Comparison of mid-term haemodynamic performance between the BioValsalva and the BioIntegral valved conduits after aortic root replacement†

ORIGINAL ARTICLE – ADULT CARDIAC Interactive CardioVascular and Thoracic Surgery 23 (2016) 112–117 doi:10.1093/icvts/ivw066 Advance Access publication 4 April 2016 Cite this article as: Wendt D, Raweh A, Knipp S, El Gabry M, Eißmann M, Dohle DS et al. Comparison of mid-term haemodynamic performance between the BioValsalva and the BioIntegral valved conduits after aortic root replacement. Interact CardioVasc Thorac Surg 2016;23:112–17. Comparison of mid-term haemodynamic performance between the BioValsalva and the BioIntegral valved conduits after aortic root replacement† Daniel Wendta,*‡, Ayman Raweha,‡, Stephan Knippa, Mohammed El Gabrya, Mareike Eißmannb, Daniel Sebastian Dohlea, Konstantinos Tsagakisa, Matthias Thielmanna, Heinz Jakoba and Jaroslav Benedika a b Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany Department of Cardiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany * Corresponding author. Department of Thoracic and Cardiovascular Surgery, West-German Heart and, Vascular Center Essen, University Hospital Essen, Hufelandstraße 55, 45122 Essen, Germany, Tel: +49-201-72384912; fax: +49-201-7235451; e-mail: (D. Wendt). Received 29 September 2015; received in revised form 25 January 2016; accepted 3 February 2016 Abstract OBJECTIVES: We retrospectively compared the haemodynamic performance of the BioValsalva (BV) and BioIntegral (BI) biological aorticvalved conduits in the aortic root position. METHODS: Between July 2008 and June 2014, a total of 55 patients underwent aortic root replacement using the BV conduit (n = 27) or the BI conduit (n = 28). The primary study endpoints were haemodynamic performance during follow-up, including mean pressure gradients (MPGs) and effective orifice areas (EOAs). Secondary study endpoints were early postoperative outcomes within 30 days and survival. RESULTS: Both groups did not differ in regard to demographics (BV: median age 71 years, 70.4% female; BI: median age 66 years, 85.7% female, P = 0.15 and P = 0.17) and risk profile (median EuroSCORE-II BV: 3.8 vs 5.3% for BI, P = 0.38). A total of 20% of the total patients (BV 5/27, 18.5% vs BI 6/28, 21.4%) presented with acute type-A aortic dissection. During follow-up, both groups showed no difference in MPGs for all valve sizes [BV, 11.0 mmHg (8.3–14.8 mmHg) vs BI, 11.5 mmHg (9.0–13.0), P = 0.82]. Similar results were achieved for EOAs for all valve sizes [BV, 1.85 cm2 (1.55–2.21) vs BI, 1.80 cm2 (1.64–1.83), P = 0.24]. Moreover, there was no statistically significant difference in aortic regurgitation (AR) with none/trace AR in (21/23) 91.3% in BV patients versus (16/21) 76.2% in BI patients (P = 0.23) at follow-up. Both groups showed a high rate of concomitant procedures (BV: 59.3% vs BI: 71.4%, P = 0.40) and emergency indication (BV: 18.5% vs BI: 21.4%, P = 0.79), resulting in an overall 30-day mortality rate of 7.3% (4/55 patients). CONCLUSIONS: The present small single-centre study is one of the first to evaluate and compare the BioValsalva and BioIntegral biological aortic-valved conduit in the aortic root position. Both conduits showed optimal haemodynamic results with a low incidence of aortic regurgitation. Keywords: Aortic valve • Bentall procedure • BioValsalva • BioIntegral • No-react valve • Bioprosthesis • BioConduit • Biological conduit INTRODUCTION Until now, the Bentall procedure represents the golden standard in treating patients with aneurysm of the ascending aorta/aortic root combined with aortic valve disease, in whom the David or the Yacoub procedure cannot be performed [1–3]. The originally described procedure was performed with a mechanical valved conduit [4]. Nowadays, various biological valved conduits are † Presented at the 29th Annual Meeting of European Association for CardioThoracic Surgery, October 3–7, 2015, Amsterdam, The Netherlands. ‡ Both authors contributed equally. available and have been evaluated so far. One of these models, the Shelhigh conduit, was withdrawn from the market and just recently was reintroduced in a modified version made of a porcine aortic valve and bovine pericardium (BioIntegral™). Meanwhile, several other biological conduits have been introduced such as the BioValsalva™ graft, which combines a trilaminate graft with a porcine aortic valve. Of note, most of these biological conduits have been evaluated only in regard to technical, clinical and outcome data. We therefore aimed to compare the haemodynamic performance of the BioValsalva (BV) and BioIntegral (BI) aortic valve conduits in the aortic root position. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. D. Wendt et al. / Interactive CardioVascular and Thoracic Surgery The present study was a single-centre, two-armed, retrospective observational study including 55 consecutive patients who underwent aortic root replacement with the use of the BV (n = 27) or BI (n = 28) prosthesis at the West-German Heart and Vascular Center Essen between July 2008 and May 2014. Patients received either the BV or the BI bioprosthesis depending on surgeons’ preference, and depending on the later availability of the BI prosthesis. Patients were enrolled in the study when aortic valve leaflet pathology was present making a valve-sparing aortic root operation impossible. Patients requiring reoperation or additional surgical procedures like concomitant coronary artery bypass grafting (CABG) or valve surgery were also included in the study. Operations were performed on an elective or urgent basis, with emergency operations being included in the present analysis. Institutional Review Board approval was obtained according to the Declaration of Helsinki. The primary study endpoints were haemodynamic data during follow-up. Secondary study endpoints were early postoperative outcomes within 30 days and survival. Survival was obtained by active follow-up by contacting the corresponding registration office. All surviving patients were contacted to undergo the transthoracic echocardiographic evaluation on this basis. Demographics and operative parameters were recorded in a prospective institutional database and retrospectively extracted and evaluated. Echocardiographic data were stored in an institutional parallel workflow platform (Horizon Cardiology™, Medcon/McKESSON, San Francisco, CA, USA). Valve characteristics Biovalsalva™. The BV biological valved conduit consists of a biological porcine aortic valve (Elan™ stentless valve, Vascutek, Terumo, Inchinnanm, Scotland, UK) presewn into a particular triple-layer self-sealing graft material that proximally recreates the sinuses of Valsalva. The main body length ranges between 11.9 and 12.4 cm, and the conduit is available in 21, 23, 25 and 27 mm sizes [5]. Biointegral™. The stentless and all-biological BI comp (...truncated)