Risk profiles and outcomes of patients receiving antibacterial cardiovascular implantable electronic device envelopes: A retrospective analysis

Table 1 Comparison across cohorts

	Total	Biologic envelope	Non-biologic envelope	No envelope	1P value	Any envelope	2P value
	(N = 248)	(n = 89)	(n = 102)	( n = 57)		( n = 191)
Age (yr, mean ± SD)	71.6 ± 13.3	73.6 ± 13.3	68.2 ± 14.0	74.9 ± 10.6	0.002	70.7 ± 14.0	0.017
BMI, mean ± SD	29.9 ± 7.1	28.0 ± 6.2	31.0 ± 7.9	31.0 ± 6.3	0.008	29.6 ± 7.3	0.206
BMI category					0.016		0.080
Underweight (< 18.5)	5 (2.0%)	2 (2.2%)	2 (2.0%)	1 (1.8%)		4 (2.1%)
Normal (18.5 - < 25.0)	54 (21.8%)	30 (33.7%)	19 (18.6%)	5 (8.8%)		49 (25.7%)
Overweight (25.0 - < 30.0)	73 (29.4%)	20 (22.5%)	31 (30.4%)	22 (38.6%)		51 (26.7%)
Obese (30.0 - < 40.0)	97 (39.1%)	34 (38.2%)	38 (37.3%)	25 (43.9%)		72 (37.7%)
Morbidly obese (40.0 ±)	19 (7.7%)	3 (3.4%)	12 (11.8%)	4 (7.0%)		15 (7.9%)
Medical history
Heart failure	106 (42.7%)	41 (46.1%)	49 (48.0%)	16 (28.1%)	0.037	90 (47.1%)	0.011
Systemic anticoagulant use	99 (39.9%)	43 (48.3%)	40 (39.2%)	16 (28.1%)	0.050	83 (43.5%)	0.037
CIED device type					0.004		0.001
Pacemaker	152 (61.3%)	52 (58.4%)	52 (51.0%)	48 (84.2%)		104 (54.5%)
CRT-P	12 (4.8%)	8 (9.0%)	4 (3.9%)	0 (0.0%)		12 (6.3%)
ICD	54 (21.8%)	17 (9.1%)	30 (29.4%)	7 (12.3%)		47 (24.6%)
S-ICD	2 (0.8%)	0 (0.0%)	52 (51.0%)	1 (1.8%)		1 (0.5%)
CRT-D	24 (9.7%)	10 (11.2%)	13 (12.7%)	1 (1.8%)		23 (12.0%)
N/A	4 (1.6%)	2 (2.2%)	2 (2.0%)	0 (0.0%)		0 (0.0%)
CIED category					0.006		0.004
Low-powered	164 (66.1%)	60 (67.4%)	56 (54.9%)	48 (84.2%)		116 (60.7%)
High-powered	80 (32.3%)	27 (30.3%)	44 (43.1%)	9 (5.8%)		71 (37.2%)
N/A	4 (1.6%)	2 (2.2%)	2 (2.0%)	0 (0.0%)		4 (2.1%)
Procedure type					< 0.001		< 0.001
De novo	158 (63.7%)	33 (20.9% de novo)	68 (43.0% de novo)	57 (36.1% de novo)		101 (63.9% de novo)
Re-operative	90 (36.3%)	56 (62.2% re-op)	34 (37.8% re-op)	0 (0.0% re-op)		90 (100% re-op)
Infection risk factors					< 0.001		< 0.001
0-1	65 (26.2%)	14 (15.7%)	22 (21.6%)	29 (50.9%)		36 (18.8%)
≥ 2	183 (73.8%)	75 (84.3%)	80 (78.4%)	28 (49.1%)		155 (81.2%)
Hematoma (total)	6 (2.4%)	5 (5.6%)	1 (1.0%)	0 (0.0%)	0.046	6 (3.0%)	0.176
Requiring intervention	6 (2.4%)	5 (5.6%)	1 (1.0%)	0 (0.0%)		6 (3.0%)
Infection
Pocket infection	1 (0.4%)	1 (1.1%)	0 (0.0%)	0 (0.0%)	0.408	1 (0.5%)	0.584
Minor infection	1 (0.4%)	1 (1.1%)	0 (0.0%)	0 (0.0%)	0.408	1 (0.5%)	0.584

¹P value across 3 cohorts: Biologic, non-biologic, and no envelope.

²P value across 2 cohorts: Any envelope and no envelope.

Values are reported as: n (%) unless specified otherwise. BMI: Basal metabolic index; CIED: Cardiovascular implantable electronic device; CRT-D: Cardiac resynchronization therapy/defibrillator; CRT-P: Cardiac resynchronization therapy/pacemaker; ICD: Implantable cardioverter defibrillator; N/A: Not applicable; S-ICD: Subcutaneous implantable cardioverter defibrillator; SD: Standard deviation.