Quality of Life in Pediatric VAD- How are we doing?

INTERMACS Eighth Annual Meeting

May 5, 2014

Karen Uzark, PhD, CPNP University of Michigan

Congenital Heart Center

Definitions HEALTH = “not only the absence of disease and

infirmity, but the presence of physical, mental, and social well-being”

QUALITY OF LIFE = “the individual’s perception of their

position in life, in the context of culture and value systems in which they live and in relation to their goals, expectations, standards and concerns”

Quality of Life ≠ Physical Health Status or Abilities Quality of life cannot be simply inferred from clinical and

laboratory findings or objective criteria.

1948 WHO

1991 WHO

Dimensions of Quality of Life • Physical functioning

• (Disease state and physical symptoms) • Psychological/Emotional functioning • Social functioning • School/role functioning

• (Neurodevelopmental functioning)

Ventricular Assist Devices –Goals: • Survival to Transplant or Recovery • Improved cardiac output

• → improvement in end-organ function • Physical rehabilitation

• Extubation • Mobilization/Ambulation • Enteral nutrition • Neurological evaluation-rehabilitation

• → Improved psychosocial quality of life

Quality of Life (QOL) in Children Bridged to Transplant with VADs

• No significant difference in QOL between 21 children who had VAD and 42 without VAD at a median of 4.2 years post-transplant (Ezon et al, J Thorac Cardiovasc Surg 2014)

• Limitations: small sample size, wide age range, parent survey only, type of VAD support varied, survivor bias

• Children who required VAD/ECMO (n=26) reported QOL

similar to children without MCS (n=58) at a median of 3 years post transplant * (Wray et al, J Heart Lung Transplant 2012) • Limitations: small sample size, wide age range, CHD dx

exclusion, type of support varied, parent survey in younger patients, survivor bias

* Longer period of heart failure in MCS was associated with poorer child ratings of social QOL.

Experience of Children with VAD as Bridge to Transplant*

• Qualitative study with semi-structured interviews with children (n=4) over 13 years old.

• Child responses : Frightened, scared of clots and

strokes, appreciative/relieved (would die without it) • Not prepared for “big washing machine”, big hoses.

*Gilmore and Newall, Pediatr Cardiol 2011.

PediMACS QOL

indicators

Sedated

ParalyzedIntubatedAmbulatingPrimary Nutrition OrallyPrimary Nutrition per feeding tubePrimary Nutrition TPN

PlayroomCafeteriaWalk outsideSitting RoomGeneral RehabNoneOther, specify_________________

9.    I cannot participate in usual play activities with the assist device.10. I find it difficult to express feelings, talk to others about the assist 11. Overall, I would describe my level of day-to-day worry/anxiousness on 12. Overall, I would describe my level of day-to-day happiness on the assist device to be: (1 high to 5 low)

2. Has the patient had any non-medically required excursions off the unit? If so, where (please select all that apply)

4.    I have difficulty sleeping due to the position of the driveline (tubing) exit 5.    I am bothered by how I look with the assist device.6.    I worry about the assist device breaking or malfunctioning.7.    I am bothered that I cannot visit family or friends outside home or the 8.    I am frustrated that I cannot move easily from place to place with the

4. I miss school because of not feeling well.5. I miss school to go to the doctor or hospital.1.    The assist device noise bothers I am awake.2.    The assist device noise bothers me when I am trying to sleep.3.    I have pain or discomfort at the driveline (tubing) exit site.

5. It is hard to keep up when I play with other kids.1. It is hard to pay attention in class.2. I forget things.3. I have trouble keeping up with my schooolwork.

4. I have trouble sleeping.5. I worry about what will happen to me.1. I have trouble getting along with other kids2. Other kids do not want to be my friend.3. Other kids tease me.

Func

tiona

l Sta

tus

1. It is hard for me to walk more than one block.

1. Functional Capacity: Answer Yes or No

2. It is hard for me to run.3. It is hard for me to do sports activity or exercise.4. It is hard for me to lift something heavy

7. I hurt or ache.8. I have low energy.1. I feel afraid or scared.2. I feel sad or blue3. I feel angry

VAD

QOL

Peds

QL (a

ges 8

-12)

5. It is hard for me to take a bath or shower by myself.6. It is hard for me to do chores around the house.

4. I cannot do things that other kids my age can do.

PedsQL

VAD-specific QOL

1. The assist device noise bothers me when I am awake.

Always Very Often Sometimes Rarely Never

2. The assist device noise bothers me when I am trying to sleep.

Always Very Often Sometimes Rarely Never

3. I have pain or discomfort at the driveline (tubing) exit site.

Always Very Often Sometimes Rarely Never

4. I have difficulty sleeping due to the position of the driveline (tubing) exit site.

Always Very Often Sometimes Rarely Never

5. I am bothered by how I look with the assist device.

Always Very Often Sometimes Rarely Never

6. I worry about the assist device breaking or malfunctioning.

Always Very Often Sometimes Rarely Never

7. I am bothered that I cannot visit my family or friends outside home or the hospital with the assist device.

Always Very Often Sometimes Rarely Never

8. I am frustrated that I cannot move easily from place to place with the assist device.

Always Very Often Sometimes Rarely Never

9. I cannot participate in usual play activities with the assist device.

Always Very Often Sometimes Rarely Never

10. I find it difficult to express feelings and talk to others about the assist device.

Always Very Often Sometimes Rarely Never

11. Overall, I would describe my level of day-to-day worry/anxiousness on the assist device to be:

Low Medium High

Peds QL and VAD Qol Completion Status for Parents/Children by Patient Age

N

PedsQL - Child PedsQL - Parent PedsOL - either

Completed % Completed % Completed % Age at Follow-Up

(24) N/A N/A 0 0.0% 0 0.0%

<2 years

2-4 years

11 N/A N/A 1 9.1% 1 9.1% 5-7 years

9 0 0.0% 1 11% 1 11% 8-12 years

31 2 6.5% 7 23% 7 23% 13-18 years

38 6 16% 10 26% 10 26% TOTAL

113 8/78 (10%) 19 17% 19 17%*

Pre-Implant

*21% excluding <2 years

Peds QL and VAD Qol Completion Status for Parents/Children by Patient Age

3 month Follow-up

N

Peds QL - Child PedsQL - Parent PedsQL - either VAD QOL - Child VAD QOL - Parent VAD QOL - either

Complete % Complete % Complete % Complete % Complete % Complete % Age at Follow-Up

(9) N/A N/A 0 0.0% 0 0.0% 0 0.0% 1 11% 1 11%

<2 years

2-4 years

4 N/A N/A 1 25% 1 25% 0 0.0% 1 25% 1 25% 5-7 years

3 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 8-12 years

10 2 20% 2 20% 2 20% 2 20% 1 10% 2 20% 13-18 years

20 7 35% 5 25% 7 35% 4 20% 3 15% 4 20% 19+ years

2 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% TOTAL

48 9/30 (30%)_ 8 17% 10 21% 6 13% 6 13% 8 17%*

*21% excluding <2 years

Peds QL – Reasons For Incompletion

Reasons for Peds QoL Incompletion

Parent Child

N % N % Too Sick

18 21.2 39 40.6 Urgent Implant, No Time

13 15.3 6 6.3 Coordinator Too Busy or Forgot

3 3.5 2 2.1 Unable to Contact Patient

2 2.4 . . Other Reason, Specify

49 57.6 49 51.0 TOTAL

85 100 96 100

Pre-implant Reasons for Peds QoL

Incompletion

Parent Child

N % N % Too Sick

3 12 3 11.5 Urgent Implant, No Time

1 4 1 3.8 Coordinator Too Busy or Forgot

8 32 8 30.8 Other Reason, Specify

13 52 14 53.8 TOTAL

25 100 26 100

3 month Follow-up

OTHER Reasons Form Incomplete

Pre-implant (n=43) • Forms/IRB not approved -17 (40%)

• (? license pending -2)

• Age too young -10; 1 too old (26%) • Not consented -12 (28%) • Other:

• Patient autistic -1 • No coordinator -2

Post-implant (n=13) • Forms/IRB -4 (31%)

• Age -2 (15%) • No Consent -3 (23%) • Transplanted -2 (15%)

Reason Missing -35

VAD QOL – Parent Report n=4-6

01234

VAD noise bothers while awake

Pain/discomfort at driveline site

VAD noise bothers while asleep

01234

Difficulty sleeping due to driveline

Bothered cannot move easily with VAD

Bothered cannot participate in activities

VAD QOL – Parent Report (continued) (n=4-6)

01234

Bothered by appearance with VAD (n=4)

Bothered cannot visit family/friends (n=4)

Worry VAD will break / malfunction (n=4)

01234

Difficult to express feelings about VAD (n=4)

Overall day-to-day VAD worry level (n=4)

Overall day-to-day VAD happiness level

VAD QOL – Child Self-Report (n=6)

01234

VAD noise bothers while awake

Pain/discomfort at driveline site

VAD noise bothers while asleep

01234

Difficulty sleeping due to driveline

Bothered cannot move easily with VAD

Bothered cannot participate in activities

VAD QOL – Child Self-Report (continued) (n=6)

01234

Bothered by appearance with VAD

Bothered cannot visit family/friends

Worry VAD will break / malfunction

01234

Difficult to express feelings about VAD

Overall day-to-day VAD worry level

Overall day-to-day VAD happiness level

VAD QOL – Child Self-Report Differences between 3 and 6 months

(n=6 at 3 mos, 5 at 6 mos)

0

1

2

3

4

5

VAD noise bothers while awake

3 mos6 mos

0

1

2

3

4

5

Difficult to express feelings about VAD

3 mos6 mos

0

1

2

3

4

5

Overall Day-to-Day Worry Level

3 mos6 mos

THANK YOU!