1. Risk Stratification of Severe, Symptomatic Aortic Stenosis Patients
AHA/ACC 2014 Guidelines
Low
Operative Risk (Must Meet ALL Criteria in This Column)
Intermediate Operative Risk (Any 1 Criterion in This Column)
High
Operative Risk (Any 1 Criterion in This Column)
Prohibitive
STS PROM1
< 4% AND
4% to 8% OR
> 8% OR
Prohibited risk with surgery of death or major morbidity (all-cause) > 50% at 1 year OR
Frailty2
None AND
1 Index (mild) OR
> 2 Indices (moderate to severe) OR
Major organ
system compromise not to be improved
postoperatively3
1 organ system OR
No more than 2 organ systems OR
> 3 organ systems OR
Procedure specific
impediment4
None
Possible procedure-specific impediment
Possible procedure- specific impediment
Severe procedure- specific impediment
Use of the STS PROM to predict risk in a given institution with reasonable reliability is appropriate only if institutional outcomes are within 1 standard deviation of STS average observed/expected ratio for the procedure in question.
Seven frailty indices: Katz Activities of Daily Living (independence in feeding, bathing, dressing, transferring, toileting, and urinary continence) and independence in ambulation (no walking aid or assist required or 5-meter walk in <6 s). Other scoring systems can be applied to calculate no, mild-, or moderate-to-severe frailty.
Examples of major organ system compromise: Cardiac—severe LV systolic or diastolic dysfunction or RV dysfunction, fixed pulmonary hypertension; CKD stage 3 or worse; pulmonary dysfunction with FEV1 <50% or DLCO2 <50% of predicted; CNS dysfunction (dementia, Alzheimer’s disease, Parkinson’s disease, CVA with persistent physical limitation); GI dysfunction—Crohn’s disease, ulcerative colitis, nutritional impairment, or serum albumin <3.0; cancer—active malignancy; and liver—any history of cirrhosis, variceal bleeding, or elevated INR in the absence of VKA therapy.
Examples: tracheostomy present, heavily calcified ascending aorta, chest malformation, arterial coronary graft adherent to posterior chest wall, or radiation damage.
Nishimura RA, et al. Circulation. 2014;129.

2. Transcatheter Therapy
First explored for in-operable AS patients
No other interventional options available
Outcomes far superior than what was expected

3. Landmark PARTNER Trials
High-Risk Patients: Defined by Risk of Mortality ≥ 15%
Inoperable Patients: Defined by Risk of Mortality > 50% 7

4. Absolute Reduction in Mortality at 3 Year in Inoperable Patients
Standard Rx
HR [95% CI] = 0.53 [0.41, 0.68]
p (log rank) <
100%
TAVR
80.9%
80%
68.0%
26.8%
60%
50.8%
25.0%
54.1%
All Cause Mortality (%)
20.1%
NNT = 3.7 pts
40%
43.0%
NNT = 4.0 pts
30.7%
20%
NNT = 5.0 pts
Updated WNA to Oct 9 data
Point-in-time at 2 yrs: p < 0% 6 12 18 24 30 36
Months
Numbers at Risk
Standard Rx
179
121 85 62 46 27 17
TAVR
138
124
110
101 88 70 8

5. Reduction in Repeat Hospitalization in Inoperable Patients
Rehospitalization
Standard Rx
HR [95% CI] = 0.39 [0.28, 0.54]
p (log rank) <
TAVR
75.7%
72.5%
53.9%
33.4%
37.6%
Rehospitalization (%)
26.9
42.3%
34.9%
NNT = 3.0 pts
27.0%
NNT = 2.7 pts
NNT = 3.7 pts
Months
Days Alive Out of Hospital Median [IQR]
TAVR 944 [ ]
Standard Rx 368 [ ]
p <.0001
Numbers at Risk
Standard Rx
179 86 49 30 19 11 7
TAVR
115
100 89 77 64 9

6. Options for Aortic Valve Replacement
Surgery
Low- to Moderate-Risk
High Risk
Greater Risk
TAVR
Open-Heart Surgery (AVR)
Minimal Incision
Valve Surgery
(MIVS)
Transcatheter Heart Valve
Multiple treatment options are now available for patients with severe aortic stenosis. For patients at high or greater risk for open surgical therapy, transcatheter aortic valve replacement is available.
High Risk Patients
Defined by Risk of Mortality > 15%
Surgical Heart Valve

7. Access Routes for TAVR

8. TAVR Video
ir.net/media_files/IROL/25/251324/videos/CoreValve-Final- Animation preview.mp4

9. TAVR Trials at SMH
SURTAVI - Intermediate Risk
Low Risk TAVR Trial

10. Low Risk TAVR Trials
PARTNER 3
Medtronic TAVR Low Risk

11. MitraClip® Therapy Filling a Treatment Gap
Medical therapy is limited to symptom management
MV surgery has been the only option that reliably reduces MR
A significant gap exists between medical and surgical options
MitraClip® therapy is a first-in-class, percutaneous option to reduce MR*
Less Invasive
Medical Therapy
MitraClip®
MV Surgery
Increased MR Reduction
*Reference Source: Instructions For Use
See important safety information referenced within

12. MitraClip® System Overview