2013 transfusion-weltert-nardella-rodninelli-pierelli-de paulis-reduction of allogeneic red blood-cardiopat

O R I G I N A L A R T I C L E
Reduction of allogeneic red blood cell usage during cardiac
surgery by an integrated intra- and postoperative blood salvage
strategy: results of a randomized comparison_3836 1..8
Luca Weltert, Saverio Nardella, Maria Beatrice Rondinelli, Luca Pierelli,* and Ruggero De Paulis*
BACKGROUND: The amount of allogeneic blood trans-fusion
may relate to worse outcome in cardiac surgery.
The reinfusion of red blood cells (RBCs) lost by
patients, including those of chest drains, is a promising
strategy to minimize allogeneic transfusions.
STUDY DESIGN AND METHODS: To verify this
hypotheis, 1047 cardiac surgery patients were randomly
assigned to either traditional intraoperative blood
salvage followed by chest drain insertion or intra- and
postoperative strategy with the Haemonetics cardioPAT
system. Allogeneic RBC transfusion rate (primary end-point)
and postoperative complications (secondary end-point)
were recorded at the time of discharge from the
hospital and at first month follow-up visit, respectively.
RESULTS: The cardioPAT arm received 1.20 units of
allogeneic RBCs per patient, whereas the control group
required 2.11 units per patient, and this difference
proved to be highly significant (p = 0.02). We observed
a comparable 45-day mortality rate but a lower rate of
deep vein thrombosis (p = 0.04) and atrial fibrillation
(p = 0.04) in the cardioPAT arm.
DISCUSSION: A significant reduction in patient expo-sure
to allogeneic RBCs was observed in the cardioPAT
system arm. Complications were slightly less frequent
in the cardioPAT group. The use of the cardioPAT is a
safe and effective strategy to reduce allogeneic RBC
transfusions in cardiac surgery.
Continuous progress in the policies and tech-nologies
for blood collection and blood quali-fication
have determined a great reduction in
the rate of transfusion-transmitted infections
in developed countries. On the other hand, despite a sig-nificant
reduction of transfusion-transmitted infection
originated bywell-known microbic and viral agents, blood
transfusions remain related to a wide series of adverse
reactions due to clerical errors, immunologic reactions,
and transmission of unrecognized blood-borne patho-gens.
1,2 Patients undergoing cardiac surgery account
for a large proportion of blood transfusions worldwide
(10% of all blood transfusions). Allogeneic red blood cell
(RBC) transfusion during coronary artery bypass grafting
(CABG) has been shown to alter immunity3 and to be asso-ciated
with a greater risk of acute lung injury,4 periopera-tive
myocardial infarction,5 postoperative low-output
heart failure,6 and death.7 These risks, along with the
limited availability of blood products and the undefined
costs of blood transfusion, have heightened the interest
for those procedures that spare and save blood during
cardiac surgery, including the use of perioperative blood
salvage (PBS), transfusion algorithms to restrict allogeneic
RBC usage, and antifibrinolytic therapy as a measure to
ABBREVIATIONS: CABG = coronary artery bypass grafting;
ICU = intensive care unit; PBS = perioperative blood salvage.
From the Cardiac Surgery Department, European Hospital; the
Transfusion Medicine Department, San Camillo Forlanini
Hospital; and the Department of Experimental Medicine,
Sapienza University, Rome, Italy.
Address reprint requests to: Luca Pierelli, MD, Transfusion
Medicine Department, San Camillo Forlanini Hospital,
Circonvallazione Gianicolense 87, 00152 Roma, Italy;
e-mail: luca.pierelli@tiscali.it.
*These authors contributed equally to this work.
Received for publication December 29, 2011; revision
received June 14, 2012, and accepted June 14, 2012.
doi: 10.1111/j.1537-2995.2012.03836.x
TRANSFUSION **;**:**-**.
Volume **, ** ** TRANSFUSION 1

WELTERT ET AL.
reduce bleeding.8-10 By the use of PBS, patients’ blood lost
from surgical sites may be collected and reinfused after
extensive washing and concentration. The cardioPAT
device (Haemonetics, Braintree, MA) is a unique PBS
system that offers cardiovascular surgeons an uninter-rupted
blood salvage in both the operating room and the
postoperative intensive care unit (ICU). The cardioPAT
system consists of an electromechanical device and a
sterile, single-use disposable set. It is a small and portable
system with a battery back-up that facilitates moving from
the operating room to the ICU. In this context, we con-ducted
a single-center prospective, randomized trial to
compare in cardiac surgery the use of the cardioPAT
system for intra- and postoperative blood salvage to a
standard approach based on the Cell Saver system (Hae-monetics)
for the sole intraoperative blood salvage, fol-lowed
by insertion of traditional chest drains. The primary
endpoint of the study was the rate of allogeneic RBC usage
while the secondary endpoint was the evaluation of
adverse events in the two distinct arms.
MATERIALS AND METHODS
Patient enrollment
This study adheres to the CONSORT principles and
patients followedtheCONSORT2005FlowChart. Informed
consent was then obtained and all aspects of the opera-tion,
blood collection, transfusion, and any other relevant
matter was explained to the patient by one of the investi-gators.
The study followed the Helsinki Declaration
requirements for randomized case–control trials and was
approved by our institutional review board. All patients
who were candidates for heart surgery at our institution,
suffering from several cardiovascular disease (Table 1)
were enrolled in the study. No specific exclusion criteria
were applied for primary disease, with the aim to include
the entire patient sample that is usually enrolled in
surgerypractice. All patients’ risk factors for ischemic heart
disease (family history, the presence of diabetes, hyper-cholesterolemia,
smoking, obesity, hypertension) as well
as factors included in the Euroscore analysis (age, sex,
chronic pulmonary obstructive disease, the presence of
extracardiac arteriopathy, neurologic dysfunction, previ-ous
cardiac surgery, serum creatinine, active endocarditis,
critical preoperative state, unstable angina, left ventricle
dysfunction, recent myocardial infarct, pulmonary hyper-tension,
emergency conditions, postinfarct septal rupture)
and biometric variables (height, weight, and body surface
area) were collected and stored in the database before
running a custom randomization application working in
Windows XP. All descriptive and inferential statistics were
calculated via the commercial software (IBM SPSS,Version
17, International BusinessMachines Corp., Armonk, NY).
PBS procedure and patients’ management
and follow-up
The patients randomly assigned to the cardioPAT (Hae-monetics)
group received both intraoperative and postop-erative
blood salvage. A strict time limit was applied for
TABLE 1. Patients’ disease and planned surgical interventions at randomization*
Surgical procedures cardioPAT system Cell Saver system p value†
CABG 197 (38.47) 208 (38.73) 0.31
CAGB on pump 13 (2.53) 17 (3.16) 0.16
CAGB off pump 184 (35.93) 191 (35.56) 0.21
AVR 63 (12.34) 66 (12.29) 0.12
Combined CABG and AVR 48 (9.38) 51 (9.50) 0.22
MVR 24 (4.69) 26 (4.84) 0.30
MR 22 (4.30) 24 (4.47) 0.34
AVR + MVR 10 (1.95) 12 (2.23) 0.11
AVR + MR 6 (1.17) 5 (0.93) 0.10
TR + AVR + MVR 8 (1.56) 9 (1.68) 0.08
MVR + TR 16 (3.17) 17 (3.17) 0.11
MR + TR 12 (2.34) 11 (2.05) 0.12
AVR + TR 4 (0.78) 3 (0.56) 0.19
Ascending aorta replacement 23 (4.49) 24 (4.47) 0.08
Wheat (AVR + ascending aorta replacement sparing the root) 22 (4.30) 21 (3.91) 0.10
Bentall (AVR + ascending aorta and aortic root replacement) 29 (5.67) 32 (5.96) 0.08
David (ascending aorta and aortic root replacement sparing AV) 5 (1.06) 6 (1.12) 0.12
Aortic arch replacement 2 (0.35) 2 (0.37) 0.07
Ascending aorta replacement + MR + TR 2 (0.39) 2 (0.37) 0.09
Aortic dissection 2 (0.35) 2 (0.37) 0.12
Left ventricle aneurism repair 2 (0.47) 3 (0.56) 0.10
Other 14 (2.74) 13 (2.42) 0.11
Total number of patients 512 537
* Data are reported as patient number (%).
† p value at ANOVA.
AVR = aortic valve replacement; MR = mitral repair; MVR = mitral valve replacement; TR = tricuspid repair.
2 TRANSFUSION Volume **, ** **

the cardioPAT by limiting PBS to the first 6 hours after
operation. A dedicated perfusionist helped nurses in
charge of PBS to get acquainted to the system and to mini-mize
the new technology bias impact. The cardioPAT pro-cedure
consisted of sterile and continuous shed blood
collection from both the operating field and the chest
drains by a unique dedicated disposable kit with washing
by a dynamic disk-based procedure, which allowed the
subsequent reinfusion of the whole amount of saved
blood, as described by the manufacturer’s instructions.
The cardioPAT view and a brief description of its function-ing
are presented in Fig. 1.
The control group received a standard Cell Saver
system (Haemonetics) salvage treatment of shed blood in
the intraoperative phase and insertion of traditional chest
drains (Pleur-evac chest drainage systems, Sahara S-1100-
08LF, TeleflexMedical, Athlone Co.,Westmeath, Ireland) in
the postoperative time, with no sterile blood salvage in
this last phase. No patients of either group underwent
preoperative autologous blood donation or acute normo-volemic
hemodilution or were subjected to erythropoietin
(EPO) administration. Both groups received standardized
doses of tranexamic acid (400 mg/hr as intravenous
continuous infusion; Tranex, Lusofarmaco, Peschiera Bor-romeo,
Italy) as antifibrinolytic agent during operation.
The primary endpoint was the need for RBC allogeneic
transfusion. The secondary endpoint was the evaluation
of the difference in terms of adverse events. Ancillary
objectives were the cost-effectiveness of the cardioPAT.
Allogeneic RBC transfusion (prestorage leukoreduced
RBCs in all cases) need was triggered by a hemoglobin
(Hb) level of less than 8.0 g/dL, and the same criteria were
applied in both groups. Fresh-frozen plasma (FFP) and
platelet (PLT) concentrates (each containing 3 ¥
1011 PLTs and leukoreduced prestorage) were transfused
according to a thromboelastogram-oriented policy (TEG,
Haemonetics, Hemoscope Division, Niles, IL). Hb values
were automatically collected by the central laboratory
computer on the day of admission; on the day of surgery;
and on Postoperative Days 0, 1, 2, 3, and 4. The number of
units transfused, the amount of bleeding, any adverse
reaction, and the patients’ outcome were collected
directly from the clinical records 2 weeks after discharge.
All patients underwent an outpatient follow-up approxi-mately
45 days after surgery and at this time all adverse
events were investigated.
Statistical analysis
All data were processed by the IBM SPSS Version 17,
including sample sizing, analysis of variance (ANOVA),
and risk analysis. A preliminary power estimation analysis
Fig. 1. View of the cardioPAT device with a scheme of the disposable kit. Shed blood is aspirated and combined with an adequate
proportion of anticoagulant (1, 3) through the line from the sterile field (4) and collected into the cardioPAT reservoir (a) during
the intra- and postoperative phase. Recovered blood is then processed and extensively washed into the dynamic disk (b) by saline
(2) and RBCs are concentrated into the specific collection bag (c).Waste materials are collected into an additional large-volume bag
(d). Once collection and waste bags are full and/or saline and anticoagulant bags empty, respectively, they are replaced with extra
collection or waste and solution bags and aspiration line is replaced with an extra line before pass from intraoperative to postop-erative
blood salvage.
BLOOD SALVAGE IN CARDIAC SURGERY

WELTERT ET AL.
suggested that 360 patients per sample were needed to
obtain a 95% power goal, considering an alpha error level
of 5% and expecting a decrease in the incidence of trans-fusion
from the previously observed 58% to 30%. The first
step of the analysis was to ascertain whether the random-ization
process had been effective in controlling as many
known confounding factors as possible. ANOVA of the
dependent variables “cardioPAT System or Control” was
performed (ANOVA and univariate ANOVA as needed;
95% confidence interval [CI], p = 0.05) on all preopera-tive
data, namely, general cardiovascular risk variables,
Euroscore risk variables, biometric variables, bleeding,
surgeons directly involved in surgical procedure, and pre-scribers
of transfusions. The second step was to assess
whether the two groups differed in terms of transfusion
rate, relative risk of undergoing allogeneic blood
transfusion, and adverse events, using an “intention-to-treat”
analysis, by which all patients had been evaluated
in their respective arm for primary and secondary end-points,
irrespective of the real application or com-pletion
of the originally designed blood salvage procedure
by randomization. For a third level of data analysis,
patients were classified into three categories (low,
intermediate, and high bleeding risk) according to the
theoretical risk of blood loss associated with the specific
surgical procedures. Distinct patients’ categories of both
study and control arm were compared for bleeding
volume and allogeneic RBC exposure. Due to a compa-rable
beeding volume observed in patients belonging to
intermediate- and high-risk categories after a preliminary
analysis, they were cumulated in a unique intermediate-and
high-risk category for comparison (see Table 4). Every
comparison was tested with several statistical techniques
(t test, Yates’ continuity-corrected chi-square test), as
appropriate.
RESULTS
Recruitment took place between January 1, 2009, and
April 31, 2010, with assessment for patients’ eligibility
criteria; no patient was excluded from the study and
patients’ disease characteristics and relative surgical
interventions are shown in Table 1. A total of 512 patients
were allocated to the cardioPAT group and all received the
intended treatment; 537 patients were allocated to the
control group. ANOVA confirmed the efficacy of the ran-domization
process, as all variables analyzed proved to be
not statistically different in the two groups, including
primary disease characteristics. The baseline demo-graphic
and clinical characteristics of each group are sum-marized
in Table 2. There was no difference between
groups in the assignment to a specific investigator or a
specific transfusion prescriber (p = 0.162 and p = 0.121,
respectively) and both groups received standardized
doses of an antifibrinolytic agent (tranexamic acid) during
operation; there was no statistical difference between
groups in number of reoperations for bleeding (4.6% vs.
5.1%, p = 0.25) nor in transfusion of FFP or PLTs (FFP, 0.8
unit/patient vs. 0.94 unit/patient, p = 0.4; PLTs, 0.11 unit/
patient vs. 0.16 unit/patient, p = 0.3). The time in the
TABLE 2. Patients’ baseline characteristics at randomization*
Patients’ characteristics cardioPAT system Cell Saver system p value at ANOVA
Number of patients 512 537
Family history 53.2 47.2 0.22
Obesity 23.6 24.6 0.34
Diabetes 40.6 44.5 0.10
Hypercholesterolemia 58.3 52.7 0.51
Smoking habit 39.1 46.1 0.40
Hypertension 71.8 74.5 0.22
Euroscore 9.4 9.27 10.0 10.2 0.22
Age (years) 68.3 9.6 66.4 9.8 0.42
Sex (male) 73 75 0.40
Chronic pulmonary obstructive disease 21.1 24.5 0.38
Presence of extracardiac arteriopathy 24.1 24.8 0.31
Neurologic dysfunction disease 3.7 4.1 0.36
Previous cardiac surgery 4.4 5.4 0.27
Serum creatinine 1.27 0,9 1.36 0.4 0.33
Severe renal impairment 3.2 3.9 0.11
Presence of active endocarditis 2.7 2.9 0.25
Critical preoperative state 2.1 2.4 0.12
Unstable angina 17.1 20.6 0.10
Ejection fraction 47.5 9.2 52.2 8.4 0.09
Recent myocardial infarct 13.7 12.9 0.20
Pulmonary hypertension 5.4 6.1 0.13
Postinfarct septal rupture 0.3 0.2 0.15
Height (cm) 164 6. 163 9 0.22
Weight (kg) 74 13 76 9 0.31
Baseline Hb (g/dL) 11.9 1.4 11.5 1.2 0.11
* Results are presented as patients’ percentage (%) or mean standard deviation (SD), as indicated.

TABLE 3. Retransfused volume, blood transfusions, perioperative bleeding, and postoperative morbidity*
Postoperative patients’ characteristics cardioPAT system Cell Saver system p value at t test
Number of patients 512 537
Intraoperative retransfused volume (mL) 370 250 390 230 0.30
Postoperative retransfused volume (mL) 350 370 NA
Allogeneic RBC transfusion (units) 1.20 0.8 2.11 0.9 0.02
FFP transfusion (units) 0.8 1.2 0.94 1.3 0.40
PLT transfusion (units) 0.11 0.9 0.16 0.9 0.30
ICU stay (days) 2.41 1.7 2.67 1.9 0.30
Perioperative MI 2.9 2.4 0.19
Peak troponin level (nmol/L) 5.5 7.2 4.5 6.5 0.21
Epileptic syndrome 3.7 3.3 0.19
Focal neurologic damage 2.6 2.0 0.09
Generalized neurologic damage 1.2 1.9 0.11
Bleeding at 24 hr (mL) 720 450 760 380 0.14
Revision for hemostasis 4.1 4.9 0.12
Cardiac tamponade 2.8 3.1 0.20
Atrial fibrillation 24.2 30.4 0.04
Acute respiratory distress syndrome 7.2 5.2 0.25
Acute pulmonary edema 3.3 4.2 0.10
Pneumonia 5.8 6.3 0.09
Need for reintubation 5.2 5.9 0.12
Increase in liver enzymes 6.4 6.8 0.23
Bowel ischemia 2.2 2.5 0.23
Creatinine level before surgery (mmol/L) 1.12 0.8 1.29 0.7 0.21
Maximum creatinine level (mmol/L) 1.84 0.6 2.2 0.9 0.31
First 24-hr urine output (mL) 1800 700 1740 800 0.22
Use of fenoldopam 7.70 6.90 0.16
Need for hemdiafiltration (CVVHDF) 6.7 4.20 0.10
Need for insulin infusion 18.0 16.0 0.09
Fluid balance on discharge from ICU (mL) 500 350 580 340 0.10
Central venous pressure on discharge from ICU (mmHg) 10 3 12 3 0.24
Length of stay after operation (days) 6.9 2.1 7.4 3.0 0.09
Neurologic complications at 45 days 2.3 2.1 0.27
Long-term wound infection 5.4 5.9 0.06
Deep vein thrombosis 1.9 2.7 0.04
Renal failure 3.4 3.7 0.17
45-day mortality 3.6 3.8 0.20
* Results are presented as patients’ percentage (%) or mean SD, as indicated.
CVVHDF = continuous venovenous hemodiafiltration; MI = myocardial infarction; NA = not applicable.
operating theater was 186 minutes versus 198 minutes
(p = 0.3) for the cardioPAT and the control groups, respec-tively.
There was no significant difference in the baseline
Hb or the amount of bleeding between groups (p = 0.11
and p = 0.14, respectively).
Considering the entire population, the cardioPAT
group required 1.20 0.8 allogeneic RBC units per
patient, whereas the control group required 2.11 0.9
units per patient, and this difference proved to be highly
significant (p = 0.02). Excluding patients receiving more
than 10 units, who experienced either tragic hemorrhagic
events or prolonged ICU stay for postoperative complica-tions,
the difference between the two groups becomes
lower albeit statistically significant: the cardioPAT group
required 0.92 units per patient while the control group
required 1.44 units per patient (p = 0.03). Moreover,
37.65% of the patients in the cardioPAT group required
allogeneic RBCs; from those, 11.7% required 1 unit,
13.25% 2 units, and 12.7% 3 or more units. In the control
group 57.13% of the patients required allogeneic RBCs:
18.18% required 1 unit, 21.1% 2 units, and 17.85% 3 or
more units. The risk ratio of being exposed to allogeneic
RBCs was 0.56 (p = 0.02, 95% CI) for the cardioPAT group
compared to the control group.
Table 3 shows the adverse events analysis. There was
overall no significant difference between groups in com-plications
and 45-day mortality; however, there were
significantly less events of atrial fibrillation and deep vein
thrombosis in the cardioPAT group (24.2% vs. 30.4%,
p = 0.04; 1.9% vs. 2.7%, p = 0.04, respectively). Additional
data analysis carried out on distinct bleeding risk catego-ries,
defined on the basis of blood loss observed for dis-tinct
class of surgical procedures, showed that the use of
the cardioPAT was associated with a significant reduction
of allogeneic RBC transfusions in all types of surgery, irre-spective
of the amount of blood lost in the perioperative
phase (Table 4). Prothrombin time, activated partial
thromboplastin time, fibrinogen, and fibrinogen d-dimer
levels evaluated and compared in the study and control
arms within 2 and 12 hours from the end of retransfusion
of saved blood were not significantly different at appropri-ate
statistical analysis (data not shown).

The cost of disposable sets used in the control group
was $258 (each economic value of this analysis must be
considered as the cost to the hospital to purchase the
indicated equipment), $159 for the intraoperative Cell
Saver system, and $99 for the chest drains. The cost of a
cardioPAT was $291, with a surplus cost per patient of
$33 compared to that of Cell Saver plus the conventional
chest drains. If we consider that the cost of RBC produc-tion
may range from $154 to $248 per unit (this cost
production does not include the additional costs for
transfusion-related services, as described by Shander
et al.11), the saving of approximately 0.9 RBC unit per
patient by the cardioPAT was quite cost-effective, generat-ing
a saving of at least $109 per patient. In the subgroup
analysis of the distinct bleeding risk categories, the saving
of allogeneic RBCs by the cardioPAT in the low-beeding-risk
category was approximately 0.7 unit per patient
with an estimated cost saving of $85, compared to the
intermediate- and high-risk category, which had a RBC
use (Table 4) and cost saving identical to the entire cardio-
PAT patient population.
DISCUSSION
The objective of this randomized study was to assess
whether the use of the cardioPAT instead of the well-established
Cell Saver system plus conventional chest
drains is advantageous, safe, and cost-effective in reduc-ing
the risk of exposure to allogeneic blood transfusion
in cardiac surgery. Blood conservation techniques are of
relevant importance in cardiac surgery, as postoperative
bleeding is common, and RBC allogeneic transfusion
carries the risks of clerical errors, immunologic reactions,
and transmission of both well-known and unrecognized
blood-borne pathogens.Moreover, allogeneic blood prod-ucts
are quite expensive in their production process
and represent a limited resource worldwide. Nowadays,
despite all efforts, a relevant proportion of patients
undergoing cardiac surgery requires allogeneic RBC trans-fusion.
Several studies have reported that intraoperative
blood salvage may reduce the rate of allogeneic blood
transfusions.12-14 In contrast, Klein and coworkers15 did not
find a reduction of blood transfusion in a blood cell
salvage group. Carless and coworkers16 analyzed 75 ran-domized
controlled trials in which adult patients, sched-uled
for nonurgent surgery, were randomly assigned to
blood salvage or to a control group, who did not receive
the intervention. Data were independently extracted and
the risk of bias assessed. Relative risks and weighted mean
differences with 95% CIs were calculated. Overall, the use
of blood salvage reduced the rate of exposure to allogeneic
RBC transfusion by a relative risk of 38%. The use of blood
salvage resulted in a mean saving of 0.68 units of alloge-neic
RBCs per patient. A further detailed and complete
TABLE 4. Allogeneic RBC exposure according to distinct bleeding risk categories in the cardioPAT and Cell Saver arms*
cardioPAT system Cell Saver system p value†
allogeneic RBC units‡ Number
allogeneic RBC units‡ Bleeding Transfusion
Transfusion of
Bleeeding
volume (mL)‡
Transfusion of
Bleeeding
volume (mL)‡
Number
Patients’ bleeding category
Low bleeding risk|| 197 420 235 0.7 0.5 208 470 250 1.4 0.4 0.34 0.01
Intermediate¶ and high** bleeding risk 223/92 716 280 1.50 0.6 233/96 776 275 2.40 0.7 0.11 0.03
* Bleeding volume and RBC transfusion units of patients who had undergone surgical procedures associated with intermediate and high bleeding risk have been cumulated in unique cat-egory
due to the results of a first-level analysis which showed no significant differences between their bleeding volume in the entire patient sample (699 225 vs. 813 276; p = 0.10).
† p value at t test.
‡ Mean SD.
|| CABG.
¶ Aortic valve replacement (AVR), combined CABG and AVR, mitral valve replacement (MVR), mitral repair (MR), AVR + MVR, tricuspid repair (TR) + AVR + MVR, MVR + TR, MR + TR,
AVR + TR.
** Ascending aorta replacement, Wheat (AVR + ascending aorta replacement sparing the root), Bentall (AVR + ascending aorta and aortic root replacement), David (ascending aorta and
aortic root replacement sparing AV), aortic arch replacement, ascending aorta replacement + MR + TR, aortic dissection, left ventricle aneurism repair.
WELTERT ET AL.

meta-analysis carried out on 31 randomized trials involv-ing
2282 patients confirmed that the use of a standard cell
salvage approach (intraoperative) reduces the exposure to
allogeneic blood products or RBC transfusion for patients
undergoing cardiac surgery.17 Subanalyses included in this
meta-analysis suggest that a cell saver may be beneficial
only when it is used for shed blood during the entire
operative period. It has been found that processing car-diotomy
suction blood with a cell saver only during car-diopulmonary
bypass has no significant effect on blood
conservation and increases FFP transfusion. Albeit of rel-evant
significance, all these studies have not specifically
addressed the question relative to the role of continuing
blood salvage also in the postoperative period, to maxi-mize
blood salvage and allogeneic RBC saving.
The design of this study was simple and adequately
powered. All patients presenting for heart surgery at our
institution were eligible for the study and no exclusion
criteria were applied. All variables analyzed proved to
have no significant difference between the two groups at
randomization and we applied the same transfusion
trigger and strategy in both groups and both received
equal doses of antifibrinolytic agents during operation.
None of the patients in either group underwent pre-operative
autologous blood donation or acute nor-movolemic
hemodilution or were subjected to EPO
administration. Our experience shows that an integrated,
dynamic disk-based intra- and postoperative blood
salvage strategy with the Haemonetics cardioPAT led to a
significant reduction of patients’ allogeneic RBC expo-sure,
almost halving the risk of allogeneic RBC transfu-sion
compared to the only intraoperative approach with
the Haemonetics Cell Saver (1.20 vs. 2.11 RBC units per
patient, respectively; p = 0.02). The analysis of adverse
events occurring during hospitalization indicates that
the integrated intra- and postoperative blood salvage
strategy with the cardioPAT is a safe approach. A
decreased rate of atrial fibrillation and deep vein throm-bosis
was observed in the cardioPAT group. We observed
no difference in 45-day mortality after surgical interven-tions.
Optimization and integration of blood-saving
approaches including EPO treatment,18 intra- and post-operative
blood salvage, and proper bleeding control
could ascertain whether reduction in allogeneic blood
exposure relates to better postoperative patient outcome.
Cost analysis showed that the use of cardioPAT for
patients undergoing surgical procedures associated with
intermediate or high bleeding risk led to a transfusion-related
cost saving of $109 per patient and $85 per
patient for patients with low bleeding risk.
In summary, our data show that an intra- and post-operative
blood salvage strategy with the Haemonetics
cardioPAT system in cardiac surgery is not associated with
complications and is therefore considered safe and effec-tive
in reducing the rate of allogeneic RBC exposure.
CONFLICT OF INTEREST
None of the authors has any conflict of interest with the subject
matter of this article.
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