Figure 1.
Figure 3a.
Figure 3b.
Figure 3c.
Figure 2.
Baseline characteristics of LVAD patients (prior to LVAD implantation), 85 patients
| Variable | |
| Age at the time of implantation, years | 58.2 [48.6–63.8] |
| NYHA class | 4[3.5–4] |
| INTERMACS | 3[2–4] |
| LVEF, % | 15[11–17] |
| LVEDD, mm | 75[70–82] |
| Prior stroke | 13 (17.6) |
| Hypertension | 38 (44.7) |
| Diabetes mellitus | 35 (41.2) |
| eGFR< 60ml/min/1.73m2, | 37 (45.1) |
| Medications, n (%) | |
| Beta blockers | 65 (76.5) |
| ACEI | 44 (51.8) |
| ARB | 12 (14.1) |
| Aldosterone antagonists | 74 (87.1) |
| Aspirin | 24 (28.2) |
| Clopidogrel | 5(5.9) |
| Statin | 51 (60) |
| Vitamin K antagonists | 38 (44.7) |
Comparison of CLT according to bleeding events in the course of time_ Subgroup of patients with completed four observations (n=23)_ In the analyzed subgroup of patients, bleedings occurred in 5 patients
| Clot Lysis Time [min] | baseline | 3–4 months | 6–12 months | Last available |
|---|---|---|---|---|
| Patients with bleedings during the whole observation period, n=5 | 90.5 (94.5–111) | 85 (75.6–112) | 110.3 (88.5–119) | 144.5 (111–153.5) |
| Patients without bleedings during the whole observation period, n=18 | 107.5 (94.1–127.1) | 80 (74.8–94.9) | 110.3 (88.5–119) | 144.5 (111–153.5) |
Laboratory investigations in LVAD patients who completed the whole study, n=23_ Patients who died prior to the end of observation and incomplete observations were excluded from the further analyses
| Laboratory parameters | baseline, N = 23 | 3–4 months, N = 23 | 6–12 months, N = 23 | last sample, N = 23 | p-value1 | q-value2 | Effect size | Effect size (without baseline) |
|---|---|---|---|---|---|---|---|---|
| White blood cell count, 103/µL | 9.93 (7.52–11.05) | 7.70 (6.28–9.17) | 7.31 (5.88–8.76) | 7.80 (6.89–9.41) | 0.066 | 0.078 | 64.3% | 21.1% |
| Hemoglobin, mmol/L | 7.70 (7.15–9.00) | 8.10 (7.30–8.45) | 8.30 (7.50–8.90) | 8.80 (7.85–9.45) | 0.015 | 0.022 | 48.5% | 53.6% |
| Platelet count, 103/µL | 194 (146–254) | 245 (199–261) | 211 (171–257) | 185 (172–228) | 0.003 | 0.008 | 47.4% | 56.2% |
| Bilirubin, µmol/L | 18 (8–33) | 8 (7–11) | 11 (9–13) | 11 (8–15) | <0.001 | 0.004 | 70.0% | 55.1% |
| Albumin, g/L | 40.0 (35.0–42.0) | 44.0 (41.5–47.5) | 45.0 (43.0–49.0) | 46.0 (42.0–47.5) | <0.001 | <0.001 | 81.2% | 17.0% |
| Creatinine, µmol/L | 125 (110–184) | 100 (81–125) | 110 (93–131) | 111 (95–154) | 0.001 | 0.005 | 58.4% | 35.3% |
| hsCRP, mg/L | 8 (4–25) | 8 (3–18) | 6 (4–10) | 4 (2–13) | 0.2 | 0.2 | 38.7% | 28.4% |
| NT-proBNP, pg/mL | 11259 (5521–20366) | 2244 (1230–3273) | 1854 (895–2995) | 1992 (1138–3005) | <0.001 | <0.001 | 89.0% | 10.1% |
| Fibrinogen, g/L | 479 (380–542) | 424 (359–476) | 394 (346–428) | 368 (321–453) | 0.010 | 0.017 | 62.7% | 34.4% |
| D-dimer, ng/mL | 1.66 (1.00–3.46) | 1.79 (1.43–2.46) | 1.25 (0.97–1.66) | 1.11 (0.69–1.53) | 0.001 | 0.005 | 62.7% | 77.9% |
| CLT, min | 104 (93–125) | 82 (75–104) | 91 (79–113) | 98 (86–117) | 0.022 | 0.027 | 56.6% | 41.0% |
| Von Willebrand Factor, % | 290 (210–368) | 168 (140–215) | 177 (139–212) | 174 (131–288) | 0.009 | 0.017 | 77.3% | 17.9% |
| Factor VIII, % | 281 (232–349) | 200 (171–229) | 197 (131–226) | 174 (114–226) | 0.007 | 0.015 | 83.4% | 28.0% |
| Antitrombin, % | 87 (73–94) | 93 (87–99) | 97 (92–104) | 104 (90–108) | 0.013 | 0.020 | 76.0% | 52.6% |
| International Normalized Ratio, % | 1.53 (1.21–1.89) | 2.29 (2.06–2.37) | 2.24 (2.01–2.65) | 2.31 (2.17–2.57) | <0.001 | <0.001 | 90.0% | 17.4% |
| Thrombin Time, s | 16.90 (15.85–18.05) | 16.00 (15.70–16.60) | 15.80 (15.20–16.38) | 16.60 (15.85–17.30) | 0.017 | 0.023 | 66.7% | 63.7% |
| Activated Partial Thromboplastin Time, s | 43 (33–46) | 45 (40–50) | 41 (37–45) | 38 (36–42) | 0.003 | 0.008 | 56.7% | 71.0% |
| ASPI, AU × min | 590 (362–1,058) | 431 (276–705) | 331 (239–754) | 533 (312–880) | 0.2 | 0.2 | 37.2% | 22.4% |
| ADP, AU × min | 364 (274–658) | 466 (223–621) | 408 (268–655) | 461 (341–653) | 0.10 | 0.11 | 6.9% | 7.3% |
Major adverse cardiac and cerebrovascular events (MACCE), bleeding events and Net Adverse Clinical Events (NACE) in the whole group of patients (n=85)
| 0 to 3 months | 3–4 months | 6–12 months | Last available (median 21 months;IQR:10–29 months) | |
|---|---|---|---|---|
| MACCE, pts. (%) | 11(12.9) | 4(5.1) | 10(12.9) | 9(13.4) |
| Bleeding events, pts. (%) | 3(3.5) | 8(10.3) | 5(6.5) | 6(8.9) |
| NACE, pts (%) | 14(16.5) | 12(15.4) | 14 (18.2) | 15(22.4) |
| Deaths, pts (%) | 7(8.2) | 1(1.3) | 10(12.9) | 9(13.4) |
Comparison of CLT according to Major Adverse Cardiac and Cerebrovascular Events (MACCE) in the course of time, subgroup of patients with completed four observations (n=23)_ In the analyzed subgroup of patients MACCE occurred in 7 patients
| Clot Lysis Time [min] | baseline | 3–4 months | 6–12 months | Last available |
|---|---|---|---|---|
| Patients with MACCE during the whole observation period, n=6 | 111 (105.4–116.3) | 100.8 (79.2–112) | 103.8 (76.5–119.8) | 125.8 (112.33–142.2) |
| Patients without MACCE during the whole observation period, n=17 | 103 (91–129.5) | 78 (74.5–94.5) | 90.5 (83–105) | 90.5 (77.5–105) |
Comparison of CLT according to Net Adverse Clinical Events (NACE) events in the course of time_ Subgroup of patients with completed four observations (n=23)_ In the analyzed subgroup of patients, NACE occurred in 8 patients
| Clot Lysis Time [min] | baseline | 3–4 months | 6–12 months | Last available |
|---|---|---|---|---|
| Patients with NACE during the whole observation period, n=8 | 107.3 (96.4–112.8) | 87.3 (73.6–112) | 99.4 (80.4–119.3) | 125.8 (107.8–146.7) |
| Patients without NACE during the whole observation period, n=15 | 104 (91.3–131) | 78 (75–94.8) | 90.5 (79.5–101.3) | 87.5 (77–102.8) |