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J Thorac Cardiovasc Surg 2006;132:665-671
© 2006 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

Encouraging results for the Contegra conduit in the problematic right ventricle–to–pulmonary artery connection

David L.S. Morales, MDa,1,*, Brandi E. Braudb, Kathryn S. Gunter, BS, BAb, Kathleen E. Carberry, RNb, Karol A. Arrington, RNb, Jeffrey S. Heinle, MDa,1, E. Dean McKenzie, MDa,1, Charles D. Fraser, Jr, MDa,1

a Division of Congenital Heart Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Tex
b Division of Congenital Heart Surgery, Texas Children's Hospital, Houston, Tex.

Received for publication December 13, 2005; revisions received February 16, 2006; accepted for publication March 6, 2006.

* Address for reprints: David L. S. Morales, MD, Division of Congenital Heart Surgery, Texas Children's Hospital, 6621 Fannin St MC-WT 19345H, Houston, TX 77030. (Email: dlmorale{at}texaschildrenshospital.org).


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 References
 
OBJECTIVE: The Contegra conduit was developed for right ventricular outflow tract reconstruction. This report evaluates the Contegra conduit, with focus on certain subpopulations in which conduits are known to perform poorly (ie, patients with previous homograft conduits and infants).

METHODS: A retrospective review of 76 patients who had 77 Contegra conduits placed for right ventricular outflow tract reconstruction (January 2001 through August 2005) was completed. Characteristics include the following: median age of 1.6 years (range, 17 days–15.1 years), weight of 9.8 kg (range, 2.5–64.0 kg), and conduit diameter of 16 mm (range, 12–22 mm). Operations performed include right ventricular outflow tract reconstruction for pulmonary atresia–stenosis (n = 33), conduit exchange (n = 28), truncus repair (n = 7), primary conduit placement (n = 6), and the Ross procedure (n = 3). Seventy-nine percent were reoperations.

RESULTS: There was no hospital mortality. Mean follow-up was 20 ± 14 months. One-, 2-, and 3- year freedom from severe conduit regurgitation was 97%, 86%, and 81%, respectively, and freedom from severe conduit stenosis was 100%. Freedom from reoperation for conduit failure at 1 and 3 years is 98.3% and 93.1%, respectively. All conduit failures (n = 3) were for asymptomatic conduit pseudoaneurysms in the setting of multiple-level pulmonary branch stenoses. Survival at 3 years is 96%. Infants (n = 26) had a freedom from Contegra conduit failure at 3 years of 100%. Patients with previous homograft conduits (n = 26) had a freedom from Contegra conduit failure at 3 years of 100%.

CONCLUSION: At midterm follow-up, the Contegra conduit remains a reliable, accessible, and easily implantable conduit for right ventricular outflow tract reconstruction. It appears to be the most promising conduit option for patients with previous homograft conduits and for infants.

Abbreviations and Acronyms CI = confidence interval; CPB = cardiopulmonary bypass; PA = pulmonary artery; PAR = pulmonary artery resistance; RV = right ventricle; RVOT = right ventricular outflow tract; TCH = Texas Children's Hospital


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 References
 

Figure 1
Dr Morales


Reconstruction of the congenitally abnormal right ventricle (RV)–to–pulmonary artery (PA) tract presents a significant challenge for the congenital heart surgeon. The long-term life expectancy of patients after ventricular outflow tract operations continues to be less than that of the general population.1Go In the absence of a perfect conduit, the search for an optimal existing RV-PA conduit continues. Since its introduction in 1999, the Contegra bovine jugular vein conduit (Medtronic, Inc, Minneapolis, Minn) has received much interest because of several inherent advantages. Unlike cryopreserved homograft valved conduits, it is readily available in many sizes (12–22 mm) and is comparatively less expensive. Compared with other conduits, it is especially pliable, with excellent suturing and tailoring characteristics.2Go The conduit is fixed with 0.6% gluteraldehyde under zero pressure conditions, and with no additional anticalcification treatment, it has demonstrated an excellent durability, low calcification rate, and low rate of stenosis in animal trials.3–6Go Most importantly, several clinical reports have shown excellent early and midterm hemodynamic and clinical results that compare favorably with the results of cryopreserved homograft valved conduits, the gold standard of RV-PA conduits.7–11Go Despite being the gold standard, homograft conduits have consistently performed poorly in certain patient cohorts, specifically patients with previous homograft conduits and infants.12–15Go The aims of this study were to evaluate the Contegra conduit's function and durability and to analyze its performance in those subpopulations in which homograft conduits have unsatisfactory results.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 References
 
Patient Population
Between January 2001 and August 2005, 76 patients between 17 days and 15.1 years old underwent 77 RV-PA reconstructions with the Contegra valved bovine jugular vein conduit (Figure 1) at Texas Children's Hospital (TCH). Their medical records were retrospectively reviewed with the approval of the Baylor College of Medicine Institutional Review Board. Mean weight was 13.5 ± 12.1 kg. Thirty-four percent (n = 26) of the entire cohort were infants. All available sizes of the Contegra conduit (12–22 mm) were implanted, with the median size being 16 mm. Indications for surgical intervention included pulmonary atresia (n = 31), replacement of a previous conduit (n = 28; 26 homografts, 1 Contegra conduit, and 1 polytetrafluoroethylene* conduit), truncus arteriosus (n = 8), tetralogy of Fallot (n = 6), aortic valve disease (the Ross procedure; n = 3), and D-transposition of the great arteries.1Go Since receiving its human device exemption, the Contegra conduit is not a conduit option in the United States for the Ross procedure. Sixty-one (79%) of the 77 conduit placements were in patients undergoing a reoperation. All patients underwent preoperative, transthoracic, 2-dimensional echo-Doppler examination and intraoperative transesophageal echocardiography. Of the 46 children who had preoperative catheterizations, 6 (13%) had PA or conduit angioplasty or stents.


Figure 1
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  		Figure 1. Age distribution of the study cohort.

 
Surgical Technique
All patients underwent median sternotomy, direct aortobicaval cannulation, and cardiopulmonary bypass (CPB). Other concomitant procedures included ventricular septal defect closure (n = 41), truncus repair (n = 7), Blalock-Taussig shunt takedown (n = 14), the Ross procedure (n = 3), and truncal valve replacement (n = 1). Mean CPB time was 197.5 ± 74.8 minutes. Mean crossclamp time was 103.6 ± 79.3 minutes. All conduits exchanged without a concomitant procedure were done on CPB with a beating heart. The implantation technique was guided by the principles of (1) trimming the distal graft to make the distance between the valve and the distal anastomosis as short as possible, (2) ensuring the conduit was thoroughly washed to avoid bleeding of the gluteraldehyde, (3) creating a generous pulmonary arteriotomy that widely splays open the PAs, and (4) oversizing of the conduit. Conduit oversizing is especially practiced in the infant population, where the largest conduit that can fit comfortably in the mediastinum is used. However, this oversizing is tempered by the consideration of sternal compression. When the anatomy is favorable, the conduit is placed as lateral as possible to the left. A course rightward of the aorta is avoided when possible. Each of the anastomoses is created with running Prolene sutures (Ethicon, Inc, Somerville, NJ). No patient left the operating room with more than mild conduit insufficiency or stenosis.

Postoperative Care and Follow-up
All patients underwent postoperative transesophageal echocardiography while still in the operating room. Hospital morbidity end points observed were postoperative hemorrhage (requiring reoperation), sepsis (bacteremia with hemodynamic compromise), and neurologic event. After discharge, 40 (53%) patients with the Contegra conduit had routine echocardiography follow-up as part of a multi-institutional US Food and Drug Administration study at 1 month, 3 months, 6 months, 1 year, and yearly thereafter. All other patients were followed and underwent echocardiography at the discretion of the referring cardiologist. All patients were started on aspirin for anticoagulation. No patient was started on another anticoagulant because of the conduit. There was a mean follow-up interval of 19.7 ± 13.6 months. Twenty-four (32%) of the 76 patients have been followed for 2 years or more. Conduit failure is defined as exchanging the conduit because of a problem with the conduit. Stenosis was defined as mild when the peak velocity across the conduit was less than 2.5 m/s, moderate when it was 2.5 to 4.5 m/s, and severe when it was 4.5 m/s or greater. The peak velocity was measured throughout the length of the conduit, and the maximum value was used.

Statistical Analysis
The follow-up data for survival, reoperation, reintervention, and conduit function were analyzed by using standard Kaplan-Meier analysis. Nonparametric, binomial, and descriptive statistics were computed when appropriate. The Fisher exact test was used to analyze binary variables.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 References
 
Hospital Course
There were no hospital deaths. Length of intubation was 2.9 ± 4.1 days. Intensive care unit length of stay was 5.2 ± 5.2 days. One patient was chronically intubated preoperatively and remained so at home after discharge. Mean hospital length of stay was 12.5 ± 14.3 days. There were no neurologic events, episodes of sepsis, or postoperative hemorrhages requiring reoperation.

Mortality and Reintervention
One patient died of congestive heart failure 34 days after the operation. This was a 17-day-old infant with truncus arteriosus who was taken to the operating room in cardiogenic shock caused by a myocardial infarction in evolution and severe truncal insufficiency. He underwent truncus arteriosus repair with a 12-mm conduit and was discharged home 27 days after the operation. He returned to the clinic 5 days later poorly perfused. He was difficult to resuscitate and eventually arrested and died. His autopsy stated that his sudden decompensation could be related to thrombi in the sinuses obstructing the conduit's valve orifice. Clinically, it appeared that poor cardiac output superimposed on significant preexisting endocardial ischemia and damage accentuated myocardial dysfunction and led to death.

The second death occurred in a patient who presented at 9 years of age with tetralogy of Fallot and renal failure that required dialysis preoperatively. Her hospital course at the time of repair was uneventful; however, she was severely dehydrated and septic at presentation 20 months postoperatively. She went into multisystem organ failure and died 3 weeks after admission on postoperative day 517.

Survival at 1 and 3 years is 98.6% and 96.4%, respectively.

Seven patients with the Contegra conduit had a reoperation. Two patients had reoperations unrelated to the Contegra conduit, which was left in place. Two conduits that were functionally sound were exchanged during reoperations for non–conduit-related issues and to facilitate access to other structures. Three exchanges were required for conduit failure at a mean interval of 337 ± 144 days. All failures were caused by pseudoaneurysms at the proximal anastomosis. Freedom from reoperation for conduit failure was 98.3% (95% confidence interval [CI], 0.92–0.99) at 1 year and 93.1% (95% CI, 0.85–0.96) at 3 years (Figure 2). Of the patients with pseudoaneurysms, all were asymptomatic. All 3 patients had the diagnosis of pulmonary atresia and ventricular septal defect with major aortopulmonary collateral arteries. One patient had a dehiscence of his ventricular septal defect patch after a febrile illness and had a chest radiograph that demonstrated a mass in the left superior mediastinum. A cardiac catheterization demonstrated a large pseudoaneurysm of the right ventricular outflow tract (RVOT). The second patient underwent a routine follow-up echocardiogram, which revealed a pseudoaneurysm in the RVOT. The third patient had difficult distal branch PA reconstruction at the primary operation and was scheduled for cardiac catheterization 6 months later, which revealed a large pseudoaneurysm at the proximal anastomosis of the conduit (Figure 3). All patients undergoing reoperation were discharged and are still alive.


Figure 2
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  		Figure 2. Freedom from reoperation for Contegra conduit failure. Vertical lines represent 95% confidence intervals.

 

Figure 3
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  		Figure 3. A, Angiogram of pseudoaneurysm (anteroposterior view). B, Angiogram of pseudoaneurysm (lateral view).

 
Seven patients had balloon angioplasty of or stent placement in their PAs distal to the conduit. Four patients underwent interventional catheterization on the conduit at a mean interval of 17.5 ± 9.9 months. One patient had balloon angioplasty of bilateral PAs and conduit stent placement, and 3 patients had balloon angioplasty of their distal conduits. Freedom from catheter intervention on the conduit is 98.5% (95% CI, 0.91–0.99) at 1 year and 92.9% (95% CI, 0.85–0.96) at 2 years.

In addition to the patient who died, one other patient had a small thrombus in the conduit valve sinuses discovered during routine echocardiographic follow-up. This patient has been asymptomatic and receives aspirin therapy only. The thrombus has not changed in 3 years.

Conduit Function
The overall freedom from severe conduit stenosis is 100% at 3 years, and freedom from moderate stenosis at 1, 2, and 3 years is 100%, 92%, and 82%, respectively (Figure 4, A). The freedom from severe regurgitation at 1, 2, and 3 years is 97%, 86%, and 81%, respectively, and that from moderate regurgitation is 91%, 80%, and 64%, respectively (Figure 4, B). The mean time interval between the day of the operation and the last echocardiographic follow-up was 1.5 ± 1.2 years. Of the 6 patients who had a preoperative PA resistance (PAR) of greater than 2.5 Woods units or mean PA pressures of greater than 18 mm Hg, 67% (n = 4) had moderate or severe pulmonary insufficiency compared with 25% (n = 17) for the rest of the cohort (P = .07).


Figure 4
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  		Figure 4. A, Freedom from moderate or severe conduit stenosis. B, Freedom from moderate or severe conduit regurgitation. Vertical lines represent 95% confidence intervals.

 
Subpopulation Results
In the infant population (n = 26; mean age, 6.7 ± 3.8 months; mean weight, 6.1 ± 2.2 kg; mean follow-up, 18.3 ± 11.3 months) freedom from failure at 3 years is 100%. One infant required catheter intervention and balloon conduit plasty at 31/2 years. In patients with previous RV-PA homograft conduits (n = 26; mean age, 5.4 ± 3.8 years; mean follow-up, 19.5 ± 16.3 months), freedom from failure at 3 years is 100%. None of these patients have required catheter intervention on the conduit.


   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
References
 
Since receiving human device exemption approval in November 2003, the Contegra bovine jugular vein conduit has been increasingly used for RVOT reconstruction. One reason that the Contegra conduit has enjoyed such a wide acceptance is the lack of a clearly superior RV-PA conduit. The Shelhigh porcine-valved conduit (Shelhigh, Inc, Union, NJ) and porcine xenografts have proved disappointing.16–18Go Dacron xenograft valve conduits, like the Hancock conduit (Medtronic, Inc), have had good short and midterm results but are difficult to implant, require preclotting, and have a tendency toward stenosis and calcification, especially in small-diameter conduits.19Go Therefore their use in infants has been avoided. In the TCH experience the Perimount bovine pericardial tissue prosthesis (Edwards Lifesciences, Irvine, Calif) appears to be a promising option when seeking to provide pulmonary valve competence, such as in patients with previous transventricular repair of tetralogy of Fallot. However, it cannot be used to reconstruct the RVOT and it cannot be used in smaller children.

Since the homograft became the conduit of choice for RVOT reconstruction in the mid-1980s, the superiority of homograft conduit performance to xenograft composite conduits in terms of durability, function, and malleability has been reported numerous times.9,13,16Go However, a recent report by Brown and colleagues12Go conveyed an unsatisfying performance for homograft conduits at a midterm follow-up of 5 years. Homograft dysfunction and failure were 60% and 40%, respectively. The TCH experience with the Contegra conduit demonstrates a 3-year conduit failure rate of 7%. Boethig and associates11Go have reported a freedom from explantation of 100% at 4 years for the Contegra conduit, whereas homografts in the same study had an explantation rate of 20% over the same time period. Therefore the Contegra conduit appears comparable with, if not better than, the presently available RV-PA conduits {freedom from conduit replacement for pulmonary homografts of 80% at 3 years; Shelhigh, 30% at 18 months; porcine xenografts, 30% at 2 years; and porcine-valved conduits-Hancock, 90% at 2 years).11,16–19Go

More importantly, the Contegra conduit appears to have superior results in subpopulations in which all other RV-PA conduits, especially the homograft, have had particularly poor results (ie, patients with prior homografts and infants). Brown and colleagues12Go reported an incidence for homograft conduit dysfunction and failure of 79% and 58%, respectively, for their infant cohort. This high rate of failure has also been seen in several other studies that described the increased risk of homograft degeneration when used for RVOT reconstruction in infants.13–15Go Limited availability of small-sized homografts for infants often results in the compromise of conduit selection, which factors into the rate of conduit failure.20Go This compromise manifests itself in the use of downsized larger conduits or use of slightly flawed conduits because of limited supply. Although many believe that a stronger predictor of conduit failure in infants is patient size and not conduit type,20–23Go the TCH experience with the Contegra conduit demonstrates that conduit type is important. The Contegra conduit's constant availability in many sizes allows the surgeon to consistently apply an oversized and reliable conduit. The 26 infants who had the Contegra conduit placed in this series had a 100% freedom from conduit failure at 3 years.

Another advantage of the Contegra conduit is its promising performance in patients who have had previous RV-PA reconstructions with cryopreserved homografts. Many centers have avoided using a second homograft conduit in these patients because of the higher rate of failure of the second homograft conduit compared with that of the original homograft.24Go Using multivariate analysis, Stark and coworkers25Go found that a previous homograft was the most significant risk factor for second homograft failure. Many believe this to be a result of a heightened immune state caused by viable endothelial cells in the first homograft. This immune response to homografts has been clearly documented by several groups who have shown a significant increase in panel reactive antibody levels after homograft insertion.23,26,27Go Many hypothesize that this immune state accentuates the failure of the second homograft by means of an immune-mediated narrowing of the conduit. The development of the SynerGraft pulmonary allograft (CryoLife, Inc, Kennesaw, Ga) is an attempt to address this immune response issue.23,26,27Go In patients with previous homografts, the TCH preference is to use the Contegra conduit. The freedom from conduit exchange at 3 years is 100% in this population.

As with all RV-PA conduits, inherent disadvantages of the Contegra conduit exist. Patients with high PA pressures and PARs have a higher rate of conduit insufficiency. This finding is not surprising because the Contegra conduit contains a venous valve not created for high pressures. This trend toward insufficiency probably did not reach statistical significance in this study because of the limited number of patients with high pulmonary pressures who received Contegra conduits. These limited numbers are a result of a management decision during this current series to cautiously apply the Contegra conduit in patients with high PA pressures. This policy is based on the earlier experiences in the series. In addition to this consideration, the length of the Contegra conduit's valve can be prohibitive in certain low-birth-weight children (<2.5 kg) when the distance between the RV opening and the PAs is short. Also, larger adults usually receive a Perimount valve or a Hancock conduit at TCH because 22 mm is the largest Contegra conduit size. In almost all other cases, the Contegra conduit's application is preferred over that of other conduits, especially in neonates.

Pseudoaneurysm formation in patients with compromised PA vasculature or high PARs are also a concern with the Contegra conduit. We theorize that the treatment of the conduit that prevents calcification also minimizes periconduit adhesions and tissue ingrowth, which contributes to the structural integrity of most conduit anastomoses. The lack of this healing process in patients with increased PA pressures might contribute to pseudoaneurysm formation. Although surgical technique must be considered as a cause, the development of psuedoaneurysms was not limited to one surgeon, and pseudoaneurysm formation has not been a complication at TCH with the use of other RV-PA conduits. Moreover, there are other reports of pseudoaneurysm formation in the literature,28–30Go all in similar patients. Therefore the application of the Contegra conduit in patients with a compromised pulmonary vasculature (multilevel stenoses) or a high PAR is approached cautiously.

Thrombosis is another concern with the Contegra conduit. Several centers have recently reported cases of thrombus formation in the Contegra conduit in early and midterm follow-up.28,29,31,32Go Some groups suggest the use of anticoagulation during the first postoperative weeks in response to the potential for early valve failure caused by a local thrombotic process.2,29Go The TCH practice is to use aspirin only because the presence of a thrombus has not been a significant factor in a patient's clinical course or the conduit's function in this series.

This report reconfirms the Contegra conduit's favorable outcome in function and durability at short-term and midterm follow-up. Vigilance is still required regarding thrombus formation and asymptomatic pseudoaneurysms. Moreover, the Contegra conduit's durability and function in a high-pressure circulation warrants further study. Overall, the TCH experience reinforces the growing enthusiasm about the Contegra conduit as a reliable, accessible, and easily implantable conduit for RVOT reconstruction. Most importantly, the Contegra conduit presently appears to be the most promising RV-PA conduit option for patients with previous homograft conduits and for infants.


   Acknowledgments
 
We thank Dr Dan Graves for his contribution to the statistical analyses of the data presented in this manuscript.


   Footnotes
 
1 David L. S. Morales, Jeffrey S. Heinle, E. Dean McKenzie, and Charles D. Fraser report receiving a research grant from Medtronic Heart Valves, the manufacturer of the Contegra conduit. Back

* Gore-Tex conduit, registered trademark of W. L. Gore & Associates, Inc, Newark, Del. Back


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 

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Interactive CardioVascular and Thoracic Surgery, February 1, 2009; 8(2): 272 - 274.
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E. J. Hickey, B. W. McCrindle, E. H. Blackstone, T. Yeh Jr., F. Pigula, D. Clarke, C. I. Tchervenkov, J. Hawkins, and the CHSS Pulmonary Conduit Working Group
Jugular venous valved conduit (Contegra(R)) matches allograft performance in infant truncus arteriosus repair
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