Biventricular congestive heart failure Life Threatening
Item
1. patients with ife-threatening, irreversible biventricular heart failure (intermacs patient profile classifications 1 - 4)
boolean
C0685095 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Heart Transplantation Ineligibility | Medical contraindication Therapeutic immunosuppression Malignant Neoplasms Panel-reactive antibody Elevated
Item
2. ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [pras]) as determined by the implanting center at time of implant screening assessment.
boolean
C0018823 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0021079 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1141951 (UMLS CUI [2,4])
C3163633 (UMLS CUI [2,5])
Therapeutic procedure No response | Artificial Ventricle Therapeutic procedure failed
Item
3. on optimal medical management and failing to respond or failing dt vad therapy (continuing to decline)
boolean
C0087111 (UMLS CUI [1,1])
C3844738 (UMLS CUI [1,2])
C0085842 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Ambulate | Helping Behavior
Item
4. ambulatory without assistance
boolean
C4036205 (UMLS CUI [1])
C0018896 (UMLS CUI [2])
Age
Item
5. patients between 19 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
Body Surface Area
Item
6. patients with body surface area (bsa) of ≥ 1.7m2
boolean
C0005902 (UMLS CUI [1])
Distance Sternum T10 | Chest Space Adequate | Three-Dimensional Imaging Assessment
Item
7. sternum to t10 distance > 10cm or adequate room in chest as determined by 3-d imaging assessment or by other standard clinical assessments
boolean
C0012751 (UMLS CUI [1,1])
C0038293 (UMLS CUI [1,2])
C0223341 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C1883067 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0887832 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Heart Transplantation Patients eligible
Item
1. cardiac transplant-eligible patients
boolean
C0018823 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
ANTICOAGULATED STATE | Temporary artificial heart
Item
2. patients who cannot be adequately anticoagulated on the tah-t
boolean
C0741134 (UMLS CUI [1])
C0182433 (UMLS CUI [2])
Chest Space Insufficient
Item
3. patients with insufficient space in the chest
boolean
C0817096 (UMLS CUI [1,1])
C1883067 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
Cardiac support using ECMO
Item
4. patients on ecmo support
boolean
C0397132 (UMLS CUI [1])
Liver Cirrhosis | Ultrasonics (sound) | X-Ray Computed Tomography | Biopsy Positive
Item
5. patients with cirrhosis (evidenced by ultrasound, ct scan, or positive biopsy)
boolean
C0023890 (UMLS CUI [1])
C1456803 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0005558 (UMLS CUI [4,1])
C1446409 (UMLS CUI [4,2])
Renal dysfunction | Adverse event Definition
Item
6. patients with acute or chronic renal dysfunction (per intermacs ae definitions)
boolean
C3279454 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C1704788 (UMLS CUI [2,2])
Cardiac cachexia | Prealbumin measurement | Fragility | Catabolic Process Imbalance | Anabolism Imbalance
Item
7. patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
boolean
C0562491 (UMLS CUI [1])
C0337441 (UMLS CUI [2])
C0302113 (UMLS CUI [3])
C1516314 (UMLS CUI [4,1])
C1397014 (UMLS CUI [4,2])
C0220781 (UMLS CUI [5,1])
C1397014 (UMLS CUI [5,2])
Comorbidity Continuance of life Prognosis bad
Item
8. patients with a comorbidity that has a poor prognosis of survival beyond six months
boolean
C0009488 (UMLS CUI [1,1])
C0038952 (UMLS CUI [1,2])
C0278252 (UMLS CUI [1,3])
SOCIAL SUPPORT POOR | Compliance behavior Limited
Item
9. patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the principal investigator)
boolean
C0748876 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Protocol Treatment Arm Secondary
Item
secondary arm
boolean
C1522541 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
Ineligibility Participation Protocol Treatment Arm Primary
Item
1. patients who are not eligible to participate in the primary arm
boolean
C1512714 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
Biventricular congestive heart failure Life Threatening
Item
2. patients with life-threatening, irreversible biventricular heart failure (intermacs patient profile classifications 1 - 7)
boolean
C0685095 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Heart Transplantation Ineligibility
Item
3. ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
boolean
C0018823 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Therapeutic procedure No response | Artificial Ventricle Therapeutic procedure failed
Item
4. on optimal medical management and failing to respond or failing dt vad therapy (continuing to decline)
boolean
C0087111 (UMLS CUI [1,1])
C3844738 (UMLS CUI [1,2])
C0085842 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Age
Item
5. patients 19 years of age or older
boolean
C0001779 (UMLS CUI [1])
Distance Sternum T10 | Chest Space Adequate | Three-Dimensional Imaging Assessment
Item
6. sternum to t10 distance > 10cm or adequate room in chest as determined by 3-d imaging assessment or by other standard clinical assessments
boolean
C0012751 (UMLS CUI [1,1])
C0038293 (UMLS CUI [1,2])
C0223341 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C1883067 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0887832 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Age
Item
1. patients who are less than 19 years old
boolean
C0001779 (UMLS CUI [1])
Heart Transplantation Patients eligible
Item
2. cardiac transplant-eligible patients
boolean
C0018823 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
Liver Cirrhosis | Ultrasonics (sound) | X-Ray Computed Tomography | Biopsy Positive
Item
3. patients with cirrhosis (evidenced by ultrasound, ct scan, or positive biopsy)
boolean
C0023890 (UMLS CUI [1])
C1456803 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0005558 (UMLS CUI [4,1])
C1446409 (UMLS CUI [4,2])
Renal dysfunction chronic | Adverse event Definition
Item
4. patients with chronic renal dysfunction (per intermacs ae definitions)
boolean
C3279454 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1704788 (UMLS CUI [2,2])
Chest Space Insufficient
Item
5. patients with insufficient space in the chest
boolean
C0817096 (UMLS CUI [1,1])
C1883067 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
ANTICOAGULATED STATE | Temporary artificial heart
Item
6. patients who cannot be adequately anticoagulated on the tah-t
boolean
C0741134 (UMLS CUI [1])
C0182433 (UMLS CUI [2])
SOCIAL SUPPORT POOR | Compliance behavior Limited
Item
7. patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the principal investigator)
boolean
C0748876 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])