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J Thorac Cardiovasc Surg 2006;131:1192-1193
© 2006 The American Association for Thoracic Surgery

Brief Communication

Off-pump pulmonary valve replacement with the new Shelhigh Injectable Stented Pulmonic Valve

Clinic for Cardiovascular Surgery, Swiss Cardiovascular Center Bern, University Hospital, Bern, Switzerland

Received for publication November 17, 2005; revisions received January 4, 2006; accepted for publication January 10, 2006.

^_* Address for reprints: P.A. Berdat, MD, Clinic for Cardiovascular Surgery, Inselspital, CH-3010 Bern, Switzerland (Email: pascal.berdat{at}insel.ch).

Dr Berdat

Significant pulmonary regurgitation (PR) is common after surgical or percutaneous treatment of pulmonary stenosis and tetralogy of Fallot (TOF) and leads to significant late morbidity and mortality. ¹ Optimal timing of pulmonary valve replacement (PVR) and procedures minimizing surgical trauma are therefore important. ² The new Shelhigh Injectable Stented Pulmonic Valve NR4000-PA MIS (Shelhigh Inc, Union, NJ) offers the possibility of PVR without cardiopulmonary bypass (CPB). Here we report our early experience with the first clinical use of this new device.

Patients and Methods

Patients
Four patients, median age 14.8 (11.2-40) years, received PVR with the Shelhigh Injectable Stented Pulmonic Valve. Three had PR following transannular patch or commissurotomy at previous TOF repair, and 1 after repair of congenital pulmonary stenosis. Median interval between initial repair and actual surgery was 14 (10.4-33.4) years. All patients had exercise intolerance and dyspnea on exertion; all presented with severe PR, progressive RV dilatation, impaired RV function, and 2 with impaired left ventricular function. Informed consent for compassionate use under CE regulations were obtained from all patients.

Device description and implantation technique
The Shelhigh Injectable Stented Pulmonic Valve, an evolution of the Shelhigh Pulmonic Valved No-React-treated Conduit NR4000-PA, consists of a porcine pulmonic valve mounted inside a self-expandable stent covered by No-React-treated pericardium (Figure 1, A and B), available in sizes 17 to 29 mm. Through a median sternotomy main pulmonary artery (MPA), bifurcation and right ventricular outflow tract (RVOT) were dissected free and 2 purse-string sutures were placed on the distal RVOT. For preinjection preparation, the chosen valve was gently compressed with the supplied loop restrictor, slid into the barrel of the delivery trocar (Figure 1, C), and the introducer tip secured on the barrel (Figure 1, D). After heparinization (Liquemin, Roche Pharma Inc., Reinach, Switzerland; 70 IU/kg body weight), the delivery trocar was introduced through a small incision across the purse-string sutures and the barrel further advanced through the introducer tip into the MPA (Figure 2). Under digital control, the valve was ejected from the barrel while the delivery trocar system was slowly withdrawn. After deployment, the valve was secured with several transmural sutures placed at the proximal and distal rim of the valve. After assessment of the valve performance, the chest was closed in a routine fashion.

View larger version (155K): [in this window] [in a new window]   Figure 1. A, The Shelhigh Injectable Stented Pulmonic Valve device system. B, Detailed view of the Stented Pulmonic Valve. C, The valve is gently compressed and slid into the barrel of the delivery trocar. D, Barrel with loaded valve and mounted insertion tip.

View larger version (155K): [in this window] [in a new window]   Figure 2. Surgical view showing insertion of the delivery trocar system across the RVOT into the main pulmonary artery (asterisk) before ejection of the valve.

Valve insertion, delivery, and placement were successful and hemodynamic performance was excellent in all patients (Figure E3, Table E1). Before valve insertion, 1 patient required additional reduction plasty of the severely enlarged MPA (33 mm). Early recovery was uneventful and all patients were discharged home. However, 1 patient required reoperation 2 months later due to valve migration with severe MPA obstruction and recurrent PR. This failure is explained by a dilated and conical-shaped MPA (maximal diameter 35 mm), which had not been reduced at the time of valve insertion, and insufficient transmural valve fixation. Routine echocardiographic follow-up after 4, 9, 12, and 18 (median 12.2, range 4.3-18.2) months showed good results in the remaining 3 patients with low gradients in all and moderate paravalvular PR in 1. RV function has recovered to subnormal values in all but the 1 patient with moderate PR. All patients were in New York Heart Association functional class I at the latest follow-up.

View larger version (70K): [in this window] [in a new window]   Figure E1. A, Postoperative chest radiograph showing the stented valve in correct position (arrow). B, Postoperative transthoracic echocardiography showing excellent valve function (arrow) without regurgitation or gradient.

Because patients with TOF or isolated congenital pulmonary stenosis usually need several cardiac reinterventions in the long term, minimizing procedural invasiveness and risks is mandatory. To date, surgeons reduce the impact of repetitive surgery by performing most of these procedures on a beating heart under normothermia with very low early mortality and morbidity in recent years. The new Shelhigh Injectable Stented Pulmonic Valve now offers the advantage of avoiding completely CPB use. Compared with the percutaneous approach, ³ it offers several advantages. All implant sizes needed are available and the procedure is not limited by small catheters or access vessel diameters. Furthermore, No-React-treated biologic implants resist calcification and degeneration with excellent results ⁴ in contrast to the percutaneously used conduit. ⁵ Additionally, concomitant procedures frequently necessary on the RVOT or the pulmonary artery can be performed simultaneously. Preoperatively, RVOT and pulmonary artery morphology has to be studied carefully by transthoracic echocardiography and magnetic resonance imaging to determine prosthetic valve size and decide on additional procedures. Our early experience shows that reduction plasty of an enlarged MPA of >28 mm and semicircular fixation of the implant are mandatory to ensure a stable position and prevent paravalvular regurgitation. Device handling and valve implantation, however, have proven easy and straightforward. The follow-up will provide the necessary information on mid- to long-term performance of the Shelhigh Injectable Stented Pulmonic Valve.

References

1. 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]
   
2. 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]
   
3. 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]
   
4. 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]
   
5. 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]
   

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