The Journal of invasive cardiology · 2016
A Comparison Between First-Generation and Second-Generation Transcatheter Aortic Valve Implantation (TAVI) Devices: A Propensity-Matched Single-Center Experience.
Сравнительное исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Ruparelia Neil, Latib Azeem, Kawamoto Hiroyoshi, Buzzatti Nicola, Giannini Francesco, Figini Filippo, Mangieri Antonio, Regazzoli Damiano, Stella Stefano, Sticchi Alessandro, Tanaka Akihito, Ancona Marco, Agricola Eustachio, Monaco Fabrizio, Spagnolo Pietro, Chieffo Alaide, Montorfano Matteo, Alfieri Ottavio, Colombo Antonio
Аннотация
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.
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.