Tình hình thay van động mạch chủ qua đường ống thông ở hoa kỳ current status of TAVR in the US

TAVR Update 2014 Marvin H. Eng, MD FSCAI FACC Assistant Professor of Medicine Division of Cardiology University of Texas Health Sciences Center San Antonio, Texas Disclosures • Speakers Bureau for Edwards Lifesciences • Consultant for NAVIGATE CSI Goals of Percutaneous Valve Therapy • No paravalvular leak • Durable • Safe • Repositionable • Low-Profile – Transfemoral access • Prevents myocardial injury – Heart block • Easy to Implant Edwards Balloon-Expandable Valves Characteristics Frame SAPIEN Stainless Steel SAPIEN XT Cobalt Chromium S3 Cobalt Chromium Annulus range 18-25 mm 18-29 mm 17-29 mm Sizes 23,26 mm 23, 26, 29 mm 20, 23, 26, 29 mm Sheath Size (ID) 22, 24Fr 16, 18, 20 Fr 14, 16Fr Vascular Complications (30D) 15.5% 9.5% 6.0% Pacemaker (30D) 5.9 % 6.4% 13.3% Stroke (30D) 3.0% 3.2% 2.7% ≥ Moderate AR 12.2% 4.1 % 3.4% Edwards Balloon-Expandable Valves Access- XT Sheath ID Sheath OD Sheath OD Expanded Minimum Vessel Diameter 23 mm 16Fr 6.7 mm 8.9 mm 6.0 mm 26 mm 18 Fr 7.2 mm 8.9 mm 6.5 mm 29 mm 20 Fr 8.0 mm 9.9 mm 7.0 mm Balloon-Expandable Valves Sapien 3 (S3) Sheath ID Sheath OD Sheath OD Expanded Minimum Vessel Diameter 23 mm 14 Fr (4.6 mm) 6.0 mm 7.6 mm 5.5 mm 26 mm 14 Fr (4.6 mm) 6.0 mm 8.0 mm 5.5 mm 29 mm 16 Fr (5.3 mm) 6.7 mm 8.6 mm 6.0 mm Binder R et al. JACC Int. 2013;6:301-7 PARTNER I-A Leon MB ACC 2013 Edwards Sapien PARTNER IB 5 Year data PARTNER I-B Kapadia S TCT 2014 S3 High-Risk Registry 30D Clinical Outcome TF N=96 TA N= 54 Overall N= 150 Mortality 2 (2.1%) 6 (11.1%) 8 (5.3%) CV Mortality 2 (2.1%) 5 (9.3%) 7 (4.7%) Stroke 1 (1.0%) 3 (5.6%) 4 (2.7%) Disabling Stroke 0 (0.0%) 0 (0.0%) 0 (0.0%) Major Vascular Complications 5 (5.2%) 4 (7.4%) 9 (6.0%) Major Bleeding 19 (19.8%) 11 (20.4%) 30 (20%) Re -Hospitalization 0 (0.0%) 0 (0.0%) 0 (0.0%) Webb J TCT 2014 Washington D.C. Self-Expanding Medtronic CoreValve Series Engager TA 23/26 mm Annulus Range 18-29 mm 18-26 mm 21-26.7 mm Sheath Size (ID) 18Fr 14Fr 29Fr Access TF, SC, TAo TF, SC, TAo TA, TAo Pacemaker rate 26.1% ? 16.9% [...]... Direct Flow • 23, 25, 27, 29 mm valves – – – – – 19-28 mm annuli 18Fr Conformable polyester cuff Rings pressurized with saline and contrast Infuse polymer to solidify rings Schoafer J et al JACC 2014;63: 763-8 Bijuklic C et al Eurointervention 2013;8:Q75-8 Direct Flow Inner Curve Technique DeMarco F et al Eurointervention 2014;10 :400-402 Direct Flow Registry and DISCOVER Trial 30 DAY Outcome Real World... JACC Int 2013;6:301-7 Kuck KH TCT 2014 Washington D.C “Mechanical Expanding” Valve Lotus Valve • Neither self or balloon expandable – Mechanical expansion • Repositionable • Retrievable • Adaptive Seal Merideth, I et al EuroIntervention 2014;9: 1264-1270 Lotus Valve “Mechanical” Deployment Merideth, I et al EuroIntervention 2014;9: 1264-1270 Lotus Valve in High Risk Pts REPRISE II- 1 Year (n=120)... (4/120) Disabling stroke 1.7% (2/120) 4.2% (5/119) 4.2% (5/119) 1.7% (2/119) 10.9% (13/119) 6.7% (8/119) 3.4% (4/119) Non-disabling stroke Total stroke 4.2% (5/119) 5.9% (7/119) 4.2% (5/120) 31.9% (7/119) 5.9% 5.9% (7/120) 9.3% (11/119) Merideth, I et al TCT 2014 Washington D.C Self-Expanding Valve VENUS A • Nitinol frame • Porcine Pericardium • 23, 26, 29, 32 mm – Rounded eyelets – Enhanced inflow (20... Composite Safety End-Point 17% 89.5% Tuzcu EM TCT 2014 Washington D.C Self-Expanding Valves Portico Valve • Bovine Leaflets – Porcine Cuff • • • • • • 23 mm 19-21 mm 25 mm 21-23 mm 27mm  23-25 mm 29mm  25-27 mm 18Fr Retrievable Manohoran G et al Eurointervention 2012;8: Q97-Q101 Portico Valve CE mark Trial N=103 30 day 1 year Death 2.8% 8.7% CV Death 2.9% 5.8% Stroke (major +minor) 3.9% 5.8% New... Major Bleeding 3.9% 3.9% Manoharan G et al TCT 2014 Washington D.C Self-Expanding Valves Edwards Centera 14 ⟩ 12 ⟩ 10 ⟩ 8 ⟩ ⟩ 6 4 ⟩ 2 ⟩ 0 None/Trace Mild 23, 26, 29 mm sizes Bovine pericardium leaflets PET skirt Discharge Baseline Motorized deployment Paravalvular Leak Recapturable at 70% deployment Anticipate14Fr e-sheath 4/15 (27%) pacemaker implant Moderate Severe Binder R et al JACC Int 2013;6:301-7... 32 mm – Rounded eyelets – Enhanced inflow (20 mm) strength – Tapered Inflow – Radiopaque Markers – Sheathless 19fr Gao R el al TCT 2014 Washington D.C Other Valves Accurate, Jena, Innovare, Syntheon Stroke Prevention Embolic Protection • CLEAN-TAVI (Claret Device) – Randomized 100 patients 1:1 • SENTINEL (Claret device) – Randomizing 360 TAVI patients – MRI study 4-7 days post-procedure • PROTAVI-C... Protects entire arch Samim M et al EuroPCR 2014 Kodali S et al TCT 2013 Iterative Advances TAVI • TAVI in Intermediate Risk – OBSERVANT- Registry Data – PARTNER IIA-Randomized Data – S3 Prospective Data • Patient Selection – Cohort C • New THV’s • Valve Sizing and Selection – CT, 3D-TEE, Calcium Distribution • Prevention of In- Hospital Complications – Stroke – Vascular Access – LOS • Post-Procedure Care... 5.8% 2.6% 2.26 (0.60-8.52) 0.33 Major Bleeding 8.3% 12.0% 1.31 (0.74-2.32) 0.36 Vascular Complications 14.0% 12.8% 1.10 (0.57-2.09) 0.78 Device Success Final AR (angio) . TAVR Update 2014 Marvin H. Eng, MD FSCAI FACC Assistant Professor of Medicine Division of Cardiology University of Texas Health Sciences Center San. Conformable polyester cuff – Rings pressurized with saline and contrast – Infuse polymer to solidify rings Direct Flow Inner Curve Technique DeMarco F. et al. Eurointervention 2014;10 :400-402 CHOICE Aortic insufficiency Abdel-Wahab M et al. TCT 2014 Washington D.C. Self-Expanding Valves Direct Flow Schoafer J et al. JACC 2014;63: 763-8. Bijuklic C et al. Eurointervention 2013;8:Q75-8.