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.
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.
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).
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: firstname.lastname@example.org
Received 30 May, 2018
Revised 04 January, 2019
Accepted 04 January, 2019
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