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Propensity-score-adjusted comparison of Evolut vs. Portico devices for transcatheter aortic valve implantation

Giordano, Arturoa; Corcione, Nicolaa,b; Ferraro, Paoloa,b; Pieri, Pietroc; Avellino, Raffaellaa,b; Frati, Giacomod,e; De Persio, Giovannif,g; Altamura, Lucaf,g; Tomai, Fabriziof,g; Biondi-Zoccai, Giusepped,e

Journal of Cardiovascular Medicine: May 2019 - Volume 20 - Issue 5 - p 351–357
doi: 10.2459/JCM.0000000000000764
Research articles: Structural heart intervention
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Aims Transcatheter aortic valve implantation has become an established treatment for severe aortic stenosis, thanks to key improvements achieved by new-generation devices. Their comparative effectiveness and safety are, however, still uncertain.

Methods We queried a prospective registry on transcatheter aortic valve implantation to compare Evolut and Portico devices, focusing on procedural, in-hospital, and mid-term outcomes. Unadjusted and propensity-adjusted analyses were carried out.

Results In all, 233 patients were included, 119 (51.1%) receiving Evolut and 114 (48.9%) Portico. Several differences in baseline and procedural features were evident, including comorbidities, device size, and postdilation (all P < 0.05). Unadjusted analysis for procedural results showed significant differences in fluoroscopy time, left ventricular ejection fraction, and aortic regurgitation (all P < 0.05), whereas device and procedural success rates were not significantly different (both P > 0.05). In-hospital outcomes were not significantly different (all P > 0.05). Survival analysis for mid-term follow-up (6 ± 7 months) outcomes showed no significant differences in death, stroke, myocardial infarction, major vascular complication, or major bleeding (all P > 0.05). Conversely, Evolut appeared associated with lower peak and mean aortic gradients (both P < 0.05), but higher rate of permanent pacemaker implantation (P = 0.043). Propensity-score-adjusted analysis largely confirmed the similar performance of the two devices, including peak and mean aortic gradients (both P > 0.05). However, Evolut continued to be associated even at adjusted analysis with an increased risk of pacemaker implantation (P = 0.018).

Conclusion The acute and mid-term comparative safety and effectiveness of Evolut and Portico in experienced hands are similar, with the notable exception of a lower risk of permanent pacemaker implantation with Portico.

aUnità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno

bUnità Operativa di Emodinamica, Casa di Salute Santa Lucia, San Giuseppe Vesuviano

cDivision of Cardiology, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

dDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina

eIRCCS Neuromed, Pozzilli

fDivision of Cardiology, European Hospital

gDivision of Cardiology, Aurelia Hospital, Rome, Italy

Correspondence to Professor Giuseppe Biondi-Zoccai, Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 79, 04100 Latina, Italy E-mail: giuseppe.biondizoccai@uniroma1.it

Received 30 May, 2018

Revised 04 January, 2019

Accepted 04 January, 2019

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© 2019 Italian Federation of Cardiology. All rights reserved.