Medtronic Plc. · NYSE:MDT
Medtronic — EuroPCR 2022
25 slides from Medtronic's conference presentation, May 17, 2022
Slide 1: Impact of a standardized TAVI technique and care pathway in the Optimize PRO study
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Kendra J. Grubb, M.D., M.H.A. Emory University, Atlanta, GA For the Optimize PRO Study Investigators
Slide 2: Disclosures
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Disclosures Relationship Company Principal investigator, proctor, and advisory board Medtronic Speaker, principal investigator, and proctor Edwards Principal investigator, proctor, and advisory board Ancora Heart Proc
Slide 3: Background
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Background • Safety and efficacy of utilizing standardized implant protocols and care pathways is limited in large prospective studies of TAVI. • Post-procedure conduction disturbance and new permanent pacemaker impla
Slide 4: Primary objective
Primary objective To collect clinical evidence on valve performance and procedural outcomes associated with an “optimized” pre- and post- procedural TAVI care pathway, utilizing the Cusp Overlap Technique to deploy the Evolut™ valves. 4 Grubb K. Impact of a standardized TAVI technique and care pathw
Slide 5: Overall study design
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Overall study design Nonrandomized, prospective, post-market study Conducted in the United States, Canada, Europe, Middle East, and Australia Symptomatic severe AS “Optimized” pre-procedure care pathway Medtronic Evol
Slide 6: Study Oversight
Study Oversight Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Study oversight Principal investigators: Kendra Grubb, M.D., M.H.A.; Steven Yakubov, M.D. Steering committee: Douglas Fraser, M.D.; Hemal Gada, M.D.; Kendra Grubb, M.D., M.H.A.; Suneet Mittal, M.D.; Ta
Slide 7: Participating sites in the U.S. and Canada
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Participating sites in the U.S. and Canada Site name # Enrolled Site name # Enrolled UPMC Pinnacle Harrisburg Campus 50 The Heart Hospital Baylor Plano 8 Morton Plant Hospital 38 Institut Universitaire de Cardiologie
Slide 8: Key inclusion/exclusion criteria
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Key inclusion/exclusion criteria Inclusion Exclusion • Symptomatic aortic stenosis with NYHA • Implanted permanent pacemaker/ICD class II or greater • LVEF < 35% • Suitability for transfemoral treatment • Prior aortic
Slide 9: Methods
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Methods • Adverse events are CEC adjudicated and all echocardiograms, ECGs, and procedural angiograms are assessed by central core labs. • The current interim analysis includes 400 main cohort and 104 roll-in patients
Slide 10: Optimized TAVR care pathway
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Optimized TAVR care pathway Pre-procedure Peri-procedure Post-procedure • 12-lead ECG • Valve deployment using • 12-lead ECG within 2 hours the cusp overlap technique • Early discharge plan with • If no preexisting RB
Slide 11: Cusp Overlap Technique with Evolut PRO/PRO+
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Cusp Overlap Technique with Evolut PRO/PRO+ Key steps* Cusp overlap view 3-cusp coplanar view LAO view 1. Initial deployment in the cusp overlap projection to estimate implant depth at the NCC. 2. Deploy with the mark
Slide 12: Patient flow
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Patient flow Roll-in* Main Cohort* N = 104 N = 400 Died: 1 Discharge Discharge 100% (104/104) 100% (399/399) Died: 2 Withdrew: 2 30 days 30 days 94.2% (98/104) 93.2% (368/395) *10.4% screen failure rate for roll-in an
Slide 13: Baseline Characteristics
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Baseline Characteristics Main Cohort Roll-In (N=104) Combined (N=504) (N=400) Age (years) 77.3 ± 8.0 78.7 ± 6.6 78.4 ± 6.9 BMI (kg/m2) 29.5 ± 6.0 30.4 ± 6.2 30.2 ± 6.2 Male (%) 54.8% 54.0 54.2 NYHA Class III/IV 37.5 4
Slide 14: Procedural characteristics
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Procedural characteristics Main Cohort Roll-In (N=104) Combined (N=504) (N=400) Total time in procedure room (minutes) 121.5 ± 34.6 112.8 ± 38.1 114.6 ± 37.6 Femoral access site 100.0 100.0 100.0 Lunderquist extra-sti
Slide 15: Procedural characteristics
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Procedural characteristics Main Cohort Roll-In (N=104) Combined (N=504) (N=400) Conduction Disturbance Group No ECG changes 51.0 64.0 61.3 Pre-existing RBBB & no ECG changes 5.8 4.8 5.0 New onset LBBB 28.8 18.3 20.4 E
Slide 16: 30-day primary clinical outcomes
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study 30-day primary clinical outcomes Main Cohort Roll-In (N=104) Combined (N=504) (N=400) All-cause mortality or all stroke 0.0 (0) 3.8 (15) 3.0 (15) All-cause mortality 0.0 (0) 0.8 (3) 0.6 (3) All stroke 0.0 (0) 3.0 (12)
Slide 17: 30-day secondary clinical outcomes
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study 30-day secondary clinical outcomes Main Cohort Combined Roll-In (N=104) (N=400) (N=504) Life-threatening or disabling bleed 1.0 (1) 1.8 (7) 1.6 (8) Major vascular complications 1.9 (2) 2.8 (11) 2.6 (13) Myocardial inf
Slide 18: Compliance with key cusp overlap steps (Main cohort)
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Compliance with key cusp overlap steps (Main cohort) 14.0% Followed* Not Followed† 12.0% 11.5% 10.0% 8.1% 8.0% Kaplan- Meier event rate 6.0% 4.0% 2.6% 2.0% 1.3% 1.3% 0.9% 0.0% 0.0% 0.0% Valve Migration Valve Embolizat
Slide 19: Hemodynamics (Main cohort)
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Hemodynamics (Main cohort) 2.5 50.0 Effective orifice area (cm2) 2.3±0.6 AV mean gradient (mm Hg) 2.0 39.7±11.2 40.0 Effective Orifice Area 1.5 30.0 AV Mean Gradient 1.0 20.0 0.9±0.2 0.5 10.0 8.2±4.0 0.0 0.0 Baseline
Slide 20: Aortic regurgitation at discharge (Main cohort)
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Aortic regurgitation at discharge (Main cohort) 78% None/Trace Regurgitation with Evolut PRO/PRO+ 0.0% 0.0% 100% 21.8% 22.0% 80% Percent of patients 60% 40% 78.2% 78.0% 20% 0% Paravalvular Total N = 380 N = 387 None/T
Slide 21: PVL at discharge by valve type (Main cohort)
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study PVL at discharge by valve type (Main cohort) 100.0% 100% 79.8% 80.2% 80% 76.0% Percent of Patients 60% 40% 24.0% 20.2% 19.8% 20% 0.0% 0.0% 0.0% 0.0% 0.0% 0% 23mm 26mm 29mm 34mm N=4 N=99 N=196 N=81 None/Trace Mild* ≥ M
Slide 22: NYHA functional class (Main Cohort)
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study NYHA functional class (Main Cohort) 66.2% NYHA Class I at 30 days with Evolut PRO/PRO+ 2.5% 0.0% 100% 4.5% 80% 38.3% 29.3% Percent of patients 60% 40% 66.2% 59.3% 20% 0% Baseline 30 Days N = 400 N = 382 NYHA I NYHA II
Slide 23: Summary
Impact of a standardized TAVI technique and care pathway in the Optimize PRO study Summary • Utilization of the Cusp Overlap Technique with an optimized care pathway provides excellent outcomes, low pacemaker implantation rate, expedited discharge and low rates of residual aortic regurgitation: • 30
Slide 24: Indications and safety information
Indications The Medtronic CoreValve™ Evolut™ R, CoreValve™ Evolut™ PRO, and Evolut™ PRO+ systems are indicated for relief of aortic packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the stenosis in patients with
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