Table 3.
Prospective + retrospective studies |
Prospective studies only |
|||||||
---|---|---|---|---|---|---|---|---|
Factor | Studies (n) | Total (n) | Pooled estimate | P-value | Studies (n) | Total (n) | Pooled estimate | P-value |
Patient-related factors | ||||||||
ESRDa | 8 | 3045 | 8.73 [3.42, 22.31] | 0.00001 | NA | |||
History of device infection | 4 | 463 | 7.84 [1.94, 31.60] | 0.004 | NA | |||
Fever prior to implantation | 3 | 6652 | 4.27 [1.13, 16.12] | 0.03 | 2 | 6580 | 5.34 [1.002, 28.43] | 0.05 |
Corticosteroid use | 10 | 3432 | 3.44 [1.62, 7.32] | 0.001 | 3 | 1349 | 2.10 [0.47, 9.32] | 0.33 |
Renal insufficiencyb | 5 | 2033 | 3.02 [1.38, 6.64] | 0.006 | NA | |||
COPD | 6 | 2810 | 2.95 [1.78, 4.90] | 0.00003 | 2 | 2393 | 2.30 [0.97, 5.48] | 0.06 |
NYHA class ≥ 2 | 3 | 2447 | 2.47 [1.24, 4.91] | 0.01 | 2 | 2393 | 2.77 [1.26, 6.05] | 0.01 |
Skin disorders | 4 | 6810 | 2.46 [1.04, 5.80] | 0.04 | 2 | 6519 | 2.60 [0.88, 7.70] | 0.08 |
Malignancy | 6 | 1555 | 2.23 [1.26, 3.95] | 0.006 | NA | |||
Diabetes mellitus | 18 | 11839 | 2.08 [1.62, 2.67] | <0.000001 | 7 | 9815 | 1.88 [1.19, 2.98] | 0.007 |
Heparin bridging | 2 | 6373 | 1.87 [1.03, 3.41] | 0.04 | NA | |||
CHF | 6 | 1277 | 1.65 [1.14, 2.39] | 0.008 | NA | |||
Oral anticoagulants | 9 | 8527 | 1.59 [1.01, 2.48] | 0.04 | 3 | 7271 | 1.18 [0.44, 3.11] | 0.75 |
Procedure-related factors | ||||||||
Procedure duration | 9 | 4850 | 9.89 [0.52, 19.25] | 0.04 | 6 | 4508 | 13.04 [-0.64, 26.73] | 0.06 |
Haematoma | 12 | 14228 | 8.46 [4.01, 17.86] | <0.000001 | 6 | 9715 | 9.33 [2.84, 30.69] | 0.0002 |
Lead repositioning | 5 | 1755 | 6.37 [2.93, 13.82] | 0.000003 | 4 | 1659 | 7.03 [2.49, 19.85] | 0.0002 |
Inexperienced operatorc | 2 | 1715 | 2.85 [1.23, 6.58] | 0.01 | 2 | 1715 | 2.85 [1.23, 6.58] | 0.01 |
Temporary pacing | 10 | 10683 | 2.31 [1.36, 3.92] | 0.002 | 4 | 8683 | 3.29 [1.87, 5.80] | 0.00004 |
Device replacement/revision/upgrade | 26 | 21214 | 1.98 [1.46, 2.70] | 0.00001 | 8 | 8793 | 0.95 [0.49, 1.87] | 0.89 |
Generator change | 20 | 12134 | 1.74 [1.22, 2.49] | 0.002 | 6 | 2139 | 0.91 [0.37, 2.22] | 0.83 |
Antibiotic prophylaxis | 16 | 14166 | 0.32 [0.18, 0.55]d | 0.00005 | 11 | 10864 | 0.29 [0.13, 0.63] | 0.002 |
Device-related factors | ||||||||
Epicardial leads | 3 | 623 | 8.09 [3.46, 18.92] | 0.000001 | NA | |||
Abdominal pocket | 7 | 4017 | 4.01 [2.48, 6.49] | <0.000001 | 2 | 2268 | 5.03 [1.96, 12.91] | 0.0008 |
≥2 leads | 6 | 1146 | 2.02 [1.11, 3.69] | 0.02 | NA | |||
Dual-chamber device | 14 | 45224 | 1.45 [1.02, 2.05] | 0.04 | 7 | 12102 | 1.28 [0.73, 2.25] | 0.38 |
Risk parameters which were statistically significant for retrospective and prospective data are shown. Analyses restricted to prospective data only for the same parameters (if available) are also shown. Adapted from Polyzos et al.21
CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; ESRD, end-stage renal disease; NA, not available; NYHA, New York Heart Association.
GFR ≤15 mL/min or haemodialysis or peritoneal dialysis.
Glomerular filtration rate (GFR) <60 mL/min or creatinine clearance (CrCL) <60 mL/min.
<100 previous procedures.
The pooled effect estimate from randomized studies was 0.26 [0.13, 0.52].