Unfavorable Mediastinal Anatomy Yes/No Yes/No (includes sternotomies, sternal resection, radiation, flail chest, etc.) Enter # of Sternotomies: ________ Thoracic Aortic Disease Yes/No Yes/No Tracheostomy Yes/No Yes/No Plastic Bronchitis Yes/No Yes/No Nutritional/GI/Genetics: Large BMI Yes/No Yes/No Severe Diabetes Yes/No Yes/No Malnutrition/Cachexia Yes/No Yes/No History of GI Ulcers Yes/No Yes/No History of Hepatitis Yes/No Yes/No Dysfunction Yes/No Yes/No Anasarca Yes/No Yes/No Protein Losing enteropathy Yes/No Yes/No Genetic Syndrome Yes/No Yes/No (Dropdown: Muscular Dystrophy Down’s syndrome Noonan’s Other ______) Vascular issues: Heparin Induced Thrombocytopenia Yes/No Yes/No Chronic Coagulopathy Yes/No Yes/No Major Stroke Yes/No Yes/No Other Cerebrovascular Disease Yes/No Yes/No Peripheral Vascular Disease Yes/No Yes/No Oncology/infection issues: History of Organ Cancer Yes/No Yes/No History of Lymphoma, Leukemia Yes/No Yes/No History of Bone Marrow Transplant (BMT) Yes/No Yes/No History of HIV Yes/No/Unknown Yes/No (If yes, answer HIV questions below) Chronic Infectious Concerns Yes/No Yes/No Psychosocial issues: If patient is < 10 old at time of implant, based on chart review of the patient, are these conditions present or absent. Limited Cognition/Understanding Yes/No/Unknown Yes/No Limited Social Support Yes/No/Unknown Yes/No Repeated Noncompliance Yes/No/Unknown Yes/No History of Illicit Drug Use Yes/No/Unknown Yes/No History of Alcohol Yes/No/Unknown Yes/No Narcotic Dependence Yes/No/Unknown Yes/No History of Smoking Yes/No/Unknown Yes/No Currently Smoking Yes/No/Unknown Yes/No Severe Depression Yes/No/Unknown Yes/No Other Major Psychiatric Diagnosis Yes/No/Unknown Yes/No Neurological/developmental abnormalities Yes/No/Unknown Yes/No Other Comorbidity Yes/No Yes/No
Note: This only applies to patients who have a CVA, TIA, or Anoxic Brain Injury. Once “Yes” is selected you must complete this section for the patient’s complete STS Pedimacs lifespan. If yes, provide Modified Rankin Scale: 0 – No symptoms at all 1 – No Significant disability: despite symptoms: able to carry out all usual duties and activities 2 – Slight disability: unable to carry out all previous activities but able to look after own affairs without assistance 3 – Moderate disability: requiring some help, but able to walk without assistance. 4 – Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5 – Severe disability: bedridden, incontinent and requiring constant nursing care and attention. 6 – Dead ST= Not Done or Not Documented Major Outcomes and Adverse Events
RVAD Both (in the same OR visit) Enter Date of onset of adverse event: in MMDDYYYY format. Location of patient: Select whether patient was In hospital or Out of hospital at time of adverse event. If location was not known, select Unknown. In Hospital Out of Hospital Unknown Please briefly describe this device adverse (malfunction and/or thrombus) including what happened, which component was involved, method of diagnosis, intervention(s) if any, and the result in the text box provided: Thrombus Event If a device malfunction is associated with this thrombus event (suspected or confirmed) please remember to fill out the device malfunction section of this form. Did the patient experience a thrombus event (suspected or confirmed)? Yes, No, or Unknown If yes, then complete the following questions: Was the suspected or confirmed thrombus associated with one or more of the following or symptoms? Select all that apply: Hemolysis (complete the Hemolysis form) Heart Failure Abnormal Pump Parameters Stroke (complete the Neurological Dysfunction Form) TIA (complete the Neurological Dysfunction Form) Arterial Non-CNS Thromboembolism (complete the Arterial Non-CNS Thromboembolism Form) None Other, Specify If specify, then complete the text box. Did the patient have one or more of the following? Select all that apply: Treatment with intravenous anticoagulation (e.g. heparin) Intravenous thrombolytic (e.g. TPA) Intravenous antiplatelet therapy (e.g. eptifibatide) Other, Specify If specify, then complete the text box. Was the thrombus confirmed (see definition below)? Yes, No, or Unknown If yes, then complete the following question: Please select method of confirmation: Select all that apply: Imaging Study
Patient Accident Patient Non-Compliance Sub Therapeutic Anticoagulation Prothrombotic States End of Component Expected Life Technical and/or Procedural Issues (e.g. cannula or malposition or kinking) No Cause Identified Additional Adverse Events Cardiac Arrhythmias Did a documented arrhythmia result in clinical compromise since last STS Pedimacs report / last followup? Yes, No, or Unknown If yes, Event date in MMDDYYYY format. ST= Unknown Enter Type of arrhythmia from selection below: Sustained ventricular arrhythmia requiring defibrillation or cardioversion Sustained supraventricular arrhythmia requiring drug treatment or cardioversion Unknown Pericardial Fluid Collection
It is hard for you to walk: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to run: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to play sports or exercise: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to pick up big things: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to take a bath or shower: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to do chores (like pick up your toys): 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Do you have hurts or aches: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented If yes, where? __________ Do you ever feel too tired to play: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented EMOTIONAL FUNCTIONING (problems with…) Do you feel scared: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented
Do you feel sad: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Do you feel mad: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Do you have trouble sleeping: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Do you worry about what will happen to you: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented SOCIAL FUNCTIONING (problems with…) Is it hard for you to get along with other kids: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Do other kids say they do not want to play with you: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Do other kids tease you: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Can other kids do things that you cannot do: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to keep up when you play with other kids: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented
1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to lift something 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to take a bath or shower by myself: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to do chores around the house: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I hurt or ache: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented If yes, where? __________ I have low energy : 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented ABOUT MY FEELINGS (problems with…) I feel afraid or scared: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented
I cannot do things other kids my age can do: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard to keep up when I play with other kids: 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented ABOUT SCHOOL (problems with…) Is it hard to pay attention in school: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented I forget things: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I have trouble keeping up with schoolwork: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I miss school because of not feeling well: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I miss school to go to the doctor or hospital: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often
4 – A lot Unknown or Not Documented PedsQL Child (Teen 13-18 yrs) ABOUT MY HEALTH AND ACTIVITIES (problems with…) It is hard for me to walk more than one block: 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to run: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to do sports or exercise: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to lift something heavy: 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to take a bath or shower by myself: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to do chores around the 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented I hurt or ache: 0 – Not at all
1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented If yes, where? __________ I have low energy : 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented ABOUT MY FEELINGS (problems with…) I feel afraid or scared: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I feel sad or blue: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I feel angry: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I have trouble sleeping: 0 – Not at all 1 – Almost 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented I worry about what will happen to me: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented
3 – Often 4 – Almost Always Unknown or Not Documented Running: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Participating in active play or exercise: 0 – Never 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Lifting something heavy: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Bathing: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Helping to pick up his or her toys: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Having or aches: 0 – 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Low energy 0 – 1 – Almost 2 – Sometimes 3 – Often
4 – Almost Always Unknown or Not Documented EMOTIONAL FUNCTIONING (problems with…) Feeling afraid or scared: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling sad or blue: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling angry: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Trouble sleeping: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Worrying: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented SOCIAL FUNCTIONING (problems with…) Playing with other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Other kids not wanting to play with him or her: 0 – Never
1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Getting teased by other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Not able to do things that children his or her age can do: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Keeping up when playing with other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented SCHOOL FUNCTIONING (problems with…) the same school activities as peers: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Missing school/daycare because of not feeling well: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Missing school/daycare to go to the doctor or hospital: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented
2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Low energy 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented EMOTIONAL FUNCTIONING (problems with…) Feeling afraid or scared: 0 – 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling sad or blue: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling angry: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Trouble sleeping: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Worrying about what will happen to him or her: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented SOCIAL FUNCTIONING (problems with…)
Getting along with other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Other children not wanting to be his or her friend: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Getting teased by other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Not able to do things that other children his or her age can do: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Keeping up when playing with other children: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented SCHOOL FUNCTIONING (problems with…) Paying attention in class: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Forgetting things: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always
Unknown or Not Documented Keeping up with activities: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Missing school because of not feeling well: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Missing school to go to the doctor or hospital: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented PedsQL Parent 8-12 yrs) PHYSICAL FUNCTIONING (problems with…) Walking more than one blcok: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Running: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Participating in sports activity or exercise: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Lifting something heavy:
Feeling angry: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Trouble sleeping: 0 – 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Worrying about what will happen to him or her: 0 – Never 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented SOCIAL FUNCTIONING (problems with…) Getting along with other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented children not wanting to be his or her friend: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Getting teased by other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Not able to do things that other children his or her age can do: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented
Keeping up when playing with other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented SCHOOL FUNCTIONING (problems with…) Paying attention in class: 0 – Never 1 – Almost 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Forgetting things: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Keeping up with activities: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Missing school because of not feeling well: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Missing school to go to the doctor or hospital: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented PedsQL Parent (Teen 13-18 yrs) PHYSICAL FUNCTIONING (problems with…) Walking more than one blcok: 0 – Never
1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Running: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Participating in sports activity or exercise: 0 – Never 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Lifting something heavy: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Taking a bath or shower by him or herself 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented chores around the house: 0 – 1 – Almost 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Having hurts or aches: 0 – Never 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Low energy level: 0 – Never 1 – Almost Never
2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented EMOTIONAL FUNCTIONING (problems with…) Feeling afraid or scared: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling sad or blue: 0 – 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Feeling 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Trouble sleeping: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Worrying about what will happen to him or her: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented SOCIAL FUNCTIONING (problems with…) Getting along with other teens: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented
Other teens not wanting to be his or her friend: 0 – 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Getting teased by other teens: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Not able to do things that teens his or her age can do: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Keeping up with other teens: 0 – 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented SCHOOL FUNCTIONING (problems with…) Paying attention in class: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Forgetting things: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Keeping up with school schoolwork: 0 – Never 1 – Almost 2 – Sometimes 3 – 4 – Almost Always