Table 3 Access related outcomes after Impella removal.

Access-related outcomes	Overall (n = 87)	MANTA device (n = 31)	Manual compression (n = 56)	OR (95% CI)*	P value^†
Immediate hemostasis^‡	62 (71.3)	28 (90.3)	34 (60.7)	5.76 (1.46–32.67)	0.0049
Successful MANTA deployment^§		29 (93.5)	–	–	–
Strategy success^II	82 (94.3)	29 (93.5)	53 (94.6)	0.54 (0.04–7.97)	0.55
Any access-related adverse outcome	32 (36.8)	6 (19.4)	26 (46.4)	0.276 (0.08–0.84)	0.012
VARC bleeding
Overall	24 (27.6)	2 (6.5)	22 (39.3)	0.106 (0.01–0.50)	0.001
Minor bleeding (BARC 2)	16 (18.4)	1 (3.2)	15 (26.8)	0.091 (0.002–0.67)	0.006
Major bleeding (BARC 3a)	7 (8.0)	1 (3.2)	6 (10.7)	0.277 (0.005–2.49)	0.22
Life-threatening (BARC 3b/5)	1 (1.1)	0 (0)	1 (1.8)	-	0.45
VARC vascular complications
Overall	17 (19.5)	5 (16.1)	12 (21.4)	0.70 (0.17–2.47)	0.55
Minor complications	3 (3.4)	2 (6.5)	1 (1.8)	3.79 (0.19–227.73)	0.25
Major complications	14 (16.1)	3 (9.7)	11 (19.6)	0.44 (0.07–1.88)	0.22
Urgent vascular surgery	7 (8.0)	3 (9.7)	4 (7.1)	1.39 (0.19–8.84)	0.67

Data are median (interquartile range) or number (percentage), as appropriate. BARC, Bleeding Academic Research Consortium; CI, confidence intervals; OR, odds ratio; VARC, Valve Academic Research Consortium.
*OR and CI was calculated using manual compression as control group.
^†P values were based on Mann–Whitney-U test as appropriate.
^‡Immediate hemostasis was defined as a state of no relevant bleeding or oozing with no additional medical action needed directly after access closure. Only 86 patients could be included for this, 1 patient in the manual compression group could not be evaluated.
^§Successful MANTA deployment was defined as a correct release and placement of the MANTA toggle and plug and was evaluated at each closure by the responsible operator.
^IIStrategy success was achieved when there were no signs of bleeding within 30 min after Impella removal and, in case of MANTA usage, if there was correct deployment of the vascular closure device and no complications had occurred.

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