Novel Thoughts on Patient–Prosthesis Mismatch in Aortic Valve Replacement: The Rationale for the PAR I Trial

Abstract

The hemodynamic performance of prosthetic tissue valves is influenced by valve design and valve-specific sizing strategies. Design determines the actual geometric opening area (GOA) of the prosthetic valve and sizing strategy its actual chosen size. Currently, hemodynamic performance is assessed by determining the effective orifice area (EOA; derived from the continuity equation by relating flow velocities with the area of the left ventricular outflow tract [LVOT_A]). The question whether a valve is too small (patient–prosthesis mismatch [PPM]) is currently addressed by relating EOA to body surface area (EOA index [EOAi]). However, this relation may not be appropriate because the EOAi relates flow velocity to patient-specific anatomic parameters twice (i.e., LVOT_A and body surface area). This potential confounder may explain the controversies regarding PPM. However, intuitively, leaving a gradient behind after aortic valve replacement cannot be irrelevant. PPM becomes even more relevant with transcatheter valve-in-valve implantation, where a second prosthesis is taking up inner space of a valve that may have already been too small initially. Thus, a reliable method to determine the presence of PPM is needed. The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the LVOT_A as a potentially new parameter for the prediction of hemodynamic outcome. The results may possibly guide future valve size selection and may allow prediction of functionally relevant PPM. Here, we will demonstrate the shortcomings of the currently applied EOAi for the assessment of hemodynamic relevance and present the rationale for the PARI trial, which recently started recruiting patients.

Keywords

patient–prosthesis mismatch - heart valve surgery - aortic valve replacement

Note

T.D., A.R., and W.E. received honoraria from St. Jude Medical, Inc. for lectures on aortic valve topics. The PAR I trial is sponsored by St. Jude Medical, Inc. The content of this article has been presented at the annual meeting of the DGTHG 2013.

• References

• 1 Doenst T, Amorim PA, Al-Alam N, Lehmann S, Mukherjee C, Faerber G. Where is the common sense in aortic valve replacement? A review of hemodynamics and sizing of stented tissue valves. J Thorac Cardiovasc Surg 2011; 142 (5) 1180-1187
• 2 Doenst TDM, Sack FU, Paraforos A , et al. Prosthesis-Annulus-Relation (PAR) as predictor of hemodynamic outcome in aortic valve replacement—rationale of the PAR I trial. Thorac Cardiovasc Surg 2013; 61: OP201
• 3 Diab M, Faerber G, Bothe W , et al. Sizing strategy is a major determinant of postoperative pressure gradients in commonly implanted stented tissue valves. Eur J Cardiothorac Surg 2013; 44 (4) e289-e294
• 4 Goetzenich A, Langebartels G, Christiansen S, Hatam N, Autschbach R, Dohmen G. Comparison of the Carpentier-Edwards Perimount and St. Jude Medical Epic bioprostheses for aortic valve replacement—a retrospective echocardiographic short-term study. J Card Surg 2009; 24 (3) 260-264
• 5 Maitland A, Hirsch GM, Pascoe EA. Hemodynamic performance of the St. Jude Medical Epic Supra aortic stented valve. J Heart Valve Dis 2011; 20 (3) 327-331
• 6 Eichinger WB, Botzenhardt F, Guenzinger R , et al. The effective orifice area/patient aortic annulus area ratio: a better way to compare different bioprostheses? A prospective randomized comparison of the Mosaic and Perimount bioprostheses in the aortic position. J Heart Valve Dis 2004; 13 (3) 382-388 , discussion 388–389
• 7 Dalmau MJ, María González-Santos J, López-Rodríguez J, Bueno M, Arribas A, Nieto F. One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic bioprosthesis in the aortic position: a prospective randomized study. Interact Cardiovasc Thorac Surg 2007; 6 (3) 345-349
• 8 Botzenhardt F, Eichinger WB, Guenzinger R , et al. Hemodynamic performance and incidence of patient-prosthesis mismatch of the complete supraannular perimount magna bioprosthesis in the aortic position. Thorac Cardiovasc Surg 2005; 53 (4) 226-230
• 9 Rahimtoola SH. The problem of valve prosthesis-patient mismatch. Circulation 1978; 58 (1) 20-24
• 10 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
• 11 Pibarot P, Dumesnil JG, Cartier PC, Métras J, Lemieux MD. Patient-prosthesis mismatch can be predicted at the time of operation. Ann Thorac Surg 2001; 71 (5, Suppl): S265-S268
• 12 Howell NJ, Keogh BE, Barnet V , et al. Patient-prosthesis mismatch does not affect survival following aortic valve replacement. Eur J Cardiothorac Surg 2006; 30 (1) 10-14
• 13 Ng AC, Delgado V, van der Kley F , et al. Comparison of aortic root dimensions and geometries before and after transcatheter aortic valve implantation by 2- and 3-dimensional transesophageal echocardiography and multislice computed tomography. Circ Cardiovasc Imaging 2010; 3 (1) 94-102
• 14 Poh KK, Levine RA, Solis J , et al. Assessing aortic valve area in aortic stenosis by continuity equation: a novel approach using real-time three-dimensional echocardiography. Eur Heart J 2008; 29 (20) 2526-2535
• 15 Hagendorff A, Stoebe S, Tarr A, Pfeiffer D. [Standard transthoracic echocardiography examination in patients with degenerative stenosis of the aortic valve]. Ultraschall Med 2012; 33 (6) 520-538 , quiz 539–542
• 16 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
• 17 Baumgartner H, Hung J, Bermejo J , et al; American Society of Echocardiography; European Association of Echocardiography. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr 2009; 22 (1) 1-23 , quiz 101–102
• 18 Jamieson WR, Janusz MT, MacNab J, Henderson C. Hemodynamic comparison of second- and third-generation stented bioprostheses in aortic valve replacement. Ann Thorac Surg 2001; 71 (5, Suppl): S282-S284
• 19 Thomson HL, O'Brien MF, Almeida AA, Tesar PJ, Davison MB, Burstow DJ. Haemodynamics and left ventricular mass regression: a comparison of the stentless, stented and mechanical aortic valve replacement. Eur J Cardiothorac Surg 1998; 13 (5) 572-575
• 20 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
• 21 Ross Jr J, Braunwald E. Aortic stenosis. Circulation 1968; 38 (1, Suppl): 61-67
• 22 Doenst T, Diab M, Faerber G . Is the effective orifice area index appropriate to assess patient-prosthesis mismatch? [Letter to the editor] Eur Heart J, published online July 31, 2012
• 23 Rao V, Jamieson WR, Ivanov J, Armstrong S, David TE. Prosthesis-patient mismatch affects survival after aortic valve replacement. Circulation 2000; 102 (19) (Suppl. 03) III5-III9
• 24 Pibarot P, Dumesnil JG, Lemieux M, Cartier P, Métras J, Durand LG. Impact of prosthesis-patient mismatch on hemodynamic and symptomatic status, morbidity and mortality after aortic valve replacement with a bioprosthetic heart valve. J Heart Valve Dis 1998; 7 (2) 211-218
• 25 Moon MR, Pasque MK, Munfakh NA , et al. Prosthesis-patient mismatch after aortic valve replacement: impact of age and body size on late survival. Ann Thorac Surg 2006; 81 (2) 481-488 , discussion 489
• 26 Ennker J, Rosendahl U, Albert A, Dumlu E, Ennker IC, Florath I. Stentless bioprostheses in small aortic roots: impact of patient-prosthesis mismatch on survival and quality of life. J Heart Valve Dis 2005; 14 (4) 523-530
• 27 Walther T, Rastan A, Falk V , et al. Patient prosthesis mismatch affects short- and long-term outcomes after aortic valve replacement. Eur J Cardiothorac Surg 2006; 30 (1) 15-19
• 28 Ryomoto M, Mitsuno M, Yamamura M , et al. Patient-prosthesis mismatch after aortic valve replacement in the elderly. Gen Thorac Cardiovasc Surg 2008; 56 (7) 330-334
• 29 Tasca G, Mhagna Z, Perotti S , et al. Impact of prosthesis-patient mismatch on cardiac events and midterm mortality after aortic valve replacement in patients with pure aortic stenosis. Circulation 2006; 113 (7) e288 (Quiani, Eugenio [corrected to Quaini, Eugenio])
• 30 Mascherbauer J, Rosenhek R, Fuchs C , et al. Moderate patient-prosthesis mismatch after valve replacement for severe aortic stenosis has no impact on short-term and long-term mortality. Heart 2008; 94 (12) 1639-1645
• 31 Moon MR, Lawton JS, Moazami N, Munfakh NA, Pasque MK, Damiano Jr RJ. POINT: Prosthesis-patient mismatch does not affect survival for patients greater than 70 years of age undergoing bioprosthetic aortic valve replacement. J Thorac Cardiovasc Surg 2009; 137 (2) 278-283
• 32 Florath I, Albert A, Rosendahl U, Ennker IC, Ennker J. Impact of valve prosthesis-patient mismatch estimated by echocardiographic-determined effective orifice area on long-term outcome after aortic valve replacement. Am Heart J 2008; 155 (6) 1135-1142
• 33 Mohty D, Dumesnil JG, Echahidi N , et al. Impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: influence of age, obesity, and left ventricular dysfunction. J Am Coll Cardiol 2009; 53 (1) 39-47
• 34 Urso S, Sadaba R, Vives M , et al. Patient-prosthesis mismatch in elderly patients undergoing aortic valve replacement: impact on quality of life and survival. J Heart Valve Dis 2009; 18 (3) 248-255
• 35 Jamieson WR, Ye J, Higgins J , et al. Effect of prosthesis-patient mismatch on long-term survival with aortic valve replacement: assessment to 15 years. Ann Thorac Surg 2010; 89 (1) 51-58 , discussion 59
• 36 Head SJ, Mokhles MM, Osnabrugge RL , 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 (12) 1518-1529
• 37 Cotoni DA, Palac RT, Dacey LJ, O'Rourke DJ. Defining patient-prosthesis mismatch and its effect on survival in patients with impaired ejection fraction. Ann Thorac Surg 2011; 91 (3) 692-699
• 38 Hong S, Yi G, Youn YN, Lee S, Yoo KJ, Chang BC. Effect of the prosthesis-patient mismatch on long-term clinical outcomes after isolated aortic valve replacement for aortic stenosis: A prospective observational study. J Thorac Cardiovasc Surg 2013; 146 (5) 1098-1104
• 39 Jeong DS, Chang HW, Kim KH, Ahn H. Impact of patient-prosthesis mismatch in the aortic position: twenty-year experience with Korean patients. J Heart Valve Dis 2013; 22 (1) 56-63
• 40 Hernández-Vaquero D, Llosa JC, Díaz R , et al. Impact of patient-prosthesis mismatch on 30-day outcomes in young and middle-aged patients undergoing aortic valve replacement. J Cardiothorac Surg 2012; 7: 46
• 41 Concistrè G, Dell'aquila A, Pansini S , et al. Aortic valve replacement with smaller prostheses in elderly patients: does patient prosthetic mismatch affect outcomes?. J Card Surg 2013; 28 (4) 341-347