1. Lessons from PARTNER I (A & B) CRT, Washington DC, Feb 5, 2012
Peter C. Block M.D.
Andreas Gruentzig Cardiovascular Center
Emory University, Atlanta, GA.
Lessons from
PARTNER I (A & B)
What have we not yet learned
CRT, Washington DC, Feb 5, 2012
What have
we learned

2. COI Medtronic: consultant DirectFlow Medical: consultant; equity
Edwards Lifesciences; PARTNER site

3. PARTNER I (B): TAVR = BIG WIN
Lesson 1
PARTNER I (B): TAVR = BIG WIN
TAVR Med Rx
Death - All Cause
Death - Cardiovascular
NYHA Functional Class I
or II
Repeat Hospitalization

4. So far.. So good Pooled Transfemoral AVR All Cause Mortality (n=216)
Are European Data Throwaways?
(“Registries are NOT Truth”)
Is PARTNER “Just One Trial” ?
Is PARTNER I (B) a Fluke?
Edwards
Device
So far.. So good Pooled Transfemoral AVR All Cause Mortality (n=216)
Lesson 2
1992 BAV
Registry
Survival
Canada Reg
Revive Reg
Revival Reg
PARTNER EU
France Reg
BAV Registry
PARTNER contr
France
PARTNER EU
Months Post Procedure
Answer: NO, NO, NO 4

5. The PARTNER I (A) Trial (ACC New Orleans April 2011)
How about operable patients?
The PARTNER I (A) Trial (ACC New Orleans April 2011)
Comparing TAVR (either transfemoral or transapical) to surgical AVR in high-risk, operable patients with AS.

6. All-Cause Mortality Transfemoral (N=492)
PARTNER I (A) = Equivalence
All-Cause Mortality Transapical (N=207)
All-Cause Mortality Transfemoral (N=492)
Higher AVR risk
brings out
co-morbidities early
Transcatheter
Surgical AVR
Co-morbidities
cause greater
mortality in TF’s later

7. Lesson 3 PARTNER 1A Conclusions
Both TAVR and AVR were associated with important but different peri-procedural hazards:
Strokes and major vascular complications were more frequent with TAVR
Major bleeding and new onset AF were more frequent with surgical AVR
TAVR and AVR are both acceptable therapies in high-risk patients; differing peri-procedural hazards should influence case-based decision-making
This is the Bulleted List slide.
To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page.
Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows:
Choose View / Master / Slide Master from your menu.
Select the text at the bottom of the slide and type in a short version of your presentation title.
Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 7

8. PARTNER IA: Excellent Surgical Outcomes
Lesson 4
Success
Better (8% mortality) than predicted (12% mortality) surgical outcomes in the “control” AVR patients. 8

9. The TA approach is not dead
We are teachable
Lesson 5
The TA approach is not dead
Dewey: STS Jan 30, 2012
Results of on-going data from continued access show: Improvement in outcomes and CVA incidence for TA: THERE IS A REAL LEARNING CURVE
This is the Bulleted List slide.
To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page.
Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows:
Choose View / Master / Slide Master from your menu.
Select the text at the bottom of the slide and type in a short version of your presentation title.
Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 9

10. All-Cause Mortality Dewey, STS Jan 30, 2012
PARTNER IA: randomized to AVR
PARTNER IA: randomized to TA vs AVR
29.1%
Continued access TA
25.3%
23.6%
No. at Risk
AVR 92 76 71 70 67
PMA-TA
104 87 82 73
NRCA-TA
822
571
370
297
126

11. Stroke Dewey STS Jan 30, 2012 PARTNER IA: randomized to AVR
PARTNER IA: randomized to TA vs AVR
Continued access TA
10.8.%
7.0%
3.7.%
No. at Risk
AVR 92 72 67 66 63
PMA-TA
104 81 77 70
NRCA-TA
822
563
365
291
123

12. All-Cause Mortality or Stroke Dewey STS Jan 30, 2012
Continued access TA
34.8%
29.7%
25.7%
No. at Risk
AVR 92 72 67 66 63
PMA-TA
104 81 77 70
NRCA-TA
822
563
365
291
123

13. What are the TAVR lessons we still need to learn?
Need to work on the negative issues:
1: BLEEDING(17%) & VASCULAR COMP (16%)
2. HEART BLOCK
& the BIG HITTERS
3: CVA 30 days to 1 yr
4: PARAVALVAR LEAK ?

14. The next challenge: stroke prevention
Umbrella/deflector devices: 3 currently available
Aortic Embolic Embrella Claret dual filter
Protection Device
(AEPD)

15. But…~15% have >2+ AR… what about the LV? The PVL Issue
PVL is relatively common following TAVI
Most pts (~85%) have 0, 1+ or 2+ PVL
PVL remains stable to 12 months
But…~15% have >2+ AR…
what about the LV?

16. My Take on PVL (for now) No PVL would be better
Many TAVR pts have PVL: > 85% is mild or trivial
PVL does not worsen over 1 yr
PARTNER says 2+ or less PVL is tolerated by the hypertrophic LV acutely and in short term F/U
Should we Rx PVL ? Who knows …….. But Senning mortality data are troubling -- ? Rx 2+ or more PVL
For elderly pts long term
issues may be moot
No, mild
Mod, severe

17. PARTNER 1(B) 2 yr. All Cause Mortality
“Who are those guys?”
Butch Cassidy
100
Standard Rx
TAVR 80
Perhaps the most
imp’t thing we
don’t know
68.0%
43.3% 60
50.7%
All-cause mortality (%) 40
30.7% 20
Months
Patient selection; Patient selection; Patient selection