Journal of cardiovascular medicine (Hagerstown, Md.) · 2019
Propensity-score-adjusted comparison of Evolut vs. Portico devices for transcatheter aortic valve implantation.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Giordano Arturo, Corcione Nicola, Ferraro Paolo, Pieri Pietro, Avellino Raffaella, Frati Giacomo, De Persio Giovanni, Altamura Luca, Tomai Fabrizio, Biondi-Zoccai Giuseppe
Аннотация
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.
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.
Предметные рубрики MeSH
AgedAged, 80 and overAortic ValveAortic Valve StenosisComparative Effectiveness ResearchFemaleHeart Valve ProsthesisHemodynamicsHumansItalyMalePostoperative ComplicationsProsthesis DesignRecovery of FunctionRegistriesRetrospective StudiesRisk AssessmentRisk FactorsSeverity of Illness IndexTime FactorsTranscatheter Aortic Valve ReplacementTreatment Outcome