TY - JOUR
T1 - A comparison of the fully repositionable and retrievable Boston Lotus and direct flow medical valves for the treatment of severe aortic stenosis
T2 - A single center experience
AU - Giannini, Francesco
AU - Latib, Azeem
AU - Montorfano, Matteo
AU - Ruparelia, Neil
AU - Romano, Vittorio
AU - Longoni, Matteo
AU - Ferri, Luca
AU - Jabbour, Richard
AU - Mangieri, Antonio
AU - Regazzoli, Damiano
AU - Ancona, Marco
AU - Buzzatti, Nicola
AU - Azzalini, Lorenzo
AU - Tanaka, Akihito
AU - Agricola, Eustachio
AU - Chieffo, Alaide
AU - Alfieri, Ottavio
AU - Colombo, Antonio
N1 - Publisher Copyright:
© 2017 Wiley Periodicals, Inc.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - Background: Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL. Objectives: To compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-2 criteria following TAVI with the fully repositionable and retrievable Lotus and DFM devices. Methods and Results: 175 patients with severe aortic stenosis underwent transfemoral TAVI with the Lotus (n = 60) and DFM (n = 115) valve. Baseline clinical characteristics did not differ between the two groups. All devices were successfully implanted, with one case of valve embolization in the Lotus group. Device success (95 vs. 98.2%, P = 0.89), VARC-defined combined safety (90 vs. 93%, P = 0.48), and clinical efficacy (86.7 vs. 90.4%, P = 0.65) rates at 30-days were similar between Lotus and DFM groups. There was no severe PVL; one patient in both Lotus and DFM group developed moderate PVL after the procedure. The Lotus valve was associated with a higher rate of new pacemaker implantation (37.3 vs. 11.2%, P < 0.001) and a lower mean aortic gradient (9.4 ± 5 vs. 12.3 ± 5, P < 0.001) at 30-days as compared with the DFM valve. Conclusions: In this single-center, retrospective analysis, both Lotus and DFM devices demonstrated excellent device success, safety and efficacy at 30-day follow-up. The DFM valve was associated with minimally higher transvalvular gradients but lower new pacemaker implantation rates when compared to the Lotus valve.
AB - Background: Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL. Objectives: To compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-2 criteria following TAVI with the fully repositionable and retrievable Lotus and DFM devices. Methods and Results: 175 patients with severe aortic stenosis underwent transfemoral TAVI with the Lotus (n = 60) and DFM (n = 115) valve. Baseline clinical characteristics did not differ between the two groups. All devices were successfully implanted, with one case of valve embolization in the Lotus group. Device success (95 vs. 98.2%, P = 0.89), VARC-defined combined safety (90 vs. 93%, P = 0.48), and clinical efficacy (86.7 vs. 90.4%, P = 0.65) rates at 30-days were similar between Lotus and DFM groups. There was no severe PVL; one patient in both Lotus and DFM group developed moderate PVL after the procedure. The Lotus valve was associated with a higher rate of new pacemaker implantation (37.3 vs. 11.2%, P < 0.001) and a lower mean aortic gradient (9.4 ± 5 vs. 12.3 ± 5, P < 0.001) at 30-days as compared with the DFM valve. Conclusions: In this single-center, retrospective analysis, both Lotus and DFM devices demonstrated excellent device success, safety and efficacy at 30-day follow-up. The DFM valve was associated with minimally higher transvalvular gradients but lower new pacemaker implantation rates when compared to the Lotus valve.
KW - Lotus valve system
KW - direct flow medical valve system
KW - severe aortic stenosis
KW - trans-femoral aortic valve implantation
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U2 - 10.1002/ccd.27319
DO - 10.1002/ccd.27319
M3 - Article
C2 - 28941127
AN - SCOPUS:85030124763
SN - 1522-1946
VL - 91
SP - 966
EP - 974
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 5
ER -