TAVI and TAVR: Radical and Revolutionary: The Newest Insights for the CV Community and a Panel Discussion Moderator: Joseph E. Bavaria, MD Roberts-Measey Professor of Surgery Vice Chair, Division of Cardiovascular Surgery University of Pennsylvania Past President-Society of Thoracic Surgeons (STS 2016-17) PCS Philadelphia, November 2018
Disclosures Site PI or Co-PI, Consultant: Edwards, Abbott/St. Jude Site PI or Co-PI: Medtronic Consultant: W.L. Gore STS/ACC TVT Steering Committee Chairman Founders Shares/Equity Holder CardiAQ (since sold to Edwards Oct. 2015, presently no financial interest)
Disclosures Site PI or Co-PI, Consultant: Edwards, Abbott/St. Jude Site PI or Co-PI: Medtronic Consultant: W.L. Gore STS/ACC TVT Chairman Founders Shares/Equity Holder CardiAQ (since sold to Edwards Oct. 2015, presently no financial interest) I Love both TAVR and SAVR!!
STS/ACC TVT National Adoption Volumes of SAVR and TAVR
TAVR Median LOS (Days) 8 7 6 5 4 3 2 6 5 7 6 6 5 4 4 3 3 3 2 Total LOS Post TAVR LOS 1 0 2012R4Q 2013R4Q 2014R4Q 2015R4Q 2016R4Q 2017R4Q Source: STS/ACC TVT Registry Outcomes Report as of Oct 17, 2017
STS/ACC TVT Database: SAVR & TAVR Volumes 60000 50000 40000 TAVR, for the first time, in 2017 surpassed SAVR 43548 47779 30000 20000 10000 0 AVR 29829 30265 28857 28493 AVR & CABG 25580 18384 TAVR 18090 17544 17507 15910 This does NOT include AVR + other (Bentall, STS Volume AVR/MVR, annualized Ascend, etc) 2014 2015 2016 2017 STS/ACC TVT Registry Database as of 3-1-18
STS/ACC TVT Trending data on TAVR Mortality
TAVR In Hospital and 30 Day Mortality 7.00% 6.00% 6.01% 5.00% 4.00% 3.00% 2.00% 4.11% 2.86% 4.38% 2.02% 3.20% 1.74% 3.05% In Hospital 30 Day 1.00% 0.00% 2014 2015 2016 2017 Jan- Jun Source: DCRI 2017 Q3 Data Query
Mortality After TAVR In-Hospital, 30 Day, and One Year Mortality
U.S. FDA Prospective Randomized Trials: Presented at ACC and published in NEJM 2016-17 Intermediate Risk Patients STS score > 3-4 to 8 And Low Risk!
P2 RCT Primary Endpoint (ITT) All-Cause Mortality or Disabling Stroke All-Cause Mortality or Disabling Stroke (%) 50 40 30 20 10 0 8.0% 6.1% Surgery TAVR AVG STS = 5.8 16.4% 14.5% HR [95% CI] = 0.89 [0.73, 1.09] p (log rank) = 0.253 21.1% 19.3% 0 3 6 9 12 15 18 21 24 Months from Procedure Number at risk: Surgery 1021 838 812 783 770 747 735 717 695 TAVR 1011 918 901 870 842 825 811 801 774 1
RCT: All-Cause Mortality (ACC 4/2017) All-Cause Mortality 30% 25% 20% 15% 10% 5% STS PROM 4.4/4.5% 30 Day SAVR 1.7% O:E 0.38 TAVR 2.2% O:E 0.50 TAVR Both CoreValve and Evolute R 24 Months SAVR 95% CI for Difference 11.4% 11.6% -3.8, 3.3 No. at Risk SAVR TAVR 0% 0 6 12 Months Post-Procedure 18 24 796 690 569 414 249 864 762 621 465 280 13
The PARTNER 3 Low Risk Trial Study Design Severe, Calcific Aortic Stenosis Patients at Low Operative Risk Heart team agrees the patient has low risk and STS < 4 Registries Assessment by Heart Team: Transfemoral access No Alternative Access TAVR Yes 1:1 Randomization TAVR (SAPIEN 3 valve) CT Imaging Sub-study Actigraphy/Quality of Life Sub-study Surgical AVR (surgical bioprosthetic valve) CT Imaging Sub-study Actigraphy/Quality of Life Sub-study Primary Endpoint: Composite of all-cause mortality, all stroke, and rehospitalization at 1 year post procedure. Follow-up: 30 day, 6 months, and annually through 10 years
STS/ACC TVT: Heart Team Reason for TAVR Procedure Source: STS/ACC TVT Registry Outcomes SAG Report as of Sept, 2018
Pacemakers/Heart Block
S3: Other Clinical Events Intermediate Risk At 30 Days (As Treated Patients) Events (%) S3HR Overal l (n=583) S3HR TF (n=491) S3HR TA/TA o (n=92) S3i Overall (n=1076) S3i TF (n=951) S3i TA/TA o (n=125) Major Vascular Comps. 5.0 5.3 3.3 5.6 5.9 3.2 Bleeding - Life Threatening 6.3 5.5 10.9 5.4 4.4 12.9 Annular Rupture 0.3 0.2 1.1 0.2 0.2 0 Myocardial Infarctions 0.5 0.4 1.1 0.3 0.3 0 Coronary Obstruction 0.2 0 1.1 0.4 0.4 0 Acute Kidney Injury 1.0 0.8 2.2 0.5 0.3 1.6 New Permanent Pacemaker Aortic Valve Reintervention 13.0 13.2 12.0 10.1 10.4 7.2 1.0 0.8 2.2 0.7 0.8 0 Endocarditis 0.2 0.2 0 0.1 0.1 0
TAVR 30-Day New Pacemaker Rate In-Hospital = 9.9% NEW pacemakers. Important as it is well known that pacemaker in younger patients (Low Risk?) die earlier
PVL and Aortic Valve Insufficiency
ACC 2015 Clinical Performance Evolute CE Mark Event, % N=60 Absence of procedural mortality 100.0 (60/60) Correct positioning of 1 valve in proper location 98.3 (59/60) Mean gradient < 20 mm Hg or peak velocity < 3m/sec 98.3 (59/60) Absence of moderate or severe regurgitation 93.3 (56/60) Absence of patient prosthesis mismatch* 83.6 (46/55) VARC-2 device success 78.6 (44/56) 6.7% *Effective orifice area could not be determined in 5 patients to calculate patient prosthesis mismatch. First time reporting of device success according to VARC-2 criteria Source: Meredith IT, et al. Early Results from the CoreValve Evolut R CE Study [2101-295]. Presented at the Annual Meeting of the American College of Cardiology. March 14, 2015. 22
Paravalvular Leak: S3HR & S3i (Valve Implant Patients) 0.1% 4.2% in S3I Lots of Residual AI: Even with 3 rd generation S3 No. of Echos 1504
LOTUS Valve Superior to Evolut R / CoreValve * In Primary Efficacy Endpoint Presented by T. Feldman, MD at EuroPCR 2017
N=1,016 patients Paravalvular Leak in the modern era of SAVR is basically ZERO! AVG STS = 4.02
Paravalvular Leak: Dilate, Plug or Watch? Mild or Moderate PVL: Should I be concerned? Variable HR 95% CI P-value Arrhythmia 1.41 1.14-1.75 0.002 TF vs TA 0.73 0.59-0.91 0.005 AI is Bad AV annular diameter AV mean gradient 1.07 1.03-1.11 0.001 0.98 0.97-0.99 <0.0001 Mild PVL 1.35 1.07-1.72 0.013 Mod/Sev PVL 2.20 1.6-3.03 <0.0001 Creat > 2 1.35 1.04-1.74 0.023 BMI 0.95 0.93-0.97 <0.0001 Kodali S et al, Eur Heart J 2015
Durability??
Age at TAVR=82.6 50% at <7 years Median time to degeneration = 61 months
Catastrophic Rates/ Hybrid OR Concepts
TAVR Procedure Details (Disasters) 5.0% 4.5% 4.0% 4.2% 4.7% 4.3% 3.5% 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% 3.2% 1.40% 2.7% 1.5% 2.3% 1.6% 0.9% 1% 1.8% 1.1% 0.7% 0.7% 0.8% 0.5% 0.5% 2012 R4Q 2013 R4Q 2014 R4Q 2015 R4Q 2016 R4Q 2017 R4Q Source: STS/ACC TVT Registry Database. >120,000 records as of Jan 18, 2018 CPB req Convert to OHS Procedure Aborted 2.0-2.3% Catastrophe
STS/ACC TVT TAVR Where is this Procedure Being Performed? 100 90 80 70 60 50 40 30 20 10 0 15 13 10.8 9.3 11 23.5 25.3 26.4 27.4 32.5 62.7 63.7 63.2 50.7 61.6 2012 2013 2014 2015 2016 Regular Cath Lab Hybrid Cath Lab Hybrid OR Source: STS/ACC TVT Registry Database as of Jul 17, 2017
National Policy Recommendations: The Big Question in the U.S. Regarding TAVR: Is There a Significant Volume Outcome Relationship??
J Am Coll Cardiol 2017;70:29 41. Unadjusted (orange) and risk-adjusted (blue) frequency of outcomes. The p value < 0.05 for linearity suggests a nonlinear relationship. The orange- and bluecolored bands represent 95% confidence limits, which are broader for stroke due to the low rate of site-reported stroke and the fewer hospital sites contributing cases.
QUALITY: There is a Greater Frequency of Procedure-Related Mortality That Occurs at Low Volume TAVR Sites Unadjusted In-Hospital Mortality versus Annual TAVR Volume of Sites Observed to Expected In-Hospital Mortality versus Annual TAVR Volume of Sites Also Huge VARIABILITY in Low Volume sites
30 Day Composite Major Outcomes Related to Site Annual Volume 2016-2017 Complete One-Year Data from STS-ACC TVT Registry Frequency of Major Complications % P<0.001 Site Annual TAVR Volume
National Policy Recommendations: The Big Question in the U.S. Regarding TAVR: Is There a Significant Volume Outcome Relationship?? Do you think there should be a minimum number of TAVR performed at a TAVR site in the U.S.?
V-in-V PPM
Incidence, Predictors, and Outcomes of Prosthesis-Patient Mismatch in 62,125 TAVR Patients An STS/ACC TVT Registry Report Presented 2018 TCT showing worse outcomes with TAVR PPM. Severe PPM in 12% of all TAVR Howard C. Herrmann, et al JACC (presented at TCT 2018)
TAVR Valve in-mitral module of STS/ACC TVT Registry: TMVR Update (Including Valve-in-Ring)
TMVR Mortality
TMVR All-cause Readmission: 30 Day and One Year (CMS linked)
Functional MR?!?! What to Do??
Mitral Valve Surgery better than Mitra-Clip out to 5 years
Wow!! Significant Data and Results Everest II
Mitra-Clip better than Best Medical Management
More Real World Data: No Difference between Mitraclip and Best Medical Management in Functional MR
OMG!! This is stunning!? At 1 Year: No difference in reverse remodeling - LVESVI 45 40 35 MR Recurrence ( moderate) p<0.001 No difference in clinical end points; Mortality; MACCE No difference in QOL metrics Percent (%) 30 25 20 15 Severe Moderate 10 5 Acker MA et al. N Engl J Med 2014;370:23-32 0 Repair Replacement
Cumulative Failure Over Time (failure = death, mod MR or MV reoperation) OMG!! This is even MORE stunning!? 60% Recurrent MR at 2 years 68% vs. 29% overall incidence of failure at 2 years (RR = 2.3; 95% CI: (1.69-3.22) p<0.001
TVT Leaflet Clip Mortality (Real World) And this is in mostly degenerative!! What will this look like now after COAPT for functional?? Safe, but DOUBLE the mortality by 30 day??
All RCT NEJM papers!!!! Functional MR?!?! What to Do?? MVR better than Repair MV Repair better than Mitra-clip Mitra-Clip better than GDMT Or Maybe just the same!
Questions?
New STS/ACC/AATS/SCAI NCD: Volumes; CMS mandates; etc??
STS TAVR Survey Results Joseph Bavaria, Richard Prager, Keith Naunheim, Mark Allen, Robert Higgins, Thomas MacGillvary, Vinod Thourani, Natalie Boden, and Joseph Sabik On Behalf of the Executive Committee of the STS Presented at STS Jan 24, 2017; Houston, Texas; Ann Thor Surg 2017
Logistics Survey conducted June-July 2016 Delivered to 2,594 surgeon participants in the STS Adult Cardiac Surgery Database 487 surveys were completed Response rate was 18.8% Survey Avg = 11%
From which department is your TAVR program administratively run? Cardiology Cardiac Surgery Both Other Answer Options Response Percent Response Count Cardiology 25.9% 105 Cardiac Surgery 15.3% 62 Both Cardiology and Cardiac Surgery 58.0% 235 Other 0.7% 3 answered question 405
Please list all the intraoperative technical aspects of TAVR that you personally perform on a regular basis? Obtain femoral access Obtain alternative access Insert transvenous catheter Cross the aortic valve Insert delivery sheath Perform balloon dilation Position valve Deploy valve Operate imaging eqpt Remove arterial sheath Perform open artery repair Other Only one area below 50% participation rate Answered by every (99%) (n=308/313) surgeon who performed TAVI