Medtronic Plc. · NYSE:MDT
Medtronic — Technical Presentation
27 slides from Medtronic's technical presentation
Slide 1: Final Global Results from the Optimize PRO Study
Final Global Results from the Optimize PRO Study Steven J Yakubov, MD, MSCAI, FACC Douglas Fraser, MB, BChir, MA, DM on behalf of the Optimize PRO Investigators
Slide 2: Disclosure of relevant financial relationships
Disclosure of relevant financial relationships Within the prior 24 months, I have had a financial relationship with a company producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: Financial Relationship Company Institutional grants/research support Bo
Slide 3: Background and Objective
Background The Optimize PRO study collected clinical evidence on valve performance and procedural outcomes associated with an “optimized” TAVR care pathway, post-TAVR conduction Objective Report final results from the Optimize disturbance pathway and cusp overlap technique (COT). PRO study, includin
Slide 4: Study administration
Study administration Principal Investigators Steering Committee Steven Yakubov, MD Kendra Grubb, MD Douglas Fraser, MD Hemal Gada, MD Suneet Mittal, MD Tamim Nazif, MD Josep Rodes-Cabau, MD OhioHealth Riverside Emory University Manchester UPMC The Valley Hospital NewYork-Presbyterian Quebec Heart Me
Slide 5: Study design
Study design Prospective, nonrandomized, post-market, multicenter study conducted at 50 global centers in 653 patients 1 Valve deployment was performed with cusp overlap technique (COT) and the standard procedures of the “optimized” TAVR care pathway protocol requirements. Symptomatic severe aortic
Slide 6: Evolution of Evolut transcatheter aortic valves
Evolution of Evolut transcatheter aortic valves Optimize PRO Study Valves Earlier Generations 21.5% 78.4% Subsequent Generations *0.2% CoreValve Evolut R Evolut PRO Evolut PRO+ Evolut FX Evolut FX+ 2014 2015 2017 2019 2022 2024 •First self-expanding •Recapturability •Reduction in •Lower delivery pro
Slide 7: Global study sites (N=50)
Global study sites (N=50) Inslitut Universitaire de Cardiologie Canada aye imologiede Québec (lUCPO) © Sunnybrook Health Sciences UPMC Pinnacle Harrisburg Campus (PA) Allegheny General Hospital (PA) Lehigh Valley Hospital - Cedar Crest (PA) York Hospital (PA) Prbvidence |University of Pittsburgh Med
Slide 8: Patient flow
Patient flow Global Cohort Attempted Implant N=653 Unsuccessful procedure: 1 Died: 3 Discharge N=649 Withdrew: 3 Died: 3 30-Days N=643 expected N= 640 evaluated Withdrew: 9 Lost to follow-up: 2 Died: 24 1 Year N=608 expected N= 602 evaluated 1-year analysis: Data evaluated for 92.2% (602/653) of pat
Slide 9: Baseline characteristics
Baseline characteristics Characteristic Optimize PRO Global Cohort (N=653) Age – yr 79.1 ± 6.5 Female sex 47.0% STS-PROM score – % 3.2 ± 2.5 Body mass index, kg/m2 29.6 ± 5.9 NYHA functional class III/IV 42.7% Diabetes 32.2% Hypertension 78.9% COPD or chronic lung disease 19.6% Cerebrovascular dise
Slide 10: Key procedural data
Key procedural data Optimize PRO Global Outcome / Assessment Cohort (N=6521) 4-step cusp overlap technique (COT) compliance 2 Yes 50.3% No 39.7% Length of stay (days) 2 (1-3) Femoral access site 100% Lunderquist extra stiff guidewire 80.7% Resheathing or recapture 41.3% NCC implant depth, mm, core
Slide 11: Clinical outcomes at 1 year
Clinical outcomes at 1 year Outcome Optimize PRO Global Cohort (N=653) All-cause mortality or all stroke 9.7% All-cause mortality 4.6% Cardiovascular mortality 2.4% All stroke 6.0% Disabling stroke 2.7% Reintervention 0.3% Myocardial infarction 2.9% Clinical valve thrombosis 0.3% Endocarditis 0.3% M
Slide 12: Cusp Overlap Technique with Evolut PRO/PRO+ and FX
Cusp Overlap Technique with Evolut PRO/PRO+ and FX 4-Step COT PRO/PRO+ 3-Step COT FX 1. Initial positioning: Start deployment in cusp overlap 1. Initial positioning: Start deployment in cusp view and estimate implant depth at NCC. overlap view and estimate implant depth at NCC. 2. Guidewire: Confirm
Slide 13: Pacemaker implantation
Pacemaker implantation The 30-day PPI rate was 11.1% overall and 6.4% with 4-step COT compliance. The new 1-year PPI rate was 12.8% overall and 8.9% with 4-step COT compliance. For reference, the 1-year PPI rate was 8.8% in the FX Addendum Study. 30 Days 1 Year COT followed n=328; COT followed vs no
Slide 14: Valve hemodynamics through 1 year
Valve hemodynamics through 1 year Excellent hemodynamics through 1 year
Slide 15: Paravalvular regurgitation through 1 year
Paravalvular regurgitation through 1 year No patients had moderate or severe paravalvular regurgitation at 1 year Core lab data
Slide 16: New York Heart Association through 1 year
New York Heart Association through 1 year Improvement in NYHA score by at least 1 functional class from baseline to 1 year occurred in 84% of patients
Slide 17: Quality of life through 1 year
Quality of life through 1 year >75% of patients had improved quality of life at 1-year post-procedure VARC-3 ordinal outcome: (i) death; (ii) worsened: decrease from baseline >5 points; (iii) no change: change between -5 and <5 points; (iv) mildly improved: increase between 5 and <10 points; (v) mod
Slide 18: Limitations
Limitations 1. Not all sites had access to the Evolut PRO+ valve or recommended Lunderquist wire, making protocol adherence less consistent. 2. Potential confounders could have been introduced as data was site-reported, and some variables (pre-existing RBBB, wire use, and COT compliance) may not hav
Slide 19: Conclusions
Conclusions Evolut TAVR platform continues to demonstrate a strong safety profile (2.4% cardiovascular mortality) Procedural technique drives lower PPI rates with COT compliance (6.4% at 30 days and 8.9% at 1 year) Hemodynamic performance is sustained with Evolut TAVR with no moderate or severe para
Slide 20: Thank You to All of Our Patients, Study Investigators
• University of Pittsburgh Medical Center (UPMC) Pinnacle Hospitals, Harrisburg, PA, USA • Shaare Zedek Medical Center, Jerusalem, Israel • Hôpitaux Universitaires - Hôpital Henri Mondor, Créteil, France • Morton Plant Hospital - BayCare Health System, Clearwater, FL, USA • Allegheny General Hospita
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Slide 22: Backup
Backup
Slide 23: Optimized TAVI Care Pathway with Evolut PRO/PRO+
Optimized TAVI Care Pathway with Evolut PRO/PRO+ Pre-Procedure Peri-Procedure Post-Procedure • 12-lead ECG • Valve deployment using the cusp • 12-lead ECG within 2 hours • Early discharge plan with multi- overlap technique • If no pre-existing RBBB or ECG disciplinary team • Pre-BAV not required cha
Slide 24: Valve size and type
Valve size and type Index Set N=652 is the first procedure that the Medtronic Evolut PRO/PRO+ System delivery catheter is introduced. *Evolut R implanted in one subject as Evolut PRO or PRO+ were not available at study site on the index procedure date. †Sapien transcatheter aortic valve implanted af
Slide 25: Pacemaker implantation based on Lunderquist wire usage
Pacemaker implantation based on Lunderquist wire usage A Lunderquist Extra-Stiff guide wire was used in 80.7% of implants. Failure to use a Lunderquist guide wire resulted in a higher 1-year PPI rate.
Slide 26: KCCQ outcomes through 1 year
KCCQ outcomes through 1 year VARC-3 ordinal outcome: (i) death; (ii) worsened: decrease from baseline >5 points; (iii) no change: change between -5 and <5 points; (iv) mildly improved: increase between 5 and <10 points; (v) moderately improved: increase between 10 and <20 points; (vi) substantially
Slide 27: New York Heart Association score through 1 year
New York Heart Association score through 1 year