Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: A case-matched comparison

C. Giannini, M. De Carlo, C. Tamburino, F. Ettori, A.M. Latib, F. Bedogni, G. Bruschi, P. Presbitero, A. Poli, F. Fabbiocchi, R. Violini, C. Trani, P. Giudice, M. Barbanti, M. Adamo, P. Colombo, S. Benincasa, M. Agnifili, A.S. Petronio

Research output: Contribution to journalArticlepeer-review

Abstract

Background Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. Methods Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n = 1846) or Evolut R (n = 302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. Results Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p = 0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. Conclusion In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1 year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning. © 2017 Elsevier B.V.
Original languageEnglish
Pages (from-to)126-131
Number of pages6
JournalInternational Journal of Cardiology
Volume243
DOIs
Publication statusPublished - 2017

Keywords

  • Self-expandable transcatheter aortic valve
  • Transcatheter aortic valve implantation
  • acute kidney failure
  • aged
  • aortic stenosis
  • aortic valve prosthesis
  • Article
  • artificial heart pacemaker
  • bleeding
  • blood transfusion
  • cerebrovascular accident
  • clinical outcome
  • controlled clinical trial
  • controlled study
  • female
  • hospitalization
  • human
  • incidence
  • major clinical study
  • major vascular access complication
  • male
  • overall survival
  • paravalvular leak
  • percutaneous aortic valve
  • priority journal
  • prognosis
  • prospective study
  • surgical risk
  • survival rate
  • transcatheter aortic valve implantation
  • vascular closure device
  • vascular disease
  • very elderly

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