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Ann Thorac Surg 2001;71:S371-S374
© 2001 The Society of Thoracic Surgeons


Autografts, allografts, and biological valves in children

Repair of truncus arteriosus in early infancy with antibiotic sterilized aortic homografts

Christos Alexiou, FRCSa, Barry R. Keeton, FRCPb, Anthony P. Salmon, FRCPb, James L. Monro, FRCSa

a Department of Cardiac Surgery, The General Hospital, Southampton, United Kingdom
b Department of Paediatric Cardiology, The General Hospital, Southampton, United Kingdom

Address reprint requests to Dr Monro, Department of Cardiac Surgery, The General Hospital, Tremona Rd, Southampton SO16 6YD, UK
e-mail: monro1711{at}aol.com

Presented at the VIII International Symposium on Cardiac Bioprostheses, Cancun, Mexico, Nov 3–5, 2000.


    Abstract
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
Background. To evaluate the fate of the truncal valve, the antibiotic sterilized aortic homografts, and the survival after repair of truncus arteriosus in the first 6 months of life.

Methods. Between 1974 and 1994, 23 infants (mean age 1.7 months, range 5 days to 6 months) underwent primary repair of truncus arteriosus by one surgeon (J.L.M). Sixteen were neonates (age range 5 to 30 days). Continuity between the right ventricle and the pulmonary artery was established with an aortic antibiotic sterilized homograft (mean diameter 14.9 mm, range 11 to 17 mm). Follow-up was 100% complete.

Results. Four neonates with severe truncal regurgitation died early (17.4%). Fourteen patients underwent reoperations. Five had a truncal valve replacement (mean time 7 years, range 6 months to 17 years). Ten-year freedom from truncal valve replacement was 78.2%. Eleven patients had homograft replacement (mean time 12.7 years, range 2 to 26.2 years). Ten-year freedom from homograft replacement for any cause was 77.1% (for homograft-related problems it was 86.7%). Seven patients retained the original homografts (mean time 14.3 years, range 6 to 18.7 years). There was one late death. Overall 10-year survival was 79% and for the hospital survivors it was 95%. All survivors are in New York Heart Association functional class I.

Conclusions. Abnormal truncal valves pose serious early and late problems but the patients with normal truncal valves do well and seem unlikely to need replacement of these valves. The durability of the antibiotic sterilized aortic homograft even in sizes less than 14 mm is remarkably good. Late survival is excellent.


    Introduction
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
The poor natural history of truncus arteriosus, the disappointing results achieved with medical therapy or palliative intervention, and the unfavorable outcomes after delayed repair, have led to the generally accepted view that corrective operations should be performed during the first few months of life [15].

Since 1974 we have favored elective primary repair of truncus arteriosus in early infancy and have used antibiotic sterilized aortic homografts to establish right ventricular (RV)–pulmonary artery (PA) continuity.

The purpose of this study was to assess early and late outcomes obtained with this approach, placing emphasis on the late fate of the truncal valve and the antibiotic sterilized aortic homograft, the long-term survival, and the physical status of survivors.


    Patients and methods
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
Between July 1974 and March 1994, 23 consecutive infants less than 6 months of age (13 female and 10 male) underwent primary repair of persistent truncus arteriosus by one surgeon (J.L.M.) in Southampton, UK. Their mean age (± standard deviation) was 1.7 ± 1.5 months (range 5 days to 6 months) and 16 were neonates (5 to 30 days old). Their mean body weight was 3.4 ± 0.7 kg (range 2.2 to 5.9 kg).

Clinical and pathologic features
Type I truncus arteriosus was present in 16, type II in 6 and type III in 1 patient. The operations were elective in 8 patients, urgent in 7, and emergencies in 8. Truncal regurgitation (TR) was present in 9 and was mild/moderate in 1, moderate in 4 and severe in 4 patients.

Operation
Cardiopulmonary bypass with deep hypothermia and circulatory arrest, and surface or core cooling, was used until the late 1980s. Since then, repair of truncus arteriosus under cardiopulmonary bypass alone has been our standard practice.

Interatrial communications were closed. The ventricular septal defect was closed with a Dacron or, more recently, with a Gore-Tex (W. L. Gore & Associates, Flagstaff, AZ) patch.

Right ventricular–pulmonary artery continuity was established with an antibiotic sterilized aortic homograft including the anterior leaflet of the mitral valve. Care was taken to use a high ventriculotomy, so that the homograft could be placed in the anatomical position and thus avoid sternal compression [6]. The use of the anterior leaflet of the mitral valve obviated the need for an extra patch to close the right ventriculotomy in most cases [6]. The mean size of the homografts was 14.9 ± 1.4 mm (range 11 to 17 mm). In 6 patients a less than 14-mm homograft (range 11 to 13 mm) was implanted. In 3 patients in whom a small homograft was not available, one of the cusps of the homograft with the corresponding segment of the aortic wall was removed, creating a bicuspid homograft of reduced size [7].

Concomitant procedures included repair of type B interrupted aortic arch in 2 patient and homograft aortic root replacement with reimplantation of the coronaries in 1 patient.

Mean RV/left ventricular pressure ratio before sternal closure was 0.4 ± 0.4 (range 0.2 to 0.6). In no patient was the sternum left open at the end of the procedure.

Follow-up
Mean follow-up was 14.8 ± 4.9 years (range 0.6 to 26.2 years) and was 100% complete.


    Results
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
Operative mortality and morbidity
There were four early deaths in neonates 5, 6, 13, and 24 days old who presented in severe cardiac failure due to TR and who underwent emergency operation.

Eleven patients sustained nonfatal early postoperative complications. Five had cardiac arrests (in 4 patients the cardiac arrest was thought to have been precipitated by a pulmonary vascular crisis), 7 required prolonged ventilation, 6 required prolonged inotropic support, and 3 patients received peritoneal dialysis. Chest infection occurred in 2 patients and left-sided pneumothorax in 1.

Reoperations or reinterventions
Fourteen patients required reoperations or catheter reinterventions for replacement of a truncal valve (n = 5), a homograft (n = 11), or enlargement, ballooning, and stenting of a stenosed homograft or pulmonary arteries (n = 2). Kaplan–Meier freedom from any reoperation or catheter reintervention (± standard error from the mean) at 5 and 10 years was 74% ± 10% and 57% ± 12%, respectively.

Truncal valve replacement
Five patients, all of whom had various degrees of TR at the time of the repair of truncus arteriosus, had truncal valve replacement (TVR) with a mechanical valve at a mean time of 7 ± 4.9 years (range 6 months to 17 years after the initial operation). Freedom from TVR at 5 and 10 years was 84.2% ± 8.4% and 78.2% ± 9.7%, respectively.

Homograft replacement
Eleven patients had homograft replacement at a mean time of 12.7 ± 5.8 years (range 2 to 26.2 years) with no operative mortality. In 1 patient with pulmonary artery stenosis and 1 in whom the truncal valve was being replaced this was not related to the homograft. Five patients received a cryopreserved aortic homograft, 5 a cryopreserved pulmonary homograft, and 1 patient, who had at the same time a mechanical TVR, a Carboseal composite conduit (mean size 20.4 ± 1.6 mm, range 19 to 23 mm). Freedom from homograft replacement for any cause at 5 and 10 years was 89% ± 7.4% and 77.1% ± 10%, respectively (Fig 1).



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Fig 1. Kaplan–Meier freedom from homograft replacement for any cause (———-) at 5 and 10 years was 89% ± 7.4% and 77.1% ± 10.1%, respectively; for homograft-related causes (- - - - - -) it was 100% and 86.7% ± 8.8%.

 
Nine patients required conduit replacement because of homograft-related causes at a mean time of 13.4 ± 5.2 years (range 7 to 26.2 years). Freedom from homograft replacement because of homograft-related problems at 5 and 10 years was 100% and 86.7% ± 8.8%, respectively (Fig 1).

Seven patients retained their original antibiotic sterilized aortic homografts for a mean time of 14.3 ± 2.5 years (range 6.2 to 18.7 years).

Five of the six infants who had a less than 14-mm (range 11 to 13 mm) homograft were among the hospital survivors. Two had their conduits (11 and 12 mm) replaced 13 and 7 years postoperatively and 3 have their original homografts (12, 12, and 13 mm) 12, 14, and 15 years postoperatively.

Long-term survival and functional status
There has been one late death. This patient had moderate TR at the first operation and died from low cardiac output, after an emergency TVR, at 12 months of age.

Overall 10-year survival was 79% ± 8.6%; for the hospital survivors 10-year survival was 95% ± 5.1% (Fig 2). Recent echocardiographic investigations demonstrated no significant regurgitation or gradients across the native or mechanical truncal valves. The mean RV–PA gradient among the 7 patients who have the original homografts in situ was 41.5 ± 8.8 mm Hg (range 23 to 55 mm Hg). We usually consider a RV pressure of more than 2/3 of systemic as a rough guide as to when to replace the homograft.



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Fig 2. Kaplan–Meier 10-year survival for all patients (———-) was 79% ± 8.6% and for the hospital survivors (- - - - - -) it was 95% ± 5.1%.

 
At the latest clinical evaluation all survivors were in New York Heart Association class I leading a normal or near normal lifestyle.


    Comment
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
In the management of truncus arteriosus, there is some controversy regarding the timing of an operation, the management of the truncal valve, and the choice of the RV–PA conduit, or indeed whether one is needed at all [8].

We have always undertaken correction of truncus arteriosus when the clinical state required it. Some patients remained well until older than 2 months of age, but 16 (69.5%) required correction in the neonatal period. There is some merit in waiting to allow the use of a larger conduit, but not at the expense of deterioration in the infant’s clinical state or the development of pulmonary vascular disease. Opinions vary regarding timing [35], but since the excellent early results achieved by Ebert and colleagues[2] most surgeons would agree on operating during early infancy.

The 100% freedom from TVR among the patients with normal truncal valves in this series is encouraging, indicating that a TVR in this subset of patients is rarely needed [9].

The management of an abnormal truncal valve is a difficult problem. Postponing the replacement of a mildly or moderately regurgitant truncal valve at the time of the repair of truncus arteriosus seems to be a reasonable option [3]. Four of the 5 patients with moderate or mild-to-moderate TR treated in such a way in this series did well and are among the long-term survivors. When the initial TR is severe, repair or replacement should be considered but achieving a competent valve is very difficult.

Mechanical TVR at the time of the initial repair has yielded poor results [10]. Elkins and coworkers [11] obtained promising early results with concomitant homograft root replacement, but other reports and our experience with only 1 patient were disappointing [10].

Truncal valve repair in small series of patients has been described with encouraging early and midterm outcomes [12]. Given the dismal outlook for patients with severe TR we now would consider repair, and have on a few occasions attempted it since this series, but some valves are clearly irreparable.

The overall 10-year freedom from homograft replacement among our patients of 77.1% (86.7% for homograft-related causes) is considerably higher than the figures quoted previously for various RV–PA conduits [2, 9, 13]. In the report by Weipert and colleagues [14], 10-year freedom from aortic or pulmonary homograft replacement was 69%, but all homografts less than 15 mm had to be replaced sooner than 7 years after their implantation. Surprisingly, the small-sized conduits (11 to 13 mm) fared well in our series with four of five such conduits lasting for at least 12 years.

We cannot explain with certainty why the homografts used in this series fared so well. It is of note that they were treated with the same preparation used for the homografts implanted in the aortic position in adults, which also had good durability [15]. In addition, it may be that our placement of the homograft in the anatomical position [6] avoids sternal compression, which may be a contributing factor in longer homograft survival.

Antibiotic sterilized aortic homografts, owing to their excellent performance, remain the conduit of our choice, but if they are not available then cryopreserved aortic or pulmonary homografts are used.

In conclusion, dysplastic and regurgitant truncal valves at the time of the repair of truncus arteriosus pose serious early and late problems. The patients with normal valves do well and seem unlikely to require TVR. The performance and the durability of the antibiotic sterilized homograft even in sizes less than 14 mm is remarkably good. The late survival and the functional status of the late survivors are excellent.


    References
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 

  1. DiDonato R.M., Fyfe D.A., Puga F.J., et al. Fifteen-year experience with surgical repair of truncus arteriosus. J Thorac Cardiovasc Surg 1985;89:414-422.[Abstract]
  2. Ebert P.A., Turley K., Stanger P., Hoffman J.I.E., Heymann M.A., Rudolph A.M. Surgical treatment of truncus arteriosus in the first six months of life. Ann Surg 1984;200:451-456.[Medline]
  3. Brizard C.P., Cochrane A., Austin C., Nomura F., Karl T.R. Management strategy and long term outcome of truncus arteriosus. Eur J Cardiothorac Surg 1997;11:687-696.[Abstract]
  4. Urban A.E., Sinzobahamvya N., Brecher A.M., Wetter J., Malorny S. Truncus arteriosus: ten-year experience with homograft repair in neonates and infants. Ann Thorac Surg 1998;66:S183-S188.
  5. 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]
  6. Monro J.L., Shore G. Colour atlas of cardiac surgery: congenital heart disease. London: Wolfe Medical, 1984:144.
  7. Monro J.L., Tolan M.J., Slavik Z., Salmon A.P., Keeton B.R. Downsizing of valve allografts for use as right heart conduits. Ann Thorac Surg 1995;59:789.[Free Full Text]
  8. Barbero-Marcial M., Riso A., Atik E., Jatene A. A technique of correction of truncus arteriosus types I and II without extracardiac conduits. J Thorac Cardiovasc Surg 1990;99:364-369.[Abstract]
  9. Rajasinghe H.A., McElhinney D.B., Reddy M.V., Mora B.N., Hanley F.L. Long-term follow-up of truncus arteriosus repair in infancy: a twenty-year experience. J Thorac Cardiovasc Surg 1997;113:869-879.[Abstract/Free Full Text]
  10. McElhinney D.B., Reddy M.V., Rajasinghe H.A., Mora B.N., Silverman N.H., Hanley F.L. Trends in the management of truncal valve insufficiency. Ann Thorac Surg 1998;65:517-524.[Abstract/Free Full Text]
  11. Elkins R.C., Steinberg J.B., Razook J.D., Ward K.E., Overhold E.D., Thompson W.M. Correction of truncus arteriosus with truncal valve stenosis or insufficiency using two homografts. Ann Thorac Surg 1990;50:728-733.[Abstract]
  12. Imamura M., Drummond-Webb J.J., Sarris G.E., Mee R.B. Improving early and intermediate results of truncus arteriosus repair: a new technique of truncal valve repair. Ann Thorac Surg 1999;67:1142-1146.[Abstract/Free Full Text]
  13. Bull C., Macartney F.J., Merrill W., et al. Evaluation of long-term results of homograft and heterograft valves in extracardiac conduits. J Thorac Cardiovasc Surg 1987;94:12-19.[Abstract]
  14. Weipert J., Meisner H., Mendler N., et al. Allograft implantation in pediatric cardiac surgery: surgical experience from 1982 to 1994. Ann Thorac Surg 1995;60:S101-S104.
  15. Langley S.M., Livesey S.A., Tsang V.T., et al. Long-term results of valve replacement using antibiotic-sterilised homografts in the aortic position. Eur J Cardiothorac Surg 1996;10:1097-1106.[Abstract]



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