Table 1.
Baseline and procedure characteristics
| Characteristics | Acute hematoma (N = 151) | No hematoma (N = 6649) | Total (N = 6800) |
|---|---|---|---|
| Female | 26 (17.2%) | 1890 (28.4%) | 1916 (28.2%) |
| Age (years) | 72.1 ± 11.5 | 70.0 ± 12.5 | 70.1 ± 12.4 |
| BMI (kg/m2) | 27.4 ± 6.0 | 29.2 ± 6.2 | 29.2 ± 6.2 |
| Medical history | |||
| Cardiomyopathy | 112 (74.2%) | 4521 (68.0%) | 4633 (68.1%) |
| Ischemic | 64 (42.4%) | 2337 (35.1%) | 2401 (35.3%) |
| Non-Ischemic | 48 (31.8%) | 2018 (30.4%) | 2066 (30.4%) |
| Hypertrophic | 2 (1.3%) | 257 (3.9%) | 259 (3.8%) |
| Coronary artery disease | 82 (54.3%) | 2780 (41.8%) | 2862 (42.1%) |
| Myocardial infarction | 47 (31.1%) | 1831 (27.5%) | 1878 (27.6%) |
| COPD | 26 (17.2%) | 828 (12.5%) | 854 (12.6%) |
| Diabetes | 41 (27.2%) | 2068 (31.1%) | 2109 (31.0%) |
| Renal dysfunction or failure | 37 (24.5%) | 1069 (16.1%) | 1106 (16.3%) |
| Vascular disease | 21 (13.9%) | 569 (8.6%) | 590 (8.7%) |
| Stroke | 30 (19.9%) | 985 (14.8%) | 1015 (14.9%) |
| Cardiovascular surgical history | |||
| CABG | 43 (28.5%) | 1411 (21.2%) | 1454 (21.4%) |
| Valve surgery | 33 (21.9%) | 570 (8.6%) | 603 (8.9%) |
| No. of previous CIEDs | 1.6 ± 1.3 | 1.3 ± 1.1 | 1.3 ± 1.1 |
| Medication use | |||
| Antiplatelets | 100 (66.2%) | 4009 (60.3%) | 4109 (60.4%) |
| Antibiotics | 25 (16.6%) | 1120 (16.8%) | 1145 (16.8%) |
| Insulin | 15 (9.9%) | 775 (11.7%) | 790 (11.6%) |
| Anticoagulants | 100 (66.2%) | 2868 (43.1%) | 2968 (43.6%) |
| Heart failure/NYHA classifications | |||
| NYHA class I | 9 (6.0%) | 558 (8.4%) | 567 (8.3%) |
| NYHA class II | 42 (27.8%) | 1870 (28.1%) | 1912 (28.1%) |
| NYHA class III | 34 (22.5%) | 1465 (22.0%) | 1499 (22.0%) |
| NYHA class IV | 1 (0.7%) | 49 (0.7%) | 50 (0.7%) |
| Subject does not have heart failure | 29 (19.2%) | 1290 (19.4%) | 1319 (19.4%) |
| Class not available | 36 (23.8%) | 1417 (21.3%) | 1453 (21.4%) |
| Capsulectomy | |||
| None/new system | 76 (50.3%) | 3991 (60.0%) | 4067 (59.8%) |
| Partial† | 65 (43.0%) | 2325 (35.0%) | 2390 (35.1%) |
| Complete† | 10 (6.6%) | 330 (5.0%) | 340 (5.0%) |
| Procedure reason | |||
| Generator replacement w/o lead modification | 80 (53.0%) | 4191 (63.0%) | 4271 (62.8%) |
| Generator replacement w/ lead modification | 13 (8.6%) | 438 (6.6%) | 451 (6.6%) |
| Device upgrade (w/ or w/o lead modification) | 38 (25.2%) | 812 (12.2%) | 850 (12.5%) |
| Pocket or lead revision | 2 (1.3%) | 67 (1.0%) | 69 (1.0%) |
| Procedure time (hours) | 1.1 ± 0.9 | 0.9 ± 0.8 | 0.9 ± 0.8 |
| Unconnected leads | 35 (23.2%) | 894 (13.4%) | 929 (13.7%) |
Data are reported as n (%) or mean ± SD.
BMI = body mass index; CABG = coronary artery bypass graft; CIED = cardiac implantable electronic device; COPD = chronic obstructive pulmonary disease; NYHA = New York Heart Association; w/ = with; w/o = without.
†
For the main analysis model, “partial” and “complete” capsulectomy were combined.