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.
Propensity-score-adjusted comparison of evolut vs. Portico devices for transcatheter aortic valve implantation / Giordano, A.; Corcione, N.; Ferraro, P.; Pieri, P.; Avellino, R.; Frati, G.; De Persio, G.; Altamura, L.; Tomai, F.; Biondi-Zoccai, G.. - In: JOURNAL OF CARDIOVASCULAR MEDICINE. - ISSN 1558-2027. - 20:5(2019), pp. 351-357. [10.2459/JCM.0000000000000764]
Propensity-score-adjusted comparison of evolut vs. Portico devices for transcatheter aortic valve implantation
Frati G.;Biondi-Zoccai G.
2019
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.