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Blood Management Strategies in

Scoliosis Surgery:

Minimizing Blood Loss and

Transfusion Requirements.

Matthew A. Halanski, MD

Pediatric Orthopaedic Surgery

Helen DeVos

Children’s Hospital

(2)

Outline

Review our treatment protocol at HDVCH and present our 2 year retrospective data.

Review the literature to understand the multi-modal treatments used to minimize blood loss during scoliosis surgery.

Understand why scoliosis surgery is associated with high blood loss.

(3)

We Cut Therefore…

They Bleed.

Blood loss during surgery is a combination of

(4)

The question is …

Why SO much during

Scoliosis Surgery?

>50% blood volume losses.

Highly Vascular

Arterial-High Pressure

Venous-Baston’s Plexus

Common Problem Vessels

Anterior surgery – Segmental vessels

Posterior -Sacral foraminal bleeding

Posterior - Vessels just lateral to facet

(5)

Scoliosis Surgery- Why all the Blood

loss?

Spinal Deformity Requires Complex Surgery

Osseous Bleeding

Large incisions

Large surface area

(6)

Things to Remember #1

Not all

Scoliosis

is the Same

Adolescent

Idiopathic Scoliosis

Neuromuscular

(7)

Things to Remember #2

(8)

Things to Remember #3

Don’t Lose Sight of the FOREST

When Looking at the TREES!!!

(9)
(10)

What’s the problem with Blood

Transfusion?

(11)

Less Known problems with Increased

Blood Loss and Transfusions.

Difficulty with Surgery.

Difficult to operate where you can’t see!

Neuro-monitoring

Large fluid shifts, changes in BP can cause changes in

spinal cord monitoring.

Post-operative Pulmonary Complications

Increased Post-Operative Infection Rates

Triulzi et al. (Spine) Relative Risk of Infection 5.9*

Murphy et al. (THA) Relative Risk of Infection 10

(12)

Known

Patient

Risk Factors for

Increased Blood Loss and Transfusion

Patient weight <30 kg

Patient diagnosis

(Estimated

Blood Loss)

Neuromuscular

(2000-3500mL)

>Idiopathic

(600-1500mL)

Duchenne Muscular

Dystrophy

(930-4000mL)

>SMA/SB>Cerebral Palsy

(1300-2200mL)

.

(13)

Known

Surgical

Risk Factors for

Increased Blood Loss

 Increasing number of levels = Increase

blood loss

 Best predictor – Guay et al 1994.

 Average estimate 200cc/level – Murray et al

1997.

 Anterior and Posterior Spinal

fusions>Posterior spinal Fusions (600-1500mL)>Anterior Spinal fusions (350-650mL)**.

 PSF (65-150mL/level)

 ASF (65-135mL/level)

 ICBG – increased blood loss (1828 mL vs

1120mL).

 Length of procedure

 More Time = More Blood loss PSF

(Pouliquen JC. Chirurgie 1990 116:303-311.)

 2 hours- EBL 500mL  3 hours- EBL 1500mL  4 hours- EBL 2400mL

(14)

How can we minimize blood loss and

Ultimately use of blood products?

Medical (BAS/ND/H)

Surgical Anesthesia

(15)

Pre-operative Evaluation:BAS**

Bleeding Disorders and Filling up the Tank

 Comprehensive Pre-operative Evaluation

 Family Hx/Bleeding History.

 Anemia (hematinics and Epo if needed)  Coagulopathy (factor replacement)  Thrombophilia (avoid Antifibrinolytics)  Contraceptives for Menorrhagia

 Routine and “special” labs based on apparent risk from history.

 CBC w/o diff  Retic count  PT  PTT  Fibrinogen  CMP

 Type & Screen

 Von Willebrand Antigen

 Von Willebrand Ristocetin Cofactor  FactVIII (8) Act

 Von Willebrand Multimer

(16)

Pre-operative Treatment**

Comprehensive Pre-operative Treatment

Procrit

(Orthobiotech, Bridgewater NJ)

Epoetin alpha, Fe++

Colomina et al.

Alone may increase Hct enough

for procedures with expected blood loss <30%

total volume.

Vitale et al. 2007

Procrit

in NM patients higher

starting and discharge Hct, but no difference in

transfusion rate. (levels fused and time)

Decrease in allogenic blood transfusion up to

(17)

Autologous Pre-Operative Blood

Donation

Multiple blood donations for upcoming

surgery

Hematocrit maintained >33%

>50 kg donate normal unit (450+/- 50 mL)

<50 kg donation proportionally smaller

Maximum 1/3 days however standard is 1

week to 10 days.

Shelf life~35 days

Last donation 5-7 days prior to allow

(18)

Autologous Pre-Operative Blood

Donation

Benefits

Often meets any transfusion

requirements.

Murray et al 90% PSF

patients requirement met.

Thomson et al. 71% patients

only received autologous

blood while 64% of the blood given to those that required homologous transfusion was auto transfusion.

Primarily indicated for

procedures involving

30-50% patients blood volume.

Risks

Pediatric patients won’t

participate- Murray et al 70% patients for

PSF donated.

Adverse reaction rate

similar to that for

homologous transfusions,

1.5-5%.

30-50% autologous blood

not transfused-discarded.

Risks of bacterial

contamination and

identification errors.

(19)
(20)

Preventing Blood Loss: Patient Positioning

Un-Kinking the Hose!!**

(21)

Anesthesia:

Saving the Blood

Normovolemic Hemodilution

 Removal of blood day of surgery after

anesthesia.

 From estimated blood volume and

pre-operative Hct; volume to be remove calculated roughly 20% blood volume.

 Average 644 mL (Copely et al 1999)  Desired Hct of 30%

 Replaced with crystalloid – (Lactated

Ringers)

 Ratio of replacement 3:1 (3 LR:1 blood).  Thus when patient bleeds – they bleed

dilute blood.

 Held at room temperature- until end of

procedure.

 Given back in reverse – RBC plus clotting

factors Saved To be Given After Patient’s Circulating Blood to Bleed

(22)

Anesthesia: “Controlled Hypotension”

Turning Down the Faucet**

 Hypotensive Anethesia “Controlled Hypotension”

 Systolic BP 80-90 mmHg

 MAP 50-70 mmHg or 30% decrease in baseline MAP

 End organ perfusion is maintained via the

auto-regulatory function in the end organ arteriolar beds.

 Spinal cord autoregulates (between mean pressures

of 50-150mmHg, Fahmy et al ) to maintain perfusion.

Risk

 Posterior Ischemic Optic Neuropathy (PION)– increased

intra-ocular pressure (prone positioning), hypotension, anemia, prolonged prone surgery >6 hours.

Benefits- Significant Blood Loss Reduction

Patel et al. PSF with hypotensive anesthsia

 -EBL decreased by 40% and transfusion requirements by 45%. Also decreased operative times by 10%

(Fentanyl and Enflurane).  Malcom-Smith and McMaster

(23)

Minimizing Blood Loss:

Anti-Fibrinolytics**

Increased fibrinolysis can cause increased

bleeding

Inhibit fibrinolysis by preventing

plamisminogen

plasmin.

Anti-fibrinolytics prevent this.

Pharmacologic- Anti-Fibrinolytics- All Off label

use in Orthopaedic Procedures PSF.

Aprotinin

Tranexamic Acid (

TXA

, Cyklokapron, Pfizer, NY, NY)

Epsilon amino-caproic acid (

Amicar

) (Xanodyne

(24)

Minimizing Blood Loss:

Anti-Fibrinolytics

Aprotinin

 Protease inhibitor isolated from bovine

lung (1930).

 Two effects on coagulation:

 Inhibits enzymatic formations of plasma kallikrein. This in turn inhibits conversion on plamsinogenplasmin.  Protects vWF receptors on platelets

which preserves platelet adhesion.

 Scoliosis (High Risk)

 15,000 KIU/kg LD/20 minutes  7,500 KIU/kg/hr during procedure

 Majority of benefit demonstrated in

cardiac patients to decrease blood loss and transfusion requirements.

 Similar in Orthopaedic literature

Kohshhal et al 2003 Scoliosis (N=43)  decreased EBL, transfusion rate but

no significant.

Urban et al. Adult spine surgery (N=60 total)

 Compared with Placebo, Amicar, and Aprotinin

 showed a lower blood loss and transfusion requirement in Aprotinin <Amicar <Control.

(25)

Minimizing Blood Loss:

Anti-Fibrinolytics

Aprotinin

Problems

 Anaphylactoid reactions – increase with repeated exposures:

 No exposure incidence 0.1%

 Exposure within last 6 months 5%  Exposure >6 months 1%

 Contra-indicated in those exposed within 12 months.

(BART Study) Blood Conservation Using Antifibrinolytics

in a Randomized Trial – increased 30 day mortality with

Aprotinin lead to worldwide suspension of use in 2007.

 Conflicting data on Renal Failure and MI.

 Increased risk of renal dysfunction in those with DM.

Shown Safe in pediatric patients (cardiac surgery)

Backer et al 2007 (N=1230 without, N=1251 with) no difference in mortality, kidney failure, dialysis, neurologic complications.

(26)

Minimizing Blood Loss:

Anti-Fibrinolytics**

 TXA  7-10X as potent as Amicar.  Loading dose 10mg/kg  Infusion 1mg/kg/hr  Amicar  Loading dose 100-150mg/kg  Infusion 10-15mg/kg/hr

 Both are Lysine analogs- Excreted in urine

 Saturate the Lysine binding sites of plasminogen to prevent binding to fibrin.

Amicar Transexamic Acid

(27)

Minimizing

Blood Loss:

(28)

Prospective Comparisons

Anti-Fibrinolytics**

Transexamic Acid (TXA)

 Neilipovitz, AIS (N=40)

1253+/-884mL vs 1784+/-733 (cell

saver plus transfusion) significant.

 Sethna, PSF (N=44)

EBL decreased 41% vs placebo.

(1230+/-535 vs 2085 +/-1188)  Shapiro, DMD (N=56)  EBL decreased 42% (1944+/-789 vs 3382+/-1795)  Homologous transfusion decreased 41%

Cell Saver Autologous transfusion

decreased 42%100 mg/kg LD then 10 mg/kg/hr Amicar  4 separate studies  Florentino-Pineda 2001, 2004  Thompson 2005, 2007 (N=36)

Total Peri-operative blood loss

decreased was significant 1391+/-212 vs 1716+/- 284 mL)

 EBL not significant (893+/-166 mL vs

952+/-303 mL)

 Post-operative drainage – significant.

(498+/-179 mL vs 764+/-284 mL)

Decreased Autologous units

transfused 1.1+/-1U vs 2.1+/-1.3.

 Increasing fibrinogen levels throughout

post operative period

(29)

Meta-Analysis

Anti-Fibrinolytics**

Cochrane Collaboration – Tzortopoulou 2007

 1950-2007 studies looking at the effect of anti-fibrinolytics on peri-operative blood loss in patients <18 years old undergoing scoliosis surgery.

 Included Aprotinin, TXA, Amicar.

 6 studies, 127 controls, 127 given anti-fibrinolytics.

 Anti-fibrinolytic use decreased amount of blood loss by 427 mL.Risk of transfusion was similar in placebo or treatment groups.Amount of blood transfused was less in the treatment group then

control group by 327 mL.

All three drugs appeared similarly effective.

(30)

Minimizing

Blood Loss:

Other Agents

 DDAVP- Desamino-8-d-arginine-Vasopressin

 Diabetes insipidus

 Interacts with factor VIII and vWF by increasing their release from endothelial

storgae sites.

 VIII works with IX to activate X  vWF stabilizes VIII

 transports throughout circulation

 Mediates platelet adhesion to subendothelium

 Recommended dose 0.15-0.3 ug/kg

 IV administration 15-20 minutes before the case – prevents hypotension.  Increases baseline levels 3-5X’s.

 Intra-nasal and subcutaneous administration also works

 Mixed Results in the literature – no difference in randomized double blinded trials.

Theroux et al 1997

 EBL and Transfusion rates the same DDAVP/Control  Factor VIIIC and VWF increased*

(31)

Minimizing

Blood Loss:

Other Agents

 Recombinant factor VIIa

 Used in hemophiliacs patients with factor VIII inhibitors.

 Recent use in non-hemophiliac patients – who have failed to clot – and has

controlled otherwise life threatening hemmorage

 Dosed 40-100 g/kg repeating doses at 2-6 hour intervals.  Sachs et al 2007

 decreased adjusted blood loss and adjusted transfusion levels  No ill effects (one ischemic stroke and death!)

 Premarin (Wyeth-Ayerst Laboratories, Philidelphia,PA)

 Conjugated estrogen- action unknown –

 they induce polymerization of acid mucopolysaccharides in the walls of capillaries

and change them into a gel state-thus the vessel becomes less permeable.

 Alter factor V levels

 Alter vessel wall –platelet interactions

McCall and Bilderback

1997- 1mg/kg IV post-operatively

 37% decrease in post-operative drainage over 48 hours in pediatric scoliosis

(32)
(33)

Help Stop The Bleeding:

Preventing Hypothermia**

Mild hypothermia,

defined as

temperatures less than 36°C,may cause:

Coagulopathy due to decreased platelet

function

Decreased resistance to surgical Infection

May affect spinal cord monitoring (SSPE

latencies)

Maintain at 37°C

forced-air warming devices

fluid warmers

increased ambient temperature in the

(34)

Minimizing Blood Loss:

Surgical Technique

Exposure.

Epinepherine injection or electrocautery

Sub-periosteal dissection

Electrocautery vs blunt cobb exposure

“Meticulous hemostasis”

Visualize bleeding

 Adequate lighting +/-headlamps

 Magnification if needed – (Loupes 3.2X magnification)

Hemostasis saves time in allowing

better visualization and allows surgery

to proceed easier and faster.

(35)

Minimizing Blood Loss:

Cautery

Mono-polar– Bovie

 high temperature irreversibly shrinks

collagen in vesslescompletely occluding vessel lumen.

 High surrounding thermal injury to tissue. Bi-polar –current is between tips of forceps

 More localized

 Less collateral damage

Aquamantys (TissueLink Medical, Dover NH)  Bipolar radiofrequency

 Continuous saline to prevent charring  Decreases burning

(36)

Minimizing Blood Loss:

Topical Hemostasis

Surgical Techniques- topical hemostasis used.

Bone Wax= Dutch boy but inhibits bone healing

Gel Foam Floseal Surgiflo

(37)

Minimizing Blood Loss:

Topical Hemostasis

(38)

Minimizing Blood Loss:

Instrumentation

Type and Amount

(39)

Minimizing Blood Loss:

Surgical Technique – Cutting the Bone

Save to the End of the Procedure

Osteotomies

Facetectomies

Bone Graft

Decortication

(40)

Salvaging Lost Blood**

 Surgical Technique-Blood Salvage Systems

 Blood rich Coagulation poor may precipitate DIC – some

give post-operatively only.

 Recycles blood lost on the field-relatively safe at volumes

<3000mL

 Flynn et al - 50% decrease in homologous blood

requirements mean of 1.5 Units salvaged. (spine and orthopaedic)

 Lennon et al 1987- 50% decrease in the amount of

homologous blood used.

 Copley et al 1999- question routine use – only 5% spared

transfusion from its use.

 Simpson 1994 found only 12% patients benefited from the

salvage (total joints).

Expensive and Must lose enough to have enough to

get back.

Cell Saver (Haemonetics, Braintree MA)

Minimum EBL ~500mL

Orthopat (Haemonetics, Braintree MA)

 Smaller Volume blood losses intra-operative  Post-Operative Blood Captured and Re-infused.

(41)

Turning off the Faucet:

Post-Operative Care

Blood Avoidance – Management.

Continuation of Anti-fibrinolytics, Hematinics

Lab Values

Standard Protocol –

No transfusion<7

others individual basis

Surgeon–To drain or not to drain.

Anesthesia –

Eyes OK

No missing teeth

(42)

Cost Analysis

From Thoms et al JAAOS 2009

Decrease Allogenic Transfusion Priceless?? $300-$2300+ Pre-operative BAS Evaluation Hematinics /Procrit Referral $2100 Autologous Donations 3X$700 $800 Blood Salvage $$ Surgical Technique Two Surgeon Approach Topical Hemostasis Hypotensive Anesthesia BAS Transfusion Practices Post op Hemantics $1-1200 Anti-Fibrinolytics TXA- $300 Amicar-$3 Aprotinin-$1200 NormoVolemic Hemodilution Bone Graft $2600 Implants $10-40,000 Surgeon/Anesthesia fees $10,000’s Spinal Cord Monitoring $3000

(43)

HDVCH Standard Approach

Decrease Allogenic Transfusion Pre-operative BAS Evaluation Hematinics Procrit Referral Autologous Donations Blood Sallvage Surgical Technique Two Surgeon Approach Hypotensive Anesthesia BAS Transfusion Practices Post op Hematinics Anti-Fibrinolytics TXA Amicar Aprotinin NormoVolemic Hemodilution

(44)

September 2007 - September 2009*

Number of surgeries 110

 Neuromuscular 28

 Idiopathic 60

 Others (Congenital & Secondary) 22

 Pre-operative Screening 104 (94%)

 Pre-operative Hematinics 37 (34%)

 Pre-operative Epo 13 (12%)

Contceptives 2x for Menorrhagia + Antifibrinolytics 1 for month prior to surgery. No Antifibrinolytics developed venous

thrombosis

HDVCH 2 Year Experience

(45)

Type of Scoliosis and

Demographics

0 2 4 6 8 10 12 14 16 # of Segments # of Osteotomies Idiopathic Neuromuscular Idiopathic n=60 Neuromuscular n=28 P Value (Mann Whitney) Sex (F) % 45 (75%) 14 (50%) .02* Weight 58 + 18 46 + 18 .004 Age (months) 162 + 39 157 + 51 .869 Comorbidities 18 (30%) 27 (96%) .001* Cobb Angle 61 + 18 66 + 21 .188 No of segments fused 10 + 3 15 + 2 .001 No of osteotomies 6 + 3 8 + 5 .27

* Chi Square test

(46)

Type of Scoliosis and

Outcome

0 10 20 30 40 50 60

Total Blood Loss ml/kg *

Hb drop gm/dL * % Transfused ** Idiopathic Neuromuscular

P .001

P .002 P .001

(47)

Cobb Angle, Blood Loss and

Transfusions

0 10 20 30 40 50 60 0-40 41-50 51-60 61-70 71-80 81-140

Blood Loss ml/kg % Transfused

n=6 n=20 n=25 n=18 n=15 n=10 Cobb Angle

(48)

Anti-Fibrinolytics Effect

Amicar (67) Tranexamic (17) Non (12) P Value Initial Hb 13.6 + 1.2 14.1 + 1.1 14.1 + 1 0.16 KW Post-Op Hb 8.8 + 1.5 10 + 1.1 a 8.9 + 1.2 b 0.12 KW Total blood loss /kg 30 + 32 17 + 15 18 + 10 .33 KW

Hypotension in PACU 31 (46%) 5 (39%) 0 .007 * Transfused 11 (16%) 1 (6%) 1 (8.3%) -Pre Op Fibrinogen 244 + 84 232 + 50 267 + 84 -Highest Post Op Fibrinogen 488 + 235 670 + 248 561 + 238

-* Fishers Exact test

(49)

Markers of

Transfused

Scoliosis Patients

0 10 20 30 40 50 60 70 80 90

Weight * Idiopathic % ** # Levels Fused * Total Blood loss/kg * Non Transfused Transfused

P .006 P .001

P .003 P .0001

* Mann Whitney test **Fisher Exact test

(50)

Predictors of Transfusion

Requirement

P .001

P .009

P .007

* Logistic regression of individual variables:

Logistic regression of all variables:

Older age OR .973 (.951-.996) P 0.025 Higher blood loss OR 1.129 (1.06-1.2) P .001

more

higher

higher

(51)

Incidence of Von Willebrand

Disease

12 out of 110 (10.9% ) diagnosed with Von Willebrand disease

 4 of 24 (14.3%) Neuromuscular  6 of 60 (10%) Idiopathic

 2 of 22 (9.1%) In other scoliosis types 

Overall P 0.074 Fisher Exact test

Out of groups AIS & NM Von Willebrand patients (n=10)

 5 had (+) personal or family history of bleeding  4 received Humate-P intra-operatively

One patient out of 10 required a transfusion (10%) (AIS).

One patient (in AIS group) had Von Willebrand activity level of <

30, received Humate-P & was not transfused.

(52)

Von Willebrand in Scoliosis

Patients

VW Activity

AIS NM (+) History Received

Humate P

Total blood loss a Transfused

< 50% 2 4 2 2 1133 ± 19 1 50-70% 3 0 2 1 725 ± 56 0 > 70% 1 0 1 1 400 0 Mean Activity b 53 ± 19 36 ± 8

a. P .188 (Kruskall Wallis) b P .171 (Mann Whitney) Only one patient below 30%

There was a trend toward higher blood loss with

(53)

Summary

Blood management in Scoliosis Surgery requires a

Multi-Disciplinary Multi-modal Approach.

Here at HDVCH – we have found our data to compare well

with that in the literature:

■ Posterior spinal fusion is associated with significant blood loss & risks of needing transfusions – particularly in neuromuscular scoliosis.

■ High blood losses were associated with higher Cobb Angles

■ Transfusion needs were associated with Neuromuscular curves,

smaller weight, larger number of segments fused and higher blood losses.

■ Unexpected high incidence of mild Von Willebrand disease was

noticed (more in neuromuscular scoliosis) and tended to be associated with higher blood loss.

References

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