Slide 1: TAVI with Self-Expanding ACURATE neo2: Post-Procedural Hemodynamic and Short-Term Clinical Outcomes
TAVI with Self-Expanding ACURATE neo2: Post- Procedural Hemodynamic and Short-Term Clinical Outcomes The ITAL-neo Registry CAUTION: In Europe, the ACURTE neo2 Aortic Valve System is CE-marked. Approved for physician use only. In the USA, the ACURATE neo2 Valve is an Investigational Device and restri
Slide 2: ITAL-neo Registry Study Design
ITAL-neo Registry Study Design Objective: To assess safety and efficacy of ACURATE neo2 in patients with severe native aortic stenosis Consecutive Patients with severe aortic stenosis treated with ACURATE neo and ACURATE neo2 13 Italian Centers | Procedures performed: September 1st 2019 – May 31st 2
Slide 3: ITAL-neo Registry Study Summary
ITAL-neo Registry Study Summary Design Investigator-initiated and conducted, sequential two-arm multicenter Registry 13 Italian centers To assess the safety and efficacy of the ACURATE neo2 Aortic Valve System in patients with severe Objective aortic valve stenosis. Primary More-than-mild po
Slide 4: Comparing ACURATE neo and ACURATE neo2
Comparing ACURATE neo and ACURATE neo2 Common ACURATE neo Aortic Valve ACURATE neo2 Aortic Valve System Features System Radiopaque Positioning Marker Open Stabilization Arches Supra Annular Leaflets Upper Crown Outer T Skirt Lower Crown CAUTION: In Europe, the ACURTE neo2 Aortic Valve System is CE-m
Slide 5: Baseline Characteristics
Baseline Characteristics Propensity-Score Matched Population 9.8 P=1.00 35 10 P=1.00 9.3 31.2 30.7 9 30 8 P=1.00 7 25 24.4 23.9 6 20 5 P=0.89 P=0.67 4 3.33 3.4 15 3.07 3.01 3 2 10 1 5 0 Euroscore II STS-PROM Previous Pacemaker 0 Implantation (%) Previous PCI (%) History of AF (%) ACURATE neo ACURATE
Slide 6: Baseline ECG and Echo Characteristics
Baseline ECG and Echo Characteristics Propensity-Score Matched Population 14 13.2 13.2 P=1.00 100 97.1P=1.00 97.1 12 90 • Baseline ECG and echocardiographic P=0.86 80 characteristics were non-significantly 10 9.3 70 different between ACURATE neo and 8.3 ACURATE neo2. 8 60 50 6 • Although statistical
Slide 7: Multi-slice computer tomography (MSCT) Characteristics
Multi-slice computer tomography (MSCT) Characteristics MILD MODERAT E SEVERE CAUTION: In Europe, the ACURTE neo2 Aortic Valve System is CE-marked. Approved for physician use only. In the USA, the ACURATE neo2 Valve is an Investigational Device and restricted under federal law to investigational use
Slide 8: Procedural Characteristics
Procedural Characteristics Propensity-Score Matched Population 10 P=0.1 9 8.8 • Concomitant PCI was performed less frequently 8.3 with ACURATE neo2 compared to ACURATE neo. 8 7 • Although statistically non-significant, the need for 6 a 2nd THV was less frequent with ACURATE neo2 vs ACURATE neo: 5 •
Slide 9: In-Hospital Outcomes
In-Hospital Outcomes Propensity-Score Matched Population 100 10 P=0.709 9.1 99 9 P=0.29 3 P=0.136 98 97.6 8 7.6 7.0 97 7 6 96 6 95.1 95 5 94 4 3 93 P=0.003 P=0.623 2 1.5 P=1.0 P=1.0 1.5 92 1.0 1 1 1 0.5 0.5 91 0 0 90 VARC-3 Technical Success (%) ACURATE neo ACURATE neo ACURATE neo2 *All-cause mortal
Slide 10: Pre-Discharge and 90-Day Echo Outcomes
Pre-Discharge and 90-Day Echo Outcomes Propensity-Score Matched Population Paravalvular Aortic 50.0 2 1.88 1.83 Regurgitation 44.0 1.74 Mean transvalvular gradient (mmHg) 100% 0.5 0 0.8 0 40.0 1.76 10.7 3.5 11.9 3.5 43.0 1.5 90% Effective orifice area (cm²) 80% 30.0 46.5 45.6 70% 1 60% 58.8 56.3 20.
Slide 11: Study Limitations
Study Limitations The ITAL-neo Registry is an investigator-initiated, non-randomized site conducted retrospective analysis and therefore, selection and confounding bias cannot be excluded. The difference in enrollment timing between the ACURATE neo2 and ACURATE neo patients may introduce bias.
Slide 12: Conclusion
Conclusion Favorable ACURATE neo2 outcomes from the ITAL-neo Registry further validate the design enhancement of ACURATE neo2: • Significantly reduced rates of paravalvular leak vs previous generation ACURATE neo • Single digit pacemaker implantation rate • Excellent hemodynamics with large EOA’s