This article is more than 5 years old. Information may no longer be current.
Time for more vigilance, education and randomized studies in blood management
Orthopedic surgeons employ various preoperative, intraoperative and postoperative blood management practices to keep patients from losing excessive amounts of blood or encountering untoward blood-related events. Yet experts contend the results of those efforts in total joint replacement, spine, trauma and other surgical cases are variable and poorly documented. They also question why certain strategies are being used, including transfusions, salvaging blood from drains postoperatively, and others.
Another area of debate is that modalities to prevent or minimize blood loss vary greatly among orthopedists and hospitals. Some involve historic practices lacking solid scientific evidence, according to Hospital for Special Surgery’s Surgeon-in-Chief Thomas P. Sculco, MD, of New York.
In orthopedics, this complex landscape of blood management is starting to evolve in tandem with the need for increased protocols, more evidence-based practices and better training in this area. Sculco’s own blood management practices exemplify how such change is unfolding. Until recently he had nearly all his total joint arthroplasty (TJA) patients autologously pre-donate blood in the event they needed a unit or two later, but said that now he rarely does that and is starting to employ other strategies.
“Orthopedic surgeons are much more knowledgeable about blood management than they were 10 or 15 years ago, but I think we can still do a better job,” Sculco said. “It is something we have to continue to talk about and try and improve.”
|
Image: Hospital for Special Surgery |
Sculco discussed a key development at Hospital for Special Surgery (HSS) and elsewhere: hospital-based blood management programs. Still getting underway, the HSS program started about a year ago and he predicts such coordinated internal efforts will help orthopedists, nurses, anesthesiologists and others at hospitals make consistent, patient-focused decisions concerning blood management while yielding some cost savings.
“I think ultimately the Joint Commission is going to require that hospitals have blood management programs and they will have metrics to assess utilization of transfusion that are part of the quality of care,” said Neil Blumberg, MD, director of the University of Rochester Medical Center Laboratories and an expert in blood transfusion immunology.
The money saved on the autologous program will end up funding other blood management programs. “The care of the patients is better when you do that,” he said.
Blood-management performance measures have been a recent focus at the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In December, its technical advisory panel submitted seven recommended measures for surgical blood management to the National Quality Forum. A decision on final approval for measures related to red cell, plasma, platelet transfusion, preoperative anemia screening, typing/antibody screening and other areas is expected shortly, according to JCAHO.
Preoperative steps
The good news comes from renewed interest in the topic of blood management within the specialty, coupled with a growing body of related literature and increased attention given to it at meetings, the surgeons and blood experts who spoke with Orthopedics Today noted. Yet, they voiced concerns about the rationale for many methods now used pre-, intra- and postoperatively and the need for more randomized studies.
Preoperatively, the risk of an orthopedic patient losing blood or having his or her hemoglobin (Hb) or hematocrit (Hct) drop too low must constantly be weighed against the possible risks of blood transfusion, they said. Therefore, many orthopedists check Hb and Hct levels to determine the patient’s blood or anemia “status” and if they are a possible transfusion candidate.
“We do an Hb test when I schedule a TJA. If the Hb is below 13 g/dl, we start Procrit (epoetin alfa, Amgen),” Douglas E. Garland, MD, medical director of the Memorialcare Joint Replacement Center in Long Beach, Calif., and a member of the Orthopedics Today Editorial Board, said.
Starting with Hb at about 13 g/dl and having everyone on the same page, he said, are critical for going forward with most TJA cases.
Do numbers count?
“Erythropoietin has been indicated for patients with Hb between 10 and 13 g/dl and that is based on how regulatory approval was obtained for that particular drug.” said Javad Parvizi, MD, FRCS, of the Rothman Institute in Philadelphia, who also tries to optimize Hb preoperatively.
But, increasing Hb and Hct preoperatively with erythropoietin, which stimulates the body’s production of red blood cells, remains controversial as do ideal “trigger” or low points for both levels before transfusion is indicated.
“The jury’s still out on a lot of this. But most of what we’ve been taught, whether it is orthopedic surgeons or leukemia doctors, is turning out to be wrong, that we are actually not doing our patients a favor by treating them on the basis of their numbers,” Blumberg said.
“Animal model and other data show that patients who are not having an acute myocardial infarction or some other catastrophic vascular event have pretty good oxygen delivery to the tissue down to hematocrit levels of perhaps 15% [5 g/dl Hb] or so. So transfusing hemodynamically stable patients as we commonly do now at hematocrits of 22 or 24 or 25 g/dl is probably buying us minimal to no benefit and dramatic increases in side effects,” he told Orthopedics Today.
Complex cases, added measures
According to Parvizi, an Orthopedics Today Editorial Board member, bilateral joint replacements and complex TJA revisions are often associated with measurable intraoperative blood loss. “These patients are in extreme need of evaluation preoperatively to ensure they have optimum hemoglobin to be able to avoid the risk of transfusion,” he said.
Preop Hb must also be weighed against the complexity of the procedure, particularly in individuals with chronic renal failure, cardiac problems or other chronic diseases that usually cannot tolerate lower Hb, Parvizi noted. “These factors are pretty well delineated in the literature,” Parvizi said.
Taking hormones, vitamin B-12 or iron to address underlying anemia, and possibly erythropoietin, may help increase Hb, he said.
Minimizing blood loss
Sculco and Garland stressed the importance of stopping nonsteroidals and aspirin preoperatively to mitigate bleeding issues. Concerning the timing of that, there is no consensus, Garland said, noting that depending on the case he still occasionally has a patient pre-donate blood. But, for a variety of reasons, including the fact his hospital’s overall transfusion rate was about 33% in 2010, he is trying to do that less often.
“There is a lot of work being done in the area of blood and transfusion management protocols or blood salvage and there is a view that transfusion may be risky,” said T. Forcht Dagi, MD, MPH, FAANS, FACS, FCCM, chair of the American College of Surgeon’s Committee on Perioperative Care. Substituting for the blood or preventing transfusions by identifying who may be vulnerable are approaches orthopedists should consider, he noted.
According to Blumberg, with allogeneic blood, “Transfused patients have a dose-dependent increase in complications, such as postoperative infections, thrombosis, multi-organ failure syndromes and unfortunately death. On the other hand … the evidence that we are actually doing any good with transfusion the way we are using it now in patients is pretty much zero.”
Autologous donation trends
Sculco said HSS led the push in the United States for autologous donation in the late 1980s when the safety of the blood supply seemed uncertain. “Until about 3 or 4 years ago almost all of our patients went through the autologous program — pre-deposited their own blood. It began with 2 units for every primary joint replacement and then went to 1 unit. That is being phased out. … We still use autologous blood, but much less than we did previously,” he said.
The program was also fairly inefficient in terms of actual utilization of the blood and Sculco estimated the cost of running it at $1 million annually with half the blood usually not used.
Blumberg agreed wasted blood is a problem and he said studies show about 50% of such blood is discarded because it is not needed.
But, since the blood pool today is much safer, Sculco said, “We have morphed into a very selective process in terms of using autologous blood and we use a lot of other modalities to reduce the need for blood replacement.”
Intraoperative approaches
“Making bloodless surgery a priority is a route toward better clinical outcomes in all patients,” Blumberg said.
|
However, in the event allogeneic blood is required intra- or postoperatively, it is a safe option, Parvizi explained. Strict blood supply testing and donor screening today can detect HIV, hepatitis and other transmittable infections, but it may fall short during the “window” when a virus is still not detectable in high enough quantities to be picked up, he said.
Dagi, a neurosurgeon with a faculty appointment at Harvard MIT Health Sciences and Technology, said some research indicates intraoperative Hb monitoring can significantly reduce transfusions.
“What you have to do is balance two things. One is the amount of time that you are in the OR and the other is perfect hemostasis,” Dagi said. “Everyone wants to reduce blood loss. By definition you want to do that. It diminishes mortality and makes people feel better, happier. Most spine surgery that does not involve a lot of bone work can be done with relatively little blood loss if it is not tumor or trauma surgery, so that is always a goal.”
Parvizi discussed using a meticulous surgical technique: “Do the surgery safely, but do it through the smallest incision and the smallest dissection you can.”
Blood salvage
Intraoperative blood salvage from drains and cell salvage systems have advantages and disadvantages. “I view blood salvage as a second-tier concern in TJA,” Garland said.
Dagi noted: “There’s an entire shadow industry of cell salvage,” with two points of view. One touts the wisdom of giving patients back their own cells and the other questions if the availability of cell salvage makes surgeons sloppier.
Parvizi and colleagues studied this area and found the four independent risk factors for needing blood by transfusion or intraoperative blood salvage were as follows:
- complexity of the procedure;
- operative time up to 2 hours;
- need for an extended trochanteric osteotomy in total hip arthroplasty (THA); and
- patients and a low body mass index (BMI) with low blood volume who cannot tolerate much blood loss.
However, Blumberg said there is not much evidence from randomized trials on the benefits of salvage or recovering blood from the operative field from drains or using cell saver devices, but noted it is reasonable to do in orthopedic trauma cases and those with lots of bleeding and an uncontaminated field, particularly when the team has the expertise to do it.
Hemodilution, a method of taking autologous blood preoperatively and giving fluids intraoperatively that the anesthesiologist performs, is another approach Blumberg and Dagi favored because it conserves the patient’s own red blood cells.
Intraoperative transfusion issues
Concerning transfusion, some non-randomized trials showed a trend toward fewer deep venous thromboses (DVTs) in those who received autologous rather than allogeneic blood, Blumberg said.
Dagi noted the scientific evidence is still not clear that autologous blood is safer than allogeneic blood in all situations. Therefore, the circumstances of blood loss in elective surgery, such as damage to vessels or discovery of a bloody tumor, typically dictate the best action to take. However, in mixed cases in orthopedics, concomitant traumatic injuries may dictate what is done for blood management more than anything else, he said.
“I think the intraoperative piece of this has been successfully managed with the use of anesthetic techniques,” such as hypotensive regional anesthesia, Sculco said. This speeds the procedure and leads to less blood loss by dropping the blood pressure fairly low, but could have detrimental effects in anyone with cardiac problems and other comorbidities, he said.
“Now we are becoming interested in other areas,” such as fibrin glues and the anti-fibrinolytic tranexamic acid (TXA), which are being studied in randomized trials at HSS, Sculco said.
TXA is low-cost and can be administered topically as a spray or intravenously. In a 2011 meta-analysis in the Journal of Bone and Joint Surgery (Br), it resulted in fewer THA patients needing allogeneic transfusion without affecting complication rates.
Leukoreduction of transfused blood — removing leukocytes that may cause problematic or contaminated transfusions — is an option Blumberg urged orthopedists to consider when transfusion is unavoidable, noting fairly large randomized trials in cardiac surgery showed it reduced postoperative infections by about 30% and mortality by nearly 50%.
Postoperative management
Postoperatively, transfusion triggers remain an issue as more evidence is needed for or against the 10/30 concept, where Hb must be kept at 10 g/dl and Hct at 30 g/dl, Garland said. Even when he permits a patient’s numbers to drop to below those levels, the problem is the nursing staff is trained to give blood when the numbers get below 10/30. Therefore, the patient is transfused. “There is increasing evidence that transfusion is not good for you.”
Keeping the amount of blood drawn for tests postoperatively to a minimum is a practice many have found helps maintain sufficient blood volume.
As for some current trends, Dagi said, “The past 2 or 3 years have reflected increased thinking about the management of large amounts of blood loss based on experience in Iraq and Afghanistan. I think that’s the real change, but there is no new magic bullet.”
The war experience has also raised awareness of the benefits of hemostatic dressings designed to absorb free water and concentrate clotting factors and of other hemostatic agents that work similarly. Garland now applies such a material, a ready-to-use active topical agent called Superstat (Superstat Inc.), at the end of surgery. “It is another method to prevent blood loss,” he said.
“I would say the trend is giving less blood, dropping the trigger down, using more hypotensive anesthesia, using cell savers where there is significant blood intraoperatively or postoperatively,” Sculco said. “All those have reduced the need for autologous blood and allogeneic blood.” – by Susan M. Rapp
References:
- Brown CVR, et al. Arch Surg. 2010;145:690-694.
- Carson J. LBCT02 # 116. Presented at: American Heart Association Scientific Sessions; Nov. 14-18, 2009; Orlando, Fla.
- CRASH-2 trial collaborators. Lancet. 2010; 376:23-32.
- Hébert PC, et al. N Engl J Med. 1999;340(6):409-417.
- Shaz BH, et al. Transfusion. 2010;50(2):493-500.
- Sukeik M, et al. J Bone Joint Surg Br. 2011;93(1):39-46.
- Neil Blumberg, MD, can be reached at 601 Elmwood Ave., Box 608, Rochester, NY 14642; 585-275-9656; e-mail: Neil_Blumberg@URMC.Rochester.edu.
- T. Forcht Dagi, MD, MPH, FAANS, FACS, FCCM, can be reached at 423 Commonwealth Ave., Newton Centre, MA 02139; 617-301-0404; e-mail: tdagi@post.harvard.edu.
- Douglas E. Garland, MD, can be reached at 2760 Atlantic Ave., Long Beach, CA 90806; 562-424-6666; e-mail: dougarland@msn.com.
- Javad Parvizi, MD, FRCSC, can be reached at 925 Chestnut St., 2nd Floor, Philadelphia, PA 19107; 267-399-3617; e-mail: parvj@aol.com.
- Thomas P. Sculco, MD, can be reached at 525 East 71st St., New York, NY 10021; 212-606-1475; e-mail: sculcot@hss.edu.
- Disclosures: Dagi, Garland, Parvizi and Sculco have no relevant financial disclosures. Blumberg has acted as a consultant to Fenwal and Pall Biomedical, manufacturers of leukoreduction filters.
Do you have your patients pre-donate blood prior to surgery? Why or why not?
Fusion surgery may warrant pre-donation
|
|
I have routinely had elective spine fusion patients pre-donate 2 units autologous blood within the 30 days before surgery. I began this custom at a time when I was routinely harvesting iliac crest bone graft and so my total blood loss for one- or two-level posterolateral fusions (including postoperative drain loss) would often warrant blood replacement.
I do recognize that pre-donation does result in some anemia and may not decrease the need for transfusion.
At the same time, there is always the emotional issue for patients that nothing is safer than their own blood.
Scott D. Boden, MD, is director of Emory University Spine
Center in Atlanta and spine section editor for Orthopedics Today.
Disclosure: He has no relevant disclosures.
Plan rather than transfuse
|
|
I do not routinely ask my patients to pre-donate blood prior to surgery, whether total hip, total knee or revision joint surgery.
Simply because patients receive pre-donated autologous blood (PAD) does not mean these transfusions are risk free. Donating blood prior to surgery makes the patient anemic to start with. While PAD is less risky than allogeneic transfusions there is still the risk of mislabeling and getting the wrong blood. Old blood that is stored is not the same as freshly drawn blood or the blood that we can save and give back to the patient during surgery. There is injury to the blood from handling and storage with chemical and physical deformations demonstrated. When one notes that 50% of the autologous units are thrown away it becomes even clearer that careful planning can take the place of transfusions. Transfusing a PAD unit so it won’t be wasted puts patients at risk of fluid overload.
Putting our patients’ blood on a cold shelf somewhere getting old as 2,3-DPG (2,3-diphosphoglycerate) levels decrease makes this blood not an effective oxygen delivery system. In circuit intraoperative blood management techniques of acute normovolemic hemodilution combined with careful intraoperative technique and perioperative cell saver systems are better options benefitting our patients.
The challenge in joint replacement is to precisely place our implants and ensure the best functional outcome in our patients while minimizing the morbidity of the procedure and postoperative course. I work with each patient to go into surgery with a high Hb/Hct, to perform surgery in a way that minimizes blood loss, and to have postoperative protocols that will protect the patient from the risks of thrombosis while maintaining hemostasis.
David N. Feldman MD, FACS, FAAOS, is a founding member of the
Society for the Advancement of Blood Management and is Associate Medical
Director of the Institute for Patient Blood Management and Bloodless Medicine
and Surgery at Englewood Hospital and Medical Center, Englewood, N.J.
Disclosure: He has no relevant disclosures.