ARCHIVED

Medical Policy

Policy Num:      11.001.001
Policy Name:    Autologous blood transfusion (Cell Saver)
Policy ID:          [11.001.001]  [Ar / L / M+ / P+]  [0.00.00]

Last Review:    September 10, 2024
Next Review:    Policy Archived
 

Related Policies: None

 Autologous blood transfusion (Cell Saver)

Summary

Surgical blood conservation techniques are used to reduce patient exposure to allogeneic blood during and after surgery. Techniques include preoperative autologous donation, intraoperative hemodilution, and blood salvage (also called cell salvage) during surgery.

Objective

The objective of this evidence-based  review  is to evaluate  the indications, advantages, and potential complications of intraoperative blood salvage

Policy Statements

The self-transfusion "cell savers" is considered for payment in the following surgeries:

A. General Surgery

.
1. Liver Resections
2. Bridges for splenectomy
3. Vascular surgery
4. Aneurysm
5. Liver Transplant
6. Kidney Transplant
7. Aortobifemoral graft

B. Orthopedics

1. Open reduction and fixation of pelvic fractures
2. Hip Replacement
3. Knee Replacement
4. Scoliosis (correction)

C. Thoracic surgery

1. Aortic aneurysm
2. Cardiac Transplant
3. Replacement or repair of heart valves
4. Aortocoronary bypass

D. Obstetrics and Gynecology

1. Ectopic pregnancy
2. Premature separation of placenta
3. Placenta accreta

E. Trauma

1. Aneurysm (cranial and aortic)
2. Lacerations of larger vessels
3. Liver fracture
4. Kidney Fracture

Policy Guidelines

In the emergency setting pre-authorization will be performed after the acute emergency has been resolved.

Benefit Application

BlueCard/National Account Issues

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Intraoperative blood salvage is suggested in surgical procedures having a high likelihood of significant blood loss (>1000 mL), based on evidence that allogeneic transfusion and associated complications can be avoided with a very low incidence of adverse events

Indications and benefits — Intraoperative blood salvage has the following potential benefits:

●Avoidance of allogeneic transfusion – The technique can be effective in avoiding or reducing allogeneic blood transfusion, with its attendant costs and risks (eg, transfusion reactions, transfusion-transmitted infections). Thus, intraoperative blood salvage is presumed to be beneficial, although randomized trials have not demonstrated improved outcomes. In a 2010 systematic review including 75 trials (36 involving orthopedic procedures, 33 involving cardiac procedures, 6 involving vascular surgery), the absolute reduction in the use of allogeneic red blood cell (RBC) transfusion was 21 percent (95% CI 15-26 percent). In a 2015 systematic review in emergency abdominal or thoracic trauma surgery (one trial; n = 44), the reduction in the use of allogeneic RBCs in the blood salvage group was 4.7 units (95% CI 1.31-8.09 units). These systematic reviews concluded that intraoperative blood salvage did not increase the risk of adverse events, including mortality and infection 

Intraoperative blood salvage has been applied effectively in a variety of surgical procedures having a high likelihood of requiring a transfusion, whether elective or emergency, including cardiac, vascular, orthopedic, urologic, trauma, gynecologic, and transplantation procedures. Intraoperative blood salvage has also been effective in neurosurgery and plastic surgery cases with a high likelihood of blood transfusion.

Intraoperative blood salvage may also be acceptable to some Jehovah's Witnesses, who will not accept allogeneic blood. Requirements for acceptance by these patients may include assurance that the blood does not leave the operating room for processing and/or that the blood remains continuously connected to the patient via intravenous tubing. 

Intraoperative blood salvage may be lifesaving in patients with a rare blood type or multiple RBC alloantibodies when crossmatch-compatible blood cannot readily be obtained.

Greater number of units available compared with other autologous blood conservation techniques – Intraoperative blood salvage complements other methods of blood conservation. It has the potential to deliver much larger amounts of blood than either preoperative autologous donation or intraoperative hemodilution, which generally only provide 1 to 3 units of autologous blood.

●Time savings – Intraoperative blood salvage is usually done in the operating room without direct involvement of the transfusion service and also eliminates the need for the patient to provide autologous donations. Thus, intraoperative salvage may save time for the patient and the blood collection facility.

Contraindications — There are both absolute and relative contraindications to the use of intraoperative blood salvage .

Absolute contraindications

●Presence of contraindicated fluids – Salvaged blood must never be mixed with fluids such as sterile water (or any hypotonic solution) because RBC hemolysis will occur . Also, intraoperative blood salvage cannot proceed if solutions that would be toxic with intravascular administration could come into contact with the salvaged blood. Examples include antibiotic irrigation or hydrogen peroxide, alcohol, or povidone-iodine solutions.

●Admixture with hemostatic products or bone cement – Blood salvage cannot be used during suctioning of blood from the surgical field when there is any potential for simultaneous collection of hemostatic products such as topical thrombin, fibrin glue, or microfibrillar bovine collagen-based products (eg, Avitene, Actifoam Collagen Sponge, Ultrafoam Sponge, Instat, Helitene, or similar products), or any chance of admixture with methyl methacrylate (ie, bone cement).

Relative contraindications — The following relative contraindications are controversial, in that there is no compelling evidence to suggest an association with adverse outcomes. Notably, use of intraoperative blood salvage in these settings has been expanded without clear-cut negative consequences.

●Bacterial infections – Decisions about using intraoperative blood salvage in patients with bacterial infections are made on a case-by-case basis, with consideration of relative risks and benefits for the individual patient, and with informed consent.

Bacterial contamination of the surgical wound has traditionally been a contraindication to use of intraoperative blood salvage. However, small studies support the appropriateness of more liberal use of intraoperative blood salvage in this setting. In a case series of intraoperative blood salvage in 11 hemorrhaging trauma patients with enterically contaminated wounds, rapid access to a large volume of autologous blood for reinfusion was potentially lifesaving; no patient developed intraabdominal sepsis, and no deaths were reported. A 2015 systematic review in emergency abdominal or thoracic trauma surgery (one trial; n = 44) noted no difference in sepsis (measured by blood cultures) or mortality in the blood salvage group compared with the control group receiving allogeneic blood [4]. A study that retrospectively evaluated clinical outcomes in 36 patients who received salvaged blood during cardiac surgery found no clinical sequelae in the third of patients who were transfused with blood found to contain bacteria or endotoxin.

There are no reports of bacteremia and sepsis in otherwise healthy people who were transfused in the intraoperative period with salvaged blood containing bacteria. Absence of clinical sequelae may be attributable to the use of broad-spectrum antibiotics in surgical patients, irrigation of surgical wounds before resuming salvage procedures when contamination occurs, and the thorough washing and filtration process used for intraoperative blood salvage. Although washing blood that contains bacteria cannot completely sterilize it, processing blood via a blood salvage system and then filtering it using a leukocyte reduction filter has been associated with a 98 to 100 percent reduction in a variety of bacterial organisms. Thus, decisions regarding reinfusion of salvaged blood in the setting of systemic infection should consider the potential infection risk of this technique compared with the known risk of postoperative infection after transfusion of allogeneic blood.

●Active malignancy – Decisions about using intraoperative blood salvage in patients with active malignancy are made on a case-by-case basis, with consideration of factors such as the risk of major intraoperative bleeding, the need for transfusion, the availability of allogeneic blood, and informed patient consent.

The successful use of intraoperative blood salvage in cancer surgery supports more liberal use of the technique in patients with active malignancy. Malignant cells have been observed in shed blood collected intraoperatively, and extensive cell washing does not remove these cells. However, leukocyte depletion filters have been shown to remove tumor cells from salvaged blood, similar to their ability to remove bacteria. Importantly, in a 2012 systematic review and meta-analysis including 10 controlled but not randomized studies, patients who received salvaged autologous blood during oncology surgery had no increase in cancer recurrence or development of metastases compared with those receiving allogeneic blood.

Areas of uncertainty — Intraoperative blood salvage has been used successfully in the following settings, with continuing research to clarify its risks and benefits :

●Obstetrics – Blood salvage, if available, can be helpful in managing patients at risk for postpartum hemorrhage (PPH) during cesarean delivery, when patients refuse allogeneic blood, or when banked blood is not available. Preoperative planning for its use is prudent in obstetric patients at high risk for significant PPH (eg, placenta accreta). Blood salvage in this setting is discussed separately.

In some centers, blood salvage is used routinely for patients undergoing cesarean section, or in patients who develop abnormal bleeding during the procedure . In this setting, unique hazards include the possibility of aspiration of amniotic fluid or hemostatic agents together with blood in the surgical field.

●Hemoglobinopathies – There is uncertainty regarding the safety of intraoperative blood salvage for patients with sickle cell disease (eg, theoretical risk of increased sickling) or thalassemia (eg, theoretical risk of increased hemolysis).

●Cold agglutinin disease – There is uncertainty regarding the safety of intraoperative blood salvage for patients with cold agglutinin disease, dependent on the thermal amplitude of the antibody and the temperature of the room. If intraoperative blood salvage is used in a patient with known cold agglutinin disease, the reinfused blood should be passed through a blood warmer. 

Technology and procedural steps — The intraoperative blood salvage machine (commonly referred to as a "cell saver") separates, washes, and concentrates salvaged RBCs. Several steps are involved, including suctioning of shed blood from the surgical field, addition of an anticoagulant, separation and washing of RBCs (to remove the anticoagulant, free hemoglobin molecules, activated thrombogenic substances, and cellular stroma), concentration of the blood, and eventual reinfusion to the patient .

Aspiration of blood from the surgical field — RBC salvage with the intraoperative blood salvage machine starts with the surgeon aspirating blood through a suction wand as it collects in the surgical field or is squeezed out from blood-soaked surgical gauze pads . The blood is mixed with an anticoagulant (eg, heparin or citrate) as it is aspirated to prevent coagulation . Typically, heparin in saline with a concentration of approximately 30,000 units/L is used. This solution is slowly and automatically added to the aspirated blood at a rate of 15 mL per 100 mL of collected blood . During subsequent washing of the collected blood, all but a trace of heparin is removed .

If there is concern about heparin-induced thrombocytopenia (HIT), a citrate-based anticoagulant/preservative solution (eg, citrate-phosphate-dextrose [CPD] or citrate-phosphate-dextrose-adenine [CPD-A]) should be used instead of heparin. Citrate-containing solutions are administered at a rate of 15 mL per 100 mL of collected blood . Citrate is rapidly metabolized by the liver after transfusion. Therefore, iatrogenic anticoagulation is unlikely with intraoperative blood salvage techniques. However, if there is concern about citrate-induced hypocalcemia (eg, due to impaired liver function, changes consistent with hypocalcemia on the electrocardiogram, or a low measured ionized calcium level), intravenous calcium chloride or calcium gluconate can be administered  In patients with advanced liver disease who receive a large volume of salvaged blood, it is helpful to monitor calcium levels to detect hypocalcemia.

Processing of blood — The aspirated blood is collected in a sterile, filtered reservoir until the amount is sufficient for processing (typically 375 to 750 mL).

Centrifugation — The salvaged blood is then pumped into the centrifuge bowl in which the higher density RBCs are separated and concentrated. The plasma, platelets, and waste components are sent to the waste bag.

Washing — Salvaged blood has a high concentration of free hemoglobin, inflammatory mediators, and other cellular debris. Therefore, it is washed with an isotonic solution, usually normal (0.9 percent) saline. Some centers change to a balanced electrolyte solution (eg, PlasmaLyte-A) after administration of a large volume of normal saline (eg, after approximately 1500 mL of saline is reinfused with 3000 mL of salvaged blood).  

Blood salvage instruments can process a full reservoir of blood in approximately three minutes, resulting in 55 to 250 mL of RBCs with hemoglobin concentration as high as 17 g/dL. A "partial bowl" that is at least one-half full of RBCs can be processed if necessary (eg, insufficient blood to process a full bowl), but the resulting hemoglobin concentration will be <17 g/dL.

Reinfusion — The processed red cell suspension is pumped from the centrifuge bowl into a blood salvage bag for reinfusion. Reinfusion is typically instituted as soon as the washed blood is available, but may be delayed for up to six hours if not clinically indicated at the moment of preparation (eg, in a patient who is clinically hypervolemic).

●Microaggregate filters – A 40-micron microaggregate filter is installed between the blood salvage bag and the patient to filter the final blood product as it is reinfused into the patient.

●Leukocyte depletion filters – Although not routinely used, a leukocyte depletion filter is an excellent alternative to a microaggregate filter when it is desirable to achieve optimal removal of bacteria, cancer cells, fat particles, or amniotic fluid. This type of filter must be changed after reinfusion of each 500 mL of blood.

Typically, leukocyte-reduced blood has <1x10⁶ leukocytes/mL of blood, corresponding to approximately 99 percent leukocyte depletion.

Other components in the blood such as platelets and contaminants can also adhere to these filters, but at least 85 percent of RBCs pass through the filter and into the patient. Commonly used polyester or polyamide filters have a 40-micron pore size and promote relatively selective adhesion of negatively charged leukocytes via three passive mechanisms (blocking, bridging, and interception) and one active mechanism (adhesion). Adhesion-based filters are the most efficient, allowing >99.9 percent leukocyte depletion.

Washed versus unwashed blood — We recommend using washed blood for all patients undergoing intraoperative blood salvage, based on the likely lower risk of complications compared with infusing salvaged blood that has not been washed. Although washing reduces the platelet count, it mitigates the negative effects on platelet function after reinfusion of salvaged blood [64]. The quality of salvaged, washed, autologous RBCs, as measured by posttransfusion RBC survival and enzymatic indices of RBC function, is equivalent, if not superior, to washed RBCs obtained by standard blood donation.

Salvaged washed red cells — Separation, washing, and concentration of RBCs is performed by the blood salvage machine (ie, "cell saver") in the operating room. 

Separation and washing of RBCs removes added anticoagulant and virtually eliminates free hemoglobin, platelets, white blood cells, and cellular stroma products (which are potentially thrombogenic). Thus, patients who receive a large number of units of washed autologous RBCs may develop a dilutional coagulopathy that requires treatment with fresh frozen plasma and/or platelet infusion. Centrifuging salvaged blood concentrates the RBCs, which reduces the total fluid volume administered to the patient.

Salvaged unwashed blood — In rare intraoperative settings with extremely rapid sustained blood loss (eg, >500 mL/min), it may be lifesaving to return the salvaged blood without separating or washing, until control of bleeding can be achieved. Returning whole blood in this setting allows the blood to be almost immediately available for reinfusion and may preserve some clotting factors and platelets. However, the risks and disadvantages of infusing unwashed blood are significant, including :

●The anticoagulant that was added to the blood is not removed and may cause coagulopathy.

●The reinfused platelets may be dysfunctional after being suctioned from the surgical field [64].

●Thrombogenic substances (eg, inflammatory mediators and microaggregates consisting of white cell and platelet debris) may be introduced.

●Hemoglobin levels are low (range: 7 to 9 g/dL or lower [depending on the patient's current hemoglobin level], versus 16 to 18 g/dL in processed washed blood).

●Free hemoglobin levels may be very high due to hemolysis.

●Fat may be present in the unwashed product, which increases the risk of fat embolism.

In these rare emergency circumstances, it is particularly important to use a 40-micron microaggregate filter for reinfusion. Also, the anticoagulant drip rate is increased due to the larger blood volume being processed; thus, a heparin-neutralizing agent, such as protamine, is administered following infusion of unwashed RBC to avoid coagulopathy.

Storage and handling — Blood collected by intraoperative blood salvage may be stored either at room temperature for up to six hours or at 1 to 6°C for up to 24 hours, provided that it is collected under aseptic conditions with a device that provides washing and that cold storage is begun within six hours of initiating the collection. Such stored blood must be properly labeled. Minimum requirements for labeling include the name and identifying number of the patient, the component name, the statement "For Autologous Use Only," and the expiration date and time.

Blood collected by intraoperative salvage should never be transfused to any patient other than the one from whom it was collected.

POSTOPERATIVE BLOOD SALVAGE

Postoperative blood salvage refers to the collection of blood from surgical drains and subsequent reinfusion through a 40-micron microaggregate filter, with or without a washing process

Major orthopedic procedures — Major orthopedic surgery is the main setting in which postoperative blood salvage is used. Randomized trials have demonstrated a reduction in allogeneic blood transfusion in joint replacement surgery.

The use of postoperative blood salvage after major orthopedic surgery is evolving and is individualized based upon institutional expertise and available technologies. Development of efficient systems for collecting, anticoagulating, and filtering blood for reinfusion has increased interest in salvaging blood after major orthopedic surgery, despite residual concerns regarding the safety of unwashed salvaged blood (see 'Washed versus unwashed blood' above). However, other techniques to reduce allogeneic blood transfusion may be equally effective in this setting (eg, use of an antifibrinolytic drug such as tranexamic acid or adhering to a restrictive transfusion protocol).

Cardiac surgery — We avoid reinfusion of shed mediastinal blood from postoperative chest tube drainage following cardiac surgery. Shed mediastinal blood contains fibrinogen degradation products, tissue-type plasminogen activators, inflammatory cytokines, complement, and endotoxin, resulting in activation of the extrinsic coagulation pathway, and possible association with postoperative bleeding tendency and sternal or systemic infections.

Regulatory Status

ESTABLISHING A BLOOD SALVAGE PROGRAM

The AABB (formerly known as the American Association of Blood Banks) Standards for Perioperative Autologous Blood Collection and Administration recommend that hospitals with intraoperative blood salvage programs and blood centers providing the service should establish written policies and procedures for proper collection, labeling, and storage of the collected blood. All policies and procedures should be regularly reviewed by a clinician responsible for the program. Periodic quality control testing of collected blood is recommended to ensure that collection equipment and techniques result in an aseptic blood product.

Guidelines and training are essential for the quality assurance of intraoperative blood salvage, which has been pointedly described in an editorial as a "largely unregulated cottage industry" . The technique can potentially be performed by a cross-trained operating room employee (eg, an anesthesia technician) or by a member of a specialist service (eg, an extracorporeal technologist or perfusionist). Cross-training employees as blood salvage technicians might be more economical than using an outsourced specialist service when the caseload exceeds 55 cases per year.

Rationale

An autotransfuser is a mechanical device that is used in the process of collecting and re-infusing blood lost from hemorrhage.  Different forms of autologous transfusers include intra-operative, emergency, or post-operative salvage devices and hemodilution devices used to re-infuse a patient's own blood.

Many people have safety concerns about receiving transfusions of donated blood.  "Cell salvage" with autotransfusion is a technique designed to reduce the need for such transfusions.  The technique involves collecting blood from surgical sites, to be transfused back into the person during or after surgery if necessary.  The blood is either "washed" before transfusion or transfused directly after being filtered (unwashed).  Risks from cell salvage include infection and blood clotting problems.

Autologous blood transfusion or the use of autotransfusers are contraindicated in blood exposed to bacteria (an infected wound or blood with fecal contamination) or in blood with malignant cells.

A meta-analysis of studies of cell savers in cardiac and orthopedic surgery (Huet et al, 1999) found that both devices that wash and do not wash salvaged blood decrease the proportion of patients who receive a peri-operative allogeneic transfusion.  These investigators found, however, that the post-operative use of devices that do not wash salvaged blood in cardiac surgery was only marginally effective.  The authors noted that cell salvage did not appear to increase adverse events, although side-effects were inconsistently reported and the number of patients studied was relatively small.

A Cochrane evidence review (Carless et al, 2003) found evidence suggesting that cell salvage reduces the need for transfusions of donated blood.  However, the investigators concluded that better quality research is needed to assess the cost-effectiveness of cell salvage across a range of surgical settings compared to other blood-sparing techniques.

Reitman et al (2004) evaluated the necessity and cost-effectiveness of the use of Cell Saver for adult lumbar spine fusions.  These investigators concluded that while patients in the Cell Saver group did require fewer post-operative transfusions, the difference was not as much as expected.  In elective fusions for degenerative conditions of the lumbar spine, blood requirements can usually be satisfied with pre-donation of autologous blood.  With contemporary practices of pre-donation, the use of the Cell Saver appears to be neither necessary nor cost-effective during most elective lumbar fusions.

Gause et al (2008) examined the effectiveness of using intra-operative Cell Saver in decreasing the need for blood transfusion.  Data were collected from 188 patients undergoing consecutive instrumented lumbar laminectomy and fusion.  A total of 141 of these patients had Cell Saver used during their procedures, whereas 47 did not.  In addition, previously published data from similarly treated patients were used for analysis.  Operative blood loss, autologous and allogeneic blood transfusions, discharge hematocrit, and patient factors were analyzed.  A significant increase in the number of blood transfusions was found in the Cell Saver group, which also had a significantly increased blood loss compared with the non-Cell Saver group.  Using analysis of co-variance, these investigators determined the effect of blood loss on the need for transfusion.  The results showed that correcting for blood loss eliminated the significance in the transfusion difference, but Cell Saver still was not able to decrease the transfusion need.  Comparing their current results with their previously published results also demonstrated no benefit of Cell Saver use.  The authors concluded that the use of Cell Saver in instrumented lumbar fusion cases was not able to decrease the need for blood transfusion.  Furthermore, Cell Saver use was associated with a significantly higher blood loss.

In a retrospective review, Scannell et al (2009) examined if Cell Saver use in patients with acetabular fractures reduces the volume or rate of allogeneic blood transfused intra-operatively and post-operatively and if this translated to a decrease in blood-related charges to the patient.  A total of 186 patients with operatively treated acetabular fractures were included in this study.  All patients underwent open reduction internal fixation of their acetabular fracture.  The decision to use Cell Saver was at the surgeon's discretion.  The volume and rate of intra-operative and post-operative allogeneic blood transfused and blood-related charges were evaluated.  Cell Saver was used in 60 cases (32 %), and the average volume of blood autotransfused was 345 ml.  No differences were observed in the rates (58.3 % versus 48 %, p = 0.1883) or the mean volumes (770 versus 518 ml, p = 0.0537) of intra-operative and post-operative allogeneic blood transfusions between the Cell Saver and the non-Cell Saver groups.  Total blood-related charges in the Cell Saver group were significantly higher than that in the non-Cell Saver group ($1,958 versus $694, p < 0.0001).  Sub-analyses based on fracture pattern, injury severity score, body mass index, days to surgery, and estimated blood loss were performed.  In each sub-analyses, no differences were observed in intra-operative and post-operative transfusion rates and volumes, and total blood-related charges were higher in the Cell Saver groups.  The authors concluded that in the routine use of Cell Saver in acetabular surgery, there was no reduction in the volume or rate of allogeneic blood transfused intra-operatively or post-operatively.  However, blood-related charges were significantly increased.

In a systematic review and meta-analysis of published randomized controlled trials, Wang et al (2009) examined the overall safety and effectiveness of cell salvage in cardiac surgery.  Medline, Cochrane Library, Embase, and abstract databases were searched up to November 2008.  All randomized trials comparing Cell Saver use and no Cell Saver use in cardiac surgery and reporting at least 1 pre-defined clinical outcome were included.  The random effects model was used to calculate the odds ratios (OR, 95 % confidence intervals [CI]) and the weighted mean differences (WMD, 95 % CI) for dichotomous and continuous variables, respectively.  A total of 31 randomized trials involving 2,282 patients were included in the meta-analysis.  During cardiac surgery, the use of an intra-operative Cell Saver reduced the rate of exposure to any allogeneic blood product (OR 0.63, 95 % CI: 0.43 to 0.94, p = 0.02) and red blood cells (OR 0.60, 95 % CI: 0.39 to 0.92, p = 0.02) and decreased the mean volume of total allogeneic blood products transfused per patient (WMD -256 ml, 95 % CI: -416 to -95 ml, p = 0.002).  There was no difference in hospital mortality (OR 0.65, 95 % CI: 0.25 to 1.68, p = 0.37), post-operative stroke or transient ischemia attack (OR 0.59, 95 % CI: 0.20 to 1.76, p = 0.34), atrial fibrillation (OR 0.92, 95 % CI: 0.69 to 1.23, p = 0.56), renal dysfunction (OR 0.86, 95 % CI: 0.41 to 1.80, p = 0.70), infection (OR 1.25, 95 % CI: 0.75 to 2.10, p = 0.39), patients requiring fresh frozen plasma (OR 1.16, 95 % CI: 0.82 to 1.66, p = 0.40), and patients requiring platelet transfusions (OR 0.90, 95 % CI: 0.63 to 1.28, p = 0.55) between Cell Saver and non-Cell Saver groups.  The authors concluded that current evidence suggests that the use of a cell saver reduces exposure to allogeneic blood products or red blood cell transfusion for patients undergoing cardiac surgery.  Sub-analyses suggest that a Cell Saver may be beneficial only when it is used for shed blood and/or residual blood or during the entire operative period.  Processing cardiotomy suction blood with a Cell Saver only during cardiopulmonary bypass has no significant effect on blood conservation and increases fresh frozen plasma transfusion.

Population Reference No. 1

Emergency or intra-operative autotransfusion, where blood is collected from the wound or a body cavity, processed, and then returned to the individual. Post-operative autotransfusion (usually done within 2 hours with a chest tube collection device), where the blood from the chest (or other sterile operative sites) is re-infused following heart surgery and traumatic hemithorax. Individuals in need of  autotransfusion and cell saver devices medically necessary for procedures that may deplete blood volume

Supplemental Information

Avoidance of allogeneic transfusion – The technique can be effective in avoiding or reducing allogeneic blood transfusion, with its attendant costs and risks (eg, transfusion reactions, transfusion-transmitted infections) [1]. Thus, intraoperative blood salvage is presumed to be beneficial, although randomized trials have not demonstrated improved outcomes. In a 2010 systematic review including 75 trials (36 involving orthopedic procedures, 33 involving cardiac procedures, 6 involving vascular surgery), the absolute reduction in the use of allogeneic red blood cell (RBC) transfusion was 21 percent (95% CI 15-26 percent) . In a 2015 systematic review in emergency abdominal or thoracic trauma surgery (one trial; n = 44), the reduction in the use of allogeneic RBCs in the cell salvage group was 4.7 units (95% CI 1.31-8.09 units). These systematic reviews concluded that cell salvage did not increase the risk of adverse events, including mortality and infection.

Practice Guidelines and Position Statements

The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists' updated clinical practice guideline on "Blood Conservtion" (Ferraris et al, 2011) noted that during cardiopulmonary bypass, intra-operative autotransfusion, either with blood directly from cardiotomy suction or recycled using centrifugation to concentrate red cells, may be considered as part of a blood conservation program.

United States

●American Society of Hematology (ASH): Guidelines for sickle cell disease – Transfusion support (2020)

●Children's Oncology Group (COG): Guidance on platelet transfusion for patients with cancer (2019)

●Choosing Wisely: Do not continue simple transfusions in patients with stroke from sickle cell disease who have iron overload, if red blood cell exchange is available (2018)

●Choosing Wisely: Do not routinely continue a series of apheresis procedures without a predefined objective goal, and stop the series if it is apparent that the goal cannot be reached or adverse effects outweigh potential benefits (2018)

●Choosing Wisely: Do not routinely monitor coagulation tests during a course of therapeutic plasma exchange, unless the procedure is performed daily (2018)

●Choosing Wisely: Do not routinely use plasma as replacement fluid for therapeutic plasma exchange unless there is a clear indication to replete a plasma component (2018)

●American Society of Clinical Oncology (ASCO): Clinical practice guideline on platelet transfusion for patients with cancer, update (2017)

●Choosing Wisely: Don't routinely transfuse stable, asymptomatic hospitalized patients with a hemoglobin level greater than 7–8 grams (2016)

●American Society of Anesthesiologists (ASA): Practice guidelines for perioperative blood management (2015)

●Choosing Wisely: Don't perform serial blood counts on clinically stable patients (2014)

●Choosing Wisely: Don't routinely transfuse fresh frozen plasma and platelets prior to abdominal paracentesis or endoscopic variceal band ligation (2014)

●Choosing Wisely: Don't routinely transfuse patients with sickle cell disease (SCD) for chronic anemia or uncomplicated pain crisis without an appropriate clinical indication (2014)

●Choosing Wisely: Don't routinely use blood products to reverse warfarin (2014)

●Choosing Wisely: Don't transfuse more units of blood than absolutely necessary (2014)

●Choosing Wisely: Don't transfuse O negative blood except to O negative patients and in emergencies for women of child bearing potential with unknown blood group (2014)

●Choosing Wisely: Don't transfuse red blood cells for iron deficiency without hemodynamic instability (2014)

●Choosing Wisely: Don't transfuse red blood cells in hemodynamically stable, non-bleeding ICU patients with a hemoglobin concentration greater than 7 g/dL (2014)

●Choosing Wisely: Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms of active coronary disease, heart failure or stroke (2013)

●Choosing Wisely: Don't administer packed red blood cells (PRBCs) in a young healthy patient without ongoing blood loss and hemoglobin of ≥6 g/dL unless symptomatic or hemodynamically unstable (2013)

●Choosing Wisely: Don't transfuse more than the minimum number of red blood cell (RBC) units necessary to relieve symptoms of anemia or to return a patient to a safe hemoglobin range (7 to 8 g/dL in stable, non-cardiac in-patients) (2013)

●Society of Thoracic Surgeons (STS) and Society of Cardiovascular Anesthesiologists (SCA): Blood conservation clinical practice guidelines, update (2011)

●Eastern Association for Surgery of Trauma (EAST) and Society of Critical Care Medicine (SCCM): Clinical practice guideline on red blood cell transfusion in adult trauma and critical care (2009)

Medicare National Coverage

CMS National Coverage Determinations (NCDs) NCD 110.7 Blood Transfusions

References

1. Johnson HD, Morgan MS, Utley JR, Leyland SA, Nguyen-Duy T, Crawley DM.   Comparative analysis of recovery of cardiopulmonary bypass residual blood: Cell saver vs. hemoconcentrator. J Extra Corpor Technol. 1994;26:194-9.
2. Serrano FJ, Monux G, Aroca M. Should the cell saver autotransfusión system be routinely used in elective aortic surgery? Ann Vasc Surg.2000;14(6):663-
3. Klebanoff, G. (1970), "Early Clinical experience with a disposable unit for intraoperative salvage and reinfusion of blood loss (intraoperative autotransfusion)", Am J Surg 120: 718–722 
4. Duncan, J. (1886), "On re-infusion of blood in primary and other amputations", Brit M J 1:10.1136/bmj.1.1309.192 5.
5. .Waters JH. Intraoperative blood recovery. ASAIO J 2013; 59:11.
6. Chanda A, Smith DR, Nanda A. Autotransfusion by cell saver technique in surgery of lumbar and thoracic spinal fusion with instrumentation. J Neurosurg 2002; 96:298
7. Esper SA, Waters JH. Intra-operative cell salvage: a fresh look at the indications and contraindications. Blood Transfus 2011; 9:139.
8. Bland LA, Villarino ME, Arduino MJ, et al. Bacteriologic and endotoxin analysis of salvaged blood used in autologous transfusions during cardiac operations. J Thorac Cardiovasc Surg 1992; 103:582.
9. Waters JH, Tuohy MJ, Hobson DF, Procop G. Bacterial reduction by cell salvage washing and  leukocyte depletion filtration. Anesthesiology 2003; 99:652.

10.Wollinsky KH, Oethinger M, Büchele M, et al. Autotransfusion--bacterial contamination during hip arthroplasty and efficacy of cefuroxime prophylaxis. A randomized controlled study of 40 patients. Acta Orthop Scand 1997; 68:225.

11.Dzik WH, Sherburne B. Intraoperative blood salvage: medical controversies. Transfus Med Rev 1990; 4:208.

  12.Waters JH, Lukauskiene E, Anderson ME. Intraoperative blood salvage during cesarean delivery in a patient with beta thalassemia intermedia. Anesth  Analg 2003; 97:1808.

13.  Smith DF, Mihm FG, Mefford I. Hypertension after intraoperative autotransfusion in bilateral adrenalectomy for pheochromocytoma. Anesthesiology 1983; 58:182.

14.  American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology 2015; 122:241.

15.  Moonen AF, Knoors NT, van Os JJ, et al. Retransfusion of filtered shed blood in primary total hip and knee arthroplasty: a prospective randomized clinical trial. Transfusion 2007; 47:379.

16.  Sarkanović ML, Gvozdenović L, Savić D, et al. Autologous blood transfusion in total knee replacement surgery. Vojnosanit Pregl 2013; 70:274.

17.  Thomas D, Wareham K, Cohen D, Hutchings H. Autologous blood transfusion in total knee replacement surgery. Br J Anaesth 2001; 86:669.

18.  Carless PA Henry DA , Moxey AJ et als . Cell salvage for minimishing perioperative allogeneic blood transfusion. Cochrane Database Sysmte REV 2010; CD001888.

19. Li J, Sun SL, Tian JH, et al. Cell salvage in emergency trauma surgery. Cochrane Database Syst Rev 2015; 1:CD007379

20. Surgical blood conservation: Blood salvage Authors:Arthur J Silvergleid, MD ichele Heath, LP, CCP Section Editors: Steven Kleinman, MD Jonathan B Mark, MD Deputy Editors: Nancy A Nussmeier, MD, FAHA Jennifer S Tirnauer, MD Contributor Disclosures All topics are updated as new evidence becomes available and our peer review process is complete. Literature review current through: Oct 2020. | This topic last updated: Sep 17, 2019.

Codes

Appplicable Modifiers

Some modifiers

Policy History