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Ann Thorac Surg 2008;86:1466-1472. doi:10.1016/j.athoracsur.2008.06.085
© 2008 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Pulmonary Valve Implantation With the New Shelhigh Injectable Stented Pulmonic Valve

Stefano M. Marianeschi, MDa,*, Francesco Santoro, MDa, Elena Ribera, MDa, Emanuele Catena, MDa, Gabriele Vignati, MDa, Simone Ghiselli, MDa, Stefano Pedretti, MDa, Ozkan Suleyman, MDb, Hasim Ustunsoy, MDc, Pascal A. Berdat, MDd

a Pediatric Cardiology, Anesthesiology, MR Unit and Cardiac Surgery, Niguarda Hospital, Milan, Italy
b Department of Cardiovascular Surgery, Baskent University Hospital, Ankara, Turkey
c Department of Cardiovascular Surgery, Gaziantep University Medical School, Gaziantep, Turkey
d Cardiovascular Center Zurich, Clinic Im Park, Zurich, Switzerland

Accepted for publication June 13, 2008.

* Address correspondence to Dr Marianeschi, Niguarda Hospital, Piazza Ospedale Maggiore 3, 20162, Milan (Email: marianeschi{at}hotmail.com).

Presented at the Forty-fourth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2008.


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 Acknowledgments
 References
 
Background: Pulmonary regurgitation (PR) occurs frequently after tetralogy of Fallot (TOF) repair, impairing long-term prognosis and necessitating reinterventions. Myocardial damage, invasiveness, and the risks of pulmonary valve replacement (PVR) therefore need to be minimized. The new Shelhigh Injectable Stented Pulmonic Valve (Shelhigh Inc, Union, NJ) allows implantation without cardiopulmonary bypass (CPB) under direct control.

Methods: Twelve symptomatic patients (age, 21.3 ± 12.5; range, 5.8 to 53.5 years) with severe PR and progressive right ventricular (RV) dilatation with dysfunction received the Shelhigh valve in sizes 21 (n = 1), 25 (n = 4), 27 (n = 3), 29 (n = 2), and 31 mm (n = 2).

Results: Valve insertion was successful and hemodynamic performance excellent in all: peak systolic gradient, 14.5 ± 4.6 (range, 10 to 20) mm Hg; mean gradient, 6.3 ± 1.6 (range, 4 to 8) mm Hg. Four patients underwent concomitant procedures on CPB: one reduction plasty of a dilated main pulmonary artery, two tricuspid valve repairs, and one VSD closure. Early recovery was uneventful. There were no reoperations. During a mean follow-up of 5.4 ± 4.3 months (range, 0.3 to 10.6 months) echocardiography showed good results, with low gradients and recovered RV function in all. All presented in New York Heart Association functional class 1 at the latest follow-up.

Conclusions: The Shelhigh valve allows easy PVR without CPB up to large valve sizes, with less invasiveness compared with a conventional approach. Further follow-up is needed to assess its durability and long-term performance.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Discussion
 Acknowledgments
 References
 
Significant pulmonary regurgitation (PR) is a common problem after surgical or percutaneous treatment of congenital cardiac defects such as pulmonary stenosis or tetralogy of Fallot (TOF) [1]. Chronic volume overload leads to significant late morbidity and death in a substantial number of patients due to progressive dilatation and dysfunction of the right ventricle (RV), decrease in exercise tolerance, and malignant arrhythmias resulting in increased risk of sudden death [2, 3]. Frequently, repetitive cardiac operations to treat recurrent right ventricular outflow tract (RVOT) obstruction and additional residual lesions such as ventricular septal defect (VSD), tricuspid regurgitation, or pulmonary branch stenosis further adversely affect right and also left ventricular function [4, 5].

Timely pulmonary valve replacement (PVR) with minimized invasiveness is therefore warranted. Despite the development of percutaneous PVR, surgical PVR still offers some advantages, including implantation of larger valve substitutes, no access limitations, and concomitant treatment of additional residual defects or sequelae. In selected cases a hybrid approach of surgical PVR without cardiopulmonary bypass (CPB) through sternotomy can be performed with the new Shelhigh Injectable Stented Pulmonic Valve NR4000-PA MIS (Shelhigh Inc, Union, NJ). We report our multi-institutional experience with the clinical use of this device in patients scheduled for surgical PVR.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Discussion
 Acknowledgments
 References
 
This study was approved and the need for individual patient consent waived by the institutional Ethics Committee of the participating centers. Informed consent for the operation was obtained from all patients.

Between April 2007 and January 2008, 12 patients (4 from Niguarda Hospital, Italy; 6 from Baskent University Hospital, Turkey; and 2 from Gaziantep University Medical School, Turkey), with a mean age of 21.3 ± 12.5 years (range, 5.8 to 53.5 years), received PVR with the Shelhigh valve. Nine patients needed PVR after transannular or infundibular patch, 2 after surgical valvuloplasty, and 1 after balloon valvuloplasty. The mean interval between the initial repair and the actual operation was 18.9 ± 9.8 years (range, 9.1 to 31.7 years).

All patients presented with severe PR, progressive RV dilatation, and impaired RV function. All patients were symptomatic, presenting with either exercise intolerance, dyspnea on exertion, chest pain, or a combination of those. Preoperative patient characteristics are presented in Table 1. Patients were selected for hybrid PVR according to the inclusion/exclusion criteria presented in Table 2. Preoperative evaluation consisted of clinical examination and echocardiography in all 12 patients. Preoperative magnetic resonance imaging (MRI) evaluation of anatomic features and volumetric and flow dynamic indicators was done in the 4 patients from Italy, where MRI is available.


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  		Table 1 Patient Characteristics
 

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  		Table 2 Patient Selection Criteria
 
Systolic and diastolic flow through the pulmonary valve was quantified by velocity mapping allowing for calculation of pulmonary regurgitant fraction. RV mass, volumes, and function, as well as RVOT, and distal pulmonary artery and aortic root anomalies (aneurysm, akinetic areas, fibrosis) were evaluated. We used an Avanto 1.5-Tesla MRI (Siemens Healthcare, Malvern, PA) aimed to obtain the best RVOT to pulmonary arteries anatomic view and a precise ventricular volumetric and valvular flow dynamics definition (velocity encoding technique was also used).

Device Description and Implantation Technique
Device description and technique of implantation have previously been published [6]. In brief, the Shelhigh Injectable Stented Pulmonic Valve consists of a porcine pulmonic valve inside a tube of bovine pericardium mounted on a self-expandable nitinol stent and is available in size 17 to 31 mm (Fig 1). Through a median sternotomy, the RVOT and the main pulmonary artery (MPA) and its bifurcation are dissected free. The pulmonic valve is inserted across 2 purse-string sutures placed on the distal RVOT with the aid of a delivery trocar system under direct digital control. To avoid migration, several transmural sutures are used to secure the valve after deployment. After assessment of valve performance, the chest as closed in a routine fashion.


Figure 1
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  		Fig 1. Injectable Pulmonic Valve Shelhigh NR-4000PA-MIS. Reprinted with permission of Shelhigh Inc.

 
In patients with a MPA of more than 29 mm, a reduction plasty of the MPA should be considered to obtain at least 2 mm of oversizing of the largest valve prosthesis (31 mm) available. Oversizing is considered necessary to minimize the risk for paravalvular leakage and valve prosthetic migration. Reduction plasty is accomplished by a longitudinal polypropylene running suture starting at the level of the bifurcation down to the RVOT, reducing the external diameter to the desired size. Reassessment of the shape of the RVOT, and measurements of the diameters at the level of the RVOT, the pulmonary annulus, and the MPA by transesophageal echocardiography is essential to choose the correct size of the valve prosthesis after reduction plasty.

Follow-Up
The follow-up schedule was left at the discretion of the medical team in charge. Follow-up data were retrospectively collected and analyzed. Two patients had MRI studies performed at 6 to 12 months postoperatively.

Statistics
Data are expressed as the mean value ± standard deviation (range). Percentages are given where appropriate. Statistical analysis was performed using Statview 5.0.1 software (SAS Institute Inc, Cary, NC). For univariate analysis, the Mann-Whitney U test for continuous data and the {chi}2 test for contingency tables for nominal data were used. A value of p < 0.05 was determined statistically significant.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Discussion
 Acknowledgments
 References
 
Patients received prosthetic valves in the following sizes: 21 mm (n = 1), 25 mm (n = 4), 27 mm (n = 3), 29 mm (n = 2), and 31 mm (n = 2). The mean prosthetic valve size was 26.8 ± 2.9 mm (range, 21 to 31 mm). Prosthetic valve insertion, delivery, and placement were successful in all patients. Mean procedural time was 185.9 ± 45.6 minutes (range, 120 to 240 minutes). Echocardiographic and invasive hemodynamic assessment showed no regurgitation in 10 patients and a mild paravalvular regurgitation in 2, a mean peak systolic gradient of 14.5 ± 4.6 mm Hg (range, 10 to 20 mm Hg), and a mean systolic gradient of 6.3 ± 1.6 mm Hg (range, 4 to 8 mm Hg). Data are summarized in Table 3.


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  		Table 3 Perioperative and Postoperative Data
 
After successful PVR, CPB was initiated in 3 patients who underwent concomitant procedures: 2 patients with repaired TOF needed tricuspid valve repair (DeVega plasty) because of severe tricuspid regurgitation, and 1 patient with a repaired double-outlet RV underwent residual VSD closure. Another patient with a repaired double-outlet RV required CPB for an extensive reduction plasty of a severely dilated MPA (> 35 mm) before PVR.

Early recovery was uneventful, and all the patients were discharged home after a mean hospital length of stay of 6.3 ± 2.4 days (range, 2 to 12 days). During a mean follow-up of 6.3 ± 4.3 months (range, 1.2 to 11.5 months) no patients required reoperations. Routine echocardiography and MRI during follow-up showed good results, with low peak gradients of 15 ± 4.2 mm Hg (range, 10 to 20 mm Hg), a mean gradient of an 12.4 ± 2.9 mm Hg (range, 10 to 16 mm Hg), trivial valvular regurgitation, and recovered RV function (mildly impaired to normal) in all but the 2 patients with mild paravalvular leak. No valvular dysfunction, peel formation, or calcification was noted. No arrhythmia was recorded during early and late follow-up, and mortality rate was 0%. All patients presented in New York Heart Association functional class 1 at the latest follow-up.

In the 2 patients who had MRI studies preoperatively and at 7 months postoperatively, reverse RV remodelling was observed during follow-up, with a RV volume reduction between 35% and 50% (Table 4; Fig 2). Strain values had recovered to normal. Interventricular interaction improved as well within 7 months postoperatively on echocardiography in these patients (Fig 3).


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  		Table 4 Magnetic Resonance Imaging Preoperative and Postoperative Data
 

Figure 2
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  		Fig 2. Example of a magnetic resonance image volume by frame curve of 1 patient (A) preoperatively and (B) postoperatively. (A) In the right ventricle (RV), systole is delayed, in (B) the RV function after 7 months from the implant is quantitatively and qualitatively similar to the left ventricle. The synchronization also is improved and the minimum RV volume during systole is reached in shorter time.

 

Figure 3
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  		Fig 3. Example of echocardiographic assessment of the valve and right ventricular (RV) function 7 months after implantation. (A, B) Valve position and normal right ventricular outflow tract (RVOT) flow velocity are shown. (C, D) Right ventricular motion of the tricuspid annulus (Strain) recovered to normal. (PA = pulmonary artery; RA = right atrium.)

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Discussion
 Acknowledgments
 References
 
Patients with TOF, isolated or combined with congenital pulmonary stenosis, usually need several cardiac reinterventions during their lifetime because of sequelae, residual lesions, recurrent obstructions, or conduit failure. Most patients present with longstanding PR [1], which is known to be deleterious to RV function and to their long-term prognosis [4, 5]. Function of the RV is furthermore jeopardized by repetitive surgery and other conditions such as pressure and volume overload from residual VSD, recurrent obstructions, tricuspid regurgitation, or myocardial damage from RVOT scarring, and aneurysm. Patients may also present with impaired left ventricular function. A more aggressive approach with timely correction of PR is therefore currently advocated [5, 7]. Because earlier PVR will inadvertently lead to an increased number of reinterventions, the invasiveness and risks of PVR have to be kept as minimal as possible for maximum myocardial preservation. In addition, new implants, both durable and designed for alternative implantation techniques should be available.

Currently, surgeons try to minimize the effect of repetitive operations on cardiac function by performing most of the RV and pulmonary artery procedures on CPB with a beating heart under normothermic temperatures. Thus, early death and morbidity has consistently been reported to be low in recent years [8, 9]. Bonhoeffer and coworkers [10] have developed another approach that minimizes invasiveness by performing PVR percutaneously.

The Shelhigh Injectable Stented Pulmonic Valve, a device available since 2004, fulfills advantages of both the surgical and percutaneous approach. However, compared with the on-pump beating-heart method, the Shelhigh valve offers the advantage of eliminating completely the use of CPB and additional right ventriculotomies. It may therefore be less invasive, better tolerated, and offer a shorter hospital length of stay with faster recovery than conventional treatment with CPB support. We think that approximately 10% of our patients may qualify for this method of PVR, but a larger amount may probably be included with continuous refinement of the selection criteria and increased experience.

Compared with the percutaneous approach, off-pump PVR with the Shelhigh valve offers several advantages: all sizes of implants needed are available up to size 31 mm, and the procedure is not limited by a small catheter or access vessel diameter. Modified No-React treated biologic valves (Shelhigh Inc, Millburn, NJ) of the latest generation have shown promising results with respect to calcification and degeneration [11, 12] in contrast with those implanted in earlier series and with the conduit used for percutaneous implantation [13–16]. It also inhibits scar formation between the device and the inside of the MPA wall, which together with some oversizing may allow some increase in device diameter during the patient's growth, thus potentially minimizing the number of PVRs during a patient's lifetime.

Another important advantage is that additional procedures frequently necessary on the RVOT or the pulmonary artery, such as reduction plasty or pulmonary artery branch enlargement, can be performed. Although in this series one MPA reduction plasty was done with support of CPB, others [6] have shown that this may be done off-pump as well.

It has been shown that RVOT aneurysms negatively affect RV function [17, 18] and therefore need to be reduced at the time of reoperation. Furthermore, the Shelhigh valve offers the potential to be used with a more limited access other than a full sternotomy.

This Shelhigh valve was used in those patients who then underwent CPB because concomitant procedures needed to be done, including tricuspidal valve repair, closure of residual VSD, and extensive MPA reduction plasty. In both patients with repaired double-outlet RV and with anteriorly lying ascending aorta and coronary anomalies crossing the RVOT, it was considered to be advantageous to use this implantation technique. The responsible surgeons determined that the stented valve that is usually used in these patients for PVR might stretch the annulus and put tension on the abnormal coronaries. To avoid the complication of potential myocardial ischemia, a smaller valve would then have been implanted. To offer the largest valve possible without interference with coronaries, the injectable Shelhigh valve was selected.

Preoperatively, the morphology of the RVOT and MPA, including the bifurcation and the pulmonary artery, has to be studied carefully by transthoracic echocardiography and ideally by cardiac MRI, if available, to determine the prosthetic valve size and decide on additional procedures [19]. Early reported experience shows that reduction plasty of an enlarged MPA of > 29 mm and semicircular fixation of the implant should always be done to ensure a stable position and prevent paravalvular regurgitation [6]. Although no patient in our series has required a valve-related reoperation so far, others have reported reoperations due to migration and paravalvular leakage in cases with a too large MPA not reduced at the time of valve insertion [6].

Handling of the device and valve implantation has proven easy and straightforward. On a midterm follow-up of up to 11 months, the device shows excellent performance in all patients with a correct implantation result. Our data show that RV reverse remodeling is consistently taking place after successful PVR.

As with any other new technology, its disadvantage is that long-term data are lacking. Currently, availability is temporarily restricted due to a production stop of Shelhigh products enforced by the United States Food and Drug Administration (see the Addendum).

In conclusion, the Shelhigh Injectable Pulmonic Valve Shelhigh NR-4000PA-MIS allows safe and easy pulmonary valve replacement without CPB in carefully selected patients. Its mode of implantation may offer a less invasive approach. Special care must be taken on sizing and fixation of the device to avoid paravalvular leakage and later migration. The device appears to function adequately and shows no degeneration at a follow-up of up to 11 months. Longer follow-up is necessary to assess its performance.


   Discussion
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
Acknowledgments
 References
 
DR CHRISTOPHER A. CALDARONE (Toronto, Ontario, Canada): In the first version of the manuscript, there are 2 patients who had distal migration of the device. Could you comment on the external fixation techniques used? Were they used in these cases? Have you evolved in terms of how you do the external fixation?

DR MARIANESCHI: These 2 patients mentioned in the preliminary version of the manuscript come from the Bern experience. Bern was the pioneer in the implantation of this valve. They were the first cases who received this implant. And after those patients, we started to fix the valve inside the pulmonary artery with external transmural stitches. The present series reported here does not contain any patient from the Bern experience.

DR CALDARONE: So there are no migrations after you started the external fixation?

DR MARIANESCHI: We haven't seen any other migration.

DR JOSEPH J. AMATO (Chicago, IL): I might be off-base or a little naive, but I would ponder on the possibility of what might happen if when you opened the heart off-bypass, that you might encounter a previously undetected small patent foramen ovale or a previously undetected atrial septal defect. Might you not fear that air might go from the right side to the left side. How then would you prevent or avoid the possibility of any air embolism?

DR MARIANESCHI: It's one of the exclusion criteria. If there is an ASD [atrial septal defect] or a VSD [ventricular septal defect], we don't do the implant of the pulmonary valve without bypass.

DR CARLOS TROCONIS (Caracas, Venezuela): I'd like to know if the reduction plasty of the MPA [main pulmonary artery] to less than 31 mm is because you don't have any larger valve or you choose the reduction for better dynamics purpose? And the second question is, could you explain a little more about how you do that reduction of the annulus or the pulmonary artery off-pump?

DR MARIANESCHI: The largest valve is 31, so we cannot use other valves. So the only brand we have is this one. And there are no valves larger than 31, so we have to do the reduction for this reason. We do the reduction with a simple continuous suture to reduce the caliber on all the length of the main pulmonary artery. If there is calcification or the patient needs some reduction of the transannular patch, we don't do that in this kind of operation.

DR FRANK A. PIGULA (Boston, MA): You do this through a sternotomy, presumably, right?

DR MARIANESCHI: Yes.

DR PIGULA: And what are the advantages of this valve over the percutaneous valves that are delivered by catheter?

DR MARIANESCHI: The size.

DR PIGULA: The size.

DR MARIANESCHI: Yes, we can put in a valve with a diameter of up to 31 mm.

DR CALDARONE: And you have the potential to do a reduction plasty, which, of course, you wouldn't do with a catheter-based approach, right?

DR MARIANESCHI: Right.

DR EMILE M. BACHA (Boston, MA): Just a clarification related to Dr Pigula's question about advantages of this technique over the percutaneous technique. The percutaneous pulmonary valve can only be implanted in patients who have right RV-PA [right ventricle–pulmonary artery] conduits. This valve can be implanted in a patient who has had a transannular patch; is that correct?

DR MARIANESCHI: Yes.

DR BACHA: So that would be, I think, a major difference.

DR MARIANESCHI: It can be implanted in any, when the anatomy of the main pulmonary artery is cylindrical in shape. Whether it's a conduit or a transannular patch, it doesn't matter.

DR BACHA: The vast majority of patients with PR [pulmonary regurgitation] have had a transannular patch and not a conduit, so this valve applies to these patients, as opposed to the percutaneous valve, which has to go into a previously placed conduit.

DR MARIANESCHI: Yes.

DR BACHA: That is a key difference.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 Acknowledgments
References
 
Although the Shelhigh valve has received the CE (Conformité Européene) mark, some European health authorities have issued warning letters to restrict the use of Shelhigh products to compassionate use. Therefore, only symptomatic patients with impaired RV function with or without concomitant left ventricle dysfunction may profit from this procedure at this time in certain European countries. By June 25, 2007, a no-fault settlement agreement was reached between Shelhigh Inc and the Food and Drug Administration, so that resumption of operations at Shelhigh Inc can be expected within due time. This study, however, was not affected by these issues, because neither the Italian nor the Turkish health authorities restricted the use of these products, nor was there a shortage of implants during the study period owing to large enough stocks in Italy and Turkey.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 Acknowledgments
 References
 

  1. Oechslin EN, Harrison DA, Harris L, et al. Reoperation in adults with repair of Tetralogy of Fallot: indications and outcomes J Thorac Cardiovasc Surg 1999;118:245-251.[Abstract/Free Full Text]
  2. Knott-Craig CJ, Elkins RC, Lane MM, Holz J, McCue C, Ward KE. A 26-year experience with surgical management of Tetralogy of Fallot: risk analysis for mortality or late reintervention Ann Thorac Surg 1998;66:506-511.[Abstract/Free Full Text]
  3. Nollert GD, Dabritz SH, Schmoeckel M, Vicol C, Reichart B. Risk factors for sudden death after repair of Tetralogy of Fallot Ann Thorac Surg 2003;76:1901-1905.[Abstract/Free Full Text]
  4. Abd El, Rahman MY, Abdul-Khaliq H, Vogel M, Alexi-Meskishvili V, Gutberlet M, Lange PE. Relation between right ventricular enlargement, QRS duration, and right ventricular function in patients with Tetralogy of Fallot and pulmonary regurgitation after surgical repair Heart 2000;84:416-420.[Abstract/Free Full Text]
  5. Gatzoulis MA, Balaji S, Webber SA, et al. Risk factors for arrhythmia and sudden cardiac death late after repair of Tetralogy of Fallot: a multicentre study Lancet 2000;356:975-981.[Medline]
  6. Berdat PA, Carrel TP. Off-pump pulmonary valve replacement with the new Shelhigh Injectable Stented Pulmonic Valve J Thorac Cardiovasc Surg 2006;131:1192-1193.[Free Full Text]
  7. Therrien J, Siu SC, McLaughlin PR, Liu PP, Williams WG, Webb GD. Pulmonary valve replacement in adults late after repair of Tetralogy of Fallot: are we operating too late? J Am Coll Cardiol 2000;36:1670-1675.[Abstract/Free Full Text]
  8. Kanter KR, Budde JM, Parks WJ, et al. One hundred pulmonary valve replacements in children after relief of right ventricular outflow tract obstruction Ann Thorac Surg 2002;73:1801-1806discussion 1806–7.[Abstract/Free Full Text]
  9. Carrel T, Berdat P, Pavlovic M, Pfammatter JP. The bovine jugular vein: a totally integrated valved conduit to repair the right ventricular outflow J Heart Valve Dis 2002;11:552-556.[Medline]
  10. Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction Lancet 2000;356:1403-1405.[Medline]
  11. Marianeschi SM, Iacona GM, Seddio F, et al. Shelhigh No-React porcine pulmonic valve conduit: a new alternative to the homograft Ann Thorac Surg 2001;71:619-623.[Abstract/Free Full Text]
  12. Carrel TP, Berdat P, Englberger L, et al. Aortic root replacement with a new stentless aortic valve xenograft conduit: preliminary hemodynamic and clinical results J Heart Valve Dis 2003;12:752-757.[Medline]
  13. Kadner A, Dave H, Stallmach T, Turina M, Pretre R. Formation of a stenotic fibrotic membrane at the distal anastomosis of bovine jugular vein grafts (Contegra) after right ventricular outflow tract reconstruction J Thorac Cardiovasc Surg 2004;127:285-286.[Free Full Text]
  14. Meyns B, Van Garsse L, Boshoff D, et al. The Contegra conduit in the right ventricular outflow tract induces supravalvular stenosis J Thorac Cardiovasc Surg 2004;128:834-840.[Abstract/Free Full Text]
  15. Tiete AR, Sachweh JS, Roemer U, Kozlik-Feldmann R, Reichart B, Daebritz SH. Right ventricular outflow tract reconstruction with the Contegra bovine jugular vein conduit: a word of caution Ann Thorac Surg 2004;77:2151-2156.[Abstract/Free Full Text]
  16. Boudjemline Y, Agnoletti G, Piechaud JF, et al. [Percutaneous pulmonary valve replacement: towards a modification of the prosthesis] Arch Mal Coeur Vaiss 2003;96:461-466.[Medline]
  17. Mittal SR, Agrawal D, Mathur D. Right ventricular regional wall motion abnormality in congenital heart disease Int J Cardiol 1996;54:76-80.[Medline]
  18. Fogel MA, Rychik J. Right ventricular function in congenital heart disease: pressure and volume overload lesions Prog Cardiovasc Dis 1998;40:343-356.[Medline]
  19. Schreiber C, Hoerer J, Vogt M, et al. A new treatment option for pulmonary valvular insufficiency: first experiences with implantation of a self-expanding stented valve without use of cardiopulmonary bypass Eur J Cardiothorac Surg 2007;31:26-30.[Abstract/Free Full Text]




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