Table 4.
Intervention (no. of papers) | Type of Study, Surgery | Author (year) [reference]1* | No.2† | Inflammatory Biomarker(S) Suppressed Yes–No: Biomarker3‡ | Clinical Benefit Yes–No: Outcome Modified | Comment |
Heparin coating (9) | RCT, CABG | Heyer (2002) [20]4* | 265† | Yes: C3a6‡ | Yes: cognitive function | Significantly improved cognitive dysfunction but no other clinical changes; mild benefit |
RCT, CABG | Svenmarker (2002) [21] | 256 | Yes: WBC | Yes: neurologic deviation | No difference in mortality, ventilator time or ICU stay, but significantly less neurological deviation; mild benefit | |
RCT, CABG | De Vroege (2004) [22] | 26 | Yes: C3b | Yes: pulmonary shunt | Decreased pulmonary vascular resistance and pulmonary shunt; no other clinical changes | |
RCT, mixed valve/CABG | Ueyama (2004) [23] | 10 | Yes: IL-6, CRP, bradykinin | Yes: A-a O2 gradient | Two intervention groups: heparin and poly-2-methoxyethyl acrylate (PMEA) coating; both improved the A-a O2 gradient | |
RCT, mixed valve/CABG | Lindholm (2004) [24] | 21 | Yes: IL-8, NE, C5b-9 | No | No statistically significant change in ICU or respirator time or inotrope support; no myocardial protection (Tn T) | |
RCT, CABG | Baufreton (2005) [25] | 12 | Yes: C5b-9 | No | No statistically significant improvements in prespecified neurological outcomes | |
RCT, mixed valve/CABG | Vanden Eynden (2008) [26] | 99 | No | No | No myocardial protection (CK-MB); no change in ICU stay, intubation time, or other hard clinical end points | |
RCT, CABG | Mirow (2011) [27] | 21 | Yes: TAT | No | No change in neurological lesions by diffusion-weighted imaging; no change in ICU stay or other clinical outcomes | |
RCT, CABG | Baufreton (2011) [28] | 12 | Yes: C5b-9 | No | No statistically significant differences between groups in hard clinical end points | |
Heparin head-to-head | RCT, mixed valve/CABG | Hoel (2004) [29] | 15 | N/A7§ | N/A | No control group in this heparin head-to-head trial; no difference in inflammatory markers or clinical outcomes |
Poly-2-methoxyethylacrylate (4) | RCT, mixed valve/CABG | Ueyama (2004) [23] | 10 | Yes: IL-6, CRP, bradykinin | Yes: A-a O2 gradient | Two intervention groups: heparin and PMEA coating; both improved the A-a O2 gradient significantly |
RCT, CABG | Skrabal (2006) [30] | 19 | Yes: NE | Yes: neurocognitive function | Significant improvement in neurocognitive function (Go/NoGo and Mini-Mental-test); Nn change in ICU stay; mild benefit | |
RCT, mixed valve/CABG | Ninomiya (2003) [31] | 11 | Yes: C3a, NE | No | No improvement in ICU stay or intubation time; no clinical benefit | |
RCT, CABG | Thiara (2011) [32] | 15 | No | No | No benefit of PMEA over phosphorylcholine as control; no difference in ICU stay | |
Amphophilic silicone-caprolactone oligomer (1) | RCT, CABG | Allen (2005) [33] | 20 | Yes: IL-10 | No | No difference between groups in creatinine, urea, or N-acetyl glucosamine; no change in intubation time or ICU stay |
Minimized extracorporeal circuit (8) | RCT, CABG | Kofidis (2008) [34] | 50 | Yes: IL-8 | Yes: ventilator time, cTnI | Improved myocardial protection (Tn I) and ventilator time in minigroup |
RCT, CABG | Gunaydin (2009) [35] | 20 | Yes: IL-6, C3a, CD11b | Yes: ICU, O2sat. cerebral, CK-MB | Significantly improved ICU stay, myocardial protection (CK-MB), cerebral oxygen saturation, and intubation time | |
RCT, CABG | Rimpilainen (2011) [36] | 18 | Yes: IL-6, IL-8, TNFα, NE, C3a | Yes: ICU stay, cerebral emboli | Significantly decreased ICU time and microemboli by retinal fluorography in minigroup | |
RCT, valve | Tanaka (2003) [37] | 9 | No | No | Closed cardiopulmonary bypass circuit does not improve any prespecified clinical endpoints in this small study | |
Intervention (no. of papers) | Type of Study, Surgery | Author (year) [reference]8* | No.9† | Inflammatory Biomarker(S) Suppressed Yes–No: Biomarker10‡ | Clinical Benefit Yes–No: Outcome Modified | Comment |
RCT, CABG | Abdel-Rahman (2005) [38] | 101 | Yes: NE, C5b-9 | No | No change in ICU duration or other clinical end points in mini-group | |
RCT, CABG | Rex (2006) [39] | 15 | No | No | No improvement in myocardial injury marker (Tn T) in minigroup | |
RCT, CABG | Huybregts (2007) [40] | 25 | Yes: IL-6, thromboxane B2 | No | No statistically significant improvements in ICU stay or prespecified clinical end points | |
RCT, CABG | Ohata (2008) [41] | 34 | Yes: IL-8, NE | No | No change in any reported clinical outcomes | |
Leukocyte-depleting filter (8) | RCT, CABG | Alexiou (2004) [42] | 25 | Yes: WBC, oxidative burst | Yes: A-a O2 gradient | Arterial line leuko-depleting filter; improved A-a O2 gradient; no other clinical changes; mild benefit |
RCT, CABG | Gunaydin (2009) [43] | 10 | Yes: IL-6, C3a, CD11b | Yes: CK-MB | Dual filter approach (continuous and after x-clamp) provided significant myocardial protection (CK-MB) | |
RCT, valve | Zhang (2010) [44] | 26 | No | No | Arterial line filter improved myocardial protection and respiratory index but increased inflammatory cytokines | |
RCT, valve | Hayashi (2003) [45] | 10 | Yes: NE, oxidative stress | No | Cardioplegia leukocyte-depleting filter placed after oxygenator reservoir did not change clinical outcomes | |
RCT, mixed valve/CABG | Chen (2004) [46] | 16 | Yes: IL-8, sP-sel., sICAM, ox. stress | No | Arterial line filter did not improve prespecified clinical endpoints | |
RCT, valve/CABG | Koskenkari (2006) [47] | 10 | No | No | Arterial line filter did not improve ICU stay or clinical end points; neutrophil activation noted in filter group | |
RCT, valve/CABG | Soo (2010) [48] | 20 | No | No | Arterial line filter did not improve ICU stay or clinical end points; leukocyte activation noted in filter group | |
RCT, CABG | Rubino (2011) [49] | 41 | No | No | Continuous arterial line plus cardioplegia filters did not improve myocardial markers or ICU stay | |
Ultrafiltration (3) | RCT, CABG | Tallman (2002) [50] | 15 | No | No | Zero balance ultrafiltration; no change ventilator or ICU time; paradoxical rise in plasma inflammatory markers |
RCT, mixed valve/CABG | Oliver (2004) [51] | 62 | No | No | Ultrafiltration; no clinical benefit in pulmonary function or other prespecified outcomes | |
RCT, CABG | Torina (2010) [52] | 20 | No | No | Modified ultrafiltration demonstrated no change in A-a O2 gradient; no benefit | |
Pericardial blood processing (1) | RCT, CABG | Marcheix (2008) [53] | 25 | No | No | Blood processing with cell saving device did not significantly improve ICU length of stay or other hard clinical end points |
Discard mediastinal blood (1) | RCT, CABG | Westerberg (2004) [54] | 17 | Yes: IL-8, TNFα | No | Discarding mediastinal and cardiotomy suction blood had no effect on adverse events or myocardial marker (TnT) |
Number in square bracket refers to reference number in the Appendix B.
N, number of subjects in treatment group.
Abbreviations used: RCT, randomized controlled trial; CABG, coronary artery bypass grafting; WBC, white blood cell count; IL, interleukin; CRP, C-reactive protein; TNF, tumor necrosis factor; NE, neutrophil elastase; TAT, thrombin antithrombin; sP-sel., soluble P-selectin; sICAM, soluble ICAM-1; A-a O2, arterial–alveolar oxygen gradient; CK-MB, creatine kinase MB fraction; cTn, cardiac-specific troponin.
N/A, not appropriate.