PVL en Pacemaker rate problems solved. Tailored patient treatment, with a valve choice best for different anatomical features.
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- Bernadette Townsend
- 6 years ago
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2 New TAVR devices : PVL en Pacemaker rate problems solved Tailored patient treatment, with a valve choice best for different anatomical features. Unresolved issue is durability.
3 Direct Flow Medical Transcatheter Aortic Valve System Designed to minimize AR and improve outcomes Second generation design Non-metallic, conformable Polymer-filled double ring frame Controlled procedure Precise placement via 3 positioning wires Assess hemodynamic function prior to release Fully repositionable and retrievable Safe placement Valve fully functional throughout procedure No rapid pacing during valve release (stable F. De Marco, patient) DISCOVER Trial 3yr results presented at EuroPCR 2016
4 Delivery System - Terminology Guide Wire Nosecone Valve Positioning Wires Guide Wire Lumen Inner Catheter Outer Sheath
5 Direct Flow Medical Clinical Evidence Schema Clinical DISCOVER Trial Single arm; N=100, EuroScore 20 Corelab adjudicated FU up to 5yrs (36-month FU available) Enrolled Clinical Registry DISCOVER Registry Single arm; N=503 Enrolled SALUS Feasibility Trial Single arm; N=30, Extreme risk Corelab adjudicated Enrolled SALUS Pivotal Trial Randomized 2:1 (DFM vs. Sapien 3 and CoreValve Evolut R) N=648 Extreme and High Risk Enrolling F. De Marco, DISCOVER Trial 3yr results presented at EuroPCR 2016
6 The DISCOVER Registry Freedom from cardiovascular mortality 100% 80% 97% (30 d) Kaplan-Meier estimate 92% (6 m) 90% (1 yr) 60% 40% 20% 0% at risk: Interim Analysis presented by F DeMarco TCT2015 F. De Marco, DISCOVER Trial 3yr results presented at EuroPCR 2016
7 More Than 80% of Patients Treated with the Direct Flow Medical System Show None or Trace Paravalvular AR Percentage of patients showing none or trace PVL in major trials at 30 84% 33% 32% n=81 55% 30% Note: Different trial designs and patient populations, not directly comparable data. Provided for educational purposes only. Sources: A. Colombo, DISCOVER Trial, PCR I. Meredith, Corevalve Evolut R CE Mark Trial, ACC 2015; A. Linke, Portico CE Study, PCR London Valves 2015; T. Rudolph, Accurate Neo TF CE Study, PCR 2015; S. Kodali, PARTNER II Sapien 3 30-day results, ACC 2015 F. De Marco, DISCOVER Trial 3yr results presented at EuroPCR 2016
8 ADVANTAGES COMPAIRING TO OTHER DEVICES VERY LOW PVL RATE VERY LOW PM RATE 4% IMPLANTATION TEE GUIDED WITHOUT CONTRAST(RENAL FAILUR AT ALL TIME RETRIEVABLE AFTER HEAMODYNAMIC ASSESMENT PITTFALLS DIFFICULT LEARNING CURVE HIGHLY CACLIFIED VALVES CAN GIVE TO HIGH GRADIENTS, ESPECIALLY IN SMALL ANATOMIE LESS THAN 23 MM
9 Portico Transcatheter Valve System Small insertion profile (13.5F) 1 Where EXPERTISE MEETS SIMPLICITY No rapid pacing required 2 Intra-annular positioning for early valve functionality Flexible and trackable delivery system 3 pacemaker rates 4 14% Open cell frame designed to Minimize PVL Provide coronary access 1.Competitive Profile Comparison_SJM-PTC Portico IFU 3. Søndergaard L. How Portico helps solve challenging cases: Horizontal aorta & calcified annulus. Webinar March. 4, Linke, A. Multicentre Clinical Study Evaluating a Novel Self-expanding and Resheathable Transcatheter Aortic Valve System. PCR London Valves CVPipeline * Until fully deployed
10 Portico TF EU 6 M Trial Results All events adjudicated by an independent Clinical Events Committee Event Mortality Cardiovascular mortality 30 Day Rate (%) n = (3.6) 8 (3.6) 6 Month Rate (%) n = (9.0) 14 (6.3) Disabling (Major) stroke 7 (3.2) 9 (4.1) New pacemaker implantation 30 (13.5) 31 (14.0) Mean Aortic Gradient (mm Hg) ,4 0,7 Baseline N=199 1,8 1,9 1,7 9,1 8,3 8,1 Discharge N= Day N=177 Mean Aortic Gradient 6 Month N=161 EOA Presented by S. Worthley, EuroPCR ,5 2 1,5 1 0,5 0 EOA (cm 2 ) Percent 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 5,1% 5,7% 2,6% 50,5% 50,0% 54,4% 44,4% 44,3% 43,0% Discharge N=198 PVL 30 Day N=174 6M N=158 Severe Moderate Mild None/Trace
11 ADVANTAGES SMALL PROFIL,FLEXIBLE,RETRIEVABLE NO RAPID PACING, LOW PVL RATE.5,1 % DESADVANTAGES PM RATE 14% ANNULUS MAX 27 MM
12 Registries TF - Clinical Outcomes at 30 Days Mortality All Stroke XT 3 0 XT 3 Vascular Complications 20 Moderate PVL XT PARTNER A XT 3
13 Logistic EuroSCORE Analysis Clinical Outcomes at 30 Days <10 (N=517) (N=692) >20 (N=575) p-value All-Cause Mortality (%) All-Stroke (%) Non-TF** (%) < Major Vascular Compl. (%) Life-Threatening Bleeding (%) New Permanent Pacemaker* (%) Annular Rupture* (%) Mod/Sev PVL** (%) Contrast Volume (ml) Fluoroscopy Time (min) Extended Ventilation (%) Median Length of Stay (days) < * Site Reported KM Estimate event rates, except for ** Incidence
14 ADVANTAGES VERY LOW MORTALITY AND VERY LOW STROKE RATE EASY TO IMPLANT DESADVANTAGES PACING REQUIRED WITHOUT CAPTURE LOSS CAVE LVOT CALCIFICATIONS LCC AND SEPTAL BULGE DIFFUCULT IN VERY HORIZONTAL AORTA CAVE PORCELAN AORTA
15 The Lotus Valve Design Goals Bovine Pericardium in Nitinol in Frame Radiopaque Marker To aid precise positioning Adaptive Seal Controlled mechanical expansion Valve functions early in deployment to provide hemodynamic stability Valve is fully repositionable & retrievable throughout the entire deployment process Adaptive seal conforms to irregular anatomic surfaces to minimize paravalvular leak V.Falk, The RESPOND Study: Safety and Efficacy of a Fully Repositionable and Retrievable Aortic Valve Used in Routine tion: The Clinical Lotus Practice, Valve is an Euro investigational PCR 2016 device limited by federal law to investigational use only and not available for sale in the U.S. SH AA MAY 2016
16 Primary Endpoint Based on an expected rate of 10% (based on literature review) plus a test margin of 4%. P values are from the one-sample z test; 95% CI is from Clopper-Pearson Exact Method. V.Falk, The RESPOND Study: Safety and Efficacy of a Fully Repositionable and Retrievable Aortic Valve Used in Routine tion: The Clinical Lotus Practice, Valve is an Euro investigational PCR 2016 device limited by federal law to investigational use only and not available for sale in the U.S. SH AA MAY 2016
17 Key Secondary Endpoints Based on an expected rate of 16.5% from the FRANCE 2 registry. P values are from the one-sample z test; 95% CI is from Clopper-Pearson Exact Method V.Falk, The RESPOND Study: Safety and Efficacy of a Fully Repositionable and Retrievable Aortic Valve Used in Routine tion: The Clinical Lotus Practice, Valve is an Euro investigational PCR 2016 device limited by federal law to investigational use only and not available for sale in the U.S. SH AA MAY 2016
18 Safety Endpoints at 30 Days As-Treated population at 30 days (N=987) * All-cause mortality 2.2% Cardiovascular mortality 2.0% All stroke 3.0% Diabling stroke 2.2% Valve- or CHF-related repeat hospitalization 1.2% Newly implanted permanent pacemaker 30.0% *Among patients with sufficient clinical follow-up or death, or who had an adverse event, within 30 days post-procedure. V.Falk, The RESPOND Study: Safety and Efficacy of a Fully Repositionable and Retrievable Aortic Valve Used in Routine tion: The Clinical Lotus Practice, Valve is an Euro investigational PCR 2016 device limited by federal law to investigational use only and not available for sale in the U.S. SH AA MAY 2016
19 Next Generation Boston Scientific TAVI Design Goals N I 14Fr LOTUS Edge Valve System Improved Deliverability Simplified Locking Lower Proximal Profile Novel, Low Profile Sheath Expandable 14Fr Design Smaller Vessel Access BOLT Improved Access Direct aortic indication Direct aortic dedicated sheath Additional Valve Sizes (21mm and 29mm) Direct aortic Transfemoral 21mm 23mm 25mm 27mm 29mm Annulus Size (mm) Under development, not available for sale Information not intended for use in France. Lotus is an investigational device and not for sale or distribution in the US. CE mark received Information for the Lotus Valve System is for use in countries with applicable product registrations. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.
20 LOTUS Edge Valve System Features Design Feature Current Lotus LOTUS Edge Delivery System Pre-shaped Flexible Sheath 18F 14F Locking Verification Valve Sizes CE Mark Access Indication Multiple views 23mm, 25mm, 27mm Transfemoral 1 view 21mm, 23mm, 25mm, 27mm, 29mm Transfemoral, Transaortic Under development, not available for sale Information not intended for use in France. Lotus is an investigational device and not for sale or distribution in the US. CE mark received Information for the Lotus Valve System is for use in countries with applicable product registrations. Under Indications, development, contraindications, not available warnings for sale and instructions for use can be found in the product labeling supplied with each device.
21 COREVALVE EVOLUTE ADVANTAGES: SUPRA-ANNULAR VALVE DESIGN VERY SUITABLE FOR V IN V TAVI AND VERY SMALL ANATOMIE. SHEATLESS FOR SMALL ANATOMIE 14FR PITTFALLS DIFFICULT IN HORIZONTAL LARGE ANNULUS PVL 6,8% PM RATE 12%
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