TAVR in 2020: What is Next!!!!

Transcription

1 TAVR in 2020: What is Next!!!! Vinod H. Thourani, MD Professor of Surgery Chairman, Department of Cardiac Surgery Medstar Heart and Vascular Institute Washington Hospital Center Washington, DC

2 Disclosures The information provided is the experience of Emory and MedStar and Edwards Lifesciences has not independently evaluated these data. Outcomes are dependent upon a number of facility and surgeon factors which are outside Edwards control. These data should not be considered promises or guarantees by Edwards Lifesciences that the outcomes presented here will be achieved by an individual facility. Vinod Thourani is a paid consultant of Edwards Lifesciences

3 A Large Population of Severe Symptomatic AS Patients Remain Undiagnosed and Untreated Severe Symptomatic AS Patients in the U.S. 1 (1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, Freed 2010, Iung 2007, Pellikka 2005, Brown 2008, Vaes 2011, Danielson 2014, Thourani 2016

4 TAVR 2017 and beyond Severe AS patients SAVR ~65% Low Risk TAVR ~25% Intermed Risk TAVR ~10% High Risk TAVR Extr Risk* Futile Too Sick

5 TAVR Access Routes Transfemoral Transapical

6 TAVR Access Routes in 2017 Since 2007 >1,800 Patients at Emory Transfemoral Transapical Alternate Access

7 The PARTNER IIA and PARTNER II S3i Trial The NEJM and Lancet On-line

8 Mortality and Stroke: PII S3i At 30 Days (As Treated Patients) 100 Mortality 100 Stroke All-Cause Cardiovascular All Stroke Disabling O:E = 0.21 (STS 5.3%) % % S3i S3i *The PARTNER II Trial intermediate-risk cohort unadjusted clinical event rates.

9 Paravalvular Regurgitation 3-Class Grading Scheme (VI) P < P < % 3.8% Moderate 1.5% 80% 45% Mild 40% 60% 40% Severe Moderate Mild None/Trace 20% 0% TAVR Surgery TAVR Surgery No. of echos 30 Days 1 Year P2A Surgery S3i TAVR

10 ACC/AHA 2014 Risk Assessment (with MHT*) Combining STS Risk Estimate, Frailty, Major Organ System Dysfunction, and Procedure-Specific Impediments Low Risk (ALL criteria) Intermediate Risk (any 1) High Risk (any 1 criteria) Prohibitive Risk (any 1 criteria) STS PROM* <4% AND Frailty None AND 4% to 8% OR 1 index (mild) OR >8% OR 2 or more indices (moderate-severe) OR Predicted risk with surgery of death or major morbidity (allcause) >50% at 1 y OR Major organ system compromise not to be improved postop None AND 1 organ system OR No more than 2 organ systems OR 3 or more organ systems OR Procedure-specific impediment None Possible procedurespecific impediment Possible procedurespecific impediment Severe procedurespecific impediment * Multi-disciplinary Heart Team

11 2017: What we have 2 FDA approved, commercially available TAVR valves that are effective treatment options for high-risk or inoperable patients

12 As of April 2017 Over 101,264, Patients in US Have Received FDA Approved TAVR Therapy

13 Sites Enrolled in TVT Registry as of June 13, YTD

14 TAVR and SAVR* Procedures In the TVT Registry and STS ACSD* Source: STS/ACC TVT Registry Database and STS Database 2017 as of April 10, 2017

15 TAVR: Mean and Median Age Age Source: STS/ACC TVT Registry Database. as of April 10, 2017

16 TAVR Access Site % Source: STS/ACC TVT Registry Database. as of April 10, 2017

17 % of TAVRs that are Elective Valve-in-Valve Procedures Source: STS/ACC TVT Registry Database. as of April 10, 2017

18 TAVR Mortality Source: STS/ACC TVT Registry Database as of April 10, 2017

19 One Year Mortality after TAVR (CMS linked records) 28% 26% 25.8% 24% 22% 20% 22.2% 21.6% 18% One Year Mortality Source: DCRI query 17,562 records as of

20 TAVR: Bleeding and Major Vascular Complications Source: STS/ACC TVT Registry Database as of April 10, 2017

21 TAVR Stroke % Source: STS/ACC TVT Registry Database. as of April 10, 2017

22 TAVR Median LOS ( Days) Total LOS Post TAVR LOS Linear (Post TAVR LOS) Source: STS/ACC TVT Registry Database as of April 10, 2017

23 Four treatment options: SAVR, TAVR, valvuloplasty and/or medical therapy

24 Five-Year Outcomes after Randomization to Transcatheter or Surgical Aortic Valve Replacement: Final Results of The PARTNER Trial Michael J. Mack, MD on behalf of The PARTNER Trial Investigators ACC 2015 San Diego March 15, 2015

25 Aortic Valve Mean Gradient 70.0 SAVR TAVR Error bars = 1 Std Dev 60.0 Mean Gradient (mm Hg) p = 0.80 p = p = 0.19 p = 0.51 p = 0.29 p = Baseline 1 Year 2 Year 3 Year 4 Year 5 Year TAVR SAVR

26 Mid-Term Hemodynamic Trends and Between Echo Changes in Transcatheter Aortic Valves in the PARTNER Trial Five Year Results Pamela S. Douglas, MD on behalf of The PARTNER Trial Investigators and The PARTNER Publications Office TCT 2016 Washington DC November 1, 2016

27 AV Mean Gradient Population Trends: Early Post Implant and Midterm to 5 Yrs Raw data Population trends Decomposition of trends over time Early change: 12.1 to 9.2 mmhg Late change: 9.2 to 10.3 mmhg Slope: ±

28 TAVR Clinical Studies 19 Studies Capodanno D and Leon MB. EuroIntervention 2016;12:Y1-Y5.

29 Bicuspid Anatomy Verification Bicuspid aortic valve anatomy Preliminary identification was site-reported Validation performed by echocardiography core laboratory * and via systematic review of CT angiograms at Erasmus Medical Centre Type 0 0 raphe Type 1 1 raphe L-R R-N N-L Type 2 2 raphes L-R / R-N Valve sizing was determined using valve matrix Final decision was at the discretion of the operator

30 The PARTNER 3 Trial Study Design Severe Calcific Aortic Stenosis Low Risk ASSESSMENT by Heart Team AND STS < 3 PARTNER 3 Registries Aortic ViV (n = 125) Alternative Access Registry (TA/TAo/Subclavian) (n = 100) TF - TAVR (SAPIEN 3) 1:1 Randomization (n = 1,228) SAVR (Any approved Surgical Bioprosthetic Valve) Mitral ViV (n= 50) CT Imaging sub-study (n = 200) CT Imaging sub-study (n = 200) Mitral ViR (n = 50) Actigraphy/QoL sub-study Actigraphy/QoL sub-study PRIMARY ENDPOINT: Composite of all-cause mortality, all stroke, or re-hospitalization at 1 year post procedure Follow-up: Annually through 10 years v

31 TAVR UNLOAD Trial Study Design (600 patients, 1:1 Randomized) TAVR UNLOAD Trial International Multicenter Randomized Heart Failure LVEF < 50% NYHA 2 Optimal HF therapy (OHFT) Moderate AS R TAVR + OHFT OHFT Alone Follow-up: 1 month 6 months 1 year Clinical endpoints Symptoms Echo QoL Primary Endpoint Hierarchical occurrence of: All-cause death Disabling stroke Hospitalizations for HF, aortic valve disease Change in KCCQ Reduced AFTERLOAD Improved LV systolic and diastolic function

32 EARLY TAVR Trial Study Flow Asymptomatic Severe AS and 2D-TTE (PV 4m/s or AVA 1 cm 2 ) Exclusion if patient is symptomatic, EF<50%, concomitant surgical indications, bicuspid valve, or STS >8 Treadmill Stress-Test Stress-Test Normal Stress-Test Abnormal CTA and Angiography TF- TAVR eligibility Early-TAVR Randomized Trial Early TAVR Registry Randomization 1:1 Stratified by STS (<3 vs >3) TF- TAVR Clinical Surveillance Primary Endpoint (superiority): 2-year composite of all-cause mortality, all strokes, and repeat hospitalizations (CV)

33 Conclusions TAVR has supplanted SAVR in those considered high risk for surgery TAVR is poised to supplant SAVR in those with intermediate risk for surgery

34 Thanks Vinod H. Thourani, MD Please see the important safety information at the speaker's podium Edwards, Edwards Lifesciences, Edwards SAPIEN, Edwards SAPIEN XT, EDWARDS SAPIEN 3, PARTNER, PARTNER II, PARTNER design logo, SAPIEN, SAPIEN XT and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. PP--US-2356 v1.0