On RhIg (Rho-GAM) •

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Case # 1: 2009, OSHU:

On RhIg (Rho-GAM)

26 yo woman, JW, Rh anti-D alloimmunized, seen by me during her second pregnancy—fetus at risk for hemolytic disease of newborn (father heterozygous)…..

• Heartbreaking words after I explained “fractions” to her and where anti-D came from:

“ If someone had explained what you just told me about “fractions”

I would have taken the Rho-GAM and this never would have happened….”

Pooled plasma from donors with high titers of anti-D antibody

Physical + chemical separation of antibody molecules from plasma

Rh Immune

Globulin

(Rho-GAM)

Case # 2: 2007, OSHU:

Pre-delivery anemia, repeat C/S and use of intraoperative salvage ….

• 34 yo woman, JW, seen at 28 weeks with Hb 10.8,

MCV 73, ferritin 10 c/w Fe++ deficiency ;

C/S planned at 38 weeks

Received course of venofer (iron sucrose)

200 mg q d x 5 days

Hb increased to 12.2 at time of C/S

65 kg x 70 ml/kg = total blood volume of 4550 ml—

--so could lose ~ ½ this or ~2000-2500 ml before

Hb < 5-6 gm/dl

• Underwent C/S with EBL ~1800 ml and decrease in Hb 12.2

8.7 gm/dl

Cell Saver was ready in OR with supplies and trained anesthesia tech available to do intra-op salvage if necessary

—not used in this case but has been used by us in other cases

Q: Is use of intra-op salvage (with a leukoreduction filter) really “safe” in C/S re: re-infusion amniotic fluid, fetal cells, etc ???

 Let’s ask Dr Jon Waters, an academic OB anesthesiologist in Pittsburgh who has done hundreds and who sits on the Board of

Directors of Society for the Advancement of

Blood Management (SABM)…….

From SABM Website FAQs: Can cell salvage be used on an OB service? How popular is this practice and are there any medicolegal issues?

I am a strong advocate of salvage in obstetrical hemorrhage .

There are many hospitals in the US that use blood salvage in hemorrhage. At Magee Women's Hospital, we have used it over 100 times in hemorrhaging women. The National Health Services in

Britain has a policy statement that blood salvage should be the preferred option for provision of blood during an obstetrical hemorrhage. So, you have an entire country that advocates it.

As to liability, the lawyers can sue you for anything. In fact, if a patient developed a complication from an allogeneic blood product, you could be held liable in a court of law for not using blood salvage because it's a published alternative that has no reported complications in obstetrics, only theoretical complications; whereas, allogeneic has lots of reported complications, not theoretical.

Blood salvage is an off-label indication in obstetrics but most of medical practice is off-label because it's very, very expensive to get a labeling indication from the FDA . Most of the anesthetic drugs that I use in obstetrics are off-label.

-----Jonathan H. Waters, MD

From SABM Website FAQs: I would like to know what SABM's recommendations are for the use of cell salvage during cesarean section. Our

OB staff would like to use it for Jehovah Witness patients.

First SABM doesn't make medical recommendations.

This being said, the only basis for this contraindication is that the FDA has not approved the device for this use.

However, the off label use of drugs and devices is pervasive. As an anesthesiologist, most of the drugs that I use on a daily basis are done off-label. For instance, morphine or fentanyl being added to a spinal or epidural is an off label use of these drugs, but it is done within my facility 100 times a day.

I believe that if you review the literature, you will find no evidence for cell salvage being contraindicated in cesarean section . There are approximately

400 cases in the literature where it has been performed safely. I have about

100 cases in my database.

Due to the lack of evidence to support an obstetrical contraindication the American College of Obstetricians and

Gynecologists, the Obstetric Anesthetists Association of Great Britain, and the British Confidential Enquiry into Maternal and Child Health have advocated the use of blood salvage in obstetrics.

I have attached several articles on the subject from which you can make a decision about the safety. ------Jonathan Waters, MD

Cell salvage and obstentrics Amniotic fluid removal Catling cell salvage and OB

SABM FAQs: Is there a specific title or certification to operate the cell-saver or autotransfusion device? Is this normally a member of the OR staff (in this case) that is cross trained in this discipline.

Hospitals provide blood salvage through several different "specialists" The vast majority of blood salvage in the United States is performed by OR circulating nurses and anesthesia technicians. Neither of these groups is generally provided adequate training to operate these devices safely nor do most hospitals have adequate policies and procedures outlining how the devices should be used. This makes for a dangerous situation. So, it's a sound idea to have dedicated personnel who have been adequately trained where the 10 quality system essentials that are outlined in the AABB's perioperative standards have been implemented.

Cleveland Clinic has created a new job category of "autotransfusion technician". These technicians were hired from the pool of surgical scrub techs and blood bank technicians.

Salary scales were compatible with these job classifications. The hourly rate is about

$14/hour for the regular tech, and went up to $20/hr for the senior, "chief" tech.

A different staffing model is to use perfusionists or perfusion technicians.

Perfusionists typically come with a hefty price, but the perfusion technician is an individual similar to a surgical scrub tech.

Blood salvage is typically below the capabilities of a perfusionist, but if the sophistication of the service moves beyond simple blood salvage to processes such as component sequestration, then a perfusionist may be needed

---Jonathan Waters, MD

Case # 3: 2008, OSHU: hysterectomy….

Menorrhagia requiring semi-urgent

• 43 yo JW presented with 2 weeks heavy vaginal bleeding refractory to Provera, lightheadedness, tachycardia and orthostatic changes; previous

C/S x 2

• Hct 26.7 (Hb 8.9)

23.8 (Hb 7.9) overnight; taken to OR for semi-urgent hysterectomy for removal of large uterine fibroid

• All “fractions”, peri-op salvage OK

Ferritin 10 (c/w iron deficiency); INR, PTT, fibrinogen normal

Managed hematologically peri-op with:

Cell saver with pre-primed circuit (so blood in continuous contact with body)

Venofer (iron sucrose) 200 mg q d x 5 d

• Daily folate

• Intra-op dense adhesions and more than anticipated bleeding noted. EBL ?? 700 ml +

Hct 23.8 (Hb 7.9) pre-op

17.0 (Hb 5.6) POD 1

And we didn’t want her too much lower than that….

Animal studies: lower limit tolerance:

Normal CV system: Hb ~3-5 g/dl

• Coronary stenosis: Hb ~7-10 g/dl

Human perisurgical morbidity/mortality:

Post-Op Hb 30d in hospital mortality

Normal CV disease

1.1-2.0

100 %

2.1-3.0

100 %

52.6 %

30d morbidity/mortality

Normal CV disease

100 %

88.9 %

100 %

100 %

3.1-4.0

10.0 % 62.5 % 42.9 % 80.0 %

4.4-5.0

20.0 % 58.3 % 50.0 % 75.0 %

5.1-6.0

7.5 % 14.3 % 23.5 %

6.1-7.0

11.4 % 0 % 22.5 %

7.1-8.0

0 % 0 % 9.8 %

From: Carson JL, Transfusion, 2002, 48: 812-18

40.0 %

20.0 %

7.1 %

Put on epo 20,000 U SQ daily (~360U/kg/d) with increase in reticulocyte count : rel/abs: 5.7 (0.5-1.5) / 113.2 (10-90) POD 0

11.3 / 260.7 4 days later

Hb increased from 5.6

8.0 ~ 1 wk later and was up to 9.9

~2 weeks later and epo d/c’d

Note: Pre-op epo: 300-500 U/kg /wk—takes 2-3 weeks to get meaningful increase in Hb

Post-op epo: 300-500 U/kg/d SQ --works less well due to antagonism by inflammatory mediators

Iron repletion alone in the absence of inflammation can also yield almost as rapid and effective response

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