TY - JOUR
T1 - Outcomes of Transcatheter Aortic Valve Replacement in Patients With Severely Reduced Left Ventricular Systolic Function in the Low Systolic Function and Transcatheter Aortic Valve Implantation (LOSTAVI) International Registry
AU - Giordano, Arturo
AU - Schaefer, Andreas
AU - Bhadra, Oliver D.
AU - Barbanti, Marco
AU - Costa, Giuliano
AU - Sammartino, Sofia
AU - Sondergaard, Lars
AU - De Backer, Ole
AU - Dalsgaard, Marie
AU - D'Ascenzo, Fabrizio
AU - Musto, Carmine
AU - Fineschi, Massimo
AU - Maisano, Francesco
AU - Testa, Luca
AU - Vercellino, Matteo
AU - Berni, Andrea
AU - Galasso, Gennaro
AU - Cammardella, Antonio G.
AU - Morello, Alberto
AU - Pepe, Martino
AU - Albanese, Michele
AU - Cimmino, Michele
AU - Giordano, Salvatore
AU - Biondi-Zoccai, Giuseppe
AU - Corcione, Nicola
AU - Bedogni, Francesco
AU - Bruno, Francesco
AU - Giacobbe, Federico
AU - Musumeci, Francesco
AU - Cesario, Vincenzo
AU - Herrero, Javier Gómez
AU - Iadanza, Alessandro
AU - Schiavi, Davide
AU - Zancarano, Edoardo
AU - Porto, Italo
AU - Zecchino, Simone
AU - LOSTAVI Study Group
N1 - Funding Information:
Funding: Research leading to these results has received funding from the European Union - NextGenerationEU, through the Italian Ministry of University and Research, under PNRR - M4C2-I1.3 Project PE_00000019 "HEAL ITALIA" to Giuseppe Biondi-Zoccai CUP B53C22004000006 Sapienza University of Rome. The views and opinions expressed are those of the authors only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the European Commission can be held responsible for them.
Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023
Y1 - 2023
N2 - Transcatheter aortic valve replacement (TAVR) is an established therapy for severe, symptomatic aortic valve stenosis even in patients with impaired left ventricular systolic function. However, there is uncertainty on the clinical effectiveness of the currently available TAVR devices in patients with reduced left ventricular ejection fraction (LVEF). The LOSTAVI (Low Systolic function and Transcatheter Aortic Valve Implantation) registry is a retrospective observational study using baseline, procedural, discharge, and long-term follow-up details. A total of 3 groups of interest were distinguished: extremely reduced LVEF (<25%), severely reduced LVEF (25% to 30%), and reduced LVEF (31% to 35%). Unadjusted and adjusted analyses were carried out for in-hospital and follow-up outcomes. A total of 923 patients were included from 12 centers, with 146 patients (16%) with LVEF <25%, 425 (46%) with LVEF 25% to 30%, and 352 (38%) with LVEF 31% to 35%. Several baseline and procedural features were different across groups, including age, risk, functional class, and prevalence of bicuspid disease (all p <0.05). In-hospital mortality was similar in the 3 groups (7 [4.8%], 18 [4.2%], and 7 [2.0%], respectively, p = 0.661), but major adverse events were more common in those with extremely reduced and severely reduced LVEF (19 [13%], 53 [13%], and 25 [7.1%], respectively, p = 0.024). The 12-month follow-up confirmed the significant detrimental impact of reduced LVEF on both death (21 [14%], 49 [12%], and 25 [7.1%], respectively, p = 0.024) and major adverse events (37 [25%], 89 [21%], and 53 [15%], respectively, p = 0.016). The adjusted analysis confirmed the significant prognostic role of LVEF on both outcomes, whereas TAVR device type was not associated with death or major adverse events (all p >0.05). In conclusion, TAVR yields favorable early and 1-year results in patients with reduced LVEF, including those with extremely depressed systolic dysfunction. However, reduced LVEF still represents a major adverse prognostic factor for both short- and mid-term outcomes.
AB - Transcatheter aortic valve replacement (TAVR) is an established therapy for severe, symptomatic aortic valve stenosis even in patients with impaired left ventricular systolic function. However, there is uncertainty on the clinical effectiveness of the currently available TAVR devices in patients with reduced left ventricular ejection fraction (LVEF). The LOSTAVI (Low Systolic function and Transcatheter Aortic Valve Implantation) registry is a retrospective observational study using baseline, procedural, discharge, and long-term follow-up details. A total of 3 groups of interest were distinguished: extremely reduced LVEF (<25%), severely reduced LVEF (25% to 30%), and reduced LVEF (31% to 35%). Unadjusted and adjusted analyses were carried out for in-hospital and follow-up outcomes. A total of 923 patients were included from 12 centers, with 146 patients (16%) with LVEF <25%, 425 (46%) with LVEF 25% to 30%, and 352 (38%) with LVEF 31% to 35%. Several baseline and procedural features were different across groups, including age, risk, functional class, and prevalence of bicuspid disease (all p <0.05). In-hospital mortality was similar in the 3 groups (7 [4.8%], 18 [4.2%], and 7 [2.0%], respectively, p = 0.661), but major adverse events were more common in those with extremely reduced and severely reduced LVEF (19 [13%], 53 [13%], and 25 [7.1%], respectively, p = 0.024). The 12-month follow-up confirmed the significant detrimental impact of reduced LVEF on both death (21 [14%], 49 [12%], and 25 [7.1%], respectively, p = 0.024) and major adverse events (37 [25%], 89 [21%], and 53 [15%], respectively, p = 0.016). The adjusted analysis confirmed the significant prognostic role of LVEF on both outcomes, whereas TAVR device type was not associated with death or major adverse events (all p >0.05). In conclusion, TAVR yields favorable early and 1-year results in patients with reduced LVEF, including those with extremely depressed systolic dysfunction. However, reduced LVEF still represents a major adverse prognostic factor for both short- and mid-term outcomes.
U2 - 10.1016/j.amjcard.2023.06.025
DO - 10.1016/j.amjcard.2023.06.025
M3 - Journal article
C2 - 37423004
AN - SCOPUS:85165239037
VL - 201
SP - 349
EP - 358
JO - Am. J. Cardiol.
JF - Am. J. Cardiol.
SN - 0002-9149
ER -