Table 2.
Characteristics of Study Participants (n=272), by Time of Last PRO Assessment and Reason for Withdrawal/Dropout
| Group | ||||||||
|---|---|---|---|---|---|---|---|---|
| A | B | C | D | E | F | Groups B-F | ||
| No Assessments Completed (n=21) | Pre-Implant Assessment Only (n=84) | Withdrawn for Heart Transplant After Month 3 (n=23)a | Withdrawn/Dropped Out for Other Reason After Month 3 (n=16) | Month 6 Assessment Completed (n=34)b | All Pre- and Post-Implant Assessments Completed (n=94) | p-value | Model sample (n=251) | |
| Sociodemographic Characteristics | ||||||||
| Age in Years, mean (SD) | 61.0 (9.5) | 56.6 (11.2) | 50.7 (12.3) | 50.4 (17.7) | 58 (12.6) | 55.5 (12.0) | 0.030 | 55.4 (12.4) |
| Female | 3 (14%) | 26 (31%) | 3 (13%) | 4 (25%) | 10 (29%) | 21 (22%) | 0.396 | 64 (26%) |
| Married/committed partner | 11 (52%) | 50 (62%) | 13 (59%) | 4 (25%) | 23 (68%) | 57 (61%) | 0.096 | 147 (60%) |
| Ethnicity, Race | ||||||||
| Hispanic, any race | 1 (5%) | 13 (16%) | 2 (9%) | 3 (19%) | 1 (3%) | 6 (6%) | 0.090 (Non-Hispanic White vs. All Others) | 25 (10%) |
| Non-Hispanic, White | 16 (76%) | 42 (52%) | 15 (65%) | 9 (56%) | 22 (65%) | 67 (72%) | 155 (63%) | |
| Non-Hispanic, Black | 3 (14%) | 21 (26%) | 3 (13%) | 4 (25%) | 6 (18%) | 16 (17%) | 50 (20%) | |
| Non-Hispanic, Other | 1 (5%) | 5 (6%) | 3 (13%) | 0 (0%) | 5 (15%) | 4 (4%) | 17 (7%) | |
| Highest Education | ||||||||
| High School or Less | 6 (30%) | 30 (36%) | 11 (48%) | 8 (50%) | 14 (41%) | 29 (32%) | 0.514 (High School or Less vs. All Others) | 92 (37%) |
| Attended College/Tech School | 8 (40%) | 27 (33%) | 6 (26%) | 5 (31%) | 10 (29%) | 27 (29%) | 75 (30%) | |
| Associate/Bachelor’s Degree | 4 (20%) | 20 (24%) | 3 (13%) | 1 (6%) | 8 (24%) | 29 (32%) | 61 (25%) | |
| Graduate Degree | 2 (10%) | 6 (7%) | 3 (13%) | 2 (13%) | 2 (6%) | 7 (8%) | 20 (8%) | |
| Clinical Characteristics (prior to LVAD Implant) | ||||||||
| LVAD Implant Strategy | ||||||||
| Bridge to transplant/Short-term McS | 5 (38%) | 17 (21%) | 15 (65%) | 2 (13%) | 9 (26%) | 24 (26%) | 0.003 (Destination vs. All Others) | 67 (27%) |
| Possible bridge to transplant/Possible short-term MCS | 0 (0%) | 17 (21%) | 4 (17%) | 3 (20%) | 2 (6%) | 22 (24%) | 48 (19%) | |
| Destination therapy/Long-term MCS | 8 (62%) | 48 (59%) | 4 (17%) | 10 (67%) | 23 (68%) | 47 (51%) | 132 (53%) | |
| Etiology of Heart Failure | ||||||||
| Dilated cardiomyopathy | 9 (69%) | 48 (57%) | 17 (74%) | 11 (73%) | 22 (65%) | 65 (70%) | 0.494 (Dilated vs. All Others) | 163 (65%) |
| Ischemic cardiomyopathy | 2 (15%) | 21 (25%) | 5 (22%) | 3 (20%) | 7 (21%) | 22 (24%) | 58 (23%) | |
| Other | 2 (15%) | 15 (18%) | 1 (4%) | 1 (7%) | 5 (15%) | 6 (6%) | 28 (11%) | |
| NYHA Class | ||||||||
| Class I | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | 0.568 (I-III vs. IV) | 1 (0%) |
| Class II | 0 (0%) | 1 (1%) | 1 (4%) | 0 (0%) | 1 (3%) | 2 (2%) | 5 (2%) | |
| Class III | 1 (8%) | 16 (19%) | 7 (30%) | 2 (13%) | 6 (18%) | 18 (19%) | 49 (20%) | |
| Class IV | 11 (92%) | 67 (80%) | 15 (65%) | 13 (87%) | 26 (79%) | 72 (77%) | 193 (78%) | |
| Intermacs Profile | ||||||||
| 1 (critical cardiogenic shock) & 2 (progressive decline) | 8 (67%) | 39 (49%) | 6 (26%) | 5 (33%) | 9 (28%) | 25 (27%) | 0.686 (1–2 vs. 37) | 84 (35%) |
| 3 (stable, but inotrope-dependent) | 2 (17%) | 24 (30%) | 10 (43%) | 8 (53%) | 14 (44%) | 41 (45%) | 97 (40%) | |
| 4–7 (ambulatory advanced heart failure) | 2 (17%) | 16 (20%) | 7 (30%) | 2 (13%) | 9 (28%) | 25 (27%) | 59 (25%) | |
| Left Ventricular Ejection Fraction | ||||||||
| 30+ (normal/mild/moderate) | 0 (0%) | 3 (4%) | 1 (5%) | 1 (7%) | 4 (13%) | 3 (3%) | 0.334 (Severe vs. All Others) | 12 (5%) |
| 20–29 (moderate/severe) | 5 (38%) | 32 (40%) | 5 (26%) | 6 (43%) | 9 (28%) | 17 (20%) | 69 (28%) | |
| <20 (severe) | 8 (62%) | 45 (56%) | 13 (68%) | 7 (50%) | 19 (59%) | 67 (77%) | 151 (61%) | |
a
Pre-Implant Assessment missing for n=1 participant
b
Pre-Implant Assessment missing for n=9 participants; Month 3 Assessment missing for n=27
Entries in the table represent the number of participants (percentage), unless otherwise specified. Missing data were excluded.
MCS: mechanical circulatory support
PRO: Patient-Reported Outcome
p-value for comparison of Groups A through F