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ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths PowerPoint Presentation
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ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths. (423). (224). (137). (32). Months % Survival 1 83 % 3 74 % 6 67 % 12 50 %. Deaths / Month. Percent Survival. Hazard. Event: Death after Implant *. 2005. ISHLT. Months after Device Implant.

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slide1

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

178 Deaths

(423)

(224)

(137)

(32)

Months % Survival

1 83 %

3 74 %

6 67 %

12 50 %

Deaths / Month

Percent Survival

Hazard

Event: Death after Implant *

2005

ISHLT

Months after Device Implant

J Heart Lung Transplant 2005;24:1182-1187

* censored at transplant

slide2

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Primary Device Implant:

LVAD + RVAD

at the same operation

(biventricular failure)

Predicted % Mortality at 6 months

LVAD alone

(left ventricular failure)

Age (years) at Device Implant

slide3

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 (n=655)

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

Infection Episodes (n=668)

175

Cumulative Events per 100 Patients

Bleeding Episodes (n=396)

75

Thromboembolism Episodes (n=86)

18

Months after Device Implant

slide4

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

66 Patients with Major Device Malfunction

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

(410)

(212)

(122)

(38)

Months % Survival

1 95 %

3 92 %

6 84 %

12 66 %

Percent Freedom from Major Device Malfunction

Major Device Adverse Event / Month

Hazard

Event: Death after Implant *

Months after Device Implant

* censored at transplant

slide5

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004

Bridge to Transplant

Age > = 50 (n=292)

Age < 30 (n=52)

slide6

Alive

(Still waiting)

Proportion of Patients

45 %

Explanted (recovery)

45 %

37 %

27 %

Death (before transplant)

12 %

Transplanted

17 %

12 %

5 %

2005

ISHLT

Months after Device Implant

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004

Intent to Treat: Bridge to Recovery (n=35)

slide7

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004

Intent to Treat: Destination Therapy (n=78)

Alive

65 %

55 %

Proportion of Patients

33 %

34 %

Death

11 %

Transplanted

2 %

0 %

Explanted (recovery)

0 %

2005

ISHLT

Months after Device Implant

J Heart Lung Transplant 2005;24:1182-1187

slide8

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004

Destination Therapy

Age < 65 (n=37)

Age >= 65 (n=41)

slide9

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Primary Device Implant n

LVAD (alone) 542*

Pulsatile flow, chronic device 487

Continuous flow, chronic device 39

LVAD + RVAD Combinations 100

TAH Pulsatile flow, chronic device 13

Total 655

* Type of VAD not specified in 16 patients

slide10

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Intention to Treat n % of 655

Bridge to transplant 513 78.3%

Bridge to recovery 35 5.3%

Destination Therapy 78 11.9%

Not specified 29 4.4%

Total 655 100%

slide11

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

slide12

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Risk factors for death* after device implant

slide13

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Summary of Post-Implantation Patient-related Events

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

slide14

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Major Device Malfunctions n

Controller 31

Pump/pump drive unit 14

Pump thrombosis 13

Pump inflow 11

Percutaneous lead/drive line 4

Pump outflow 4

Cannula dislodgement 1

Power base electrical malfunction 1

Pump stoppage 1

Other 3

Total Events 83

66 Patients with 83 major device malfunctions

slide15

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Intent to Treat: Bridge to Recovery

Primary Device Implant n

LVAD (alone) 21*

Pulsatile flow, chronic device 16

Continuous flow, chronic device 1

LVAD + RVAD Combinations 14

Total 35

* Type of VAD not specified in 4 patients

slide16

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Indications for Destination Therapy n % of 78

Advanced age 38 48.7%

Co-morbidity 28 35.9%

Fixed pulmonary hypertension 8 10.3%

Contraindication to immunotherapy 2 2.6%

Patient refuses transplant 2 2.6%

Total 78 100%

slide17

2005

ISHLT

J Heart Lung Transplant 2005;24:1182-1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

Intent to Treat: Destination Therapy

Primary Device Implant n

LVAD (alone) 74

Pulsatile flow, chronic device 71

Continuous flow, chronic device 3

LVAD + RVAD Combinations 3

TAH Pulsatile flow, chronic device 1

Total 78