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Ann Thorac Surg 1999;68:542-548
© 1999 The Society of Thoracic Surgeons

Original Articles

Valved homograft conduit repair of the right heart in early infancy

Jean Perron, MDa,b, Adrian M. Moran, MDa,b, Kimberlee Gauvreau, ScDa,b, Pedro J. del Nido, MDa,b, John E. Mayer, Jr, MDa,b, Richard A. Jonas, MDc,d

a Departments of Department of Cardiology, Children’s Hospital, Boston, Massachusetts, USA
b Department of Cardiac Surgery, Children’s Hospital, Boston, Massachusetts, USA
c Department of Surgery, Harvard Medical School, Boston, Massachusetts, USA
d Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA

Address reprint requests to Dr Jonas, Department of Cardiac Surgery, Children’s Hospital, 300 Longwood Ave, Boston, MA 02115


   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Comment
 References
 
Background. Valved homograft conduit repair in neonates and young infants creates a physiologically normal biventricular circulation, and unlike shunts, avoids surgery on the branch pulmonary.

Methods. Retrospective chart review was used for 84 patients operated on between 1990 and 1995 (mean age 26 ± 28 days, mean weight 3.3 ± 0.8 kg) undergoing homograft conduit repair in the first 3 months of life. Cases were divided into simple and complex, eg, absent pulmonary valve syndrome or associated interrupted arch. Mean homograft size was 9.0 ± 2 mm.

Results. Early mortality was 4.7% (simple) and 30% (complex). Mean hospital stay was 18 days. Mean follow-up was 34 months. Thirty-seven (47%) patients underwent conduit replacement. Median time to reoperation was 3.1 years. Mean size of replacement homograft was 17 ± 2 mm. There were no deaths at reoperation. Mean hospital stay at conduit change was 6.3 days. Probability of survival at 5 years is 75%.

Conclusions. Biventricular repair employing a conduit can be performed safely in noncomplex anomalies in the first 3 months of life. Time interval until repeat surgery is relatively short but equal or greater than that with most palliative procedures.


   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Comment
 References
 
Cardiac repair employing a conduit is not considered to be standard management during the neonatal period and early infancy in many centers. However, in contrast to palliative procedures such as shunts, conduit repair creates a physiologically normal biventricular circulation, avoids surgery on the branch pulmonary arteries, and might not increase the total number of procedures. In this report, we describe our experience with the use of cryopreserved valved homograft conduits for neonates and young infants requiring right ventricle-to-pulmonary artery connection as part of biventricular complete repair of various congenital cardiac anomalies.


   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Comment
 References
 
Between January 1990 and December 1995, 84 neonates ranging in age from 1 to 92 days had a homograft conduit implanted at our institution as part of a complete repair for anomalies requiring right ventricle to pulmonary artery connection. Diagnoses are listed in Table 1. Cases were divided into simple and complex as determined by diagnosis. Complex cases were considered to include: absent pulmonary valve syndrome, aortic arch interruption, or need for truncal valve surgery. We excluded all infants who had undergone previous palliative procedures, usually elsewhere. Institutional Review Board permission was obtained. Hospital records and the computerized data base of the Cardiovascular Program were reviewed. Long-term follow-up was attempted for all patients between November 1995 and November 1996. Families of patients not seen within the last year were contacted by phone directly, or recent follow-up was obtained through their cardiologist. Five patients were lost to follow-up, all from out of state or country. Follow-up between November 1995 and November 1996 was obtained in the remaining 79 patients (94%). Ten patients were known to be alive by correspondence sent to our hospital but did not complete an extensive questionnaire of clinical state for long-term follow-up.


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  		Table 1. Diagnosis

 
The average age at operation was 26 ± 28 days (range 1 to 92 days; median 13.5 days). The mean weight was 3.3 ± 0.8 kg (range 1.5 to 5.6 kg; median 3.2 kg). Twenty-eight patients had associated extracardiac anomalies (Table 2). Eighty-four homografts ranging from 6 to 15 mm were implanted: 42 aortic, 41 pulmonary, and 1 unknown. The average size was 9 ± 2 mm (aortic = pulmonary) and the average length was 2.8 ± 1.8 cm (range 0.9 to 9 cm; median 2.4 cm, aortic 3.6 ± 1.7 cm, and pulmonary 1.9 ± 1.5 cm). Homograft size was grouped into three classes: class 1, 6, 7, 8 mm (n = 38); class 2, 9, 10, 11 mm (n = 31); and class 3, 12, 14, 15 mm (n = 14). Homografts were provided from five different tissue banks. At surgery, the choice of homograft was determined by size, availability, and surgeon’s preference. No patient had an extension with a tube graft. In 4 patients, the proximal anastomosis was supplemented with a hood of homograft, and in all other patients, with a hood of glutaraldehyde-treated autologous pericardium.


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  		Table 2. Associated Anomalies

 
Statistical data
The primary outcome variables for this study were times to death, homograft failure, and reoperation. Homograft failure was defined as the performance of a procedure on the homograft at either dilation, stenting, or reoperation. Reoperation included only the reoperation on the homograft. For each outcome, patients who did not achieve the endpoint were considered to be censored at the time of the last follow-up. Probabilities of freedom from failure were estimated by means of the Kaplan-Meier method; 95% confidence bands were generated using Greenwood’s formula. Relationships between time to outcome and perioperative variables, including age at surgery, weight at surgery, pathology, type of case (simple vs complex), conduit type (aortic vs pulmonary), size of homograft, and length of homograft, were evaluated with the log-rank test. All statistical analyses were performed using the Stata statistical package (College Station, TX).


   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Comment
 References
 
Initial operation
Hospital mortality was 3 of 64 patients (4.7%) for the simple cases and 6 of 20 (30%) for the complex cases. The operations performed are listed in Table 3. At the initial surgery, the mean cardiopulmonary bypass time (CPB) was 145 ± 56 minutes (range 14 to 350 minutes; median 132.5 minutes), the mean cross-clamp time 72 ± 24 minutes (range 36 to 161 minutes; median 71 minutes), and the mean circulatory arrest time 39 ± 19 minutes (range 6 to 89 minutes; median 36 minutes). Thirty-two percent of the survivors had their chest left open (complex = 50% and simple = 28%) at the initial surgery or reopened within 6 hours for low-output syndrome or bleeding. They were closed 3.1 ± 1.9 days postoperatively.


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  		Table 3. Procedure Performed

 
Summary statistics regarding ventilatory and inotropic support and length of stay in the intensive care unit (ICU) and hospital for hospital survivors are listed in Table 4.


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  		Table 4. Perioperative Parameter (Days) at the Initial Surgery

 
Homograft failure
Homograft failure occurred in 43 patients (55%) at a median interval of 2.3 years after surgery (mean 3.6 years). The probabilities of freedom from graft failure at 1, 2, and 5 years were 82%, 54%, and 17%, respectively (Fig 1). Time to graft failure (Fig 2) is shortest for size class 1 and longest for class 3 (p = 0.02). Five patients had their homograft dilated, 10 had their homograft stented, and 28 had a reoperation as the primary mode of graft failure.



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  		Fig 1. Probability of freedom from graft failure over time. All pathologies included. Upper and lower bars indicate 95% confidence limits. Number of patients who have not yet failed at the beginning of each 1-year interval are indicated above the x-axis. Small circles represent follow up times for individuals who did not fail.

 


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  		Fig 2. Probability of freedom from graft failure over time according to homograft size.

 
Interventional catheterization
Five patients had their homograft dilated and 12 had their homograft stented. In the stented group, 2 had a previous dilatation. Four had a second stent implanted or a redilation of a stent placed previously. The right ventricular pressure expressed as a percentage of systemic pressure and the gradient before and after those procedures are listed in Table 5.


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  		Table 5. Right Ventricular Pressure and Homograft Gradient Before and After Interventional Catheterization

 
Reoperation
Thirty-seven patients (47%) had a reoperation on their homograft conduit at a median interval of 3.1 years (mean 4.6 years). The probabilities of freedom from reoperation at 1, 2, and 5 years were 91%, 67%, and 22%, respectively (Fig 3). Time to reoperation (Fig 4) is shortest for size class 1 and longest for class 3 (p = 0.01).



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  		Fig 3. Probability of freedom from reoperation over time. All pathologies included. Upper and lower bars indicate 95% confidence limits. Number of patients who have not yet undergone reoperation at the beginning of each 1-year interval are indicated above the x-axis. Small circles represent follow up times for individuals who did not fail.

 


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  		Fig 4. Probability of freedom from reoperation according to homograft size over time.

 
Before reoperation, 8 patients had a stent implanted (4 had a second stent or dilatation of the previous stent) and 1 had a dilation of the homograft. The preoperative homograft gradient was 55 ± 23 mm Hg and the right ventricular systolic pressure 95% ± 19% of systemic pressure. The homograft conduit was replaced in 23 patients, opened with onlay plasty in 12 patients (7 aortic, 5 pulmonary), or removed with direct right ventricle-to-pulmonary artery (RV-PA) anastomosis in 2 patients. There were 28 associated procedures in 20 patients (Table 6). The operative findings when available are listed in Table 7.


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  		Table 6. Associated Procedure With Reoperation

 

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  		Table 7. Operative Finding in 17 Patients at Reoperation

 
Twenty-three replacement homograft conduits were used with mean size 17 ± 2 mm and length 4.6 ± 1.9 cm (17 aortic homografts, mean size 16 ± 2 mm and length 5 ± 1.9 cm; 6 pulmonary homografts, mean size 19 ± 3.2 mm and length 3.2 ± 1.2 cm.). The mean cardiopulmonary bypass (CPB) time was 97 ± 32 minutes. When patients required associated procedures that required aortic cross-clamping, the mean cross-clamp time (n = 5) was 30.4 ± 20 minutes, and circulatory arrest (n = 2) was 5.5 minutes.

There were no operative deaths. Patients were ventilated for 1.2 ± 0.5 days and on inotropic support 0.8 ± 0.6 days. The average length of stay in the ICU was 2.9 ± 2.5 days (median 2 days), and total hospital days were 6.3 ± 4.

Two patients had wound infections, 1 of them had a similar complication at the initial surgery, 1 patient had a retained pulmonary artery line that had to be surgically removed, and 1 patient had paradoxical motion of the right diaphragm.

Second reintervention
Three patients had undergone dilatation and stent placement after their reoperation. Four patients had a reoperation for pathology unrelated to management of their conduit.

Univariate analysis
Univariate analysis of risk factors (Table 8) revealed that patients with an initial small homograft (class 1) were most likely to suffer early graft failure (p = 0.02) and reoperation (p = 0.01), but survival was unaffected. Simple cases have better survival than complex (p = 0.02). Age, weight, pathology, type (aortic vs pulmonary), length of homograft, and the different tissue banks providing homografts were not significant statistically.


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  		Table 8. Univariate Analysis

 
Survival and follow-up
There were 10 late deaths. The probabilities of survival at 1 month, 6 months, 1 year, and 5 years are 89%, 84%, 81%, and 75%, respectively (Fig 5). The time interval from initial surgery to death (Fig 6) was shorter for complex cases than for simple cases (p = 0.02).



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  		Fig 5. Probability of survival over time. Upper and lower bars indicate 95% confidence limits. All pathologies included. Number of patients who have not yet died at the beginning of each 1-year interval are indicated above the x-axis. Small circles represent follow up times for individuals who did not fail.

 


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  		Fig 6. Probability of survival according to cases divided into simple or complex cases over time.

 
One patient died at 82 days having received an immunization the day before. She had no postmortem examination. She had undergone repair of tetralogy of Fallot and pulmonary atresia. At surgery, she had a dual left anterior descending, which limited the ventriculotomy. On follow-up, she was suspected to have a residual ventricular septal defect. One patient had CHARGE syndrome (Coloboma, Heart disease, Atresia choanae, Retarded development, Genital hyperplasia, Ear anomalies) and died at 2 months while being operated elsewhere for a cleft palate. She had been noted by a recent echocardiography to have good ventricular function, minimal residual ventricular defect, and a 10-mm Hg gradient across the homograft. She had no postmortem examination. One patient died suddenly at home. This patient had a previous reoperation for compression of the left main coronary artery by poststenotic dilatation of the right PA. An angiogram done 2 months earlier had shown a right ventricular pressure at 42% of systemic and mild gradient at the homograft without any coronary artery compression. One patient had a complicated recovery after correction of tetralogy of Fallot and pulmonary atresia. He required an aortopexy for tracheal compression and had bronchomalacia. He was discharged and readmitted for severe bronchospasm secondary to a viral infection. He had a hemodynamic study to exclude a cardiac component of this condition. The catheterization showed systemic right ventricular pressure and a 30- to 40-mm Hg gradient across the proximal right pulmonary artery. The right pulmonary artery was dilated, which led to pulmonary artery perforation, cardiac arrest, and death. Another patient died of respiratory failure. He had had a hemodynamic study at 6 months. It showed systemic right ventricular pressure and a 70-mm Hg gradient across his right pulmonary artery. He had two stents placed. The right ventricular pressure fell to 50% systemic. He presented with respiratory distress at home 2 days later and developed unilateral pulmonary edema and death. One patient died of multiple organ failure. He had a history of a viral prodrome, sustained a respiratory arrest, showed markedly depressed right ventricular function on echo, and an aneurysm of the right ventricular outflow tract. The cause of death was attributed to viral sepsis with underlying congestive heart failure. Four deaths are recorded with minimal clinical details.

Of the 55 patients available for detailed clinical long-term follow-up, 44 are asymptomatic (80%), 8 have mild shortness of breath (SOB), fatigability, sweating upon exercise, or cyanosis, and 3 have more severe symptoms. Thirteen families (24%) report some form of neurological problem with their child (Table 9).


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  		Table 9. Neurological Outcome of 55 Patients Available for Follow-up

 

   Comment
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
References
 
Homograft conduit repair to form a RV-PA connection using a valved homograft was first described by Ross and Somerville [1]. Currently, at our institution, it is the preferred conduit for RV-PA connection in neonates requiring biventricular repair early in life. We continue to believe that complete repair in the neonatal period has advantages over palliative surgery: it ensures normal pulmonary blood flow and pressure, restores normal arterial oxygenation, minimizes the volume and pressure load on the developing heart, and provides a natural pulmonary arterial approach for further dilation and stenting procedures.

Until tissue engineering provides us with a better alternative, we prefer the use of homografts over synthetic conduits. Homograft has better hemostatic properties [2, 3] when compared with a bioprosthesis. It also provides technical ease at the time of surgery and is preferred in the neonatal period when the pulmonary vascular resistance is high and the presence of a valve is important. With a median time of 3.1 years before reoperation and acceptable freedom from graft failure and reoperation intervals, we consider the homograft to be a satisfactory conduit.

Previous reports have compared the fate of homograft conduits to bioprostheses. In a large series from Toronto, Razzouk and associates [4] compared four types of valved implants for ventricle-to-pulmonary artery connection. They concluded that Dacron conduits containing a porcine valve had significantly better durability than cryopreserved homografts. Their series is quite different from our report: the mean age was 9.1 years and the average homograft diameter 23 mm. Smaller homografts for infants were not studied.

Lacour-Gayet and associates [5] studied three different valved conduits for truncus arteriosus repair in neonates. They used Dacron-valved conduits ranging from 12 to 14 mm. The operative mortality was 16% for the entire cohort. Cases were not divided between simple and complex but were divided between anatomic and nonanatomic pulmonary valve (PV) replacement. The hospital mortality was lower in the anatomic PV replacement (7%), including placement of a homograft valved conduit, compared with 43% in the nonanatomic repair. Freedom from reoperation at 7 years was 77% for Dacron conduit and 43% for homograft. They prefer the use of Dacron-valved conduit when small cryopreserved homografts are not available.

Reddy and associates [2] have compared Dacron conduits containing porcine valves and cryopreserved homograft conduits for repair of truncus arteriosus. In a cohort of patients, actuarial freedom from conduit-related reintervention at 5 years was statistically better with homografts compared with xenograft-valved conduits. Conduit-related deaths occurred in 5.7% in the group with xenograft valved-related conduits, compared with 0% in the homograft group. This difference did not reach statistical significance and xenograft-valved conduits tended to be used early in the series compared with homografts, which were used routinely from 1992.

The only risk factor associated with decreased freedom from graft failure in our series was the use of small homografts. Reddy and associates [2] have also demonstrated that conduit size is a significant predictor of early conduit-related reintervention. In contrast to Heinemann and associates [6] from our institution, during a different time frame and with a smaller series, we could not establish a statistically significant difference between the use of pulmonary and aortic cryopreserved homografts for graft failure and reoperation.

As reported by others [2], the most frequent causes of conduit failure leading to replacement were calcification of the homograft, patient-conduit mismatch resulting from patient growth, and sternal compression of the homograft.

The role of interventional catheterization has been reported previously from our institution. Powell and associates [7] have shown the utility of angioplasty in the prolongation of conduit life. We have confirmed this finding by showing improvement in the hemodynamics across homograft conduits after stent implantation in 12 patients. However, it appears that repeat stent implantation and redilation is met with less significant improvement, reflecting the rapid growth of children over this period relative to the fixed conduit size.

The Pediatric Cardiac Care Consortium [8] has described 100% mortality for infants under 6 months of age undergoing RV-to-PA connection procedures. However, we and others [9, 10] have demonstrated the feasibility of conduit repair with low mortality in noncomplex cases. ICU and hospital stay are comparable with other neonatal procedures.

Long-term follow-up has been reported after truncus arteriosus repair in infancy [11]. Our intermediate follow-up at 5 years has demonstrated a 75% survival rate for all patients. Simple cases have 80% survival at 5 years. Complex-associated anomalies were the only significant risk factors by univariate analysis. Eighty percent of the patients are asymptomatic on follow-up. They all will require continued surveillance of their homograft valved conduit. Speech delay seemed to be the most frequent impairment in the 13 neurological problems observed by parents, but this was not the aim of this study and a complete neurological assessment was not performed. The importance of genetic factors such as microdeletion of chromosome 22 was not defined, though this is likely to have been common in these patients, many of whom had conotruncal anomalies.

The limitations of this study include its retrospective nature and single institution bias. The cohort studied was 84 consecutive neonates with various pathologies, who required homograft-valved conduits. Although the pathology was not a statistically significant factor for intermediate results on univariate analysis, it may show some correlation with time for late survival and reoperation.

Biventricular repair employing a homograft-valved conduit can be performed with low mortality with noncomplex anomalies. The postoperative course is acceptable for both complex and noncomplex anomalies. Reoperation can be performed safely in both complex and noncomplex cases. Smaller homografts have earlier graft failure and reoperation. Most patients are asymptomatic at follow-up. We believe that these data support our contention that neonatal repair, even when a conduit is necessary, is preferred over palliative alternatives.


   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 

  1. Ross D.N., Somerville J. Correction of pulmonary atresia with an allograft aortic valve. Lancet 1966;2:1446-1447.[Medline]
  2. Reddy M.V., Rajasinghe H.A., McElhinney D.B., Hanley F.L. Performance of right ventricle to pulmonary artery conduits after repair of truncus arteriosus; a comparison of Dacron-housed porcine valves and cryopreserved allografts. Sem Thorac Cardiovas Surg 1995;7:133-138.
  3. Albert J.D., Bishop D.A., Fullerton D.A., Campbell D.N., Clarke D.R. Conduit reconstruction of the right ventricular outflow tract. Lessons learned in a twelve-year experience. J Thorac Cardiovasc Surg 1993;106:228-236.[Abstract]
  4. Razzouk A.J., Williams W.G., Cleveland D.C., et al. Surgical connections from ventricle to pulmonary artery. Circulation 1992;86(Suppl II):154-158.[Abstract/Free Full Text]
  5. Lacour-Gayet F., Serraf A., Komiya T., et al. Truncus arteriosus repair. J Thorac Cardiovasc Surg 1996;111:849-856.[Abstract/Free Full Text]
  6. Heinemann M.K., Hanley F.L., Fenton K.N., et al. Fate of small homograft conduits after early repair of truncus arteriosus. Ann Thorac Surg 1993;55:1409-1412.[Abstract]
  7. Powell A.J., Lock J.E., Keane J.F., Perry S.B. Prolongation of RV-PA conduit life span by percutaneous stent implantation. Circulation 1995;11:3282-3288.
  8. Rosengart R.M., Degner T., Moeller J., et al. A multi-center study of the surgical results of right ventricular to pulmonary artery conduits. Pediatrics 1996;98:524.
  9. Bove E.L., Lupinetti F.M., Pridjian A.K., et al. Results of a policy of primary repair of truncus arteriosus in the neonate. J Thorac Cardiovasc Surg 1993;105:1057-1066.[Abstract]
  10. Hanley F.L., Heinemann M.K., Jonas R.A., et al. Repair of truncus arteriosus in the neonate. J Thorac Cardiovasc Surg 1993;105:1047-1056.[Abstract]
  11. Rajasinghe H.A., McEhinney D.B., Reddy V.M., Mora B.N., Hanley F.L. Long-term follow-up of truncus arteriosus repaired in infancy. J Thorac Cardiovasc Surg 1997;113:869-878.[Abstract/Free Full Text]
Accepted for publication March 1, 1999.




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N. Sinzobahamvya, J. Wetter, H. C. Blaschczok, M.-Y. Cho, A. M. Brecher, and A. E. Urban
The fate of small-diameter homografts in the pulmonary position
Ann. Thorac. Surg., December 1, 2001; 72(6): 2070 - 2076.
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