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Original Articles: Pediatric Cardiac

The Performance of Hancock Porcine-Valved Dacron Conduit for Right Ventricular Outflow Tract Reconstruction

Emre Belli, MD^_*, Ece Saliholu, MD, Bertrand Leobon, MD, François Roubertie, MD, Mohammed Ly, MD, Régine Roussin, MD, Alain Serraf, MD

Department of Pediatric Cardiac Surgery, Marie Lannelongue Hospital, University Paris-Sud, Le Plessis-Robinson, France

Accepted for publication September 17, 2009.

^_* Address correspondence to Dr Belli, 133, avenue de la Résistance, Le Plessis-Robinson, 92350, France (Email: e.belli{at}ccml.fr).

Presented at the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26–28, 2009.

	Abstract

Top Abstract Introduction Patients and Methods Results Comment Discussion Acknowledgments References

 
Background: The surgical reconstruction of right ventricle outflow tract (RVOT) often requires the implantation of a valved conduit. Homografts are lacking availability and are associated with limited durability in children. Our experience with the Hancock porcine-valved Dacron (DuPont, Wilmington, DE) conduit (Medtronic, Minneapolis, MN) was retrospectively assessed.

Methods: Follow-up was studied in 214 survivors who underwent 247 conduit implants between January 1990 and January 2007. Pulmonary atresia/ventricular septal defect was present in 86 (40.2%) and truncus arteriosus in 62 (29%). Conduit implantation was associated with anatomic repair in 136, conduit replacement in 96, and secondary pulmonary valve insertion in 15. Median age at operation was 62.5 months (range, 1 week to 50 years), including 14 neonates (6%). Median conduit size was 17.4 mm because of routine over-sizing. Pulmonary bifurcation patch augmentation was necessary in 26 patients. Periodic echocardiography studies were performed for a median follow-up of 98 months (range, 13 to 142 months).

Results: Three (1.4%) late deaths occurred. No conduit-related deaths or complications occurred. Conduit degeneration was associated with increase in valvular gradient. Valve regurgitation was absent or mild. Higher RVOT systolic pressure gradient at discharge did not influence conduit longevity. Conduit reoperation was delayed due to percutaneous balloon dilatation in 14 patients, associated with stenting in 7. Survival with freedom from conduit reoperation was 98% (95% confidence interval [CI], 97% to 100%) at 1 year, 81% (95% CI, 75% to 87%) at 5 years, and 32% (95% CI, 22% to 42%) at 10 years.

Conclusions: The Hancock valved conduit is a safe and reliable alternative to homografts. It appears to be appropriate in patients with limited pulmonary vascular bed and high pulmonary artery pressures. Caution is required in neonates because of the rigidity of the Dacron housing. Initial results with secondary percutaneous procedures are encouraging.

	Introduction

Top Abstract Introduction Patients and Methods Results Comment Discussion Acknowledgments References

 
The use of valved conduit for right ventricular outflow tract (RVOT) reconstruction allowed routine anatomic repair of a wide variety of congenital heart defects associated with absent RV to pulmonary artery (PA) connection and also contributed to the popularity of Ross procedure to treat aortic valve disease [1]. Conduits formed of autologous tissue that grows and does not deteriorate do not exist yet. Considered as substitutes of choice, homografts are lacking availability and eventually are associated with limited durability in younger patients, especially when implanted in a heterotopic position where they require proximal extension [2–4].

The Hancock Dacron (DuPont, Wilmington, DE)-housed porcine valve conduit (Medtronic, Minneapolis, MN) was first used in the 1970s [5, 6]. Several types of xenograft have been developed since then as an alternative, with varying success [7–14]. At our hospital, the choice of the type of conduit to reconstruct the RVOT usually depends on the availability of the homograft, the patient's size and hemodynamic condition, the level of success of the alternative xenograft of the moment, and the surgeon's preference. This study was initiated to evaluate the performance of Hancock conduit in a large patient cohort and, possibly, to identify specific conditions that justify its preferential use.

	Patients and Methods

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Between January 1990 and June 2006, 268 patients underwent procedures using 301 Hancock conduits to reconstruct the RVOT. Excluded from the study were 18 patients who died in the hospital and 4 other patients lost within 6 months postoperatively. No conduit-related death was documented. The study also excluded 32 overseas patients for whom valuable follow-up information was not available after discharge.

The study cohort consisted of 214 patients for whom 247 conduits were used to reconstruct the RVOT. Median age was 62.5 months (range, 1 week to 50 years), and the median weight was 14.8 kg (range, 3 to 109 kg; Fig 1). Indications for operation, including RVOT conduit reconstruction, are listed in Table 1. Conduits were implanted during anatomic repair of the cardiac anomaly in 136 patients. In 96, the previously implanted RVOT conduits (including 33 Hancock conduits) were replaced. For the remaining 15, the indication for conduit insertion was related to treatment of chronic pulmonary valve regurgitation in adults with repaired tetralogy of Fallot.

View larger version (6K): [in this window] [in a new window]   Fig 1. Age distribution.

Conduit size was decided intraoperatively, with particular caution to rinsing requirements. The conduit metallic ring was removed in most cases to avoid potential compression of cardiac structures. The external surface of the Dacron conduit was staunched by means of biologic glue (Tissucol, Baxter Inc, Deerfield, IL). The distal part of the Dacron tube was cut close to the top of the commissures so that the valve was positioned as far distally as possible; then, the proximal end of the conduit was bevelled and anastomosed directly to the right ventriculotomy. Monofilament sutures were used in all procedures. To treat stenosis on pulmonary arteries but also to create a larger distal anastomosis site, patch enlargement of the pulmonary arteries was performed in 65 patients.

Conduits used were a mean size of 17.4 ± 3.9 mm (range, 12 to 25 mm; Fig 2). Routine conduit over-sizing was performed. Figure 3 shows the relationship of the indexed main pulmonary artery diameter and the implanted conduit size (median ratio, 1.44). Conduit size was decided to be as large as possible according to the size of PA trunk and bifurcation, the patient's body weight, and the surgeon's intraoperative impression.

View larger version (13K): [in this window] [in a new window]   Fig 2. Conduit size distribution.

View larger version (10K): [in this window] [in a new window]   Fig 3. Linear regression analyzing the effects of conduit over-sizing showed the implanted conduit size/expected pulmonary valve diameter ratio (abscissa) correlated with better conduit longevity (p = 0.048).

Indication for conduit reoperation was considered when RV pressure reached 75% of systemic blood pressure, with evidence of severe RVOT gradient across the conduit. Evident deterioration of RV systolic function, RV dilatation, and appearance of clinical symptoms were also considered even when conduit function appeared satisfactory.

Data Analysis
Patient records were analyzed retrospectively. To have more valuable follow-up information, the study end point was decided as January 2007. Hospital mortality was defined as death occurring before hospital discharge or within 30 days postoperatively. Overseas survivors for whom regular follow-up information was not available were excluded, even in presence of information confirming survival with absence of clinical symptoms. The follow-up data for survival, reoperation, and conduit function were analyzed by using Kaplan-Meier method with 95% confidence intervals (CI). The ² test was used to compare percentages. The potential benefit of over-sizing was controlled by linear regression analysis.

	Results

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Early Results
Conduit-related early complications were observed in 3 patients. Two were related to the metal ring. Coronary artery compression in 1 patient was treated by conduit repositioning and removal of the metal ring. The second required revision for bleeding on postoperative day 4 due to left internal mammary artery abrasion injury because of the metal ring. In the remaining patient, a thrombus was observed inside the conduit and managed by oral anticoagulant therapy.

Postoperative discharge echocardiography allowed identification of absent or mild conduit valve regurgitation in all patients. At discharge, residual RVOT gradient was moderate in 33 (13%) and severe in 4 (1.6%); however, the level of the residual RVOT gradient did not influence conduit longevity.

Invasive Procedures
Percutaneous angioplasties were attempted in 31 patients with the aim to delay conduit reoperation and were associated with significant gradient decrease in 14 for whom the principal obstacle was valvular but not at the site of the proximal or distal anastomosis [15]. The remaining 16 patients were scheduled for conduit reoperation. In 7 the conduit was stented, and in 2 the conduit was replaced with a Melody (Medtronic Inc) transcatheter pulmonary valve during a percutaneous procedure (Fig 4).

View larger version (85K): [in this window] [in a new window]   Fig 4. Consecutive angiograms show (A) percutaneous stented pulmonary valve implantation and (B) confirmation of optimal valve competence.

View larger version (7K): [in this window] [in a new window]   Fig 5. The actuarial survival is shown for freedom from conduit reoperation.

View larger version (6K): [in this window] [in a new window]   Fig 6. The actuarial rate is shown for conduit longevity (88 explanted conduits).

	Comment

Top Abstract Introduction Patients and Methods Results Comment Discussion Acknowledgments References

 
Reconstruction of the RVOT using valved conduits has become a common procedure in the surgical management of congenital heart disease. First reported in the late 1960s and commonly used since the successful application of cryopreservation in the 1980s, homografts presented limited duration due to patient outgrowth, shrinkage, calcification, and valve regurgitation. Factors associated with shorter homograft longevity include a non-Ross procedure, an aortic homograft, younger donor age (or smaller diameter), second homograft, and ABO incompatibility [2–4]. Despite these disadvantages, the homograft remained the first option for RVOT reconstruction, especially during the Ross procedure.

The Hancock is oldest xenograft valved conduit that is still available [5, 6]. Since the wide use of cryopreserved homografts, it has become an auxiliary device. After the spread of surgical indications and widening practice of routine neonatal operations, especially small-sized homografts have become rare. Although several biologic devices were proposed, the best alternative to homografts remains to be established.

Several RVOT reconstruction techniques have been described that avoid the use of biologic substitutes [16–18]. These techniques appeared reproducible; however, they were more likely suitable for larger patients with eventually preserved autologous pericardial tissue. We also have avoided using homografts or xenografts in several patients with pulmonary atresia or truncus arteriosus as well as during conduit replacement in the presence of a nonrestrictive low-pressure pulmonary vascular bed. RVOT reconstruction was achieved by direct RV to PA connection establishment or by using a valveless polytetrafluoroethylene (PTFE) conduit, both associated with the creation of a pericardial or PTFE monocusp valve.

The expanding indications for repair of congenital heart disease resulted in an increasing demand/supply mismatch, particularly for younger patients. During the last 2 decades, several xenografts were reported with disappointing or at least controversial results. More recently, the Contegra valve containing bovine jugular vein conduit (Medtronic Inc) was introduced. Although long-term outcome is not yet available, most of the published studies have reported satisfactory early and midterm results [10–13]. However, the development of peel, resulting in distal anastomosis stenosis, conduit dilatation, and conduit valve regurgitation were also reported [9, 19–21]. Therefore, one can be doubtful about the outcome of this particular prosthesis. At our hospital, Contegra was used as soon as it was commercially available but was abandoned because of very poor early outcome: distal stenosis development was of concern. Since 2006, we reintroduced Contegra in light of recent favorable publications, with particular caution to perform an intima-to-intima distal anastomosis and avoiding specific anatomic and hemodynamic conditions:

• not suitable for newborns because of the high profile valve,

• significant over-sizing can result in more turbulence and distal stenosis, and

• contraindicated in presence of pulmonary hypertension or restrictive pulmonary vascular bed where the valve competence is crucial.

At our department, the Hancock is the most commonly used valved conduit. Homografts are rarely available in pediatric sizes in France. We favor their use in the orthotopic position during Ross procedure, where they demonstrated optimal outcome. The rigidity of the Dacron housing constitutes a limit for neonatal use. During truncus arteriosus repair in the neonate, RVOT reconstruction is increasingly being performed without the conduit, either by direct anastomosis or by means of a PTFE conduit, both associated with a monocusp valve.

Beyond the neonatal period, the longevity of a conduit appears to be also related to turbulence of the crossing blood flow. Mechanisms resulting in peel formation were observed in all types of xenograft, although with individual variability. Although conduits with postoperative residual gradients were not exchanged earlier, the shortest conduit longevities were observed in patients with restrictive pulmonary vascular bed as in pulmonary atresia/ventricular septal defect patients with diminutive pulmonary artery branches.

The rigidity of Dacron tube also necessitates the preparation of an appropriate distal anastomosis site. Thus, 65 patients underwent associated PA patch enlargement (PTFE or pericardium) even though most had associated branch stenosis.

The presence of increased pulmonary vascular resistance is not uncommon in congenital heart disease. The long-term protection of RV function is mandatory and necessitates a competent valve. No more than mild valve regurgitation was observed during the study, except the case of subsequent valve destruction after some percutaneous procedures. The Hancock conduit appeared to be an adapted device in the presence of high pulmonary artery pressure because of increased pulmonary vascular resistance or surgically inaccessible distal branch stenosis. The stability of the Dacron housing constitutes an additional favorable quality for this particular condition.

The metal ring surrounding the valve is removable and was removed in most of the patients to avoid cardiac compression and injury. No data were available to analyze if ring removal influenced conduit longevity.

Although our attitude concerning percutaneous procedures can be qualified as conservative, or minimally aggressive, notable RV pressure decrease was observed in 14 of 31 patients who underwent balloon dilatation with or without stenting. Conduit reoperation could be delayed by interventional cardiology only if the principal RVOT gradient was located at conduit valvular level. Stenoses located at proximal or distal anastomosis were not suitable for balloon dilatation, with peel detachment being a serious adverse event.

Other advantages of the Dacron housing were that it allowed a safer approach and easy removal during conduit reoperation and the limitation of the late conduit calcification was only at the valvular level. The Hancock porcine-valved Dacron conduit constitutes a valuable alternative to homografts for RVOT reconstruction. Its use was associated with minimal complication and constant long-term outcome. We recommend its use particularly:

• beyond neonatal period,

• in the presence of a restrictive pulmonary vascular bed or increased pulmonary vascular resistance, or both,

• as a palliative RV-PA conduit, and

• when dissatisfaction with other xenografts occurs.

Further study is mandatory for comparison between the Hancock conduit and other types of xenograft as well as homografts.

	Discussion

Top Abstract Introduction Patients and Methods Results Comment Discussion Acknowledgments References

 
DR ANTHONY AZAKIE (San Francisco, CA): You reported that there was an 83% 5-year freedom from reoperation. Did you do a subgroup analysis on the neonates and the small infants, and what was the experience with those 13 neonates who had the Hancock valve [Medtronic, Minneapolis, MN]? This is my first question. And the other question is: Do you think that the metal ring can in fact be advantageous in certain reconstructions where you are concerned about sternal compression?

DR BELLI: Thank you. I will start with the second question. As far as we used to put the valve in a more distal position, as distal as possible, the metallic ring falls in an oblique position. So it is not supposed to protect from the potential sternal compression. However, the Dacron [Du Pont, Wilmington, DE] sheet is rigid, so is probably the best, most adapted device to avoid potential sternal compression; although, I don't believe that exists. It must be often related to a problem of tailoring, beveling the tube, to prepare the infundibulotomy and to position the conduit inside the chest more than sternal compression.

Concerning the size-related conduit survival, I didn't do specific analysis for each size. But certainly outgrowth factor is more likely involved in smaller conduits.

DR ZOHAIR AL-HALEES (Riyadh, Saudi Arabia): I notice that despite the fact that the Hancock conduit was your preferred conduit, in one slide you mentioned many other alternatives, but there was no mention of the Contegra [Medtronic] conduit. Have you had any experience using it, or is there any particular reason that you did not use it?

DR BELLI: Yes, we worked with bovine vein in the early '90s, in our animal lab as a study that was not properly ended. Then, we started to use it as soon as it was available commercially, and we had the same experience as with some recent publications, that being peel formation and stenosis at the level of the distal anastomosis. Thus we stopped using it. We started with Shelhigh [Union, NJ]. As you know, this device also had other problems and was associated with very poor outcome. During that period, I had listened to some presentations to learn some technical details about how to implant a Contegra; finally, I started again to use Contegra, moderately.

The problem with Contegra in the newborn is the length of the valve. The distance between the right ventriculotomy and the optimal place of the pulmonary bifurcation being shorter, you often crucify the branches. In this condition, we don't use valved conduit anymore, and we try to manage with direct continuity or Gore-Tex tube [W. L. Gore and Assoc, Flagstaff, AZ] with a monocusp.

In the orthotopic position as tetralogy of Fallot or Ross procedures, Contegra can probably be used safely. We use it if we cannot get a homograft in the Ross operation; in patients with complex repair, if we are sure to finish with very low pulmonary pressure in the presence of large pulmonary arteries where potential turbulence will not occur, we more likely use the pulmonary Contegra conduit. In other conditions we prefer to use the Hancock.

DR JOHN LAMBERTI (San Diego, CA): I think this paper is quite important because it tells us everything we need to know about the role of the Hancock conduit in 2009. An important aspect of Dr Belli's approach is that he cuts off the redundant Dacron at each end of the conduit. That is the site where the neointimal peel, the Achilles heel of these conduits, tended to form. I think that when you need a competent pulmonary valve and you are thinking of putting in a stented bioprosthesis, this is a reasonable alternative. The porcine-valved conduit was the only type of conduit that we had available from the early 1970s until the late 1980s in North America. I think these outcomes with the Hancock conduit are very predictable. Similar long-term data have been accumulated in many centers over a period of 20 or 30 years. In addition, you don't usually have distal anastomotic problems if the anastomosis is properly performed. But it is tough to get it into a small patient. While we are here in San Francisco, it is worth paying a tribute to Paul Ebert. Dr Ebert set the standards for infant truncus repair in the 1980s and all he had to work with were 12-mm Dacron porcine-valved conduits. Thank you very much demonstrating that there is still a role for these conduits, Dr Belli.

	Acknowledgments

Top Abstract Introduction Patients and Methods Results Comment Discussion Acknowledgments References

 
We acknowledge André Capderou, MD, for his contribution with statistical analysis and Dr M. Talat Odman for editorial assistance.

	References

Top Abstract Introduction Patients and Methods Results Comment Discussion Acknowledgments References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Emre Belli Ece Salihoglu Bertrand Leobon Alain Serraf Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Belli, E. Articles by Serraf, A. Search for Related Content PubMed PubMed Citation Articles by Belli, E. Articles by Serraf, A. Related Collections Congenital - cyanotic