Transcatheter procedures of the future; expanding the treatment options for patients with severe aortic stenosis

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1 Transcatheter procedures of the future; expanding the treatment options for patients with severe aortic stenosis John Webb MD Director interventional cardiology, St Paul s Hospital McLeod Professor of heart valve intervention, University of British Columbia Medical director transcatheter heart valve program, Province of BC Vancouver, Canada

2

3 All-cause Mortality 30-day Mortality by Valve Platform in the PARTNER Trials Inoperable High-risk or greater Intermediate-risk 6.3% n = % n = % n = % 3.9% n = 282 n = 1, % n = % n = 1,077 PARTNER IB Trial (Transfemoral) PARTNER IA Trial (Overall) PARTNER IIB Trial (Transfemoral) PARTNER IIB Trial (Transfemoral) PARTNER IIA Trial (Overall) PARTNER II HR Trial PARTNER II S3i Trial (Overall) (Overall) SAPIEN Valve SAPIEN XT Valve SAPIEN 3 Valve

4 All-stroke (%) Stroke Rates Continue to Decline 7.3% 4.4% 4.3% 1.4% PARTNER I B (TF) PARTNER II B (TF) PARTNER II B (TF) PARTNER II HR (TF) SAPIEN valve SAPIEN XT valve SAPIEN 3 valve

5 Patients (%) Do Trial Outcomes Reflect Real World Outcomes in the US TVT Registry? Propensity Matched - TF Patients - AT 20 All-cause Mortality 20 All Stroke 15 p-value = p-value = STS O:E = 0.17 O:E = 0.20 O:E = S3i S3iCAP TVT-R (IR) S3i S3iCAP TVT-R (IR) # Patients # Sites

6 Lower Profile Systems Mean Fewer Vascular Problems 1.Pichard A. et al, A Randomized Comparisons of Vascular Complications on P2B Results. JACC April 1, 2014 Volume 63, Issue Kodali S., Clinical and Echocardiographic Outcomes at 30 Days with the SAPIEN 3 TAVR System in Inoperable, High-Risk and Intermediate- Risk AS Patients. Presented at ACC 2015, March 15, 2015; San Diego, California. 3.Webb J., Multicenter Evaluation of a Next-Generation Balloon-Expandable Transcatheter Aortic Valve. JACC, VOL.64,NO.21, pg.2238, 2014

7 With Newer Valves and CT Sizing Severe Leaks Are Infrequent PARTNER II SAPIEN 3: High and Intermediate risk, 30 day TTE 100% 80% 60% 40% 20% 0% Days 1/1,000 Severe Moderate Mild None/Trace

8 Durability: 10 years after TAVI Mean gradient 11 mmhg Mild AR

9 The Journey to the Vancouver Clinical Pathway 85 y.o. man admitted for elective TF TAVR with GA and TEE Traumatic insertion of urinary catheter prolonged anesthesia Successful TAVR Avoid: Standardized Gross hematuria, Unnecessary continuous bladder irrigation Clinical interventions Pathways Blood transfusions and urosepsis-related complications Respiratory failure and pneumonia ICU death POD 14 9

10 Lesson Learned: The Goal is to Succeed Every Time!

11 Standardized Patient and Family Education

12 Standardized multidisciplinary practice Nursing practice standard TF TAVR physician orders

13 Standardized criteria driven discharge Physician s order for discharge. Consider multidisciplinary consensus for patient s readiness for discharge. Absence of persistent (> 3 hrs) intraventricular conduction delays. Absence of laboratory contraindications (i.e., clinically important change in hgb. and egfr). Transthoracic echocardiogram completed and reviewed (if required). Return to baseline mobilization. Confirmed availability of family member or home health care staff (To stay with patient and assist during the initial 48 hrs after discharge). Discharge teaching completed. Content to cover: Vascular access site care Follow-up bloodwork and medical appointments Indications for emergent care Activity and exercise prescription Telephone follow-up (confirmed contact information) Confirmed telephone follow-up plan (Site contact)

14 96 year old former physician 3 hours post TAVI Asks: What Does TAVI Mean? 96 year old former physician 3 hours post TAVI Asks: What does TAVI What mean? does TAVI mean? Totally awesome Totally Awesome valve implantation Valve Implantation

15 Lesson Learned: Length of Stay is a Quality Indicator Vancouver Program TF TAVR Change in Median Length of Stay ( )

16 Number of Discharges Length of Stay Distribution 5,569 N=17,870 Patients with no in-hospital complications 3,954 4,007 2,258 2,082 1 Day 2 Days 3 Days 4 Days 5+ Days 34 %

17 >$2,000 Savings per Day of Length of Stay Reduction Cross Sectional Regression Estimates $2,031 $2,027 No Fixed Effects Regression Type Fixed Effects Lauck S, Cohen D. TCVT 2018

18 Streamlining the Way We Care for TAVR Patients Avoid GA and intubation Avoid TEE Avoid neck lines Early temporary pacer removal Avoid opiates and sedatives Bedrest: 4 Hours Mobilize on day 0 Discharge on day 1 18

19 The Likelihood of AV Conduction Varies by Valve Type

20 Time to Onset of Conduction Disturbances in PARTNER 2 S3HR and S3i 76% 8% 2% 13% <24 Hours Hours Hours 3-7 Days Data on File, Edwards Lifesciences

21 Temporary Pacemakers Post-TAVR, British Columbia, % 67.3% 3.0% BEV SEV MEV

22 New Pacemakers by Valve Type at 30 Days 32.80% 24% p< % BEV SEV MEV

23 Late (>30-day to 1 year) Pacemaker Rate by Valve Type 2.90% 3.10% 2.30% p=0.82 BEV SEV MEV

24 Late mortality and rehospitalization in patients with new pacemakers following TAVR Chamandi C, Rodes-Cabau J, JACC CVI 2018

25 New Pacemakers Add Significant Incremental Costs Adjusted incremental hospital resource utilization associated with new pacemakers following TAVR $5,055 $695 $1,132 $12,789 $4,481 $1,426 ICU/CCU OR/ Cardiology/ Cath Lab Supplies Pharmacy/ Lab/ Radiology Other Total *FY 2015 MedPAR claims. Note: Other includes routine care, therapy services, MRI/CT, ER, Blood, inhalation, anesthesia and other

26 New AV Block Has Implications for: Early Temporary pacing Mobilization EP investigations New pacemakers Morbidity ICU and hospital stay Late Re-hospitalization Pacer follow-up, replacements LV function Late mortality? Patient Experience Cost

27 How we do TAVR How we care for TAVR patients

28 Baseline and Procedural Characteristics Overall (N=411) Baseline characteristics Age (yrs) 84 years STS score (mean) 4.9 STS score 8% 14.6% SAPIEN 3 valve 41.8% SAPIEN XT valve 58.2% Procedural characteristics Procedure Time 45 min Local/Conscious Sedation 98.3% Local anesthetic only 32.2% Conversion to GA 1.5%

29 Endpoints at 30 Days Overall (N=411) KM % Mortality 1.5 Stroke 1.5 Readmission 9.2 Cardiac Readmission 5.7 PAR >mild 3.8 Permanent Pacemaker Implantation 5.7

30 Place SAPIEN 3 central marker just above the annular plane to reduced pacemaker rates

31 40% 35% 30% 25% 20% 15% 10% 5% 0% 30-Day Events 1.5% 1.5% Mortality Stroke Overall (N=411) Timing of Discharge 89.5% 92.8% High (N=183) Next Day p = % Medium (N=80) 90.5% Low (N=148) Hospital Volume

32 SAPIEN 3 Ultra Trial Up to 4 Sites and a minimum of 20 Patients Severe, Calcific Aortic Stenosis Intermediate Risk Assessment by Heart Team and STS > 3 to < 8 Enrollment TAVR (SAPIEN 3 Ultra THV and Delivery System) Follow-up: Discharge, 30 days, 6 months, and annually through 5 years Primary Endpoint: freedom from all of the following at exit from the procedure room: Mortality Conversion to surgery Moderate or severe paravalvular regurgitation Protocol Version 1.0, dated March 2018

33 Edwards SAPIEN 3 Ultra System Edwards SAPIEN 3 Ultra Valve Frame and Leaflet Design Proven SAPIEN 3 leaflet and frame design Outer Skirt Textured 3-dimensional PET skirt design 40% taller skirt 14F sheath compatible

34 The Edwards SAPIEN 3 Ultra System Edwards SAPIEN 3 Ultra Delivery System Edwards Axela Sheath Redesigned distal end for improved crossability On-balloon delivery system removes the need for valve alignment Responsive articulation avoids contact with aortic wall Next-generation seamless expandable sheath design 14F sheath for all valve sizes Valve Size Sheath Size 14F 20 mm 14F 14F 23 mm 14F 14F 26 mm 14F 14F 29 mm 14F

35 The Edwards SAPIEN 3 Ultra System 74 year old male Bicuspid aortic valve Area: 640 mm 2 Mean gradient: 43 mmhg Thoracic aortic replacement and LITA graft in 2010 Plan: 29 mm SAPIEN 3 Valve

36 SAPIEN 3 Ultra System: Sheath Insertion Edwards Axela Sheath Seamless expandable sheath design 14F sheath for all valve sizes, including the largest 29mm valve

37 SAPIEN 3 Ultra System: Valve Delivery Edwards SAPIEN 3 Ultra Delivery System Redesigned distal end for improved crossability On-balloon delivery system removes the need for valve alignment Responsive articulation avoids contact with aortic wall No lock

38 SAPIEN 3 Ultra System: Final Result Final Result No paravalvular leak Temporary pacemaker removed Mobilized that evening Next-day discharge

39 Evolving How We Care for TAVR Patients Less invasive Reduced hospital stay Reduced AV block and pacemakers Improved patient experience Less cost

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