Matched Comparison of Two Different Biological Prostheses for Complete Supra-annular Aortic Valve Replacement

Abstract

Objective The aim of this retrospective study was to evaluate the hemodynamic performance of the St. Jude Medical Trifecta (SJM Trifecta; St. Jude Medical, St Paul, Minnesota, United States) and the Carpentier-Edwards Perimount Magna Ease (CEPM Ease; Edwards Lifesciences, Irvine, California, United States) bioprostheses early postoperative and at 1 year.

Methods From October 2007 to October 2008, a total of 61 consecutive patients underwent aortic valve replacement (AVR) with the CEPM Ease prosthesis. From a prospective cohort of 201 patients (March 2011 to January 2012) who received AVR with the SJM Trifecta valve, a matched group of 51 patients was selected. Matching was conducted 1:1 by ejection fraction, gender, age, and body surface area. A Hegar dilator was used to define the aortic tissue annulus diameter. Data were grouped on the basis of the patient's tissue annulus diameter (≤22 mm; 23–24 mm; ≥25 mm).

Results Early postoperative and at 1 year mean pressure gradients (MPGs) in the various groups ranged from 7.2 ± 4.6 to 7.1 ± 2.4 mm Hg and from 10.0 ± 4.3 to 8.0 ± 2.8 mm Hg in the SJM Trifecta group and from 18.0 ± 5.0 to 12.1 ± 3.6 mm Hg and from 17.7 ± 4.5 to 11.8 ± 3.2 mm Hg in the CEPM Ease group, respectively. Likewise, effective orifice areas (EOAs) ranged from 1.7 ± 0.5 to 2.0 ± 0.5 cm² and from 1.5 ± 0.3 to 1.7 ± 0.4 cm² in the SJM Trifecta group and from 1.3 ± 0.5 to 1.9 ± 0.5 cm² and from 1.2 ± 0.3 to 1.8 ± 0.3 cm² in the CEPM Ease group, respectively. A marked left ventricular mass (LVM) regression across all annulus sizes was noted in both groups. Severe patient–prosthesis mismatch (PPM) was infrequent overall.

Conclusion The SJM Trifecta valve showed lower MPGs early postoperative and at 1 year as well as higher EOA and effective orifice area index early postoperative. No significant differences were detected with regard to LVM regression and PPM.

Keywords

aortic valve and root - heart valve surgery - aorta/aortic

• References

• 1 Vahanian A, Alfieri O, Andreotti F , et al; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012; 33 (19) 2451-2496
• 2 Funkat AK, Beckmann A, Lewandowski J , et al. Cardiac surgery in Germany during 2011: a report on behalf of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg 2012; 60 (6) 371-382
• 3 El Oakley R, Kleine P, Bach DS. Choice of prosthetic heart valve in today's practice. Circulation 2008; 117 (2) 253-256
• 4 Totaro P, Degno N, Zaidi A, Youhana A, Argano V. Carpentier-Edwards PERIMOUNT Magna bioprosthesis: a stented valve with stentless performance?. J Thorac Cardiovasc Surg 2005; 130 (6) 1668-1674
• 5 Guenzinger R, Eichinger WB, Botzenhardt F , et al. Rest and exercise performance of the Medtronic Advantage bileaflet valve in the aortic position. Ann Thorac Surg 2005; 80 (4) 1319-1326
• 6 Ruzicka DJ, Hettich I, Hutter A , et al. The complete supraannular concept: in vivo hemodynamics of bovine and porcine aortic bioprostheses. Circulation 2009; 120 (11, Suppl): S139-S145
• 7 Wagner IM, Eichinger WB, Bleiziffer S , et al. Influence of completely supra-annular placement of bioprostheses on exercise hemodynamics in patients with a small aortic annulus. J Thorac Cardiovasc Surg 2007; 133 (5) 1234-1241
• 8 Dalmau MJ, Maríagonzález-Santos J, López-Rodríguez J, Bueno M, Arribas A. The Carpentier-Edwards Perimount Magna aortic xenograft: a new design with an improved hemodynamic performance. Interact Cardiovasc Thorac Surg 2006; 5 (3) 263-267
• 9 Wyss TR, Bigler M, Stalder M , et al. Absence of prosthesis-patient mismatch with the new generation of Edwards stented aortic bioprosthesis. Interact Cardiovasc Thorac Surg 2010; 10 (6) 884-887 , discussion 887–888
• 10 Edmunds Jr LH, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD ; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity of The American Association for Thoracic Surgery and The Society of Thoracic Surgeons. Guidelines for reporting morbidity and mortality after cardiac valvular operations. J Thorac Cardiovasc Surg 1996; 112 (3) 708-711
• 11 Nolan SP. The International Standard Cardiovascular implants—Cardiac Valve Prostheses (ISO 5840:1989) and the FDA Draft Replacement Heart Valve Guidance (Version 4.0). J Heart Valve Dis 1994; 3 (4) 347-349
• 12 Du Bois D, Du Bois EF. A formula to estimate the approximate surface area if height and weight be known. 1916. Nutrition 1989; 5 (5) 303-311 , discussion 312–313
• 13 Devereux RB, Alonso DR, Lutas EM , et al. Echocardiographic assessment of left ventricular hypertrophy: comparison to necropsy findings. Am J Cardiol 1986; 57 (6) 450-458
• 14 Tasca G, Brunelli F, Cirillo M , et al. Mass regression in aortic stenosis after valve replacement with small size pericardial bioprosthesis. Ann Thorac Surg 2003; 76 (4) 1107-1113
• 15 Pibarot P, Dumesnil JG. Hemodynamic and clinical impact of prosthesis-patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol 2000; 36 (4) 1131-1141
• 16 Dalmau MJ, González-Santos JM, Blázquez JA , et al. Hemodynamic performance of the Medtronic Mosaic and Perimount Magna aortic bioprostheses: five-year results of a prospectively randomized study. Eur J Cardiothorac Surg 2011; 39 (6) 844-852 , discussion 852
• 17 Wendt D, Thielmann M, Plicht B , et al. The new St Jude Trifecta versus Carpentier-Edwards Perimount Magna and Magna Ease aortic bioprosthesis: is there a hemodynamic superiority?. J Thorac Cardiovasc Surg 2014; 147 (5) 1553-1560
• 18 Ugur M, Suri RM, Daly RC , et al. Comparison of early hemodynamic performance of 3 aortic valve bioprostheses. J Thorac Cardiovasc Surg 2014; 148 (5) 1940-1946
• 19 Botzenhardt F, Eichinger WB, Bleiziffer S , et al. Hemodynamic comparison of bioprostheses for complete supra-annular position in patients with small aortic annulus. J Am Coll Cardiol 2005; 45 (12) 2054-2060
• 20 Eichinger WB, Botzenhardt F, Wagner I , et al. Hemodynamic evaluation of the Sorin Soprano bioprosthesis in the completely supra-annular aortic position. J Heart Valve Dis 2005; 14 (6) 822-827
• 21 Guenzinger R, Eichinger WB, Hettich I , et al. A prospective randomized comparison of the Medtronic Advantage Supra and St Jude Medical Regent mechanical heart valves in the aortic position: is there an additional benefit of supra-annular valve positioning?. J Thorac Cardiovasc Surg 2008; 136 (2) 462-471
• 22 Bavaria JE, Desai ND, Cheung A , et al. The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg 2014; 147 (2) 590-597
• 23 Blais C, Dumesnil JG, Baillot R, Simard S, Doyle D, Pibarot P. Impact of valve prosthesis-patient mismatch on short-term mortality after aortic valve replacement. Circulation 2003; 108 (8) 983-988
• 24 Levy D, Garrison RJ, Savage DD, Kannel WB, Castelli WP. Prognostic implications of echocardiographically determined left ventricular mass in the Framingham Heart Study. N Engl J Med 1990; 322 (22) 1561-1566