Low-Volume Transfusion Safe for Some Elderly Patients

View on the News

Restrictive Transfusion Seems Safe – But Shouldn’t Be Cookbook Medicine

FOCUS should give some reassurance that a more restrictive postsurgical transfusion protocol is a reasonable option for elderly patents at risk for cardiovascular events, Paul J. Barr, Ph.D., and Dr. Karen E.M. Bailie wrote in an accompanying editorial (N. Engl. J. Med. 2011 Dec. 14 [doi:10.1056/NEJMe111087]).

Such a strategy not only conserves the limited blood supply, but helps protect these patients from the hazards of transfusion, they wrote.

"Even though red-cell transfusion is an accepted and widely used intervention, questions regarding which patients should receive transfusions and under what circumstances continue to spark debate. Meanwhile, concern about potential risks of blood transfusion and the costs of maintaining an adequate and safe blood supply have heightened interest in strategies to reduce the risk of red-cell transfusions."

FOCUS provides some insight into the matter for one high-risk group: elderly patients with cardiovascular disease or risk factors who undergo hip fracture surgery. "The study population is an important one in which to pose this question, since such patients are likely to be transfused because of surgical blood loss and their age, and it is plausible that they may be compromised at lower hemoglobin levels."

The trial was well conducted and had excellent statistical power, noted Dr. Barr and Dr. Bailie. But although statistically significant, the small between-group hemoglobin difference (1 g/dL) might have not been clinically relevant.

"This difference may not have been clinically significant in this group of elderly patients and may, therefore, have contributed to the lack of detectable difference in the primary outcome between the groups."

The authors cautioned, however, against applying the trial’s positive results to all patients similar to those in the FOCUS study. Despite the apparent advantages of receiving less blood, "the risks of under-transfusion should not be overlooked. The decision to transfuse should be guided by an assessment of individual patients on the basis of a combination of signs, symptoms, and laboratory measures, and not by a single hemoglobin measure."

Dr. Barr is from Queen’s University Belfast, Ireland. Dr. Barrie is from the West of Scotland Blood Transfusion Center, Glasgow. Neither disclosed any financial conflicts with the work.



Elderly hip surgery patients with cardiovascular disease do equally well whether they receive transfusions to maintain a hemoglobin level of 8 g/dL or more than 10 g/dL, a randomized trial has found.

Neither the restrictive nor the liberal transfusion protocol significantly altered the primary outcomes of mortality or functional status, or any of the prespecified secondary outcomes, Dr. Jeffrey L. Carson and his colleagues wrote in the Dec. 14 issue of the New England Journal of Medicine.

"Our findings suggest that it is reasonable to withhold transfusion in patients who have undergone surgery in the absence of symptoms of anemia or a decline in the hemoglobin level below 8 g/dL, even in elderly patients with underlying cardiovascular disease or risk factors," Dr. Carson, of the University of Medicine and Dentistry of New Jersey, Piscataway, and his coauthors wrote (N. Engl. J. Med. 2011 Dec. 14 [doi:10.1056/NEJMoa1012452]).

The investigators randomized 2,016 patients undergoing hip fracture surgery to either a liberal or restrictive transfusion protocol. The liberal protocol called for 1 unit of packed red cells and additional blood to maintain a hemoglobin level of more than 10 g/dL, whereas the restrictive one called for transfusions at the physician’s discretion or when hemoglobin levels fell to below 8 g/dL.

The study’s primary end points were death or an inability to walk 10 feet without assistance by 60 days after surgery. The secondary outcomes were in-hospital heart attack, unstable angina, or death for any reason.

The patients’ mean age was 82 years; 63% had cardiovascular disease. Women made up 75.2% of the liberal strategy group and 76.3% of the restrictive group. Postoperative hemoglobin before transfusion was 1.3 g/dL higher in the liberal protocol group than in the restrictive group – a significant difference.

Those in the liberal group also received significantly more blood than did those in the restrictive group (median 2 vs. 0 units). A total of 59% of patients in the restrictive group did not receive any blood, compared with only 3% in the liberal group.

Despite the differences in transfusion volume, the study found no significant differences in any primary or secondary outcomes. The 60-day rate of mortality or the inability to walk 10 feet unassisted was 35% in each group. At 60 days, 8% of the liberal protocol group and 7% of the restrictive group had died, a nonsignificant 1% absolute risk reduction.

Nor were the combined secondary end points significantly different. In-hospital heart attack, unstable angina, or death within 30 days occurred in 4% of the restrictive group and in 5% of the liberal group. There were no significant differences in adverse events or length of hospital stay.

Men in the liberal protocol group were significantly more likely than women to achieve the primary end point (odds ratio, 1.45 vs. 0.74). The investigators said this was an unexpected finding that could have been due to chance. Interactions based on age, race, or cardiovascular disease were not significant.

FOCUS (Transfusion Trigger Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair) was sponsored by the National Institutes of Health. Dr. Carson reported that he had received NIH funding for the study. Two other authors reported multiple financial relationships with pharmaceutical and medical device companies.

Recommended Reading

Fewer Than 10% of PCI Transfer Cases Meet 30-Minute DIDO Limit
MDedge Cardiology
Spontaneous Labor Best for Congenital Heart Disease
MDedge Cardiology
Clinical Use of TAVI Poses Potential Quandaries
MDedge Cardiology
CLEVER Trial: Supervised Exercise, Stenting Beats Medical Therapy for PAD
MDedge Cardiology
Risk Assessment Systems Found Flawed, Imprecise
MDedge Cardiology
Perception of Aortic Valve Surgery Risk May Be Exaggerated
MDedge Cardiology
Predictors Identified for Hospital Readmission After CABG
MDedge Cardiology
Ultrasound Thrombolysis a Quick Clot Buster
MDedge Cardiology
Early Thrombolysis Improves Long-term Outcomes After DVT
MDedge Cardiology
New-Onset AF Seen in One-Third of TAVI Patients
MDedge Cardiology