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Eur J Cardiothorac Surg 2005;27:58-66
© 2005 Elsevier Science NL

Mid term course after pediatric right ventricular outflow tract reconstruction: a comparison of homografts, porcine xenografts and Contegras

^a Department for Pediatric Cardiology and Intensive Care, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625 Hannover, Germany
^b Pediatric Cardiology Practice, Karmarschstr. 36, D-30159 Hannover, Germany
^c Institute of Biometrics, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625 Hannover, Germany
^d Department of Surgery for Congenital Heart Disease, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625 Hannover, Germany

Received 9 February 2004; received in revised form 12 August 2004; accepted 1 September 2004.

^* Corresponding author. Tel.: +49 511 532 9828; fax: +49 511 532 9832. (E-mail: breymann{at}thg.mh-hannover.de).

	Abstract

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusion Appendix A References

 
Objective: Homografts and porcine xenografts are valved conduits for pediatric RVOT reconstruction. They lack availability and durability. The Contegra, a glutaraldehyde fixed bovine jugular vein, was developed as an alternative. In this article, we compare single center results of 190 RVOT conduit implantations. Methods: 52 homografts, 30 porcine xenografts, 108 Contegras were implanted since 1992. Since 1999, data collection was prospective, for Contegras within a controlled clinical trial. Follow-up is complete for all evaluated items. We stratified reoperations by problem zone (sub-, intra-, and supravalvular) and analyzed the role of patient age, diagnosis, graft type, graft size, previous operations and year of operation on freedom from explantation or reoperation related to supravalvular reasons. Results: Porcine xenografts were inferior concerning freedom from explantation and reoperation (P<0.0001). They gave erlier reason for explantation in each zone (P<0.001). At 4 years, homograft valve related reoperation need reached 20%, Contegras 0% (P=0.002). Supravalvlar reoperation reasons developed about equally in homografts and Contegras. Multivariable Cox' regression analysis showed porcine xenografts and age <1 year as independent risk factors for explantation due to supravalvular reasons. We found no reason to assume that supravalvular reoperation reasons occured more frequently after Contegra than after homograft implantation. Conclusion: After 12 years RVOT reconstruction with 190 valved conduits, Contegras remain our device of choice. At 4 years, they show no subvalvular or valvular reason for explantation or reoperation. Contegras have the advantages of easy handling and availability, and they compare well with homografts regarding freedom from explantation and freedom from reoperation.

Key Words: Right ventricular outflow tract • Conduit durability • Congenital cardiac surgery • Contegra

	1. Introduction

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusion Appendix A References

 
The reasons for complications with valved devices commonly used for pediatric right ventricular outflow tract reconstruction (porcine xenografts, homografts, bovine jugular veins) can lie within the conduit (subvalvular: inflow or ventricular anastomosis, valvular: stenosis and/or insufficiency or supravalvular: distal part of the conduit, peripheral anastomosis) or within the patients' pulmonary vessels (bifurcation or pulmonary artery branch stenoses). Previously published articles indicate factors as porcine xenograft origin [1–4], age under 1 year [5,6], diameter <15mm [7,8] primary operation [9,5] or diagnoses as truncus arteriosus communis or double outlet right ventricle [4,5,9] as risk factors for reoperation or explantation of the RVOT conduit. Based on the 12 year experience with 190 implanted valved right ventricular outflow tract conduits, we try to find out whether explantation or reoperation rates are device-specific, if they differ with regard to the predominant problem region, and finally, if the Contegra is a competitive conduit for the reconstruction of congenital malformations that include the right ventricular outflow tract (RVOT).

	2. Patients and methods

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusion Appendix A References

 
Between April 1991 and January 2003, 190 right ventricular outflow tract conduits have been implanted after written informed consent (that included also the anonymised evaluation) in the Heart Center North-Rhine Westphalia, Bad Oeynhausen. Table 1 shows the patients' characteristics, device sizes and gives an outcome overview. The expected mortality rates refer to the RACHS-1 classification elaborated by Jenkins et al. [10].

Fifty-two homografts (30 aortic and 22 pulmonary homografts, all cryopreserved and stored in the Bad Oeynhausen homograft bank),

Thirty porcine Tissuemed^TM xenografts (glutaraldehyde fixed porcine aortic roots, formerly Tissuemed Ltd., Astley Lane Industrial Estate, Astley Lane, Swillington, Leeds LS268XT, UK), and

One-hundred and eight Contegra^TMs (Medtronic GmbH, Am Seestern 3, D-40547 Düsseldorf, Germany). The Contegra, a valve bearing low pressure glutaraldeide fixed bovine jugular vein, is tear resistant, but well pliable and has abundant material on both sides of the valve. It is available in sizes from 12 to 22mm and can be stored in the operating room shelf for several years.

2.2. Implantation periods of the various conduits

1. Early phase: from January 1992 to December 1996, only homografts were implanted (n=39).

2. Intermediate phase: between January 1997 and March 1999, all 30 Tissuemed porcine xenografts and 13 homograft conduits were implanted; within this time frame, porcine xenografts were implanted whenever a homograft was not available.

3. Recent phase: after May 1999, Contegras were used exclusively.

The nonrandomized distribution depended on availability and quality of the devices: lack of homografts led to the use of porcine xenografts, and the initation of the Contegra clinical phase II trial offered the opportunity to implant the Contegra.

2.3. The implanting surgeon
All implantations have been performed by one surgeon. He was already well trained when the conduit implantation series began (certified for general, vascular and cardiac surgery, and having performed all types of operative procedures of congenital cardiac malformations). That is why no learning curve of relevant inclination must be assumed.

2.4. Implantation details
Cardioplegia during the conduit implantation was obtained using Bretschneider HTK-solution (Dr F. Köhler Chemie, Neue Bergstr. 3-7, D-64665 Alsbach-Hähnlein, Germany), if appropriate.

The proximal anastomosis of homografts and porcine xenografts required a Dacron or pericardium hood to attach the conduit to the right ventricle. Contegras were always sewn directly onto the ventricle after their long proximal tubular part was tailored appropriately.

2.4.1. Distal positioning of the valve
Placing the valve as distal as possible within the conduit means keeping the supravalvular tubular part of the conduit possibly short. This helps to prevent the supravalvular conduit wall from high pressures. The reason is: if high pulmonary vascular resistance (due to stenoses of supravalvular pulmonary artery branches or high arteriolar resistance) is present or develops, the elastic pulmonary arteries act as a Windkessel. While diastolic blood pressure in the subvalvular compartment decreases instantly after closure of the pulmonary valve, the diastolic pressure in the supravalvular compartment might remain at higher levels due to the Windkessel effect. This causes a remarkably higher average pressure load for the supravalvular conduit compartment—during each heart beat, but also in total over a longer period of time.

Flap formation with supravalvular conduit material: porcine xenografts and homografts are too stiff or have a too short supravalvular tube to use them for pulmonary artery augmentation at the distal anastomosis. Moreover, they do require pericardium or foreign material for pulmonary artery plasties. In contrast, implanting the Contegra, the supravalvular part of the conduit itself can be tailored form a pulmonary artery (branch) flap plasty. If necessary, the other pulmonary artery branch can be augmented with a second flap of the supravalvular conduit tube. For details see Fig. 1.

View larger version (19K): [in this window] [in a new window]   Fig. 1. Contegra implantation details. (A) Temporary transsection of the aorta to facilitate access to the pulmonary artery trunc, bifurcation and branches. (B) Double flap tailoring of the supravalvular tubular part of the Contegra. Note the high profile valve (drawn in very light grey) whose commissures begin immediately proximal from the future suture line. (C1) Suture line for an end-to-side anastomosis after a T-shaped incision of the hypoplastic bifurcation, (C2) preparation and sewing technique of the hypoplastic pulmonary artery for an end-to-end anastomosis with the Contegra.

2.4.2. Oversizing
In order to avoid early outgrowth of conduits in young patients, conduits should be reasonably oversized [11]. Contegra walls are more pliable than porcine or human aortas, and they are available from the shelf in any size between 12 and 22mm. So an adequate oversizing (avoiding plications or kinking) can be achieved easier.

2.4.3. Rinsing
All Contegras were implanted after completion of the rinsing procedure that was conducted exactly as described in the relevant instructions (3 times for 5min in 500ml physiological saline each), in order to remove the toxic glutaraldehyde solution. All anastomoses were made with running sutures and without any glue.

2.4.4. Postoperative anticoagulation
Three Contegra patients had previously implanted mechanical valve prostheses in the aortic position and were anticoagulated with warfarin; 2 patients (1 Contegra, 1 homograft) received aspirin to reduce pleural effusions. Other anticoagulation did not take place.

2.5. Data sources, management and statistical evaluation
Data sources for homo- and xeno-graft patients were patient records and echo tapes. Data collection has to be considered retrospective until the end of 1998; from May 1999 on we collected data prospectively within a controlled clinical extended phase I trial, conducted to obtain FDA and CE Mark approval. Contegra patients were examined in a standardised manner every 3 months, homograft and porcine xenograft patients were seen in the ambulatory twice a year. The kind of data that was evaluated in this study was completely recorded for the prospectively as well as for retrospectively included patients.

Data were registered in a FileMaker Pro 4.0 database (FileMaker Inc., Santa Clara, CA, USA) and evaluated with SPSS 11.5.1 (SPSS Inc., Chicago, IL, USA).

Porcine xenografts are today rarely considered a serious option for RVOT reconstruction. Despite this fact we included them in our analysis, in order to have a sensitive indicator for degeneration: if some factors promote degeneration, they become earlier evident in such a conduit, and the same factors might appear later on in other conduits that are less prone to calcification.

The main time-dependent events were displayed as Kaplan Meier curves. Log rank tests regarding porcine xenograft performance are merely descriptive, since we consider porcine xenografts obsolete as conduits for RVOT reconstruction.

Risk factors for reoperation or explantation (age under 1 year, conduit diameter under 15mm, diagnosis of truncus arteriosus communis or double outlet right ventricle, primary operation) were extracted from the literature (1–x). We analysed these factors concerning their meaning as risk factors for supravalvular reoperation reasons. Additionally, we included the year of conduit implantation in the Cox' model since the experience of the implanting surgeon might have influenced the results. The role of the risk factors at 4 years in our patient population is shown descriptively in Fig. 2 that displays the 4-year extractions of the relevant Kaplan Meier curves. To analyse the main question: ‘Is freedom from reoperation for supravalvular reasons conduit related or patient related?’, a Cox' regression model was calculated including the described risk factors (stepwise forward, linear regression, all risk factors except year of operation introduced as categorial variables, with homograft contrast evaluation). The detailed results of this analysis are given in Appendix A.

View larger version (28K): [in this window] [in a new window]   Fig. 2. Univariate analyses of variables concerning freedom from reoperation for supravalvular reasons at 4 years after implantation: the error bars are excerpts from Kaplan Meier curves with their 95% confidence intervals at 4 years.

(a) declaring the descriptive elements of the evaluation, and

(b) application of the Bonferroni–Holm correction method.

It is evident that a larger number of cases and events would permit to clarify more questions with multivariable analyses. However, considering revisions of RVOT-conduits (that were often necessary only for corrections of peripheral pulmonary artery stenoses) is a very conservative approach compared to looking at explanations only.

	3. Results

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusion Appendix A References

 
3.1. Explantation reasons
Overall, peeling and valve degeneration were the main reasons for explantation of the RVOT conduits (Table 2). Revised homografts and porcine xenografts were always in such a bad general state that they were explanted whenever a revision was necessary. Severe calcification of conduit walls and valves were observed in all 19 explanted porcine xenografts and in 12 of the 20 explanted homografts. Extensive peel formation, valvular stenosis and/or insufficiency were very common findings in explanted homografts and porcine xenografts.

3.2. Overall freedom from events
The Kaplan Meier curves, stratified by conduit type, suggest Contegras not to be inferior when compared to homografts concerning survival (Fig. 3A) and freedom from explantation (Fig. 3B, P=0.02); their freedom from reoperation or explantation (Fig. 3C), however, seems quite similar to the homograft course. Porcine xenografts are significantly worse than homografts concerning the endpoint ‘explantation’ and ‘explantation or reoperation’ (P<0.001).

View larger version (20K): [in this window] [in a new window]   Fig. 3. (A) Survival after RVOT graft implantation. Not needing additional foreign material to be sutured to the conduit might contribute to the good survival of Contegra patients. (B) Two of the four Contegra explantations were not due to conduit degeneration, but only to facilitate access to the pulmonary arteries who needed a plasty. All were included in this curve. Not included are reoperations of Contegra patients for augmentations of narrow pulmonary artery branches—they are shown in (C). (C) The graph for homografts and xenografts rests equal as in (B), because in contrast to the Contegras, these grafts were always explanted for degeneration when a revision was necessary. Note the approximation of the Contegra curve to the homograft curve when compared to (B).

View larger version (18K): [in this window] [in a new window]   Fig. 4. (A) subvalvular reoperation reasons include stenoses in the right ventriculotomy region or in the subvalvular tubular conduit part, as well as aneurysmatic dilatations of the latter. The observation time and the relevant curve for Contegras terminates at 4.15 years. (B) In contrast to Contegras, homografts do show relevant numbers of valve degeneration after 4 years. (C) Patients with a Contegra show (statistically not significant) inferior freedom from reoperation when compared to homografts. Since most of the Contegra conduits were not exchanged on behalf of the reoperations, but all reoperated homografts had to be explanted, the question arose whether the higher reoperation rate of Contegra patients was due to the Conduit or due to other factors.

3.4.1. The role of the inhomogeneous conduit implantation intervals
Above we mentioned that the initial phase with homografts as the only implanted conduit type was followed by a ‘mixed’ phase when homografts and porcine xenografts were implanted as available; both phases terminated after the Contegra became available. Four arguments support the hypothesis that this inhomogeneous distribution did not have major influence on the outcome:

1. reoperations due to postvalvular reoperation reasons in homograft recipients were not more frequent in the early phase than in the late phase;

2. in the intermediate phase, xenografts were explanted significantly more often than the homografts in the same phase;

3. as mentioned, the year of implantation was no significant risk factor in the Cox' models.

4. the surgeon was already well experienced in vascular and pediatric cardiac surgery when the first conduit implantation took place.

Nonetheless, the nonrandomised conduit distribution must be considered a limitation of the study.

3.5. Summarizing our results
We saw that Contegra conduits are free from subvalvular or valvular reoperation reasons up to 4 years. We did not observe such freedom rates in homografts or porcine xenografts. The good subvalvular and valvular performance accounts for the good freedom from explantation of Contegras when compared to homografts.

Reoperations for supravalvular reasons occur both in Contegras and homografts. ‘age under 1’ year and ‘porcine xenograft implantation’, but not ‘Contegra implantation’ were independent risk factors for such an event.

	4. Discussion

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusion Appendix A References

 
4.1. Conduits for RVOT reconstruction
The optimal choice among underoptimal (non-growing, foreign body) conduits for right ventricular outflow tract reconstruction is not easy.

Porcine aortic roots have shown relevant early degeneration rates in our and other institutions (Fig. 5). Better results with 5-year degeneration free rates have been reported from populations with higher mean age, while results in populations with a mean age under 5 years are not convincing [7].

View larger version (36K): [in this window] [in a new window]   Fig. 5. This figure summarizes a series of publications dealing with durability of valved right ventricular outflow tract conduits [21–25]. The kind of graft is coded by different symbols, and subgroups are labeled by letters beneath the reference numbers. The non-inferiority of Contegras is underlined by the fact that the two groups with equal or better results included patients of low-risk patient populations (larger conduits) while the Contegra curve reflects ‘all-inclusive’ results.

Valveless Gore tex or Dacron tubes might be tolerable for infants with permanently low pulmonary vascular resistance. But for routine implantations, a more physiological well working valved conduit is surely preferable.

Currently, homografts are often given the preference, but their availability is limited—the European Homograft Bank states that 10% of the requests cannot be satisfied [13], and Sinzobahamvya [11] describes the bad results of size related compromises: the 16% implanted underoptimally sized homografts in his patient group had a significantly worse freedom from deterioration than sufficiently oversized prostheses. Additional foreign material is needed for proximal hoods and distal pulmonary artery plasties, and homografts are not free from wall calcification, shrinking, and valve degeneration [8,7,14,15]. Outgrowth, the only tolerable explantation reason for a non-growing conduit, is seldom reached as cause of homograft replacement [16].

The Contegra is an interesting alternative to the previously described devices. The availability of the Contegra in a broad spectrum of different sizes does not enforce compromises in size selection, avoiding implantation of smaller conduits than possible.

4.2. Contegra problems
Dilatation: critical Contegra dilatation has been reported [17]—we have never seen a relevant diameter enlargement. The above described implantation technique might be a reason for the non-occurrence of this phenomenon in our patient population. Due to the fact that any biological conduit is not a technically constructed standardized product, but grows individually different within its donor, such events cannot completely be excluded. Critical dilatations are also reported from other biological conduits ([16,18]).

Insufficiency: slight insufficiencies of the Contegra's high profile valve turned out not to be problematic (no insufficiency progredience, no relevant increase of the diameter ratio right- to left ventricle) [19].

Calcification: we observed only one non-obstructive circumscript nonstenotic calcified vegetation—retrosternally, on a ventral subvalvular tube wall that was adherent to the sternum after a mild postoperative sternal infection. In no case we saw severe calcification of valves or conduit walls. At the pathological examination of the explanted conduits, trace or moderate calcifications were found by X-ray analysis; they were clinically insignificant. The cited calcified vegetation was identified as ossification in the pathological examination. Regular X-ray examinations of the conduits that were implanted mainly in children have not taken place.

Supravalvular stenoses: despite the frequently used opportunity to form pulmonary artery branch augmentation flaps from the distal Contegra conduit, we saw (and reoperated) repeatedly stenoses in the pulmonary artery region. The basic question that emerged from the data analyses was: Is the Contegra more prone to supravalvular stenoses than other right ventricular outflow tract conduits (homografts or porcine xenografts)? If so, is this due to the Contegra or due to the patients? Juxtaductal pulmonary artery coarctation is a known concomitant malformation in patients with pulmonary atresia [20]. In our work, this specific question came up because—despite a better freedom from explantation—the reoperation rate of Contegras at 4 years is not lower than the homograft explantation rate. Up to now, Contegras showed no valvular or subvalvular explantation or reoperation reasons. This stands in contrast to the alternatively implanted conduits (homografts and porcine xenografts).

4.3. Length of the study period
The minor importance of the implantation year as risk factor for longevity of pulmonary valved conduits is confirmed by Caldarone [2], who found no influence of this parameter over a study period from 1966 to 1996.

4.4. Otherwise stated risk factors
In the literature, we found many described risk factors for early reoperation or explantation (regardless of the localization) to be univariately important also in our population (Appendix A1). Age under 1 year at the operation was the only independent significant risk factor for supravalvular reoperation reason. The frequent association of age under 1 year with other conditions (smaller patients get smaller conduits, are more likely to get their first operation or to get operated due to certain diagnoses) explains the occasional appearance of these conditions as risk factors in other groups with slightly different patient group composition.

4.5. Comparison with results from other studies
In our patient group, Contegras' freedom from reoperation was well comparable to the results of other studies with different conduit types (Fig. 5). Reason may be seen in Contegra durability, availability (appropriate oversizing without availability problems) or handling properties [15,19].

4.6. Limitating factors
The study was not randomized—but conduit selection based on availability and not on patient related criteria. Learning effects cannot completely be excluded—but they were not marked enough to be statistically significant. Data was collected partially retrospectively—but we have complete record of the analysed items. The limited follow-up-time for Contegras permits no long-term statements—but the 4 year results seem worth to be communicated. One surgeon in one institution did all the operations, and the operative procedure was standardized—this may imply a reduced transferability of our results. On the other hand, the variable ‘surgeon’ is transformed into nearly a constant. To state equivalence of homografts and xenografts, larger patient numbers and longer observation periods are required—we will try to work on it.

	5. Conclusion

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusion Appendix A References

 
Freedom from conduit explantation was unsatisfying in our porcine xenograft recipients. At 4 years, the Contegra was not inferior to homografts concerning freedom from subvalvular and valvular reoperation reasons. Not the Contegra (vs. homograft), but age under 1 year or use of a porcine xenograft were independent risk factors for the development of supravalvular reoperation reasons. A comparison of our results to those of other studies also suggests Contegras' superiority to porcine xenografts and its non-inferiority to homografts. We conclude that up to 4 years the Contegra is a valid alternative to homografts for pediatric right ventricular outflow tract reconstruction.

	Appendix A

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusion Appendix A References

 
Cox model description (endpoint: explantation or reoperation).

Method: forward linear regression. All variables except ‘year of implantation’ were entered as categorial variables, a contrast was set on ‘graft type’.

A.1. Variables not in the equation

	Acknowledgments

 
We thank Carolin Breymann for drawing the artwork of Fig. 1.

	References

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusion Appendix A References

 

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