Trans Catheter Aortic Valve Replacement

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1 Trans Catheter Aortic Valve Replacement Satish K Surabhi, MD,FACC,FSCAI Medical Director, Cardiac Cath Labs AnMed Health Heart and Vascular Care

2 No financial conflict of interest related to this talk Will discuss some non FD approved devices

3 Review the clinical course of severe symptomatic aortic stenosis Identify treatment options for severe symptomatic aortic stenosis Review clinical trial data regarding TAVR Discuss future developments in TAVR

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5 5 Aortic stenosis is estimated to be prevalent in up to 7% of the population over the age of Million People in US Over the Age of 65 2 It is more likely to affect men than women; 80% of adults with symptomatic aortic stenosis are male 3 Percentage Diagnosed with Aortic Stenosis

6 More Common Age-Related Calcific Aortic Stenosis Aortic stenosis in patients over the age of 65 is usually caused by calcific (calcium) deposits associated with aging Rheumatic Fever Adults who have had rheumatic fever may also be at risk for aortic stenosis Congenital Abnormality In some cases adults may develop aortic stenosis resulting from a congenital abnormality Less Common

7 3 Major Etiologies for aortic stenosis

8 Shortnss of breath Syncope/ pre-syncope Angina Fatigue Dyspnea on exertion CHF A-fib related

9 Survival after onset of symptoms is 50% at 2 years and 20% at 5 years 1 Surgical intervention for severe aortic stenosis should be performed promptly once even minor symptoms occur 1

10 5-Year Survival 8 Survival, % Breast Cancer Lung Cancer Colorectal Cancer Prostate Cancer Ovarian Cancer Severe Inoperable AS* *Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic 5 year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis

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14 Survival, % Patient Survival Years AVR, AVR, no Sx No Symptoms AVR, Sx AVR, Symptoms No No AVR, AVR, no No SxSymptoms No AVR, No AVR, Sx Symptoms Study data demonstrate that early and late outcomes were similarly good in both symptomatic and asymptomatic patients It is important to note that among asymptomatic patients with SAS, omission of surgical treatment was the most important risk factor for late mortality

15 Aortic Valve Replacement No Aortic Valve Replacement Studies show at least 40% of patients with severe AS are not treated with an AVR

16 16 An aortic valve replacement as an alternative to traditional thoracotomy. Less invasive than traditional thoracotomy for patients considered too high risk for traditional surgery.

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18 Edwards Sapien Valve Stainless Steel Frame More Aortic Regurg, less AV block/ppm Better for severe bulky calcification. Medtronic CoreValve Nitinol Frame-self expanding Less Aortic Regurg, More heart block/ppm

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21 Patients at Extreme Surgical Risk Foundational trials tested new TAVR therapy in patients without the option for a surgical aortic valve replacement US CoreValve Pivotal Trial PARTNER 1B CoreValve, N=489, STS 10.3% SAPIEN, N=179, STS 11.2%

22 Patients at Extreme Surgical Risk 3-Year Follow-Up PARTNER showed that by 3 years, TAVR had reduced mortality by approximately 30% compared to standard medical management. 100% Similar survival results were achieved with CoreValve in the US Pivotal Trial All-Cause Mortality 80% 60% 40% 20% PARTNER B PARTNER All-Cause B Standard Rx % % % 0% Months

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25 Patients at High Surgical Risk Trials randomizing high risk patients to either TAVR or SAVR soon followed US CoreValve Pivotal Trial CoreValve, N=390, STS 7.3% vs. SAVR, N=357, STS 7.5% PARTNER 1A SAPIEN, N=348, STS 11.8% vs. SAVR, N=351, STS 11.7%

26 PARTNER 1A 5-Year Follow-Up Presented at ACC 2015 PARTNER showed that ~35% of patients survived to 5 years, regardless of treatment This study provided the first confirmation that TAVR is a reasonable alternative to surgery in high risk patients 1 Mack, et al., presented at ACC 2015

27 CoreValve US Pivotal Trial 3-Year Follow-Up Presented at ACC 2016 The CoreValve Pivotal Trial was the first to show a survival advantage with TAVR compared to SAVR, with separation of the all-cause mortality curves maintained to 3 years 1 Deeb, et al., J Am Coll Cardiol 2016 Mar 22; doi: /j.jacc

28 Patients at Intermediate Surgical Risk Randomized trial data comparing TAVR to SAVR in lowerrisk patients recently became available SAPIEN XT and SAPIEN 3 CoreValve

29 Intermediate Risk PARTNER 2A SAPIEN XT The PARTNER 2A Trial showed that TAVR with SAPIEN XT was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years 1 Smith, et al., presented at ACC 2016

30 Intermediate Risk PARTNER 2A SAPIEN XT This study also generated convincing evidence that transfemoral TAVR provides an outcome advantage to intermediate risk patients In the as-treated population, TF TAVR significantly reduced all-cause mortality or disabling stroke vs. surgery (p = 0.04) 1 Smith, et al., presented at ACC 2016

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33 All cause mortality 1.1% vs 4% at 30 days 7.4% vs 13.5 % at 1 yr Disabling Stroke 1% vs 4.4% at 30 days 2.3% vs 5.9 % at 1 year 75% reduction In Death and in disabling stroke

34 Low Surgical Risk Active Trials Randomizing TAVR to SAVR Currently there is significant clinical investment in applying TAVR to younger patients at low surgical risk, both in North America and in Europe Medtronic PARTNER 3 2 UK TAVI 3 Low Risk 1 NOTION-2 4 N = ~1200 N = 1228 N = 808 N = 992 Up to 80 centers Evolut R, all routes Up to 64 centers SAPIEN 3, transfemoral All UK TAVI centers All valves, all routes All Nordic countries All valves, transfemoral Industry-sponsored 10-year follow-up Industry-sponsored 10-year follow-up Publically funded 5-year follow-up Physician and industry-sponsored 5-year follow-up 1 Popma, et al., presented at TCT 2016; 2 Mack, et al., presented at TCT 2016; 3 Moat, et al., presented at TCT 2016; 4 Sondergaard, et al., presented at TCT 2016

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37 EARLY TAVR TAVR in asymptomatic severe AS TAVR UNLOAD TAVR in moderate AS with CHF/ LV dysfunction

38 Foundational TAVR Devices Complications Foundational randomized trials did provoke some concern about the safety of TAVR due to the incidence of certain complications, including stroke, conduction disturbances, paravalvular leak, and vascular trauma SAPIEN CoreValve SAPIEN XT

39 Death Stroke Vascular Complications Pacemaker implantation Paravalvular regugitation Late valve dysfunction

40 Transfemoral TAVR Devices Iterative Device Design Iterative devices have been designed to mitigate complications, simplify the procedure, and improve upon current anatomic exclusions to enable the treatment of more patients Evolut R Lotus SAPIEN 3 Portico Frame Nitinol Nitinol Cobalt Chromium Nitinol ACURATE neo Nitinol PVL Managment Extended Skirt Adaptive Seal PET Fabric Skirt Pericardial cuff Pericardial skirt Annular Range mm mm mm mm mm Positioning Recapturable Recapturable -- Recapturable -- Caliber 14 Fr/ 16 Fr equiv. 18 Fr 14 Fr / 16 Fr 18 Fr / 19 Fr 18 Fr

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42 Embrella Embolic Deflector (Edwards Lifesciences) Triguard (Keystone Heart, Herzliya Pituach, Israel)

43 Claret Montage (Claret Medical, CA)

44 Auscultation Transthoracic Echo (TTE) Cardiac Cath. Chest X-ray Electrocardiogram

45 Confirm the patient is diagnosed with severe symptomatic native aortic stenosis Confirm the patient has been independently evaluated by two cardiac surgeons and meets the indication for TAVR Evaluate the aortic valvular complex using echocardiography Evaluate the peripheral vasculature and aortic valvular complex using MDCT Evaluate the peripheral vasculature and aortic valvular complex using catheterization Note: Evaluation using CT is typically not done unless the Heart Team confirms that patient is a candidate for TAVR

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48 20 cases in the last 6 months Ages 59 to 85 High STS scores/ high risk for SAVR No Death/CVA/PPM implantation No major vascular complications ( one pseudoaneurysm ) One expected ICD to remove life-vest

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50 TAVR is the only option for extreme risk patients TAVR is an equal or better for high risk patients TAVR is an equal or better option for intermediate risk patients TAVR for low risk patients being studied

51 SAPIEN SAPIEN XT SAPIEN 3

52 Foundational TAVR Devices Complications Foundational randomized trials did provoke some concern about the safety of TAVR due to the incidence of certain complications, including stroke, conduction disturbances, paravalvular leak, and vascular trauma SAPIEN CoreValve SAPIEN XT

53 Foundational TAVR Devices Stroke 10% Weighted average (n=8,987) 4.2% 30-Day All Stroke 8% 6% 4% 2% 6.7% 4.1% 4.6% 4.3% 5.5% 4.0% 4.9% 0% Extreme Risk P 1B N=179 Extreme Risk P 2B N=276 High Risk P 1A N=348 Extreme Risk P 2B N=284 Intermediate Risk P 2A N=1,011 Extreme Risk US Pivotal N=489 High Risk US Pivotal N=390 1 Leon, et al., N Engl J Med 2010;363: ; 2 Webb, et al., J Am Coll Cardiol Intv 2015;8: ; 3 Smith, et al., N Engl J Med 2011;364: ; 4 Leon, et al., N Engl J Med 2016;374: ; 5 Popma, et al., J Am Coll Cardiol 2014;63: ; 6 Adams, et al., N Engl J Med 2014;370:1790-8;;

54 Foundational TAVR Devices New Permanent Pacemaker Implantation 30-Day Permanent Pacemaker 30% 20% 10% 0% 3.4% Extreme Risk P 1B N= % Extreme Risk P 2B N=276 Weighted average (n=8,987) 11.3% 3.8% High Risk P 1A N= % Extreme Risk P 2B N= % Intermediate Risk P 2A N=1, % Extreme Risk US Pivotal N= % High Risk US Pivotal N=390 1 Leon, et al., N Engl J Med 2010;363: ; 2 Webb, et al., J Am Coll Cardiol Intv 2015;8: ; 3 Smith, et al., N Engl J Med 2011;364: ; 4 Leon, et al., N Engl J Med 2016;374: ; 5 Popma, et al., J Am Coll Cardiol 2014;63: ; 6 Adams, et al., N Engl J Med 2014;370:1790-8;;

55 Foundational TAVR Devices Vascular Complications 20% 30-Day Major Vascular Complications 15% 10% 5% 16.2% 15.2% 11.0% Weighted average (n=8987) 7.7% 9.5% *Definitions vary across studies 7.9% 8.2% 5.9% 0% Extreme Risk P 1B N=179 Extreme Risk P 2B N=276 High Risk P 1A N=348 Extreme Risk P 2B N=284 Intermediate Risk P 2A N=1,011 Extreme Risk US Pivotal N=489 High Risk US Pivotal N=390 Minimum Vessel Diameter 8.0/ / / (mm) 1 Leon, et al., N Engl J Med 2010;363: ; 2 Webb, et al., J Am Coll Cardiol Intv 2015;8: ; 3 Smith, et al., N Engl J Med 2011;364: ; 4 Leon, et al., N Engl J Med 2016;374: ; 5 Popma, et al., J Am Coll Cardiol 2014;63: ; 6 Adams, et al., N Engl J Med 2014;370:1790-8;;

56 Foundational TAVR Devices Paravalvular Leak 100% Weighted average (n=5,127) Mild 34% / Moderate-Severe 10% 30-Day Paravalvular Leak 80% 60% 40% 20% 0% 12.0% 68.0% 17.1% 12.0% 24.2% 43.0% 41.0% 37.9% 3.7% 22.5% 11.4% 41.5% 9.0% 35.7% Extreme Risk P 1B N=153 Extreme Risk P 2B N=225 High Risk P 1A N=287 Extreme Risk P 2B N=236 Intermediate Risk P 2A N=872 Extreme Risk US Pivotal N=418 High Risk US Pivotal N=356 SAPIEN SAPIEN XT CoreValve 1 Leon, et al., N Engl J Med 2010;363: ; 2 Webb, et al., J Am Coll Cardiol Intv 2015;8: ; 3 Smith, et al., N Engl J Med 2011;364: ; 4 Leon, et al., N Engl J Med 2016;374: ; 5 Popma, et al., J Am Coll Cardiol 2014;63: ; 6 Adams, et al., N Engl J Med 2014;370:1790-8;;

57 Transfemoral TAVR Devices Iterative Device Design Iterative devices have been designed to mitigate complications, simplify the procedure, and improve upon current anatomic exclusions to enable the treatment of more patients Evolut R Lotus SAPIEN 3 Portico Frame Nitinol Nitinol Cobalt Chromium Nitinol ACURATE neo Nitinol PVL Managment Extended Skirt Adaptive Seal PET Fabric Skirt Pericardial cuff Pericardial skirt Annular Range mm mm mm mm mm Positioning Recapturable Recapturable -- Recapturable -- Caliber 14 Fr/ 16 Fr equiv. 18 Fr 14 Fr / 16 Fr 18 Fr / 19 Fr 18 Fr

58 Real-World Evidence Base New Transfemoral Valves A literature search was conducted to identify studies reporting procedural and 30-day outcomes for groups of patients treated with new valves in real-world practice The rates of paravalvular leak, new pacemaker implantation, stroke, and major vascular complications were tabulated and the weighted average was calculated for each valve type

59 Real-World Evidence Base New Transfemoral Valves 45 unique cohorts were identified through the literature search, representing over 15,000 patients treated with new valves in real-world practice SAPIEN Evolut R 5232 Lotus 1960 ACURATE Neo 1273 Portico Patients With Data Reported

60 TAVR Stroke Rates with Contemporary Devices In contemporary practice, the overall stroke rate remains around 3.5% 30-Day All Stroke 10% 8% 6% 4% 2% 3.0% 4.0% Weighted average (n=5,547) ~3.5% 1.9% 5.5% 2.7% 1.4% 4.0% 2.7% 6.8% 3.0% 0% 0.0% CE Study N=60 FORWARD Interim Analysis N=300 US IFU N=151 SAVI Registry N=1,000 CE Study N=220 1 Manoharan, et al., J Am Coll Cardiol Intv 2015; 8: ; 2 Moellman, et al., presented at PCR London Valves 2015; 3 Linke, et al., presented at PCR London Valves 2015; 4 Kodali, et al., Eur Heart J 2016; doi: /eurheartj/ehw112; 5 Vahanian, et al., presented at EuroPCR 2015; 6 Webb, et. al. J Am Coll Cardiol Intv 2015; 8: ; 7 DeMarco, et al, presented at TCT 2015; 8 Meredith, et al., presented at PCR London Valves 2015; 10 Falk, et al., presented at EuroPCR 2016 P2 S3 IR N=1,078 P2 S3 HR/ER N=583 S3 CE IR N=101 S3 CE N=150 REPRISE II N=250 RESPOND N=1,014

61 New Permanent Pacemakers Real-World Evidence The rate of new permanent pacemaker implantation is sensitive to device type The rates are typically around 15% with Evolut R and SAPIEN 3, and approximately 2x higher with the Lotus valve New Permanent Pacemaker (Weighted Averages) 35% 30% 25% 20% 15% 10% 5% 0% 30.2% 18.2% 13.4% 8.0% 6.4% Lotus Evolut R SAPIEN 3 ACURATE Neo Portico

62 Moderate / Severe Paravalvular Leak Real-World Evidence The Lotus valve virtually eliminates moderate or severe PVL Other valves have brought the rates to ~5% or less Moderate / Severe PVL Weighted Averages 7% 6% 5% 4% 3% 2% 1% 0% 6.1% 3.8% 3.5% 2.3% 0.5% Evolut R ACURATE Neo Portico SAPIEN 3 Lotus

63 Major Vascular Complications Real-World Evidence Major vascular complications have come down under 5% across all valve types 6% Major Vascular Complications (Weighted Average) 5% 4% 3% 2% 1% 4.8% 3.8% 2.4% 2.4% 0.7% 0% SAPIEN 3 (N=6,300) Portico (N=389) Lotus (N=1,960) Evolut R ACURATE Neo (N=5,232) (N=1,273)

64 Access Trends United States The preferred access site has been dynamic in the US as the regulatory landscape has changed With the introduction of Evolut R and SAPIEN 3, more than 90% of TAVRs are performed through the TF approach 100 femoral transapical transaortic other 93% % of TAVR Procedures FDA Approval (High Risk): CoreValve Sapien XT FDA Approval (High Risk): Evolut R SAPIEN Carroll, et al., presented at TCT 2016

65 % General Anesthesia Anesthesia New Valves Increased use of the transfemoral approach has facilitated a simpler procedure, shown by the decreased use of general anesthesia in favor of conscious sedation Wide variation in anesthesia mode likely reflects geographical differences and individual physician preferences 100% 80% 60% 40% 20% 0% 37.0% FORWARD (N=300) 60.2% 72.1% IMPLANTERS Registry (N=264) STS / TVT Registry (N=3,810) 17.8% RELEVANT Registry (N=225) RESPOND (N=996) 32.9% UK Registry (228) 84.5% PARTNER 2 S3 (N=1,661) Evolut R Lotus SAPIEN 3 N R 40.1% SOURCE 3 (N=1,947) Multicenter cohorts with >200 patients

66 Foundational TAVR Devices Stroke 10% Weighted average (n=8,987) 4.2% 30-Day All Stroke 8% 6% 4% 2% 6.7% 4.1% 4.6% 4.3% 5.5% 4.0% 4.9% 0% Extreme Risk P 1B N=179 Extreme Risk P 2B N=276 High Risk P 1A N=348 Extreme Risk P 2B N=284 Intermediate Risk P 2A N=1,011 Extreme Risk US Pivotal N=489 High Risk US Pivotal N=390 1 Leon, et al., N Engl J Med 2010;363: ; 2 Webb, et al., J Am Coll Cardiol Intv 2015;8: ; 3 Smith, et al., N Engl J Med 2011;364: ; 4 Leon, et al., N Engl J Med 2016;374: ; 5 Popma, et al., J Am Coll Cardiol 2014;63: ; 6 Adams, et al., N Engl J Med 2014;370:1790-8;;

67 Foundational TAVR Devices New Permanent Pacemaker Implantation 30-Day Permanent Pacemaker 30% 20% 10% 0% 3.4% Extreme Risk P 1B N= % Extreme Risk P 2B N=276 Weighted average (n=8,987) 11.3% 3.8% High Risk P 1A N= % Extreme Risk P 2B N= % Intermediate Risk P 2A N=1, % Extreme Risk US Pivotal N= % High Risk US Pivotal N=390 1 Leon, et al., N Engl J Med 2010;363: ; 2 Webb, et al., J Am Coll Cardiol Intv 2015;8: ; 3 Smith, et al., N Engl J Med 2011;364: ; 4 Leon, et al., N Engl J Med 2016;374: ; 5 Popma, et al., J Am Coll Cardiol 2014;63: ; 6 Adams, et al., N Engl J Med 2014;370:1790-8;;

68 Foundational TAVR Devices Vascular Complications 20% 30-Day Major Vascular Complications 15% 10% 5% 16.2% 15.2% 11.0% Weighted average (n=8987) 7.7% 9.5% *Definitions vary across studies 7.9% 8.2% 5.9% 0% Extreme Risk P 1B N=179 Extreme Risk P 2B N=276 High Risk P 1A N=348 Extreme Risk P 2B N=284 Intermediate Risk P 2A N=1,011 Extreme Risk US Pivotal N=489 High Risk US Pivotal N=390 Minimum Vessel Diameter 8.0/ / / (mm) 1 Leon, et al., N Engl J Med 2010;363: ; 2 Webb, et al., J Am Coll Cardiol Intv 2015;8: ; 3 Smith, et al., N Engl J Med 2011;364: ; 4 Leon, et al., N Engl J Med 2016;374: ; 5 Popma, et al., J Am Coll Cardiol 2014;63: ; 6 Adams, et al., N Engl J Med 2014;370:1790-8;;

69 Foundational TAVR Devices Paravalvular Leak 100% Weighted average (n=5,127) Mild 34% / Moderate-Severe 10% 80% 60% 40% 20% 12.0% 68.0% 17.1% 12.0% 24.2% 43.0% 41.0% 37.9% 3.7% 22.5% 11.4% 41.5% 9.0% 35.7% 0% Extreme Risk P 1B N=153 Extreme Risk P 2B N=225 High Risk P 1A N=287 Extreme Risk P 2B N=236 Intermediat e Risk P 2A N=872 Extreme Risk US Pivotal N=418 High Risk US Pivotal N= Day Paravalvular Leak 1 Leon, et al., N Engl J Med 2010;363: ; 2 Webb, et al., J Am Coll Cardiol Intv 2015;8: ; 3 Smith, et al., N Engl J Med 2011;364: ; 4 Leon, et al., N Engl J Med 2016;374: ; 5 Popma, et al., J Am Coll Cardiol 2014;63: ; 6 Adams, et al., N Engl J Med 2014;370:1790-8;;

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