Medtronic Plc. · NYSE:MDT
Medtronic — Technical Presentation (October 2023)
31 slides from Medtronic's technical presentation, Oct 7, 2023
Slide 1: Medtronic
Medtronic
Slide 2: Presentation disclaimer
This Presentation is entitled Hemodynamic Function of Contemporary Surgical Aortic Valves 1 Year Postimplant and was prepared by Professor Robert Klautz for presentation on 7 October during the 37th EACTS Annual Meeting, 4-7 October 2023. The European Association for Cardio-Thoracic Surgery does not
Slide 3: Hemodynamic Function of Contemporary Surgical Aortic Valves 1 Year Postimplant
000574 Hemodynamic Function of Contemporary Surgical Aortic Valves 1 Year Postimplant Robert J.M. Klautz, Vivek Rao, Michael J. Reardon, G. Michael Deeb, Francois Dagenais, Michael G. Moront, Joseph F. Sabik III, Jae K. Oh THE 37TH EACTS ANNUAL MEETING | 4 – 7 OCTOBER 2023
Slide 4: Disclosures
DISCLOSURES Research support: Medtronic Consultation fees: Medtronic Study sponsor: Medtronic Data analyses: Medtronic 4 | THE 37TH EACTS ANNUAL MEETING | 4 – 7 OCTOBER 2023 | VIENNA, AUSTRIA
Slide 5: Methods
METHODS • 4 clinical trials of SAVR with contemporary surgical valves were pooled: • PERIGON Pivotal • Evolut Low Risk • SURTAVI • CoreValve US High Risk • A single core lab (Mayo Clinic, Rochester, MN, USA) evaluated 1-year echocardiograms PERIGON, PERIcardial SurGical AOrtic Valve ReplacemeNt (PER
Slide 6: Background/Objectives
BACKGROUND/OBJECTIVES • Serial echocardiography is an essential tool for monitoring valve performance • Measurement variability • Previous analyses of “normal” valve functioning have been limited • Lack of modern valves • Limited sample sizes • Variability in data collection • Multiple or no echocar
Slide 7: Study Sites
STUDY SITES 145 sites 14 countries 2958 patients 61 1 3 7 6 2 5 98 2 1 8 4 1 7 | THE 37TH EACTS ANNUAL MEETING | 4 – 7 OCTOBER 2023 | VIENNA, AUSTRIA
Slide 8: Study Characteristics
STUDY CHARACTERISTICS Characteristic PERIGON Evolut Low Risk SURTAVI CoreValve High Risk 2014 – 2017 Enrollment period 2016 - 2018 2012 - 2016 2011 - 2012 2019-2023 (size 29) No. of SAVR patients 1129 682 793 354 Aortic valve pathology Moderate/severe AS or AR Severe AS Severe AS Severe AS Concomita
Slide 9: Patient Characteristics
PATIENT CHARACTERISTICS PERIGON Evolut Low Risk SURTAVI CoreValve High Risk Characteristic (N=1129) (N=682) (N=793) (N=354) Age, y 70 ± 9 74 ± 6 80 ± 6 83 ± 6 Male 75 % 66 % 55 % 52 % NYHA class I/II 58 % 72 % 42 % 13 % III/IV 42 % 28 % 58 % 87 % STS risk of mortality 2.0 1.9 4.5 7.5 Prior coronary
Slide 10: Patients
PATIENTS PERIGON N=1129 Evolut Low Risk N=682 Pooled Cohort Analysis Cohort N=2958 N=2938 SURTAVI N=793 20 exclusions (valves implanted in <10 patients) CoreValve High Risk N=354 Patients included in this analysis had an attempted and successful surgical valve implantation. 10 | T H E 3 7 T H E A C
Slide 11: Valve Models
VALVE MODELS 1200 High Risk 1000 SURTAVI Low Risk 800 PERIGON No. of Valves 600 271 1129 400 121 354 200 39 208 18 124 19 11 6 5 15 26 32 5 116 6 116 65 69 89 0 30 18 22 24 Avalus Perimount Trifecta Mitroflow Mosaic Epic Hancock Freestyle Intuity Perceval N=1134 N=741 N=394 N=53 N=232 N=39 N=67 N=67
Slide 12: Mean Aortic Gradient
MEAN AORTIC GRADIENT Stented Bovine Pericardial Stented Porcine Stentless Sutureless 13.1 ± 4.5 11.2 ± 4.6 10.6 ± 4.7 13.0 ± 5.3 15.3 ± 6.2 14.1 ± 10.1 16.1 ± 6.2 9.2 ± 6.0 8.6 ± 3.4 11.4 ± 4.6 Avalus Perimount Trifecta Mitroflow Mosaic Hancock Epic Freestyle Intuity Perceval N=1023 N=567 N=314 N=35
Slide 13: Gradient by Labeled Valve Size
GRADIENT BY LABELED VALVE SIZE 17* 19 21 23 25 27 29* All Sizes N=1 N=146 N=674 N=1029 N=812 N=239 N=36 Stented bovine pericardial Avalus 13.1 ± 4.5 21.9 17.1 ± 4.9 15.6 ± 5.1 12.7 ± 4.0 12.4 ± 3.9 10.3 ± 3.5 9.5 ± 3.3 Perimount 11.2 ± 4.6 – 14.4 ± 4.7 12.6 ± 4.8 11.2 ± 4.1 9.9 ± 4.3 8.0 ± 3.2 6.6 ±
Slide 14: Effective Orifice Area
EFFECTIVE ORIFICE AREA Stented Bovine Pericardial Stented Porcine Stentless Sutureless 2.0 ± 0.5 1.8 ± 0.6 1.8 ± 0.5 1.6 ± 0.6 1.6 ± 0.5 1.9 ± 0.8 1.5 ± 0.3 2.0 ± 0.7 2.1 ± 0.6 2.0 ± 0.6 Avalus Perimount Trifecta Mitroflow Mosaic Hancock Epic Freestyle Intuity Perceval N=902 N=510 N=275 N=28 N=172 N
Slide 15: EOA by Labeled Valve Size
EOA BY LABELED VALVE SIZE 17* 19 21 23 25 27 29* All Sizes N=1 N=146 N=674 N=1029 N=812 N=239 N=36 Stented bovine pericardial Avalus 2.0 ± 0.5 1.2 1.4 ± 0.2 1.6 ± 0.3 2.0 ± 0.4 2.1 ± 0.4 2.5 ± 0.5 3.0 ± 0.5 Perimount 1.8 ± 0.6 – 1.3 ± 0.5 1.5 ± 0.4 1.8 ± 0.5 2.1 ± 0.6 2.6 ± 0.6 3.8 Trifecta 1.8 ± 0.
Slide 16: Prosthesis-Patient Mismatch
PROSTHESIS-PATIENT MISMATCH Stented Bovine Pericardial Stented Porcine Stentless Sutureless 100% 2.9% 2.1% 8.6% 6.9% 7.1% 9.1% 13.6% 90% 17.6% 21.4% 20.9% 23.8% 16.5% Severe 13.6% 80% 23.9% 23.4% 23.8% Moderate Prosthesis-Patient Mismatch (%) 20.5% None 70% 28.6% 29.1% 60% 33.3% 50% 40% 79.5% 81.4%
Slide 17: Aortic Regurgitation: Transvalvular
AORTIC REGURGITATION Stented Bovine Pericardial Stented Porcine Stentless Sutureless 0.2% 0.3% 100% 1.9% 3.2% 5.1% 3.8% 2.3% 1.9% 5.2% None 6.6% 8.8% 11.1% 90% 15.1% 16.4% 9.0% 11.5% 18.2% Trace 4.4% 21.2% 19.5% 17.1% Transvalvular Regurgitation (%) 80% 20.6% Mild 70% Moderate 60% Severe 50% 83.0% 8
Slide 18: Limitations
LIMITATIONS • Differences in the patient population among individual studies • PERIGON enrolled patients with bicuspid anatomy and regurgitant lesions • The PERIGON and Evolut Low Risk patients were generally healthier than patients in the CoreValve High Risk and SURTAVI studies • Number of each val
Slide 19: Conclusions
CONCLUSIONS • Largest cohort of contemporary bioprosthetic surgical aortic valves with 1-year echocardiograms analyzed by a single core lab – 10 valve models, 2938 patients • Overall hemodynamic performance at 1 year was generally good, with low average gradients over all valve sizes. Some models sh
Slide 20: Thank You
THANK YOU @EACTS #EACTS2023 #EACTS The picture can't be displayed. www.eacts.org
Slide 21: Backup Slides
BACKUP SLIDES @EACTS #EACTS2023 #EACTS The picture can't be displayed. www.eacts.org
Slide 22: Stroke Volume
STROKE VOLUME Stented Bovine Pericardial Stented Porcine Stentless Sutureless Avalus Perimount Trifecta Mitroflow Mosaic Hancock Epic Freestyle Intuity Perceval N=906 N=516 N=278 N=28 N=172 N=44 N=21 N=42 N=98 N=66 22 | T H E 3 7 T H E A C T S A N N U A L M E E T I N G | 4 – 7 O C T O B E R 2 0 2 3
Slide 23: Peak Aortic Velocity
PEAK AORTIC VELOCITY Stented Bovine Pericardial Stented Porcine Stentless Sutureless Avalus Perimount Trifecta Mitroflow Mosaic Hancock Epic Freestyle Intuity Perceval N=1023 N=566 N=315 N=35 N=183 N=47 N=26 N=44 N=104 N=81 23 | T H E 3 7 T H E A C T S A N N U A L M E E T I N G | 4 – 7 O C T O B E R
Slide 24: Dimensionless Valve Index
DIMENSIONLESS VALVE INDEX Stented Bovine Pericardial Stented Porcine Stentless Sutureless Avalus Perimount Trifecta Mitroflow Mosaic Hancock Epic Freestyle Intuity Perceval N=996 N=548 N=304 N=33 N=177 N=46 N=21 N=43 N=100 N=75 24 | T H E 3 7 T H E A C T S A N N U A L M E E T I N G | 4 – 7 O C T O B
Slide 25: Aortic Regurgitation: Paravalvular
AORTIC REGURGITATION Stented Bovine Pericardial Stented Porcine Stentless Sutureless 2.4% 0.4% 2.3% 2.2% 1.0% None 100% 2.7% 1.0% 1.3% 1.5% 5.0% 5.7% 5.1% 4.4% 8.0% 9.1% 4.8% 6.6% 6.6% 3.8% Trace 90% 8.6% 4.5% 4.0% 12.5% Paravalvular Regurgitation (%) Mild 80% 70% Moderate 60% Severe 50% 95.7% 90.7%
Slide 26: Labeled Valve Sizes
LABELED VALVE SIZES 100% 90% 80% Implanted Valve Size (%) 70% 60% 50% 40% 35.5% 36.4% 33.4% 33.4% 31.0% 31.7% 27.9% 32.3% 30% 22.8% 18.7% 19.6% 19.8% 20% 8.9% 11.0% 8.7% 10% 3.8% 6.1% 5.9% 4.9% 3.7% 2.0% 0.1% 0.4% 0.9% 0.9% 0% PERIGON Evolut Low Risk SURTAVI CoreValve High Risk N=1129 N=682 N=783 N=
Slide 27: Avalus Bioprosthesis Indications
Avalus™ Bioprosthesis Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Contraindications: None known. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repl
Slide 28: Freestyle Aortic Root Bioprosthesis Indications
Freestyle™ Aortic Root Bioprosthesis Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Contraindications: None known. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of biopros
Slide 29: Hancock II Bioprosthesis Indications
Hancock™ II Bioprosthesis Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Contraindications: None known. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, a
Slide 30: Mosaic Bioprosthesis Indications
Mosaic™ Bioprosthesis Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Contraindications: None known. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolesc
Slide 31: medtronic.com
710 Medtronic Parkway Europe Asia Minneapolis, MN 55432-5604 Medtronic International Medtronic International Ltd. USA Trading Sàrl 49 Changi South Avenue 2 Toll-free in USA: 800.633.8766 Route du Molliau 31 Nasaco Tech Centre Worldwide: +1.763.514.4000 CH-1131 Tolochenaz Singapore 486056 Switzerland