TAVR today: High Risk, Intermediate Risk Population, and Valve in Valve Therapy
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1 TAVR today: High Risk, Intermediate Risk Population, and Valve in Valve Therapy Alan Zajarias, MD FACC Structural Interventional Fellowship Director Associate Professor Medicine Cardiovascular Division
2 Conflict of Interest Consultant for Edwards Lifescience Consultant for Phillips Imaging I will be discussing items that are not currently FDA approved.
3 Outline High Risk population and TAVR The current use of TAVR in the intermediate risk population Intermediate risk (published data) Intermediate risk ongoing and future clinical trials Valve in Valve Procedure Highlight major presented/published results
4 Procedural Risk and Use of Valve Replacement Surgery TAVI Risk
5 CoreValve Revalving system US Pivotal Trial SurTAVI
6 A B C D PARTNER 1 Sapien Valve PARTNER 2 ViV Sapien XT S3i and HR Sapien 3
7 TAVR in High Risk Patients Primary Endpoint: 1 Year All-cause Mortality Surgical Transcatheter 19.1% 14.2% 4.5% P = 0.04 for superiority 3.3% NEJM 2011;364: NEJM 2014;DOI: /NEJMoa
8 CoreValve High Risk Trial Higher: vascular complications and PPM rate Lower: post op Afib, life threatening bleeding
9 PARTNER 1 A: 5 year follow up All-cause Death CVA and TIA
10 The PARTNER II S3 Trial Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team n = 1076 Patients Intermediate Risk Operable (PII S3i) SAPIEN 3 2 Single Arm Non-Randomized Historical-Controlled Studies High Risk Operable / Inoperable (PII S3HR) n = 583 Patients ASSESSMENT: Optimal Valve Delivery Access PII A SAVR PI A SAPIEN ASSESSMENT: Optimal Valve Delivery Access Transfemoral (TF) Transapical / Transaortic (TA/TAo) Transfemoral (TF) Transapical / Transaortic (TA/TAo) TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3 TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3
11 Baseline Patient Characteristics S3HR Patients Average STS = 8.6% (Median 8.4%) Average Age = 82.6yrs TA, 10% TAo, 6% TF, 84% N = 583 Female 42% Male 58% 1.9% 34.3% 38.9% 24.9% 20 mm 23 mm 26 mm 29 mm
12 Mortality and Stroke: S3HR At 30 Days (As Treated Patients) 100 Mortality All-Cause Cardiovascular 100 All Stroke Stroke Disabling % O:E = (STS 8.6%) % S3HR S3HR
13 Other Clinical Events (30 days AT) Events (%) Major Vasc. complications S3HR N=583 S3HR TF n= Bleeding Annular rupture MI Coronary obstruction AKI New PPM Ao Valve reintervention Mod Severe AI 2.9% S3HR TA/Tao n=92 From ACC 2015/PPO
14 Loutus Valve Self expanding valve Fully retrievable Fully repositionable Adaptive seal No rapid pacing Evaluated in Reprise trials Braided Nitinol Frame Central Radiopaque Positioning Marker Locking Mechanism Bovine Pericardium Adaptive Seal
15 REPRISE II with Extended Cohort (N=250) Device Performance Successful access, delivery, deployment & system retrieval 98.8%* Successful valve repositioning, if attempted (n=85) 100.0% Partial valve resheathing (n) 71 Full valve resheathing (n) 14 Successful valve retrieval, if attempted (n=13) 92.3%* Aortic valve malpositioning 0.0% Valve migration 0.0% Valve embolization 0.0% Ectopic valve deployment 0.0% TAV-in-TAV deployment 0.0% *2 intraprocedural complications occurred prior to valve deployment; 1 retrieval with incomplete retraction into delivery catheter but Ian successfully Meredith, London removed. Valves Lotus 2014 valve implanted 42 days afterwards in this patient.
16 REPRISE II (N=120) & Extended Cohort (N=250) Primary Endpoints Mean Aortic Valve Gradient at 30 Days (N=120) All-cause Mortality at 30 Days (N=250) Performance Goal = 18.0mmHg Performance Goal = 16% * mmHg 11.5mmHg ± UCB (12.6mmHg) is significantly below the performance goal (P<0.001) % 4.4% ± UCB (6.97%) is significantly below the performance goal (P<0.001) Based on an expected mean of 15mmHg (literature review) plus a test margin of 3mmHg * Based on an expected rate of 9.8% (literature review) plus a test margin of 6.2% Meredith, et al. JACC 2014;64:1339. Ian Meredith, London Valves 2014
17 Reprise III Ongoing clinical trial High risk and extreme risk cohorts Randomized to Corevalve 1-year endpoints
18 Other US High Risk Trials Salus Directflow valve vs. Corevalve Portico Portico Valve Currently on hold
19 INTERMEDIATE RISK TRIALS
20 Intermediate Risk Registry 30-day All Cause Mortality 1-year All Cause Mortality Mortality 30 day 1 yr TAVR 7.8% 16.5% SAVR 7.1% 16.9% J Am Coll Cardiol Interv 2013;6:443-51
21 Baseline Characteristics European Heart J 2013;34:
22 All Cause Mortality 30 day 1-year Low 2.4% 10.1% Intermediate 3.9% 16.1% High 14.9% 34.5% European Heart J 2013;34:
23 Complications
24 Nordic Aortic Valve Intervention Trial (NOTION) Randomized, all comers with severe AS Comparing CoreValve to SAVR in pts > 70yrs with severe AS N= 280 patients 5 year follow up Primary endpoint: All Cause mortality, MI and stroke at 1 year
25 Notion At 1 year, no difference in composite endpoint of death, MI or CVA 13% vs 16% TAVR patients: Higher rate of paravalvular leak Moderate: 15.7% vs. 0.9 % (p<0.001) Higher PPM rate: 38% vs. 2.4% (p<0.001) Less major bleeding: 11.3% vs. 20% (p=0.03) SAVR patients New onset Afib: 57.8% vs. 16.9% (p<0.001) Shock: 4.2% vs. 10.4% (p= 0.05) AKI stage 2/3:.7 vs.6.7% (p=0.01) Patients with less dyspnea at 1 year /j.jacc
26 The PARTNER II S3 Trial Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team n = 1076 Patients Intermediate Risk Operable (PII S3i) SAPIEN 3 2 Single Arm Non-Randomized Historical-Controlled Studies High Risk Operable / Inoperable (PII S3HR) n = 583 Patients ASSESSMENT: Optimal Valve Delivery Access PII A SAVR PI A SAPIEN ASSESSMENT: Optimal Valve Delivery Access Transfemoral (TF) Transapical / Transaortic (TA/TAo) Transfemoral (TF) Transapical / Transaortic (TA/TAo) TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3 TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3
27 Baseline Patient Characteristics S3i Sapien Patients 3 Intermediate Risk Average STS = 5.3% (Median 5.2%) TAo, 4% N = 1076 TA, 7% Average Age = 81.9yrs TF, 89% Female 38% Male 62% 4.1% 32.2% 43.7% 20.0% 20 mm 23 mm 26 mm 29 mm
28 Mortality and Stroke: S3i At 30 Days (As Treated Patients) 100 Mortality All-Cause Cardiovascular 100 All Stroke Stroke Disabling O:E = 0.21 (STS 5.3%) % % S3i S3i
29 Percent of evaluable echos Paravalvular Leak: S3HR & S3i (Valve Implant Patients) None/Trace Mild Moderate Severe 100% 0.1% 3.7% 80% 41.3% 60% 40% 20% 55.0% 0% No. of Echos 30 Days 1504
30 Ongoing Intermediate risk trials
31 SURTAVI Trial STS mortality risk 4% and 10% Heart Team Evaluation Confirm Inclusion/Exclusion & Intermediate Risk Classification Randomization Stratified by need for revascularization N ~2,500 patients TAVI SAVR TAVI + PCI TAVI only SAVR + CABG SAVR only
32 The PARTNER II Trial Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team n = 2000 Randomized Patients Operable (STS 4) Two Parallel Randomized Trials +6 Nested Registries Inoperable n = 560 Randomized Patients Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) / TransAortic (TAo) Yes 1:1 Randomization 1:1 Randomization 1:1 Randomization 6 Nested Registries Sample Size TF TAVR SAPIEN XT VS Surgical AVR TAVR: TA / TAo SAPIEN XT Primary Endpoint: All-Cause Mortality + Disabling Stroke at Two Years (Non-inferiority) VS Surgical AVR TF TAVR SAPIEN XT VS TF TAVR SAPIEN Primary Endpoint: All-Cause Mortality + Disabling Stroke + Repeat Hospitalization at One Year (Non-inferiority) NR1 (Sm Vessel) 100 NR2 (Transapical) 100 NR3 (ViV) 100 NR4 (TAo) 100 NR5 (29 mm TF) 50 NR6 (29 mm TA) 50
33 UK TAVI Trial Severe symptomatic aortic stenosis Age 80 years or over or Age 70 years or over + intermediate or high operative risk STS score 4% - 12% but MDT has discretion Randomized to TAVR vs. AVR UK HTA funded industry independent Any TAVI device eligible Primary endpoint:12 month mortality
34 Intermediate Risk Key Points TAVR in the intermediate risk group is possible. Treating patients with lower risk profile is associated with lower procedural complications. Current risk stratification models are imperfect and do not quantify other factors that influence mortality Frailty Mobility Results of future clinical trial will help better guide our use of TAVR in this patient population
35 Valve in Valve Therapy
36 Types of Bioprosthetic Valves Stented Supra annular Intra annular External leaflets Stentless Curr Prob Cardiol 2014; 39:7-27
37 Sizing Bioprosthetic Valves for ViV ViV ViV Surgical Valves
38 Valve in Valve International Data Registry Voluntary international registry Commercially available TAVRs Medtronic Corevalve Edwards Sapien and Sapien XT Age Men STS >1 SAVR LVEF All (n=459) % 10 % 13.5% 50% Stenosis (n=181) % 9.9% 8.8% 51% Regurgitation (n=139) % 9.9% 16.5% 49% Combined (n=139) % 10.8% 16.5% 49% P JAMA 2014;312:
39 Valve in Valve International Data Registry Mortality by Failure Mechanism Mortality by Valve Size 7.6% 30 day mortality 1-yr mortality influenced by valve size and mechanism of degeneration No difference in mortality stratified by device used (p=.44) JAMA 2014;312:
40 Procedural Characteristics Device success: 93% 3 important complications Coronary Obstruction Valve migration Elevated residual gradients JAMA 2014;312: Circulation 2012;126;
41 ViV Results Coronary obstruction Incidence: 3.5% In-hospital mortality 57% Associated with Leaflet length Prosthesis position Size of aorta/sinuses Previous aortic surgery JAMA 2014;312: Circulation 2012;126:
42 ViV Results Post-procedural gradient Mean:16.9 mmhg 26.8% were > 20mmHg Risk for post procedural gradient elevation Baseline AVA OR:0.87(CI: , p=0.001) Sapien valve OR: 2.2 (CI: , p=0.02) Key Factors Know surgical prosthetic size and gradients Use small TAVR prosthesis? Circulation 2012;126;
43 ViV Results Valve Migration 2 nd Valve: 5.7% Attempted retrieval 10.9% Key Points Identify fluoroscopical characteristics of valve Identify land zone Know appropriate size JAMA 2014;312: Curr Prob Cardiol 2014; 39:7-27
44 TVT Registry Baseline 201 patients Age: 77 yrs (66-83) STS: 8 (4.7-11) NYHA III/IV: 92% ESRD: 8% Hostile chest: 19% Previous valve>2: 27% Results Conversion: 1.4% Aborted procedure: 1% Device success: 88% Coronary obstruction: 1% Death Inhospital: 4% 6 month 11.% 1 yr:15.4% CVA: 2.5% Mean gradient (post): 18.5 mmhg Tuzcu ACC 2014
45 Registry Data TVT Registry ViV Partner 2 Age 77 yrs (66-83) Male sex 55.2% STS 8 (4.7-11) NYHA III/IV 92% 95.8 Mortality 30 days 1 year 4% 15% 7.7% Stroke 2.5% 2.2% Coronary obstruction 1% 0% Major Vascular complications 5% 5.% Mean gradient 18.5% mmhg NYHA 1-2 (30 days) NR ~90% Adapted from Tuzcu and Webb ACC 2014
46 Valve in Valve Key Points Can be used in stenotic or regurgitant valves Careful patient selection is key to avoid complications Residual gradients are higher in smaller prosthesis Not effective in treating paravalvular insufficiency or patient prosthetic mismatch Limited data with 29 mm prosthesis
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