TY - JOUR
T1 - Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation
AU - Giordano, Arturo
AU - Giordano, Alessandro
AU - Corcione, Nicola
AU - Ferraro, Paolo
AU - Morello, Alberto
AU - Conte, Sirio
AU - Conte, Sergio
AU - Testa, Luca
AU - Bedogni, Francesco
AU - Iadanza, Alessandro
AU - Berti, Sergio
AU - Regazzoli, Damiano
AU - Romagnoli, Elisa
AU - Trani, Carlo
AU - Burzotta, Francesco
AU - Pepe, Martino
AU - Pepe, Maria
AU - Frati, Giacomo
AU - Biondi-Zoccai, Giuseppe
AU - Tamburino, Corrado
AU - Ettori, Federica
AU - Petronio, Anna Sonia
AU - Rinaldi, Mauro
AU - Klugmann, Silvio
AU - Rubino, Paolo
AU - Rubino, Pasquale
AU - Tremoli, Elena
AU - Marchese, Alfredo
AU - Marchese, Alessandra Maria
AU - Sardella, Gennaro
AU - Pistis, Gianfranco
AU - Brscic, Elvis
AU - Giudice, Pietro
AU - Piatti, Luigi
AU - Ardissino, Diego
AU - Indolfi, Ciro
AU - Chiarella, Francesco
AU - Tespili, Maurizio
AU - De Servi, Stefano
AU - Bonmassari, Roberto
AU - Fappani, Antonio
AU - Cuccia, Claudio
AU - Cremonesi, Alberto
AU - Tomai, Fabrizio
PY - 2019
Y1 - 2019
N2 - Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.
AB - Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.
KW - implantation
KW - transcatheter aortic valve
KW - implantation
KW - transcatheter aortic valve
UR - http://hdl.handle.net/10807/157003
U2 - 10.1038/s41598-019-53081-w
DO - 10.1038/s41598-019-53081-w
M3 - Article
SN - 2045-2322
VL - 9
SP - 17098-N/A
JO - Scientific Reports
JF - Scientific Reports
ER -