Hemodynamic Comparison of Sutureless and Rapid-Deployment Valves with Conventional BioprosthesesFunding The authors received no funding for this study.
27 November 2018
04 February 2019
21 March 2019 (online)
Background Sutureless and rapid-deployment bioprostheses (RPDs) are advantageous due to shorter aortic cross-clamp times (ACCs); however, few studies have investigated hemodynamic outcomes in comparison to conventional bioprostheses (CBs).
Methods All patients receiving the Perceval (LivaNova, London, United Kingdom) and Intuity (Edwards Lifesciences, Irvine, California, United States) valves from February 2016 to December 2017 were included (n = 61). For controls, patients who underwent aortic valve replacement using CB from 2015 to 2018 (n = 743) were propensity-matched (n = 108). Primary end points were mean gradient at discharge, true internal diameter (ID) after implantation, and paravalvular leakage. Secondary end points were ACCs, cardiopulmonary bypass times (CPBTs), mortality, and pacemaker implantation.
Results Age was 73.2 years (standard deviation [SD]: 7.6) in the RPD group and 72.9 years (SD: 7.3) in the CB group (p = 0.827). Median logistic EuroSCORE II was 3.4% (Q1: 2; IQ3: 5.3) and 3% (Q1: 1.9; IQ3: 5.6; p = 0.599). While ACCs and CPBT were shorter in RPDs (97 [SD: 31.4] vs. 125.4 minutes [SD: 62.1], p = 0.003; and 76.1 [SD: 25.7] vs. 89.7 minutes [SD: 34.3], p = 0.022), procedural times were similar (p = 0.257). True ID was 21.97 mm (SD: 1.79) in RPDs and 20.15 mm (SD: 1.70) in CB (p < 0.001).
RPDs and CB resulted in comparable mean gradients (12.8 mm Hg [SD: 6.4] vs. 13.8 mm Hg [SD: 5.6]; p = 0.387) and rate of paravalvular regurgitation. There were no differences in the rates of pacemaker implantation and mortality.
In a subanalysis of RPDs, mean gradient was 15.48 mm Hg (SD: 7.51) in Perceval (n = 21) and 10.79 mm Hg (SD: 4.78) in Intuity (n = 33; p = 0.010).
Conclusions RPDs provided comparable hemodynamic performance, although implanted valves were larger in true ID. Whether this provides superior hemodynamic performance during exercise and longer durability needs further investigation. Among RPDs, the Intuity valve provided lower mean gradients at rest than Perceval valve.
Presented at the 32nd annual meeting of the European Association of Cardiothoracic Surgery on November 19, 2018, in Milan, Italy.
- 1 Baumgartner H, Falk V, Bax JJ. , et al; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2017; 38 (36) 2739-2791
- 2 Beckmann A, Funkat AK, Lewandowski J. , et al. German Heart Surgery Report 2016: the annual updated Registry of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg 2017; 65 (07) 505-518
- 3 Davies RA, Bandara TD, Perera NK, Orr Y. Do rapid deployment aortic valves improve outcomes compared with surgical aortic valve replacement?. Interact Cardiovasc Thorac Surg 2016; 23 (05) 814-820
- 4 Shrestha M, Folliguet TA, Pfeiffer S. , et al. Aortic valve replacement and concomitant procedures with the Perceval valve: results of European trials. Ann Thorac Surg 2014; 98 (04) 1294-1300
- 5 Nissinen J, Biancari F, Wistbacka JO. , et al. Safe time limits of aortic cross-clamping and cardiopulmonary bypass in adult cardiac surgery. Perfusion 2009; 24 (05) 297-305
- 6 Shrestha M, Fischlein T, Meuris B. , et al. European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients. Eur J Cardiothorac Surg 2016; 49 (01) 234-241
- 7 Barnhart GR, Accola KD, Grossi EA. , et al; TRANSFORM Trial Investigators. Transform (Multicenter experience with rapid deployment Edwards Intuity valve system for aortic valve replacement) US clinical trial: performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg 2017; 153 (02) 241-251.e2
- 8 Tasca G, Vismara R, Mangini A. , et al. Comparison of the performance of a sutureless bioprosthesis with two pericardial stented valves on small annuli: an in vitro study. Ann Thorac Surg 2017; 103 (01) 139-144
- 9 Ai L, Chen H, Lin V, Bapat VN. Rapid deployment aortic valves deliver superior hemodynamic performance in vitro. Innovations (Phila) 2017; 12 (05) 338-345
- 10 Kappetein AP, Head SJ, Généreux P. , et al; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg 2013; 145 (01) 6-23
- 11 LivaNova. Stent folding by oversizing of the Perceval valve, FSCA Referenz Nr.:HV-SAL-2018–001. https://www.bfarm.de/SharedDocs/Kundeninfos/DE/11/2018/07039-18_kundeninfo_de.pdf?__blob=publicationFile&v=1 . Accessed October 3, 2018
- 12 Pfeiffer S, Wilbring M, Kappert U, Santarpino G. The ‘entangled’ stent: a preventable cause of paravalvular leak of the Perceval bioprosthesis. Interact Cardiovasc Thorac Surg 2017; 25 (06) 987-989
- 13 Ensminger S, Fujita B, Bauer T. , et al; GARY Executive Board. Rapid deployment versus conventional bioprosthetic valve replacement for aortic stenosis. J Am Coll Cardiol 2018; 71 (13) 1417-1428
- 14 Di Eusanio M, Phan K, Berretta P. , et al. Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR): early results from 3343 patients. Eur J Cardiothorac Surg 2018; 54 (04) 768-773
- 15 Vogt F, Pfeiffer S, Dell'Aquila AM, Fischlein T, Santarpino G. Sutureless aortic valve replacement with Perceval bioprosthesis: are there predicting factors for postoperative pacemaker implantation?. Interact Cardiovasc Thorac Surg 2016; 22 (03) 253-258
- 16 Kawashima T, Sato F. Visualizing anatomical evidences on atrioventricular conduction system for TAVI. Int J Cardiol 2014; 174 (01) 1-6
- 17 O'Keefe Jr JH, Abuissa H, Jones PG. , et al. Effect of chronic right ventricular apical pacing on left ventricular function. Am J Cardiol 2005; 95 (06) 771-773