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Prof. Rosanna Abbate
Università di Firenze
AOU Careggi
Preoperative hemostatic evaluation
Low
Moderate or high
History only (?)
History, PTT, PT, Plt count
Surgical Risk
Routine screeningApproach
Francis and Kaplan Clin Med Cardio, Fi
History
Consultation
Approach
Negative or minimalfor bleeding
Suggestive ofbleeding disorder
PT, PTT, Plt count, biochemicalprofile, complete blood count anddifferential,review of peripheral blood smear
Add to above as indicated:BT,, von Willebrand atg F VIII,F IX,F XI, F XIII
IL LABORATORIO DI EMOSTASI NELLA VALUTAZIONE DEL RISCHIO EMORRAGICO OPERATORIO (da Rappaport)
LIVELLO 1 (rischio minimo)Anamnesi negativa - Intervento minore NESSUN TEST
LIVELLO 2 (rischio basso)Anamnesi negativa - Intervento maggiore aPTT
Conta piastrinicaT.sanguinamento (?)
LIVELLO 3 (rischio moderato)Anamnesi sospetta o intervento di particolare impegno (cardiochirurgia, SNC, prostata) idem +
PT XIII (?)
LIVELLO 4 (rischio elevato)Anamnesi sicura per patologia emorragicaintervento minore o maggiore idem + VIII, IX, XI, TT, ev.ricerca inibitori etc.
In caso di esami alterati si procede con ulteriori indagini fino a chiarirne il quadro
ANAMNESI EMOSTASIOLOGICA ESSENZIALE PREOPERATORIA
A) facilità alle ecchimosi compaiono frequentemente? senza cause apparenti? più grandi di una moneta di 100 lire?B) emorragie pregresse: ha eseguito tonsillectomia, biopsie o altre operazioni? se sì, ha avuto particolari emorragie? ha avuto parti? se sì. vi sono state complicanze emorragiche? ha avuto emorragie durate per più di un giorno dopo estrazione dentaria o piccola chirurgica? C) patologie acquisite ha sofferto di malattie epatiche o renali? quali malattie ha avuto negli ultimi anni?D) farmaci nell’ultima settimana ha assunto aspirina, ticlopidina, altri antinevralgici o antidolorifici?E) storia familiare ha avuto consanguinei con problemi emorragici spontanei o post-operatori?
Sensitivity of PT and aPTT to procoagulants
Approximate level For NormalPTb aPTTb
Procoagulant
Fibrinogen (Factor I) 100 mg/dL 60
mg/dL
Prothrombin (Factor II) 50%
15%
Factor V 50% 40%
Factor VII 50%
Factor VIII 35%
Factor IX 20%
Factor X 60% 25%
Factor XI 30%
Factor XII 20%•Data from the Hematology Science, Clinical Pathology Department, Warren G, Magnusson Clinical Center, derived using the STA (Diagnostica Stago, Asnieres, France) and provided by Ms. Khanh Nghiem and Dr. Margaret Rick.
Clin Med Card (Fi)
Sensitivity of PT and aPTT to procoagulants
Hemostasis *ProcoagulantFibrinogen (Factor I) 50-100 mg/dL
Prothrombin (Factor II) 20-30%
Factor V >20%
Factor VII >10%
Factor VIII >40%
Factor IX >30%
Factor X >20%
Factor XI >50% (variable)
Factor XII 0
•Data from Roberts HR, Bingham MD: Other coagulation factor deficiencies. In Loscalzo J, Schafer AL (eds): Thrombosis and Hemorrhage, Baltimore, Williams & Wilkins, 1998, pp.773-802.
Clin Med Card Fi
Preoperative bleeding time
In the absence of a clinical history of a bleeding disorder, the bleeding time is not a useful predictor of the risk of hemorrhage associated with surgical procedure
Peterson, Arch Surg 1998 Clin Med Cardio, Fi
A normal bleeding time does not exclude the possibility of excessive hemorrhage associated with invasive procedure
The bleeding time cannot be used to reliably identify patients who may have recently ingested aspirin or non steroidal anti-inflammatory agents, or who have a platelet defect attributable to these drugs
80706050
40
20100
30
n=66
8070605040
3020100
n=10
CV
%, M
EA
N +
SD
VARIABILITYOF BLEEDING TIME
Clin Med Gen Card, Fi De Caterina, Blood 1994
intra observer
inter observer
Lehman,Clin Chem 2001Clin Med Cardio, Fi
0.00
.01
.02
.03
.04
.05
.06
.07
Feb98
Mar9
8Apr98
May9
8Ju
n98
Jul9
8
Oct9
8
Mar 9
9
Aug98
Sept9
8
Dec9
8Ja
n99
Feb99
Apr 9
9M
ay 99
June 9
9
Nov 9
8
BT discontinued
Rate of postprocedural hemorrhage or hematoma for patients in the major Surgery Risk Pool for the 12 months before and 5
months after discontinuation of the BT testP
rop
ort
ion
of
pts
wit
h c
om
plicati
on
Lehman,Clin Chem 2001Clin Med Cardio, Fi
Lehman,Clin Chem 2001Clin Med Cardio, Fi
Clinical practice behavior before and after discontinuation
Monthly plt unit transf
Total plt-aggr studies
Total pts receiving DDAVP
Uremic pts receiving DDAVP
44.814.8
17
NA
NA
42.013.9
9
24
22
0.687
0.958
NT
NT
NT
BT test available2/98-6/98
p
41.68.9
9
10
8
BT test available9/98-1/99
BT test unavailable2/99-6/99
NA not assessedNT not tested
Lehman,Clin Chem 2001
Clin Med Cardio, Fi
Algorithm for evaluating the risk of bleeding after discontinuation of BT
Patient and/or familyhistory of bleeding
No
No testNecessary
Normal Abnormal
von Willebrand’swork-up Consult
Hematology
Normal Abnormal
Plt Aggrstudies
Consult Hematology
Yes
Pt, PTT,Plt count
Jackson MR et al, CHEST 2001
Sixth ACCP Consensus Conference on Antithrombotic Therapy
Peripheral Vascular Reconstructive Surgery
We recommend that clinicians use aspirin (81 to 325 mg/d)
in patients having prosthetic, femoropopliteal bypass
operations, and antiplatelet therapy should be begun
preoperativelypreoperatively (grade 1A). The addition of dipyridamole
(75 mg three times daily) to aspirin may provide additional
benefit (grade 2B)
INDIRECT COMPARISONS OF PROPORTIONAL EFFECTS OF ANTIPLATELET THERAPY STARTED BEFORE OR AFTER VASCULAR PROCEDURES ON
OCCLUSIONTime
antiplatelet
therapy began
N° of triale with
data
Odds ratio and confidence interval
(Antiplatelet: Control)
% Odds reduction
(SD)Anti-platelet
Adjusted controls
OCCLUSION
O-E Variance
STRATIFIED STATISTICS
Before procedure 25 569/2966 829/2949 -102.6 189.6 42.6% (6)
(19.2%) (28.1%) Up to 24h after 8 70/781 158/780 -31.6 36.8 58% (11)procedure (10.1%) (20.3%)
More than 24h 12 177/942 262/982 -35.2 75.0 37% (9) after procedure (18.8%) (26.7%)ALL PROCEDURE 45 825/4589 1249/4711 -169.5 301.4 43% (4) TRIALS†
Test for heterogenecy: 2 = 4.0: n.s.
0 0.5 1.0 1.5 2.0
Antiplatelet therapy better
Antiplatelet therapy worse
Treatment effect 2P<0.00001
1 2 3 4 5 6 7 8 9 10
Prothrombin variant
OR (95% CI)
2.9 (1.6-5.1)
0
Hcy p < 0.0001
p < 0.001PAI-1
3.1 (1.8-5.2)
Lp (a)
Multivariate regression Multivariate regression analysis*analysis*
p < 0.0001
3.4 (1.8-6.1)
ACA+
3.4 (1.8-6.1)
8.6 (1.4-51.3)
p = 0.03
p = 0.02
*Adjusted for all traditional risk factors Sofi et al J Vasc Surg 2005
PADPAD pts n=280; ctrl n=280
1 2 3 4 5 6 7 8 9 10
Hcy x Lp(a)
OR (95% CI)
2.9 (1.6-5.1)
0
Hcy
3.1 (1.8-5.2)Lp (a)
Association of risk factors at multivariate Association of risk factors at multivariate analysis*analysis*
37.7 (3.7-381.5)
29 (6.2-51.3)
p < 0.0001
p = 0.02
Dyslipidemia
7.4 (4.2-12.9)
Lp(a) x dyslipidemi
a
*Adjusted for all traditional risk factors Sofi et al J Vasc Surg 2005
PADPAD pts n=280;ctrl n=280
ACA and occluded bypass graftsACA and occluded bypass grafts%
cum
ula
tive p
ate
ncy
0
20
40
60
80
100
0 12 24 36 48 60 72 84 Months Taylor et al. Ann Surg 1994Clin Med Card FI
Anticardiolipin negative patients
Anticardiolipin positive patients
The cardiac surgical literature is remarkably devoid of carefully controlled, randomized trials that would
permit definitive conclusions concerning routine preoperative coagulation testing. At present, it
appears appropriate to perform a few inexpensivetests (platelet count, aPTT, and possibly PT),
knowing that their main usefulness is to providebaseline values for patients who will undergo a stronghemostatic challenge along with various degrees and
methods of anticoagulation, and who may require transfusions to restore normal haemostasis after CPB
Clin Med Gen Card, Fi Ph De Moerloose 1996
RELATIONSHIP BETWEEN HEMORRHAGE AND SCREENING TESTS IN 4499 PATIENTS
(data pooled from 3 studies)
Hemorrhage No Hemorrhage
Abnormal tests* 15 420Normal tests 70 3994
Prevalence of Bleeding = 85/4499 (2%)Sensitivity = 15/85 (18%)Specificity = 3994/4414 (90%)PPV = 15/435 (3%)NPV = 3994/4064 (98%)
* Test included prothrombin time, partial thromboplastin time, and platelet count
IL LABORATORIO DI EMOSTASI NELLA
VALUTAZIONE DEL RISCHIO EMORRAGICO
•Valutazione preoperatoria
•Valutazione intra e postoperatoria
VALUTAZIONE DELL’EMOSTASI NEL BLOCCO OPERATORIO
- Ematocrito- Piastrine- ACT- PT- APTT- TEG ?- Funzione piastrinica (PFA, Sonoclot)?
Clin Med Gen Card, Fi
COAGULATION TESTS PREDICT BLEEDING AFTER CARDIOPULMONARY BYPASS (10 min after CPB)
24 hr Chest Intraoperative Test Tube Bleeding Bleeding
Platelets (109/L) NS -0.32 MPV (fL) -0.31* NS Platelet crit -0.27* NS BT (Duke) (min) NS NS PT (sec) 0.24* 0.39* aPTT (sec) 0.27* 0.27* Fibrinogen (mg/dL) -0.33* NS
TEG Profile R (mm) NS NS R+ K (mm) NS NS angle (degrees) NS NS MA (mm) NS NS MA +30 (mm) NS NS
Nuttall et al, J Cardiothor Vasc Anesth, 1997
*P< 0.05
BLOOD PRODUCT USE, OPERATIVE TIMES, CHEST TUBE DRAINAGE, AND EXPLORATION
FOR POSTOPERATIVE (24H) BLEEDING (CBP) (1)
Algorithm Standard therapy group therapy group
(n=30) (n=36)
Platelet concentrates Intraop (U) 3.9+4.1 6.7+6.0 Postop (U) 1.6+5.9 6.4+8.2*
Frozen plasma Intraop (U) 0.4+1.1 2.4+2.8# Postop (U) 1.2+1.9 2.7+3.6 Red blood cells Intraop (U) 2.3+1.5 3.6+3.4 Postop (U) 1.9+1.7 4.1+4.1§
* p<0.05 # p<0.001 § p<0.01 Despotis et al, J Thor card Surg, 1993
BLOOD PRODUCT USE, OPERATIVE TIMES, CHEST TUBE DRAINAGE, AND EXPLORATION
FOR POSTOPERATIVE (24H) BLEEDING (CBP) (2)
Algorithm Standard therapy group therapy group
(n=30) (n=36)
DDAVP (%) 60% 44%
MVB time (min) 27+16 66+45#
Post-CPB time (min) 69+24 108+54#
Chest tube drainage (ml) Intraop + postop hour 1 158+169 326+258§ Postop hours 2-4 299+399 436+444 Postop hours 5-8 256+353 456+431 Postop hours 9.24 501+247 947+1180
Exploration (%) 3% 14%
* p<0.05 # p<0.001 § p<0.01 Despotis et al, J Thor card Surg, 1993
Association of Factor XIII deficiency and postoperative hematoma after
neurosurgical procedures
Gerlach,Surg Neurol 2000 Clin Med Cardio, Fi
Factor XIII>60%
Factor XIII<60%
3
8
PostoperativeHematoma
No PostoperativeHematoma
23
0
Conditions with low factor XIII concentrations
Major surgery
Sepsis
Disseminated intravascular coagulation
Hepatic diseases (hepatitis, acute hepatitis
failure)
Chronic inflammatory bowel diseases
Purpura Schönlein-Henoch
Hematologic disorders (leukemia,
myelodysplastic syndrome)
Clin Med Cardio, FiGerlach,Surg Neurol 2000
IL LABORATORIO DI EMOSTASI NELLA
VALUTAZIONE DEL RISCHIO EMORRAGICO
•Valutazione preoperatoria
•Valutazione intra e postoperatoria
Risk of bleeding with surgical procedures
Low
Moderate
High
Nonvital organsinvolved, exposed surgical site,limiteddissection
Vital organs involved deep or extensivedissection
Bleeding likely to compromise surgicalresults, bleeding complications frequent
Risk Type of surgery Examples
Lymph node biopsy,Dental extraction
Laparotomy, thoracotomymastectomy
Neurosurgery, Ophthalmicsurgery,CP bypass, Prostatic surgerySurgery to stop bleeding
Francis and Kaplan Clin Med Cardio, Fi
Clin Med Card –FI Jackson MR et al, CHEST 2001
Sixth ACCP Consensus Confeterence on Antithrombotic Therapy
Chronic Extremity Arterial Insufficiency
1. Aspirin alone or in combination with dipyridamole may
modify the natural history of intermittent claudication.
As these patients are at high risk of vascular events (stroke
and MI), we recommend life-long aspirin (81 to 325 mg/d) in
the absence of contraindications
(grade 1C+).
Clin Med Card –FI Jackson MR et al, CHEST 2001
Sixth ACCP Consensus Confeterence on Antithrombotic Therapy
Chronic Extremity Arterial Insufficiency4. For patients experiencing disabling claudication, particularly
when lifestyle modification alone is ineffective and
revascularization cannot be offered or is declined by the
patient, we recommend a trial of cilostazol therapy (grade
2A). Cilostazol is not recommended for routine use in all
patients with intermittent claudication because of its high
cost and modest clinical benefit.
Clin Med Card –FI Jackson MR et al, CHEST 2001
Sixth ACCP Consensus Confeterence on Antithrombotic Therapy
Chronic Extremity Arterial Insufficiency2. Clopidogrel may be superior to aspirin in reducing ischemic
ischemic complications in patients with peripheral vascular
disease and intermittent claudication, and we recommend
that clinicians consider clopidogrel for treatment
(grade 2A).
Clin Med Card –FI Jackson MR et al, CHEST 2001
Sixth ACCP Consensus Confeterence on Antithrombotic Therapy
Chronic Extremity Arterial Insufficiency
3. We recommend that pentoxifylline should not be routinely
used in patients with intermittent claudication (grade 1B).