Long-term follow-up after aortic root replacement with the Shelhigh® biological valved conduit: a word of caution!

ORIGINAL ARTICLE European Journal of Cardio-Thoracic Surgery 50 (2016) 1172–1178 doi:10.1093/ejcts/ezw167 Advance Access publication 26 May 2016 Cite this article as: Sahin A, Müggler O, Sromicki J, Caliskan E, Reser D, Emmert MY et al. Long-term follow-up after aortic root replacement with the Shelhigh® biological valved conduit: a word of caution!. Eur J Cardiothorac Surg 2016;50:1172–8. Long-term follow-up after aortic root replacement with the Shelhigh® biological valved conduit: a word of caution! Ayhan Sahina, Oliver Mügglera, Juri Sromickia, Etem Caliskana, Diana Resera, Maximilian Y. Emmerta, Hatem Alkadhib, Francesco Maisanoa, Volkmar Falkc and Tomas Holubeca,* a b * Corresponding author. Division of Cardiovascular Surgery, University Hospital Zurich, University of Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. Tel: +49-151-11122381; fax: +41-44-2554446; e-mail: (T. Holubec). Received 30 December 2015; received in revised form 2 April 2016; accepted 13 April 2016 Abstract OBJECTIVES: The aim of this study was to analyse long-term results of aortic root replacement with the Shelhigh® NR-2000C conduit. METHODS: From January 2001 to October 2005, 63 patients with a median age of 62 years underwent aortic root replacement with a Shelhigh® conduit. Aneurysm (27%), aortic valve endocarditis (30%) and acute type A aortic dissection (33%) were the predominant indications for the surgery. Fifty-four patients (86%) were entered in the follow-up study with the end-points of death, aortic root-related reoperation and endocarditis. RESULTS: The overall 30-day mortality rate was 8% (n = 5). The median follow-up was 9.5 years (range 0–14.2 years). In total, 13 (24%) deaths occurred during follow-up; of these, 4 were directly conduit-related. The overall estimated survival rates at 1, 5 and 10 years were 85 ± 5, 79 ± 6 and 71 ± 7%, respectively. Reoperation was necessary in 10 (19%) patients due to endocarditis (n = 5), aortic stenosis (n = 3), pseudoaneurysm due to detachment of the right coronary artery (n = 1) and detachment of the non-coronary leaflet (n = 1). The overall estimated rate of freedom from aortic root-related reoperation at 1, 5 and 10 years was 83 ± 5, 79 ± 6 and 64 ± 7%, respectively. Endocarditis of the prosthesis was reported in 9 (17%) patients; of whom, 5 patients required reoperation and 4 were treated medically. In 1 patient with endocarditis, a stroke was reported due to a thromboembolic event. CONCLUSIONS: The first long-term follow-up after aortic root replacement with the Shelhigh® BioConduit revealed a relatively high rate of death and very high rate of reoperations due to endocarditis, aorto-ventricular disconnection and structural valve failure. This may be potentially connected to the nature of the implanted valved conduit. Keywords: Aortic root replacement • Shelhigh prosthesis • Biological valved conduit INTRODUCTION The treatment of choice for patients with aortic root disease— when the valve cannot be repaired and when the patient is not a candidate for a Ross procedure—is the implantation of a composite graft [1–4]. In 1968, Bentall and DeBono [5] described the first complete aortic root replacement with a conduit. The initial composite valved graft contained a mechanical valve; nowadays, there are also complete biological conduits as substitutes for aortic root replacement. The homograft or autograft is an alternative, but it has the disadvantage of limited donor availability and durability [6]. At the end of the 1990s, a new stentless xenopericardial conduit (Shelhigh®, Inc., Millburn, NJ, USA) was introduced in Europe [7, 8]. The Shelhigh® NR-2000C conduit consists of a bovine pericardial straight graft with an incorporated porcine stentless valve. The conduit is preserved in a special process, called No-React® by the manufacturer, meaning it is glutaraldehyde cross-linked, detoxified and heparin-treated with the aim of less calcification and tissue deterioration in the long term [9–11]. The aim of this study was to analyse the short- and long-term results of aortic root replacement with the Shelhigh® NR-2000C conduit with particular regard to survival, need for reoperation and endocarditis rate. METHODS Study design A review of our single-centre database of the Division of Cardiovascular Surgery, University Hospital Zurich, revealed a total of 63 patients who underwent aortic root replacement with a Shelhigh® BioConduit model NR-2000C for various aortic root © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. c Division of Cardiovascular Surgery, University Hospital Zurich, University of Zurich, Zurich, Switzerland Institute of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany 1173 A. Sahin et al. / European Journal of Cardio-Thoracic Surgery pathologies from January 2001 to October 2005. Before surgery, all patients were examined by transthoracic or transoesophageal echocardiography (TOE) and the majority of the patients received also a computed tomography. An intraoperative TOE was performed to assess the immediate result of the valve. Clinical data were retrospectively collected and analysed. Information about the status of all patients was obtained from the referring cardiologist, general physician or from patients themselves. End-points of the study were death, conduit-related death, freedom from aortic root-related reoperation and endocarditis of the aortic valve. These end-points were defined according to the guidelines reported by Akins et al. [12]. The study was approved by the Cantonal Ethical Committee of Zurich (KEK-ZH-Nr. 2015-0579), and an informed consent was obtained from each patient. Surgical procedure Early clinical data Follow-up Despite the strong effort taken, the follow-up was not able to be completed in 9 (14%) patients. The reasons for loss of follow-up were as follows: 4 (6%) patients were international visitors, 3 (5%) patients emigrated to another continent and 2 (3%) became drug-addicted. The median follow-up was 9.5 years (range 0–14.2 years). The total follow-up was 423.2 patient-years. Statistical analysis Continuous and discrete variables were reported as mean ± standard deviation or median and range for data not normally distributed. Categorical and ordinal variables were reported using the number and percentage of observations. The probability of freedom from any event was calculated according to the Kaplan– Meier method. Statistical analysis was performed using the IBM® SPSS® Statistics software program (version 22.0.0.0 for MS Windows, IBM Corporation, Armonk, NY, USA). RESULTS Study population and clinical data From January 2001 to October 2005, 63 patients with a median age of 62 years (range 28–80 years) underwent aortic root repl (...truncated)