Intraoperative cell salvage in obstetrics.
Abstract: The use of Intraoperative Cell Salvage (ICS) in obstetrics has been slow to develop as a result of theoretical concerns relating to amniotic fluid embolism and fetal red cell contamination. In this article we examine the current UK position on the use of ICS in this clinical speciality and the recommendations for its safe and appropriate use.

KEYWORDS Cell salvage / Caesarean section / Obstetric haemorrhage / Blood transfusion
Subject: Disease transmission (Risk factors)
Blood transfusion (Health aspects)
Blood collection and preservation (Methods)
Authors: Grainger, Hannah
Catling, Sue
Pub Date: 08/01/2011
Publication: Name: Journal of Perioperative Practice Publisher: Association for Perioperative Practice Audience: Academic Format: Magazine/Journal Subject: Health; Health care industry Copyright: COPYRIGHT 2011 Association for Perioperative Practice ISSN: 1750-4589
Issue: Date: August, 2011 Source Volume: 21 Source Issue: 8
Geographic: Geographic Scope: United Kingdom Geographic Code: 4EUUK United Kingdom
Accession Number: 272168031
Full Text: Better blood transfusion

Allogeneic (donated) blood is essential to the care of many surgical patients. It is however, a limited resource which is subject to the threat of future shortages. Allogeneic blood is also increasingly expensive and, although potentially life-saving, can present a source of risk for patients, such as the risk of 'wrong blood' incidents (SHOT 1997-2009).

The management of the supply of allogeneic blood is carefully balanced to ensure that supply meets demand without excessive wastage. Changes to the donor selection criteria because of the perceived risk of vCJD transmission through blood transfusion, mean that donors who have themselves received a blood transfusion are now no longer eligible to donate blood. This and other restrictions have reduced the already diminishing blood donor population. The future introduction of a test for vCJD could, in addition, impact on the willingness of donors to donate. The threat of significant blood shortages is ever present and such shortages could result in the restriction of transfusion to the treatment of active major bleeding, emergency surgery and life-threatening anaemia (CMO's National Blood Transfusion Committee 2009).

While the threat of blood shortages is of great concern, it is the known risks of allogeneic transfusion that are a quantifiable reality. The Serious Hazards of Transfusion (SHOT) scheme began collating data on the rate of UK transfusion incidents in 1996. Since that time, the risk of 'incorrect blood component transfused' has remained one of the most frequently reported hazards of transfusion (SHOT 1996-2009) (Figure 1).

The data from SHOT has reinforced the recommendation that transfusion should only be used when the benefits outweigh the risks and when there is no appropriate alternative.

To help address the safe and appropriate use of allogeneic blood, the Department of Health's Better Blood Transfusion (BBT) Health Service Circulars (Department of Health 1998, 2002, 2007) recommend that transfusion is an integral part of care and clinical governance responsibilities and hospitals are encouraged to explore the use of alternatives, such as intraoperative cell salvage (ICS), where appropriate.

Intraoperative cell salvage

The process of ICS involves the collection of surgical blood loss through a special aspiration line (aspiration and anticoagulation (A&A) line) which allows an anticoagulant to be mixed with the aspirated blood at the point of collection to prevent clotting. This anticoagulated blood enters a collection reservoir where it passes through a filter that will take out any large debris from the surgical field such as bone fragments in orthopaedics. The anticoagulated blood then passes into a centrifuge which separates the red blood cells (RBCs) from the rest of the blood (plasma, clotting factors etc), anticoagulant and other waste products such as damaged RBCs. The waste products are expelled into a waste bag and the RBCs form a concentrated pack within the centrifuge. The concentrated RBCs are washed with intravenous saline to ensure that any remaining waste products are removed and are then transferred to a reinfusion bag ready to reinfuse to the patient (Figures 2 & 3).

The appropriate use of ICS can reduce allogeneic transfusion, therefore reducing patient exposure to allogeneic blood (and its associated risks) and alleviating the demand on allogeneic blood supplies.

ICS is used routinely in many areas of surgical practice for both elective and emergency procedures which are at risk of significant blood loss and where there are no contraindications to use (such as the presence of contamination within the surgical field e.g. bowel contents). The definition of significant blood loss may be different for different patients. It depends on factors such as the patient's size and preoperative haemoglobin, but is likely to include any patient who loses a volume of blood which would normally result in an allogeneic transfusion. The benefits of returning small volumes of blood to the patient, regardless of whether or not they would have required an allogeneic transfusion as a result of the blood loss, are uncertain.

[FIGURE 2 OMITTED]

In 2006 a UK Cell Salvage Action Group (UK CSAG) was formed to support the continued development of ICS services in the UK. This group has developed numerous resources to support all aspects of both intra and postoperative cell salvage e.g. training resources, generic policies for hospitals to use/adapt and standardised labelling for autologous blood. These resources can be accessed through the Department of Health's Better Blood Transfusion Toolkit (www.transfusionguidelines.org.uk).

The use of ICS in obstetrics has been slower to progress than in other specialities. This is mainly due to theoretical fears over contamination of the salvaged blood with fetal RBCs and/or amniotic fluid. These issues will now be explored in more detail.

[FIGURE 3 OMITTED]

ICS in obstetrics

Historical background, safety and the evolution of current thinking

Seventy thousand units of red cells are transfused to obstetric patients annually (Wells et al 2002) despite this being a young, fit population. The estimated incidence of major obstetric haemorrhage in the UK is 6.7 per 1000 deliveries (Waterstone & Bewely 2001), so there is an opportunity to reduce allogeneic blood transfusion and conserve the national blood supply by using ICS in caesarean sections where major blood loss is anticipated.

However, obstetrics was originally cited as a contra-indication to the use of ICS because of the possible risks of amniotic fluid embolism and Rhesus (Rh) immunisation. The former has never been documented and remains entirely theoretical, and the latter is preventable with adequate Anti-D immunisation (Catling & Joels 2005). ICS has been safely used in over 400 published obstetric cases (Jackson & Lonser 1993, Rainaldi et al 1998, Rebarber et al 1998, Camann 1999, Fong et al 1999, Potter et al 1999, Weiskopf 2000) and also in many hundreds of unpublished cases recorded through individual hospital or regional databases, the UK Cell Salvage Action Group and through personal communications to the authors. There has been no proven incidence of harm, and in massive unexpected obstetric haemorrhage, where the immediate supply of allogeneic blood was exceeded, ICS has been successfully used as a life-saving procedure to re-circulate ongoing losses and maintain tissue oxygenation until bank blood became available (Catling et al 2002).

Because the incidence of amniotic fluid embolism is extremely low in obstetric cases where ICS is not used, proving that ICS does not increase the likelihood of occurrence through a randomised controlled trial would require a study with 265,000 patients, and it is unlikely that this will ever be performed (Weiskopf 2000). However, on all the available clinical evidence, the use of ICS in obstetrics has been officially endorsed by CEMACH (CEMACH 2002), the AAGBI (OAA/AAGBI 2005) and NICE (NICE 2005). It is strongly recommended that any healthcare professional involved with obstetric ICS be familiar with all these guidelines.

Consequently, ICS is being increasingly used in the UK in obstetrics for women at risk from post-partum haemorrhage during caesarean section. In the year 2005-2006, 38% of UK maternity units used ICS, and 28% included the use of ICS in their massive obstetric haemorrhage (MOH) protocol (Teig et al 2007). Early theoretical concerns over amniotic fluid embolism have not been borne out in clinical practice and 80% of maternity units identified that the barrier to greater use of ICS was lack of training rather than safety concerns.

Amniotic fluid--current position

The ICS process alone removes the small, plasma-phase (dissolved) molecules in amniotic fluid, such as alpha-feto-protein and tissue factor, along with the plasma (Thornhill et al 1991, Bernstein et al 1997, Catling et al 1999). Any particulate amniotic fluid elements that might remain in the centrifuge (because they happen to have a mass similar to red cells) are effectively removed by the leukocyte depletion filter (LDF) (Leuco Guard RS, Pall Biomedical Products Co., East Hills, NY) through which the blood passes as it is re-infused. Using the Haemonetics Cell Saver 5 in combination with the Pall RS LDF (Waters et al 2000) has been shown to remove all detectable amniotic fluid markers (fetal squames and phospholipid lamellar bodies) from blood salvaged at caesarean section.

Despite this evidence of adequate contaminant removal, the theoretical concern remained about possible clinical consequences of even the smallest quantity of amniotic fluid remaining in the final product. However, even as long ago as 2000 it was realised that if small quantities of amniotic fluid escaped the filter they would probably do no damage, because amniotic fluid embolism is no longer regarded as an embolic disease, but as a type of anaphylactic reaction (Clarke et al 1995, Fineschi et al 1998, Farrar & Gherman 2001). There was also good evidence at that time that all recently delivered women have amniotic fluid in their blood, with no ill effects detectable (Waters et al 2000).

On this evidence it therefore followed that the reinfusion of ICS blood, even if contaminated with traces of amniotic fluid, did not present an increased risk to the woman. It nevertheless seemed intuitively reasonable to remove amniotic fluid and placental tissue as far as possible with conventional suction, before aspirating to the ICS machine after delivery of the placenta in order to minimise the initial load presented to the ICS system/LDF (Catling et al 1999). This is currently accepted as best practice (UK Cell Salvage Action Group 2007). Similarly, it is now routine for a LDF to be used during the reinfusion of blood salvaged during obstetric cases, and this has been accepted as standard practice.

Fetal red blood cells--current position

In any pregnancy involving a Rh negative mother and a Rh positive fetus there is a danger of Rh immunisation if the maternal circulation is exposed to fetal RBCs. Antibodies against the fetal RBCs can cause haemolytic disease of the newborn in subsequent pregnancies if untreated.

Consequently, all Rh negative women currently receive routine Anti-D prophylaxis during pregnancy that will protect them against this immunisation from a fetal bleed of up to 4mls. Any subsequent sensitising event, such as an abruption, a caesarean section, or ICS may require extra Anti-D to be given. As such, all Rh negative mothers of Rh positive babies will have a Kleihauer test performed in the immediate post partum period.

Kleihauer testing is required to establish the amount of fetal RBC exposure and ensures that the mother receives an appropriate dose of Anti-D immunoglobulin (usually 125iu/ml of fetal blood). Depending on the results of the Kleihauer, a minimum of 500iu Anti-D will be offered in the post partum period to Rh negative mothers with Rh positive babies.

Fetal RBC contamination of maternal blood salvaged using ICS remains unavoidable because the ICS machine cannot distinguish between fetal and maternal RBCs. In-vitro work suggests that between 0.2ml and 19ml of fetal RBCs could be retransfused when ICS is used (Catling et al 1999, Fong et al 1999, Waters et al 2000) requiring up to 2,500iu of extra Anti-D.

Kleihauer testing to establish the correct dose should therefore be performed as soon as practicable after exposure. In practice, this means within two hours of completing reinfusion of the ICS blood.

In this context it is worth remembering that it is also possible that fetal antigens other than Rh are transfused in ICS blood. The significance of this is unknown and work continues (personal communication SC).

Practical considerations for ICS in obstetrics

How to collect blood

The practical use of ICS in obstetrics can be tricky because it is difficult to predict which cases will benefit most. It is recommended that ICS is set up for high risk cases, emergencies and for patients who refuse to accept allogeneic transfusions (NICE 2005). In cases where unexpected blood loss occurs, it is important that ICS is not forgotten.

The equipment needed to collect the blood can be set up in a matter of minutes. Providing there is a drip stand with a bracket suitable for the collection reservoir, the ICS machine does not need to be present in order to start collecting blood. This can be extremely beneficial in hospitals that do not have an ICS machine in their obstetric theatres and rely on transferring the machine from main theatres when needed. The manufacturers of the ICS machines can usually supply a bracket for this purpose. The bracket and drip stand along with the collection reservoir, A&A line/yankauer sucker, anticoagulant and a vacuum source (wall suction is fine) are all that is needed to start blood collection.

Many scrub staff express concern over what they should and shouldn't aspirate into the ICS collection reservoir. The current recommendations are to avoid aspirating the amniotic fluid and therefore it is necessary to have a second suction line that is attached to the standard theatre suction. It is recommended that a yankauer sucker is used with ICS because this does minimal damage to the RBCs. It is easy to distinguish it from the suction tips generally used in obstetric procedures, making it less likely that the wrong suction will be picked up at the wrong time.

Managing the controversies

Confidence in the use of ICS in obstetrics is growing and the technique is now used routinely in many UK centres. Early stringent safety recommendations were often based on theoretical fears. These recommendations were often not evidence based but represented a failsafe position. More recent work has suggested that some of these recommendations may be unnecessary. For example:

One versus two suckers

In a small randomised controlled trial it has been shown that using one sucker throughout the procedure (i.e. aspirating the amniotic fluid into the ICS collection reservoir), results in no more contamination of the RBCs that are given back to the mother than using a second, separate, theatre suction to remove the amniotic fluid before commencing ICS (Sullivan et al 2008).

This means that ALL operative blood loss can be collected, even the initial 'gush' which is heavily contaminated with amniotic fluid. The procedure is now routine practice at several large maternity units, and improves the volume of RBCs salvaged, as the initial bleed, which can be considerable in placenta praevia, is not lost. Although the technique of one suction use is not routine in the UK at this time, if collection of blood throughout the procedure is considered to be beneficial it can now be justified.

Leukocyte depletion filters (LDFs)

It is now routine for a LDF to be used during the reinfusion of blood salvaged during obstetric cases and this has been accepted as standard practice. In 2009, the UKCSAG in conjunction with SHOT, carried out a pilot for cell salvage incident reporting. Eight reported cases in which significant hypotension has occurred during the use of the LDF are under investigation by SHOT and the UKCSAG. Two of these reports were in caesarean sections. It is not yet possible to say whether the LDF is causing the hypotension, but in 1999 a similar reaction was seen in the USA in 80 of 20 million allogeneic transfusions where bedside filtration using LDF was used, prompting an FDA warning (Zoon et al 1999).

The proposed mechanism is a massive release of bradykinin from the white cells trapped on the negatively charged LDF surface. The phenomenon has been elegantly demonstrated in whole blood allogeneic transfusion (Iwama 2001) but has not yet been demonstrated in ICS blood, so this remains hypothetical at present. The hypotension seen in UK cell salvage practice so far has been easily reversible with standard treatment, (stopping transfusion, fluids and vasopressors) but users should be aware of this rare possibility. A recent editorial in the journal Anaesthesia recommends no change to current practice at present, and to remove the filter to continue transfusion after the hypotension resolves (Hussain & Clyburn 2010).

It should be remembered that prior to 2000 the LDF filter was not available, and over 250 obstetric cases worldwide safely received ICS blood without a problem. Therefore, in life-threatening haemorrhage where the LDF limits the rate of reinfusion of ICS blood, a clinical decision to reinfuse ICS blood without this filter could be carefully considered.

The risk/benefit balance of the LDF needs to be re-evaluated, and future recommendations may suggest that it can be dispensed within obstetric practice.

Patient selection and preparation in obstetrics

Patient information

Wherever possible, the advantages and risks of both ICS and allogeneic blood transfusion should be discussed with the mother prior to undergoing an obstetric surgical procedure, and her agreement (consent) to undergo either should be clearly documented. In a pre-planned case this can be during the pregnancy, however, such detailed consent for either ICS or allogeneic transfusion may not be practicable in an emergency.

It is also recommended that the mother receives a written information leaflet regarding the need for transfusion and possible alternatives, such as is available from the UK blood services. A joint UK Cell Salvage Action Group and National Patient Safety Agency leaflet 'Please Ask About Cell Salvage' may also be obtained from www.transfusionguidelines.org.uk/docs/pdfs/bbt- 03Cell_Salvage_Patient_Information_V5.pdf [Accessed July 2011] (Figure 4).

Indications for ICS

Patient selection for ICS is at the discretion of the obstetrician and anaesthetist caring for the patient. The type of obstetric cases that should be considered for selection include:

Emergency situations:

* Ruptured ectopic pregnancy

* Post-partum haemorrhage

[FIGURE 4 OMITTED]

Elective situations:

* Patients with an anticipated blood loss of >1000mls e.g. placenta accreta, large uterine fibroids, and other predictable causes of MOH

Other situations:

* Patients who for religious or other reasons refuse allogeneic blood and have consented to the use of ICS in elective or emergency bleeding situations, or in significant anaemia.

Controversies for the future

Routine obstetric ICS

Some authorities believe that ICS should be set up for all caesarean sections, not only those for whom major haemorrhage is anticipated. The arguments for this are both clinical and financial and that blood loss is not always predictable. In the absence of a controlled trial, the clinical and financial efficacy of this cannot be known. However, there is robust evidence from non-obstetric practice that routine ICS reduces exposure to allogeneic blood in cardiac, orthopaedic and vascular surgery, and there is no reason to suppose that this would not also apply in obstetrics (Carless et al 2010).

Indications for re-infusion of ICS blood

Some authorities believe that any available ICS blood should always be returned to the patient, even if the haemoglobin (Hb) remains above the allogeneic transfusion threshold of 7g/dl (Hebert et al 1999), while others think that the same indications for transfusion should apply to ICS. There is a short window of opportunity to reinfuse ICS blood; if it is not given at this time and a clinical need for transfusion arises later this opportunity may be lost and allogeneic blood may be needed.

In Jehovah's Witnesses, especially where the individual has requested what is referred to in ICS as a continuous circuit (where the machine is primed with saline to ensure a fluid contact between the individual and their blood) the only opportunity to increase the Hb is while the ICS machine is connected in continuity, and the full extent of the bleeding may not be apparent. In these circumstances it is clearer that ICS blood should be returned to the patient whatever the blood loss, so long as the patient consents.

Vaginal blood loss

Not all major obstetric haemorrhage occurs at caesarean section, and the problem of how to salvage vaginal blood loss is being considered. The theoretical fear of causing septicaemia by reinfusing 'dirty' blood is not supported by the evidence. In the USA, ICS has been used extensively in surgery for abdominal gunshot wounds and no clinical sepsis has been caused by reinfusion of the ICS blood. Also, any organisms cultured from post-operative infection sites in these circumstances have not been those found in the salvaged blood. All patients would be on antibiotics in these circumstances (Waters 2009).

The problem is related to how to physically collect the blood--a reasonable suggestion is to use a plastic drape under the patient to collect the blood, as is used for theatre drapes.

Conclusion

The use of ICS in obstetrics is a vital blood conservation strategy and can reduce and even help to eliminate the use of allogeneic blood in obstetric cases that would otherwise require a transfusion of allogeneic blood. The obvious benefit for this young, fit, population is the avoidance of exposure to the risks of allogeneic blood. However, it should be remembered that avoiding allogeneic transfusion in this group also helps to conserve an important section of the potential blood donor population, who, if transfused with allogeneic blood, would no longer be able to donate. In cases of massive obstetric haemorrhage, the use of ICS can greatly reduce the number of units of allogeneic blood transfused and represents a source of rapidly available blood which may sustain the requirements for RBCs until allogeneic blood arrives.

The use of the technique is dependant upon a multidisciplinary team approach, adequately trained staff and clinical drive to ensure its safe and appropriate use. Hospitals should explore the use of ICS in this speciality and consider the appropriateness of including its use in their massive obstetric haemorrhage protocol.

Provenance and Peer review: Commissioned by the managing editor; Peer reviewed; Accepted for publication June 2011.

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Correspondence address: Hannah Grainger, Welsh Blood Service, Bocam Park, Ffordd Yr Hen Gae, Pencoed, CF35 5LJ ????????????????????? Email: hannah.gralnger@wales.nhs.uk

About the authors

Hannah Grainger MSc, PGCE, BSc (Hons)

Cell Salvage Co-ordinator, Welsh Blood Service

Sue Catling BA (Cantab), MB BS, FRCA

Consultant Obstetric Anaesthetist, Singleton Hospital, Swansea ABMU Trust

No competing interests declared
Figure 1. Cumulative transfusion incidents: 1996-2009 SHOT Reports
Image from the SHOT Report 2009

IBCT           2637 (39.6%)
I&U             421  (6.3%)
HSE             703 (10.6%)
Anti-D          721 (10.8%)
ATR            1234 (18.5%)
HTR             443  (6.7%)
TRALI           257  (3.9%)
TACO             52  (0.8%)
TAD               5  (0.1%)
PTP              49  (0.7%)
TA-GvHD          13  (0.2%)
TTI              69    (1%)
Autologous       42  (0.6%)
Unclassified      7  (0.1%)

SHOT cases 2009 n = 1279

ICBT           Incorrect blood component transfused
I&U            Inappropriate and unnecessary transfusion
HSE            Handling and storage errors
Anti-D         Anti-D related events
ATR            Acute transfusion reactions
HTR            Haemolytic transfusion reactions
TRALI          Transfusion-related acute lung injury
TACO           Transfusion-associated circulatory overload
TAD            Transfusion-associated dyspnoea
PTP            Post-transfusion purpura
TA-GvHD        Transfusion-associated graft-versus-host disease
TTI            Transfusion transmitted infection
Autologous     Autologous transfusion incidents
Unclassified   Unclassified transfusion incidents

Note: Table made from pie chart.
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