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Ann Thorac Surg 2008;86:1941-1947. doi:10.1016/j.athoracsur.2008.08.004
© 2008 The Society of Thoracic Surgeons
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Original Articles: Pediatric Cardiac

Pediatric Warm Open Heart Surgery and Prolonged Cross-Clamp Time

Yves D. Durandy, MDa,*, Mohamed Younes, MDb, Bruno Mahut, MDc

a Department of Perfusion and Intensive Care, Institut Hospitalier Jacques Cartier, Massy, France
b Department of Pediatric Cardiac Surgery, Institut Hospitalier Jacques Cartier, Massy, France
c Department of Pediatric Pneumology, Institut Hospitalier Jacques Cartier, Massy, France

Accepted for publication August 4, 2008.

* Address correspondence to Dr Durandy, Perfusion and Intensive Care Unit, Institut Hospitalier Jacques Cartier, Avenue du Noyer Lambert, Massy, 91300, France (Email: iciprea{at}icip.org).


This article has been selected for the open discussion forum on the CTSNet Web Site: http://www.ctsnet.org/sections/newsandviews/discussions/index.html

 

   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: The safety of normothermic pediatric cardiac surgery remains controversial. This study evaluated the performance of normothermic cardiopulmonary bypass (CPB) associated with intermittent warm blood cardioplegia during prolonged aortic cross-clamp time (CCT).

Methods: This retrospective study included 234 consecutive patients weighing less than 10 kg operated under CPB from August 2006 to November 2007. Patients were divided into two groups: group 1 contained 38 patients with CCT exceeding 90 minutes, and group 2 had 196 patients with shorter CCT. Classic factors were used to analyze outcomes, and outcomes were compared with those from the Society of Thoracic Surgeons–European Association for Cardio-Thoracic Surgery database.

Results: Results, expressed as values for group 1 vs those for group 2, were mortality rate, 5.3% vs 2%; length of hospital stay exceeding 21 days, 5% vs 0.5%; delayed chest closure, 21% vs 2.6%; epinephrine infusion, 45% vs 11%; organ failure, 13% vs 2%; reoperation due to bleeding, 3% vs 0.5%; heart block, 3% vs 1%; time to extubation, in hours, 64 ± 94 vs 19 ± 48; plasma lactate concentrations after bypass, 2.6 vs 1.9 mmol/L; length of stay in intensive care, in hours, 100 ± 105 vs 52 ± 48.

Conclusions: Despite expected differences between the two groups, our results were within the range of values described in the literature. This led us to conclude that warm pediatric cardiac surgery with a long CCT is safe. A large, multicenter, randomized prospective study comparing normothermic and hypothermic pediatric cardiac surgery is underway.

Although some cardiac surgical pediatric institutions have progressively shifted to moderate hypothermic perfusion [1, 2], classical hypothermic perfusion and circulatory arrest are still advocated [3, 4], and normothermic pediatric cardiac surgery is still under scrutiny in the academic community [5]. However, the adverse effects of hypothermia are well described in the literature, and they counterbalance its protective effects. Compared with normothermia, hypothermia is associated with:

• a higher incidence of surgical wound infection [6],
• longer bleeding times with bleeding diathesis, platelet dysfunction, and lower thromboxane B2 levels even during mild hypothermia (32° to 35°C) [7, 8],
• greater fluid extravasation [9],
• altered oxygen and glucose uptake in the brain [10], and inadequate brain perfusion [11, 12].

We have previously demonstrated the feasibility of warm open heart surgery in pediatric patients [13], and this technique is currently used in several European institutions. The cumulative experience includes more than 8000 unpublished procedures. However, the safety of warm surgery remains a matter of concern for many cardiac surgeons, especially when a prolonged aortic cross-clamp time (CCT) is needed. Long procedures are often necessary for the surgical treatment of complex congenital abnormalities. In such cases, the risk of suboptimal surgical repair is added to the metabolic risks of prolonged extracorporeal circulation.

The goals of this study were:

• To present our experiences performing warm surgery during high-risk cardiac procedures with aortic CCT equal to or greater than 90 minutes.
• To evaluate the safety of prolonged CCT by comparing the outcome of patients experiencing long aortic CCT with patients experiencing shorter aortic CCT.
• To compare the results of warm surgery to those obtained with hypothermic surgery, using those cases recently published in the Society of Thoracic Surgeons (STS)–European Association for Cardio-Thoracic Surgery (EACTS) database. To do so, the Aristotle basic complexity score (ABCS) [14] was used, which allowed for comparison to be made between results obtained at our site and the average value obtained at other sites participating in the databases.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Approval to conduct this anonymous study without the need for individual parental consent was obtained from our Institutional Review Board. During a 16-month period between August 2006 and November 2007, 234 patients weighing less than 10 kg underwent warm operations for the treatment of a congenital cardiopathy. Patients were divided into two groups. Group 1 included 38 patients with aortic CCT of at least 90 minutes, and group 2 included 196 patients with aortic CCT of less than 90 minutes.

A miniaturized bypass circuit was composed of 3/16-inch inner diameter silicon tubing for arterial and venous lines, and connected to the Baby RX oxygenator (Terumo Cardiovascular Tystems, Ann Arbor, MI) or, more recently, to the KidsD100 oxygenator (Sorin Group, Milano, Italy). No arterial filter or hemofilter was added so that the priming volume could be uniformly decreased to 120 mL for patients weighing less than 10 kg.

Patients weighing less than 8 kg had a blood prime composed of packed red blood cells and fresh frozen plasma, whereas patients weighing more than 8 kg received an asanguinous blood prime, with 50% hydroxyl ethyl starch and 50% lactated Ringer's, solution to achieve an estimated hemoglobin level on bypass of at least 8 g/dL. Blood transfusions, whenever necessary, were for the most part performed after discontinuing CPB. The techniques for warm perfusion and intermittent warm blood cardioplegia have been previously described [13–15]. The prime solution was heated to 37°C before the institution of the CPB, and the water heater was set to 37.5°C during the entire bypass period. Full-flow CPB with an index of 2.7 l/min/m2 was used during the entire perfusion time, and the interval of warm blood cardioplegia reinjection was 20 minutes during aortic CCT.

In accordance with the Prophylactic Intravenous Use of Milrinone After Cardiac Operation in Pediatrics (PRIMACORP) study [16], a phosphodiesterase III inhibitor was used prophylactically in neonates and infants to minimize the risk of low cardiac output. Before being weaned from bypass, patients were given a loading dose of 1-mg/kg enoximone followed by a continuous dose of 10 µg/kg/min. When needed, epinephrine was infused at a concentration of 0.05 to 0.2 µg/kg/min.

Patient data from groups 1 and 2 are summarized in Tables 1 and 2, Go respectively, which illustrate procedure type, age, weight, cardiopulmonary bypass time, and aortic CCT values.


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  		Table 1 Procedures and Aristotle Basic Complexity Score in Group 1 and Group 2
 

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  		Table 2 Patients Characteristics
 
The quality and safety of warm operations were assessed from clinical data and plasma lactate levels, monitored before, during, and after the procedure. Operative mortality rate and prolonged length of hospital stay were defined according to criteria from the STS- EACTS database [14]. Operative death represented all deaths occurring during the same hospitalization as the operation or during the first 30 post-operative days. Prolonged length of hospital stay was defined as a stay greater than 21 days. Ventilation time was considered as prolonged when the time to extubation exceeded 4 days, and the main reasons for delayed extubation were recorded for each group. The use of inotropic support with epinephrine, the incidence of delayed sternal closure, the presence of postoperative organ failure or atrioventricular block, reoperation for bleeding, time to extubation, and intensive care unit length of stay were analyzed.

Respiratory failure was evaluated using fiberoptic tracheobronchial examination, bronchoalveolar lavage with sampling for cytobacteriologic examination, viral screening and computed tomography scan, whenever necessary.

Data analyses were performed using an unpaired t test for continuous, independent data or a {chi}2 test for categoric data. Differences were considered statistically significant when p < 0.05.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
Overall mortality in our series was 2.6% (Table 3) with a mean ABCS of 7.6 ± 2.2. In group 1 the mean ABCS was 9.9 ± 1.0 and the mortality rate was 5.3% (2 of 38 patients), whereas in group 2 they were 7.1 ± 2.0 and 2% (4 of 196 patients), respectively. These differences were not statistically significant.


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  		Table 3 Mortality Rates Reported in the Society of Thoracic Surgeons and European Association for Cardio-Thoracic Surgery Databases and Observed at Our Institution
 
In group 1, 2 of 38 patients died. Both deaths were patients with complete atrioventricular septal defect (AVSD). In the first patient, this was associated with multiple ventricular septal defects and compression of the main bronchus by the left atrium. In the second patient, who had Down syndrome, the complete AVSD was associated with a 15-mm-long tracheal stenosis and a complete tracheal cartilaginous ring. No attempt was made to treat the airway stenosis and this was, therefore, considered the cause of death.

In group 2, 4 of 196 patients died. Two patients had pulmonary atresia and intact septum with right ventricle hypoplasia and no known right ventricular–dependent coronary circulation. After a one and half attempt repair with bidirectional Glenn, both patients were found to have low cardiac output state, and cardiac arrest occurred within the first postoperative day. A third patient with total pulmonary anomalous venous return experienced a postoperative suprasystemic pulmonary pressure that was unresponsive to optimal therapy. Finally, a fourth patient with a complete AVSD died from a third operation within 6 months, this operation was for a mitral valve replacement for residual mitral insufficiency.

Tables 4, 5 and 6 Go Go illustrate additional results. It is noteworthy that only 1 patient in group 1 (2.6%) and 3 patients in group 2 (1.5%) had a prolonged hospital stay (>21 days).


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  		Table 4 Rates of Prolonged Hospital Length of Stay (>21 Days) Reported in the Society of Thoracic Surgeons and European Association for Cardio-Thoracic Surgery Databases and Observed at Our Institution
 

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  		Table 5 Postoperative Variables
 

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  		Table 6 Plasma Lactate Concentrations
 
Morbidity variables assessed were:
• Delayed sternal closure was used in 8 patients, and it was used prophylactically, in the absence of hemodynamic data in 5.
• Epinephrine infusion was necessary in 17 patients and was discontinued within the first postoperative day in 13.
• Heart block, treated with a dual-chamber external pacemaker, was present in 1 patient.
• Bleeding was present in 1 patient who subsequently underwent reoperation during the third postoperative hour.
• Prolonged mechanical ventilation (time to extubation exceeding four days) was necessary in 5 patients with respiratory failure.

No patients experienced any clinical neurologic complications or renal insufficiency. In this study, organ failure was limited to pulmonary diseases, including airway stenosis and parenchymal abnormalities with or without infection.

The incidence of prolonged ventilation was 18% in group 1 (7 of 38) and 4% in group 2 (8 of 196 patients). The causes of prolonged mechanical ventilation were related to the operation (persistence of a cardiac defect or diaphragmatic paralysis leading to reoperation) or to infections. These causes are listed in Tables 7 and 8. Go


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  		Table 7 Prolonged Mechanical Ventilation in Group 1 Patients
 

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  		Table 8 Prolonged Mechanical Ventilation in Group 2 Patients
 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
High morbidity and mortality rates after long aortic CCT times have been previously reported [17–19]. Long procedures are often associated with complex surgical treatments and result in increased ischemic times and inflammatory responses [1]. Therefore, despite technical improvements in pediatric cardiac surgery, time remains an important challenge for surgical repair. This study demonstrated that warm surgery with long aortic CTT is correlated with increased risk. These results raise the question, then, about whether there is any specific risk (or advantage) to performing normothermic perfusion with intermittent warm blood cardioplegia during prolonged procedures.

We have chosen to enhance the complexity of the cases examined by including only patients weighing less than 10 kg. Because there is no consensus on the definition of a long procedure or long aortic CCT, we arbitrarily chose 90 minutes as a cut off between "long" and "normal" CCT. The choice of 90 minutes was justified because a shorter cutoff time would likely have meant the inclusion of simpler cases and therefore might have masked some of the negative effects of warm surgery.

Preoperative differences in the two groups of patients studied were reflected in postoperative results. Although morbidity and mortality were higher in group 1, the 5.2% mortality rate for group 1 was nonetheless equivalent to or lower than rates reported in the literature [14, 19–21]. Furthermore, the primary complication in the 2 patients who died was critical airway stenosis, which was not related to these patients having undergone warm surgery. The overall rate of prolonged hospitalization stay of 1.3% compares favorably with the 12% incidence reported in the STS-EACTS database [14].

The higher morbidity incidence in group 1 included a longer time to extubation and a longer ICU length of stay; however, further differences between groups were limited. The median duration of mechanical ventilation decreased from 20 hours to 6 hours from group 1 to group 2. The median length of ICU stay varied from 48 hours in group 1 to 45 hours in group 2, which was a noticeable moderate decrease. The incidence of the five morbidity variables measured, including delayed sternal closure, epinephrine infusion, heart block, bleeding, and mechanical ventilation exceeding 4 days, was low and most likely unrelated to warm surgery.

No patients experienced any neurologic complications or renal insufficiency, and we believe that this likely demonstrates a beneficial effect of normothermia. Electroencephalographic monitoring and perioperative magnetic resonance imaging were not used during this study. Neurologic assessments were limited to clinical evaluation by medical staff and parents who recorded temporary or permanent neurologic deficits, and the occurrence of seizures, irritability, or abnormal behavior. Deleterious neurologic effects from deep hypothermia and circulatory arrest have been extensively studied [22–24], and the potential benefits of warm surgery on neurologic function warrant further investigation.

Perfusion adequacy during CPB was mainly assessed by plasma lactate concentration. Plasma lactate levels before and during CPB were equivalent in the two groups. The significant difference between the two groups seen postoperatively was reversible and had disappeared by the time the patients were extubated. Peaking of serum lactate levels is commonly observed during the early postoperative period. Nonetheless, the 2.6-mmol/L median value observed in group 1 was far lower than the published values known to be associated with an increased risk of adverse outcome [25–28].

We defined mechanical ventilation time as prolonged when the duration exceeded 4 days. By that time, 96% of group 2 patients were spontaneously breathing; therefore, in this study, a prolonged time to extubation was uncommon. The two main reasons for prolonged mechanical ventilation were pulmonary disease and persistent cardiac defect. Prolonged CPB time is known to be a risk factor for early pulmonary dysfunction and to be associated with a higher incidence of nosocomial infection [29–30]. In group 1, infections developed in 4 patients with prolonged mechanical ventilation compared with only 1 patient in group 2. The higher infection rate seen with prolonged procedures was probably related to immunomodulation generated by the activation of a systemic inflammatory response. When compared with hypothermia, normothermia showed no obvious inflammatory or systemic adverse effects [1, 2, 31]. The higher incidence of pneumonia in group 1 patients was, therefore, most likely a manifestation of the global increase in risk associated with prolonged procedures rather than a specific side effect of warm surgery.

There has been some concern about lung protection during warm CPB, where the only blood supply to the lungs is the bronchial circulation. We have, in the past, seen acute respiratory distress syndrome and severe postoperative pulmonary bleeding develop in 2 patients after two procedures involving mobilization of the aorta (one arterial switch operation and one interruption of the aortic arch repair) and potential bronchial artery bent. Fiberoptic examinations did not reveal the origin of the bleeding, but they did rule out the presence of a proximal tracheobronchial lesion. Cardiogenic pulmonary edema or perioperative pulmonary wounds could not be excluded. These 2 patients represent the only two cases of hemoptysis in our experience. Therefore, although concern about pulmonary injury is reasonable, we did not observe such complications during this study.

The present study had some limitations, including the relatively small number of patients in group 1 and the absence of transplant procedures or hypoplastic left heart operations due to an extensive policy of antenatal detection and a strategy of compassionate care at our institution. However, this retrospective study demonstrated satisfactory results in both group 1 and 2, without a clear trend toward poorer outcomes in the group with long CCT. Concerns are increasing about the effectiveness of protection provided by hypothermia [9, 32, 33]. The results from this preliminary study are encouraging and warrant continuation of warm pediatric cardiac surgery. In addition, these results strongly suggest that a multicenter, randomized prospective study comparing normothermic and hypothermic pediatric cardiac surgery should be performed.

In conclusion, long aortic CCT during warm surgery remain a major risk factor.

The overall differences between the two groups of patients studied here were limited and within the expected values published in the literature for hypothermic surgery. These preliminary data provide a basis for the implementation of a larger, prospective randomized study, which is, in fact, currently underway.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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Invited Commentary
François Lacour-Gayet
Ann. Thorac. Surg. 2008 86: 1947. [Extract] [Full Text] [PDF]



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Ann. Thorac. Surg., December 1, 2008; 86(6): 1947 - 1947.
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