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Ann Thorac Surg 2000;70:742-750
© 2000 The Society of Thoracic Surgeons
a Divisions of Cardiovascular Surgery and Cardiology, Miami Children’s Hospital, Miami, USA
b Division of Thoracic and Cardiovascular Surgery, All Children’s Hospital, University of South Florida College of Medicine, St. Petersburg, Florida, USA
Address reprint requests to Dr Jacobs, Division of Thoracic and Cardiovascular Surgery, All Children’s Hospital, 603 Seventh St S, Suite 450, St. Petersburg, FL 33701
e-mail: jjacobs1{at}compuserve.com
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Abstract |
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Patients and Methods. The cardiopulmonary support system includes a preassembled, completely heparin-coated circuit, a BP-50 Bio-Medicus centrifugal pump, a Minimax plus membrane oxygenator, a Bio-Medicus flow probe, and a Bio-trend hematocrit/oxygen saturation monitor. Short tubing length permits a 250-mL bloodless prime in less than 5 minutes. From 1995 to 1997, 23 children with congenital heart disease were supported with this technique.
Results. Overall survival to discharge was 48% (11 of 23 patients). Survival to discharge was 80% (4 of 5) in the preoperative support group, 20% (1 of 5) in the postoperative failure to wean from cardiopulmonary bypass group, 44% (4 of 9) in the group placed on support postoperatively after transfer to the intensive care unit, and 50% (2 of 4 patients) in the nonoperative group. Neonatal cardiopulmonary support survival to discharge was 46% (6 of 13 patients).
Conclusions. This pediatric cardiopulmonary support system is safe and effective. Advantages over conventional extracorporeal membrane oxygenation include rapid setup time, decreased postoperative blood loss, and simplified transport.
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Introduction |
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Extracorporeal membrane oxygenation (ECMO) remains the standard pediatric technique used for extracorporeal life support. Limitations in available therapeutic modalities, combined with the effectiveness and familiarity of ECMO in long-term pulmonary support, have compelled most pediatric centers to use conventional ECMO for cardiac support and emergency resuscitation. Although effective in providing pulmonary support, conventional ECMO may not be the best method of providing complete cardiopulmonary support for children with congenital heart disease and refractory cardiopulmonary dysfunction. In this patient population, ECMO has several limitations including prolonged setup times (45 to 60 minutes), larger priming volumes (450 to 800 mL), increased postoperative blood loss, and difficulty during transport. Extracorporeal membrane oxygenation assembly times are often prolonged by numerous factors including debubbling the silicone membrane oxygenator, using CO2 flushing, and adding blood to the prime. Systemic heparinization can lead to bleeding complications, particularly in the postoperative patient. Patient transport on ECMO is challenging due to nonmobile systems that require gravitational drainage and separate battery packs.
In an attempt to address these limitations, we developed a miniaturized cardiopulmonary support (CPS) circuit that can be assembled and primed in less than 5 minutes. Short tubing length permits a 250-mL bloodless prime even in neonates. Complete Carmeda (Carmeda, Medtronic Cardiopulmonary, Anaheim, CA) coating reduces heparin requirements in an effort to reduce postoperative blood loss. The modular system is designed to facilitate patient transport; furthermore, gravity drainage is not necessary with the centrifugal pump. We report our initial experience with this CPS system in 23 children with congenital heart disease and severe cardiopulmonary dysfunction.
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Material and methods |
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After assembly, the circuit is primed with a total volume of 250 mL of Plasma-Lyte A solution (Baxter Healthcare Corporation, Deerfield, IL) and quickly debubbled. The arterial and venous lines are in a sterile wrapper and both include tubing spikes for rapid connection to the crystalloid bag. The flow probe transducer and venous saturation monitor are attached and calibrated. The gas line and temperature probe are then attached to the oxygenator. The arterial and venous lines are clamped and transferred to the sterile field.
Before cannulation, the preoperative and nonoperative support patients are heparinized using 100 IU/kg (9 of 23 patients). The postoperative group is given 50 IU/kg (7 of 23 patients) or no heparin if actively bleeding (7 of 23 patients). Patients are cannulated by one of three techniques: a midsternotomy with direct right atrial and aortic cannulation (12 of 23 patients), a cervical cut-down with right common carotid artery and right internal jugular vein cannulation (10 of 23 patients), or a groin cut-down with femoral artery and femoral vein cannulation (1 of 23 patients). Patients with open chests and those status post recent sternotomy undergo mediastinal cannulation; otherwise, neck cannulation is used. Femoral cannulation may be considered in larger children; the femoral venous cannula can be advanced superiorly to the right atrium.
After cannulation, the arterial and venous lines are connected to the appropriate cannulas. The bypass bridge is clamped, bypass is initiated, and the flow rate slowly increased to 60 to 120 mL · kg-1 · min-1 depending on patient size and blood flow requirements. Patients with direct mediastinal cannulation also have a left-sided vent placed if left heart decompression is considered necessary. This vent is then connected to the right atrial venous line tubing with a Y connector.
Boluses of 5% albumin are administered to maintain the central venous pressure at more than 5 mm Hg to prevent venous line cavitation. Blood products are administered directly to the patient only after achieving full support. None of the patients required blood for priming the CPS circuits.
The activated clotting time is measured as soon as possible and maintained between 180 to 220 seconds with a heparin infusion titrated at a minimum of 25 IU · kg-1 · h-1. Heparin administration is withheld from postoperative patients until bleeding subsides. Seven patients were maintained on CPS without heparin administration until bleeding ceased; the longest period on CPS without heparin administration was 24 hours. Coagulation function is monitored and treated based on thromboelastograph results. In an attempt to prevent circuit thrombus formation, platelets and calcium chloride are administered directly to the patient and not through the CPS circuit. Protamine is avoided at all times. Preoxygenator pressures are continuously monitored with the pressure monitor built into the Bio-Medicus pump console.
Systemic-to-pulmonary shunts are partially occluded during support with a bulldog clamp or tourniquet to prevent excess pulmonary blood flow. The degree of shunt occlusion is decreased during the CPS weaning process.
Patients
From 1995 to 1997, 23 children with congenital heart disease were supported with this technique, representing 2.2% (23 of 1,029) of patients with congenital heart disease treated at Miami Children’s Hospital during this time period. A CPS database (a component of the CardioAccess International Clinical Outcomes Database, CardioAccess Inc, Miami, and St. Petersburg, FL) has been prospectively maintained on all patients and has been used for data collection and analysis. Patient data are summarized in Table 1. Children with congenital heart disease were supported with CPS when they demonstrated a severe refractory low cardiac output state despite maximal medical management including maximal inotropic support.
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Overall median patient age was 22 days (mean, 1,105 days; mode, 2 days; range, 2 to 5,366 days). Overall median patient weight was 3.8 kg (mean, 12.9 kg; mode, 3.5 kg; range, 2.6 to 53 kg). Overall CPS time per patient was 57.95 ± 11.31 hours (2.4 ± 0.47 days) (mean ± standard error of the mean; range, 0.77 to 213.58 hours or 0.03 to 8.9 days). Total CPS time was 1,332.76 hours or 55.53 days.
In group 1, diagnoses included double outlet right ventricle (n = 2), critical aortic stenosis (n = 1), cardiomyopathy (n = 1), and tetralogy of Fallot (n = 1). Group 1 median patient age was 29 days (mean, 1,096 days; range, 2 to 5,366 days). Group 1 median patient weight was 4 kg (mean, 12.8 kg; mode, 4 kg; range, 3.2 to 49 kg). Group 1 CPS time per patient was 10.3 ± 6.45 hours (0.43 ± 0.27 days) (mean ± standard error of the mean; range, 0.77 to 33.85 hours or 0.03 to 1.41 days). Total CPS time in group 1 was 51.52 hours or 2.15 days.
In group 2, diagnoses included hypoplastic left heart syndrome (HLHS) (n = 5), aortic stenosis (n = 3), total anomalous pulmonary venous drainage (n = 2), pulmonary atresia (n = 2), tetralogy of Fallot (n = 1), and mitral regurgitation (n = 1). Group 2 median patient age was 17.5 days (mean, 905 days; mode, 7 days; range, 2 to 4,968 days). Group 2 median patient weight was 3.75 kg (mean, 12.03 kg; mode, 3.5 kg; range, 3 to 53 kg). Group 2 CPS time per patient was 76.32 ± 16.13 hours (3.2 ± 0.67 days) (mean ± standard error of the mean; range, 17.67 to 213.58 hours or 0.74 to 8.9 days). Total CPS time in group 2 was 1,068.43 hours or 44.52 days.
In group 2a, diagnoses included HLHS (n = 3), aortic stenosis (n = 1), and mitral regurgitation (n = 1). In group 2b, diagnoses included HLHS (n = 2), aortic stenosis (n = 2), total anomalous pulmonary venous drainage (n = 2), pulmonary atresia (n = 2), and tetralogy of Fallot (n = 1).
In group 3, diagnoses included truncus arteriosus (n = 1), previously repaired mitral stenosis with pneumonia (n = 1), Wolff-Parkinson-White syndrome (n = 1), and tricuspid regurgitation (n = 1). Group 3 median patient age was 1,162.5 days (mean, 1,818 days; range, 2 to 4,945 days). Group 3 median patient weight was 4.9 kg (mean, 16.4 kg; range, 2.6 to 53 kg). Group 3 CPS time per patient was 53.2 ± 8.0 hours (2.2 ± 0.3 days) (mean ± standard error of the mean; range, 37.03 to 74.17 hours or 1.5 to 3.1 days). Total CPS time in group 3 was 212.82 hours or 8.9 days.
Thirteen neonates required CPS for perioperative support. Diagnoses included HLHS (n = 5), total anomalous pulmonary venous drainage (n = 2), tricuspid regurgitation (n = 1), aortic stenosis (n = 1), tetralogy of Fallot (n = 1), pulmonary atresia (n = 1), double outlet right ventricle (n = 1), and truncus arteriosus (n = 1). Neonatal median patient age was 9 days (mean, 10.1 days; mode, 2 days; range, 2 to 29 days). Neonatal median patient weight was 3.5 kg (mean, 3.4 kg; mode, 3.5 kg; range, 2.6 to 4.0 kg). Neonatal CPS time per patient was 52.30 ± 13.5 hours (2.2 ± 0.22 days) (mean ± standard error of the mean; range, 0.77 to 169.5 hours or 0.03 to 7.1 days). Total neonatal CPS time was 679.88 hours or 28.33 days.
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Results |
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In 13 neonates requiring CPS, survival to successful weaning from CPS and decannulation was 69% (9 of 13 patients). Excluding HLHS, neonatal CPS survival to successful weaning and decannulation was 63% (5 of 8 patients).
Survival to discharge
Overall survival to discharge was 48% (11 of 23 patients). Excluding HLHS, survival to discharge was 50% (9 of 18 patients). Survival was 40% (2 of 5 patients) in the HLHS patients. Survival to discharge was 80% (4 of 5) in the preoperative group (group 1), 20% (1 of 5) in the postoperative failure to wean group (group 2a), 44% (4 of 9) in the postoperative intensive care unit group (group 2b), and 50% (2 of 4 patients) in the nonoperative group (group 3).
In 13 neonates requiring CPS, survival to discharge was 46% (6 of 13 patients). Excluding HLHS, neonatal CPS survival to discharge was 50% (4 of 8 patients).
Late survival
Two patients died after hospital discharge resulting in an overall late survival rate of 39% (9 of 23 patients). Excluding HLHS, late survival is 39% (7 of 18 patients). Late survival is 40% (2 of 5 patients) in the HLHS patients. Both of these surviving Norwood stage I patients have since gone on to have successful stage 2 bidirectional Glenn procedures.
Late survival is 80% (4 of 5) in the preoperative group (group 1), 0% (0 of 5) in the postoperative failure to wean group (group 2a), 44% (4 of 9) in the postoperative intensive care unit group (group 2b), and 25% (1 of 4 patients) in the nonoperative group (group 3).
In 13 neonates requiring CPS, late survival is 46% (6 of 13 patients). Excluding HLHS, neonatal CPS late survival is 50% (4 of 8 patients).
Blood transfusion data
Overall total blood product (red blood cells [RBC]) requirements during support averaged 37.3 ± 6.55 mL · kg-1 · day-1 (mean ± standard error of the mean; range, 0 to 119.6 mL · kg-1 · day-1). This RBC requirement equates to 12.85 mL/m2 per hour or 4.58 adult units per patient.
In group 1, blood product (RBC) requirements during support averaged 21.0 ± 15.2 mL · kg-1 · day-1 (mean ± standard error of the mean; range, 0 to 78 mL · kg-1 · day-1). In group 2, blood product (RBC) requirements during support averaged 44.1 ± 8.8 mL · kg-1 · day-1 (mean ± standard error of the mean; range, 5.7 to 119.6 mL · kg-1 · day-1).
Cardiopulmonary resuscitation time
Four patients required cardiopulmonary resuscitation (CPR) before the initiation of CPS. Cardiopulmonary resuscitation time was 12.3 ± 3.1 minutes (mean ± standard error of the mean; range, 5 to 20 minutes). All of these 4 patients survived to discharge.
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Comment |
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The intraaortic balloon pump provides hemodynamic augmentation, increases diastolic coronary blood flow, and decreases left ventricular afterload. Advantages of the intraaortic balloon pump in adults include its relative ease of insertion and removal as well as the need for limited, if any, anticoagulation. This technique is also the least invasive form of mechanical support. Unfortunately, the intraaortic balloon pump has numerous disadvantages in the pediatric population [1]. Hemodynamic augmentation is often inadequate because of the compliant elastic aortic wall in children [2]. Vascular problems occur with insertion because of the small femoral artery size [3]. The rapid heart rate in many children interferes with timing of the intraaortic balloon [4]. Finally, the balloon has been reported to occasionally occlude the superior mesenteric artery and renal artery as well as cause severe limb ischemia [2]. Consequently, although smaller balloons are currently being developed [5], the application of intraaortic balloon pump is mainly limited to larger children and adults.
Three types of VAD may be used: (1) the left VAD (LVAD), (2) the right VAD (RVAD), and (3) the biventricular assist device (BVAD). The LVAD has been shown to be extremely useful in adults with ischemic heart disease and isolated left ventricular dysfunction. Children with left ventricular dysfunction are less likely to have preserved right ventricular function and pulmonary function. Nevertheless, in cases of isolated left ventricular dysfunction, the LVAD has been used with eventual survival of 40% to 70% [6–8]. Similarly, a RVAD can be used for isolated right ventricular dysfunction, which is uncommon in the pediatric population. Finally, a BVAD can be used in cases of biventricular dysfunction, which unfortunately is uncommon without pulmonary dysfunction in small children. Furthermore, BVAD utilization can be technically challenging in smaller children. Advantages of VADs include providing good oxygen delivery to the tissues as well as unloading the supported ventricle to allow time for ventricular healing. Also, the VAD may allow for lower levels of anticoagulation than ECMO. Disadvantages of VAD include bleeding complications, potential pulmonary dysfunction necessitating conversion to ECMO, potential renal dysfunction necessitating hemofiltration, and potential for infection. Furthermore, most VADs also require a median sternotomy for direct access to the heart before cannulation, which restricts their use during acute cardiac failure.
Several newer VADs including the implantable TCI Heartmate (Heartmate, Thermo Cardiosystems, Inc, Woburn, MA) and the paracorporeal Abiomed pump (ABIOMED, Danvers, MA) are being used successfully in adults to replace ventricular function for long periods of time. Unfortunately smaller versions of these systems are not yet available for the pediatric patient. New pediatric VAD systems are now being studied including the "Berlin Heart" VAD (Berlin Heart, German Heart Institute, Berlin, Germany) [9] and the Jarvik 2000 (Oxford Heart Centre, Oxford, UK, and Texas Heart Institute, Houston, TX) [10]. The MEDOS HIA-VAD System (Helmholtz Institute of Biomedical Technology, Aachen, Germany) is also under development in Europe. This pneumatic paracorporeal VAD has three left ventricular sizes (10, 25, and 60 mL) and 3 right ventricular sizes (9, 22.5, and 54 mL), is pulsatile, and can be operated at up to 180 cycles per minute [11]. The goal of creating a completely implantable VAD has been achieved in adults but remains elusive in children.
Extracorporeal membrane oxygenation using venoarterial bypass with a membrane oxygenator remains the standard technique for extracorporeal life support in children, providing both hemodynamic and pulmonary support [12, 13]. Extracorporeal membrane oxygenation systems generally consist of a silicone membrane oxygenator, a bladder, and a roller pump. Extracorporeal membrane oxygenation results have been excellent as treatment for neonatal respiratory failure with survival more than 80% in many groups including neonates with meconium aspiration and those with persistent fetal circulation (persistent pulmonary hypertension of the newborn) [14]. Extracorporeal membrane oxygenation has been used with increased frequency to provide postcardiotomy support for children with severe cardiopulmonary dysfunction after operation for congenital heart disease. Although the Extracorporeal Life Support Organization reports only 44% survival for cardiac ECMO patients [15], survival in some centers now exceeds 50% [16]. Advantages of ECMO include the possibility of providing total cardiopulmonary support and allowing for cardiac and pulmonary healing. Although this may be accomplished with venous drainage from the right atrium and inflow into the aorta, many centers believe it is important to decompress the left side of the heart as well with an additional drainage catheter in the left atrium. Disadvantages of ECMO include prolonged setup times (45 to 60 minutes), increased postoperative blood loss (blood product requirements, multiple reexplorations to control hemorrhage, and potential for infection), and difficulty during transport.
During acute cardiac or pulmonary failure, speed is critical and prolonged ECMO setup times are problematic because of numerous factors including debubbling the silicone membrane oxygenator using CO2 flushing and adding blood to the prime. Extracorporeal membrane oxygenation requires a large priming volume (450 to 800 mL) that results in unnecessary hemodilution and necessitates blood priming of the circuit. Blood products also require the addition of bicarbonate and calcium to reverse the effect of citrate phosphate dextrose; these additives have been implicated in reperfusion injury [17]. Some centers have resorted to maintaining preprimed ECMO circuits for allotted periods of time in an attempt to overcome the problem of prolonged ECMO setup times [18, 19]. Use of these preprimed circuits accepts the added risk of infection should the circuit become contaminated and the added expense of not using the circuit during the allotted time span.
Published reports by centers with extensive ECMO experience in cardiac support also report serious drawbacks with conventional ECMO. These centers report survival rates of 38% to 58% [16, 20, 21]. Extended CPR times are a limiting factor in the effectiveness of any rescue during acute cardiac and pulmonary failure. At the Children’s Hospital of Pittsburgh, survival was 100% in patients with CPR times less than 15 minutes, whereas survival was 55% in those who underwent CPR for more than 42 minutes [20]. In a series of 11 children with congenital heart disease who underwent cardiac operation and subsequently suffered postoperative cardiac arrest, del Nido and colleagues [22] reported that the mean duration of CPR was 65 ± 9 minutes until ECMO flow was started. They concluded that the "success of resuscitation depends largely on the speed and recognition of the arrest event and the establishment of effective respiratory and circulatory support [22]." Four patients in our series required CPR before the initiation of CPS. Cardiopulmonary resuscitation time was 12.3 ± 3.1 minutes (mean ± standard error of the mean; range, 5 to 20 minutes). All of these 4 patients survived to discharge.
Postoperative blood loss while on support is associated with increases in morbidity and mortality. In a series of 68 patients with congenital heart disease requiring ECMO, RBC requirement was 24.0 ± 2.6 mL/m2 per hour in survivors and 87.7 ± 25.0 mL/m2 per hour in nonsurvivors [16]. Our patients required 12.85 mL/m2 per hour while on CPS. Other published ECMO series document blood loss of 57 mL · kg-1 · day-1 [16] and 6.2 adult units per patient [20] (compared to our CPS RBC requirement of 37.3 ± 6.55 mL · kg-1 · day-1 or 4.58 adult units per patient). The heparin-bonded circuit allows for lower activated clotting time levels and may decrease blood requirements. In postoperative patients with excessive bleeding, heparin is withheld until the bleeding subsides; our CPS circuit has been used without heparin seven times for up to 24 hours without problems. Also, this heparin-bonded circuit may allow a decrease in inflammatory mediators, which could potentiate a decreased transfusion requirement.
Children with congenital heart disease often require transport to and from remote sites including the catheterization laboratory, intensive care unit, and operating room. Conventional ECMO systems are often not designed to facilitate patient transport as these nonmobile systems require gravitational drainage and separate battery packs. Our CPS system has been designed to facilitate patient transport. Drainage is not gravity dependent and the system is constructed to create ease of patient transport. The system has been structured to even allow patient transport on CPS by helicopter or fixed-wing aircraft and has actually been used for patient transport by helicopter.
Adult CPS systems have been used for rapid resuscitation during acute cardiac and pulmonary failure for many years [23–25]. Cardiopulmonary support systems are designed as highly mobile units that offer the high-risk cardiac patient a safety net in the interventional cardiac catheterization laboratory. In the pediatric setting, CPS has not achieved widespread acceptance, in part due to the lower number of pediatric interventional catheterizations being performed. The relatively large priming volume of these systems causes excessive hemodilution and further limits their appeal in the pediatric setting.
The volumes of both pediatric interventional catheterization and complete neonatal surgical repair are increasing. The need exists for a rapid and mobile miniature CPS system suitable for neonates. Dalton and colleagues [20] reported that neonates requiring ECMO for congenital heart disease had a 27% survival rate when compared to 42% for older children. Miniaturized versions of the adult CPS systems have previously been described, but these systems still require the addition of blood during priming [26]. We created a modified CPS system to accelerate circuit setup time, reduce the priming volume, eliminate the need for blood priming, reduce transfusion-related risk, prevent the inherent delay required to obtain blood products, decrease postoperative blood loss, and simplify patient transport. Our CPS system permits rapid assembly and bloodless prime. This circuit can be assembled and primed in less than 5 minutes; critically ill patients with closed chests can be placed on support within 15 minutes minimizing end organ injury and preserving ventricular function. Postoperative blood loss and related complications such as multiple reexplorations may be reduced with the Carmeda coating and decreased heparin requirements. The streamlined modular system simplifies patient transport. Patient mobility is also enhanced with an adjustable arm that attaches the cart to the stretcher making the transport safer.
Systemic-to-pulmonary shunt management during ECMO or CPS is controversial. We partially occluded these shunts during support with a bulldog clamp or tourniquet to prevent excess pulmonary blood flow. We then gradually decreased the degree of shunt occlusion during the CPS weaning process. Jaggers and colleagues [27] at Duke University have reported successful results leaving the shunt open during the period of ECMO support. In their series, for patients with aortopulmonary shunt, survival was significantly better (4 of 5; 80%) if the aortopulmonary shunt was left open during the period of support (with pump flows increased as necessary to adequately perfuse both the systemic and pulmonary bed) compared to those in whom the shunt was occluded (0 of 4; 0%) (p = 0.047).
The correct timing for initiation of support is critical but difficult to define. Some studies have shown hospital survival was generally better for those patients in whom support was initiated in the operating room (10 of 15; 67%) versus postoperatively in the intensive care unit (11 of 20; 55%) [27]. In our series, although successful weaning and decannulation was better for those patients in whom support was initiated in the operating room versus postoperatively in the intensive care unit, survival to discharge was better in those in whom support was initiated postoperatively in the intensive care unit compared to in the operating room.
The optimal candidate for mechanical circulatory support should be the patient with cardiac or respiratory dysfunction refractory to maximal medical management who falls into at least one of four groups:
Our CPS system may prove useful in any of the above settings. Two potential disadvantages with our CPS system exist. The first shortfall is limited oxygenator durability. Hollow fiber oxygenators are not intended for long-term use (> 6 hours) due to plasma breakthrough and loss of oxygenator efficiency [28]. Still, only 4 of our patients required oxygenator and circuit changes during the period of support and the vast majority were supported for several days without circuit failures. The second disadvantage is the increased potential for air embolism secondary to venous line cavitation. Although the centrifugal cone and membrane oxygenator will trap small amounts of air, they are not 100% effective. Because of these potential risks, close continuous circuit monitoring by a perfusionist is necessary.
This experience demonstrates that this pediatric CPS system is safe and effective. Advantages over conventional ECMO for children with congenital heart disease and refractory cardiopulmonary dysfunction include rapid setup time, decreased postoperative blood loss, and simplified transport.
Further research should lead to more biocompatible support systems as well as smaller support systems. The eventual possibility of developing implantable support systems for long-term system in children is appealing but logistically challenging.
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