SAVR versus TAVI: What about the Hemodynamic Performance? An In Vivo and In Vitro Analysis
10 May 2019
15 July 2019
10 September 2019 (online)
Background Surgical aortic valve replacement (SAVR) is nowadays discussed whether it remains the gold standard of treatment. In the last decade, there has been a tremendous increase in transcatheter aortic valve implantation (TAVI) due to the growing expertise and excellent results of the catheter-based approach. We, therefore, retrospectively compared the rapid deployment valve (RDV), the Edwards Intuity valve (IEV), with the Edwards Sapien 3 (S3V) with regard to post-procedural hemodynamics.
Methods A total of 246 patients treated with TAVI or SAVR between February 2009 and November 2015 were included. One-hundred twenty-five patients were analyzed in the SAVR group and compared with 121 patients undergoing TAVI. Transvalvular pressure gradients (PGs) and the incidence and extent of aortic regurgitation (AR) were compared post-procedurally by echocardiography for each valve size. In vitro hemodynamics were analyzed by placing both valves into an aortic silicone phantom connected to a pulsatile flow pump and measured using phase-contrast magnetic resonance imaging (4D flow MRI).
Results Post-procedurally, mean transvalvular PGs for the 23 mm valves were 9 (7;11.5) versus 13 (9;18) (p < 0.001), whereas maximum PGs were 16.5 (14;22) versus 25.5 mm Hg (17.5;34) (p < 0.001) in IEV and S3V patients, respectively. The 21 mm IEV showed significantly lower transvalvular PGs compared with the 23 mm S3V: mean PGs: 11 (8;13) versus 13 (9;18) (p < 0.05); maximum PG: 19.5 (13;24) versus 25.5 (18;34) mm Hg (p < 0.05). Analysis revealed significantly lower post-procedural transvalvular PGs for larger valves sizes. With respect to AR, the incidence of AR was significantly lower in IEV group (p < 0.05). In vitro velocities and turbulent kinetic energy values showed similar results between both valves.
Conclusion Implanted RDVs presented a lower incidence of paravalvular regurgitation and were associated with significantly lower post-procedural transvalvular PGs, especially for small valve sizes. Our data might support the application of rapid deployment aortic valves in patients with small aortic annulus in the TAVI era.
KE & PR: study design, data interpretation, statistical analysis, wrote the manuscript.
DG: manuscript preparation, in vitro analysis, and data interpretation.
EWK: data collection, statistical analysis, literature search.
ID: data collection, literature search.
SK: data interpretation, manuscript preparation.
CW: data interpretation, manuscript preparation.
SB: data interpretation, manuscript preparation.
NM: study design, data interpretation, manuscript preparation.
TW: study design, data interpretation, manuscript preparation.
* Both the authors contributed equally to the manuscript.
- 1 Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014; 371 (10) 967-968
- 2 Kodali SK, Williams MR, Smith CR. , et al; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012; 366 (18) 1686-1695
- 3 Smith CR, Leon MB, Mack MJ. , et al; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364 (23) 2187-2198
- 4 D'Onofrio A, Messina A, Lorusso R. , et al. Sutureless aortic valve replacement as an alternative treatment for patients belonging to the “gray zone” between transcatheter aortic valve implantation and conventional surgery: a propensity-matched, multicenter analysis. J Thorac Cardiovasc Surg 2012; 144 (05) 1010-1016
- 5 Santarpino G, Pfeiffer S, Jessl J. , et al. Sutureless replacement versus transcatheter valve implantation in aortic valve stenosis: a propensity-matched analysis of 2 strategies in high-risk patients. J Thorac Cardiovasc Surg 2014; 147 (02) 561-567
- 6 Wahlers TC, Haverich A, Borger MA. , et al. Early outcomes after isolated aortic valve replacement with rapid deployment aortic valve. J Thorac Cardiovasc Surg 2016; 151 (06) 1639-1647
- 7 Kocher AA, Laufer G, Haverich A. , et al. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg 2013; 145 (01) 110-115 , discussion 115–116
- 8 Haverich A, Wahlers TC, Borger MA. , et al. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg 2014; 148 (06) 2854-2860
- 9 Lorusso R, Gelsomino S, Renzulli A. Sutureless aortic valve replacement: an alternative to transcatheter aortic valve implantation?. Curr Opin Cardiol 2013; 28 (02) 158-163
- 10 Moat NE, Ludman P, de Belder MA. , et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol 2011; 58 (20) 2130-2138
- 11 Gilard M, Eltchaninoff H, Iung B. , et al; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012; 366 (18) 1705-1715
- 12 Gotzmann M, Korten M, Bojara W. , et al. Long-term outcome of patients with moderate and severe prosthetic aortic valve regurgitation after transcatheter aortic valve implantation. Am J Cardiol 2012; 110 (10) 1500-1506
- 13 Abdel-Wahab M, Zahn R, Horack M. , et al; German transcatheter aortic valve interventions registry investigators. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart 2011; 97 (11) 899-906
- 14 Zahn R, Gerckens U, Linke A. , et al; German Transcatheter Aortic Valve Interventions-Registry Investigators. Predictors of one-year mortality after transcatheter aortic valve implantation for severe symptomatic aortic stenosis. Am J Cardiol 2013; 112 (02) 272-279
- 15 Athappan G, Patvardhan E, Tuzcu EM. , et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 2013; 61 (15) 1585-1595
- 16 Binder RK, Rodés-Cabau J, Wood DA. , et al. Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve. JACC Cardiovasc Interv 2013; 6 (03) 293-300
- 17 Herrmann HC, Thourani VH, Kodali SK. , et al; PARTNER Investigators. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation 2016; 134 (02) 130-140
- 18 Eghbalzadeh K, Kuhn EW, Sabashnikov A. , et al. Latest generation of balloon-expandable valve, the Edwards Sapien 3 Valve: less paravalvular regurgitation but higher transvalvular pressure gradients. Thorac Cardiovasc Surg 2017
- 19 Kappetein AP, Head SJ, Généreux P. , et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012; 60 (15) 1438-1454
- 20 Leon MB, Smith CR, Mack M. , et al; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363 (17) 1597-1607
- 21 Pibarot P, Hahn RT, Weissman NJ, Monaghan MJ. Assessment of paravalvular regurgitation following TAVR: a proposal of unifying grading scheme. JACC Cardiovasc Imaging 2015; 8 (03) 340-360
- 22 Giese D, Weiss K, Baeßler B. , et al. In vitro evaluation of flow patterns and turbulent kinetic energy in trans-catheter aortic valve prostheses. MAGMA 2018; 31 (01) 165-172
- 23 Kodali S, Pibarot P, Douglas PS. , et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards Sapien valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J 2015; 36 (07) 449-456
- 24 Une D, Mesana L, Chan V. , et al. Clinical impact of changes in left ventricular function after aortic valve replacement: analysis from 3112 patients. Circulation 2015; 132 (08) 741-747
- 25 Rallidis LS, Moyssakis IE, Ikonomidis I, Nihoyannopoulos P. Natural history of early aortic paraprosthetic regurgitation: a five-year follow-up. Am Heart J 1999; 138 (2 Pt 1): 351-357
- 26 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
- 27 Wahlers TC, Rahmanian PB. Rapid deployment valve implantation using the EDWARDS Intuity Valve system: a word of caution regarding sizing in calcified sinotubular junctions. Thorac Cardiovasc Surg 2015; 63 (06) 504-507
- 28 Rahmanian PB, Kaya S, Eghbalzadeh K, Menghesha H, Madershahian N, Wahlers T. Rapid deployment aortic valve replacement: excellent results and increased effective orifice areas. Ann Thorac Surg 2018; 105 (01) 24-30
- 29 Andreas M, Wallner S, Habertheuer A. , et al. Conventional versus rapid-deployment aortic valve replacement: a single-centre comparison between the Edwards Magna valve and its rapid-deployment successor. Interact Cardiovasc Thorac Surg 2016; 22 (06) 799-805
- 30 Zegdi R, Ciobotaru V, Noghin M. , et al. Is it reasonable to treat all calcified stenotic aortic valves with a valved stent? Results from a human anatomic study in adults. J Am Coll Cardiol 2008; 51 (05) 579-584
- 31 Hahn RT, Pibarot P, Stewart WJ. , et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (placement of aortic transcatheter valves). J Am Coll Cardiol 2013; 61 (25) 2514-2521
- 32 Chacko SJ, Ansari AH, McCarthy PM. , et al. Prosthesis-patient mismatch in bovine pericardial aortic valves: evaluation using 3 different modalities and associated medium-term outcomes. Circ Cardiovasc Imaging 2013; 6 (05) 776-783
- 33 Dawkins S, Hobson AR, Kalra PR, Tang AT, Monro JL, Dawkins KD. Permanent pacemaker implantation after isolated aortic valve replacement: incidence, indications, and predictors. Ann Thorac Surg 2008; 85 (01) 108-112
- 34 Folliguet TA, Laborde F, Zannis K, Ghorayeb G, Haverich A, Shrestha M. Sutureless perceval aortic valve replacement: results of two European centers. Ann Thorac Surg 2012; 93 (05) 1483-1488
- 35 Rubino AS, Santarpino G, De Praetere H. , et al. Early and intermediate outcome after aortic valve replacement with a sutureless bioprosthesis: results of a multicenter study. J Thorac Cardiovasc Surg 2014; 148 (03) 865-871 , discussion 871
- 36 Buellesfeld L, Stortecky S, Heg D. , et al. Impact of permanent pacemaker implantation on clinical outcome among patients undergoing transcatheter aortic valve implantation. J Am Coll Cardiol 2012; 60 (06) 493-501
- 37 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
- 38 Gersak B, Fischlein T, Folliguet TA. , et al. Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel. Eur J Cardiothorac Surg 2016; 49 (03) 709-718