医生培训原文7.evar course-clinical evidence.pptxVIP

Evidence-based approach;The Endurant Experience; 150 patients;Mean age: 73.1 ± 8.0 years (min 52, max 88);Baseline AAA Characteristics US IDE Trial; ASA Classification; Duration in minutes (mean ± SD; N=150);Source: Endurant BIFUR APR2014;Source: Endurant BIFUR APR2014 * One subject experienced a new Type I endoleak at the 3 year time frame which led to an aneurysm expansion. The subject refused intervention and voluntarily entered hospice, and expired on day 1212 due to an aneurysm rupture ;Midterm Results US IDE Trial;Durability Markers;Source: Endurant BIFUR APR2014 ; AAA Diameter Changes US IDE Trial;The Endurant Stent Graft sets a new standard for sustained clinical performance across key endpoints at 4 years: 0% migration or conversion Low rates of AAA Sac Enlargement (2%), 2nd Procedures and Endoleak Significant AAA Sac Shrinkage (62%) Only 1 Aneurysm-Relate Mortality through 4 yrs (0.8%) Robust es from the US IDE Trial confirm the sustained durability of the Endurant stent graft In the absence of Randomized Controlled Trials comparing different new generation SG devices, best comparisons can be made by looking at results from individual US IDE Trials;Implant Success;Clinical Results;Registry;Single-arm Clinical Trial (30-60 patients); How will Endurant perform across different patient populations/practices? ;;High quality registry data;Baseline Demographics;Tobacco use; ASA Classification; SVS/ISCVS Risk Level; Challenging/Real World Population;1263 patients;Robust follow-up ensures complete reporting of events;; Duration in minutes (mean ± SD; N=1252); Technical Success;;;Days?;Days;;99.4 % 3 yrs;;;;Endurant has proven a lower reintervention rate vs. previous generation devices;Days?;;Circulation. 2011;123:00-00;Majority of AAA show decrease/stable diameter: proven durability in real world patients;US IDE Trial;US IDE Trial;91.0% Decrease 5 mm/Stable;Durable; consistent performance in straight-forward and challenging anatomies;CONCLUS