Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial

Figures & data

Table I. Baseline clinical and procedural characteristics of the study groups.

	OAC group n = 213	Aspirin group n = 128	Control group n = 106	P value
Age (y)	72.2 ± 8.7	72 ± 10.7	64.3 ± 15.2	< 0.001
Male gender	131 (61.5)	70 (54.7)	59 (55.7)	0.39
Atrial fibrillation	200 (93.9)	37 (28.9)	13 (12.3)	< 0.001
Diabetes	38 (21.2)	32 (31.7)	14 (15.9)	0.028
Hypertension	81 (43.8)	63 (57.8)	40 (41.7)	0.031
Heart failure	45 (24.9)	19 (20.2)	7 (8.3)	0.007
Prior stroke	28 (13.1)	10 (7.8)	5 (4.7)	0.013
Renal failure	7 (3.3)	4 (3.1)	1 (0.9)	0.091
CHA2DS2VASc score	3.1 ± 1.7	3.1 ± 1.7	1.8 ± 1.4	< 0.001
HAS BLED score	1.4 ± 0.8	1.9 ± 0.9	0.9 ± 0.8	< 0.001
HAS BLED score ≥ 3	17 (9.2)	36 (28.8)	2 (2.4)	< 0.001
Aspirin use	6 (2.8)	127 (99.2)	0 (0)	< 0.001
Clopidogrel use	4 (1.9)	7 (5.5)	0 (0)	0.027
Venous access route
Cephalic vein	95 (44.8)	67 (52.8)	55 (52.9)	0.559
Axillary vein	89 (42.0)	44 (34.6)	37 (35.6)
Subclavian vein	28 (13.2)	16 (12.6)	12 (11.5)
Device implanted
ICD	19 (8.9)	18 (14.1)	13 (12.3)	0.318
CRT	28 (13.1)	7 (5.5)	3 (2.8)	0.013
Number of leads	1.5 ± 0.6	1.7 ± 0.5	1.8 ± 0.4	< 0.001
Duration of operation (min)	65 ± 43	76 ± 44	68 ± 37	0.085
Hemostatic use	11 (5.2)	4 (3.1)	1 (0.9)	0.298
Out-patient operations	13 (6.1)	7 (5.5)	5 (4.7)	0.695
Hospital stay (days)	2.3 ± 2.5	3.1 ± 3.8	2.5 ± 2.3	0.078

Continuous variables are presented as mean ± standard deviation, whereas categorical variables are presented as frequency (percentage).

CRT = cardiac resynchronization therapy; ICD = implantable cardioverter defibrillator; OAC = oral anticoagulation.

Table II. Laboratory data of the study groups.

	OAC group n = 213	Aspirin group n = 128	Control group n = 106	P value
Preoperative hemoglobin (g/L)	139 ± 16	138 ± 14	136 ± 20	0.534
Postoperative hemoglobin (g/L)	135 ± 17	133 ± 15	134 ± 16	0.427
Platelet count (× 10^3)	217 ± 68	236 ± 81	232 ± 69	0.038
Creatinine (μmol/L)	90 ± 24	87 ± 27	82 ± 20	0.048
Preoperative INR	2.1 ± 0.5	1.1 ± 0.3	1.0 ± 0.1	< 0.001
Postoperative INR	1.9 ± 0.6	1.3 ± 0.4	1.1 ± 0.1	< 0.001

Variables are presented as mean ± standard deviation.

INR = international normalized ratio; OAC = oral anticoagulation.

Table III. Significant hematoma and other bleeding complications.

	OAC n = 213	Aspirin n = 128	Controls n = 106	P value
Any pocket hematoma/bruise	78 (36.6)	31 (24.2)	25 (23.6)	0.014
Significant hematoma (> 100 cm^2)	12 (5.6)	7 (5.5)	1 (0.9)	0.131
Operative bleeding	19 (8.9)	9 (7.0)	3 (2.8)	0.044
Revision of pocket hematoma	0 (0)	1 (0.8)	0 (0)	0.363
Pocket infection	1 (0.5)	0 (0)	0 (0)	0.577
Blood products	2 (0.9)	1 (0.8)	0 (0)	0.616
Thromboembolic events	1 (0.5)	0 (0)	0 (0)	0.464

Variables are presented as frequency (percentage).

OAC = oral anticoagulation.

Figure 1. The incidence of clinically significant pocket hematoma classified according to the level of pre-procedural INR (A) (P = 0.06), and post-procedural INR (B) (P = 0.009) (INR = international normalized ratio).