ENDURANCE Pagani DT

Question 0

Date end enrollment?

Answer 0

Q2 2012

Question 1

Start of study?

Answer 1

Q2 2010

Question 2

Primary Endpoint?

Answer 2

Survival @2 years free from disabling stroke (MRS >4@24 weeks post-stroke) & alive on original device, transplant or explant for recovery

Question 3

Secondary end points?

Answer 3

1. Adverse events INTERMACS
2. KCCQ & EuroQoL
3. NYHA Class & 6-min. Walk Test

Question 4

N=?

Answer 4

446

HVAD=297

HMII=148

Question 5

Baseline TR?

Answer 5

HVAD 11.8%

HMII 5.4%

Question 6

Overall Primary Endpoint?

Answer 6

HMII 57.4%

HVAD 55%

Question 7

Overall Primary Endpoint Sintered?

Answer 7

HMII 57.4%

HVAD 57.5%

Question 8

Sintered N=?

Non-Sintered N=?

HMII N=?

Answer 8

Sintered N=200

Non-Sintered N=97

HMII N=148

Question 9

Success?

Answer 9

HMII= 57.4%

HVAD= 57.5%

Question 10

ADVERSE EVENTS

DIED?

Answer 10

HVAD 103 (34.7%)

HMII 39 (26.4%)

Question 11

ADVERSE EVENTS

Malfunction Exchange Urgent Explant?

Answer 11

HMII 24 (16.2%)

HVAD 26 (8.8%)

Question 12

ADVERSE EVENTS

Disabling Stroke?

Answer 12

HMII 0

HVAD 3 (1.0%)

Question 13

Overall Survival?

Answer 13

HMII 67.6%

HVAD 60.2%

Question 14

Overall Survival Sintered?

Answer 14

HMII 67.6%

HVAD 61.4%

Question 15

Stroke overall ?

Answer 15

0. 27 ppy HVAD

0. 09 ppy HMII

Question 16

ICVA?

HCVA?

Answer 16

0. 16 ppy HVAD vs. 0.06 HMII

0. 11 ppy HVAD vs. 0.03 HMII

Question 17

TIA?

Answer 17

0.07 ppy HVAD vs 0.03 HMII

Question 18

Pump Exchange?

Answer 18

HMII 0.10 ppy

HVAD 0.06 ppy

Question 19

Right Heart Failure?

Answer 19

HMII 0.22 ppy

HVAD 0.31 ppy

Question 20

Pump Exchange

Answer 20

0. 06 ppy HVAD (7.8%)

0. 10 ppy HMII (13.4%)

Question 21

Reduction in Throbosis post Sintering et al

Answer 21

52% reduction