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Ann Thorac Surg 2003;76:1896-1900
© 2003 The Society of Thoracic Surgeons


Original article: cardiovascular

Medtronic freestyle valves in right ventricular outflow tract reconstruction

Renee S. Hartz, MDa, Serafin Y. Deleon, MDa*, Jason Lane, MPHa, Jamie Dorotan, MDa, James Joyce, MDa, Elaine Urbina, MDa, Nancy Ross-Ascuitto, MDa, Robert Ascuitto, MDa

a Department of Surgery and Pediatrics, Tulane University Medical Center, New Orleans, Louisiana, USA

Accepted for publication June 19, 2003.

* Address reprint requests to Dr Deleon, Tulane University Medical Center, 1430 Tulane Ave SL-22, New Orleans, LA 70112, USA


    Abstract
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: Various pulmonary valve substitutes, with their inherent limitations, have been used in children and young adults. We chose the Medtronic Freestyle (Medtronics, Minneapolis, MN) valve because of its excellent hemodynamics, known durability in adults, and design features that allow modifications during implantation.

METHODS: Over a 3 1/2 year period the Freestyle valve was implanted in 47 patients age 2 to 58 years (mean 14.2, median 12.0) in the pulmonary position. All patients had pulmonic stenosis and(or) insufficiency from previous operations for tetralogy (27), pulmonary atresia (6), truncus (4), or other diagnosis (10). The indication for surgery was pure pulmonary insufficiency in 11 patients, pulmonic stenosis in 3, and mixed stenosis and insufficiency in 33. Root replacement technique was used with additional enlargement of the pulmonary artery branches in 10 patients.

RESULTS: Intraoperatively, one patient sustained a right ventricle tear and one a circumflex coronary artery injury during the dissection. There was one postoperative death. Two patients developed late subvalvular pannus formation, one of whom required reoperation. One patient was found to have an echo gradient of 95 mm Hg due to decreased leaflet motion and underwent cardiac catheterization at which the peak systolic gradient was determined to be 50 mm Hg. He has not required reintervention during his 3 1/2 years of follow-up. The remaining 43 patients have minimal gradients or insufficiency. All surviving patients are in New York Heart Association (NYHA) Class I.

CONCLUSIONS: The Medtronic Freestyle valve is an attractive alternative for RVOT (right ventricular outflow tract) reconstruction in children. It is readily available, versatile, and has excellent hemodynamic characteristics. Although long term follow-up is not yet available, longevity of this prosthesis, and freedom from complications, will hopefully be superior to valves with stents.


    Introduction
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
Pulmonary insufficiency, though well tolerated early on, eventually leads to progressive right ventricular dilatation and dysfunction [1, 2]. Currently, there are various techniques available to relieve pulmonary outflow tract RVOT (right ventricular outflow tract) obstruction while maintaining native valve competence at the initial operation [3, 4]. However, there remain a number of patients with significant residual pulmonic insufficiency and(or) stenosis that will require RVOT reconstruction and pulmonary valve insertion.

Although mechanical valves are durable, their use in the pulmonary position is associated with a high incidence of thrombosis despite adequate anticoagulation [5]. Until recently, homografts were preferred for RVOT reconstruction. The high failure rate of these grafts has prompted some surgeons to limit their use to very small children and to those requiring complex reconstruction with branch pulmonary artery enlargement [6, 7]. Recently, there has been a resurgence of interest in the use of xenografts for RVOT reconstruction in children. Results have been variable [711].

The Medtronic Freestyle valve is a stentless porcine aortic root bioprosthesis. The valve is manufactured in a manner that fixes the leaflets at a net pressure of zero while the root is pressurized to 40 mm Hg. This provides a physiologically shaped root with normal leaflet coaptation and normal geometry of the sinuses of Valsalva. The prosthesis is also treated with an anticalcification agent (alpha amino oleic acid). Since these features are likely to result in increased durability, we adopted this prosthesis over the stented porcine valve in RVOT reconstruction in children and young adults.


    Patients and methods
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
From February 1999 to October 2002 we performed RVOT reconstruction with the Medtronic Freestyle valve in 47 consecutive patients ages 2 to 58 years, who required pulmonary valve placement. Patient characteristics are shown in Table 1. Mean age of the group was 14.2 ± 12.0 (2 to 58 years) and median age was 12 years. Thirty-one of the 47 were male. Body surface area (BSA) was 1.26 (0.47 to 2.16).


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Table 1. Patient Characteristics (n = 47)

 
The original diagnosis was Tetralogy of Fallot in two-thirds of the patients. Six patients had pulmonary atresia and four had truncus arteriosus. Other diagnoses are listed in Table 2. Twenty-three patients had a previous homograft, 18 a transannular patch, 5 a porcine valve, and one a mechanical valve. The indications for surgery were mixed stenosis and insufficiency in 33 patients, moderate to severe insufficiency in 11, and severe stenosis in 3 (Table 3). Seven patients were in moderate to severe right heart failure at the time of operation.


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Table 2. Original Diagnosis (n = 47)

 

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Table 3. Indications for Surgery (n = 47)

 
Operative technique
All procedures were performed through a resternotomy using a Hall repeat sternotomy saw and(or) chisel and mallet [12]. Dissection of the heart was carried out as completely as possible before heparinization. In two patients with calcified homografts, the inner table of the sternum was left attached to the homograft during resternotomy [13]. Moderate hypothermia (32°C) and multidose blood cardioplegia were used. In patients with myocardial dysfunction, a final dose of warm, substrate-enhanced cardioplegia was administered before removing the aortic cross clamp (10 of 47 patients). Mean cardiopulmonary bypass time was 173 ± 94 minutes and aortic cross clamp time was 107 ± 43 minutes.

With the heart arrested, a short longitudinal incision was made on the proximal main pulmonary artery to allow inspection of the RVOT and the native pulmonary valve leaflets, and to determine the possibility of valve repair. Once replacement was deemed necessary, a circumferential incision was made on the distal main pulmonary artery resulting in transection just proximal to the bifurcation. The longitudinal incision was then extended through the annulus and onto the RVOT. The existing homograft or valve was excised leaving a rim of tissue attached to the annulus for subsequent reinforcement of the proximal suture line (Fig 1A). In ten patients, enlargement of the pulmonary artery branches was performed at this point by incising the artery(ies) through the stenotic area and using a polytetrafluoroethylene (PTFE) patch (Fig 1B).



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Fig 1. Operative technique. (A) Main PA transected and old graft and/or patch material removed as soon as valve replacement deemed necessary. (B) PTFE enlargement of the branch pulmonary artery(ies) as necessary. (C) The Medtronic freestyle valve before and after excising the coronary remnants. (D) Note the generous excision of the graft surrounding the coronary to be oriented anteriorly. Note that both the RVOT and neopulmonary artery have been enlarged with a PTFE patch. (PA = pulmonary artery; PTFE = polytetrafluoroethylene; RVOT = right ventricular outflow tract.)

 
The Freestyle valve was usually longer than the distance between the RVOT and the distal main pulmonary artery. In this situation, it was shortened by excising the distal aortic segment of the graft close to the sinotubular junction. The coronary artery remnants were then excised. One of the two was simply oversewn with running monofilament suture to minimize distortion of the rigid prosthesis by surrounding structures. The other, excised with a generous U-shaped rim of surrounding graft, was oriented directly anteriorly (Fig 1C). The posterior proximal anastomosis between the Freestyle valve and the RVOT below the original annulus was carried out first using a running monofilament suture. Next, the posterior distal anastomosis was performed. A PTFE patch was used as a roof to complete the distal anastomosis anteriorly, using PTFE suture to minimize suture line bleeding. The patch was fashioned proximally around the opening created by excision of the coronary remnant and, after testing valve competence with saline, the remainder of the proximal anastomosis between the valve and RVOT was completed with PTFE patch (Fig 1D).

Additional procedures were performed in 21 patients; tricuspid valvuloplasty in 6, ventricular septal defect closure in 6, atrial septal defect closure in 5, and aortic valvuloplasty, truncal valvuloplasty, bidirectional Glenn shunt, and pacemaker insertion in one patient each. Warm antegrade blood cardioplegia was administered before removing the cross clamp and the patient was separated from cardiopulmonary bypass after reaching normothermia.


    Results
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
Valve sizes are detailed in Figure 2. In seven patients with a BSA <=0.7, a 19- or 21-mm valve was used. In thirty-six patients (78%) we were able to implant a 25-mm or larger prosthesis, including two patients with a BSA less than 0.7 (operated in the last year of this experience). There were two intraoperative complications. One patient had a small right ventricular laceration during resternotomy that was easily controlled by reapproximation of the sternal tables. Cardiopulmonary bypass was then instituted through the femoral vessels and the procedure was carried out without further incident. One patient had an injury to the circumflex coronary artery, which was easily repaired during dissection of a calcified homograft.



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Fig 2. Histogram of valve sizes.

 
Three patients underwent reexploration for bleeding. One patient, who had a concomitant truncal valve repair, required reoperation a week later for breakdown of the truncal valvuloplasty. The valve was repaired successfully. One death occurred in a 58-year-old human who underwent emergency surgery after a paracentesis led to intraabdominal hemorrhage and hemodynamic instability. He had undergone a transannular patch repair of Tetralogy at another institution at age 35. The subclavian pulmonary artery shunt had remained patent and had enlarged over time. He had severe pulmonary insufficiency, progressive right ventricular failure, liver failure, massive ascites, and was also emaciated. He expired from multiorgan system failure 11 days postoperatively.

Late follow-up
The patients have been followed up to 3.5 years (22 ± 12 months) with a median follow-up of 14 months. Sixty percent of patients have been followed at least 2 years. One patient, a 16-month old with a BSA of 0.6, has required reintervention for pulmonic stenosis. The 19-mm Medtronic Freestyle used initially was replaced with a 25-mm Freestyle a year later. At reoperation, the valve leaflets were normal but there was a circumferential rim of obstructive neointima or pannus just beneath the valve.

Postoperative echocardiography was performed in all 46 patients at 1 to 41 months (mean 16). Seven patients had trivial insufficiency and in 35 patients the peak systolic gradient was considered to be insignificant (less than 30 mm Hg). The mean preoperative peak systolic gradient was 50 mm Hg in the 36 patients who had pulmonic stenosis or mixed pulmonic stenosis and insufficiency (Fig 3). Postoperatively, the mean peak systolic gradient in the 46 survivors was 26 mm Hg (Fig 4). Two patients had gradients higher than 50 mm Hg. The first, a 5-year-old boy with tetralogy and an anomalous left anterior descending (LAD) coronary artery arising from the right coronary artery, had repair of his native pulmonary valve and also had a 19-mm Freestyle implanted. Thus he was left with two pulmonary valves. Several echoes demonstrated systolic gradients greater than 90 mm Hg but the patient was doing well. In anticipation of balloon valvuloplasty, which proved to be unnecessary, he underwent cardiac catheterization which demonstrated a peak gradient of only 25 mm Hg. Careful reinterpretation of his echoes revealed that the turbulence caused by the dual egress from the right ventricle had markedly overestimated the peak gradient (patient B on Fig 4). The second patient, who had a 27-mm valve inserted following valvectomy for dyplastic pulmonary valve, developed a peak systolic gradient of 80 mm Hg and evidence of decreased leaflet mobility on echocardiogram. Cardiac catheterization, however, showed a 50 mm Hg gradient (patient A on Fig 4). No intervention has been performed. The patient is asymptomatic and has normal right ventricle dimensions 3.5 years after surgery. All 46 patients are in the New York Heart Association (NYHA) Class I.



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Fig 3. Peak systolic pressure gradients measured preoperatively by echocardiography.

 


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Fig 4. Peak systolic gradient at most recent follow-up. Patient A has a catheterization gradient of 50 mm Hg and is in NYHA class I. The leaflets appear stiff on echocardiogram. (NYHA = New York Heart Association.)

 

    Comment
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
The first successful pulmonary valve replacement was performed in 1966 by Ross and Somerville, who used an aortic homograft in an 8-year-old boy with an absent pulmonary valve [14]. In a 1982 review article, McGoon summarized the status of heart valve replacement (mechanical valves, xenografts, and homografts). In pediatric valve replacement he favored bioprostheses over mechanical valves and concluded, "the prospect of reoperation every 5 to 10 years is still more attractive than the potential tragedy of cerebral, myocardial, or renal infarction due to thromboembolism" [15].

The deleterious effects of pulmonary insufficiency on myocardial performance are now well recognized. Kanter and colleagues [7] recently reiterated what Ross observed 35 years ago: that chronic pulmonary insufficiency leads to right ventricular failure and eventually to left ventricular failure and arrhythmias. Also, delay in intervention leads to persistence of myocardial dysfunction following pulmonary valve replacement [16]. Aggressive prevention or management of pulmonary insufficiency is therefore justified to minimize the incidence and degree of irreversible myocardial dysfunction.

The Toronto group recently evaluated 1,000 pulmonary valve procedures to determine independent factors associated with failure of various valve substitutes. They found that young age and small valve size contribute to early bioprosthetic failure [6]. The single patient in our series who required reoperation was 16- months old and had a BSA of 0.6. We now try to implant the largest possible valve even in this small an infant.

Experience with the Medtronic Freestyle valve and similar valves in adults has been excellent. Barratt-Boyes and colleagues demonstrated experimentally that zero pressure fixation preserves extensibility of leaflet collagen allowing the leaflets to open without kinking [17]. In their clinical series they noted 81% freedom from structural valve deterioration (SVD) at 10 years for the zero pressure fixed Medtronic Intact valve in the aortic position and only one failure in patients older than 40. Other authors have demonstrated the durability of the Intact valve in both the aortic and mitral positions [1821]. Jamieson and colleagues' study of 1300 patients showed 93% freedom from SVD at 12 years in patients older than 50 years of age [22]. These impressive results in adults encouraged us to use a zero pressure fixed, stentless valve in our pediatric population.

There are also studies showing superior results with the stentless valves in the aortic position. Jasinski and colleagues randomized 28 adult patients to receive either an Intact (stented) or Freestyle valve (stentless). They were able to show better hemodynamics with the Freestyle although unable to demonstrate left ventricular mass reduction at one year using echocardiography [23]. Rajappan and colleagues, however, showed left ventricular mass reduction at one year in Freestyle patients using cardiac magnetic resonance [24].

Xenograft conduits have a high failure rate and are almost never used today for RVOT reconstruction. However, Dittrich and colleagues continue to use them because of their observation that xenograft conduits tend to fail at the distal anastomosis and can sometimes be treated successfully with angioplasty, in contrast to homografts, which tend to completely calcify [9]. Allen and colleagues recently described a technique for pulmonary valve replacement in children, which utilizes a pericardial valve in constructed PTFE conduit [25].

Before the availability of the Freestyle valve, stented porcine valves were our prosthesis of choice in older children and young adults requiring pulmonary valve replacement. These valves had an average longevity of 10 years [16]. We continue to use homografts in newborns and infants.

Our early results with this stentless valve conduit are encouraging and we continue to use it routinely except in infants where we either use homografts or repair the pulmonary valve. Only 7 of our 46 patients have trivial pulmonary insufficiency at follow-up to 3.5 years. No patients have shown a progressive increase in gradient across the valve, and several patients have lower gradients than the one determined immediately perioperatively.

Longer follow-up is needed to determine the incidence of structural valve deterioration but we feel that these early results should encourage wider use of the unstented valve conduits that have been treated with an anticalcification agent and fixed at low pressure.


    Acknowledgments
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
We acknowledge Nekita Bourne and Linda Hill (for manuscript preparation).


    References
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Ebert P.A. Second operations for pulmonary stenosis or insufficiency after repair of Tetralogy of Fallot. Am J Cardiol 1982;50:637-640.[Medline]
  2. Wessel H.U., Cunningham W.J., Paul M.H., et al. Exercise performance in Tetralogy of Fallot after intracardiac repair. J Thorac Cardiovasc Surg 1980;80:582-593.[Abstract]
  3. Roughneen P.T., Deleon S.Y., Parvathaneni S., et al. The pericardial membrane pulmonary cusp. Surgical technique and early results. J Card Surg 1999;14:370-374.
  4. Yilmaz A.T., Ozal E., Gunay C., Tatar H. Simultaneous enlargement of the pulmonary annulus and the pulmonary cusp with a transannular patch. J Thorac Cardiovasc Surg 2003;125:206-208.[Free Full Text]
  5. Ilbawi M.N., Lockhart C.G., Idriss F.S., et al. Experience with St. Jude medical valve prosthesis in children: A word of caution regarding right-side placement. J Thorac Cardiovasc Surg 1987;3:73-79.
  6. Caldarone C.A., McCrindle B.W., VanArsdell G.S., et al. Independent factors associated with longevity of prosthetic pulmonary valves, and valved conduits. J Thorac Cardiovasc Surg 2000;120:1022-1031.[Abstract/Free Full Text]
  7. Kanter K.R., Budde J.M., Parks W.J., et al. One hundred pulmonary valve replacements in children after relief of right ventricular outflow tract obstruction. Ann Thorac Surg 2002;73:1801-1807.[Abstract/Free Full Text]
  8. Fukada J., Morishita K., Komatus K., et al. Influence of pulmonic position on durability of bioprosthetic heart valves. Ann Thorac Surg 1997;64:1678-1681.[Abstract/Free Full Text]
  9. Dittrich S., Vladimir V., Meskishvili A., et al. Comparison of porcine xenografts, and homografts for pulmonary valve replacement in children. Ann Thorac Surg 2000;70:717-722.[Abstract/Free Full Text]
  10. Chard R.B., Kang N., Andrews D.R., et al. Use of the Medtronic freestyle valve as a right ventricular to pulmonary artery conduit. Ann Thorac Surg 2001;71:S361-364.[Abstract/Free Full Text]
  11. Lange R., Weipert J., Homann M., et al. Performance of allografts, and xenografts for right ventricular outflow tract reconstruction. Ann Thorac Surg 2001;71:S365-367.[Abstract/Free Full Text]
  12. Deleon S.Y., Lo Cicero J., Ilbawi M.N., Idriss F.S. Repeat median sternotomy in pediatrics: experience in 164 consecutive cases. Ann Thorac Surg 1986;41:184-188.[Abstract]
  13. Deleon S.Y., Ilbawi M.N., Tubeszewski K., et al. Resternotomy in patients with valved conduits adherent to the sternum. Ann Thorac Surg 1991;52:569-571.[Abstract]
  14. Ross DN, Somerville J. Correction of pulmonary atresia with a homograft aortic valve. Lancet 1966:1446–7
  15. McGoon D. Long term effects of prosthetic materials. Am J Cardiol 1982;50:621-630.[Medline]
  16. Ilbawi M.N., Idriss F.S., Deleon S.Y., et al. Long-term results of porcine valve insertion for pulmonary regurgitation following repair of Tetralogy of Fallot. Ann Thorac Surg 1986;41:478-482.[Abstract]
  17. Barratt-Boyes B.G., Jaffe W.M., Whitlock R.M. The Medtronic intact* porcine valve: ten-year clinical review. J Thorac Cardiovasc Surg 1998;116:1005-1014.[Abstract/Free Full Text]
  18. Lemieux M.D., Jamieson W.R., Landymore R.W., et al. Medtronic intact porcine bioprosthesis clinical performance to seven years. Ann Thorac Surg 1995;60:S258-263.
  19. O'Brien M.F., Stafford E.G., Gardner M., et al. The Medtronic intact xenograft. Analysis of 342 patients over a seven-year follow-up period. Ann Thorac Surg 1995;60:S253-257.
  20. Kon ND, Riley RD, Adair SM, et al. Eight-year results of aortic root replacement with the freestyle stentless porcine aortic root bioprosthesis. Ann Thorac Surg 2002;73–1817–21
  21. Corbineau H., Verhoye J.P., Tauran A., et al. Medtronic intact porcine bioprosthesis in the aortic position: 13-year results. J Heart Valve Dis 2002;11:531-542.
  22. Jamieson W.R., Lemieux M.D., Sullivan J.A., et al. Medtronic intact porcine bioprosthesis experience to twelve years. Ann Thorac Surg 2001;71:S278-281.[Abstract/Free Full Text]
  23. Jasinski M.J., Hayton J., Kadziola Z., et al. Hemodynamic performance after stented vs unstented aortic valve replacement. J Cardiovasc Surg 2002;43:313-317.[Medline]
  24. Rajappan K., Melina G., Bellenger N.G., et al. Evaluation of left ventricular function, and mass after Medtronic freestyle versus homograft aortic root replacement using cardiovascular magnetic resonance. J Heart Valve Dis 2002;11:60-66.[Medline]
  25. Allen B.S., El-Zein C., Cuneo B., et al. Pericardial tissue valves, and gore-tex conduits as an alternative for right ventricular outflow tract replacement in children. Ann Thorac Surg 2002;74:771-777.[Abstract/Free Full Text]



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