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Original Articles: Pediatric Cardiac

Arterial Switch Operation in the First Hours of Life Using Autologous Umbilical Cord Blood

^a Department of Perfusiology, Ukrainian Children's Cardiac Center, Kyiv, Ukraine
^b Department of Surgery, Ukrainian Children's Cardiac Center, Kyiv, Ukraine
^c Department of Immunology, Ukrainian Children's Cardiac Center, Kyiv, Ukraine
^d Department of Intensive Care, Ukrainian Children's Cardiac Center, Kyiv, Ukraine
^e Department of Anesthesiology, Ukrainian Children's Cardiac Center, Kyiv, Ukraine
^f Department of Cardiothoracic Surgery, Seattle Children's Hospital, Seattle, Washington

Accepted for publication January 31, 2012.

^_* Address correspondence to Dr Chasovskyi, Department of Perfusiology, Ukrainian Children's Cardiac Center, Chornvola St 28/1, Kyiv 01135, Ukraine (Email: kchasovskiy82{at}gmail.com).

	Abstract

Top Abstract Introduction Material and Methods Results Comment References

 
Background: In this study, we analyzed our clinical experience performing the arterial switch operation in the first hours of life using autologous umbilical cord blood transfusion (AUCBT). The safety and efficiency of AUCBT was assessed and compared with surgery with the use of homologous blood transfusion.

Methods: Between September 2009 and February 2011, 61 neonates underwent ASO at our institution. Patients were enrolled and allocated to two groups with different modalities of management strategies for neonates with dextrotransposition of the great arteries.

Results: The groups were similar in diagnoses, birth weight, cardiopulmonary bypass protocol, and surgical technique, excepting timing of surgery and blood management strategy. Preoperative mean hematocrit did not differ significantly between the groups (45% versus 45%). Mean hematocrit was significantly lower in the study group than in the control group during cardiopulmonary bypass (24% versus 31%). The hematocrit progressively increased in the study group to 38% on the first postoperative day. Serum lactate levels were higher in the study group till the second day after surgery. There were no significant differences in postoperative clinical profiles. There were no hospital deaths and no AUCBT-related side effects in our study.

Conclusions: The arterial switch operation can be performed in the first hours of life with AUCBT. Therefore, AUCBT is a safe and an efficient alternative to homologous blood in neonatal open heart surgery. During the study, we also identified positive economic effects associated with this approach.

	Introduction

Top Abstract Introduction Material and Methods Results Comment References

 
Several studies have described homologous blood transfusions (HBT) as a potential cause of various complications, such as immunologic reactions that lead to organ dysfunction, transmission of infection, and transfusion-related reactions [1, 2]. Neonatal cardiac surgery using cardiopulmonary bypass (CPB) requires the use of HBT. Blood components are used to prime the extracorporeal circuit and oxygenator and to correct anemia after CPB. Owing to the small body weight (less than 4 kg) and relatively large CPB circuit needed for neonates, the total quantity of homologous blood used intraoperatively usually accounts for more than 40% to 50% of their circulating blood volume [3].

Because of the detrimental effects of HBT and the public perception of these effects, reduction of homologous transfusion requirement is a major concern [4]. During the last 2 decades, bloodless pediatric open heart cardiac surgery has become widely accepted in many centers [1, 5, 6, 8, 9]. Numerous blood management strategies have been proposed to reduce HBT in congenital cardiac surgery, including miniaturized bypass systems, modified ultrafiltration, retrograde autologous priming, cell salvage, autologous blood donation, and so forth [1, 5, 6, 8, 9]. Nonetheless, open heart surgery in the neonatal population has been thought to be difficult to perform without priming blood in the extracorporeal circuit and transfusing blood either perioperatively or postoperatively. Thus, it is desirable to develop techniques by which homologous bloodless open heart surgery in neonates can be performed.

Progressive improvement of technique for fetal echocardiography has allowed us to develop an innovative approach in the management of neonates with critical congenital heart defects (CHD). Prenatal diagnosis of dextrotransposition of the great arteries (d-TGA) allows a controlled environment for delivery in close proximity to a pediatric cardiologic center, collecting autologous umbilical cord blood (UCB), timely patient transfer, examination, and immediate surgical repair.

We proposed using autologous UCB during open heart surgery performed in the first hours of life in neonates with prenatal diagnosis [10]. This report describes a prospective study of two alternative approaches to the management of neonates with d-TGA and includes hematocrit, serum lactate values, and short-term postoperative outcomes.

	Material and Methods

Top Abstract Introduction Material and Methods Results Comment References

 
Study Population
The Institutional Review Board of the Ukrainian Children's Cardiac Center approved this work. Written consent was obtained from the parents of the patients. Patients undergoing the arterial switch operation (ASO) for d-TGA were chosen as study subjects because of the relative homogeneity of pathology (eg, clinical presentation, anatomy), low operative mortality [7], favorable long-term hemodynamic results [12, 15], and the ability to perform surgery within the same facility using either blood management technique. Patients with d-TGA who were operated on from September 2009 to February 2011 were enrolled in this study. Patients were managed by two strategies. The first group, the autologous umbilical cord blood transfusion (AUCBT) group, included 21 patients with prenatally diagnosed d-TGA in whom autologous UCB was used during ASO performed in the first hours of life. The second group, the HBT group, included 40 patients who underwent corrective surgery for d-TGA in the conventional way using homologous blood components for perioperative management. Inclusion criteria that allowed patients to enter the AUCBT group were prenatal diagnosis of d-TGA with the possibility of collecting autologous UCB. Inclusion criteria for control group were postnatal diagnosis of d-TGA and age at operation less than 30 days. Patients in whom additional cardiac or extracardiac malformations were identified (eg, coarctation of the aorta, interrupted aortic arch, pulmonary stenosis, recognizable phenotypic syndrome of congenital anomalies, and so forth) and low birth weight (2,500 g or less) were excluded.

Preoperative Management and UCB Collection
Prenatal diagnosis of d-TGA was made between the 22nd and 28th week of gestation by fetal echocardiography. At the 36th week of gestation, reexamination was performed to confirm the diagnosis. All pregnant women were examined for blood infections, and informed consent was obtained before hospitalization into the maternity hospital. Contraindications for the collection of autologous UCB were rhesus and ABO incompatibility and confirmed maternal viral or bacterial infections. The nearest maternity hospital was selected as a study partner to decrease time between delivery and heart surgery. After obstetric examination, the date of delivery was planned to prepare for cardiac operation.

A specially trained team collected the UCB. Collection procedures were performed in accordance with the international standards [13]. Immediately after delivery of the newborn (in the first 10 s), the cord was double clamped and cut as close as possible to the abdomen of the baby. The umbilical cord was sterilized using povidone-iodide.

Irrespective of the type of delivery (vaginal or cesarean section), we harvested UCB in utero, when placenta was still in the uterus [13, 14]. The UCB was collected with a closed system that included either 250 mL or 350 mL primary bag with two satellite 150 mL bags (RT 250/2*150 CA, RT 350/2*150 containers with anticoagulant citrate phosphate dextrose adenine solution (CDPA-1); Ravimed, Masovia, Poland). The collection bag contained either 39 mL or 49 mL of anticoagulant CDPA-1 (depending on the bag volume) with donor needle. We adjusted the volume of CDPA-1 solution using a ratio of 1 mL to 5 mL of blood with a 20-mL plastic syringe. To increase the volume of harvested blood, we performed up to three consecutive punctures of the umbilical vein. Each following puncture was preceded by cord clamping above the previous puncture using sterile technique. The collected UCB in bags was placed into a mobile refrigerator (4°C) and transported to the laboratory for processing. A quantity of 0.5 mL of whole UCB was used to perform blood group typing (ABO-RhD). At least 3 mL to 5 mL was used for aerobic and anaerobic bacterial culturing. All samples of UCB were tested with CITO TEST HIV1/2 (Farmasco). All bags were registered as "autologous umbilical cord blood" and labeled with HIV1/2 test result, group type, surname of donor, and quantity of blood product. To avoid any clerical mistakes before the start of operation, we performed a cross-match of donor and recipient blood in accordance with standard transfusion practice and regulations.

After delivery, patients were transferred to the cardiac center by ambulance. Neonates arrived between 40 minutes and 60 minutes after birth. Before surgery, patients were examined by echocardiography and brain magnetic resonance imaging (to exclude perinatal brain injury).

Intraoperative Management and CPB Protocol
Anesthesia was induced with intravenous fentanyl (10 μg/kg), vecuronium (0.1 mg/kg) and was maintained with sevoflurane (or isoflurane) and infusion of morphine sulfate (40 μg/kg per hour). Additional doses of fentanyl and vecuronium infusion (0.1 mg/kg per hour) were administered during the operation as needed. Fentanyl was also used while on CPB. Central venous and arterial catheters were placed after induction of anesthesia. Both groups of patients were treated with the same protocol.

In all patients, a miniaturized bypass circuit was used with the prime volume of 120 mL to 140 mL. The CPB circuit was constructed of 3/16-inch inner diameter tubes for arterial line and 1/4 inch for venous and pump lines and connected to the Baby RX oxygenator (Terumo Cardiovascular Systems, Ann Arbor, MI) without arterial filter. Prime solution for the CPB circuit for both groups of patients contained the following: mannitol 15% 1 g/kg; albumin 20%, 10 mL/kg; sodium bicarbonate 4% 3 mL/kg; red blood cells (RBC), to achieve an estimated hematocrit level at the beginning of bypass of at least 25%; and NaCl 0.9%, if required.

For patients from the AUCBT group, autologous UCB (components or whole UCB) was used for priming the circuit. For patients from the HBT group, homologous blood components were used.

The prime solution was heated to 36.6°C before the institution of CPB. High-flow CPB with 150 mL to 200 mL/kg was performed. Blood gases (alpha-stat strategy) and electrolytes were checked frequently (usually every 20 to 30 minutes), with the first analysis after the fifth minute of bypass. All procedures were performed using moderate hypothermia (28°C to 30°C).

Cold crystalloid cardioplegia was performed in both groups of patients. The solution was injected by simple gravity for 5 minutes until cardiac arrest had been developed. Core rewarming was instituted after declamping of the aorta during completion of the pulmonary anastomosis. All patients received phenoxybenzamine, 0.5 mg/kg, during rewarming. All patients were weaned from bypass with at least 3 μg · kg^–1 · min^–1 dopamine support after esophageal temperature reached 36°C.

In the AUCBT group, after weaning from bypass, the circuit was flushed with 400 mL saline, and this volume processed by a cell-saving device (AutoLog Cell Saver, Medtronic, Minneapolis, MN). The resulting volume of blood from the extracorporeal circuit was centrifuged in closed systems. Derived RBCs were retransfused in the operating room or intensive care unit (ICU).

Postoperative Management
An anesthetic period was maintained during the first postoperative night in all patients by use of a continuous morphine sulfate infusion, 40 μg · kg^–1 · h^–1, with additional boluses of morphine sulfate every 6 hours, 100 μg/kg per dose, as needed. Routine continuous postoperative monitoring included the surface electrocardiography, transcutaneous pulse oximetry, and invasive arterial and left atrial (or central venous) pressures. Volume infusions were given in accordance the following regimen: first postoperative day, 500 mL/m² in 24 hours; second day, 750 mL/m² per 24 hours; and third day, 1,000 mL/m² per 24 hours. Diuretics (usually furosemide 1 mg/kg per dose, three to four times per day) were begun on the first postoperative day.

Continuous morphine sulfate infusion was reduced to 10 to 20 μg · kg^–1 · h^–1 on the first postoperative morning in hemodynamically stable patients. The rate of weaning from mechanical ventilation was determined by the patient's fluid balance, hemodynamic stability, gas exchange as indicated by arterial blood sampling, pattern of spontaneous breathing, and daily radiographic findings.

Clinical Data Collection
Information on birth weight, sex, quantity of harvested UCB and transfused blood products, values of hemoglobin, hematocrit, lactate, length of stay at ICU, mechanical ventilation, length of CPB, and ischemic time were documented.

Statistical Analysis
Data are presented as mean ± SD. Continuous variables were analyzed using Mann-Whitney U test and Fisher's exact p test for comparison of percentages. Differences were considered statistically significant when the p value was 0.05 or less.

	Results

Top Abstract Introduction Material and Methods Results Comment References

 
From September 2009 till February 2011, 61 neonates with d-TGA were enrolled in this study. The two groups were similar in diagnosis, birth weight, and sex (Table 1). There were significant differences between the groups with regard to preoperative ICU length of stay, Rashkind procedure, and age at operation (Table 1). The treatment groups were similar in duration of CPB and ischemic time. Hematocrit values were significantly lower in the AUCBT group than in the HBT group at the onset and at the end of bypass (Table 1). Serum lactate levels were significantly higher in the AUCBT group until the second day after surgery, when lactate levels reached normal values in both groups (Table 1).

	Comment

Top Abstract Introduction Material and Methods Results Comment References

 
Initial interest in autologous umbilical cord blood donation began at our institution in February 2009. In September 2009, the first neonate with prenatally diagnosed d-TGA underwent ASO using autologous UCB. The analysis of our results indicates that use of UCB as an option to reduce use of homologous blood in neonatal cardiac surgery indicates that this strategy is feasible, safe, and effective.

A large amount of homologous RBC may be required in neonatal cardiac surgery using CPB to avoid extreme hemodilution. That is caused by an underbalanced ratio between circulating blood volume and volume of extracorporeal circuit of the heart-lung machine. Several studies have described blood transfusion as a potential cause of numerous immunologic and nonimmunologic complications [1, 2]. For these reasons, efforts have been made to minimize homologous transfusions in pediatric cardiac surgery. There have been some reports associated with bloodless open heart surgery in children [1, 5, 6, 8, 9]. Bloodless open heart surgery in neonates has been described in only a few case reports [6]. Thus, bloodless neonatal open heart surgery is still a challenge.

From published reports of treatment of anemic preterm neonates and neonatal noncardiac surgical patients, autologous UCB was identified as a beneficial alternative to homologous transfusions [11, 17–20]. Several investigators have demonstrated the feasibility and safety of the collection, storage, and use of UCB for autologous transfusion in newborn infants. We did not find any report describing the use of AUCBT in neonatal cardiac surgery requiring CPB.

In regard to published data and special properties of UCB [20], such as high level of growth factors, fetal hemoglobin with its higher oxygen affinity, stem cells, and also painless and harmless collecting procedure, we decided to use UCB in neonatal open heart surgery. This approach allows prevention of transfusion-associated diseases, alloimmunization, reduces demand on donor blood, and also reduces consequent risks of transfusion reactions.

At the beginning of the study, we separated RBCs and fresh frozen plasma from UCB with a cell separator because it was a standard transfusion protocol in our institution. Considering the autologous nature of UCB and timing of transfusion during the first hours after collecting, we decided to use fresh whole UCB.

Prenatal diagnosis offered one more important option in the management of patients with d-TGA. Several studies reported better patient condition at presentation or improved outcomes with prenatal diagnosis [21]. Stable preoperative patient condition without any medication, ventilation support, or aggressive interventions in our study confirms these statements. We assume that complete surgical repair in the first hours of life hours of life in prenatally diagnosed neonates can be beneficial, thereby avoiding further development of hypoxemia, reducing risks from endovascular interventions, and shortening preoperative ICU stay and hospital stay. Eposito and associates [22] early demonstrated successful results of heart surgery performed in the first 24 hours of the patient's life.

Our clinical experience with an innovative approach in the management of prenatally diagnosed d-TGA demonstrates that the use of autologous UCB for perioperative transfusion and the time of surgery during the first hours of the patient's life is encouraging, and has shown the feasibility and safety of the described method. Data from this study suggest that proposed strategy and conventional way have comparable effects on the intraoperative and postoperative course in neonates after corrective surgery for d-TGA. Intraoperative data showed significantly lower levels of hematocrit during CPB in patients from the study group (Table 1). Nonetheless, in the AUCBT group, the mean value of hematocrit at onset of bypass was 26%, which was described in previous studies as safe for CHD infants without aortic arch obstruction with two ventricles repaired [7, 9].

Plasma lactate concentration was used to assess adequacy of perfusion. The significant difference between the two groups seen on bypass and postoperatively had disappeared by the second day after surgery. Furthermore, the 4.5 mmol/L mean value of lactate levels (at admission to ICU) observed in the study group was lower than the published values known to be associated with an increased risk of adverse outcome [23–26]. Postoperative short-term outcomes did not differ significantly between the two groups. Nonetheless, during the study period, we identified a few limitations of this method: limited amount of UCB; potential UCB collection problems associated with unusual placental-cord anatomy [18]; perioperative anemia; appropriateness only for neonates with prenatally diagnosed congenital malformations; and potentially higher risk of bacterial contamination.

In the majority of the observational studies, the bacterial contamination rate was mentioned. Only one study reported a higher contamination rate of 12% when the in utero collection method is used [16]. Some studies indicated that, with extensive training, the contamination rates could be lowered significantly [27, 28] As described above, there was no bacteriologic contamination of UCB samples in our study because of the technique we used.

The AUCBT strategy allowed us to avoid HBT in uncomplicated cases with acceptable results. Reduction of homologous blood transfusion in selected cohort of patients has come about because of a collaborative multidisciplinary approach with the use of many tools (multimodality). This coordinated multidisciplinary multimodality approach included all phases of treatment, from weeks before delivery and the preoperative period all the way through to hospital discharge.

Study Limitations
Despite promising initial results, we recognize certain limitations of our study such as its observational, nonrandomized nature and relatively small number of patients studied. However, this was a preliminary study to assess safety and the feasibility of a new blood management strategy in neonatal cardiac surgery. A larger multicenter randomized study would be expected to give more valuable information about the usefulness of this approach.

In conclusion, ASO in the first hours of life using AUCBT has the potential to be a safe and efficient alternative to widely accepted surgical strategy and HBT when patient management is carefully planned and conducted by a team experienced with cardiac surgical patients. To prove this new approach, a prospective clinical study is needed to evaluate the limitations and benefits of autologous UCB in neonatal cardiac surgery.

	References

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This article has been cited by other articles:

				J. Liu, B. Ji, C. Long, and S. Li An Innovative Technique to the Neonatal Arterial Switch Operation Ann. Thorac. Surg., April 1, 2013; 95(4): 1513 - 1513. [Full Text] [PDF]

				K. Chasovskyi, O. Fedevych, and I. Yemets Reply Ann. Thorac. Surg., April 1, 2013; 95(4): 1513 - 1514. [Full Text] [PDF]

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Gordon Cohen Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Chasovskyi, K. Articles by Yemets, I. Search for Related Content PubMed PubMed Citation Articles by Chasovskyi, K. Articles by Yemets, I. Related Collections Congenital - cyanotic