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Thorac Cardiovasc Surg 2021; 69(05): 420-427
DOI: 10.1055/s-0040-1722692
Original Cardiovascular

Comparison of Self-Expanding RDV Perceval S versus TAVI ACURATE neo/TF

Stephen Gerfer    *
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Victor Mauri‡   *
2   Department of Cardiology, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Elmar Kuhn
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Matti Adam
2   Department of Cardiology, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Kaveh Eghbalzadeh 
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Ilija Djordjevic 
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Borko Ivanov
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Christopher Gaisendrees 
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Christian Frerker
2   Department of Cardiology, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Tobias Schmidt
2   Department of Cardiology, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Navid Mader
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Tanja Rudolph
2   Department of Cardiology, Heart Center, University Hospital of Cologne, Cologne, Germany
3   Department of Cardiology/Angiology, Heart and Diabetes Center Bad Oeynhausen, Ruhr-University Bochum, Germany
,
Stephan Baldus
2   Department of Cardiology, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Oliver Liakopoulos
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
4   Department of Cardiac Surgery, Campus Kerckhoff, University of Giessen, Germany
,
Thorsten Wahlers
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
› Author Affiliations Funding None.
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Abstract

Background Rapid deployment aortic valve replacement (RDAVR) and transcatheter aortic valve implantation (TAVI) have emerged as increasingly used alternatives to conventional aortic valve replacement to treat patients at higher surgical risk. Therefore, in this single-center study, we retrospectively compared clinical outcomes and hemodynamic performance of two self-expanding biological prostheses, the sutureless and rapid deployment valve (RDV) Perceval-S (PER) and the transcatheter heart valve (THV) ACURATE neo/TF (NEO) in a 1:1 propensity-score-matching (PSM) patient cohort.

Methods A total of 332 consecutive patients with symptomatic aortic valve stenosis underwent either singular RDAVR with PER (119) or TAVI with NEO (213) at our institutions between 2012 and 2017. To compare the unequal patient groups, a 1:1 PSM for preoperative data and comorbidities was conducted. Afterward, 59 patient pairs were compared with regard to relevant hemodynamic parameter, relevant paravalvular leak (PVL), permanent postoperative pacemaker (PPM) implantation rate, and clinical postoperative outcomes.

Results Postoperative clinical short-term outcomes presented with slightly higher rates for 30-day all-cause mortality (PER = 5.1% vs. NEO = 1.7%, p = 0.619) and major adverse cardiocerebral event in PER due to cerebrovascular events (transient ischemic attack [TIA]-PER = 3.4% vs. TIA-NEO = 1.7%, p = 0.496 and Stroke-PER = 1.7% vs. Stroke-NEO = 0.0%, p = 1). Moreover, we show comparable PPM rates (PER = 10.2% vs. NEO = 8.5%, p = 0.752). However, higher numbers of PVL (mild—PER = 0.0% vs. NEO = 55.9%, p = 0.001; moderate or higher—PER = 0.0% vs. NEO = 6.8%, p = 0.119) after TAVI with NEO were observed.

Conclusion Both self-expanding bioprostheses, the RDV-PER and THV-NEO provide a feasible option in elderly and patients with elevated perioperative risk. However, the discussed PER collective showed more postoperative short-term complications with regard to 30-day all-cause mortality and cerebrovascular events, whereas the NEO showed higher rates of PVL.

Keywords

aortic stenosis - aortic valve replacement - transcatheter aortic valve implantation - surgical aortic valve replacement - rapid deployment valve - Perceval - Symetis

Authors' Contribution

S.G. and V.M. contributed to study design, data collection, data analysis and interpretation, and writing of the manuscript; both authors contributed equally to this work. E.K., M.A., K.E., and T.R. contributed to data collection and data analysis/interpretation. I. D., B.I., and C.G. contributed to collection of data and literature search. C.F., T.S., and N.M. contributed to data analysis and interpretation. S.B., O.L., and T. W. contributed to data analysis and interpretation, review, and correction of the manuscript.


* Both authors contributed equally to this work.




Publication History

Received: 13 September 2020

Accepted: 25 November 2020

Article published online:
24 March 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Vahanian A, Otto CM. Risk stratification of patients with aortic stenosis. Eur Heart J 2010; 31 (04) 416-423
    CrossrefPubMedGoogle Scholar
  • 2 Frilling B, von Renteln-Kruse W, Riess FC. Evaluation of operative risk in elderly patients undergoing aortic valve replacement: the predictive value of operative risk scores. Cardiology 2010; 116 (03) 213-218
    CrossrefPubMedGoogle Scholar
  • 3 Mack MJ, Leon MB, Smith CR. et al; PARTNER 1 trial investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 2015; 385 9986 2477-2484
    CrossrefPubMedGoogle Scholar
  • 4 Leon MB, Smith CR, Mack MJ. et al; PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016; 374 (17) 1609-1620
    CrossrefPubMedGoogle Scholar
  • 5 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
    CrossrefPubMedGoogle Scholar
  • 6 Popma JJ, Adams DH, Reardon MJ. et al; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 2014; 63 (19) 1972-1981
    CrossrefPubMedGoogle Scholar
  • 7 Gleason TG, Reardon MJ, Popma JJ. et al; CoreValve U.S. Pivotal High Risk Trial Clinical Investigators. 5-year outcomes of self-expanding transcatheter versus surgical aortic valve replacement in high-risk patients. J Am Coll Cardiol 2018; 72 (22) 2687-2696
    CrossrefPubMedGoogle Scholar
  • 8 Adams DH, Popma JJ, Reardon MJ. et al; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014; 370 (19) 1790-1798
    CrossrefPubMedGoogle Scholar
  • 9 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
    CrossrefPubMedGoogle Scholar
  • 10 Beckmann A, Meyer R, Lewandowski J, Markewitz A, Harringer W. German Heart Surgery Report 2018: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg 2019; 67 (05) 331-344
    Article in Thieme ConnectPubMedGoogle Scholar
  • 11 Mack MJ, Leon MB, Thourani VH. et al; PARTNER 3 Investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019; 380 (18) 1695-1705
    CrossrefPubMedGoogle Scholar
  • 12 Laborde F, Fischlein T, Hakim-Meibodi K. et al; Cavalier Trial Investigators. Clinical and haemodynamic outcomes in 658 patients receiving the Perceval sutureless aortic valve: early results from a prospective European multicentre study (the Cavalier Trial). Eur J Cardiothorac Surg 2016; 49 (03) 978-986
    CrossrefPubMedGoogle Scholar
  • 13 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
    CrossrefPubMedGoogle Scholar
  • 14 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
    CrossrefPubMedGoogle Scholar
  • 15 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
    CrossrefPubMedGoogle Scholar
  • 16 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
    CrossrefPubMedGoogle Scholar
  • 17 Biancari F, Barbanti M, Santarpino G. et al. Immediate outcome after sutureless versus transcatheter aortic valve replacement. Heart Vessels 2016; 31 (03) 427-433
    CrossrefPubMedGoogle Scholar
  • 18 Eghbalzadeh K, Rahmanian PB, Giese D. et al. SAVR versus TAVI: what about the hemodynamic performance? An in vivo and in vitro analysis. Thorac Cardiovasc Surg 2019
    PubMedGoogle Scholar
  • 19 Liakopoulos OJ, Gerfer S, Weider S. et al. Direct comparison of the Edwards Intuity Elite and Sorin Perceval S rapid deployment aortic valves. Ann Thorac Surg 2018; 105 (01) 108-114
    CrossrefPubMedGoogle Scholar
  • 20 Mauri V, Deuschl F, Frohn T. et al. Predictors of paravalvular regurgitation and permanent pacemaker implantation after TAVR with a next-generation self-expanding device. Clin Res Cardiol 2018; 107 (08) 688-697
    CrossrefPubMedGoogle Scholar
  • 21 Mauri V, Kim WK, Abumayyaleh M. et al. Short-term outcome and hemodynamic performance of next-generation self-expanding versus balloon-expandable transcatheter aortic valves in patients with small aortic annulus: a multicenter propensity-matched comparison. Circ Cardiovasc Interv 2017; 10 (10) 10
    CrossrefPubMedGoogle Scholar
  • 22 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
    CrossrefPubMedGoogle Scholar
  • 23 Popma JJ, Deeb GM, Yakubov SJ. et al; Evolut Low Risk Trial Investigators. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019; 380 (18) 1706-1715
    CrossrefPubMedGoogle Scholar
  • 24 Möllmann H, Hengstenberg C, Hilker M. et al. Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry. EuroIntervention 2018; 13 (15) e1764-e1770
    CrossrefPubMedGoogle Scholar
  • 25 Shinn SH, Altarabsheh SE, Deo SV, Sabik JH, Markowitz AH, Park SJ. A systemic review and meta-analysis of sutureless aortic valve replacement versus transcatheter aortic valve implantation. Ann Thorac Surg 2018; 106 (03) 924-929
    CrossrefPubMedGoogle Scholar
  • 26 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
    CrossrefPubMedGoogle Scholar
  • 27 Auffret V, Regueiro A, Del Trigo M. et al. Predictors of early cerebrovascular events in patients with aortic stenosis undergoing transcatheter aortic valve replacement. J Am Coll Cardiol 2016; 68 (07) 673-684
    CrossrefPubMedGoogle Scholar
  • 28 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
    CrossrefPubMedGoogle Scholar
  • 29 Liakopoulos OJ, Gerfer S, Rahmanian P. et al. Rapid deployment aortic valve replacement with the Perceval S and Intuity Elite. Thorac Cardiovasc Surg 2020
    PubMedGoogle Scholar
  • 30 D'Onofrio A, Salizzoni S, Rubino AS. et al; Italian Transcatheter Balloon-Expandable Registry and the Sutureless Aortic Valve Implantation Research Groups. The rise of new technologies for aortic valve stenosis: a comparison of sutureless and transcatheter aortic valve implantation. J Thorac Cardiovasc Surg 2016; 152 (01) 99-109.e2
    CrossrefPubMedGoogle Scholar
  • 31 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
    CrossrefPubMedGoogle Scholar
  • 32 Rahmanian PB, Eghbalzadeh K, Kaya S. et al. Determination of risk factors for pacemaker requirement following rapid-deployment aortic valve replacement. Interact Cardiovasc Thorac Surg 2018; 27 (02) 215-221
    CrossrefPubMedGoogle Scholar
  • 33 Siontis GC, Jüni P, Pilgrim T. et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol 2014; 64 (02) 129-140
    CrossrefPubMedGoogle Scholar
  • 34 Nazif TM, Dizon JM, Hahn RT. et al; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv 2015; 8 1 Pt A 60-69
    CrossrefPubMedGoogle Scholar
  • 35 Fadahunsi OO, Olowoyeye A, Ukaigwe A. et al. Incidence, predictors, and outcomes of permanent pacemaker implantation following transcatheter aortic valve replacement: analysis from the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry. JACC Cardiovasc Interv 2016; 9 (21) 2189-2199
    CrossrefPubMedGoogle Scholar
  • 36 Johnston DR, Soltesz EG, Vakil N. et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg 2015; 99 (04) 1239-1247
    CrossrefPubMedGoogle Scholar