Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.
[en] Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and haemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Durko, Andras P.
Pibarot, Philippe
Atluri, Pavan
Bapat, Vinayak
Cameron, Duke E.
Casselman, Filip P. A.
Chen, Edward P.
Dahle, Gry
Elefteriades, John A.
Lancellotti, Patrizio ; Université de Liège - ULiège > Département des sciences cliniques > Cardiologie - Pathologie spéciale et réhabilitation
Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.
The European Parliament and the Council of the European Union, Regulation (EU) 2017/745 http://eur-lex.europa.eu/legal-content/ENG/ TXT/PDF/?uri=CELEX:32017R0745&from=EN (1 February 2020, date last accessed).
U.S. Food and Drug Administration. Premarket Approval (PMA) j FDA.https://www.fda.gov/medical-devices/premarket-submissions/pre market-approval-pma (2 July 2020, date last accessed).
ISO. International Standard, ISO 5840:2015. Cardiovascular Implants- Cardiac Valve Prostheses. International Organization for Standardization (ISO), 2015. www.iso.org (1 February 2020, date last accessed).
Durko A, Head S, Pibarot P, Atluri P, Bapat V, Cameron D et al. Characteristics of surgical prosthetic heart valves and problems around labelling: a document from the European Association for Cardio- Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)- American Association for Thoracic Surgery (AATS) Valve Labelling Task Force. Eur J Cardiothorac Surg 2019;55:1025-36.
Frank M, Ganzoni G, Starck C, Grünenfelder J, Corti R, Gruner C et al. Lack of accessible data on prosthetic heart valves. Int J Cardiovasc Imaging 2016;32:439-47.
Bapat VN, Attia R, Thomas M. Effect of valve design on the stent internal diameter of a bioprosthetic valve: a concept of true internal diameter and its implications for the valve-in-valve procedure. JACC Cardiovasc Interv 2014;7:115-27.
Ruzicka DJ, Hettich I, Hutter A, Bleiziffer S, Badiu CC, Bauernschmitt R et al. The complete supraannular concept: in vivo hemodynamics of bovine and porcine aortic bioprostheses. Circulation 2009;120:S139-45.
Cameron D. Little things matter. J Thorac Cardiovasc Surg 2015;149: 918-19.
Christakis GT, Buth KJ, Goldman BS, Fremes SE, Rao V, Cohen G et al. Inaccurate and misleading valve sizing: a proposed standard for valve size nomenclature. Ann Thorac Surg 1998;66:1198-203.
Walther T, Falk V, Weigl C, Diegeler A, Rauch T, Autschbach R et al. Discrepancy of sizers for conventional and stentless aortic valve implants. J Heart Valve Dis 1997;6:145-8.
Bartels C, Leyh RG, Matthias Bechtel JF, Joubert-Hubner E, Sievers HH. Discrepancies between sizer and valve dimensions: implications for small aortic root. Ann Thorac Surg 1998;65:1631-3.
Cochran RP, Kunzelman KS. Discrepancies between labeled and actual dimensions of prosthetic valves and sizers. J Card Surg 1996;11:318-24; discussion 25.
Ruzicka DJ, Eichinger WB, Hettich IM, Bleiziffer S, Bauernschmitt R, Lange R. Hemodynamic performance of the new St. Jude Medical Epic Supra porcine bioprosthesis in comparison to the Medtronic Mosaic on the basis of patient annulus diameter. J Heart Valve Dis 2008;17:426-33; discussion 34.
Lancellotti P, Pibarot P, Chambers J, Edvardsen T, Delgado V, Dulgheru R et al. Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2016;17:589-90.
Wu C, Saikrishnan N, Chalekian AJ, Fraser R, Ieropoli O, Retta SM et al. In-vitro pulsatile flow testing of prosthetic heart valves: a round-Robin study by the ISO cardiac valves working group. Cardiovasc Eng Technol 2019;10:397-422.
Retta SM, Kepner J, Marquez S, Herman BA, S Shu MC, Grossman LW. In-vitro pulsatile flow measurement in prosthetic heart valves: an interlaboratory comparison. J Heart Valve Dis 2017;26:72-80.
Rosenhek R, Binder T, Maurer G, Baumgartner H. Normal values for Doppler echocardiographic assessment of heart valve prostheses. J Am Soc Echocardiogr 2003;16:1116-27.
Bavaria JE, Desai ND, Cheung A, Petracek MR, Groh MA, Borger MA et al. The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg 2014;147:590-7.
Sabik JF 3rd, Rao V, Lange R, Kappetein AP, Dagenais F, Labrousse L et al. One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis. J Thorac Cardiovasc Surg 2018;156: 1368-77.e5.
Bleiziffer S, Ali A, Hettich IM, Akdere D, Laubender RP, Ruzicka D et al. Impact of the indexed effective orifice area on mid-term cardiac-related mortality after aortic valve replacement. Heart 2010;96:865-71.
Pibarot P, Dumesnil JG. Hemodynamic and clinical impact of prosthesispatient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol 2000;36:1131-41.
Fallon JM, DeSimone JP, Brennan JM, O'Brien S, Thibault DP, DiScipio AW et al. The incidence and consequence of prosthesis-patient mismatch after surgical aortic valve replacement. Ann Thorac Surg 2018; 106:14-22.
Head SJ, Mokhles MM, Osnabrugge RL, Pibarot P, Mack MJ, Takkenberg JJ et al. The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient- years. Eur Heart J 2012;33:1518-29.
Pibarot P, Magne J, Leipsic J, Côté N, Blanke P, Thourani VH et al. Imaging for predicting and assessing prosthesis-patient mismatch after aortic valve replacement. JACC Cardiovasc Imaging 2019;12:149-62.
Bleiziffer S, Eichinger WB, Hettich I, Guenzinger R, Ruzicka D, Bauernschmitt R et al. Prediction of valve prosthesis-patient mismatch prior to aortic valve replacement: which is the best method? Heart 2007; 93:615-20.
Cohen RG, Bourne ET. Industry-generated charts for the selection of stented aortic valve prostheses: clinical tool or marketing ploy? Ann Thorac Surg 2011;91:1001-2.
Verbraecken J, Van de Heyning P, De Backer W, Van Gaal L. Body surface area in normal-weight, overweight, and obese adults. A comparison study. Metabolism 2006;55:515-24.
Fatima B, Mohananey D, Khan FW, Jobanputra Y, Tummala R, Banerjee K et al. Durability data for bioprosthetic surgical aortic valve: a systematic review. JAMA Cardiol 2019;4:71-80.
Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 2017;52:408-17.
Dvir D, Bourguignon T, Otto CM, Hahn RT, Rosenhek R, Webb JG et al. Standardized definition of structural valve degeneration for surgical and transcatheter bioprosthetic aortic valves. Circulation 2018;137: 388-99.
