Slide 1: One-year outcomes from the ACURATE neo2 PMCF Post-market Registry
One-year outcomes from the ACURATE neo2 PMCF Post-market Registry Won-Keun Kim, MD Kerckhoff-Klinik GmbH, Bad Nauheim, Germany On behalf of the ACURATE neo2 Post-Market Clinical Follow-up Study Investigators CAUTION: In Europe, ACURATE neo and neo2 Aortic Valve Systems are CE-marked. In the USA, ACU
Slide 2: Potential conflicts of interest
Potential conflicts of interest Speaker's name : Won-Keun Kim ☑ I have the following potential conflicts of interest to declare: Receipt of grants / research support: Boston Scientific Receipt of honoraria or consultation fees: Abbott, Boston Scientific, Edwards Lifesciences, Meril, Shockwave Medica
Slide 3: Why this study?
Why this study? ACURATE neo2 is a 2nd- generation supra-annular valve that features CE marked 2020 improvements to further reduce PVL compared to the prior-generation ACURATE Self-expanding nitinol frame neo. Top-down deployment Porcine pericardial The PMCF post-market leaflets in a supra-annula
Slide 4: What did we study?
What did we study? Prospective multicentre single-arm post-market surveillance study in a routine clinical practice setting Independent CEC adjudication of safety events Primary safety endpoint: 30-day all-cause mortality Additional endpoints evaluated through 1 year Death, stroke, bleeding, major v
Slide 5: How was the study executed?
How was the study executed? Intention-To- Successfully Treat Implanted N=250 Mean Age N=246 Device not in 80.8 ± 6.2 yrs correct position n=4* 36.4% Male 30-day 30-day Imaging Data 63.6% Female Clinical Follow-up Visit Completed Analyzed or Death TTE: 91% CT: 83% (224/246) (204/246) Mean STS Score 9
Slide 6: What are the essential results?
What are the essential results? Key Safety Events Discharg 30 Days 1 Year e All-cause mortality 0.4% (1) 0.8% 1° Safety (2)* 5.1% (12) Endpt Cardiovascular mortality 0.4% (1) 0.8% (2) 3.4% (8) All stroke 0.4% (1) 0.8% (2) 3.0% (7) Major bleeding 2.4% (6) 2.4% (6) 2.8% (7) Hospitalization for valve-r
Slide 7: What are the essential results?
What are the essential results? Echocardiography Core Laboratory Aortic Valve Haemodynamics, ITT Population Paravalvular Leak, Paired Analysis (n=116 100 2.0 1.7 ± 0.4 1.6 ± 0.4 1.6 ± 0.4 (n=134) 0.0 1.9 0.9 (n=139) (n=127) 15.3 80 1.6 22.6 16.2 Mean AV Gradient (mmHg) . Severe Mean AV Area (cm2) 60
Slide 8: What are the essential results? CT Core Laboratory
What are the essential results? CT Core Laboratory HALT, Paired Analysis (n=150) HALT @ No HALT 1-Year Event 30d or @ P- 30 30d and Days 76.0% 14.6%9.4% Rate 1y 1y value N=72 1° HALT HALT N=93 Imagin All-cause mortality 0.0% (0) g Endpt No HALT severityseverity 0.0% (0) 0.25 ≤50% >50% CV mortality 0
Slide 9: The essentials to remember
The essentials to remember s report confirms favorable performance and safety through 1 y n patients with severe aortic stenosis treated with ACURATE neo Patients treated with ACURATE neo2 exhibited early improvement in valve haemodynamics and low rates of PVL through 1 year – At 1 year, 99% of pa
Slide 10: PCRonline.com
PCRonline.com CAUTION: In Europe, ACURATE neo and neo2 Aortic Valve Systems are CE-marked. In the USA, ACURATE neo2 is an investigational device and restricted under federal law to investigational use only. Not available for sale.