BTT+CAP Slaughter

Question 0

Survival?

Answer 0

180d = 91%

360d = 84%

Question 1

N=?

Primary Outcome?

Answer 1

N=332. (140+192)

Success=Survival on orig. device, transplant or explant for recovery

Question 2

Conclusion ?

Answer 2

HVAD as BTT demonstrates high 180d survival rate despite low transplant rate.
AE’s are similar or better than historical BTT trials, despite longer exposure times due to longer survival & lower transplant rates.

Question 3

Follow up ?

Answer 3

At least 6 mos. to

Over 3 years

Analysis July 31, 2012

Question 4

Driveline Infection

Answer 4

16. 9% 56/332

0. 25 PPY

Question 5

Bleeding

Answer 5

Req. Surgery 14.8% 49/332
0.19 PPY

GI Bleeding 12.7% 42/332
0.28 PPY

Question 6

Stroke Overall

Answer 6

14. 8% (2pts having both)

28. 6% of stroke events fatal

Question 7

ICVA

Answer 7

7. 5% 25/332
8. 09 PPY

88% survived event

Question 8

HCVA

Answer 8

7. 8% 26/332
8. 09 PPY

46% of HCVA’s fatal

Question 9

Hemolysis

Answer 9

1. 2% 4/332

0. 02 PPY

Question 10

Thrombus

Device Exchange

Answer 10

4.2%

8. 7%
   - 2.1% proc. related
   - 4.2% suspected thrombus
   - 2.4% other

Question 11

After March 15, 2011 Pump Exchange for Thrombus

Answer 11

0.063 PPY to 0.027 PPY

55% drop

Question 12

After March 15, 2011 Strokes

Answer 12

ICVA w/ MRS>0
5.1% to 2.8% (45% drop)

0.089 PPY to 0.047 PPY

HCVA’s w/MRS >0
5.1% to 4.7% (8% drop)

0.082 PPY to 0.074 PPY

Question 13

6MWT distance improvement

Answer 13

Distance tripled

Question 14

Study duration

Answer 14

3 yrs. 4 mos

August 2008 - December 2011

Medical Therapy & Device Design Enhancements March 2011 - December 2011

Question 15

Medical Therapy & Device Design Enhancements

Answer 15

New Coring Tool
Sintered Pump
ASA 325mg
INR 2.0 - 3.0

Question 16

Stroke Rate compared to HMII BTT & CAP trials

Answer 16

HMII Miller (BTT)
ICVA 0.13 PPY vs 0.09 HVAD
HCVA 0.05 PPY vs 0.09 HVAD

HMII Pagani (CAP)
ICVA 0.09 PPY vs 0.09 HVAD
HCVA 0.05 PPY vs 0.09 HVAD

Question 17

ReVolve EU Study Stroke in PPY?

Answer 17

0.08 PPY

Question 17

ReVolve EU Study Stroke in PPY?

Answer 17

0.08 PPY

Question 18

Freedom from pump thrombus

Answer 18

98% at 3 mos.
92% at 1 yr.

Freedom from exchange for thrombus
99% at 3 mos.
95% at 1 yr.

Question 20

HVAD Exchange for suspected thrombus

Answer 20

0.05 PPY (4.2%)

Question 21

HVAD exchange rate for suspected thrombus post Anticoagulation adjustment, coring tool & sintering?

Answer 21

0.03 PPY

A 55% drop in exchange rate for suspected thrombus