Performance of stented biological valves for right ventricular outflow tract reconstruction

Cite this article as: Buchholz C, Mayr A, Purbojo A, Glöckler M, Toka O, Cesnjevar RA et al. Performance of stented biological valves for right ventricular outflow tract reconstruction. Interact CardioVasc Thorac Surg 2016;23:933–9. Performance of stented biological valves for right ventricular outflow tract reconstruction Christian Buchholza, Andreas Mayrb, Ariawan Purbojoa, Martin Glöcklerc, Okan Tokac, Robert A. Cesnjevara and André Rüffera,* a b c Department of Pediatric Cardiac Surgery, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany Department of Medical Biometry, Informatics and Epidemiology, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany Department of Pediatric Cardiology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany * Corresponding author. Department of Pediatric Cardiac Surgery, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Germany, Loschgestrasse 51, 91054 Erlangen, Germany. Tel: +49-9131-8541962; fax: +49-9131-8534011; e-mail: (A. Rüffer). Received 11 March 2016; received in revised form 6 June 2016; accepted 22 June 2016 Abstract OBJECTIVES: This retrospective single-centre review presents mid- and long-term results of stented biological valves (SBVs) in the pulmonary position. METHODS: Fifty-two SBVs (17 Carpentier-Edwards Supraannular; 13 Carpentier-Edwards Perimount; 12 St. Jude Medical Trifecta; 4 Sorin Mitroflow; 4 Sorin Soprano; 2 Sorin More) were implanted between 2000 and 2015. The median valve size, patient age and weight were 23 mm (range 19–27), 22.8 years (range 5–77) and 62.0 kg (range 14–110), respectively. The main cardiac diagnosis was tetralogy of Fallot in 26 patients (50%). Forty-four patients (85%) had previous cardiac surgery; 12 patients (23%) had previous conduit or biological valve replacement. Valve degeneration was defined as a valvular peak pressure gradient >50 mmHg or pulmonary valve regurgitation more than moderate. RESULTS: The mean follow-up was 7.9 ± 5.5 years. Two patients died after 5.8 and 6.1 years of causes not related to SBVs. Eleven SBVs (21%) had to be replaced surgically (n = 6) or interventionally (n = 5) after 9.0 ± 4.1 years due to valve degeneration (n = 8), endocarditis (n = 2) or right ventricular dysfunction (n = 1). The rates of freedom from valve replacement were 100%, 92% [95% confidence interval (CI) 79–97], 81% (CI 64–91) and 60% (CI 40–78) after 1, 5, 10 and 15 years, respectively. Successful interventional valve-in-valve implantation resulted in 100% freedom from surgical valve replacement in all patients older than 19.1 years. Multivariate analysis identified patient age <19.1 years (P = 0.007) as a risk factor for earlier valve degeneration. CONCLUSIONS: SBVs in the pulmonary position showed encouraging long-term results in mature patients. The design of SBVs enables interventional valve implantation, postponing the need for reoperation. Keywords: Congenital heart disease • Right ventricular outflow tract • Right ventricular outflow tract reconstruction • Heart valve bioprosthesis • Pulmonary valve replacement INTRODUCTION Reconstruction of the right ventricular outflow tract (RVOT) for pulmonary regurgitation is commonly performed with a valved conduit. Cryopreserved pulmonary homografts have been considered the gold standard for RVOT reconstruction since the 1980s [1–3], but tissue banks are not able to meet the increasing demand [4]. Therefore, valved conduits made of various materials have been introduced into the clinical routine [5–15]. In some cases, stented biological valves (SBVs) can be implanted directly into the native pulmonary artery or into a previously implanted conduit. However, just like homografts, all bioprostheses gradually degenerate, and valve failure due to calcification, immunological reactions and outgrowth is inevitable. Pulmonary stenosis and regurgitation followed by right ventricular dysfunction result, demanding intervention or surgical replacement of the valve [9, 10, 15, 16]. In the light of the great diversity of valves, conduits and approaches, it is essential to evaluate implanted bioprostheses with respect to their haemodynamic qualities and properties that permit the postponement of reoperations and interventions. This study presents our institutional experience with SBVs for RVOT reconstruction over a 15-year period. PATIENTS AND METHODS The study was presented to the local ethics committee. Institutional review board approval was obtained before any data were collected, and informed consent was waived. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. ORIGINAL ARTICLE ORIGINAL ARTICLE – CONGENITAL Interactive CardioVascular and Thoracic Surgery 23 (2016) 933–939 doi:10.1093/icvts/ivw264 Advance Access publication 22 August 2016 934 C. Buchholz et al. / Interactive CardioVascular and Thoracic Surgery Table 1: Patient characteristics Table 2: Operation characteristics n (%) or median (range) Patients Gender (male) Age (years) Weight (kg) Original diagnosis Tetralogy of Fallot Pulmonary regurgitation or stenosis Pulmonary atresia VSD Pulmonary atresia intact ventricular septum Double outlet right ventricle Endocarditis Common arterial trunk Transposition of great arteries Others Previous RVOT surgery Transannular or subvalvular RVOT patch Conduit or biological pulmonary valve replacement Pulmonary valve surgery without patch or prosthesis Previous RVOT intervention Balloon dilatation Stent 52 (100%) 29 (56%) 23 (5–77) 62 (14–110) 26 (50%) 10 (19%) 4 (8%) 3 (6%) 3 (6%) 2 (4%) 1 (2%) 1 (2%) 2 (4%) 44 (85%) 22 (42%) 13 (25%) 9 (17%) 9 (23%) 13 (25%) 2 (4%) RVOT, right ventricular outflow tract; VSD, ventricular septal defect. Patient characteristics Between January 2000 and May 2015, 52 patients (29 men, 23 women) underwent RVOT reconstruction with SBVs at a single institution. The median age and the median body weight were 22.8 years (range 5–77 years) and 62 kg (range 14–110 kg) at the time of SBV implantation, respectively. Patient characteristics with original diagnoses and previous procedures are presented in Table 1. The most frequent cardiac diagnosis was tetralogy of Fallot (50%). Forty-four patients (85%) had undergone cardiac surgery at least once (median 2; range 1–5 sternotomies). At the time of SBV implantation, 19 patients had transannular and 3 patients had only subvalvular RVOT patches (42%); 17 patients had a native RVOT with pulmonary valve remnants (33%); and 13 patients had biological valves or conduits (25%; 5 stented St. Jude Medical valves, St. Jude Medical, St Paul, MN, USA; 3 pulmonary homografts, 2 Contegra conduits, Medtronic, Inc., Minneapolis, MN, USA; 1 Hancock conduit, Medtronic, Inc.; 1 Shelhigh porcine valved conduit, Shelhigh, Inc., Millbu (...truncated)