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Ann Thorac Surg 2001;71:619-623
© 2001 The Society of Thoracic Surgeons

Original article: cardiovascular

Shelhigh No-React porcine pulmonic valve conduit: a new alternative to the homograft

Stefano M. Marianeschi, MDa, Gabriele M. Iacona, MDa, Francesco Seddio, MDa, Raul F. Abella, MDa, Claudia Condoluci, MDa, Adriano Cipriani, MDa, Fiore S. Iorio, MDa, Shlomo Gabbay, MDb, Carlo F. Marcelletti, MDa

a Department of Pediatric Cardiac Surgery, Hesperia Hospital, Modena, Italy
b New Jersey Medical School, Section of Cardiothoracic Surgery, Newark, New Jersey, USA

Accepted for publication September 15, 2000.

Address reprint requests to Dr Marianeschi, Cardiothoracic Surgery Clinic, Valley Children’s Hospital, 9300 Valley Children’s Place, Madera, CA 93638-8762
e-mail: marianeschi{at}hotmail.com


   Abstract
Top
 Footnotes
 Abstract
Introduction
 Material and methods
 Results
 Comment
 References
 
Background. The Shelhigh No-React pulmonic valve conduit is a new porcine conduit that is glutaraldehyde-treated and detoxified using a proprietary heparin process. In our institution it has been implanted in 25 patients. The aim of this present contribution is to evaluate the short-term follow-up after its implantation.

Methods. From November 1997 to August 1999, 25 patients (mean age, 20.2 years; range, 0.6 to 28.3 years) were operated on using this conduit. Seventeen patients underwent a Ross procedure for aortic valve disease, with the conduits implanted in anatomic position; 6 patients underwent right ventricular outflow tract reconstruction; 2 patients underwent the Rastelli operation. The follow-up was complete. Preoperative and postoperative two-dimensional echocardiography data were collected.

Results. There were two non–conduit-related deaths. Two conduits needed to be exchanged because of an increase in the gradient. Overall, all patients were improved in terms of New York Heart Association class. Comparison of preoperative and postoperative two-dimensional echocardiography gradient showed significant improvement. At the 30-month follow-up, no calcification was seen on the explanted conduits or on the two-dimensional echocardiography, although many of the patients are children.

Conclusions. The Shelhigh conduits seem to be an alternative to homograft especially in infants. These experiences are preliminary, and longer follow-up is required.


   Introduction
Top
 Footnotes
 Abstract
 Introduction
Material and methods
 Results
 Comment
 References
 
Homologous valve conduits to connect the right ventricle to the pulmonary artery were first used by Ross and Sommerville in 1966 [1] and Ross in 1967 [2]. Ross was again the first author to describe the use of an autologous pulmonic valve for an aortic valve substitution [2, 3]. Since then, numerous types of conduits have been used, each with its own advantages and disadvantages [4–10]. Increased survival in patients with right ventricle to pulmonary artery discontinuity and the success of the Ross operation have resulted in increased demand on the availability of pulmonary homografts in those countries where homografts are available. Developing countries where homografts are not available do not have an acceptable alternative [11]. Although cryopreserved homografts are the accepted standard for replacing diseased, damaged, or absent pulmonary arteries in children, particularly in infants less than 1 year of age, the size, availability, and longevity of these conduits is less than satisfactory [12–19].

There is increased interest in the search for valved conduits in the right ventricular outflow tract [20]. Because the treatment of a wide number of complex cardiac abnormalities requires the use of valved conduits, conduits of all sizes must be available and ready for use after the chest is open. This is an important advantage as this option is not available with homografts. This article reports a preliminary short-term follow-up of stentless porcine valve conduits with a bovine pericardium extension, processed with glutaraldehyde and detoxified by the No-React process developed by Shelhigh (Millburn, NJ) [21, 22]. The purpose of this paper is to document the short-term results of the conduit.


   Material and methods
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
Results
 Comment
 References
 
Patients
Between November 1997 and August 1999, 25 patients with complex cardiac abnormalities received 25 conduits. Informed consent was obtained from the patients or their parents, and the ethics committee gave its approval. Patient age ranged from 0.6 to 28.3 years (mean age, 20.2 years). The body weight of the patients ranged from 6.02 to 88 kg (mean, 46.1 kg). Fifteen patients were boys and 10 were girls.

The primary diagnoses of the patients are shown in Table 1. Seventeen patients (68%) had no previous cardiac repair or palliation, whereas 8 patients (32%) had previous cardiac repair (n = 5; 2 pulmonic valvulotomies, 1 Damus-Kaye-Stansel procedure, 1 subaortic membrane removal, and 1 aortoplasty) or palliation (n = 3; 2 Blalock-Taussig shunts and 1 palliative switch).


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  		Table 1. Patient Diagnoses

 
Surgical technique
Seventeen patients required a conduit between the right ventricle and the pulmonary artery as part of the Ross procedure, and in 1 patient the concomitant procedures mitral valve replacement and tricuspid valve replacement were performed. Eight patients required a conduit for a primary reconstruction of the right ventricular outflow tract (RVOT) (Table 2). The conduits were manufactured by Shelhigh, Inc, (Millburn, NJ). They are made of a porcine valve covered with a bovine pericardial sleeve (Fig 1). The conduits were treated using the No-React detoxification process. This method consists of aldehyde cross-linkage, aldehyde detoxification, and heparin bonding. The internal conduit diameter ranged from 10 to 25 mm (mean, 19.mm; Fig 2). The choice of conduit size was selected to implant a heterograft as large as possible to accommodate the patient’s growth, on the basis of body surface area, pulmonary artery diameter, and body weight.


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  		Table 2. Procedures

 


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  		Fig 1. (A) Long-sleeve pulmonic valve conduit. (B) Short-sleeve pulmonic valve conduit.

 


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  		Fig 2. Internal diameter of the conduit and number of conduits implanted.

 
During the Ross procedure, cardiopulmonary bypass was established using aortic and bicaval cannulation. Moderate hypothermia (25°C) with moderately reduced flow (60 to 80 mL/kg) and cold anterograde crystalloid cardioplegia were used. The autologous pulmonary valves were harvested after cardioplegia infusion. Aortic root replacement with coronary reimplantation was performed using the autologous pulmonary valve. The RVOT was reconstructed with heterograft conduit and running 4.0 Prolene (Ethicon, Somerville, NJ) sutures for the distal and proximal anastomoses. The aortic cross-clamp was removed during completion of the proximal connection.

The RVOT reconstruction consists of the positioning of a conduit in the shoulder of the right ventricle. After cold anterograde crystalloid cardioplegia and low flow rates, distal anastomosis to the main pulmonary artery was done in end-to-end fashion with continuous 4.0 Prolene suture. The proximal end of the conduit was anastomosed to a ventriculotomy on the infundibular area with a running 4.0 Prolene suture, after the cross-clamp had been removed.

Follow-up methods
Two-dimensional echocardiography data were collected preoperatively and postoperatively. Peak gradient and mean gradient were evaluated. The 17 patients treated with the Ross procedure had zero preoperative gradient for obvious reasons. The preoperative gradient in the 2 patients with pulmonary atresia was naturally absent. The only meaningful hemodynamic comparative study could be performed in 6 patients with RVOT reconstruction, who had substantial preoperative gradient.

Twenty patients were available for follow-up examination by echocardiography at 1 year after operation. Of the remaining patients, 1 patient died 1 month postoperatively, 1 patient had his conduit exchanged before 1 year, 1 patient was lost to follow-up, and 2 patients have not yet reached 1 year postoperatively.


   Results
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 Abstract
 Introduction
 Material and methods
 Results
Comment
 References
 
All patients underwent routine postoperative evaluation of their conduit using clinical examination and two-dimensional echocardiography before hospital discharge. Preoperative and postoperative hemodynamic characteristics obtained by two-dimensional echocardiographic data were compared in the 6 patients without pulmonary atresia who underwent RVOT reconstruction (Table 3). The mean preoperative gradient was 52.8 mm Hg (range, 45 to 77 mm Hg), and the mean postoperative gradient was 16.0 mm Hg (range, 10 to 36 mm Hg).


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  		Table 3. Preoperative and Postoperative Hemodynamic Data Obtained by Two-Dimensional Echocardiographic Data in Patients With Right Ventricular Outflow Tract Reconstruction

 
All patients were followed up by clinic visits and two-dimensional echocardiography between 3 to 6 months and after 1 year. Symptoms of fatigue, decreased exercise tolerance, or findings of right ventricular failure with a pressure gradient more than 45 mm Hg and flow velocity greater than 4.5 m/s by two-dimensional echocardiography were indications of conduit failure.

The echocardiographic data for the 3- to 6-month and 12-month follow-ups in 15 patients show a mean flow velocity at 3 to 6 months of 1.66 ± 1.00 m/s, and after 12 months, of 2.17 ± 1.18 m/s. These data show a gradual increase in the gradients and flow velocity between the early and later examinations (p < 0.006 in the mean gradient variation). One patient currently has a flow velocity of 5 m/s with a mean gradient of 45 mm Hg, and surgical revision is planned in the near future.

Two patients had prolonged intraoperative bleeding, and 1 additional patient required reoperation for postoperative bleeding. Two patients had pericardial effusions that required surgical drainage. One patient with multiple cardiac abnormalities died of heart failure in the early postoperative period, and a second patient died at 19 months of non–valve-related sepsis as a result of meningitis.

Of note is the remarkable improvement in New York Heart Association functional status after operation. All but 1 patient who was class III preoperatively improved to class I status. The exception was the first patient in the series, who had multiple previous operations and died 1 month postoperatively of a non–valve-related cause. A similar improvement was seen in patients who were class II preoperatively, where all but 3 of 9 patients improved to class I status.

Two conduits were explanted at 5 months and 19 months postoperatively. The first exchange was necessary because of an increase in postoperative gradient. The second patient required revision for an increased gradient caused by sternal compression. In the first case, a thrombus was found related to a cotton fiber remnant. Histologically, there was no evidence of foreign body reaction or calcification. The second specimen was explanted after 19 months and had been compressed by the sternum (Fig 3). It also showed subclinical infection of the distal anastomotic site, which histologic evaluation demonstrated was clearly related to the presence of Gram-positive cocci. This is an interesting case of subclinical endocarditis that needs further evaluation. The stenosis was compounded by the presence of a fibrin deposit on the distal suture line. On opening the explanted conduit, the cusps were mobile and free from any calcification, and no evidence of peel was seen. The vegetation and the fibrosis caused by the inflammation was probably the reason for the elevated gradient and the need for exchanging the conduit.



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  		Fig 3. Macroscopic view of the compressed oval-shaped conduit explanted after 19 months. We can observe good healing of the inflow suture line.

 

   Comment
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
References
 
Reconstruction of the RVOT remains a challenge for the pediatric cardiovascular surgeon. Many reports demonstrate the shortcomings of the different techniques and materials that have been used [12, 14–18]. These problems include early reoperation because of valve degradation at retraction, calcification, peel formation, tissue degeneration, and increasing stenosis as the patient grows. Of particular interest is the different mechanisms at work in children and adults. A recent paper describes the phenomenon of acute tissue rejection of homografts in young patients as a reason for early failure [23]. Clark and coworkers [18] also describe a high rate of homograft failure in infants and children. Polyethylene terephthalate (Dacron) conduits have the advantage of being less flexible than homografts or xenografts, which can prevent sternal compression. However, these grafts have shown formation of intimal peel and valvular calcification [9].

A major advantage of xenografts is improved availability, especially in the smaller sizes often needed in infants. Pediatric patients who need urgent operation may deteriorate rapidly if a correct-size homograft is not available. Studies of xenografts conventionally treated with glutaraldehyde have demonstrated early calcification and degradation [8]. In this study, we have seen no evidence of calcification in the exchanged conduits or in the echocardiography data after a 30-month follow-up, suggesting that the No-React detoxification process may be effective. Although these are short-term results, the lack of calcification in very small children, who often demonstrate accelerated calcification, is very interesting. No valve dysfunction of any kind has been observed in this series. The melting of the cusps that has been observed in young children with the homograft has not been seen with this conduit, and it may indicate that the No-React treatment prevents rejection.

Examination of the two explanted conduits provides useful insight into their function. In the first case, a thrombus was found related to a cotton fiber remnant; because it is difficult to remove all cotton material at the time of operation, the manufacturer no longer uses cotton in the manufacturing process. The second specimen showed an elliptical lumen because of compression by the sternum that altered the laminar blood flow. This conduit was implanted in a nonanatomic position as part of an RVOT reconstruction, and the altered laminar blood flow may facilitate the formation of subclinical endocarditis vegetations. As this patient did not have any clinical symptoms of endocarditis, these findings illustrated that more research is needed to understand this type of subclinical infection.

The surgeon should consider carefully the use of appropriate surgical maneuvers, such as placement of the conduit in the pleural space, that will minimize compression of the conduit. Future improvements to the conduit should be considered, which may include a stent to avoid compression of the conduit in certain cases. We also found a fibrin deposit on the distal suture line. This appeared to be a reaction to the suture material in contact with the blood. Careful attention should be paid to the anastomosis to avoid introversion of edges of the conduit and the native pulmonary artery. It is also advisable to prevent any contact of the blood by the suture material by starting with a mattress suture technique in the back of the anastomosis, followed by continuous sutures on both sides with particular attention to the apposition of intima to intima.

The increasing popularity of the Ross procedure in treating aortic valve disease in younger patients [24] underscores the importance of a durable pulmonic valve replacement. In our series, the anatomic implantation of the conduit for the Ross procedure worked well. We found that it is important to use as large a pulmonic conduit as possible to delay exchange of the conduit.

Of the 17 patients who underwent the Ross procedure, the flow velocity and peak and median gradients were 1.9 ± 1.06 m/s, 25.2 mm Hg, and 17.05 ± 8.33 mm Hg, respectively. These values are slightly better hemodynamically than for the entire series. By contrast, the 6 patients who had an RVOT reconstruction had at 1 year an average flow velocity of 3.08 ± 1.11 m/s, a peak gradient of 39 ± 20.12 mm Hg, and an average mean gradient of 33.4 ± 15.54 mm Hg. These patients with RVOT reconstruction have hypertrophied or dilated right ventricle, which results in a relatively higher stroke volume. The only solution is to try to oversize the conduit as much as possible, and to perform meticulous proximal and distal anastomosis, inasmuch as any turbulence of blood flow can cause a higher gradient.

It is also important when measuring gradient to indicate which is the flow through the valve and to indicate which particular flow gradient is measured. At high flow, the gradient might be pathologic whereas the same conduit at lower flow might not be significant.

It is generally agreed that the ideal pulmonic valve conduit replacement has not yet been discovered. This is especially true for infants and children, who demonstrate rapid calcification and deterioration of any conduit, including homografts. Narrowing of the distal anastomosis remains a challenge for the surgeon, and it is suggested that meticulous attention must be paid to ensure that no foreign material, including sutures, comes in contact with the blood. The largest possible conduit should be implanted. In our experience, the conduit in an anatomic position works better, especially in the Ross procedure. When the valve is implanted in nonanatomic position, sternal compression can affect the performance of the graft and must be avoided by the use of appropriate surgical techniques. Based on our early results, we believe the porcine pulmonic valve conduit can be an attractive alternative to homograft, especially in young children and patients undergoing the Ross procedure. Longer follow-up is needed to determine how well this alternative to the homograft will fare.


   Footnotes
Top
 Footnotes
Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Dr Gabbay is a paid consultant and has equity in Shelhigh, Inc.


   References
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

  1. Ross D.N., Sommerville J. Correction of pulmonary atresia with a homograft aortic valve. Lancet 1966;2:1446-1447.[Medline]
  2. Ross D.N. Replacement of the aortic and mitral valves with a pulmonary autograft. Lancet 1967;2:956-958.[Medline]
  3. Ross D.N. Evolution of the homograft valve. Ann Thorac Surg 1995;59:565-567.[Free Full Text]
  4. McGoon D.C., Rastelli G.C., Ongley P.A. An operation for the correction of truncus arteriosus. JAMA 1968;205:69-73.[Abstract/Free Full Text]
  5. Marcelletti C., Mair D.D., McGoon D.C., et al. The Rastelli operation for transposition of the great arteries. Early and late results. J Thorac Cardiovasc Surg 1976;72:427-434.[Abstract]
  6. Merin G., McGoon D.C. Reoperation after insertion of aortic homograft as a right ventricular outflow tract. Ann Thorac Surg 1973;16:122-126.[Medline]
  7. Bowman F.O., Jr, Hancock W.D., Malm J.R. A valve-containing Dacron prosthesis: its use in restoring pulmonary artery-right ventricular continuity. Arch Surg 1973;107:724-728.[Abstract/Free Full Text]
  8. Agarwal K.C., Edwards W.D., Feldt R.H., et al. Clinicopathological correlates of obstructed right-sided porcine-valved extracardiac conduits. J Thorac Cardiovasc Surg 1981;81:591-601.[Abstract]
  9. Jonas R.A., Freed M.D., Mayer J.E., Jr, et al. Long term follow-up of patients with synthetic right heart conduits. Circulation 1985;72(Suppl 2):77-83.
  10. Yankah A.C., Alexi-Meskhishvili V., Weng Y., et al. Accelerated degeneration of allografts in the first to years of life. Ann Thorac Surg 1995;60(Suppl):S71-S77.
  11. Vrandecic M.O.P., Fantini F.A., Gontijo B.F., et al. Porcine stentless valve/bovine pericardial conduit for right ventricle to pulmonary artery. Ann Thorac Surg 1998;66(Suppl):S179-S182.
  12. Kay P.H., Ross D.N. Fifteen years’ experience with the aortic homograft: the conduit of choice for right ventricular outflow tract reconstruction. Ann Thorac Surg 1985;40:360-364.[Abstract]
  13. Schaff H.V., DiDonato R.M., Danielson G.K., et al. Reoperation for obstructed pulmonary ventricle-pulmonary artery conduits. J Thorac Cardiovasc Surg 1984;88:334-343.[Abstract]
  14. Sano S., Karl T.R., Mee R.B.B. Extracardiac valved conduits in the pulmonary circuit. Ann Thorac Surg 1991;52:285-290.[Abstract]
  15. Hawkins J.A., Bailey W.W., Dillon T., et al. Midterm results with cryopreserved allograft valved conduits from the right ventricle to the pulmonary arteries. J Thorac Cardiovasc Surg 1992;104:910-916.[Abstract]
  16. LeBlanc J.C., Russell J.L., Set S.S., et al. Intermediate follow-up of right ventricular outflow tract reconstruction with allograft conduits. Ann Thorac Surg 1998;66:S174-S178.
  17. Bull C., Macarteney F.J., Horvath P., et al. Evaluation of long-term results of homograft and heterograft valves in extracardiac conduits. J Thorac Cardiovasc Surg 1987;94:12-19.[Abstract]
  18. Albert J.D., Bishop D.A., Fullerton D.A., et al. Conduit reconstruction of the right ventricular outflow tract. J Thorac Cardiovasc Surg 1993;106:228-235.[Abstract]
  19. Clarke D.R., Bishop D.A. Ten year experience with pulmonary allograft in children. J Heart Valve Dis 1995;4:384-391.[Medline]
  20. Gerosa G., McKay R., Ross D.N. Replacement of the aortic valve or root with a pulmonary autograft in children. Ann Thorac Surg 1991;51:424-429.[Abstract]
  21. Abolhoda A., Yu S., Oyarzun R., et al. No-React detoxification process: a superior anticalcification method for bioprostheses. Ann Thorac Surg 1996;62:1724-1730.[Abstract/Free Full Text]
  22. Abolhoda A., Yu S., Oyarzun J.R., et al. Calcification of bovine pericardium: glutaraldehyde versus No-React biomodification. Ann Thorac Surg 1996;62:169-174.[Abstract/Free Full Text]
  23. Vogt P.R., Stallmach T., Niederhauser U., et al. Explanted cryopreserved allografts: a morphological and immunohistochemical comparison between arterial allografts and allograft heart valves from infants and adults. Eur J Cardiothoracic Surg 1999;15:639-645.[Abstract/Free Full Text]
  24. Bove E. Aortic valve replacement in infancy and childhood. Abstract presented at IV International Workshop on Pediatric Cardiothoracic Surgery, October 19–22, 1999, San Diego, CA.



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B. S. Allen, C. El-Zein, B. Cuneo, J. P. Cava, M. J. Barth, and M. N. Ilbawi
Pericardial tissue valves and gore-tex conduits as an alternative for right ventricular outflow tract replacement in children
Ann. Thorac. Surg., September 1, 2002; 74(3): 771 - 777.
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T. Bove, H. Demanet, P. Wauthy, J. P. Goldstein, H. Dessy, P. Viart, A. Deville, and F. E. Deuvaert
Early results of valved bovine jugular vein conduit versus bicuspid homograft for right ventricular outflow tract reconstruction
Ann. Thorac. Surg., August 1, 2002; 74(2): 536 - 541.
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J. M. Pearl, D. S. Cooper, K. E. Bove, and P. B. Manning
Early failure of the shelhigh pulmonary valve conduit in infants
Ann. Thorac. Surg., August 1, 2002; 74(2): 542 - 549.
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 J. Thorac. Cardiovasc. Surg.Home page
J.-P. Chang, C.-L. Kao, and M.-J. Hsieh
Totally autologous Ross procedure
J. Thorac. Cardiovasc. Surg., July 1, 2002; 124(1): 194 - 195.
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J.-P. Chang, C.-L. Kao, and M.-J. Hsieh
Double-switch Ross procedure
Ann. Thorac. Surg., June 1, 2002; 73(6): 1988 - 1989.
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J. M. Pearl and P. B. Manning
The use of the Shelhigh porcine valve conduit in infants
Ann. Thorac. Surg., February 1, 2002; 73(2): 697 - 698.
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