TY - JOUR
T1 - Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system
T2 - A case-matched comparison
AU - Giannini, Cristina
AU - De Carlo, Marco
AU - Tamburino, Corrado
AU - Ettori, Federica
AU - Latib, Azeem M.
AU - Bedogni, Francesco
AU - Bruschi, Giuseppe
AU - Presbitero, Patrizia
AU - Poli, Arnaldo
AU - Fabbiocchi, Franco
AU - Violini, Roberto
AU - Trani, Carlo
AU - Giudice, Pietro
AU - Barbanti, Marco
AU - Adamo, Marianna
AU - Colombo, Paola
AU - Benincasa, Susanna
AU - Agnifili, Mauro
AU - Petronio, A. Sonia
N1 - Publisher Copyright:
© 2017 Elsevier B.V.
PY - 2017/9/15
Y1 - 2017/9/15
N2 - 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.
AB - 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.
KW - Self-expandable transcatheter aortic valve
KW - Transcatheter aortic valve implantation
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U2 - 10.1016/j.ijcard.2017.05.095
DO - 10.1016/j.ijcard.2017.05.095
M3 - Article
C2 - 28595747
AN - SCOPUS:85020200148
SN - 0167-5273
VL - 243
SP - 126
EP - 131
JO - International Journal of Cardiology
JF - International Journal of Cardiology
ER -