Ann Thorac Surg 2007;83:355-356
© 2007 The Society of Thoracic Surgeons
Correspondence
Reply
James Tatoulis, MB, BS
The Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, 3050 Australia
(Email: james.tatoulis{at}mh.org.au).
To the Editor:
My co-authors and I are greatly appreciative of the comments by Al-Ruzzeh and colleagues [1] regarding the use of recombinant activated factor VII (rFVIIa) in the treatment of postoperative hemorrhage in cardiac surgery. As they point out, factor VIIa was used as rescue therapy for uncontrollable postoperative hemorrhage, which is indeed challenging and life threatening. The points they make are appropriate and valid.
- 1 The use of rFVIIa in our study was entirely off-label [2]. We are indeed concerned about the possibility of intravascular thrombosis, and we were aware of reports in the literature of cerebrovascular accidents, myocardial infarction, and peripheral thrombosis. However, the overall reported rate of major adverse events was approximately 1%, although it is certainly probable that these complications are underreported. However, the reality in the clinical setting we faced was that the patients were bleeding profusely from a generalized coagulopathy, and the practical alternatives were more blood products, the use of rFVIIa, or eventual exsanguination. The patients treated had rFVIIa and had predominantly complex ascending aorta and arch aneurysms (7 of 12), 5 of which were acute dissections, all with complex repairs partly performed under hypothermia and circulatory arrest. Each of these 12 patients had massive blood product replacement (mean of 19 units of fresh-frozen plasma, 23 units of platelets, 20 units of cryoprecipitate) prior to the decision to use rFVIIa (see Table 3 in the report). The alternative of using even more blood products was limited by blood bank resources, and uncertainty about outcome with the potential for ongoing hemorrhage.
- 2 Al-Ruzzeh and colleagues [1] correctly point out that the pre-rFVIIa coagulation screen in the management protocol for excessive bleeding was performed between the first and second cycles of nonred cell blood product support. They suggest that following the second cycle of blood products, there should have been a control group of patients who did not receive rFVIIa versus those who did, so that a valid comparison could be made, thus enabling a better conclusion regarding cause and effect. This is logical from a theoretical point of view, but the reality was that these patients were bleeding despite massive coagulation factor replacement (on the average, double that recommended in our management protocol) and a further hemostatic intervention was desperately needed.
- 3 There is no doubt that rFVIIa is incredibly effective in promoting coagulation. We did not observe any thrombotic-related complications. This may have been due to the fact that the coagulopathy was extreme in the first place, but this is purely conjecture. One would certainly be concerned about the fate of any coronary bypass grafts.
Major thoracic aorta and arch aneurysm (resection and repair), particularly in the setting of acute dissection continues to have a high perioperative mortality, at least in part related to uncontrolled bleeding from suture lines, despite the use of good hemostatic techniques, including felt and bovine pericardium buttresses, Bioglue, and aprotinin. It is frustrating and disappointing to see ongoing nonsurgical hemorrhage after a long complex and anatomically successful reconstruction, particularly after the use of massive coagulation product replacement. If the alternative is eventual exsanguination and death, then it would seem reasonable to point out that the use of rFVIIa can result in impressive hemostasis, and that the cardiac surgeon can offer the patient potential salvage in these dire circumstances. We were pleased that all 12 patients in the report were discharged alive from the hospital and were alive at follow-up 30 to 90 days later. Nevertheless, we certainly do acknowledge and recommend that a significant degree of caution should be applied regarding the use of rFVIIa, even in this desperate setting.
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References
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- Al-Ruzzeh S, Mahmoud A, Shah S, O’Regan D. Caution with the use of recombinant activate factor VII in treating postoperative hemorrhage in cardiac surgery (letter) Ann Thorac Surg 2007;83:355.[Free Full Text]
- Bishop C, Renwick W, Hogan C, Haeusler M, Tuckfield A, Tatoulis J. Recombinant activated factor VII: treating postoperative hemorrhage in cardiac surgery Ann Thorac Surg 2006;81:875-879.[Abstract/Free Full Text]
Related Article
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Caution With the Use of Recombinant Activated Factor VII in Treating Postoperative Hemorrhage in Cardiac Surgery
- Sharif Al-Ruzzeh, Amr Mahmoud, Samir Shah, and David O’Regan
Ann. Thorac. Surg. 2007 83: 355.
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