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Ann Thorac Surg 2004;78:1717-1722
© 2004 The Society of Thoracic Surgeons

Original article: cardiovascular

Open Heart Surgery for Small Children Without Homologous Blood Transfusion by Using Remote Pump Head System

Makoto Ando, MDa,*, Yukihiro Takahashi, MDa, Natsuko Suzuki, MDa

a Department of Pediatric Cardiac Surgery, Sakakibara Heart Institute, and Department of Pediatrics, Musashino Red Cross Hospital, Tokyo, Japan

Accepted for publication May 4, 2004.

* Address reprint requests to Dr Ando, Department of Pediatric Cardiac Surgery, Sakakibara Heart Institute, 3–16–1 Asahi-cho, Fuchu-si, Tokyo 183–0003 Japan
maando{at}shi.heart.or.jp

Presented at the Fortieth Annual Meeting of The Society of Thoracic Surgeons, San Antonio, TX, Jan 26–28, 2004.


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 DISCUSSION
 References
 
BACKGROUND: To avoid excessive hemodilution, the transfusion of a large amount of homologous blood may be required in open heart surgery for small children, which in turn, can cause a significant immunologic response.

METHODS: Cardiopulmonary bypass systems with remote pump heads were used for patients weighing 5 kg or less that were undergoing ventricular septal defect repair. The procedures took place from January 1997 to August 2002. The surgery was started with bloodless prime in 122 out of 158 (77.2%) consecutive patients. Exclusion criteria were a predicted hematocrit after the initiation of bypass of less than 15%, respiratory failure or heart failure (or both), and pulmonary vascular obstructive disease.

RESULTS: The mean age and body weight were 3.8 ± 1.8 months and 4.3 ± 0.5 kg, respectively. The priming volume was 181.0 ± 32.5 (minimum: 130) mL. The hematocrit after cardiopulmonary bypass was initiated was 16.7% ± 2.3%. Six patients required subsequent blood transfusion owing to postoperative complications that resulted in compromised hematopoiesis. In the rest, the hematocrit before discharge was 30.6% ± 3.0%. Renal and liver function tests were maintained within the normal range. Patients were extubated at 5.6 ± 2.8 hours after operation with proper oxygenation. Neurodevelopment was apparently normal. The Japanese psychomotor developmental scale assessment was given to patients without chromosomal abnormality between the ages of 1 and 3 years; the resulting score was 102.2 ± 15.4 (mean = 100 for normal population).

CONCLUSIONS: Open heart surgery was achieved without blood transfusion in the selected group of small children. The use of remote pump heads reduced the overall need for blood transfusions and possibly inflammatory reactions.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 DISCUSSION
 References
 
The small circulating volume in small children renders them susceptible to extreme hemodilution when a large-circuit cardiopulmonary bypass (CPB) system is used; and hence, a homologous blood transfusion seems necessary in this context.

However, an immunologic reaction that causes organ dysfunction can counterbalance the main benefit of homologous blood. Other reasons to avoid transfusion include infectious transmissions, the hurdle it presents for Jehovah's Witness patients, patients' negative impression of transfusion, and the general blood donor shortage in Japan.

In the Department of Pediatric Cardiac Surgery at Sakakibara Heart Institute, the CPB circuits have been miniaturized to avoid unnecessary transfusion in pediatric open heart surgery. This strategy has been extended to patients with lower body weight. In this article we retrospectively review our experience with bloodless open heart surgery for patients weighing 5 kg or less.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 DISCUSSION
 References
 
Hospital and outpatient records of 158 consecutive patients weighing 5 kg or less that underwent ventricular septal defect (VSD) repair from January 1997 to August 2002 were reviewed. Those who had atrial septal defect, patent ductus arteriosus, and mild right ventricular outflow tract obstruction that could be tailored through the same cardiac incision were included in the cohort.

At the beginning of this study period, only one (SSS) system was used. This comprised a driving unit (TOW NOK compo III, Tonokura Medical Inc., Tokyo, Japan) with remote roller pump heads. Pump heads for arterial perfusion and venous drainage were placed on the left side of the operating surgeon, and those for cardiotomy suctions and left heart venting on the right side. The reservoir with built-in artificial lung (Safe-Micro System, Polystan, Værløse, Denmark) were placed close to the arteriovenous pumps. The dialysis filter (APF-01D, Asahi Medical, Tokyo, Japan) circuit was connected to the arteriovenous circuit for continuous ultrafiltration. Sizes of tubes were 1/4 inch at the pump heads and the rest were 3/16 inches. The minimum priming volume for this circuit was 160 mL.

Since November 2000, another (SSSS) system was introduced (Fig 1) and has been used for patients weighing 4.5 kg or less. This used 5/32-inch tubing, except for the pump heads. A shorter arteriovenous circuit was accomplished by placing the reservoir closer to the surgeon at a higher level. The minimal priming volume of this system was 130 mL.



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  		Fig 1. The scheme of the SSSS cardiopulmonary bypass system. A = reservoir and artificial lung; B = roller pump heads for arterial perfusion and venous drainage; C = ultrafiltration circuit; D = pump heads for cardiotomy suctions and left heart venting; E = driving unit.

 
The operation was done through a median sternotomy under fentanyl-sevoflurane anesthesia. The standard skin incision was 4 cm long. A 2.6-mm arterial cannula (Stöckert Instrumente, Münich, Germany) and 14F straight venous cannulas (Medtronic, Parker, CO) were used. An Argyle 12F cannula (Tyco Health-Care, Mansfield, MA) was inserted through the right upper pulmonary vein for left ventricular venting.

A crystalloid prime was used except in those patients with an expected hematocrit of less than 15% after the initiation of CPB, those with preexisting cardiac or respiratory failure (or both), those requiring preoperative intubation, and those with pulmonary vascular obstructive disease. Pulmonary vascular obstructive lung disease was considered present when the calculated pulmonary vascular resistance by catheterization exceeded 5 Wood units. Those patients having a resistance of greater than 10 Wood units that was not responsive to oxygen inhalation or tolazoline hydrochloride administration were brought forward for lung biopsy to assess the feasibility of the VSD closure. The main components of the priming solution contained dialysate (Sublood BD, Fuso Pharmaceutical, Osaka, Japan), 20% mannitol, and sodium bicarbonate. For those patients weighing 4 kg or less, 20 mL of 25% albumin was added to the prime; for those weighing more than 4 kg, 10 mL/kg of 2.5% hydroxyethyl starch was added. Packed red cells were used if blood prime was chosen. The protocol was approved by our Institutional Review Board and informed consent was obtained from the parents or guardians of all patients.

A high flow (150 mL · kg–1 · min–1) normal-to-mild hypothermic (> 33°C) CPB was used. Blood cardioplegic solution (20 mL/kg) was given every 20 minutes. The VSD was closed primarily through the right atrium for perimembranous VSD and through the pulmonary artery for subarterial VSD by using an interrupted suture technique. Throughout the procedure, the circuit blood was ultrafiltered at a rate of approximately 500 mL/h, with continuous replacement by Sublood BD (dilutional hemofiltration). After CPB was discontinued, the circuit blood was collected, given to the anesthesiologist, and was transfused to the patient at an appropriate rate. Dopamine was the first-line inotropic drug.

After arrival at the intensive care unit, the patients were infused with another 30 mL of 25% albumin or 10 mL/kg of hydroxyethyl starch, as appropriate. Furosemide was used to promote hemoconcentration.

Statview statistical software for Windows (version 4.5; Abacus Concepts, Inc., Berkeley, CA) was used for data analysis. Values were expressed as mean ± standard deviation. The Pearson correlation coefficient or simple linear regression was used to analyze the relationships between two continuous variables.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 DISCUSSION
 References
 
CPB was commenced with crystalloid (bloodless) prime in 122 out of 158 patients. Demographic data and outcome variables of 122 patients are listed in Table 1. Coexisting cardiac anomalies were patent foramen ovale in 74 patients, atrial septal defect in 17, patent ductus arteriosus in 13, persistent left superior vena cava in 5, and dilated cardiomyopathy/severe left ventricular dysfunction in 2. One patient had received prior pulmonary artery banding and ligation of the patent ductus arteriosus. Noncardiac anomalies included Down syndrome in 22 patients, ring chromosome 15 in 1, and cardiofacial anomaly with unknown genetic disorder in 2.


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  		Table 1. Patients' Demographic and Intraoperative Dataa

 
The main reasons to use blood prime included a low predicted hematocrit during CPB that was due either to anemia or low body weight in 20 patients, cardiac or respiratory failure (or both) in 14, and the presence of pulmonary vascular obstructive disease in 2. As a continuing effort to accurately predict hematocrit on CPB, the relationship between the rate of hemodilution, the patient's body weight, and the circuit volume were periodically assessed (Fig 2). Circulating blood volume was calculated by the formula (CPB priming volume) x (hematocrit on CPB)/(hematocrit before CPB – hematocrit on CPB). The circulating blood volume of this cohort was calculated as 55.0 ± 11.3 mL/kg, which was less than the 80 mL/kg that was initially expected.



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  		Fig 2. Circulating blood volume calculated from each patient's body weight, prebypass hematocrit, the hematocrit after initiation of cardiopulmonary bypass, and the circuit volume.

 
The outcome variables of these patients are listed in the Table 2. A significant elevation of hepatic enzymes was seen in 2 patients (aspartate aminotransferase, alanine aminotransferase >200 IU/dL), which improved rapidly by the secession of antibiotics. Urine output was maintained by the infusion of 1.93 ± 0.84 mg/kg of furosemide during the initial 24 hours after operation. Complications were seen in 14 patients (11.5%) and are listed in Table 3.


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  		Table 2. Outcome Variablesa

 

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  		Table 3. Postoperative Complications With the Number of Patients Requiring Subsequent Blood Transfusion

 
The transition of hematocrits is shown in Figure 3. Generally, erythropoiesis was swift and recombinant erythropoietin was not used. Any delay in convalescence caused by a postoperative complication was regarded as an indication for blood transfusion, which was given in 6 patients. Thus, the success rate of completely bloodless surgery among 122 patients was 95.1%. Table 3 lists the postoperative complications with the numbers of patients who required a resultant transfusion. One patient died on postoperative day 1 from an acute pulmonary hypertensive crisis that developed after extubation. The patient's postoperative course had been uneventful until that event. The postmortem specimen revealed a thick media of the pulmonary artery, representing 33% of the entire wall thickness, which should have been considered an absolute contraindication for surgery [1]. Four patients had left ventricular dysfunction that was due to the placement of a large ventricular septal patch.



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  		Fig 3. Perioperative hematocrit level. Pre = before cardiopulmonary bypass (CPB), 30.1% ± 2.9%; CPB-1 = after the initiation of CPB, 16.7% ± 2.3%; CPB-2 = minimal hematocrit during CPB, 15.2% ± 2.4%; Post = after infusion of salvaged blood, 25.0% ± 2.0%; Discharge = before discharge, 30.6% ± 3.0%.

 
No neurologic deficits, including seizure activity, delirium or delusion, or significant motor dysfunction, were found by cardiologists or parents after operation. At a follow-up of 456.7 patients x year, all patients are being followed by cardiologists either at our outpatient clinic or at referring hospitals. No mortality, reintervention, or neurologic sequelae have been reported. As a part of follow-up, the Japanese psychomotor developmental scale assessment questionnaire [2] was sent to 43 patients at the end of 2000. Inclusion criteria were an interval of more 6 months after operation, age at the time of testing between 1 and 3 years, and no known chromosomal abnormality. Thirty-four patients (79.0%) returned the questionnaire. The mean score was 102.2 ± 15.4 (73–148). In 4 patients with borderline low results (73–83), 2 had a preoperative history of prolonged mechanical ventilation, and 2 had mild mental retardation that the referring physicians had diagnosed prior to surgery. A low developmental score was not associated with decreased hematocrit during CPB (Fig 4).



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  		Fig 4. Patient scores on the Japanese psychomotor developmental scale assessment. Values are plotted against the minimal hematocrit during cardiopulmonary bypass.

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
DISCUSSION
 References
 
A large amount of blood products may be required in open heart surgery for small children to avoid hemodilution. This is caused by an underbalanced ratio of the patient's circulating blood to the large CPB circuit volume. However, complications associated with transfusion can counterbalance the main benefit. Blood transfusion used for coronary artery bypass patients was associated with increased long-term mortality [3]. The potential adverse effects of transfusion include:
  1. Increased cytokine production resulting in a transfusion reaction that may adversely affect multiple organs [4–6],
  2. Citrate-phosphate-dextrose blood causing electrolyte load and lactic acidosis [7],
  3. T-helper (Th) 2 immunity stimulated by transfusion (alloimmunization) [8],
  4. Ongoing impairments occurring in stored red cells, which render themselves to clearance from the recipient's circulation [9, 10], and
  5. Transfusion-transmitted viral infection [11, 12].

For these reasons, efforts have been made to minimize the unnecessary use of homologous blood in the pediatric population [13–15], which has also been our practice. Our principal strategy included the use of a miniature CPB circuit, with five systems currently available for appropriate patients. The minimal priming volumes of these circuits are 130 mL (SSSS) for patients that weigh less than 4.5 kg, 160 mL (SSS) for 4.5 to 6 kg, 240 mL (SS) for 6 to 10 kg, 330 mL (S) for 10 to 20 kg, and 700 mL (M) for more than 20 kg. Recently, the CPB has been conducted with a hematocrit level higher than 20% to 25% in most patients that weigh more than 10 kg. For newborns, we consider transfusion mandatory; therefore, the use of transfusion for infants has been a matter of greatest interest.

The circuit volume can be reduced by separating pump heads to shorten the length of the tube [16] and by using a small oxygenator, hemofilter, and arterial filter. With the SSSS circuit, the priming volume is 43 mL for the oxygenator (Safe-Micro system), 25 mL for the dialysis filter (APF-01D) and its circuit, 29 mL for the arteriovenous tubing, and 30 to 40 mL for the initial reservoir volume. The total resistance generated by the tubing is proportional to its length. The total length of the arteriovenous circuit, excluding that of the cannulas, is 154 cm with the SSSS circuit compared with 268 cm with the SS circuit, which is the smallest built-in pump system currently in use at our department. This enables the use of smaller caliber tubing for the SSSS circuit. The prime volume in the arteriovenous circuit in the SSSS system has been reduced 61.1% compared with the SS system.

Insults of hemodilution on organs are not known in detail, and the minimal hematocrit allowed for each patient subset is not yet understood. The oxygen carrying capacity may be maintained until the hematocrit reaches about 10% to 11% [17, 18]. Our institution has chosen a cut-off hematocrit level of 15% to secure some safety margin above this assumptive lowest threshold, which has been also applied in some centers [19].

One patient died because of a pulmonary hypertensive crisis that resulted from severe pulmonary vascular obstructive disease. Although hemodilution may improve pulmonary circulation [20], it has been our practice to use blood prime to keep the hematocrit above 30% after surgery for patients with pulmonary vascular obstructive disease so that a prophylactic vasodilator can be used without a concern for hypotension. Postoperative morbidity was low and organ function, as judged by available data, was preserved. Early extubation was possible with proper oxygenation except for a few patients with preexisting respiratory failure. Bleeding during the operation and in the chest tube output after operation was minimal. Accordingly, antifibrinolytic therapy was not necessary. In contrast with other reports [21], interstitial edema or the incidence of pleural or pericardial effusion were not increased. Copious urine output was maintained, with renal and liver function tests preserved except for those patients in whom side effects to antibiotics were suspected.

Apparently no neurologic sequelae was seen in our cohort, and psychomotor development appeared normal despite the low hematocrit observed during CPB; however, follow-up of the neurodevelopmental outcomes of patients is a shortcoming of this study. The infant psychomotor scale assessment questionnaire used in this study was designed to assess overall mental and motor developments of the individual compared with that of the normal population. It is considered reliable and valid in the age range of between 1 and 3 years, if conducted properly [2]. However, an interview-type assessment performed by a pediatric neurologist is clearly superior in terms of reliability. This was not possible in this study because of the wide distribution of the patients' residences and the referral bases.

Recent multiple reports have addressed concern for adverse effects of hemodilution during CPB on neurologic outcome. Lassnig and colleagues described diminished cerebral oxygen supply while commencing CPB that was attributable to acute hemodilution [22]. Jonas and colleagues reported that the use of a lower hematocrit during CPB ({cong}22%) resulted in lower psychomotor development than did the use of a higher hematocrit [23]. The cohort included newborns, those who required profound hypothermia or circulatory arrest (or both), and cyanotic patients. In newborns, hemodilution can be detrimental because of immature hemoglobin and other organs. With profound hypothermia, tissue oxygenation can be compromised during the cooling phase of CPB because of the leftward shift of the hemoglobin dissociation curve [24]. In the face of reduced blood viscosity with hemodilution, which is a major contributor to the vascular resistance, reduced CPB flow can cause diminished perfusion pressure and can result in compromised oxygenation. Limperopoulos and colleagues [25] showed that open heart surgery in a cyanotic infant is associated with poor neurodevelopmental outcome, and reduced hematocrit could multiply this phenomenon.

The CPB strategy presented has been applied in general for acyanotic patients with a simple heart lesion and with CPB conducted with stable high flow and mild hypothermic strategies; therefore, our cohort was completely different from the study by Jonas and colleagues [23]. However, the gap between our hematocrit strategy and the safe level suggested by their study is considerable. Moreover, the risks of alloimmunization and infection have been considerably neutralized by the contemporary blood bank systems' use of leukocyte reduction [8] and nucleic acid-based amplification tests.

Although the complete elimination of blood product usage was a goal of this study, a more liberal use of transfusion may be optimal. In terms of immunologic reaction, however, avoiding the use of a large amount of blood products from multiple donors is important. The miniature CPB circuit reduces the use of blood products and the surface contact of the circulating blood and thus is expected to reduce overall inflammatory response [26, 27].

Major limitations to this study include imperfect neurologic follow-up as well as its retrospective nature. The late detrimental effects of pediatric cardiac surgery that result in morbidities at school age have been addressed [28]. This study suggests that neurodevelopmental outcome was not adversely associated with low hematocrit within our cohort; however, it does not ascertain normal development of these patients into school age. In order to demonstrate this, a prospective randomized study is mandatory.

In summary, open heart surgery was started with bloodless prime in 77.2% of patients weighing 5 kg or less who underwent VSD repair. The success rate among these patients was 95.1%. Postoperative morbidity appeared minimal. The use of remote pump heads reduces the overall use of blood transfusion, and possibly, inflammatory reaction. The determination of the safe hematocrit strategy in this cohort warrants further evidences and information.


   DISCUSSION
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 DISCUSSION
References
 
DR SCOTT M. BRADLEY (Charleston, SC): I am interested in the NIRS data that you showed. Perhaps you could explain it a bit more fully. It looked like the baseline saturations were on the low side, around 30 or 40. Could you also give us your thoughts on why placing patients on bypass at a relatively warm temperature, 33 or 34 degrees, with a mean hematocrit of 15%, does not produce any change in their cerebral oxygenation.

DR ANDO: The reason for using a mild hypothermic strategy is because the cardiopulmonary bypass time is very short. If the temperature goes down to about 30 degrees, probably there should be a leftward shift of the oxyhemoglobin curve, and this kind of prominent hemodilution can result in trouble.

DR JOHN MAYER (Boston, MA): Perhaps I missed this, but I assume this system involves active suction on the venous line in order to obtain venous return. Is that correct?

DR ANDO: Yes.

DR MAYER: What do you think the relationship is between that and what I think I heard you say about the potential for air embolism?

DR ANDO: It has nothing to do with this. What I meant by air embolization comes from limited reservoir volume. If the venous drainage is compromised with this small reservoir volume, you can have prompt deprivation of volume and easily send an air bubble.

DR MAYER: Have you actually looked in any sort of systematic way for the presence of air embolization? I think this has been one of the questions that has been raised about so-called vacuum-assist venous drainage in the adult cardiac surgery world, and I just wondered if you have any information about using this type of vacuum-assist drainage system in your patient population.

DR ANDO: We are not using the vacuum-assist drainage, so we cannot answer your question about that. Regarding the air embolization, we have not been doing a transcranial Doppler, so we do not have so much information. However, we really have not seen the neurologic problem after this procedure. However, we may have to use a transcranial Doppler in this patient setting.

DR BRADLEY: Your data, particularly the neurologic follow-up, provides an interesting contrast to the data out of the Boston hemodilution study, as presented at least year's AATS meeting, which showed at 1-year follow-up that there was statistically significantly worse neurologic outcome with a lower versus a higher hematocrit approach. Can you hypothesize what the reasons for the apparent differences between the studies are?

DR ANDO: Probably this is due to a different patient subset and a different cardiopulmonary bypass strategy. Again, I read about the paper, and there are lots of patients who are undergoing profound hypothermic or circulatory arrest procedures, and probably some newborns are included in that study, and the cardiopulmonary bypass time was much longer than what we are doing right here. So these, I think, made the difference on the neurologic outcome.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 DISCUSSION
 References
 

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