TAVR: It’s a Career, Not Just a
`Procedure!
`
`
`Jeffrey A Southard, MD
`Cardiology
`May 5, 2012
`
`
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 1 of 43
`
`
`Procedure!
`
`
`Jeffrey A Southard, MD
`Cardiology
`May 5, 2012
`
`
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 1 of 43
`
`
`
`Transcatheter Aortic Valve
`Replacement
`
`• T- eam
`• A- pproach to
`• V- alve
`• R- eplacement
`
` UCDMC Team
`• Administration
`• Cardiology
`• CT Surgery
`• Anesthesia
`• Nurses
`• Cath Lab Techs
`• Perfusionists
`• Echo staff
`• Ancillary support
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 2 of 43
`
`
`
`Before You Start
`
`• Do you have a hybrid OR?
`• Do you have the necessary equipment?
`• Do you have the necessary staff?
`• Are you sure you want to do this?
`• Novelty wears off very fast!
`• These patients are very old, very needy
`and have lots of concerned family!
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 3 of 43
`
`
`
`Aortic Stenosis
`
`• Symptomatic Aortic Stenosis - Surgical Aortic
`Valve Replacement is the standard of care
`• Surgical Aortic Valve Replacement - Mortality
`Risk
` Isolated AVR - 3.3 to 5.7%
` AVR with CABG - 6.8 to 7.3%
`• Percutaneous Aortic Valve Implantation in high
`risk aortic stenosis patients - feasible and safe
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 4 of 43
`
`
`
`Aortic Stenosis
`– Etiology
` Calcific degenerative
`• Degenerative process with proliferative &
`inflammatory changes, lipid accumulation, up
`regulation ACE, infiltration with macrophages & T
`lymphocytes . Bone formation (vascular
`calcification)
` Congenital - Bicuspid
`• Turbulent flow - traumatizes leaflet
`fibrosis, rigidity, calcification & narrowed orifice
` Rheumatic
`• Adhesion & fusion of commissures & cusps
`retraction & stiffening cusps borders.
`• Calcific nodules both surfaces - small round or
`triangular opening
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 5 of 43
`
`
`
`Angina
`Syncope
`Failure
`
`2 3
`AV. SURVIVAL YEARS
`
`5
`
`Average age death (males)
`
`Latent Period
`(Increasing obstruction
`Myocardial overload)
`
`Onset Severe
` Symptoms
`
`100
`
`80
`
`60
`
`40
`
`20
`
`PERCENT SURVIVAL
`
`60
`
`63
`
`70
`
`80
`
`40
`
`50
`
`AGE, YEARS
`Prolonged latent period - morbidity & mortality very low
`Symptomatic aortic stenosis - Cardinal symptoms
`Angina • Syncope • Heart failure
`Onset of symptoms - Outlook changes dramatically
`Average survival 2 - 3 years - High risk of sudden death
`Management decisions based on these data
`Asymptomatic - Conservative treatment
`Symptomatic - Aortic Valve Replacement
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 6 of 43
`
`
`
`PARTNER Study Design
`
`Symptomatic Severe Aortic Stenosis
`
`ASSESSMENT: High Risk AVR Candidate
`3105 Total Patients Screened
`Total = 1058 patients
`2 Parallel Trials:
`Individually Powered
`
`n= 700
`
`High Risk
`
`ASSESSMENT:
`Transfemoral Access
`
`High Risk TF
`
`High Risk TA
`
` Inoperable n=358
`
`ASSESSMENT:
`Transfemoral Access
`
`1:1 Randomization
`
`1:1 Randomization
`
`1:1 Randomization
`
`Not In Study
`
`TAVI
`Trans
`femoral
`
` VS
`
`Surgical
`AVR
`
`TAVI
`Trans
`femoral
`
` VS
`
`Surgical
`AVR
`
`TAVI
`Trans
`femoral
`
` VS
`
`Standard
`Therapy
`(usually BAV)
`
`Primary Endpoint: All Cause Mortality
`(1 yr) (Non-inferiority)
`
`Primary Endpoint: All Cause Mortality
`over length of trial (Superiority)
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 7 of 43
`
`
`
`Absolute Reduction in Mortality Continues
`to Diverge at 2 Years
`
`8
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 8 of 43
`
`
`
`> 30% Absolute Reduction in Cardiovascular
`Mortality
`
`9
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 9 of 43
`
`
`
`Valve Clinic
`
`• Must have a dedicated valve clinic
`• Must have a dedicated valve nurse
`• Must have CT surgeons with you in clinic
`• Should have multiple screening exams
`done before patients are seen in clinic
`• Janine will go over screening exams
`• All data must be submitted online to
`Edwards for approval
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 10 of 43
`
`
`
`Valve Size Selection
`
`• The SAPIEN valve is intended to be implanted in a native annulus
`size range comparable to the following TEE measurements:
`
`Valve Size to Annulus Diameter
`
`26 mm valve
`
`Annulus diameter
`by TEE
`
`18 mm
`
`19 mm
`
`20 mm
`
`21 mm
`
`22 mm
`
`23 mm
`
`24 mm
`
`25 mm
`
`23 mm valve
`
`11
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 11 of 43
`
`
`
`Valve Size Selection
`
`•
`
`In annulus diameters 21 mm and 22 mm, either a 23 mm or 26 mm
`valve may be implanted
`
`Valve Size to Annulus Diameter
`
`26mm valve
`
`Annulus diameter
`by TEE
`
`18 mm
`
`19 mm
`
`20 mm
`
`21 mm
`
`22 mm
`
`23 mm
`
`24 mm
`
`25 mm
`
`23 mm valve
`
`12
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 12 of 43
`
`
`
`23 mm or 26 mm Valve?
`
`• The primary goal of aortic valve implantation is to maximize the
`effective orifice area and reduce the mean and peak pressure
`gradients
`– When possible a 26 mm valve should be implanted in annulus diameters
`21 mm and 22 mm
`Effective Orifice Area*
`
`23 mm valve
`
`26 mm valve
`
`13
`
`3.0
`
`2.5
`
`2.0
`
`1.5
`
`1.0
`
`0.5
`
`0.0
`
`Effective Orifice Area (cm2)
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 13 of 43
`
`
`
`Transfemoral Room Setup
`
`Members of the Heart Team present in the TAVR procedure:
`• IP: Implanting physician (Room-setup shown for transfemoral procedure)
`• PA: Physician’s Assistant
`• CTS: Cardiothoracic Surgeon
`• A: Anesthesiologist
`
`• E: Echocardiographer
`• P: Perfusionist
`• DPL: Device Prep Lead
`• OR/CCL Staff: Operating Room/Cardiac Cath Lab Staff
`
`A
`
`E
`
`Fixed C-arm
`
`OR/CCL
`Staff
`
`Ideal room size is >800ft2
`
`RAPID PACER
`
`OR/CCL
`Staff
`
`IP*
`
`PA
`
`CTS
`
`OR/CCL
`Staff
`
`P
`
`Edwards Product
`Preparation Table (≥150cm)
`
`OR/CCL
`Staff
`
`DPL
`
`14
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 14 of 43
`
`
`
`Prepare the Patient
`• RIJ large sheath and PA catheter
`• Radial arterial line
`• General Anesthesia
`• Oral Gastric Tube
`• Foley catheter
`• Full surgical prep
`• TEE probe in place
`• Defibrillator pads in place
`• IABP leads on the patient
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 15 of 43
`
`
`
`
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 16 of 43
`
`
`
`Puncture Site
`
`17
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 17 of 43
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`
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`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 18 of 43
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`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 19 0
`
`UC DAVIS
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 19 of 43
`
`
`
`RetroFlex 3 Transfemoral System
`
`23 mm RetroFlex 3 Transfemoral System
`
`9000TFX
`Edwards SAPIEN Transcatheter
`Heart Valve
`
`9120FS23
`RetroFlex 3 Transfemoral
`Delivery System
`
`9120S23 (22F)
`RetroFlex
`Introducer Sheath Set
`
`9100CR23
`Crimper
`
`9120BC20 (20 mm x 3 cm)
`RetroFlex
`Balloon Catheter
`
`96402 (25 mL)
`Two Atrion QL2530
`Inflation Devices
`
`9100DKS7
`RetroFlex Dilator Kit
`
`20
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 20 of 43
`
`
`
`RetroFlex 3 Transfemoral System
`
`26 mm RetroFlex 3 Transfemoral System
`
`9000TFX
`Edwards SAPIEN Transcatheter
`Heart Valve
`
`9120FS26
`RetroFlex 3 Transfemoral
`Delivery System
`
`9120S26 (24F)
`RetroFlex
`Introducer Sheath Set
`
`9100CR26
`Crimper
`
`9120BC23 (23 mm x 3 cm)
`RetroFlex
`Balloon Catheter
`
`96402 (25 mL)
`Two Atrion QL2530
`Inflation Devices
`
`9100DKS7
`RetroFlex Dilator Kit
`
`21
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 21 of 43
`
`
`
`Edwards SAPIEN Valve
`Model 9000TFX
`
`Edwards SAPIEN Valve
`• 23 mm and 26 mm valve sizes
`• Stainless steel frame
`• Bovine pericardial tissue
`• Carpentier-Edwards ThermaFix process*
`
`*No clinical data are available which evaluate the long-term impact of the Edwards Lifesciences tissue treatment in patients.
`
`22
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 22 of 43
`
`
`
`Edwards Crimper
`Models 9100CR23 and 9100CR26
`
`9100CR23
`
`9100CR26
`
`Uniquely designed to crimp transcatheter heart valves
`
`23
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 23 of 43
`
`
`
`RetroFlex 3 Delivery System
`
`Flex Catheter
`
`
`Tapered Distal End
`
`Articulating Delivery System
`
`24
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 24 of 43
`
`
`
`Valve Crossing and Wire Exchange
`
`• Cross native valve with straight wire (suggestion: AL1 or AL2)
`• Can measure pressure gradients prior to wire exchange
`• Exchange 0.035” Amplatz extra-stiff wire with pre-shaped distal end in left ventricle
`–
`Ensure guidecath is advanced upon wire exchange to ensure exchange wire does not
`get caught in the mitral chordae.
`
`25
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 25 of 43
`
`
`
`
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 26 of 43
`
`
`
`Rapid Ventricular Pacing:
`Test Run
`
`Effective Pulse Pressure and
`Blood Pressure Reduction
`
`• Set output to high setting to ensure proper capture
`• Note that there can be a delay between pacing onset and effective
`reduction of cardiac output
`
`27
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 27 of 43
`
`
`
`Tracking Over Aortic Arch
`
`• Rotate flex
`wheel to track
`over aortic arch
`
`• Use LAO 30 to
`40 to provide
`view of aortic
`arch
`
`• Catheter flexes
`away from the
`flush port
`
`• Five rotations of
`the flex wheel
`for full flex
`
`28
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 28 of 43
`
`
`
`Crossing Native Valve
`
`•
`
`Flex catheter should be fully flexed to
`pull wire out of commissure
`• Always keep delivery system and
`SAPIEN valve directly adjacent to
`support crossing the native valve
`• DO NOT FORCE THE VALVE
`• Use short movements to prevent
`“jumping” of the valve into the ventricle
`• Use RAO or AP projection for crossing
`to visualize the wire in the ventricle
`
`
`
`Tip extends 4.5 cm past
`crimped valve
`
`
`
`4.5 cm
`
`29
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 29 of 43
`
`
`
`Final Positioning
`
`• Fluoroscopy should be the
`primary method of
`visualization for positioning
`and deployment
`• Use of TEE will assist with
`positioning
`• Position the Edwards
`SAPIEN valve:
`–
`50% to 60% ventricular
`– Valve positioning should be
`coaxial
`
`30
`
`50% - 60%
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 30 of 43
`
`
`
`
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 31 of 43
`
`
`
`Valve Foreshortening
`
`Edwards SAPIEN
`Valve
`
`Crimped Height
`
`Expanded Height
`
`23 mm
`
`26 mm
`
`16 mm
`
`18 mm
`
`14 mm
`
`16 mm
`
`The Edwards SAPIEN valve foreshortens
`approximately 2 mm for both size 23 mm
`and 26 mm
`
`23 mm SAPIEN Valve
`
`23 mm SAPIEN Valve
`
`16 mm
`
`14 mm
`
`23 mm SAPIEN Valve
`
`23 mm SAPIEN Valve
`
`16 mm
`
`32
`
`14 mm
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 32 of 43
`
`
`
`
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 33 of 43
`
`
`
`Assessing Aortic Regurgitation:
`TEE
`
`• 2D TEE provides better visualization than TTE
`• 3D TEE
`– Biplane Imaging allows real-time evaluation of both short and long axis
`
`34
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 34 of 43
`
`
`
`Sheath Removal
`
`•Reinsert introducer into sheath
`over guidewire
`
`•Carefully withdraw sheath into
`common femoral artery
`
`•Contrast can be injected
`contralateral or through the
`sheath to detect vascular damage
`
`•Withdraw sheath
`
`•Leave guidewire and
`contralateral pigtail in place
`
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 35 of 43
`
`
`
`Post Procedure Care
`
`• Monitor patients in ICU or CCU for 24
`hours
`• Monitor closely for potential post-op
`complications
` Bleeding
` Late AV block (ECG monitoring)
` CHF
` Renal dysfunction
` CVA
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 36 of 43
`
`
`
`CCU/CTICU
`
`• Systolic blood pressure control
` Manage between 110 and 130 mmHg for
`the first 24 hours
`• Antiplatelet therapy
` 81-325 mg aspirin PO QD
` Optional: Clopidogrel 75 mg PO QD for
`six months (or 250 mg ticlodipine PO
`BID for patients who are allergic to
`aspirin or clopidogrel)
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 37 of 43
`
`
`
`Reimbursement?
`
`• CMS released a statement on May 1st:
`They will pay for TAVR in properly
`selected patients and appropriately
`selected sites.
`• Patients with severe symptomatic AS in
`whom 2 CT surgeons have deemed the
`patient not to be a candidate for
`standard surgery
`• Certain number of PCIs, AVRs
`experience etc.
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 38 of 43
`
`
`
`Registry
`
`• Mandatory reporting of every case and
`follow up for at least one year.
`• Database is not cheap
`• Follow for complications and redo
`procedures as well as quality of life
`assessment.
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 39 of 43
`
`
`
`A
`
`Position & Fill Lumens
`
`Aortic Ring
`
`B
`
`C
`
`Ventricular Ring
`
`Guidewire Lumen
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 40 of 43
`
`
`
`Boston Scientific - LotusTM Valve
`• Braided nitinol stent structure
` Radial expansion as it shortens
`• Bovine pericardial valve
`• Valve leaflets function during
`deployment
`• Repositionable
`• Retrievable at any point prior to
`release
`• Adaptive Seal
`• 23 mm, 27 mm - 18 French
`
` 2007 2008 2009 2010 2011 2012
`
`First in Man 21 French
`
`First in Man 18 French
`
`European Trial
`
`European Trial
`
`European Trial
`
`CE Mark
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 41 of 43
`
`
`
`Final Thoughts
`
`• The greatest new technology since
`stents- without question
`• Don’t rush into this, it is a career choice
`not a hobby
`• The patients aren’t going anywhere fast
`• Don’t do patients just to do patients!
`• They better be able to recover or the
`procedure is not worth doing.
`
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 42 of 43
`
`
`
`Thanks
`
`Edwards Lifesciences Corporation, et al., Exhibit 1071, p. 43 of 43
`
`
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