Table 1.
Baseline patient characteristics at enrollment into the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Study compared to pre-implant characteristics of Profile 4–7 patients who received a LVAD and were enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).
| MedaMACS Study N=161 | INTERMACS N=1753 | |
|---|---|---|
| Demographics | ||
| Age (years) | 59 ± 11 | 61 ± 12 |
| Female gender | 34% | 18%* |
| Non-Caucasian race | 32% | N/A |
| Married or domestic partnership | 60% | 71%* |
| Heart Failure Characteristics | ||
| Ischemic etiology of cardiomyopathy | 39% | 52%* |
| Idiopathic dilated cardiomyopathy | 39% | 28%* |
| Other etiology of cardiomyopathy | 22% | 20% |
| Implantable Cardioverter Defibrillator | 85% | 89% |
| Cardiac Resynchronization Therapy | 31% | N/A |
| Inotrope therapy required in preceding 6 months | 18% | N/A |
| Number of cardiac hospitalizations in preceding year | ||
| One | 29% | 32% |
| Two | 38% | 34% |
| Three | 16% | 15% |
| Four or more | 17% | N/A |
| Unknown | 0% | 19% |
| INTERMACS Patient Profile | ||
| Profile 4 | 12% | 80%* |
| Profile 5 | 32% | 13%* |
| Profile 6 | 49% | 4%* |
| Profile 7 | 7% | 3%* |
| Medication Usage at Enrollment | ||
| ACE inhibitor/Angiotensin Receptor Blocker | 60% | 38%* |
| β-blockers | 90% | 77%* |
| Aldosterone antagonist | 64% | 50%* |
| Loop diuretics | 93% | 88% |
| Digoxin | 49% | N/A |
| Laboratory Values | ||
| NT-pro BNP (pg/ml) | 5365 ± 5065 | 829 ± 893* |
| Sodium (mmol/L) | 137 ± 4 | 137 ± 4 |
| Blood urea nitrogen (mg/dL) | 35 ± 20 | 27 ± 15* |
| Creatinine (mg/dL) | 1.5 ± 0.6 | 1.4 ± 0.7* |
| Alanine aminotransferase (u/L) | 34 ± 43 | 40 ± 80 |
| Aspartate aminotransferase (u/L) | 33 ± 24 | 34 ± 53 |
| Total bilirubin (mg/dL) | 1.2 ± 0.8 | 1.0 ± 0.8 |
| Total cholesterol (mg/dL) | 131 ± 43 | 153 ± 266 |
| Uric acid (mg/dl) | 9.6 ± 5.9 | 7.9 ± 2.6 |
| Hemoglobin (g/dl) | 12.7 ± 2.4 | 12.2 ± 2.0* |
| Echocardiographic and Hemodynamic Data | ||
| Left ventricular ejection fraction (%) | 21 ± 7 | 10 ± 7* |
| Left ventricular dimension diastole (cm) | 6.5 ± 0.9 | 6.8 ± 1.0* |
| Heart rate (beats per minute) | 79 ± 14 | 79 ± 15 |
| Systolic blood pressure (mmHg) | 111 ± 15 | 109 ± 16 |
| Diastolic blood pressure (mmHg) | 68 ± 11 | 66 ± 12* |
| Right atrial pressure (mmHg) | 11 ± 6 | 12 ± 8 |
| Pulmonary artery systolic pressure (mmHg) | 52 ± 13 | 48 ± 15* |
| Pulmonary artery diastolic pressure (mmHg) | 25 ± 8 | 22 ± 9* |
| Pulmonary wedge pressure (mmHg) | 21 ± 8 | 22 ± 9 |
| Cardiac output (L/min) | 4.5 ± 1.4 | 4.3 ± 1.4 |
| Cardiac index (L/min/m2) | 2.2 ± 0.7 | 2.3 ± 1.0 |
| Baseline Functional and Quality of Life Status | ||
| Six minute walk (m) | 196 ± 156 | 304 ± 1125 |
| Gait speed (m/s) | 1.0 ± 0.4 | 1.1 ± 0.5 |
| Peak oxygen consumption (mL/kg/min) | 12.1 ± 4.6 | 19.0 ± 8.2 |
| EuroQol 5D Index Score | 0.69 ± 0.19 | 0.68 ± 0.21 |
| EuroQol Visual Analog Scale | 56 ± 21 | 43 ± 24* |
| Kansas City Cardiomyopathy Questionnaire score | 51 ± 10 | 36 ± 20* |
*
P<0.01 for comparison of MedaMACS vs. INTERMACS.
N/A=Data Not Available, as these variables were not collected in INTERMACS