Single center outcomes after temporary mechanical circulatory assist device prior to Heartmate 3 implantation – a retrospective cohort study

Figures & data

Figure 1. Mean days on ECMO, Impella CP/5.0, and Temporary Central LVAD (Levitronix CentriMag) where 5.2 (±2.8), 10.2 (±6.4), and 20 (±6.2) respectively. Median TMCS duration 19.5 (14–26) days.

Table 1. Baseline characteristics prior to HM3 implantation.

	Non-TMCS (n = 41)	TMCS (n = 22)	p Value
Sex – n (%)			.91
Male	35 (85%)	19 (86%)
Age – mean (SD)	59.8 (12.2)	51.5 (13.1)	.014
BMI – mean (SD)	26.8 (3.8)	26.6 (2.1)	.87
Etiology of heart failure – n (%)			.03
Ischemic	18 (44%)	16 (73%)
Acute myocardial infarction	3 (17%)	16 (100%)
Non-ischemic	23 (56%)	6 (27%)
ICD/pacemaker prior to hospitalization – n (%)
Yes	19 (46%)	3 (14%)	.009
Comorbidities – n (%)
Diabetes mellitus	15 (36%)	2 (9%)	.02
COPD	3 (7%)	1 (5%)	.67
Hypertension	22 (54%)	7 (32%)	.09
Hypercholesterolemia	27 (66%)	7 (32%)	.01
Dialysis	2 (5%)	11 (50%)	.00
Previously heart operated – n (%)	9 (22%)	4 (18%)	.72
Arrythmia pre-implantation – n (%)
No	10 (24%)	1 (5%)	.048
Tachyarrhythmia	30 (73%)	17 (77%)	.72
AFL/AFib/SVT	29 (97%)	16 (94%)
VT/VF/VER	15 (50%)	17 (100%)
Tdp	1 (3%)	0
Bradyarrhythmia	5 (12%)	7 (32%)	.06
AV1-block	1 (20%)	0
AV3-block	0	4 (57%)
RBBB/LBBB	4 (80%)	3 (43%)
LVAD indication – n (%)			.034
Bridge-to-transplantation	10 (24%)	8 (36%)
Destination-therapy	19 (46%)	3 (14%)
Recovery	0 (0%)	0 (0%)
Bridge-to-decision	12 (29%)	11 (50%)
NYHA class – n (%)			.002
1 or 2	0 (0%)	0 (0%)
3	14 (34%)	0 (0%)
4	27 (66%)	22 (100%)
EUROSCORE II – median (IQR)	14.06 (6.93–28.15)	23.84 (20.2–32.21)	.03
LVEF % – median (IQR)	10 (10–15)	10 (5–10)	.10
Preoperative inotropes – n (%)			.00
Yes	22 (54%)	22 (100%)

Abbreviations: HM3: Heartmate 3; TMCS: Temporary Mechanical Circulatory Support; SD: Standard deviation; BMI: Body Mass Index; ICD: Implantable Cardioverter Defibrillator; COPD: Chronic Obstructive Pulmonary Disorder; AFL: Atrial flutter; AFib: Atrial fibrillation; SVT: Supraventricular Tachycardia; VT: Ventricular Tachycardia; VF: Ventricular fibrillation; VER: Ventricular Escape Rhythm; Tdp: Torsade de Pointes; AV1-block: Atrioventricular block 1; AV3: Atrioventricular block 3; RBBB: Right Bundle Branch Block; LBBB: Left Bundle Branch Block. IQR: Interquartile range; LVAD: Left Ventricular Assist Device. EUROSCORE: European System for Cardiac Operative Risk Evaluation; LVEF: Left Ventricular Ejection Fraction. Chi-square; Wilcoxon rank-sum; and t-test with p value. Data in bold indicate a significant difference in mean, median or categorical values.

Table 2. Laboratory parameters pre-TMCS, pre-HM3 without TMCS, and pre-HM3 with TMCS.

	Pre-TMCS (1)	Non-TMCS Pre-HM3 (2)	Pre-HM3 with TMCS (3)	p Value of 1 and 2	p Value of 1 and 3	p Value of 2 and 3
Creatinine – mean (SD)	151.4 (72.9)	154.6 (50)	168.2 (101.7)*	.85	.56	.4
eGFR – mean (SD)	53.7 (26.3)	45 (19.9)	52.7 (29.3)*	.17	.9	.5
INR – mean (SD)	1.3 (0.2)	1.3 (0.4)	1.2 (0.28)	.81	.18	.1
Albumin – mean (SD)	30.6 (6.5)	30.4 (6.9)	25.9 (5.56)	.96	.06	.03
ALAT – mean (SD)	376.1 (541.6)	126.1 (161.6)	232.8 (471.1)	.051	.46	.9
Bilirubin – mean (SD)	28.8 (15.5)	22.9 (12.1)	25.3 (17.4)	.16	.54	.9
LDH – mean (SD)	1012.9 (1130)	326 (304.9)	617.1 (313.1)	.003	.18	.2

Abbreviations: eGFR: estimated glomerular filtration rate; INR: international normalized ratio; ALAT: alanine-transaminase; LDH: lactate dehydrogenase. T-test with p value. Data in bold indicate a significant difference in mean values. * 50% were on dialysis prior to HM3 implantation.

Table 3. Preoperative hemodynamics prior to HM3 implantation.

	Non-TMCS	TMCS	p Value
CO L/min – mean (SD)	4.13 (0.94)	4.58 (1.45)	.26
CI L/min/m^2 – mean (SD)	2.0 (0.4)	2.5 (0.72)	.006
PAP systolic mmHg – mean (SD)	53.9 (13.7)	35.3 (7.3)	.0003
CVP mmHg – mean (SD)	13.1 (3.8)	14 (3.7)	.47
PCWP mmHg – mean (SD)	27.8 (4.5)	18.8 (7.6)	.0003

Abbreviations: CO: cardiac output; CI: cardiac index; PAP: pulmonary arterial pressure; CVP: central venous pressure mmHg; PCWP: pulmonary capillary wedge pressure. T-test with p value. Data in bold indicate a significant difference in mean values.

Table 4. Perioperative data.

	Non-TMCS	TMCS	p Value
Skin-to-skin time (minutes) – mean (SD)	267.5 (68)	283.6 (66.1)	.4
ECC time (minutes) – mean (SD)	117.2 (27.8)	117.9 (27.3)	.9
Other procedure during OP – n (%)	6 (15%)	1 (5%)
AVR	3 (50%)	0
PFO repair	1 (17%)	1 (100%)
LV aneurism repair	1 (17%)	0
Resutur of LIMA-LAD	1 (17%)	0
Bleeding (ml) – median (IQR)	1025 (660–1550)	1400 (950–1880)	.09
SAGM (ml) – median (IQR)	490 (0–735)	1347.5 (735–1715)	.00
FFP (ml) – median (IQR)	540 (540–1080)	1080 (540–1350)	.08
Platelets (ml) – median (IQR)	360 (360–540)	450 (360–720)	.02

Abbreviations: HM3: Heartmate 3; TMCS: Temporary Mechanical Circulatory Support; SD: standard deviation; IQR: interquartile range; ECC: extracorporeal circulation; AVR: aortic valve repair; PFO: patent foramen ovale; LV: left ventricle; LIMA: left internal mammary artery; LAD: left anterior descending artery; SAGM: red blood cells in sodium chloride, adenine, glucose, and mannitol medium; FFP: fresh frozen plasma. T-test and Wilcoxon rank-sum test with p value and z-value. Data in bold indicate a significant difference in mean, median and categorical values.

Figure 2. Kaplan–Meier graph of survival censored for follow-up shows a four year survival of 80 and 82% for the TMCS and non-TMCS group.

Table 5. Early postoperative outcomes and complications (<30 days).

	Non-TMCS (n = 41)	TMCS (n = 22)	p Value
30 days mortality – n (%)	3 (7%)	0 (0%)	.2
Days in ICU after HM3 implantation – median (IQR)	4.5 (2–6)	12 (6–20)	.005
Hours in ventilator – median (IQR)	23.5 (9–68)	127 (23.5–268)	.005
Readmission – n (%)	6 (15%)	1 (5%)	.22
In hospital LOS when discharged to home – median (IQR)	29 (22–42)	68.5 (51–91)	.00
Days with inotropes – median (IQR)	4 (2–9)	5 (3–9)	.43
Delayed closure of sternum – n (%)	10 (24%)	12 (55%)	.017
Reoperation for bleeding – n (%)	12 (29%)	3 (14%)	.17
Postoperative bleeding (ml) – median (IQR)	1097.5 (710–1525)	1270 (697.5–1847.5)	.46
SAGM (ml) – median (IQR)	735 (0–2205)	1470 (980–3185)	.02
FFP (ml) – median (IQR)	0 (0–1080)	135 (0–1350)	.34
Platelets (ml) – median (IQR)	0 (0–540)	180 (0–720)	.4
Dialysis – n (%) *	7 (17%)	13 (59%)	.001
RV-failure – n (%)	3 (7%)	1 (5%)	.66
Temporary RVAD-implantation – n (%)	1 (2%)	1 (5%)	.65
Infections – n (%)
Wound infection	0 (0%)	3 (13.6%)	.015
Sternum		1 (33%)
Femoral cannulation site		1 (33%)
Subclavian cannulation site		1 (33%)
Driveline	1 (2%)	1 (5%)	.65
Pneumonia	8 (20%)	5 (23%)	.76
Pump-related thrombosis – n (%)	1 (2%)	0 (0%)	.46
Neurological complications – n (%)	2 (5%)	3 (14%)	.22
Stroke	2 (100%)	3 (100%)
GI-bleeding – n (%)	3 (7%)	2 (9%)	.8

Abbreviations: HM3: Heartmate 3; TMCS: Temporary Mechanical Circulatory Support: LOS: length of stay; SD: standard deviation; IQR: interquartile range; ICU: intensive care unit; SAGM: red blood cells in sodium chloride, adenine, glucose, and mannitol medium; FFP: fresh frozen plasma; RV: right ventricle; RVAD: right ventricular assist device; GI: gastro-intestinal. Chi-squared test and Wilcoxon rank-sum test with p value, chi-squared value, and z-value. Data in bold indicate a significant difference in mean, median and categorical values. * No patients required renal replacement therapy when discharged to home.

Table 6. Adverse events after long-term follow-up (event per patient-years).

	Non-TMCS (41 patients; 105 patient-years)	TMCS (22 patients; 46 patient-years)	Whole population (63 patients; 150 patient-years)
Patients with infections
Wound	0.009	0.086	0.033
Sternum	0	0.021	0.021
Femoral cannulation site	0.009	0.043	0.02
Subclavian cannulation site	0	0.021	0.021
Driveline	0.171	0.195	0.18
Pneumonia	0.123	0.217	0.153
Patients with complications
Pump-thrombosis	0.019	0	0.013
Neurological complications	0.057	0.173	0.093
Stroke	0.038	0.152	0.073
Hemorrhage	0.019	0.021	0.02
GI-bleeding	0.057	0.130	0.08
Operation for any pump complication	0.028	0.021	0.026

Abbreviations: HM3: Heartmate 3; TMCS: temporary mechanical circulatory support; GI: gastro-intestinal.

Data availability statement

The data are available on request to the corresponding author.