Leucodepleción para pacientes sometidos a cirugía valvular cardíaca
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias adicionales
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Randomised controlled trial. Number of centres and blinding not stated | |
| Participants | 24 adult patients undergoing coronary artery bypass grafting (CABG), heart valve replacement, or repair of a congenital heart defect randomised (leukodepletion filter (LD) 12, control filter 12) Baseline characteristics: mean age 60 years, 88% male, 21 CABG, 2 valve replacement, 1 congenital heart defect Inclusion: not stated Exclusion: infection, reoperation, emergency operation | |
| Interventions | Same standard anaesthesia and CPB regimens used in both groups. Median sternotomy, 300 units/kg sodium heparin intravenously prior to CPB using a disposable membrane oxygenator. Moderate systemic hypothermia Leukodepletion: Pall LG6 arterial line filter Control: standard arterial line filter (no detail) | |
| Outcomes | Intra‐operative: CPB time Total white blood cell count (WBC) 103/mm3, neutrophil counts of CD11a, CD11b, CD11c and L‐selectin Blood samples collected from at 7 time points: 1. after anaesthesia before sternotomy, 2‐4. After 10, 30, 60 minutes of CPB, 5. conclusion of CPB, 6. 5 mins after administration of protamine, 7. 2 hours after cessation of CPB. | |
| Notes | First author emailed requesting outcome data for valve patients alone | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Low risk | Data reported for all patients |
| Selective reporting (reporting bias) | Low risk | All collected data reported |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Study characteristics | ||
| Methods | Randomised controlled trial. Number of centres and blinding not stated | |
| Participants | 32 consecutive adult patients undergoing coronary artery bypass grafting (CABG) or heart valve operation (leukodepletion filter (LD) 16, control filter 16). Baseline characteristics: mean age 61 years, 81% male, 31 CABG, 1 valve replacement Inclusion: not stated Exclusion: prior cardiac operation, infection, emergency operation, congestive heart failure, acute myocardial infarction in past month, corticosteroid therapy, severe asthma, COPD | |
| Interventions | Identical anaesthetic and monitoring techniques were used in both groups. Median sternotomy, 300 units/kg sodium heparin intravenously prior to CPB using a disposable membrane oxygenator. Uncoated extracorporeal circuit. Moderate systemic hypothermia. Leukodepletion: Pall LG6 arterial line filter Control: standard arterial line filter (no detail) | |
| Outcomes | Intra‐operative: CPB time Total white blood cell count (WBC) 103/mm3,neutrophil count, plasma concentrations of P‐selectin, ICAM‐1, IL‐8, PECAM‐1, oxygen index (before and after CPB), duration of post‐operative intubation and mediastinal drainage (cumulative after 24hrs in ICU). Blood samples collected at 7 time points: 1. after anaesthesia before sternotomy, 2‐3. After 30 and 60 minutes of CPB, 4. five minutes after coronary reperfusion, 5. conclusion of CPB, 6‐7. two and 24 hours after cessation of CPB. | |
| Notes | No valve patients in the control group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Low risk | Data reported for all patients |
| Selective reporting (reporting bias) | Low risk | All collected data reported |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Study characteristics | ||
| Methods | Randomised controlled trial. Number of centres and blinding not stated | |
| Participants | Sept 1999‐Mar 2000 80 adult patients electively undergoing coronary artery bypass grafting (CABG) or heart valve replacement or both (leukodepletion filter (LD) 40, control filter 40) Baseline characteristics: mean age 61 years, 74% male, 65 CABG, 11 valve replacement, 3 both. EF<30% 5 pts, EF 30‐50% 25 pts, EF>50% 37 pts Inclusion: not stated Exclusion: chronic renal failure, chronic pulmonary disease, malignancies and reoperation. Acetylsalicylic acid discontinued 8 days before operation | |
| Interventions | Identical monitoring techniques were used in both groups. Median sternotomy, 300 units/kg sodium heparin prior to CPB using a membrane oxygenator primed with aprotinin. Moderate systemic hypothermia. After CPB all residual blood from the CPB machine was reinfused via the relevant arterial line filters in each group Leukodepletion: Pall LG6 arterial line filter Control: standard Pall arterial line filter | |
| Outcomes | Intra‐operative: CPB time White blood cell count (WBC) 109/L andplatelet counts pre‐operatively, 2, 18, 42 and 66 hours after CPB,mean adrenaline dose in first 12 hours and catecholamine dose,oxygenation index every 2 hours for 14 hours, ventilation time (hours), ICU stay (hours), chest tube drainage (ml/24hrs), units packed red cells, urine output (ml/24hrs), hospital stay (days), number of pts with: wound infection, perioperative infarction, pulmonary atelectasis, arrhythmias, AF, VF or VT. | |
| Notes | First author emailed requesting outcome data for valve patients alone | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Data reported for all patients |
| Selective reporting (reporting bias) | Unclear risk | All collected data reported |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Study characteristics | ||
| Methods | Randomised controlled trial. Number of centres and blinding not stated | |
| Participants | 28 adult patients undergoing open heart valvular surgery (leukodepletion filter (LD) 14, control filter 14) Baseline characteristics: mean age 54 years, gender not stated, all valve surgery, no difference in pre‐operative variables (body surface area, type of cardiac disease, haemoglobin and neutrophil count). Mean pre‐operative fractional shortening <30% in both groups. Inclusion: not stated Exclusion: abnormal pre‐operative lung function (pre‐op arterial blood gases, chest x‐ray and pulmonary function) | |
| Interventions | All patients on same CPB circuit (no detail) except for filter. Systemic cooling to 28°C Leukodepletion: Pall LG6 arterial line filter after aortic declamp Control: Pall Auto Vent‐SV filter | |
| Outcomes | Intra‐operative: aortic cross‐clamp time, CPB time White blood cell count (WBC), CK‐MB and lipid peroxide; pre‐op, in first hour (5/15/30/45/60/pump off (min), 3, 6, 12 and 24 hrs after reperfusion. Cardiac index and percent fraction shortening pre‐ and post‐op. Catecholamine dose after surgery. Pulmonary index pre‐op, 3, 6, 12 and 24 hours after reperfusion. Chest tube drainage, blood product usage, post‐operative chest x‐rays. Post‐operative infections | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Number of patients per outcome or withdrawal and completion rates not reported |
| Selective reporting (reporting bias) | Low risk | All collected data reported |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Study characteristics | ||
| Methods | Randomised controlled trial. Single centre, investigators blinded to intervention | |
| Participants | July 1993‐Jun 1994 24 adult patients electively undergoing open heart valve surgery (leukodepletion filter (LD) 11, control filter 13) Baseline characteristics: mean age 62 years, 46% male, all valve surgery. EF<50% 9 pts, 13 pts cough, 11 pts past smoker, 22 pts dyspnoea grade 1‐4 Inclusion: not stated Exclusion: informed consent unobtainable, emergency surgery | |
| Interventions | All patients followed to discharge. Surgery and anaesthesia according to usual practice of 2 participating surgeons. Systemic cooling to 24‐28°C. No CPB details Leukodepletion: Pall LG6 arterial line filter Control: Pall Autovent SP filter | |
| Outcomes | Intra‐operative: aortic cross‐clamp time, CPB time, fluid balance, mediastinal blood loss Haemodynamics and blood samples, pre‐op, after anaesthetic induction, at aortic x‐clamp, 1/4/24 hrs post‐op. systemic arterial pressure, right arterial pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac index, blood gases, oxygen saturation, WBC count, neutrophil count, platelet count, IL‐6SR, CD11b, CD18. Weight, chest x‐ray, fluid balance, FEV1 & FVC on 2nd and 5th post‐op day and discharge. Echocardiography, fractional shortening, ejection fraction, wall motion abnormalities and atelectasis measured pre‐op and on discharge. Number of MIs. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Number of patients per outcome or withdrawal and completion rates not reported |
| Selective reporting (reporting bias) | Unclear risk | All collected data reported |
| Blinding of participants and personnel (performance bias) | Low risk | Investigators blinded to intervention |
| Blinding of outcome assessment (detection bias) | Unclear risk | Some outcome assessments blinded (atelectasis and wall motion) |
| Study characteristics | ||
| Methods | Randomised controlled trial. Single centre. Stratified by risk (Parsonnet score) | |
| Participants | June 2003‐Dec 2003 162 adult patients electively undergoing cardiac surgery (leukodepletion filter (LD) 54, control filter 108) Baseline characteristics: mean age 61 years, 62% male, 57 CABG, 94 valve surgery, 8 congenital defect. Mean Parsonnet score 6 EF<50% 9 pts Inclusion: Low risk (Parsonnet score ≤ 10) Exclusion: urgent surgery, high risk (Parsonnet score > 10), abnormal pre‐operative pulmonary function (COPD, severe pulmonary hypertension), severe pre‐operative cardiac dysfunction (EF <40%, left main coronary artery disease, intra‐aortic balloon pump prior to surgery), pre‐operative anaemia (haemoglobin <110 g/L), haemostatic dysfunction (platelet count <200x109,thrombin or partial thromboplastin time >1.5 control), fever or infection symptoms before surgery | |
| Interventions | Stratified into 3 groups by Parsonnet score (low<4, middle 4‐7, high 8‐10) then within‐strata 2:1 ratio randomisation into control or filter group. Perfusion and CPB using a disposable membrane oxygenator (primed with aprotinin for valve patients) were the same for all patients except for the arterial line filter. Filtration at start of CPB until end of procedure. Systemic cooling to 31°C Leukodepletion: Pall LG6 arterial line filter Control: standard arterial line filter (no details) | |
| Outcomes | Intra‐operative: aortic cross‐clamp time, CPB time Morbidity using surrogate variables (length of stay in ICU, pulmonary function (intra‐op, after 1 and 4 hrs in ICU), cardiac function (perioperative ischemia, EF, cardiac output, post‐op heart failure, cardiac enzymes (highest in 24 hrs), incidence of peri‐operative infections (pneumonia, mediastinitis, sepsis), fever and hyperdynamic circulatory states. Leucocyte and platelet counts, and haemoglobin levels measured pre‐op, aortic de‐clamp, conclusion of CPB, after 1 and 12 hrs in ICU | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | 2:1 ratio block (block size not reported) randomisation |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered identical containers |
| Incomplete outcome data (attrition bias) | High risk | 2 pts withdrew from LD group and 1 withdrew from control group, reasons not reported. All outcome data reported per protocol |
| Selective reporting (reporting bias) | Unclear risk | All collected data reported |
| Blinding of participants and personnel (performance bias) | Unclear risk | Abstract states 'blind' study but not described or mentioned in main text |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Study characteristics | ||
| Methods | Randomised controlled trial. Number of centres and blinding not stated | |
| Participants | 36 adult patients electively undergoing open heart surgery for coronary artery disease or aortic valvular disease (leukodepletion filter (LD) 18, control filter 18) Baseline characteristics: mean age 64 years, gender not stated, number of valve patients not stated Inclusion: normal pre‐operative lung function (pre‐op arterial blood gases, chest x‐rays, pulmonary function) Exclusion: abnormal pre‐operative lung function (as above), EF not reported | |
| Interventions | All patients on same CPB circuit (no detail) except for filter. Systemic cooling to 28°C. Leukodepletion: Pall LG6 arterial line filter Control: Pall EC‐Plus filter | |
| Outcomes | Intra‐operative: aortic cross‐clamp time, CPB time, urine output, blood and blood products used White blood cell counts (103/mm3) including elastase concentrations (μg/L) measured pre‐op, immediately post‐op, 4 and 24 hrs post‐op, platelet measured as % drop from pre‐op to immediately post‐op and 4 hrs post‐op, haemoglobin (g/dl) measured pre‐op, post‐bypass, immediately post‐op, 4 and 24 hrs post‐op, urine output (L/24hrs), chest tube drainage (ml/24 hrs), blood usage (units/1st 24 hrs), chest x‐rays, arterial blood gases (pCO2 and pO2 (mmHg) measured pre‐op, post‐bypass and post‐extubation, ventilator (hrs), ICU (hrs), systemic and pulmonary vascular resistance, 1st 24 hr post‐op body temperature | |
| Notes | First author emailed requesting outcome data for valve patients alone. Author replied that data are no longer available | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Number of patients per outcome or withdrawal and completion rates not reported |
| Selective reporting (reporting bias) | Low risk | All collected data reported |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Study characteristics | ||
| Methods | Randomised controlled trial. Single centre. Blinded investigators | |
| Participants | 40 adult patients undergoing elective CABG or valvular heart surgery (leukodepletion filter (LD) 20, control filter 20) Baseline characteristics: mean age 62 years, 73% male, 18 CABG, 19 valve, 3 both, EF good/moderate/poor (no definition) Inclusion: not stated Exclusion: active infection, emergency operation, pre‐operative corticosteroid therapy, severe asthma or COPD | |
| Interventions | Similar anaesthetic and monitoring techniques were used in both groups. Median sternotomy, 300 units/kg sodium heparin intravenously prior to CPB using a membrane oxygenator primed with crystalloid solution. Mild hypothermia, 32°C Leukodepletion: Pall LG6 arterial line filter Control: standard arterial line filter (no detail) | |
| Outcomes | Intra‐operative: CPB time, aortic cross‐clamp time Bloods measured pre‐op (within 12 hrs of op), 5 mins after x‐clamp release. Total white blood cell count (WBC) (x109),% neutrophil (x109), neutrophil surface adhesion molecule expression: CD11b, CD62L, PSGL‐1. Time to extubation (hrs), duration of postoperative ventilation (hrs), respiratory index (PaO2/FiO2) before extubation (mmHg), total mediastinal chest drainage (ml) cumulatively after 24 hrs in ICU, cardiac function (CKMB‐fraction (after 24 hrs in ICU), amount and duration of inotropic support (hrs), cumulative adrenaline usage (μg/kg/hr), duration of adrenaline usage (hrs), cumulative noradrenaline usage (μg/kg/hr), duration of noradrenaline usage (hrs), highest lactate level (median), max change in serum creatinine (ratio of max post‐op to pre‐op), ICU stay (hrs) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Randomisation was achieved with sealed envelopes given to the perfusion department |
| Incomplete outcome data (attrition bias) | Low risk | Complete patient numbers reported for all outcomes indicate no study withdrawal |
| Selective reporting (reporting bias) | Low risk | All collected data reported |
| Blinding of participants and personnel (performance bias) | Low risk | A record of the filter used for each patient was kept by the perfusion staff. This record was revealed only during data analysis. All other investigators were blinded to the patient allocation |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Did not meet inclusion criteria. Blood transfusion, no filter on arterial line of cardiopulmonary bypass | |
| Not an arterial line filter. Residual blood | |
| Did not meet inclusion criteria. Ultrafiltration, no filter on arterial line of cardiopulmonary bypass | |
| Did not meet inclusion criteria. Not solely arterial line leukodepletion; also leukodepleted cardioplegia, salvaged and post‐operative blood products | |
| Did not meet inclusion criteria. Filter on venous line of cardiopulmonary bypass | |
| Did not meet inclusion criteria. Patients for coronary artery bypass graft | |
| Did not meet inclusion criteria. Patients for coronary artery bypass graft | |
| Not an RCT and did not meet exclusion criteria: mean ejection fraction; filter = 27%, control = 31% | |
| Did not meet inclusion criteria. Patients for ventricular septal defect | |
| Did not meet exclusion criteria. Patients for coronary artery bypass graft | |
| Did not meet inclusion criteria. Patients for coronary artery bypass graft | |
| Did not meet inclusion criteria. Not solely arterial line leukodepletion; also leukodepleted cardioplegia | |
| Did not meet inclusion criteria. Leukodepletion on cardioplegia circuit only | |
| Did not meet inclusion criteria. Patients for coronary artery bypass graft | |
| Did not meet inclusion criteria. Filter on venous line of cardiopulmonary bypass | |
| Did not meet inclusion criteria. In vitro study (see Soo 2010) | |
| Did not meet inclusion criteria. In vitro study (see Soo 2010) | |
| Did not meet inclusion criteria. Blood transfusion, no filter on arterial line of cardiopulmonary bypass | |
| Did not meet inclusion criteria. No leukocyte depletion filter |
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | RCT |
| Participants | 50 patients (26 LD, 24 standard filter). No detail on age, specific surgery or gender |
| Interventions | Anaesthesia, operation and CPB standardised. Pall LG6 arterial line filter versus Pall EC Plus arterial line filter. Systemic hypothermia to 28°C |
| Outcomes | Total and differential white blood cell counts measured 8 times from before start of CPB to 24 hours after CPB (pre‐op, start CPB, 15mins into CPB, 30mins into CPB, 5 mins after cross‐clamp removal, CPB+5mins, CPB+30mins, CPB+120mins, 24 hours after end of CPB) Pulmonary function: alveolar arterial oxygen gradients, compliance, clinical morbidity scale |
| Notes | Conference abstract. Unclear whether valve patients. First author emailed for further information |
| Methods | RCT |
| Participants | 40 adult patients (25 male), aged 65, undergoing CABG or valve surgery (7 relevant valve) |
| Interventions | Grp 1: Pall LG6 arterial line filter, Grp 2: Pall RS1 paired leucocyte removal filters on venous return during rewarming, Grp3: Pall RS1 leucofiltration of residual heart‐lung machine blood at transfusion after CPB, Grp4: No leucofiltration controls |
| Outcomes | Blood cell counts, arterial oxygen tension and alveolar‐arterial oxygen gradient, plasma elastase, perioperative fluid balance, use of inotropic agents, myocardial infarctions, duration of postoperative intubation, length of stay in ICU and hospital |
| Notes | Unclear whether control group included standard arterial line filters as authors state "Arterial line filters other than the one studied were not used". First author emailed for clarification |
| Methods | RCT |
| Participants | 20 adults patients (17 male), aged 70 years, undergoing valve replacement with coronary revascularisation. 10 LD and 10 control group |
| Interventions | Pall LG6 arterial line filter versus control group. Moderate systemic hypothermia 34°C |
| Outcomes | ICU stay, surgical ward stay, intubation time, arterial saturation, blood transfusion, platelet transfusion, inotropic and vasopressor support, myocardial infarction, blood cell counts, cytokine analysis |
| Notes | Unclear whether control group included standard arterial line filter as authors state LG6 used in intervention group but CPB in control conducted "without such a filter". Sixth author emailed for further information |
| Methods | Unclear. "Twenty‐six adults operated for valvular heart disease were included in this study" |
| Participants | 26 adults (12 male), aged 56, undergoing valve surgery. 13 LD and 13 control |
| Interventions | Pall LG6 arterial line leucodepletion filter verus Pall Auto Vent‐SV standard arterial line filter |
| Outcomes | Blood cell counts, elastase and lipoperoxide concentrations and oxygenation index, blood transfusions |
| Notes | Unclear whether patients were randomised to the two arms. Second author emailed for further information |
| Methods | RCT |
| Participants | 52 adult patients (20 male) aged 43 years, undergoing valve surgery. 26 LD and 26 standard filter |
| Interventions | Pall LG6 arterial line filter versus control group. Moderate systemic hypothermia 25‐28°C |
| Outcomes | Blood cell counts, creatinine kinase, troponin I, oxygen index, inotropic support, duration of mechanical ventilation, length of ICU stay and length of hospital stay |
| Notes | Unclear whether control group included standard arterial line filter as authors state that the control group "received the same CPB circuit as the filter group but without the leucocyte filter." Last author emailed for further information |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Length of hospital stay Show forest plot | 1 | 24 | Mean Difference (IV, Fixed, 95% CI) | 0.20 [‐1.78, 2.18] |
| Analysis 1.1  Comparison 1: Leukodepletion versus standard filter, Outcome 1: Length of hospital stay | ||||
| 1.2 Length of stay ICU Show forest plot | 1 | 24 | Mean Difference (IV, Fixed, 95% CI) | 0.80 [‐0.24, 1.84] |
| Analysis 1.2  Comparison 1: Leukodepletion versus standard filter, Outcome 2: Length of stay ICU | ||||
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1: Leukodepletion versus standard filter, Outcome 1: Length of hospital stay
Comparison 1: Leukodepletion versus standard filter, Outcome 2: Length of stay ICU
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Length of hospital stay Show forest plot | 1 | 24 | Mean Difference (IV, Fixed, 95% CI) | 0.20 [‐1.78, 2.18] |
| 1.2 Length of stay ICU Show forest plot | 1 | 24 | Mean Difference (IV, Fixed, 95% CI) | 0.80 [‐0.24, 1.84] |
