PFN Spanish Workshop. Dr garcia erce. Madrid, september 2014

Workshops SEFRAOS
Spanish multidisciplinary care systems
Chair : Prof.Jesús Gonzalez-Macias .President of SEFRAOS
Treatment of pre-and postoperative anemia.
Is it necessary a transfusion?
Dr. José A Garcia-Erce.
Servicio de Transfusión Hospital San Jorge. Huesca
Miembro IdiPaz 49

Prof. Antonio Herrera Rodríguez
Cátedra Department of Orthopaedic Surgery. University of Zaragoza
Dr. Jorge Cuenca Espiérrez
Department of Orthopaedic Surgery. Hospital Miguel Servet, Zaragoza
Prof. Manolo Muñoz Gómez
Medicina Transfusional. GIEMSA. Universidad de Málaga
Dr Santiago Ramón Lea-Noval
Coordinador General Documento «Sevilla» de Consenso sobre Alternativas a la
Transfusión de Sangre Alogénica
Dra. Elvira Bisbe
Department of Anaesthesiology. University Hospital Mar-Esperança, Barcelona
IACS (Institudo Aragonés de Ciencias de la Salud)
www.awge.org
Acknowledgement

www.awge.org
Conflict of interests
Asesor externo
- AMGEN Oncología 2010 y 2012
- Roche Anemia 2009
- Ditassa-Ferrer 2004
Charlas, estudios investigación y ayudas a congresos
-Vifor-Uriach/Ferralinze
-Janssen-Cilag/GSK/Novartis
-Astra-Tech de Aztra Zeneca
-Sanofi Aventis/Esteve
-Cobe-Caridian/Roche Oncología
Miembro del CAT 2002-2005
Miembro del Documento de Sevilla “Alternativas a la Transfusión”
Miembro de GIEMSA/AWGE/Socio SETS, SEHH, SEFRAOS
Editor Asociado Revista ANEMIA www.revistaanemia.org
Miembro Comité Científico NATA y TATM

• Entre un 30% y un 50% de los pacientes quirúrgicos puede
presentar una anemia preoperatoria, causada o no por la patología
motivo de la cirugía.
• Hasta un 90% de los pacientes quirúrgicos pueden presentar anemia
postoperatoria debido al sangrado y/o la inhibición de la
eritropoyesis.
• En los pacientes quirúrgicos, la presencia de anemia se correlaciona
con un aumento de la morbi-mortalidad postoperatoria y un
descenso de la calidad de vida.
Preoperative Anemia

Treatment of pre-and
postoperative anemia.
- First problem: Preoperative Anemia Incidence
HIP FRACTURE

1.0 2.0 3.0 4.0 5.0 6.0
0
10
20
30
Male Female
6.0%
8.7%
1.5%
12.2%
4.4%
6.8%
7.8%
8.5%
15.7%
10.3%
26.1%
20.1%
1-16 17- 49 50 - 64 65 - 74 75 - 84 85+
Age group (years)
Percentwhohaveanemia
26,372 individuals
WHO criteria
Preoperative Anemia Incidence

Community Nursing homes Hospital admissions
Preoperative Anemia Incidence

Anaemia: 18 %
Preoperative Anemia Etiology?

20-30
mg/día
Músculo
(250 mg)
Médula ósea
(300 mg)
Eritrocitos
(2.000 mg)
Macrófagos SRE
(500 mg)
Hígado
(1000 mg)
Absorción intestinal de hierro
(1-2 mg/día)
Transferrina
(3 mg)
Pérdidas de hierro
(1-2 mg/día)
IRON LOST!
IRON BLOCK!
Peri-operative Anemia Etiology

Blood loss (mL)
ι
0
ι
500
ι
1000
ι
1500
ι
2000
ι
2500
ι
3000
Acute anemia
Transfusion
Hemoglobin(g/dL)
9 –
11 –
13 –
7 –
5 –
15 –
Bleeding
25% 45%
Erythrocyte mass
Major surgical procedures
(Orthopedic, cardiac, cancer, etc)
Peri-operative Anemia Etiology

- Preoperative Anemia Incidence
- Preoperative Haemoglobin and transfusion risk
HIP FRACTURE

Preoperative Anaemia and
transfusion risk
ABT in anaemic patients: 57%
ABT in no-anaemic patients: 19%
ABT in anaemic patients: 62%
ABT in no-anaemic patients: 29%
HIP FRACTURE

1.00 2.00 3.00 4.00 5.00 6.00
0
25
50
75 Preoperatoria
Intraoperatoria
Postoperatoria
Hemoglobina admision (g/dL)
PacientesconTSA(%)
- EPO +EPO - EPO +EPO - EPO +EPO
≥13 g/dL <13 - ≥10 g/dL <10 g/dL
*
*
*
*
#
**
**
Miguel Servet, 2007
19%
52%
100%
Preoperative Haemoglobin
and transfusion risk
HIP FRACTURE

Hb 130-140 g/l
100
75
62
46
25
0 20 40 60 80 100
%TRANSFUSION
Hb < 110 g/l Hb 110-120 gl Hb 120-130 gl
Hb > 140 g/l
Relationship preoperative Hb and Transfusion
García Erce JA, Cuenca J, Solano VM. FACTORES PREDICTIVOS DE LA NECESIDAD DE
TRANSFUSION EN LA FRACTURA SUBCAPITAL DE CADERA EN PACIENTES DE MÁS
DE 65 AÑOS. Med Clin 2003;120(5):161-6.
Haemoglobin level and transfusion risk
HIP FRACTURE

- Transfusion and postoperative complications
HIP FRACTURE

• 9598 patients (>60 years; 1983-1993)
Carson y cols. Transfusion 1999; 39:694-700
• Ajusted Risk:
– Infección bacteriana seria: 1.35
– Pneumonía postoperatoria: 1.52
• Dose-dependent efect
• Hospital cost: + 14.000 $
Transfusion and infection in hip fracture
Transfusion and
postoperative complications
HIP FRACTURE

Mortalidad 30d
P=0.007
1.0 2.0 3.0 4.0
0
5
10
15 - TSA (n=276)
+ TSA (n=156)
Incidencia(%)
Cardio
Vascular
Infection DVT
P=0.005
P=0.003
P=0.008
Transfusion and
postoperative complications
Miguel Servet, 2007
HIP FRACTURE

- Transfusion and postoperative complications
- Transfusion and mortality
HIP FRACTURE

J Orthop Trauma 2006;20:675–679
N=3625; TSA=30%
Transfusion and mortality
HIP FRACTURE

1.0 2.0 3.0 4.0
0
5
10
15 - TSA (n=276)
+ TSA (n=156)
Incidencia(%)
Cardio
vascular
Infection Mortality 30dDTV
P=0.007
P=0.005
P=0.003
P=0.008
Miguel Servet, 2007
Transfusion and mortality
HIP FRACTURE

Patient Blood Management
HIP FRACTURE
Treatment of pre-and postoperative anemia?

The outcome, optimal use of blood is defined as:
The safe, clinically effective and efficient use of
donated human blood
Safe: No adverse reactions or infections
Clinically effective: Benefits the patient
Efficient: No unnecessary transfusions.
Transfusion at the time the patient needs it
2010
USO ADECUADO DE LA TRANSFUSIÓN

Los estudios indican que los productos sanguíneos se usan a
menudo de forma inapropiada, tanto en los países desarrollados
como en los países en desarrollo.
Las transfusiones innecesarias y las prácticas peligrosas y los
errores de transfusión comprometerán gravemente la seguridad
exponiendo a los enfermas al riesgo de sufrir reacciones
transfusionales graves e infecciones transmitidas.
El uso innecesario reduce gravemente la disponibilidad de
productos sanguíneos para los pacientes que los necesitan.
http://www.who.int/bloodsafety/clinical_use/en/

Regan y Taylor, BMJ 2002
Shander, Semin Hematol 2004
Muñoz et al, Med Clin 2007
Shander, Farmer y Hoffman, Oncologist 2011
 Costes de producción y administración elevados
 Sangre humana: un recurso limitado
 TSA no está libre de riesgos:
 Errores de identificación
 Daño pulmonar (TRALI)
 Sobrecarga de fluidos (TACO)
 Recidiva de cáncer (TRIM)
 Infección postoperatoria (TRIM)
 Prolongación de la estancia
 Dudosa eficacia
 Legislación vigente
Razones para “cerrar el grifo”

Health-care services should establish a
multidisciplinary, multimodal perioperative patient
blood management program, based on:
• Preoperative optimisation of red cell mass
• Minimization of blood loss, including meticulous
surgical hemostasis
• Tolerance to postoperative anemia
WHA 63.12 (resolution). Availability, safety and quality of blood products,
21 May 2010, Geneva, Switzerland.
Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R12-en.pdf.
Availability, safety and quality of blood products

WHA 63.12 (resolution). Availability, safety and quality of blood products, 2010.
Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R12-en.pdf.
Optimización
de la eritropoyesis
Minimización de
las pérdidas
sanguíneas
Optimización de
la tolerancia a la
anemia
Los Servicios de Salud deben establecer
programas multidisciplinares y multimodales
para el manejo perioperatorio de los pacientes, basados en:
USO ADECUADO DE LA TRANSFUSIÓN

Sangre autóloga
• Donacion preoperatoria
• Hemodilución
• Recuperación perioperatoria
Criterio “restrictivo”
de transfusión
Hb <70-80 g/L
Reducción del
sangrado
• Aprotinina
• Antifibrinoliticos
• Desmopresina
• rFVIIa
Erythropoiesis
Stimulation
• Vitamina B12
• Acido Fólico
• rHuEpo
• Hierro
Alternativas
a la TSA
Spanish Consensus Statement on alternatives to allogeneic blood transfusion:
the 2013 update of the "Seville Document“. Blood Transfus. 2013 Jun 17:1-25.
HIP FRACTURE

HIP FRACTURE

Iron deficiency Management
20-30
mg/día
Músculo
(250 mg)
Médula ósea
(300 mg)
Eritrocitos
(2.000 mg)
Macrófagos SRE
(500 mg)
Hígado
(1000 mg)
Absorción intestinal de hierro
(1-2 mg/día)
Transferrina
(3 mg)
Pérdidas de hierro
(1-2 mg/día)
Hierro IV
IRON LOST!
IRON BLOCK!
IRON GIVEN!!!
HIP FRACTURE

Perioperative IV iron
HIP FRACTURE

- Grade of recommendation: .
“For patients undergoing orthopaedic surgery expected to develop severe
postoperative anaemia we currently suggest IV iron administration during the
perioperative period”.
For all other surgeries no evidence-based recommendation can be made. We
strongly recommend that large prospective randomised controlled trials are
undertaken in patients undergoing surgery expected to develop severe post
operative anaemia.
HIP FRACTURE

Sangrado en fracturas de cadera
Autor, año N Tipo de
Fractura
Hierro IV
(mg)
Transfusión,
n (%)
Infección,
n (%)
Mortalidad 30d,
n (%)
Control
Cuenca, 2004 102 FPC --- 57 (55.9) 34 (33.3) 17 (16.7)
Cuenca, 2004 57 FSC --- 21 (36.8) 19 (33.3) 11 (19.3)
García-Erce, 2005 41 FPC, FSC --- 29 (70.7) 13 (31.4) 6 (14.6)
TOTAL 200 107 (53.5) 67 (33) 34 (17.0)
Hierro sacarosa
Cuenca, 2004 23 # FPC 100 9 (39.1) 6 (26.1)* 3 (13.0)
Cuenca, 2004 55 # FPC 200 – 300 24 (43.6) 9 (16.4)* 5 (8.9)
Cuenca, 2004 20 FSC 200 – 300 3 (15.0) 3 (15.0)* 0 (0.0)*
García-Erce, 2005 83 FPC, FSC 600## 20 (24.1)* 10 (12.5)* 6 (7.2)
TOTAL 181 56 (30.9)* 27 (14.9)* 14 (7.7)
RR [IC95%]
(p)
0,58 [0,45-0,74]
(p<0,001)
0,47 [0,32–0,69]
(p<0,001)
0,45 [0,25-0,82]
(p:0,0065)
Uso perioperatorio a corto plazo Fe ev +/- EPO

Sangrado en fracturas de cadera
Autor, año N Tipo de
Fractura
Hierro IV
(mg)
Transfusión,
n (%)
Infección,
n (%)
Mortalidad 30d,
n (%)
Control
Cuenca, 2004 102 FPC --- 57 (55.9) 34 (33.3) 17 (16.7)
Cuenca, 2004 57 FSC --- 21 (36.8) 19 (33.3) 11 (19.3)
García-Erce, 2005 41 FPC, FSC --- 29 (70.7) 13 (31.4) 6 (14.6)
TOTAL 200 107 (53.5) 67 (33) 34 (17.0)
Hierro sacarosa
Cuenca, 2004 23 # FPC 100 9 (39.1) 6 (26.1)* 3 (13.0)
Cuenca, 2004 55 # FPC 200 – 300 24 (43.6) 9 (16.4)* 5 (8.9)
Cuenca, 2004 20 FSC 200 – 300 3 (15.0) 3 (15.0)* 0 (0.0)*
García-Erce, 2005 83 FPC, FSC 600## 20 (24.1)* 10 (12.5)* 6 (7.2)
TOTAL 181 56 (30.9)* 27 (14.9)* 14 (7.7)
RR [IC95%]
(p)
0,58 [0,45-0,74]
(p<0,001)
0,47 [0,32–0,69]
(p<0,001)
0,45 [0,25-0,82]
(p:0,0065)
0
10
20
30
40
50
60
Control
Hierro sacarosa
*P<0.05
Pacientes(%)
*
*
*
Uso perioperatorio a corto plazo Fe ev +/- EPO

Transfusion. 2013 Apr 15. doi: 10.1111/trf.12195. [Epub ahead of print]
4 Spanish hospitals (October 2002 – December 2011)
HIP FRACTURE

Perioperative IV iron ± ESAs
Transfusion reduction (primary outcome variable)
Postoperative nosocomial infection (primary outcome variable)
Length of hospital stay (secondary outcome variable)
Postoperative 30-day mortality (secondary outcome variable)
Objective
We pooled all our observational data to ascertain the
benefits of this treatment on:
Note: Postoperative nosocomial infection was clinically diagnosed
by a senior member of the surgical or medical team, and was
always confirmed by laboratory, microbiological or radiological
evidence.
HIP FRACTURE

Patients, procedures and groups
Patients approached
(n=2633)
Patients included
(n=2547)
Patients excluded (Hb <10 g/dL):
- Hip fracture = 82
- Arthroplasty = 4
Hip fracture
(n=1361)
Arthroplasty
(n=1186)
Control
(n=214)
Treatment
(n=443)
PHF
(n=657)
Control
(n=147)
Treatment
(n=557)
SHF
(n=704)
THA
(n=492)
Control
(n=360)
Treatment
(n=132)
TKA
(n=694)
Control
(n=288)
Treatment
(n=406)

Perioperative IV iron ± ESAs
Intravenous iron: either 2-5 days preoperatively and/or 2-3
days postoperatively, with a maximum 600 mg.
rHuEPO: single preoperative dose (40,000 IU, sc) was
administered at the orthopedic ward to some patients
presenting with preoperative Hb level of less than 13 g/dL.
Control group: oral iron or no treatment
No other blood conservation measure was used.
Patients were managed with a restrictive transfusion trigger.
Treatment

Hip fracture repair
Transfusion

Hospital stay & mortality
Hip fracture repair

Z
Effects of IVI & transfusion
Hip fracture repair

Perioperative IV iron + EPO
Fe sucrosa 200 mg iv/48 h (3 d)
EPO 40.000 UI sc ifHb<13 g/dL

Fe sucrosa 200 mg iv/48 h (3 d)
EPO 40.000 UI sc ifHb<13 g/dL
Perioperative
IV iron + EPO

HIP FRACTURE
PREOPERATIVE INTRAOPERATIVE
POSTOPERATIVE

CRITERIOS “RESTRICTIVOS” TRANSFUSIONALES

HIP FRACTURE

The FOCUS study
Carson y cols. NEJM 2011; 365: 2453-62
• 2016 oldie patients with Hb <10 g/dL after hip fracture repair surgery
• Cardiovascular disease antecedent or risk factor
• Liberal criteria: transfuse if Hb < 10 g/dL
• Resctrive criteria: transfuse if signs/symptoms or Hb < 8 g/dL
Pacientes(%)
TSA: CR 41% vs. CL 96%
IAM
Angina inestable
FCC
Infección
Mortalidad hospital
FACIT-Fatiga 60d
No deambulación 60d
Mortalidad 60d
Liberal Restrictivo
2.3% 3.8%
0.2% 0.3%
2.7% 3.5%
8.3% 5.9%
2.0% 1.4%
41.8±7.3 42.3±7.4
40.9% 43.8%
5.2% 4.3%
Postoperative side effects
Restrictive Transfusion Criteria

•Clinical Guidelines
Red Blood Cell Transfusion:
A Clinical Practice Guideline
From the AABBJeffrey L. Carson, MD; Brenda J. Grossman, MD, MPH; Steven Kleinman, MD; Alan T. Tinmouth, MD; Marisa B. Marques, MD; Mark K. Fung, MD,
PhD; John B. Holcomb, MD; Orieji Illoh, MD; Lewis J. Kaplan, MD; Louis M. Katz, MD; Sunil V. Rao, MD; John D. Roback, MD, PhD;
Aryeh Shander, MD; Aaron A.R. Tobian, MD, PhD; Robert Weinstein, MD; Lisa Grace Swinton McLaughlin, MD; and Benjamin Djulbegovic, MD,
PhD, for the Clinical Transfusion Medicine Committee of the AABB*

Question 1
• In hospitalized, hemodynamically stable patients, at
what hemoglobin concentration should a decision to
transfuse RBCs be considered?
Recommendations
The AABB recommends adhering to a
“restrictive” transfusion strategy.
In adult and pediatric intensive care unit patients, transfusion
should be considered at Hb concentrations of 7 g/dL or less.
In postoperative surgical patients, transfusion should be
considered at a Hb concentration of 8 g/dL or less or for
symptoms (chest pain, orthostatic hypotension or tachycardia
unresponsive to fluid resuscitation, or congestive heart
failure).
Quality of evidence: high; strength of recommendation: strong.

Question 2
• In hospitalized, hemodynamically stable patients with
preexisting cardiovascular disease, at what hemoglobin
concentration should a decision to transfuse RBCs be
considered?
Recommendations
The AABB suggests adhering to a “restrictive”
transfusion strategy.
Quality of evidence: moderate; strength of recommendation: weak.
Transfusion should be considered at a Hb concentration of 8
g/dL or less or for symptoms (chest pain, orthostatic
hypotension or tachycardia unresponsive to fluid
resuscitation, or congestive heart failure).

The existing evidence supports the use of restrictive
transfusion triggers in most patients including those with
pre-existing cardiovascular disease.
In countries with inadequate screening of donor blood, the
data may constitute a stronger basis for avoiding
transfusion with allogeneic red cells.

Overall, 39% fewer patients received transfusions in the
restrictive group than in the liberal group.
The mean number of units of RBCs transfused was 1.19
units lower and the mean hemoglobin concentration before
transfusion was 1.48 g/dL lower in the restrictive group.
These findings confirm that a restrictive transfusion strategy
leads to a clinically important reduction in RBC use and a
lower mean hemoglobin concentration.

Restrictive transfusion strategies were associated with a
statistically significant reduction in hospital mortality (RR
0.77, 95% CI 0.62-0.95) but not 30 day mortality (RR 0.85,
95% CI 0.70 to 1.03).
The use of restrictive transfusion strategies did not reduce
functional recovery, hospital or intensive care length of
stay.

Actualización Documento Sevilla
ATSA Transfusión de sangre alogénica
En pacientes críticos, politraumatizados y/o quirúrgicos, sin
afectación cardiológica y/o del Sistema Nervioso Central
recomendamos la transfusión de CH para mantener cifras de
hemoglobina entre 7 y 9 g/dL, con objeto de disminuir la tasa
transfusional.
1A
Concentrado de hematíes (CH)
En pacientes críticos, politraumatizados y/o quirúrgicos, con
afectación cardiológica y/o del Sistema Nervioso Central
recomendamos la transfusión de CH para mantener cifras de
hemoglobina entre 8 y 10 g/dL, con objeto de disminuir la
tasa transfusional.
1A

http://www.choosingwisely.org/doctor-patient-lists/
Things Physicians and Patients
Should Question www.sehh.es
diisponible desde 12/12/13

Criterios generales de indicación
Uso adecuado:
•Presencia de signos o síntomas de hipoxia
tisular
•Ausencia de tratamiento específico de la
anemia
•Refractariedad al tratamiento específico
•La situación clínica del paciente precisa una
reposición inmediata de la masa eritrocitaria
Tratamiento transfusional

ADIÓSTHAT´S ALL
FOLKS!
THANK YOU
MUCHAS
GRACIAS

PFN Spanish Workshop. Dr garcia erce. Madrid, september 2014

PFN Spanish Workshop. Dr garcia erce. Madrid, september 2014

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