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1

List anatomical contraindications

Inadequate annulus size (< 18 mm or > 29mm)
Thrombus in the left ventricle
Active endocarditis
For transfemoral/subclavian approach: inadequate vascular access (vessel size, calcification, tortuosity)
plaques with mobile thrombi in the ascending aorta or arch
elevated risk of coronary ostium obstruction (asymmetric valve calcification, short distance between annulus and coronary ostium, small aortic sinuses

2

List clinical contraindications

absence of a "heart team" and no cardiac surgery on site
Appropriateness of TAVI, as an alternative to AVR, not confirmed by a "heart team"
Clinical
Estimated life expectancy of < 1 year
Improvement in quality of life by TAVI unlikely because of comorbidities
severe primary associated disease of other valves with major contribution to the pts symptoms, that can be treated only by surgery

3

What is stroke rate for TAVI

overall 53 studies including 10 037 pts from 2004 to 2011
Procedural stroke (<24 hours) occurred in 1.5 +/- 1.5%
The overall 30 day stroke/TIA was 3.3% with the majority being major strokes
During the first year after TAVI, stroke/TIA increased up to 5.2% +/- 3.4%

4

What are most common side effects of TAVI

Heart block (25% core valve vs 5% edwards)
Vascular complications (10%)
Acute renal failure requiring RRT (4.9%)

5

List intraprocedural complications

Conversion to sternotomy (2-4%)
valve embolization/migration
Severe AI
Root Rupture
Coronary artery obstruction

6

List complication rates for TAVI

AV heart block requiring permanent pacemaker (7-25% depends on device)
Moderate to severe paravalvuar leak (12% in PARTNER)
Trace to mild PVL (66%)
Vascular access
Aortic dissection/hematoma/bleeding/Iliac injury
Stroke
Apical Pseudo aneursym

7

Rates of Kidney Injury post TAVI

High!
  AKI occurred in 15/52 (28.8%) patients (mean age 84 ± 6) and three patients (6%) required dialysis. Patients with AKI (AKI+) had greater comorbidity (diabetes and cerebrovascular disease) and a trend towards reduced estimated glomerular filtration rate (eGFR) at baseline compared with those without AKI.

8

Summary of Cohort B outcomes

cohort B (n=358)-Pts inoperable -- TAVI via transfemoral approach or to standard care (which for most patients included balloon valvuloplasty).
30-day mortality higher in the TAVI group, but this difference was not statistically significant. Stroke rate was significantly higher in the TAVI group compared to standard care (6.7% versus 1.7% at 30-days).
One year, mortality was significantly lower with TAVI compared to standard medical care (30.7% versus 50.7 %).
Two years, mortality rate 43.4% with TAVI compared to 68% with standard care.
Moderate to severe paravalvular aortic regurgitation was seen in 11.8% of TAVI patients.

9

Summary Partner A

Comparisons - TAVI to conventional surgical aortic valve replacement (n=699).
Pts cohort high risk, but considered to be operable.
Mortality in the surgical and TAVI were not statistically significantly different 30-days (3.4% versus 6.5%),
One year (24.3% versus 26.8%),
Two years (33.9% vs. 35%).
Early stroke rate higher with TAVI (5.5% versus 2.4% at 30-days).
TAVI more early vascular complications (11% versus 3.2%)
Surgical more peri-procedural bleeding (19.5% versus 9.3%) and new AF (16% vs. 8.6%).

10

What was mortality difference between TF and TA

Early mortality appears to be higher with the transapical approach compared to the transfemoral approach---there are differences in underlying co-morbidities between the two groups that may confound conclusions about mortality.

11

What are differences in stroke between TF and TA

The overall incidence of stroke in the seven studies of transfemoral versus transapical approaches is lower than that seen in the PARTNER trial and similar to that reported in the TAVI registries (Table 2). When the transfemoral and transapical data are compared, the incidence of stroke appears to be slightly higher with the transfemoral approach (2.4-6%) than with the transapical approach (0-4.4%). This trend was not seen in two reports (12,13). Likewise, a tendency for a higher rate of stroke with transfemoral access was not reported in the PARTNER trial (3).

12

What are rates of vascular complications between TA and TF

vascular complications more common with the transfemoral (5.5-28.4%) than with the transapical approach (2.4-8%). A similar incidence of vascular complications was reported in the PARTNER trial and in the registries.

13

What about rates of other complications between TF and TA

PPM, PVL, and blood transfusions (10%-20%) are the same

14

Summary of most common TAVI devices used

Self-expandable CoreValve porcine pericardial device (Medtronic, Inc., Minneapolis, Minnesota)
Balloon-expandable Edwards SAPIEN bovine pericardial device (Edwards Life Sciences, Irvine, California).
Edwards SAPIEN valve can either be delivered percutaneously or via a transapical route.
A ‘transfemoral-first’ patient selection process was implemented in a number of institutions, whereby the transapical approach was reserved for patients who were more likely to have severe systemic vascular disease and other comorbidities.

15

What are indications for Transapical approach

Small femoral arteries, calcification, tortuosity

16

What were placement of of Aortic Transcathere Valve trial A inclusion criteria

1. Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10
2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of < 0.8 cm2
3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
4. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and

The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%.

17

What are relative contraindications

Biscuspid or non-calcified valves
Untreated coronary artery disease requiring revascularization
Hemodynamic instability
LVEF < 20%
For transapical approach; severe pulmonary disease, LV apex not accessible

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