now, we observed no severe Contegra® valve incompetence. Irrespective of the postoperative grade, the incompetence had no tendency at all to increase during the whole follow-up, as shown in Fig. 3
. Fig. 4
shows the course of RV/LV diameter ratio, standardised to the ratio found at the first month examination. The ratio did not change throughout the whole follow-up and resembled the standardised RV/LV ratio of the homograft group for a comparable observation time (30 months). The RV/LV ratio was significantly correlated to the degree of pulmonary incompetence (Fig. 5
), but independent from the PA bifurcation pressure gradient (Fig. 6
). In patients who presented with both pulmonary valve incompetence and peripheral pulmonary artery stenosis, the degree of peripheral stenosis did neither increase the degree of valve incompetence nor the RV/LV ratio (Fig. 6).
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3.4.4. Survival, freedom from explantation and reoperation
The survival curves of patients with Contegra® conduits, homografts, and porcine xenografts are shown in Fig. 7
. Although the differences were not yet significant, patients with a Contegra® conduit had the best survival rate. In Fig. 8
, freedom from conduit explantation of the three cohorts is shown. Up to now, no Contegra® conduit had to be explanted. That differed significantly from homografts (P=0.015) as well as from porcine xenografts (P<0.01). For the same observation period (2.25 years), freedom from explantation was 86% for the homograft group and 25% for the porcine xenograft group. Freedom from both explantation and reoperation was similar for Contegra® and homografts; both were significantly better (P<0.01) than porcine xenografts (Fig. 9
).
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4. Discussion |
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TopAbstract1. Introduction2. Patients and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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12 mm) and the beginning of the native pulmonary artery branches (often 4 mm), particularly in cases with TAC A2. In some patients, it was rather difficult to distinguish between transvalvular and pulmonary artery gradients, since the distance between the conduit valve and the pulmonary artery bifurcation was quite small. A conduit diameter increase (of 60–80%) was seen transiently in two and actually in further two patients. Both findings were inconsistent and not related to increased pulmonary vascular resistance. We have no evidence of any relevant conduit dilatation. However, severe conduit dilatation and subsequent valve incompetence is reported to occur also in Contegra® conduits by Segesser (Lucerne, Switzerland) and Lindberg (Oslo, Norway) (both personal communications).
Up to now, five patients needed secondary plastic augmentation of the pulmonary bifurcation including the origins of both pulmonary arteries. At present, the distal anastomosis is performed including a more extended augmentation plasty that reaches into the pulmonary artery branches. Although not statistically significant, survival rate 27 months after Contegra® conduit implantation was better compared to homograft implantation. This might be partially explained by the easier implantation technique of the bovine venous conduit. The majority of Contegra® conduits present a trivial to mild incompetence right from the first examination, but only very few cases presented a moderate incompetence. Up to now, no severe incompetence was seen. However, its degree did not increase over time as frequently observed in homograft conduits [13,14]. This was supported by the constant RV/LV ratio during the whole follow-up. Comparing the three conduit groups with respect to their mid-term rates of explantation or reoperation, the Contegra® group performed equal to the homograft group; both groups were significantly better than porcine xenografts. Neither the deaths (five early and one late) nor the reported seven reoperations in the Contegra® group were conduit related. Five of the six deaths were primarily due to operated high-risk patients. Hypoplastic pulmonary artery branches are easier to augment using a Contegra® conduit than using a homograft.
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5. Conclusion |
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TopAbstract1. Introduction2. Patients and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Footnotes |
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Appendix A. Conference discussion |
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TopAbstract1. Introduction2. Patients and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Dr Breymann: We do it in the same way as we would do it in the case of homograft implantation, of course. And as you have seen most of our patients are primary repairs in the first six months of life, so the most suitable one is the 12 mm Contegra.
Dr Al Qethamy: Do you size it by Hager or just whoever is less than six months you just decide?
Dr Breymann: What do you mean, sizing of the Contegra graft itself or sizing what is appropriate?
Dr Al Qethamy: The Contegra graft, it is many sizes, isn't it? It is not only one size?
Dr Breymann: There are sizes available from 12 mm to 22 mm.
Dr Al Qethamy: Exactly. How do you know that this baby required 12 or 20 or 16? Do you have a theory?
Dr Breymann: I can answer that in another way. I would say I decided it exactly the same way I would decide for homograft sizes.
Dr F. Lacour-Gayet (Hamburg, Germany): If I can add something: we have tables. But the question that is asked to you, is what maximum would you consider for oversizing. In another term, is oversizing dangerous or not?
Dr Breymann: Too much oversizing is dangerous, of course, but the smallest one is 12 mm, and in case of truncus arteriosus for instance, we often see pulmonary artery branches of 4 to 5 mm. So what to do? And this leads to some problems in peripheral stenosis. I have showed you that we have had five peripheral pulmonary artery problems, and they have to do with this, of course.
Dr J. Amato (Chicago IL, USA): I hate to be repetitive because I discussed this at a previous conference this morning. We have very little experience in the United States compared to you all in Europe, but having practiced for 30 years and having gone through the INF deal with the Hancock to the pulmonary or aortic homografts, we have only implanted in the United States I think less than 20 of them, but we find it to be a very superior graft for many reasons: It is easy to handle; the sizing can be sized by any index that you want to size it by; we have had no problems with it, and I know other people have had problems with it. So far in the Bove series, the Brown series, my series, there are about 15 of us in the United States that are implanting them, I find it to be a very superior structure. So I am looking forward to it as the choice of replacement.
We cannot get the smaller pulmonary homografts in the United States as much as we want to, and these, as you say, are off the shelf, they can be easily washed and put in place, and we have had no problems with it so far.
Dr Breymann: The main reason for starting this study in our institution has been exactly that reason, the shortage for homografts, particularly for the small ones.
Dr Amato: That was an excellent paper, excellent results.
Dr M. Wojtalik (Poznan, Poland): I have implanted over 20 such grafts. Our material is a bit different. The biggest group is the Ross group. And this graft has two advantages over the homograft: the first is the small size availability, and the second is that it is ready for use at the theater. So any time you can ask for implantation. There are also more advantages, that the valve can be positioned in any place due to excess of tissue on both ends.
You did reoperate on some patients, and I myself too, and there is jelly-like tissue on the distal part of the suture line. Did you encounter such jelly-like tissue?
Dr Breymann: Many of your comments I couldn't understand.
Dr Lacour-Gayet: Would you raise the question to the speaker after your comment, please?
Dr Wojtalik: The conclusion was that there are no complications, and still myself and my colleagues encounter peripheral stenosis due to jelly-like tissue in the suture line. The question is whether you encountered such a finding during reoperation?
Dr Breymann: We have seen these jelly deposits peripheral of the suture line. We had five redos, one reduction plasty and four times an augmentation plasty, and we didn't have any need to resolve the peripheral suture line of the conduit, and all patients we have reoperated are doing very well up to now.
Dr A. Corno (Lausanne, Switzerland): The conduit comes commercially available in two types, one is stented and one unstented. Which one do you use and why?
Dr Breymann: Only the unstented ones.
Dr Corno: We do the same, as you know. I didn't see any Ross patients in your series.
Dr Breymann: No.
Dr Corno: Why?
Dr Breymann: From my standpoint it is a simple answer, because we have some homografts and we preserve these homografts for the Ross procedures because we think they fit in this situation absolutely perfect. That is our feeling.
Dr Corno: Do you consider a contraindication this conduit?
Dr Breymann: No.
Dr H. Lindberg (Oslo, Norway): We have a very small limited experience but we have seen dilatation in the very tiny babies where you have a growth causing peripheral stenosis, and we could demonstrate that by MRI and echo. Haven't you seen any dilatation?
Dr Breymann: Honestly, we haven't seen anything like that, and I have discussion slides here. We have looked for a relationship between conduit insufficiency and high pressure in the conduit. Because not all of these babies have tricuspid insufficiency, we took as a parameter the whole RVOT gradient and we looked whether there is any correlation between the RVOT gradient and the insufficiency, and there is a correlation, but a very slight one. But dilatation we have honestly never seen.
Dr W. Daenen (Leuven, Belgium): I have a similar question. We have done 32 cases now. We had one patient after truncus arteriosus who had right ventricle pressure at systemic level and the diameter of the conduit increased, it doubled in size, and got incompetent.
Dr Breymann: In our experience with that, we had two patients from the very beginning, and the follow-up of these two patients is more than two years. One of them has primary pulmonary vascular resistance and pressure in the right ventricle of over 100 mmHg, and there is no insufficiency. This valve functions up to now perfectly. So sometimes it might dilate, sometimes not, but it is the same with the homografts as well.
Dr Z. Al-Halees (Riyadh, Saudi Arabia): After all is said, and it is well and good, I think, but we still have to understand that it is a very short follow-up, and we have the gold standard of the homograft, and I think failures generally start five years later. So I think unless we have at least a five-year follow-up, we still should be cautious about the widespread use of the single conduit.
Dr Breymann: I agree so far that we need time for further follow-up, of course.
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TopAbstract1. Introduction2. Patients and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Y. Boudjemline, D. Bonnet, and D. Sidi Reply to the Editor J. Thorac. Cardiovasc. Surg., February 1, 2004; 127(2): 611 - 611. [Full Text] [PDF]
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A. Kadner, H. Dave, T. Stallmach, M. Turina, and R. Pretre Formation of a stenotic fibrotic membrane at the distal anastomosis of bovine jugular vein grafts (Contegra) after right ventricular outflow tract reconstruction J. Thorac. Cardiovasc. Surg., January 1, 2004; 127(1): 285 - 286. [Full Text] [PDF]
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K. R. Kanter, D. A. Fyfe, W. T. Mahle, J. M. Forbess, and P. M. Kirshbom Results with the freestyle porcine aortic root for right ventricular outflow tract reconstruction in children Ann. Thorac. Surg., December 1, 2003; 76(6): 1889 - 1895. [Abstract] [Full Text] [PDF]
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Y. Boudjemline, C. Beyler, D. Bonnet, and D. Sidi Surprising outcome similarities between Contegra(R) bovine jugular vein conduit and Shelhigh No-React(R) porcine pulmonary valve conduit: role of immunologic reaction Eur. J. Cardiothorac. Surg., November 1, 2003; 24(5): 850 - 851. [Full Text] [PDF]
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P. Simon, M.T. Kasimir, G. Seebacher, G. Weigel, R. Ullrich, U. Salzer-Muhar, E. Rieder, and E. Wolner Early failure of the tissue engineered porcine heart valve SYNERGRAFTTM in pediatric patients Eur. J. Cardiothorac. Surg., June 1, 2003; 23(6): 1002 - 1006. [Abstract] [Full Text] [PDF]
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Y. Boudjemline, D. Bonnet, G. Agnoletti, and P. Vouhe Aneurysm of the right ventricular outflow following bovine valved venous conduit insertion Eur. J. Cardiothorac. Surg., January 1, 2003; 23(1): 122 - 124. [Abstract] [Full Text] [PDF]
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