A clinical evaluation of the Dideco Kids D100 neonatal oxygenator.

In August 2006, Duke University Perfusion Services had the opportunity to be the first institution in the United States to clinically evaluate the Dideco D100 Neonatal Oxygenator. The device was used on six pediatric patients to facilitate correction or palliation of their cardiac defects, which included two arterial switch operations, two truncus arteriosus repairs, one stage 1 Norwood and one repair of total anomalous pulmonary venous return. The average patient weight was 3.1 kg. The average cardiopulmonary bypass (CPB) time was 135 minutes and the average cross-clamp time was 61 minutes. Arterial and venous blood gasses were drawn and used to calculate oxygen transfer. The average oxygen transfer was 14.8 +/- 10.3 ml/O2/min. The Dideco D100 Oxygenator is the first oxygenation device designed specifically for neonates. The Dideco D100 is a microporous hollow-fiber device. It has a static priming volume of 31 ml and a maximum rated flow of 700 ml/min. The integral hard-shell venous reservoir has a minimum operating level of 10 ml and a reservoir capacity of 500 ml. For this evaluation, the Dideco Kids D100 Neonatal Oxygenator performed adequately on patients weighing up to 5 kg. This device provides an excellent first step towards offering very small children appropriate circuitry without having to sacrifice safety or performance.

Impact of modifying priming components and fluid administration using miniaturized circuitry in neonatal cardiopulmonary bypass.

Following a succession of changes in circuitry and priming additives between 1993 and 1998, a comprehensive re-evaluation of neonatal cardiopulmonary bypass (CPB) practice was undertaken. Samples from 10 infants (Group 1) undergoing CPB were evaluated for osmolality, oncotic pressure, total protein, hematocrit, glucose, and electrolytes (Na+, K+, iCa2+). These samples were tested at six measurement points: (1) after priming, (2) patient pre-CPB, (3) CPB-start, (4) CPB-mid, (5) CPB-end, and (6) post-modified ultrafiltration (MUF). Prime volumes were also carefully measured as well as the type and amount of volume given during CPB. After evaluating the initial data, changes in protocol regarding mannitol, calcium correction, and oncotic strength on CPB were made. Following implementation of these protocol changes, a second set (Group 2) of 10 infants was identically evaluated. Group 1 prime osmolality was 379 +/- 44 mOsm/kg, while Group 2 prime osmolality was 324 +/- 14 mOsm/kg (p = 0.003). There were no differences in osmolality between groups during bypass and osmolality was unaffected by modified ultrafiltration. Ionized calcium levels were significantly different at the end of bypass between Group 1, 0.6 +/- 0.1 mmol/l; and Group 2, 1.17 +/- 0.24 mmol/l (p < 0.001). In Group 1, there was a 40% drop (p = 0.001) in colloid osmotic pressure (COP) levels from pre-CPB (13.3 +/- 3.4 mmHg) to CPB-end (8.8 +/- 1.2 mmHg). In Group 2, there were no differences in COP during CPB. COP levels of Group 1 and Group 2 at CPB-end were 8.8 +/- 1.2 mmHg and 14 +/- 1.9, respectively (p < 0.0001). Total volume addition during bypass for Group 1 was 363.5 +/- 148.7 ml and for Group 2 was 245.1 +/- 92.2 ml (p < 0.05). In conclusion, progressive changes in neonatal circuits and techniques can have potentially wide-ranging effects on electrolyte and osmotic/oncotic homeostasis. An audit of perfusion management through expanded laboratory tests is recommended, especially in periods of change.

Staffing issues at open-heart centers offering both pediatric and adult perfusion service: 1998 survey results.

A survey directed to centers offering both pediatric and adult perfusion services was conducted to determine how pediatric cases were distributed among individual perfusionists in their departments. These centers were also asked what they believed the clinical activity level should be for a perfusionist each year to remain proficient in pediatric cardiopulmonary bypass. The questions were asked via e-mail and then followed up with telephone interviews as necessary. Out of the 100 centers contacted, 45 responded to the survey (43 North American, 2 European). Of the forty-five centers, forty-one provided both pediatric and adult perfusion services. Thirty-two centers (78%) offering adult as well as pediatric perfusion services distributed the pediatric caseload to a select group of perfusionists. Nine centers (22%) distributed the pediatric open-heart caseload to the entire staff. From the respondents, the average minimum number of pediatric cases believed necessary to remain proficient in pediatric perfusion was 42.8 cases annually. Centers having dedicated pediatric perfusionists had a slightly higher annual caseload than did those at non-specialized centers, despite practicing at institutions averaging fewer pediatric open-heart cases annually.

Techniques of paediatric modified ultrafiltration: 1996 survey results.

In September 1996, perfusionists from 50 paediatric open-heart surgery programmes were contacted to identify centres that are currently using the technique of modified ultrafiltration (MUF). Of the 50 centres contacted, 22 (44%) were utilizing the technique. These centres were surveyed on the following: neonatal circuit description, patient entry criteria, MUF circuit description, conduct of MUF, use of extracorporeal safety devices and/or modifications, and technical complications. All 22 centres used roller pumps and membrane oxygenators. In 19 centres, MUF was utilized exclusively in the arteriovenous mode (86%), while two centres (9%) used the venovenous mode and one centre (5%) used both methods. Most (82%) of the 22 MUF centres used a blood cardioplegia system for myocardial preservation. After cardiopulmonary bypass (CPB), these blood cardioplegia systems were often converted for use as MUF circuits in a variety of ways. Other methods of accessing the CPB circuit for MUF included utilizing either a recirculation line or a dedicated port added to the circuit specifically for MUF. Blood flow rates during MUF, pump strategies, haemoconcentrator vacuum levels and endpoints were variable from centre to centre. Technical complications related to MUF were reported by 82% of the surveyed MUF centres. The most common complication, air cavitating into the circuit, was reported by 15 centres. From these data, we propose recommendations on the integration of MUF into CPB circuits, the conduct of perfusion during MUF, and appropriate safety considerations to minimize technical complications.

Experimental use of an ultra-low prime neonatal cardiopulmonary bypass circuit utilizing vacuum-assisted venous drainage.

In adult cardiopulmonary bypass surgery, vacuum assisted venous drainage has become a popular technique to augment venous return to the bypass circuit. The application of this technique in neonatal cardiopulmonary bypass surgery could be beneficial to the further miniaturization of neonatal circuitry by coupling radical respositioning of the oxygenator and pump console with decreasing line length. This report communicates the use of an investigational, vacuum assisted venous drainage neonatal circuit that is positioned at patient level utilizing a modified pump console with elevated double head twin roller pumps. The circuit, including the oxygenator, arterial line, venous line, raceway tubing, and a functional level in the venous reservoir has a priming volume of 107 ml. Initial bench and animal tests have demonstrated that this technique may be clinically feasible in CPB applications. With vacuum assisted venous drainage, the goal of asanguinous neonatal cardiac surgery could become a reality. Safety issues must be adequately addressed to ensure that this technique does not impose unacceptable risks.

A clinical evaluation of the Terumo Capiox SX18R hollow fiber oxygenator.

The Terumo Capiox SX18R is a commercially available, low prime, reverse phase, hollow fiber membrane oxygenator. The oxygenator consists of a 1.8 m2 microporous polypropylene hollow fiber bundle, a 2200 cm2 tubular stainless steel heat exchanger, and an open hard shell venous reservoir with integral cardiotomy filter. The Terumo Capiox SX18R oxygenator was evaluated to determine its clinical oxygenating performance. Blood samples were drawn from 25 patients yielding 114 data points. The following parameters were recorded: blood flow, cardiac index, gas flow, gas to blood flow ratio, and oxygen fraction. Samples were assayed for hematocrit, hemoglobin, arterial and venous blood gas values, and venous oxygen saturation. The data and assay results were used to calculate arterial, venous, and membrane gas oxygen content, oxygen transfer, shunt fraction, and oxygen diffusion capacity. The Terumo Capiox SX18R oxygenator performed adequately with sufficient oxygen transfer reserve and carbon dioxide clearance under a variety of clinical conditions for the tested population.

Comparison of four stainless steel heat exchangers for neonatal ECMO applications.

Conventional neonatal extracorporeal membrane oxygenation (ECMO) circuits utilize a heat exchanger distal to the oxygenator to replace ambient heat loss and maintain patient normothermia. A secondary function of the ECMO heat exchanger is to act as an arterial line bubble trap to protect the patient against accidental air embolism. Using an asanguinous recirculating test circuit, we measured and compared heat transfer properties, pressure drop, air trapping capabilities, and priming characteristics of four commercially available stainless steel heat exchangers currently being used in neonatal ECMO circuits: Avecor ECMOtherm, Gish HE-3, Gish HE-4, and Electromedics D1079. Manufacturers' product specifications were also compared. The pressure drop across all four heat exchangers was less than 10 mmHg with flow rates up to 500 ml/min. The Gish HE-3 and HE-4 were the easiest to prime and de-air, while the Electromedics D1079 was the most difficult. The heat exchangers with integral bubble traps (D1079 and HE-4) have superior air trapping capabilities. The ECMOtherm provided moderate air trapping capabilities ( greater than 7.3 ml +/- 1.5 ml) at flow rates under 300 ml/min. The low prime HE-3 was the poorest at trapping air; less than 1 ml at a 400 ml/min pump flow rate. Thermal analysis indicated that the D1079 had the highest performance factor, though all four heat exchangers had similar heat transfer rates and were capable of warming perfusate from 34 degrees to 37 degrees C on a single pass at pump flow rates of 500 ml/min.(ABSTRACT TRUNCATED AT 250 WORDS)