ENDURANCE Pagani DT Flashcards

0
Q

Date end enrollment?

A

Q2 2012

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1
Q

Start of study?

A

Q2 2010

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2
Q

Primary Endpoint?

A

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

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3
Q

Secondary end points?

A
  1. Adverse events INTERMACS
  2. KCCQ & EuroQoL
  3. NYHA Class & 6-min. Walk Test
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4
Q

N=?

A

446

HVAD=297

HMII=148

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5
Q

Baseline TR?

A

HVAD 11.8%

HMII 5.4%

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6
Q

Overall Primary Endpoint?

A

HMII 57.4%

HVAD 55%

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7
Q

Overall Primary Endpoint Sintered?

A

HMII 57.4%

HVAD 57.5%

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8
Q

Sintered N=?

Non-Sintered N=?

HMII N=?

A

Sintered N=200

Non-Sintered N=97

HMII N=148

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9
Q

Success?

A

HMII= 57.4%

HVAD= 57.5%

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10
Q

ADVERSE EVENTS

DIED?

A

HVAD 103 (34.7%)

HMII 39 (26.4%)

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11
Q

ADVERSE EVENTS

Malfunction Exchange Urgent Explant?

A

HMII 24 (16.2%)

HVAD 26 (8.8%)

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12
Q

ADVERSE EVENTS

Disabling Stroke?

A

HMII 0

HVAD 3 (1.0%)

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13
Q

Overall Survival?

A

HMII 67.6%

HVAD 60.2%

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14
Q

Overall Survival Sintered?

A

HMII 67.6%

HVAD 61.4%

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15
Q

Stroke overall ?

A
  1. 27 ppy HVAD

0. 09 ppy HMII

16
Q

ICVA?

HCVA?

A
  1. 16 ppy HVAD vs. 0.06 HMII

0. 11 ppy HVAD vs. 0.03 HMII

17
Q

TIA?

A

0.07 ppy HVAD vs 0.03 HMII

18
Q

Pump Exchange?

A

HMII 0.10 ppy

HVAD 0.06 ppy

19
Q

Right Heart Failure?

A

HMII 0.22 ppy

HVAD 0.31 ppy

20
Q

Pump Exchange

A
  1. 06 ppy HVAD (7.8%)

0. 10 ppy HMII (13.4%)

21
Q

Reduction in Throbosis post Sintering et al

A

52% reduction