Thorac Cardiovasc Surg 2021; 69(05): 412-419
DOI: 10.1055/s-0040-1716892
Original Cardiovascular

Rapid Deployment Aortic Valve Replacement with the Perceval S and Intuity Elite

Oliver J. Liakopoulos*
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
2   Department of Cardiac Surgery, Campus Kerckhoff, University of Giessen, Giessen, Germany
,
Stephen Gerfer*
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Parwis Rahmanian
1   Department of Cardiothoracic Surgery, 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
,
Georg Schlachtenberger
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Mohamed Zeriouh
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
2   Department of Cardiac Surgery, Campus Kerckhoff, University of Giessen, Giessen, Germany
,
Navid Mader
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
,
Yeong-Hoon Choi
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
2   Department of Cardiac Surgery, Campus Kerckhoff, University of Giessen, Giessen, Germany
3   German Center for Cardiovascular Research (DZHK), Partner Site Rhine/Main, Frankfurt/Main, Germany
,
Thorsten Wahlers
1   Department of Cardiothoracic Surgery, Heart Center, University Hospital of Cologne, Cologne, Germany
› Institutsangaben
Funding None.

Abstract

Background Rapid deployment aortic valve replacement (RDAVR) has emerged as an alternative to conventional aortic valve replacement. This single-center study retrospectively analyzed clinical outcomes and hemodynamic performance of the Perceval S (LivaNova) and Intuity Elite (Edwards LifeSciences) rapid deployment valves (RDVs) in a propensity score matched patient cohort.

Methods A total of 372 consecutive patients with symptomatic aortic valve stenosis underwent RDAVR between 2012 and 2018 at our institution. The Intuity Elite (INT group) and Perceval S (PER group) were implanted in 251 and 121 patients, respectively. After 1:1 propensity score matching for relevant preoperative comorbidities, 107 patient pairs were compared with respect to relevant perioperative data including hemodynamic parameter, postoperative pacemaker implantation, and 30-day all-cause mortality.

Results Propensity score matching resulted in balanced characteristics between groups. Cardiopulmonary bypass and aortic cross-clamp time did not differ between groups, but more patients in the INT group received coronary artery bypass grafting compared with the PER group (56 vs. 42%; p = 0.055). Thirty-day mortality (4.7 vs. 2.2%) and need for permanent pacemaker implantation (7 versus 4.4%) were comparable between the INT and PER groups for isolated AVR and also for combined procedures, respectively. Cerebrovascular events showed comparable low rates for both RDVs (INT group [1.9%] vs. PER group [2.8%]). Indexed effective orifice area was higher in the INT group (0.90 vs. 0.82 cm2/m2) and coupled to a lower peak (17 ± 7 vs. 22 ± 8) and mean (10 ± 5 vs. 12 ± 4) pressure gradients compared with the PER group.

Conclusions Our propensity score analysis in AVR patients showed good hemodynamic characteristics with comparable 30-day mortality rate and complications rates for both investigated RDVs.

Authors' Contribution

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


Note

Part of the presented data in this paper was presented at the 2019 Annual European Association for Cardio-Thoracic Surgery Meeting, Lisbon, Portugal.


* Both authors contributed equally to this work.




Publikationsverlauf

Eingereicht: 26. Mai 2020

Angenommen: 17. August 2020

Artikel online veröffentlicht:
25. Oktober 2020

© 2020. 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
  • 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
  • 3 Phan K, Tsai YC, Niranjan N. et al. Sutureless aortic valve replacement: a systematic review and meta-analysis. Ann Cardiothorac Surg 2015; 4 (02) 100-111
  • 4 Brown JM, O'Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg 2009; 137 (01) 82-90
  • 5 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
  • 6 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
  • 7 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
  • 8 Di Eusanio M, Phan K. Sutureless aortic valve replacement. Ann Cardiothorac Surg 2015; 4 (02) 123-130
  • 9 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
  • 10 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
  • 11 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
  • 12 Barnhart GR, Accola KD, Grossi EA. et al. TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience with Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg 2017; 153 (02) 241-251.e2
  • 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
  • 14 Laufer G, Haverich A, Andreas M. et al. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg 2017; 52 (02) 281-287
  • 15 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
  • 16 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
  • 17 Berretta P, Andreas M, Carrel TP. et al. Minimally invasive aortic valve replacement with sutureless and rapid deployment valves: a report from an international registry (Sutureless and Rapid Deployment International Registry). Eur J Cardiothorac Surg 2019; 56 (04) 793-799
  • 18 Borger MA, Dohmen PM, Knosalla C. et al. Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial. Eur J Cardiothorac Surg 2016; 50 (04) 713-720
  • 19 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
  • 20 Salis S, Mazzanti VV, Merli G. et al. Cardiopulmonary bypass duration is an independent predictor of morbidity and mortality after cardiac surgery. J Cardiothorac Vasc Anesth 2008; 22 (06) 814-822
  • 21 D'Onofrio A, Salizzoni S, Filippini C. et al. Surgical aortic valve replacement with new-generation bioprostheses: sutureless versus rapid-deployment. J Thorac Cardiovasc Surg 2019; S0022-5223 (19)30977-8