Intraoperative red blood cell salvage during radical prostatectomy or radical cystectomy (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Intraoperative red blood cell salvage during radical prostatectomy or radical cystectomy

Intraoperative red blood cell salvage involves the collection of the solid components of the blood lost during an operation, which are then transfused back to the same patient.


The National Institute for Health and Clinical Excellence is examining intraoperative red blood cell salvage during radical prostatectomy or radical cystectomy and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about intraoperative red blood cell salvage during radical prostatectomy or radical cystectomy.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

  • The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and how it might be improved.

Closing date for comments: 30 January 2008
Target date for publication of guidance: April 2008


Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.


1 Provisional recommendations
1.1 Intraoperative red blood cell salvage is an efficacious technique for blood replacement and its use is well established in other areas of surgery. The evidence on safety is adequate. The procedure may be used during radical prostatectomy or radical cystectomy provided normal arrangements are in place for clinical governance and audit.
1.2 Clinicians wishing to undertake intraoperative red blood cell salvage during radical prostatectomy or radical cystectomy should ensure that patients understand the risks of the procedure compared with those of allogeneic blood transfusion and provide them with clear, written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
   
2 The procedure
2.1 Indications and current treatments
2.1.1 During either radical prostatectomy or radical cystectomy, patients may lose a considerable amount of blood. Conventionally, these patients receive blood transfusion using allogeneic, banked blood, which carries a small risk of infection (for example, with hepatitis, human immunodeficiency virus [HIV] or variant Creutzfeldt-Jakob disease [vCJD]) or antibody-mediated transfusion reaction). Alternatively, autologous blood can be collected and stored before an elective operation, and transfused during or after the operation as required.
2.1.2 Intraoperative red blood cell salvage offers an alternative to allogeneic or pre-donated autologous blood transfusion. It may also be useful in the treatment of patients who object to allogeneic blood transfusion on religious or other grounds.    
2.2 Outline of the procedure
2.2.1 Blood lost during radical prostatectomy or radical cystectomy is aspirated from the surgical field using a suction catheter. The blood is then filtered to remove debris. The filtered blood is washed or spun and the red blood cells are resuspended in saline, for transfusion during or after the operation. A leukocyte depletion filter is nearly always used; this is thought to minimise the risk of re-infusion of malignant cells that may be present in the aspirate. A number of different devices are available for this procedure.
Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more details, refer to the sources of evidence (see appendix).    
2.3 Efficacy
2.3.1 A case series of 49 patients treated with red blood cell salvage during radical cystectomy (either alone or in combination with other surgery) reported overall and disease-free survival rates of 88% (43/49) and 80% (39/49), respectively, at 24-month follow-up. No studies were available that described efficacy outcomes for the use of intraoperative red blood cell salvage during prostatectomy.
2.3.2 The Specialist Advisers considered key efficacy outcomes to include reductions in allogeneic transfusion requirements, haemoglobin levels and perioperative immunomodulation.
2.4 Safety
2.4.1 A non-randomised controlled study of patients who were treated by radical prostatectomy reported similar rates of biochemical prostate cancer recurrence in 265 patients treated intraoperatively with salvaged red blood cells and 773 patients who did not require re-infusion (15% and18% respectively, p = 0.76).) Subgroup analysis of patients at 'low', 'intermediate' and 'high' risk (Gleason score) also found no significant difference in biochemical recurrence rates between the two groups (absolute numbers not reported).
2.4.2 A second non-randomised controlled study of patients who were treated by radical prostatectomy reported biochemical recurrence at 7-month follow-up in 5% (3/62) of patients transfused intraoperatively with salvaged red blood cells and in 24% (24/101) of patients transfused with pre-donated autologous blood at 43-month follow-up (substantially different follow-up times noted). Progression-free survival was not significantly different between the groups (p = 0.41) at 43-month follow-up. In the same study, postoperative haematocrit levels were significantly higher in patients given salvaged red blood cells (31.3 ± 3.5%) than in those who received pre-donated autologous blood (27.9 ± 3.4%).
2.4.3 A third non-randomised controlled study of patients who were treated by radical prostatectomy reported that there was biochemical evidence of recurrence (based on blood levels of prostate specific antigen) at 43-month follow-up in 19% (9/47) of patients treated intraoperatively with salvaged red blood cells and at 46-month follow-up in 32% (17/53) of patients who did not require re-infusion (statistical significance not stated). This study also reported that red blood cell salvage treatment was not an independent predictor of biochemical evidence of recurrence.    
2.4.4 A fourth non-randomised controlled study of patients who were treated by cystectomy reported a non-significant difference in 3-year overall survival rate between a group of 65 patients treated intraoperatively with salvaged re-infused blood and 313 patients who did not receive re-infusion (64% and 66% respectively; absolute numbers not reported; p = 0.74). Similarly, at 3-year follow-up, there was no significant difference in disease-free survival rate between the groups (72% and 73% respectively; p = 0.90; absolute numbers not reported).    
2.4.5 A case series of 49 patients who were treated by cystectomy and who received salvaged red blood cells reported that there were no complications directly related to red blood cell salvage transfusion at 24-month follow-up. No major reactions to transfusions were noted and no patient demonstrated clinical or biochemical evidence of hepatitis.    
2.4.6 The Specialist Advisers considered key safety outcomes to include transient hypertension, length of hospital stay, need for intensive care unit stay, infection rates, thrombosis and bleeding. An additional theoretical adverse event noted by the Advisers was re-infusion of cancerous cells leading to distant metastases.    
2.5 Other comments
2.5.1 The Committee noted concern about the theoretical risk of infusing viable cancer cells that might cause metastases. However, there was no evidence in reported series that this occurred, and any such theoretical risk needs to be balanced against the potential risks of allogeneic blood transfusion.
2.5.2 The Committee did not consider it likely that further long-term research would identify metastases that might have been caused by re-infused malignant cells.
3 Further information
3.1 The Institute has produced interventional procedures guidance on intraoperative blood cell salvage in obstetrics (www.nice.org.uk/IPG144).
   

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
January 2008

Appendix: Sources of evidence
 

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • 'Interventional procedure overview of intraoperative red blood cell salvage during radical prostatectomy or radical cystectomy', January 2008

Available from: http://www.nice.org.uk/guidance/index.jsp?action=download&o=38780.

This page was last updated: 30 March 2010