Table 1.
Characteristics of patients with and without complications
| Complication or in-hospital death* | P-value | ||
|---|---|---|---|
| No (N=236,244) | Yes (N=4,388) | ||
| Admission characteristics | |||
| Age, mean ± SD | 67.3±13.2 | 68.4±13.2 | <0.0001 |
| Female, N (%) | 64,205 (27.2%) | 1459(33.9%) | <0.0001 |
| Reason for admission, N (%) | <0.0001 | ||
| Admitted for procedure | 173,561 (73.6%) | 2304 (52.7%) | |
| Heart failure | 19,325 (8.2%) | 731 (16.7%) | |
| Other | 42,819 (18.2%) | 1336 (30.6%) | |
| History of heart failure, N (%) | <0.0001 | ||
| No | 136,357 (57.9%) | 2218 (50.6%) | |
| Yes – HF hospitalization within 6 months | 36,639 (15.6%) | 1112 (25.4%) | |
| Yes – no HF hospitalization within 6 months |
62,456 (26.5%) | 1050 (24.0%) | |
| NYHA class, N (%) | <0.0001 | ||
| I/II | 121,884(51.8%) | 1489 (34.6%) | |
| III | 106,680 (45.4%) | 2652 (58.6%) | |
| IV | 6665 (2.8%) | 319 (7.3%) | |
| Non-ischemic dilated cardiomyopathy, N (%) |
79,587 (33.8%) | 1682 (38.4%) | <0.0001 |
| Syncope, N (%) | 38,212 (16.2%) | 799 (18.2%) | 0.0003 |
| Atrial fibrillation/flutter, N (%) | 84,992 (36.0%) | 1748 (39.8%) | <0.0001 |
| Ventricular tachycardia, N (%) | 90,193 (38.2%) | 1611 (36.8%) | 0.0483 |
| Cardiac arrest, N (%) | 22,004 (9.3%) | 515 (11.7%) | <0.0001 |
| Previous ICD, N (%) | 96,587 (40.9%) | 943 (21.5%) | <0.0001 |
| Previous pacemaker, N (%) | 25,322 (10.7%) | 562 (12.8%) | <0.0001 |
| Prior myocardial infarction, N (%) | 119,904 (50.8%) | 2103 (48.0%) | 0.0002 |
| Prior PCI, N (%) | 76,604 (32.5%) | 1405 (32.0%) | 0.5542 |
| Prior CABG, N (%) | 77,955 (33.0%) | 1266 (28.9%) | <0.0001 |
| Primary valvular heart disease, N (%) | 28,610 (12.1%) | 674 (15.4%) | <0.0001 |
| Cerebrovascular disease, N (%) | 37,324 (15.8%) | 806 (18.4%) | <0.0001 |
| Diabetes, N (%) | 89,436 (37.8%) | 1734 (39.6%) | 0.0233 |
| Currently on dialysis, N (%) | 6373 (2.7%) | 243 (5.5%) | <0.0001 |
| Chronic lung disease, N (%) | 50683 (21.5%) | 1180 (26.9%) | <0.0001 |
| Hypertension, N (%) | 184876 (78.3%) | 3503 (79.9%) | 0.0139 |
| Sleep apnea, N (%) | 28526(12.1%) | 550 (12.6%) | <0.0001 |
| Diagnostics | |||
| Cardiac rhythm, N (%) | <0.0001 | ||
| Sinus | 153546 (65.2%) | 2866 (65.5%) | |
| Atrial fibrillation/flutter | 34027 (14.5%) | 789 (18.0%) | |
| Paced | 44698 (19.0%) | 586 (13.4%) | |
| Atrioventricular block (2nd and 3rd
degree) |
1606 (0.7%) | 77 (1.8%) | |
| 1487 (0.6%) | 57(1.3%) | ||
| Other | |||
| Abnormal conduction, N (%) | <0.0001 | ||
| No | 110141 (46.8%) | 1556 (35.6%) | |
| Yes – left bundle branch block | 52957 (22.5%) | 1417 (32.4%) | |
| Yes – other | 72114 (30.7%) | 1402 (32.0%) | |
| Procedure type, N (%) | <0.0001 | ||
| Initial implant | 139630 (59.2%) | 3445 (78.5%) | |
| Generator replacement-end of battery life | 80790 (34.2%) | 463 (10.6%) | |
| Generator replacement-infection | 1943 (0.8%) | 83 (1.9%) | |
| Generator replacement-device relocation | 379 (0.2%) | 11 (0.3%) | |
| Generator replacement-upgrade | 10151 (4.3%) | 312 (7.1%) | |
| Generator replacement-malfunction | 912 (0.4%) | 20 (0.5%) | |
| Generator change-other | 2134 (0.9%) | 52 (1.2%) | |
| ICD type, N (%) | <0.0001 | ||
| Single chamber | 45312 (19.2%) | 514 (11.7%) | |
| Dual chamber | 90585 (38.4%) | 1459 (33.3%) | |
| CRT-D | 99875 (42.4%) | 2404 (54.9%) | |
| Body mass index, mean ± SD | 29.8 ± 13.5 | 29.3 ± 14.5 | 0.0182 |
| Left ventricular ejection fraction†, mean ± SD |
30.4 ± 12.7 | 27.7 ± 11.5 | <0.0001 |
| Systolic blood pressure mmHg, mean ± SD |
131.6 ± 22.7 | 129.2 ± 23.3 | <0.0001 |
| Hemoglobin g/dL, mean ± SD | 13.1 ± 2.0 | 12.5 ± 2.1 | <0.0001 |
| Glomerular filtration rate, mean ± SD | 65.1 ± 25.7 | 60.3 ± 27.5 | <0.0001 |
| Blood urea nitrogen mg/dL, mean ± SD | 23.7 ± 13.0 | 27.5 ± 16.9 | <0.0001 |
| Sodium mEq/L, N (%) | <0.0001 | ||
| <135 | 22316 (9.6%) | 683 (15.7%) | |
| 135-145 | 207895 (89.4%) | 3608 (83.0%) | |
| >145 | 2305 (1.0%) | 58 (1.3%) | |
| Potassium mEq/L, N (%) | 0.0009 | ||
| <3.5 | 7829 (3.4%) | 189 (4.3%) | |
| 3.5-4.5 | 167388 (71.9%) | 3128 (71.9%) | |
| >4.5 | 57627 (24.7%) | 1031 (23.7%) | |
*
Complications: include any of the following: cardiac arrest, cardiac perforation, coronary venous dissection, hemothorax, device-related infection, lead dislodgement, myocardial infarction, pericardial tamponade, pneumothorax, stroke/transient ischemic attack, urgent cardiac surgery, hematoma, or set screw problem.
†
Ejection fraction data missing for 8.8% of patients
Abbreviations: CABG = coronary artery bypass grafting, CRT-D = cardiac resynchronization therapy with defibrillation, HF = heart failure, ICD = implantable cardioverter-defibrillator, NYHA = New York Heart Association, PCI = percutaneous coronary intervention, SD = standard deviation