TY - JOUR
T1 - A Comparison between First-Generation and Second-Generation Transcatheter Aortic Valve Implantation (TAVI) Devices
T2 - A Propensity-Matched Single-Center Experience
AU - Ruparelia, Neil
AU - Latib, Azeem
AU - Kawamoto, Hiroyoshi
AU - Buzzatti, Nicola
AU - Giannini, Francesco
AU - Figini, Filippo
AU - Mangieri, Antonio
AU - Regazzoli, Damiano
AU - Stella, Stefano
AU - Sticchi, Alessandro
AU - Tanaka, Akihito
AU - Ancona, Marco
AU - Agricola, Eustachio
AU - Monaco, Fabrizio
AU - Spagnolo, Pietro
AU - Chieffo, Alaide
AU - Montorfano, Matteo
AU - Alfieri, Ottavio
AU - Colombo, Antonio
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2016/5
Y1 - 2016/5
N2 - BACKGROUND: Transcatheter aortic valve implantation (TAVI) is the treatment of choice for high-risk patients presenting with severe symptomatic aortic stenosis. The aim of this study was to investigate the impact of second-generation (2G) devices in comparison to first-generation (1G) devices with regard to procedural and short-term clinical outcomes. METHODS: Between November 2007 and May 2015, a total of 449 patients treated with 1G TAVI devices (Edwards Sapien XT, Medtronic CoreValve) were propensity matched (1:1) to 179 patients treated with 2G TAVI devices (Edwards Sapien 3, Medtronic Evolut R, Boston Scientific Lotus, Direct Flow Medical). The primary endpoint was 30-day safety according to the Valve Academic Research Consortium 2 (VARC-2) definition. RESULTS: Patients treated with 1G devices suffered more adverse events at 30-day follow-up (freedom of adverse events, 75.3% vs 88.8%; hazard ratio, 2.4; 95% confidence interval (CI), 1.4-4.0; P≤.01) and a significantly greater number of minor vascular complications (31.8% vs 10.4%; P<.001) and major vascular complications (3.2% vs 0.6%; P<.001) compared with patients treated with 2G devices. The presence of residual aortic regurgitation ≥2 was also greater in the 1G group (17.5% vs 5.8%; odds ratio, 0.30; 95% CI, 0.13-0.69; P<.001). There were no differences between groups with regard to 30-day all-cause mortality (5.2% vs 3.2%; odds ratio, 0.61; 95% CI, 0.20-1.92; P≤.40). CONCLUSION: TAVI with contemporary 2G devices was associated with a significant safety benefit at 30 days and reduction of residual moderate or severe paravalvular leak. Longer-term follow-up in more patients is required to determine if these short-term benefits translate into improvements in long-term clinical outcomes.
AB - BACKGROUND: Transcatheter aortic valve implantation (TAVI) is the treatment of choice for high-risk patients presenting with severe symptomatic aortic stenosis. The aim of this study was to investigate the impact of second-generation (2G) devices in comparison to first-generation (1G) devices with regard to procedural and short-term clinical outcomes. METHODS: Between November 2007 and May 2015, a total of 449 patients treated with 1G TAVI devices (Edwards Sapien XT, Medtronic CoreValve) were propensity matched (1:1) to 179 patients treated with 2G TAVI devices (Edwards Sapien 3, Medtronic Evolut R, Boston Scientific Lotus, Direct Flow Medical). The primary endpoint was 30-day safety according to the Valve Academic Research Consortium 2 (VARC-2) definition. RESULTS: Patients treated with 1G devices suffered more adverse events at 30-day follow-up (freedom of adverse events, 75.3% vs 88.8%; hazard ratio, 2.4; 95% confidence interval (CI), 1.4-4.0; P≤.01) and a significantly greater number of minor vascular complications (31.8% vs 10.4%; P<.001) and major vascular complications (3.2% vs 0.6%; P<.001) compared with patients treated with 2G devices. The presence of residual aortic regurgitation ≥2 was also greater in the 1G group (17.5% vs 5.8%; odds ratio, 0.30; 95% CI, 0.13-0.69; P<.001). There were no differences between groups with regard to 30-day all-cause mortality (5.2% vs 3.2%; odds ratio, 0.61; 95% CI, 0.20-1.92; P≤.40). CONCLUSION: TAVI with contemporary 2G devices was associated with a significant safety benefit at 30 days and reduction of residual moderate or severe paravalvular leak. Longer-term follow-up in more patients is required to determine if these short-term benefits translate into improvements in long-term clinical outcomes.
KW - TAVI
KW - TAVR
KW - first generation
KW - second generation
KW - transcatheter aortic valve implantation
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M3 - Article
C2 - 27145054
AN - SCOPUS:84969540910
SN - 1042-3931
VL - 28
SP - 210
EP - 216
JO - Journal of Invasive Cardiology
JF - Journal of Invasive Cardiology
IS - 5
ER -