European Journal of Obstetrics & Gynecology and Reproductive Biology 159 (2011) 19–25

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European Journal of Obstetrics & Gynecology and

Reproductive Biology
journal homepage: www.elsevier.com/locate/ejogrb

Review

The introduction of intra-operative cell salvage in obstetric clinical practice:

a review of the available evidence
Giancarlo Maria Liumbruno a,*, Antonella Meschini a, Chiara Liumbruno a, Daniela Rafanelli b
a
UOC Immunoematologia e Medicina Trasfusionale, San Giovanni Calibita Fatebenefratelli Hospital, AFAR, Rome, Italy
b
UO Immunoematologia e Medicina Trasfusionale, AUSL 3 Pistoia, Italy

A R T I C L E I N F O A B S T R A C T

Article history: Intra-operative blood salvage is common practice in many surgical specialties but its safety is questioned
Received 2 March 2011 with concerns about the risks of contamination of recovered blood with amniotic fluid and of maternal–
Received in revised form 13 May 2011 foetal alloimmunization. However, the role of cell salvage as a blood-saving measure in this clinical
Accepted 9 June 2011
setting is progressively acquiring relevance thanks to the growing body of evidence regarding its quality
and safety. Modern cell savers remove most particulate contaminants and leukodepletion filtering of
Keywords: salvaged blood prior to transfusion adds further safety to this technique. Amniotic fluid embolism is no
Intra-operative cell salvage
longer regarded as an embolic disease and the contamination of the salvaged blood by foetal Rh-
Obstetrics
Safety
mismatched red blood cells can be dealt with using anti-D immunoglobulin; ABO incompatibility tends
Efficacy to be a minor problem since ABO antigens are not fully developed at birth. Maternal alloimmunization
Blood transfusion can be caused also by other foetal red cell antigens, but it should also be noted that the risk of
Autologous blood alloimmunization of the mother from allogeneic transfusion may be even greater. Therefore the use of
cell savers in obstetric clinical practice should be considered in patients at high risk for haemorrhage or
in cases where allogeneic blood transfusion is difficult or impossible.
ß 2011 Elsevier Ireland Ltd. All rights reserved.

Contents

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2. Intra-operative cell salvage . . . . . . . . . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3. Intra-operative cell salvage in obstetrics . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4. The available evidence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.1. Is cell salvage a safe technique in obstetrics? . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.2. Does cell salvage reduce the use of allogeneic blood in obstetrics?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.3. Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.4. Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.5. Amniotic fluid contamination. . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.6. Red blood cell contamination. . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Abbreviations: ACD, acid–citrate–dextrose; AF, amniotic fluid; AFE, amniotic fluid
embolism; AFP, a-fetoprotein; CS, caesarean section; DIC, disseminated intravas-
cular coagulation; ICS, intra-operative cell salvage; Ig, immunoglobulin; LDF,
leukodepletion filter; PPH, post-partum haemorrhage; RBC, red blood cell; SB,
salvaged blood; SC, squamous cell; SHOT, Serious Hazards of Transfusion; TF, tissue
factor.
* Corresponding author at: Ospedale San Giovanni Calibita Fatebenefratelli, Via
Ponte 4 Capi, 39-00186 Rome, Italy. Tel.: +39 06 6837526; fax: +39 06 6837521.
E-mail address: giancarlo@liumbruno.it (G.M. Liumbruno).
1. Introduction
Obstetric haemorrhage is a leading cause of maternal and
perinatal mortality [1,2]. Death as a consequence of pregnancy
remains an important cause of premature mortality worldwide [2].
Each year, an estimated 500,000 women die from this potentially
preventable cause [3], up to an estimated quarter of these deaths
occurs as a consequence of bleeding [4]. During the 2006–2008
triennium, the rate of deaths from haemorrhage in the UK was 0.39

0301-2115/$ – see front matter ß 2011 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.ejogrb.2011.06.011
20 G.M. Liumbruno et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 159 (2011) 19–25
per 100,000 maternities [5]. In developed countries treatment is
generally effective with an approximate case fatality rate between
1 in 600 to 800 cases of obstetric bleeding [6–8].
The use of intraoperative cell salvage (ICS) has increased
substantially during the last two decades and the re-infusion of
shed washed blood is commonplace in many types of surgery
where heavy blood loss is expected, such as cardiac, vascular or
orthopaedic surgery [9,10].
However, the safety of ICS in obstetrics has been questioned
and, consequently, its introduction in this clinical arena delayed for
theoretical concerns stemming from the historical and ongoing
dispute focused on the risk of maternal–foetal anti-Rh(D)
alloimmunization and the risk of contamination of the cell-saved
blood with traces of amniotic fluid (AF) [11,12]. The aim of this
article is to review the available evidence regarding quality and
safety of this technique and supporting its introduction in the
obstetric clinical setting.
2. Intra-operative cell salvage
ICS is a blood saving technique that makes it possible to use
the blood lost in the surgical field; this blood is suctioned and
anticoagulated before it is sent to the collection reservoir and
from here, through filters for micro-aggregates with various
diameters, to the cell separator where it is concentrated by
means of centrifugation and then washed with saline before
being re-infused to the patient [13]. Concentrating red blood cells
(RBCs), while expressing irrigants, plasma and platelets, can
remove 70–90% of the soluble contaminants from salvaged blood
[14,15]. The subsequent proper washing with saline can
consistently reduce residual soluble contaminants. The salvaged
RBCs are then re-suspended in normal saline with a resultant
haematocrit of 50–80%.
Notwithstanding the reduction of infectious risk thanks to the
introduction of molecular biology techniques utilized for the
biological qualification of blood components [16], allogeneic blood
transfusion still carries potential risks such as: acute and delayed
haemolytic reactions, febrile, urticarial, anaphylactic reactions,
non-cardiogenic pulmonary edema, graft-versus-host disease,
post-transfusion purpura, clerical errors [17]. These consequences
of allogeneic transfusion are even more important in the obstetric
population which has many years of productive life ahead of them.
ICS can reduce exposure to allogenic blood, thereby reducing
the above risks and is also acceptable to some Jehovah’s Witnesses
provided the equipment is set up in continuity with the circulation
[18], but consent needs to be obtained on an individual basis.
For unpredictable major haemorrhage, such as in obstetrics, the
cell salvage device can be implemented in stages, setting it up in
the ‘stand-by’ mode. The ‘stand-by’ mode is simply the collection
system which includes a collection reservoir, a suction line and an
anticoagulant. The ‘stand-by’ setup cost is comparable to the
reagent costs for cross-matching two units of allogeneic blood [19].
If enough blood loss occurs, the expensive components of the
system can be used and blood processed very quickly, as adding the
centrifuge takes less than a minute in experienced hands [20]. An
in-depth discussion concerning all the financial aspects for the
provision of cell salvage services is well beyond the scope of this
article, as economic analyses of cell salvage have already been
published elsewhere [21–25].
However, ICS is an expensive technology but, once the capital
costs of the machine are accounted for and the personnel trained,
its cost compares favorably to allogeneic RBCs with the savings
increasing as the RBC transfusion volume increases. Waters et al.
showed that, assuming that every salvaged blood (SB) unit would
replace an allogeneic unit, the average savings per unit was
$110.54 [24].
3. Intra-operative cell salvage in obstetrics
At present in the US, the use of autologous blood salvage devices
has been advocated by the American College of Obstetrics and
Gynecology for use in women where massive haemorrhage is
anticipated [26,27]; the American Society of Anaesthesiologist Task
Force on Obstetric Anaesthesia has recommended that ICS should be
considered ‘‘in cases of intractable haemorrhage when banked blood
is not available or the patient refuses it’’ [28]. In Italy, recently issued
recommendations suggest that ICS should be used in obstetrics for
the emergency management of major bleeding or for cases at
increased risk of major haemorrhage, provided a leukodepletion
filter (LDF) can be used for the transfusion of SB [29]. In the UK, the
use of ICS has been endorsed by the last two reports of the
Confidential Enquiry into Maternal and Child Health and the
National Institute of Clinical Excellence [5,30,31]. The Obstetric
Anaesthetists’ Association and the Association of Anaesthetists of
Great Britain and Ireland identified emergency use (major obstetric
haemorrhage at caesarean section (CS), laparotomy for post-partum
haemorrhage (PPH), etc.) and elective use of ICS (anticipated
haemorrhage at CS, e.g. placenta praevia, placenta accreta, large
fibroid uterus, patients who refuse allogeneic blood, etc.) [32,33]. The
UK Cell Salvage Action Group suggested that ICS should be available
for cases where there is the potential for massive obstetric
haemorrhage including [34]; (1) emergency situations, such as
ruptured ectopic pregnancy, and intra-partum or post-partum
haemorrhage requiring surgical intervention; (2) elective situations,
such as patients with an anticipated blood loss of more than 1000 mL,
and patients who refuse allogeneic blood and have consented to the
use of ICS in bleeding situations or in significant anaemia.
Maternal blood loss is notoriously difficult to quantify and
tends to be under-estimated; uterine blood flow at term (20% of
cardiac output) gives rise to potential sudden massive blood loss
[35]. Therefore, additional resources should be mobilized if the
expected blood loss exceeds 1000 mL [1]. This is consistent with
the recommendation of the World Health Organization and is
based on experience showing that blood loss up to 1000 mL may be
considered to be physiological, and that, for healthy women
1000 mL is the physiological point at which a woman’s vital signs
may be affected [36,37].
Implementation of ICS could also be considered when the loss of
smaller amounts of blood is anticipated [19]. Because of the
difficulty associated with the accurate prediction of substantial
blood loss, for the majority of cases it would be appropriate to set
up the ICS device in the ‘stand-by’ mode.
4. The available evidence
4.1. Is cell salvage a safe technique in obstetrics?
Many studies have been carried out on obstetric patients and no
complications as a result of SB transfusion were reported in most of
them [38–65].
In 1983, a retrospective review of 725 mainly cardiovascular
patients, also included in the miscellaneous subgroup of 43
patients an unstated number of ectopic pregnancies and CSs [45];
in no case was mortality or morbidity attributed to autologous
blood transfusion and no evidence of major coagulopathy,
systemic sepsis, air or particulate embolism and renal failure
was detected. A retrospective database review of over 36,000 cases
of ICS from 1978 to 1996 included an indefinite number of
obstetric-gynaecology patients [48]; in this study, the eighteen
reported deaths occurred in non-obstetric patients and were not
attributed to ICS.
Rebarber et al. were the first to assess the safety of ICS during CS
and showed no statistically significant differences between the
 G.M. Liumbruno et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 159 (2011) 19–25
patients transfused with autologous blood and the group receiving
allogeneic blood transfusion only [44].
In the cases of abnormal placentation, such as placenta praevia,
accreta or percreta, the procedure showed a good level of safety
and usefulness [42,54,58,60,62,64]. The side effects reported in
patients who however fully recovered, do not seem directly linked
to ICS; they included: (i) endomyometritis, attributed to an
inability to express the uterus at the end of the surgical procedure
[43]; (ii) postoperative adult respiratory distress syndrome and
staphylococcal pneumonia, in a patient who was also massively
transfused with allogeneic blood components [52]; (iii) moderate
anaemia in a b-thalassemia intermedia patient [53]; and (iv)
unexplained hypotension during the intra-operative transfusion of
SB during a complex operation for placenta percreta [62].
Other side effects reported are disseminated intravascular
coagulation (DIC) [49], in a case report where the reinfused blood
might have been one of the several factors contributing to DIC, a
presumptive case of heparin toxicity reversed with protamine
sulfate [44], in a case where 54 units of SB were reinfused, and two
additional cases of hypotension associated with the use of LDFs for
the transfusion of SB [63,64]. The physical characteristics of the
filter might have been implicated in the development of
hypotension through the production and release of bradykinin,
but, unfortunately, in neither case was transfusion attempted
without filtration [66]. In 2009, 3 cases of clinical adverse events all
regarding hypotensive reactions related to re-infusion of intra-
operatively SB were also included in the Serious Hazards of
Transfusion (SHOT) report; common factors in 2 cases were the use
of acid–citrate–dextrose (ACD) as an anticoagulant and the use of
an LDF during re-infusion of SB [17]. However, more robust data
from haemovigilance studies are needed to change the current
recommended practice of using these filters to remove foetal
contaminants [29,31].
Theoretically, the potential to cause an iatrogenic amniotic fluid
embolism (AFE) is the greatest fear that accompanies AF
contamination [33]. The only fatal obstetric case was published
in 2000 [51]; it has not generally been accepted in literature as
secondary to AFE as the patient was at high risk in terms of
obstetric co-morbidity and not enough information was provided
to determine whether SB had any causal role [12].
4.2. Does cell salvage reduce the use of allogeneic blood in obstetrics?
At present, the ICS procedures documented in obstetrics are 826
and more than 400 patients have been transfused with SB
[38,47,49–65,67]. In case reports, the median amount of salvaged
blood transfused is 500 mL [38,41,43,49,51–55,58,59,64]. This data
is confirmed by six larger studies accounting for almost 300
patients transfused with mean or median amounts of SB not
exceeding 2 units [44,47,50,60–62]. In 46% of the cell saving
procedures (380/826) either blood loss was not enough to be
processed or SB was not enough to be transfused; in seven large
studies (Table 1) the re-transfusion rate of autologous SB ranges
from 36 to 100% [44,47,50,56,60–62]. The efficacy of ICS, defined as
avoidance/reduction of allogeneic blood use [68,69], can be
evaluated only in five studies, where the percentage of patients
who completely avoided allogeneic blood ranges from 6 to 97.1%
[44,50,60–62].
In the retrospective study by Rebarber et al. only a small
percentage of women (11/186 – 6%) completely avoided allogeneic
RBC transfusion thanks to ICS but the authors did not explain the
large use of allogeneic blood [44].
A much larger percentage of women avoided allogeneic RBC
transfusion (33/34 – 97.1%) in the only prospective randomized
controlled trial carried out [50]. In a series of 46 patients reported
by King et al. [60], 74% (14/19) avoided allogeneic RBC transfusion.
21
Preoperative haemoglobin was significantly lower in the 26% of
women who received both salvaged and allogeneic blood.
The percentage of patients who did not receive allogeneic RBC
transfusion was slightly higher (14/17 – 82%) in an audit reported
by Parry et al. who avoided the use of an estimated 14 units of
allogeneic RBCs [61].
In a prospective study carried out over a 28-month period,
33.3% of the patients (7/21) avoided allogeneic RBCs [62]. Also in
this study blood loss and preoperative haemoglobin levels
differentiate the patients who did and those who did not receive
SB; in fact, 79% of the women who did not avoid allogeneic RBC
transfusion (11/14) had preoperative haemoglobin lower than
120 g/L.
From the above studies, the total number of patients who
avoided allogeneic RBC transfusion is 79 out of 277 (28.5%).
In 2007, Fong et al. sought to determine to what extent SB might
theoretically reduce exposure to appropriately transfused alloge-
neic erythrocytes in a large retrospective cohort case–control
study [70]. Theoretically, had ICS been performed, based on best,
average, and worst RBC recovery scenarios, 25.1%, 21.2%, or 14.5%
of the appropriately transfused patients, respectively, could have
completely avoided allogeneic RBC transfusion.
However, only limited and non significant conclusions can be
drawn on the impact of ICS on the consumption of allogeneic blood
supply, because many studies had small numbers, the groups were
not homogenous, the starting haemoglobins were not matched and
varying groups had different transfusion guidelines and thresholds.
Unfortunately, a randomized controlled trial to establish the
efficacy of ICS in CS has not been launched yet; it would need to
recruit approximately 4500 patients to be adequately powered to
detect a 33% proportional reduction of the use of allogeneic blood
[68,69].
4.3. Indications
This technique has been prevalently used in elective and
emergency CS [44,46,47,50,57,60–64], also for the management of
patients with alloantibodies, where compatible blood was difficult
to be found [41,62], and for a patient with b-thalassemia
intermedia and placenta accreta [53]; other cases of abnormal
placentation are reported [39,40,42,52,54,55,58–62], also in
patients with sickle-cell trait [59], or in a clinical case where ICS
was coupled with acute normovolemic haemodilution [27]. In
several circumstances ICS was used for Jehovah’s Witnesses
[42,49,51,52,54,55,59,62] and/or PPH [38,49,52,59].
Other indications for the use of ICS were suspected placental
abruption, multiple pregnancy, multiple repeat CS (three or more
CSs), CS at full dilatation, low preoperative haemoglobin and cases
at the discretion of theatre staff [60]. For some patients multiple
indications were recorded including fibroids, high body mass
index, pregnancy induced hypertension, adhesions and low
platelet count. ICS was also considered in patients presenting
failed induction of labour and failed instrumental delivery, ectopic
pregnancies and massive fibroids [61,62]. A recent retrospective
study showed that ICS was apparently used more frequently in
patients at higher risk of obstetric haemorrhage such as multipa-
rous women and subjects with a higher number of CSs or multiple
pregnancies; additional risk factors for the use of ICS were multiple
fibroids, previous miomectomy or PPH, medical conditions
(immune thrombocytopenic purpura), and previous ruptured
uterus [65].
4.4. Contraindications
Three areas exist where ICS needs to be used with caution
and following necessary risk-benefit analysis. These include
22 G.M. Liumbruno et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 159 (2011) 19–25

Table 1
Clinical studies on cell salvage in obstetrics.

Year/author Publication Number of Number of subjects Re-transfusion Clinical setting

type cell saving transfused (446) rate of salvaged
procedures (826) blood (%)

1983/Keeling [45] RS 43a Not stated Not stated HY, CS, AP

1988/Grimes [38] CR 2 2 100 AP
PPH
1990/Zichella [46] CR 8 8 100 CS
1993/Jackson [47] RS 119 64 53 CS
1996/O’Brien [39] RS 5 5 100 Placenta percreta
1998/Rees [49] CR 1 1 100 CS/PPH/JW
1998/Rainaldi [50] Prospective 34 34 100 CS
controlled trial
1998/Rebarber [44] Retrospective 186 139 74 CS
cohort
1999/Potter [43] CR 1 1 100 CS/placenta previa
2000/Oei [51] CR 1 1 100 CS/JW/preeclampsia/HELLP
2002/Catling [52] CR 4 4 100 Extrauterine placenta/CS
PPH
CS/JW
CS/JW
2003/Waters [53] CR 1 1 100 CS/placenta accreta/b thalassemia
intermedia
2003/de Souza [54] CR 1 1 100 Placenta praevia/CS/JW
2004/McGurgan [55] CR 1 1 100 Placenta praevia/CS/JW
2005/Boonstra [41] CR 1 1 100 CS
2007/Teig [56] RSb 182 119 65 Not stated
2008/Harkness [57] RSc 7 0 0 CS
2008/Nagy [42] CRd 1 1 100 Placenta percreta/JW
2009/Araki [58] CR 1 1 100 Placenta accreta
2009/Okunuga [59] CR 2 2 100 Placenta praevia/JW/SCT
Placenta accreta/SCT
2009/King [60] RS 46 19 41 Placenta praevia, suspected placental
abruption, multiple pregnancy, multiple
repeat CS, previous PPH, refusal of blood
transfusion, CS at full dilatation, low
preoperative Hb, at the discretion of the
theatre team
2009/Eller [40] Retrospective 1 Not stated Not stated Placenta accreta
cohort
2010/Parry [61] RS 47 17 36 Patients at high risk of haemorrhage (placenta
praevia, suspected placental abruption, multiple
pregnancy, multiple repeat CS, previous PPH,
refusal of blood transfusion, CS at full dilatation,
low preoperative Hb, at the discretion of the
theatre team, failed induction of labour, failed
instrumental delivery)
2010/McDonnell [62] Prospective 51 21 41 Placenta praevia, CS, ectopic pregnancy, JW
cohort
2010/Sreelakshmi [63] CR 1 1 100 CS
2010/Kessack [64] CR 1 1 100 CS
2010/Hatfield [67] CRe 1 1 100 Placenta accreta
2010/Malik [65] RS 77 Not stated Not stated Placenta praevia, JW

AP: abdominal pregnancy; CR: case report; CS: caesarean section; HY: hysterectomy; JW: Jehovah’s witness; PPH: post-partum haemorrhage; RS: retrospective series; SCT:
sickle cell trait.
a
Includes a not stated number of exploratory laparatomy.
b
Survey of cell-salvage use (includes 63 episodes of cell-salvage set-up without processing blood).
c
Survey of cell-salvage use.
d
Combined use of acute normovolemic haemodilution and cell-salvage.
e
Use of standard cardiopulmonary bypass machine and transfusion of unwashed whole blood.

blood aspirated from contaminated or septic wounds or
obstetric/surgical fields, and areas of malignancy. Procedural
measures to reduce the AF load to the mother to a minimum
include: (i) the use of two suction devices to avoid the aspiration
of AF into the collection reservoir; (ii) delay of salvage until after
removal of the foetus, placenta and AF [71]; (iii) extra washing;
(iv) not processing partially filled bowls, which produce a final
product with very low haematocrit and a higher concentration
of cellular debris, and (v) the use of LDFs.
Relative contraindications to ICS also include sickle-cell
disease and thalassemia [19]. In patients with sickle-cell disease
ICS has generally been avoided because the hypoxic environment
of the reservoir was thought to result in RBC sickling and re-
infusion of this blood may precipitate a sickle-cell crisis [19]; b-
thalassemia RBCs have increased rigidity and reduced membrane
stability which may make them more susceptible to trauma
occurring during suction from the surgical field (without
adequately down-regulated suction pressure) and to damage
from the shear forces they are exposed to during ICS. However,
autologous SB transfusion was performed in two sickle-trait
patients and in one with b-thalassemia intermedia without side
effects [53,59].
 G.M. Liumbruno et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 159 (2011) 19–25
4.5. Amniotic fluid contamination
AFE remains one of the greatest enigmas in obstetrics [72]. The
presence of cells of foetal origin in maternal blood was regarded as
a marker of AFE, but foetal cells and AF material can be commonly
found in the maternal circulation [72–74]. At present, AFE seems to
be a rare anaphylactoid reaction to the foetal antigen rather than a
predictable response to exposure to AF [75]. It has been assumed
that in order for ‘spontaneous’ AFE to occur there must be a breach
in the physical barriers between the maternal and foetal
compartments [76]. Therefore, a rigorous quality control of ICS
is necessary to provide a safe blood product and to reduce the risk
for the mother of an ‘iatrogenic’ AFE, secondary to the presence of
foetal contaminants in re-infused SB.
The incidence of AFE is low and varies tenfold between 1.3 and
12.5 per 100,000 pregnancies [9,77–79]. Proving complete safety
of ICS against the theoretical risk of AFE is not an easy task: a
prospective randomized study with a power of 90% to show that
ICS is not likely to increase this incidence fivefold would require a
population of 35,400–340,500 patients.
Therefore, to assess the degree of contamination of SB by
possible etiologic triggers of AFE surrogate markers for the various
component of AF were measured [46,50,62,73,80–86].
These included: (i) potassium (a solute of AF and a marker of
haemolysis occurring during ICS) and proteins such as a-
fetoprotein (AFP) and tissue factor (TF) [62,73,82–86], which is
postulated to be involved in the DIC that typically follows AFE [87];
(ii) the clotting activity of SB (as an indirect technique to assess AF
contamination) [46,50]; (iii) the determination of phosphatidyl-
glycerol or lamellar bodies (phospholipids from lung maturation)
[46,73]; and (iv) the degree of contamination by foetal squamous
cells (SCs) [50,73,81,82,86]. However, none of the current methods
of detection of elements of AF has a 100% sensitivity [12].
Studies carried out with different cell saver equipments
reported different results. In 1989, Durand et al. were unable to
remove all the foetal debris from SB [80]. Other studies showed
that the SB contained only a small amount of phosphatidylglycerol
due to haemolysis and did not have coagulant activity [46], or that
AFP was undetectable in all post-wash samples while SCs were
reduced but still present [82]. In 1996, despite the use of a separate
suction device to avoid the aspiration of AF, AFP and TF were not
fully eliminated [83]. On the contrary, different equipments
completely eliminated TF activity [84], coagulant activity and
SCs [50], and reduced AFP to below lower limits of detection [81].
In 1999, the efficacy of an LDF (Pall RC 100, Pall Biomedical,
Portsmouth, UK) in removing the various components of AF from
SB was examined for the first time [85]; AFP was significantly
reduced in post-wash samples but unchanged following filtration,
while leukocytes and throphoblasts were completely absent in
post-filtration samples. Filtration was not effective in removing
SCs from almost half of the post-filtration samples.
Different results were reported by Waters et al. with the same
cell saver and a newer generation filter (LeukoGuard RS, Pall
Biomedical Products Co., East Hills, NY) [73]. A significant
reduction of SCs and of lamellar body concentration was obtained;
potassium levels were also significantly lower in the post-filtration
samples. The marked difference in the clearance of SCs between
these studies can be really attributed to the use of different filters,
which vary in design features such as fibre diameter and charge
[11].
The efficiency of the above LDF was confirmed in 2008, using
only one sucker [86], and in 2010, using the two sucker technique,
as the vast majority of units currently do [62].
The differences between the results of the reported studies may
represent a flaw probably resulting from differences between cell
saver devices, amount of saline wash, and degree of technical
23
expertise in device operation [9]. Unfortunately, many of the above
reports do not contain sufficient information to evaluate these
differences.
Notwithstanding their heterogeneity, most studies reported on
consistently/significantly decreased concentrations of contami-
nants. Therefore, ICS yields RBCs significantly lacking in protein
elements of AF [62,81–83,85,86], without significant bacterial
contamination [45,50,73,80], with a consistent removal of free
haemoglobin and potassium [50,73,81], and with a debris
concentration equivalent to that of maternal venous blood [73].
Undoubtedly, leukodepletion filtering of SB prior to transfusion is a
consistent and significant step towards safety.
4.6. Red blood cell contamination
A combination of cell-salvage washing and filtration appears to
produce a blood product comparable with maternal blood, with
the exception of the contamination by foetal RBCs
[50,62,73,80,81,85,86] this could increase the risk of maternal
alloimmunization in cases of RBC antigen incompatibilities
between mother and foetus.
Foetal RBCs were still present in the final product in several
studies [62,73,81,85,86]; the degree of contamination was shown
to range from 1 to 1.8–2% [50,80]. The contamination of the SB by
foetal Rh-mismatched erythrocytes can be dealt with using anti-D
immunoglobulin (Ig). The volume of foetal RBCs transferred by ICS
ranges from 1 to 5 mL [50,73,81]; in the study carried out by
Catling et al. the maximum foetal blood volume mixed with the
maternal cell saved volume was about 19 mL (range 2–19 mL) [85].
The dose of 500 IU of anti-D Ig given to every D negative woman
with no preformed anti-D within 72 h of delivery of a D positive
baby will be sufficient to prevent sensitization from a bleed of up to
4 mL of foetal RBCs [88]. It is therefore important that the volume
of fetomaternal haemorrhage is promptly and accurately assessed
so that, if necessary, a supplementary dose of anti-D Ig can be
administered and maternal alloimmunization prevented [89].
Clinically relevant antibodies can also be formed against other
RBC antigens and be implicated in haemolytic disease of the
newborn [90]. However, the risk of alloimmunization has been
estimated to be similar to that present in a normal vaginal delivery
and maternal alloimmunization was never reported [1]. ABO
mismatch tends to be a minor problem in comparison to Rh
mismatch since ABO antigens are not fully developed at birth. The
risk of maternal alloimmunization by allogeneic blood transfusion
is much greater than that caused by foetal RBCs.
5. Conclusions
Though the overall quality of evidence is poor, and case reports
and case series represent a consistent part of it, there is so little
evidence that obstetric applications should be considered a
contraindication to ICS that its increasing use is supported by
national bodies and scientific societies.
Given the significant costs and the relatively low likelihood of
re-transfusion, where a service for other specialties is already
provided, consideration should be given to extending this service
for obstetric patients [62]. ICS is not justified in uncomplicated
emergency or elective CS; on the contrary, it should be considered
for emergency use (major haemorrhage at CS, laparotomy for PPH,
placental abruption, ruptured ectopic pregnancy) or elective use
[anticipated major haemorrhage at CS (placenta praevia, accreta or
percreta), large/multiple fibroids uterus, multiple pregnancies,
previous ruptured uterus or PPH, patients with significant
preoperative anaemia or thrombocytopenia and women who do
not have allogeneic compatible blood available or refuse it]. Where
practicable AF should be removed by a separate suction device; an
24 G.M. Liumbruno et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 159 (2011) 19–25
LDF is required for the transfusion unless the SB needs to be re-
infused under pressure (to correct hypovolemia and hypotension
due to sudden massive bleeding) or there is an unexplained
hypotension shortly following re-infusion [91].
In conclusion, though the use of ICS in combination with an LDF
appears to be safe in obstetrics, larger and adequately powered
studies are needed to define the real efficacy of this technique in
saving allogeneic blood and its impact on several outcome
variables, including the alloimmunization rate in recipients.
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