Haemodynamic comparison of sutureless and rapid deployment valves

Haemodynamic comparison of sutureless and rapid deployment valves with conventional bioprostheses Gotzmann M et al. Thorac Cardiovasc Surg. 2019. doi: 1055/s-0039 -1683426.

Study details § Aim: To compare haemodynamic outcomes of rapid deployment valves with conventional aortic valve bioprostheses § Study type: Single-centre, retrospective, propensity-matched study § Endpoints: Mean pressure gradient at discharge, true ID of prosthesis, rate of paravalvular regurgitation, CPB and cross-clamp times, VARC-2 outcomes and length of ICU stay § Methods: – Patients who had undergone RDAVR between February 2016 and December 2017 were propensity matched with patients who had undergone c. AVR between January 2015 and March 2018 – Clinical efficacy after 30 days was evaluated via telephone interviews with RDAVR patients – Median follow-up was 277 days (IQR: 151– 461 days) – True ID for each prosthesis was determined using the Vi. V Aortic smartphone app AVR: aortic valve replacement; c. AVR: conventional aortic valve replacement; CPB: cardiopulmonary bypass; ICU: intensive care unit; ID: internal diameter; IQR: interquartile range; RDAVR: rapid deployment aortic valve replacement; VARC-2: Valve Academic Research Consortium; Vi. V: valve in valve

Key study results (1/2) § Patient characteristics – After 1: 1 propensity matching, 54 patients in each group were compared – RDAVR group: § Perceval valve (Liva. Nova): 21 patients § EDWARDS INTUITY valve (Edwards Lifesciences): 33 patients – Patients receiving the EDWARDS INTUITY valve tended to be younger than those receiving the Perceval valve (71. 7 years vs 75. 5 years, p=0. 077) § Operative outcomes – Cross-clamp time: RDAVR 76. 1 minutes versus c. AVR 89. 7 minutes (p=0. 022) – CPB time: RDAVR 97 minutes versus c. AVR 125. 4 minutes (p=0. 003) § No differences in intraoperative times for Perceval versus EDWARDS INTUITY valve – True prosthesis ID: RDAVR 21. 97 mm versus c. AVR 20. 15 mm (p<0. 001) c. AVR: conventional aortic valve replacement; CPB: cardiopulmonary bypass; ID: internal diameter; RDAVR: rapid deployment aortic valve replacement

Key study results (2/2) § Haemodynamic data at discharge – Paravalvular regurgitation: comparable across all groups and subgroups – Mean gradients: RDAVR 12. 8 mm. Hg versus c. AVR 13. 8 mm. Hg (p=0. 387) § Gradients were significantly lower for the EDWARDS INTUITY valve than for the Perceval valve – Mean: 10. 79 mm. Hg versus 15. 48 mm. Hg (p=0. 010) – Peak: 19. 76 mm. Hg versus 27. 60 mm. Hg (p=0. 014) § VARC-2 outcomes – Device success: RDAVR 82. 4% versus c. AVR 87. 0% (p=0. 531) § Perceval 76. 2% versus EDWARDS INTUITY valve 86. 7% (p=0. 334) – PPI rate: RDAVR 14. 8% versus c. AVR 7. 4% (p=0. 221) § Perceval valve 23. 8% versus EDWARDS INTUITY valve 9. 1% (p=0. 138) c. AVR: conventional aortic valve replacement; PPI: permanent pacemaker implantation; RDAVR: rapid deployment aortic valve replacement

Study limitations and conclusion § Limitations – Unknown confounding variables may have affected the data – Small sample size, missing data and heterogeneous concomitant procedures – For the Perceval valve, the average true ID was calculated from the smartphone app range Conclusion RDAVR facilitates implantation of larger protheses, but this did not translate into improved haemodynamic outcomes. Mean gradients were higher with the Perceval valve than the EDWARDS INTUITY valve, although this was not associated with increased echocardiographic abnormalities or reoperations. RDAVR may facilitate combined procedures and minimally invasive surgery; however in young patients, c. AVR remains the gold standard. c. AVR: conventional aortic valve replacement; ID: internal diameter; RDAVR: rapid deployment aortic valve replacement

This document is a summary of the Gotzmann M et al. paper and covers key information including aim, type of study, methods, results, limitations and conclusions. The full publication is available at: http: //bit. ly/gotzmann 2019 Abbreviations AVR: aortic valve replacement IQR: interquartile range c. AVR: conventional aortic valve replacement PPI: permanent pacemaker implantation CPB: cardiopulmonary bypass RDAVR: rapid deployment aortic valve replacement ICU: intensive care unit VARC-2: Valve Academic Research Consortium ID: internal diameter Vi. V: valve-in-valve Important safety information: Use of the EDWARDS INTUITY Elite valve system may be associated with new or worsened conduction disturbances, which may require a permanent cardiac pacemaker implant (PPI). The rate of PPI for the EDWARDS INTUITY Elite valve is within the range reported in the literature for various rapid deployment valves, but higher than that reported for surgical aortic valves. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to implantation. See instructions for use for additional information. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS INTUITY, and EDWARDS INTUITY Elite are trademarks of Edwards Lifesciences Corporation. All other trademarks are property of their respective owners. © 2019 Edwards Lifesciences Corporation. All rights reserved. E 9585/05 -19/SUR Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards. com