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Autologous Blood Salvage in Cardiac Surgery

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Autologous Blood Salvage in Cardiac Surgery hematol transfus cell ther. 2 0 2 1;4 3(1):1–8 Hematology, Transfusion and Cell Therapy www.htct.com.br Original article Autologous blood salvage in cardiac surgery: clinical evaluation, efficacy and levels of residual heparin a,b,∗ a,b Sérgio Domingos Vieira , Fernanda da Cunha Vieira Perini , b b b b Luiz Carlos Bento de Sousa , Enio Buffolo , Paulo Chaccur , Magaly Arrais , b Fábio Biscegli Jatene a Banco de Sangue de São Paulo, São Paulo, SP, Brazil b Hospital do Corac¸ão da Assoc. Sanatório Sírio, São Paulo, Brazil a r t i c l e i n f o a b s t r a c t Article history: Objective: Intraoperative blood salvage (cell saver technique) in cardiac surgery is universally Received 4 May 2019 used in surgical procedures with a marked risk of blood loss. The primary objectives of this Accepted 20 August 2019 study were to determine the concentration of residual heparin in the final product that is Available online 7 November 2019 reinfused into the patient in the operating room and to evaluate the efficacy and safety of the cell saver technique. Keywords: Method: Twelve patients undergoing elective cardiac surgery were enrolled in this study. Using the XTRA Autotransfusion System, blood samples were collected from the cardiotomy Intraoperative blood salvage Autotransfusion reservoir, both prior to blood processing (pre-sample) and after it, directly from the bag with Residual heparin processed product (post-sample). Hematocrit and hemoglobin levels, the protein, albumin Cell saver technique and residual heparin concentrations, hemolysis index, and the platelet, erythrocyte and leukocyte counts were measured. Results: Hematocrit and hemoglobin levels and red blood cell counts were higher in post- 6 3 processing samples, with a mean variation of 54.78%, 19.81 g/dl and 6.84 × 10 /mm , respectively (p < 0.001). The mean hematocrit of the processed bag was 63.49 g/dl (range: 57.2–67.5). The residual heparin levels were ≤0.1 IU/ml in all post-treatment analyses (p = 0.003). No related adverse events were observed. Conclusion: The reduced residual heparin values (≤0.1 IU/ml) in processed blood found in this study are extremely important, as they are consistent with the American Association of Blood Banks guidelines, which establish target values below 0.5 IU/ml. The procedure was effective, safe and compliant with legal requirements and the available international literature. © 2019 Associac¸ao˜ Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier Editora Ltda. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). ∗ Corresponding author at: Transfusion Medicine Department, Hospital do Corac¸ão and Banco de Sangue de São Paulo, R. Desembargador Eliseu Guilherme 147, CEP:04004-030, Paraíso, São Paulo, Brazil. E-mail address: [email protected] (S.D. Vieira). https://doi.org/10.1016/j.htct.2019.08.005 2531-1379/© 2019 Associac¸ao˜ Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier Editora Ltda. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). 2 hematol transfus cell ther. 2 0 2 1;4 3(1):1–8 One of the major challenges threatening patient health or post-operative hemorrhage. These are the main objectives ¨ and prognosis is the development of a hemorrhagic condition¨. of this study. Whether developed in clinical patients during a surgical proce- dure or via trauma, the intensity of the hemorrhagic condition Methodology is of significant concern because it is directly proportional to the need to replace the lost blood elements, sometimes imme- A prospective, single-center, non-randomized, observational diately, to prevent the condition from becoming irreversible study was performed, with the primary outcome assessing the and fatal. The decision to undertake allogeneic blood trans- residual heparin concentration in the final product obtained fusion should be made in a rational manner, by assessing by an automated blood cell salvage (cell saver) system, as well the relative risks and benefits. The practice of blood transfu- as its clinical evaluation and efficacy, as secondary outcomes. sion saved countless lives long before complications from this 1 2,3 The study was approved by the Teaching and Research Insti- treatment were recognized, including viral infections (e.g., tute of Hospital do Corac¸ão (Instituto de Ensino e Pesquisa HIV, Hepatitis B and C), parasitic infections (e.g., malaria, T. 4 5,6 at the Hospital do Corac¸ão - IEP-HCor), the Syrian Sanato- cruzi, and babesiosis), bacterial infections, immunological 7 rium Association, São Paulo, Brazil and the National Research and anaphylactic reactions, transfusion-related acute lung 8 9 Ethics Commission (Comissão Nacional de Ética em Pesquisa - injury (TRALI) and post-transfusion purpura, among others. CONEP), under the Certificate of Presentation for Ethical Con- When considering alternatives to avoid allogeneic trans- sideration (CAAE) no. 62937216.6.0000.0060. Signed informed fusions, it was quickly determined that the ideal procedure consent was obtained from all participants, in accordance would be to recover the patient’s own blood and immedi- with the rules of the Research Ethics Committee. All aspects ately reinfuse it. This autotransfusion concept is not new, as of the surgery, blood collection, transfusion and any other rel- indicated by many reports in the literature, starting in 1818 10 11 evant concerns were explained to the patients by one of the with Blundell and subsequently with Highmore in animal investigators. The null hypothesis of the study was that the experiments. Duncan made the first report in the medical lit- reinfused blood contained a clinically significant concentra- erature of his experience in reinfusing a patient’s own blood 12 tion of heparin. For the purposes of this study, the authors have that was lost during surgery. A U.S. Air Force surgeon, Dr. adopted the American Association of Blood Banks (AABB) def- Klebanoff, developed a simple autotransfusion device based 13 inition of clinically¨ insignificantas¨ a threshold concentration on cardiopulmonary bypass equipment, later marketed as 36 of residual heparin <0.5 IU/ml. the Bentley ATS 100, due to the lack of blood during the Vietnam War. This system has been widely used, although several reports of complications have been described. In the Patients early 1970s, engineer Allen “Jack” Latham developed a new 14 form of cell salvage. He developed the Latham bowl, which Twelve patients admitted to our institution for cardiac surgery had the ability to wash the blood before it was re-transfused. over a period of 12 months agreed to participate in the study. Washing salvaged blood reduced most of the debris or elimi- Male or female patients aged 18 years or older who were in nated many of the previously encountered side effects. There a non-emergency situation were eligible. The exclusion cri- were two major stimuli for the development and improve- teria included patients who were using warfarin, heparin, or ment of this system: (1) cardiac bypass surgery, which in the other systemic anticoagulant medications prior to surgery, 1970s went from a radical procedure in advanced high-risk patients who are prevented from receiving blood and blood cases to the most performed surgery worldwide, thus requir- components due to religious or spiritual beliefs (e.g., Jehovah’s 15 ing large stocks of blood for treatment of hemorrhagic cases, Witnesses), patients with congenital or acquired platelet, red and; (2) the appearance in the 1980s of the acquired immun- blood cell or coagulation disorders, patients with ongoing odeficiency syndrome (AIDS), which was more intense and or recurrent systemic sepsis and those who were unable to shocking. The enormous fear of HIV transmission made it provide full informed consent to participate in the study. Clin- necessary to search for a safer and more effective alternative ical outcome data were collected prospectively as part of our approach, which came in the form of autologous transfusion patient screening and analysis system. The patient and surgi- 16 programs. Since then, intraoperative blood salvage (the cell cal characteristics are provided in Table 1. saver technique) has been utilized in cardiac surgery, and numerous automations in operation have been introduced Cell saver procedure through pre-established protocols to enhance safety, such as the bubble detector, balance, microaggregate filter, panels with The automated blood salvage device used was the XTRA audible, visual and interactive alarms and sensors that mon- Autotransfusion System with a pulsed flow cellular wash- itor the leuko-platelet layer, the quality of the supernatant ing system. Standard operating procedures were followed from the washing performed and the hematocrit/hemoglobin according to the manufacturer’s recommended protocols. concentration levels, modernizing intraoperative blood sal- Adequately trained operators performed the blood salvage vage systems. Although we have already standardized the use process. All aspirated blood was collected from the time of of the cell saver technique at our service, the introduction of incision of the skin to the wound closure by a double-lumen this new equipment necessitated additional research to deter- suction catheter specific for blood collection. The vacuum suc- mine its safety, efficacy and, especially, the concentration of tion pressure was maintained up to 100 mmHg to minimize residual heparin in the final product that is reinfused into the hemolysis during aspiration. Anticoagulation of the blood patient, which may significantly alter the clinical risk for intra- recovered in the cardiotomy reservoir was achieved using a hematol transfus cell ther. 2 0 2 1;4 3(1):1–8 3 Table 1 – Patient characteristics and type of surgery. Table 2 – Results of intraoperative salvage and homologous blood use. Study group (n:12) Percentage (%) Mean Minimum Maximum Age (years) 60.2 (44/73) – <70 years 10 83.3 Vol.
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