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Ann Thorac Surg 2006;81:e1-e3
© 2006 The Society of Thoracic Surgeons

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Case report

Implantation of a Prosthesis Mounted Inside a Self-Expandable Stent in the Pulmonary Valvar Area Without Use of Cardiopulmonary Bypass

Clinic for Cardiovascular Surgery, Department of Anaesthesiology, and Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich at the Technical University Munich, Munich, Germany

Accepted for publication July 21, 2005.

^_* Address correspondence to Dr Schreiber, Clinic of Cardiovascular Surgery, German Heart Center Munich at the Technical University Munich, Lazarettstrasse 36, Munich, 80636 Germany (Email: schreiber{at}dhm.mhn.de).

	Abstract

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Patients with right ventricular outflow tract reconstruction often require redo operations with time. Unique surgical problems exist in this group of patients. We report an innovative method of implantation of a pulmonary valve without the use of cardiopulmonary bypass.

	Introduction

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The perioperative mortality for repair of Tetralogy of Fallot today is exceeded by the lifetime risk of mortality due to its late morbidities [1, 2]. Valved homografts have become the most commonly used conduit for reconstruction of the right ventricular outflow tract [3]. However, progressive obstruction of any right ventricle to the pulmonary artery conduits through calcification or peel formation, somatic growth, infection, or conduit incompetence require repeat interventions.

Conduit stenting during percutaneous catheterization has emerged as an efficient technique to widen the outflow tract in selected cases, thereby delaying the need for surgery [4]. However, these techniques can lead to pulmonary insufficiency comprising the function of the right ventricle. Until March 2004, Coats and colleagues had performed 35 percutaneous pulmonary valve implantations as a novel approach [5]. However, presently this percutaneous approach is not suitable for all patients.

A 14-year-old boy presented with severe pulmonary regurgitation and dilatation of the right ventricle after previous repair of Tetralogy of Fallot at another institution. The initial repair was performed at 10 years of age and included a large transannular patch. Hemodynamic assessment with cardiac catheter showed a pulmonary arterial pressure of 26/1, with a mean of 10 mm Hg, as a sign of severe pulmonary regurgitation. Comparative measurements of the right ventricular outflow tract were performed by angiography, magnetic resonance imaging, and echocardiography, revealing a maximum diameter of 26 mm of the right ventricular outflow tract and the pulmonary trunk, respectively.

The Ethics Committee of the Technical University of Munich approved this operation (project number 1342/05), and the patient's parents consented to it after being fully informed about this innovative treatment. After median sternotomy, the right ventricle and pulmonary trunk with its bifurcations were dissected. Routinely cell-saving is performed at redo operations at our institution. The Shelhigh injectable porcine pulmonic valve, No-React treated (model NR-4000MIS, Shelhigh Inc, Union, NJ) minimally invasive surgery implantation with external fixation consists of a porcine pulmonic valve mounted inside a self-expandable stent that is covered by No-React treated porcine pericardium (EC certificate 97 07 0045 CT, Shelhigh Inc). The stent was loaded into the injector gun by gently compressing and collapsing the sides of the valve and then sliding the entire valve into the trocar (Fig 1). Then the supplied introducer tip was stuck on the end of the trocar. Two pursestring sutures were placed just beneath the transannular outflow patch about 2.5 cm proximal to the pulmonary valvar plane. At this stage the patient received heparin (400 IU per kg of body weight). After a stab incision at the site of the pursestring sutures, the introducer tip with the injector gun was put into place, and the sutures were slightly secured to avoid bleeding. After sliding the introduced tip back, the correct position of the trocar was confirmed by transesophageal echocardiography. Additional manual palpation at the area of the pulmonary trunk avoided delivery of the valve at the site of the pulmonary artery bifurcation. Then the plunger was pressed down, which fully ejected the valve. The injector gun was withdrawn and the pursestring sutures were tightened. Externally, three pledgeted sutures each were placed at the proximal and distal site of the valve to ensure fixation. The patient was hemodynamically stable throughout the procedure. During delivery of the valve only a minor blood loss was observed. Intraoperative pressure measurements confirmed a low systolic pressure of 25 to 27 mm Hg in the right ventricle with pulmonary arterial systolic pressures of 21 to 23 mm Hg. Echocardiographic assessment confirmed the desired position of the valve at the proximal area of the pulmonary trunk with a peak systolic gradient of 10 to 15 mm Hg. Right ventricular diastolic diameter dimension after 1 week was 1.86 cm with improved right ventricular function. There was only a trace of pulmonary valvar regurgitation with no signs of paravalvular leakage.

View larger version (57K): [in this window] [in a new window]   Fig 1. Porcine valve mounted inside a self-expandable stent (A) before mounting and (B) inside trocar.

View larger version (70K): [in this window] [in a new window]   Fig 2. (A, B) Roentgenograms of postoperative position of pulmonic valve in both planes.

	Comment

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In a very recent publication, Coats and colleagues reported on a number of percutaneous valve procedures [5]. The median age was 16 years (range, 9 to 39 years) with the predominant indication for reintervention being homograft and conduit stenosis or a mixed lesion (68.6%). However, the authors did not fail to point out that a right ventricular outflow tract diameter of greater than 22 mm currently precludes a percutaneous approach because of the diameter of the stented bovine jugular vein.

We have successfully used the porcine valve, which is available in sizes as great as 29 mm. This implies that the injectable valve is especially suitable for selected patients after frequently used operations for right ventricular outflow tract reconstruction or restoration other than implantation of valved conduits. Similar to the percutaneous approach, the use of cardiopulmonary bypass can be avoided. However, both the size and the mode of application require a median sternotomy to date.

Mid-term results on the longevity of the No-React treated valve series (Shelhigh Inc) exist [6–8] to date. This experience has shown that these valves resisted an exceeding calcification and degeneration process so far. With this in mind, we have demonstrated that avoiding cardiopulmonary bypass in a selected group of patients with the need of restoration of pulmonary valvar function is possible. This newly available device in combination with the wide range of prostheses sizes offers yet another treatment option and may improve outcome. Technical refinements in the future may allow either changed modes of valve delivery, different securing methods of the stented valve, or even also a closed chest approach.

	Acknowledgments

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The authors thank Shelhigh, Inc, Union, New Jersey for providing the valve. The authors have performed a free and independent evaluation of this technology.

	References

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1. Nollert G, Fischlein T, Bouterwek S, Bohmer C, Klinner W, Reichart B. Long-term survival in patients with repair of tetralogy of Fallot36-year follow-up of 490 survivors of the first year after surgical repair. J Am Coll Cardiol 1997;30:1374-1383.[Abstract]
2. Gatzoulis MA, Balaji S, Webber SA, et al. Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallota multicentre study. Lancet 2000;356:975-981.[Medline]
3. 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-S367.[Abstract/Free Full Text]
4. Ovaert C, Caldarone CA, McCrindle BW, et al. Endovascular stent implantation for the management of postoperative right ventricular outflow tract obstructionclinical efficacy. J Thorac Cardiovasc Surg 1999;118:886-893.[Abstract/Free Full Text]
5. Coats L, Tsang V, Khambadkone S, et al. The potential impact of percutaneous pulmonary valve stent implantation on right ventricular outflow tract re-intervention Eur J Cardiothorac Surg 2005;27:536-543.[Abstract/Free Full Text]
6. Marianeschi SM, Iacona GM, Seddio F, et al. Shelhigh No-React porcine pulmonic valve conduita new alternative to the homograft. Ann Thorac Surg 2001;71:619-623.[Abstract/Free Full Text]
7. Siniawski H, Lehmkuhl H, Weng Y, et al. Stentless aortic valves as an alternative to homografts for valve replacement in active infective endocarditis complicated by ring abscess Ann Thorac Surg 2003;75:803-808.[Abstract/Free Full Text]
8. Carrel TP, Berdat P, Englberger L, et al. Aortic root replacement with a new stentless aortic valve xenograft conduitpreliminary hemodynamic and clinical results. J Heart Valve Dis 2003;12:752-757.[Medline]

This article has been cited by other articles:

				C. Schreiber, J. Horer, M. Vogt, S. Fratz, M. Kunze, C. Galm, A. Eicken, and R. Lange A new treatment option for pulmonary valvar insufficiency: first experiences with implantation of a self-expanding stented valve without use of cardiopulmonary bypass Eur. J. Cardiothorac. Surg., January 1, 2007; 31(1): 26 - 30. [Abstract] [Full Text] [PDF]

				C. Schreiber, M. Vogt, R. Bauernschmitt, Z. Prodan, P. Tassani, A. Eicken, and R. Lange Pulmonary Valve Implantation With a Self-Expanding Stented Valve: 1-Year Follow-Up in the First Patient Ann. Thorac. Surg., December 1, 2006; 82(6): 2340 - 2340. [Full Text] [PDF]

				P. A. Berdat and T. P. Carrel Reply to the editor. J. Thorac. Cardiovasc. Surg., November 1, 2006; 132(5): 1246 - 1246. [Full Text] [PDF]

				Z. Amin Off-pump pulmonary valve placement. J. Thorac. Cardiovasc. Surg., November 1, 2006; 132(5): 1245 - 1246. [Full Text] [PDF]

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Christian Schreiber Robert Bauernschmitt Norbert Augustin Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Schreiber, C. Articles by Lange, R. Search for Related Content PubMed PubMed Citation Articles by Schreiber, C. Articles by Lange, R. Related Collections Valve disease