Table 2.
Patient characteristics and perioperative data in the early (2009 to 2014) and late (2014 to 2017) eras of HeartMate II implantations.
| Variables (mean±SD or n [%]) | Cohort n=51 |
Early n=25 |
Late n=26 |
P-value |
|---|---|---|---|---|
| BTT | 23 (45) | 10 (40) | 13 (50) | 0.47 |
| Demographic data | ||||
| Age, years | 58±11 | 58±12 | 58±10 | 0.77 |
| Men | 41 (80) | 19 (76) | 22 (85) | 0.43 |
| BMI, kg/m2 | 25.8±4 | 25.9±4.7 | 25.6±3.6 | 0.40 |
| Medical history | ||||
| Insulin-treated diabetes | 4 (8) | 4 (16) | 0 (0) | 0.01 |
| Obesity | 9 (17) | 5 (20) | 4 (15) | 0.66 |
| PVD | 4 (8) | 1 (4) | 3 (11) | 0.31 |
| COPD | 11 (21) | 3 (12) | 8 (31) | 0.10 |
| CKD | 24 (47) | 12 (48) | 12 (46) | 0.89 |
| History of neoplasia | 12 (22) | 8 (32) | 4 (15) | 0.16 |
| AF or flutter | 26 (51) | 13 (52) | 13 (50) | 0.89 |
| Previous stroke | 9 (18) | 6 (24) | 3 (12) | 0.29 |
| Modified Rankin Scale 0 | 5 (20) | 3 (12) | ||
| Modified Rankin Scale 1 | 1 (4) | 0 (0) | ||
| PH | 21 (41) | 11 (44) | 10 (39) | 0.68 |
| Previous cardiac surgery | 6 (12) | 4 (16) | 2 (8) | 0.35 |
| Medications at home before admission | ||||
| ACE inhibitor | 26 (51) | 13 (48) | 13 (50) | 0.88 |
| ARBs | 10 (19) | 5 (20) | 5 (19) | 0.95 |
| Beta-blocker | 39 (76) | 15 (60) | 24 (92) | 0.007 |
| MRas | 30 (61) | 12 (48) | 18 (69) | 0.12 |
| Warfarin | 23 (46) | 14 (56) | 9 (35) | 0.12 |
| Loop diuretics | 42 (84) | 18 (72) | 24 (92) | 0.05 |
| Dosage, mg/day | 100±70 | 123±77 | 82±61 | 0.25 |
| Current ICD | 38 (74) | 20 (80) | 18 (70) | 0.37 |
| CRT | 26 (51) | 12 (48) | 14 (54) | 0.67 |
| Clinical state at admission | ||||
| INTERMACS profiles 2 or 3 | 32 (63) | 16 (64) | 16 (62) | 0.89 |
| INTERMACS profiles 4, 5, or 6 | 13 (25) | 6 (24) | 7 (27) | 0.81 |
| Hospitalizations in the previous year | 2.6±1.2 | 2.7±1.2 | 2.5±1.3 | 0.64 |
| NYHA IV | 11 (22) | 5 (20) | 6 (23) | 0.49 |
| Inotropes | 37 (73) | 20 (80) | 17 (65) | 0.39 |
| ECMO support | 5 (10) | 3 (11) | 2 (9) | 0.60 |
| Primary diagnosis | ||||
| Ischemic cardiomyopathy | 18 (35) | 10 (45) | 8 (31) | 0.76 |
| Idiopathic cardiomyopathy | 16 (31) | 6 (27) | 10 (39) | 0.42 |
| Familial cardiomyopathy | 4 (8) | 2 (9) | 2 (7) | 0.78 |
| Toxic cardiomyopathy | 4 (8) | 2 (9) | 2 (8) | 0.82 |
| Other | 6 (12) | 2 (7) | 4 (17) | 0.54 |
| Biological parameters | ||||
| Serum creatinine, µmol/L | 143±45 | 148±48 | 139±42 | 0.62 |
| Total bilirubin, mg/dL | 24.7±16 | 23±16 | 24±15 | 0.93 |
| NT-proBNP, ng/L | 9,028±6,939 | 8,777±6,300 | 9,265±7,598 | 0.77 |
| Echocardiography | ||||
| LVEF, % | 18.7±5.4 | 19.3±6 | 18.2±5 | 0.29 |
| LVEDD, mm | 70±9 | 74±8 | 67±10 | 0.26 |
| RV function | ||||
| Normal function | 13 (26) | 7 (29) | 6 (23) | 0.52 |
| Mild dysfunction | 20 (40) | 8 (33) | 12 (46) | 0.16 |
| Moderate dysfunction | 13 (26) | 6 (25) | 7 (27) | 0.89 |
| Severe dysfunction | 4 (8) | 3 (13) | 1 (4) | 0.25 |
| Moderate or greater TR | 11 (22) | 5 (20) | 6 (23) | 0.51 |
| Moderate or greater MR | 17 (33) | 8 (32) | 9 (34) | 0.97 |
| Moderate or greater AR | 2 (4) | 0 (0) | 2 (9) | 0.14 |
| Right heart catheterization | ||||
| PSAP, mmHg | 51±12 | 52±13 | 50±11 | 0.38 |
| mPAP, mmHg | 34.3±8.2 | 33±8 | 35±8 | 0.54 |
| CI, L/min/m2 | 2.1±0.7 | 2.3±0.7 | 2.0±0.7 | 0.53 |
| PVR, Woods | 3.1±1.5 | 2.3±1.7 | 2.9±1.3 | 0.10 |
| RAP, mmHg | 10.5±6.1 | 11.4±6 | 9.5±5 | 0.97 |
| PCWP, mmHg | 25±7 | 24±7 | 26±6 | 0.82 |
| PAPi | 3.6±2.2 | 3.6±2.3 | 3.5±2.0 | 0.15 |
| RVSWI, g/m2/beat | 13.5±5.3 | 14.9±5.8 | 12.4±4.8 | 0.16 |
| Perioperative data | ||||
| CPB time, min | 88±35 | 89±38 | 87±32 | 0.90 |
| Aortic cross-clamp | 10 (20) | 2 (8) | 8 (31) | 0.04 |
| Cross-clamp time, min (10 patients) | 36±23 | 71±9 | 27±13 | 0.007 |
| Concomitant procedure | 22 (44) | 8 (32) | 14 (54) | 0.11 |
| CABG | 6 (12) | 3 (12) | 3 (13) | 0.89 |
| Cryoablation | 3 (6) | 2 (7) | 1 (4) | 0.82 |
| Aortic valve closure | 2 (4) | 0 (0) | 2 (9) | 0.31 |
| Tricuspid valve repair | 3 (6) | 0 (0) | 2 (9) | 0.31 |
| Other | 9 (18) | 3 (12) | 6 (23) | 0.30 |
| VV ECMO for right heart failure | 4 (8) | 2 (7) | 0 (0) | 0.26 |
ACE=angiotensin-converting enzyme; AF=atrial fibrillation; AR=aortic regurgitation; ARBs=angiotensin-receptor blockers; BMI=body mass index; BTT=bridge to transplantation; CABG=coronary artery bypass grafting; CI=cardiac index; CKD=chronic kidney disease; COPD=chronic obstructive pulmonary disease; CPB=cardiopulmonary bypass; CRT=cardiac resynchronization therapy; ECMO=extracorporeal membrane oxygenation; ICD=implantable cardioverter-defibrillator; LVEDD=left ventricular end-diastolic diameter; LVEF=left ventricular ejection fraction; mPAP=mean pulmonary artery pressure; MR=mitral regurgitation; MRAs=mineralocorticoid receptor antagonists; NT-proBNP=N-terminal (NT)-pro hormone BNP; PAPi=pulmonary artery pulsatility index; PCWP=pulmonary capillary wedge pressure; PH=pulmonary hypertension; PSAP=pulmonary systolic artery pressure; PVD=peripheral vascular disease; PVR=pulmonary vascular resistance; RAP=right atrial pressure; RV=right ventricular; RVSWI=right ventricular stroke work index; TR=tricuspid regurgitation; VV ECMO=venovenous ECMO