膜式氧合器在胎羊体外循环中的运用

目的　为了改进胎羊体外循环技术 ,探讨膜式氧合器在胎羊体外循环中的应用。　方法　将健康怀孕山羊8只 ,采用 Dideco 90 1膜式氧合器和滚轴泵建立胎羊体外循环 ,常温 (37℃ )转流 6 0分钟 ,氧合器内充低氧混合气体 (8%O2 和 92 % N2 ) ,监测胎羊的血压、心率、血气、血清乳酸和胎盘血管阻力。　结果　胎羊体外循环中动脉氧分压 (PO2 )和二氧化碳分压 (PCO2 )维持在宫内生理水平 ,胎羊心搏有力 ,血压正常。但胎羊 p H值缓慢下降 (P<0 .0 5 ) ,血清乳酸值明显增高 (P<0 .0 1) ,胎盘血管阻力显著上升 (P<0 .0 1)。停体外循环后胎羊出现低氧、高碳酸血症和酸中毒。　结论　胎羊体外循环影响胎盘功能 ,膜式氧合器可以代替胎盘气体交换功能 ,体外循环中胎羊生理低水平 PO2 是否适合其需要值得探讨。     

The new advanced membrane gas exchanger

Current membrane oxygenators are constructed for patients with a body surface under 2.2 m(2). If the body surface exceeds 2.5 m(2), commercially available devices may not allow adequate oxygenation during cardiopulmonary bypass. To address this, a hollow-fiber oxygenator with an enlarged contact surface of 1.81 m(2) was tested. In an experimental set-up, six calves of mean weight 85.4 ± 3 kg were connected to cardiopulmonary bypass. They were randomly assigned to a standard oxygenator (n = 3; ADMIRAL, Euroset, Medola, Italy) with a surface of 1.35 m(2) or to an enlarged surface oxygenator (n = 3; AMG, Euroset). Blood samples were taken before bypass, after 10 min on bypass, and after 1, 2, 5 and 6 h of perfusion. Analysis of variance was used for repeated measurements. The mean flow rate was 6.5 l/min for 6 h. The total oxygen transfer at 6 h was significantly higher in the high-surface group (P < 0.05). Blood trauma, evaluated by plasma hemoglobin and lactate dehydrogenase levels, did not detect any significant hemolysis. Thrombocytes and white blood cell count profiles showed no significant differences between the two groups at 6 h of perfusion (P = 0.06 and 0.80, respectively). At the end of testing, no clot deposition was found in the oxygenator, and there was no evidence of peripheral emboli. The results suggest that the new oxygenator allows very good gas transfer and may be used for patients with a large body surface area.     

Oxygenation strategy and neurologic damage after deep hypothermic circulatory arrest. I. Gaseous microemboli.

OBJECTIVES: Recent studies suggest that myocardial reperfusion injury is exacerbated by free radicals when pure oxygen is used during cardiopulmonary bypass. Partial replacement of the oxygenator gas mixture with nitrogen, however, such as has already been adopted clinically in many centers, could increase the risk of gaseous nitrogen microembolus formation and therefore of brain damage because of the low solubility of nitrogen, particularly under conditions of hypothermia. METHODS: Ten 7- to 10-kg piglets were cooled for 30 minutes to 15 degrees C on cardiopulmonary bypass and then rewarmed for 40 minutes to 37 degrees C. In 5 piglets cardiopulmonary bypass was normoxic and in 5 it was hyperoxic. In each group 3 bubble oxygenators without arterial filters and 2 membrane oxygenators with filters were used. Cerebral microemboli were monitored continuously by carotid Doppler ultrasonography (8 MHz) and intermittently by fluorescence retinography. RESULTS: Embolus count was greater with lower rectal temperature (P <.001), use of a bubble oxygenator (P <.001), and lower oxygen concentration (P =.021) but was not affected by the temperature gradient between blood and body during cooling or rewarming. CONCLUSIONS: Gaseous microemboli are increased with normoxic perfusion, but this is only important if a bubble oxygenator without a filter is used.     

Impact of hollow-fiber membrane surface area on oxygenator performance: Dideco D903 Avant versus a prototype with larger surface area

This study compares the gas transfer capacity, the blood trauma, and the blood path resistance of the hollow-fiber membrane oxygenator Dideco D 903 with a surface area of 1.7 m2 (oxygenator 1.7) versus a prototype built on the same principles but with a surface area of 2 m2 (oxygenator 2). Six calves (mean body weight: 68.2 +/- 3.2 kg) were connected to cardiopulmonary bypass (CPB) by jugular venous and carotid arterial cannulation, with a mean flow rate of 4 l/min for 6 h. They were randomly assigned to oxygenator 1.7 (N = 3) or 2 (N = 3). After 7 days, the animals were sacrificed. A standard battery of blood samples was taken before the bypass, throughout the bypass, and 24 h, 48 h, and 7 days after the bypass. The oxygenator 2 group showed significantly better total oxygen and carbon dioxide transfer values throughout the perfusion (p < .001 for both comparison). Hemolytic parameters (lactate dehydrogenase and free plasma hemoglobin) exhibited a slight but significant increase after 5 h of bypass in the oxygenator 1.7 group. The pressure drop through the oxygenator was low in both groups (range, 43-74 mmHg). With this type of hollow-fiber membrane oxygenator, an increased surface of gas exchange from 1.7 m2 to 2 m2 improves gas transfer, with a limited impact on blood trauma and no increase of blood path resistance.     

Brain blood flow and metabolism do not decrease at stable brain temperature during cardiopulmonary bypass in rabbits.

Cerebral blood flow (CBF) during human hypothermic cardiopulmonary bypass has been reported to decrease with time, suggesting that progressive cerebral vasoconstriction or embolic obstruction may occur. We tested the hypotheses: 1) that observed CBF reductions were due to continued undetected brain cooling and 2) that CBF during cardiopulmonary bypass would be stable after achievement of constant brain temperature. Anesthetized New Zealand White rabbits underwent cardiopulmonary bypass (membrane oxygenator, centrifugal pump, bifemoral arterial perfusion) and were assigned to one of three bypass management groups based on perfusate temperature and PaCO2 management: group 1 (37 degrees C, n = 8); group 2 (27 degrees C, pH-stat, n = 9); and group 3 (27 degrees C, alpha-stat, n = 8). Systemic hemodynamics, and cerebral cortical, esophageal, and arterial perfusate temperatures were recorded every 10 min for the first hour of bypass and again at 90 min. CBF and masseter blood flow (radiolabeled microspheres) were determined at 30, 60, and 90 min of bypass, while the cerebral metabolic rate for oxygen (CMRO2) was determined at 60 and 90 min. Groups were comparable with respect to mean arterial pressure, central venous pressure, hematocrit, and arterial oxygen content throughout bypass. Cortical temperature was stable in normothermic (group 1) animals, and there was no significant change in CBF between 30 and 90 min of bypass: 68 +/- 18 versus 73 +/- 20 ml.100 g-1.min-1 (mean +/- SD). In the hypothermic groups (2 and 3), cortical temperature equilibration (95% of the total change) required 41 +/- 6 min.(ABSTRACT TRUNCATED AT 250 WORDS)     

Oxygenator exhaust capnography as an index of arterial carbon dioxide tension during cardiopulmonary bypass using a membrane oxygenator

We have studied the relationship between the partial pressure of carbon dioxide in oxygenator exhaust gas (PECO2) and arterial carbon dioxide tension (PaCO2) during hypothermic cardiopulmonary bypass with non- pulsatile flow and a membrane oxygenator. A total of 172 paired measurements were made in 32 patients, 5 min after starting cardiopulmonary bypass and then at 15-min intervals. Additional measurements were made at 34 degrees C during rewarming. The degree of agreement between paired measurements (PaCO2 and PECO2) at each time was calculated. Mean difference (d) was 0.9 kPa (SD 0.99 kPa). Results were analysed further during stable hypothermia (n = 30, d = 1.88, SD = 0.69), rewarming at 34 degrees C (n = 22, d = 0, SD = 0.84), rewarming at normothermia (n = 48, d = 0.15, SD = 0.69) and with (n = 78, d = 0.62, SD = 0.99) or without (n = 91, d = 1.07, SD = 0.9) carbon dioxide being added to the oxygenator gas. The difference between the two measurements varied in relation to nasopharyngeal temperature if PaCO2 was not corrected for temperature (r2 = 0.343, P = < 0.001). However, if PaCO2 was corrected for temperature, the difference between PaCO2 and PECO2 was not related to temperature, and there was no relationship with either pump blood flow or oxygenator gas flow. We found that measurement of carbon dioxide partial pressure in exhaust gases from a membrane oxygenator during cardiopulmonary bypass was not a useful method for estimating PaCO2.      

Gas-exchange function of a preprimed pediatric oxygenator stored for one year for emergency cardiopulmonary bypass

To save priming time and perform more rapid initiation of emergency cardiopulmonary bypass for acute cardiopulmonary failure, an extracorporeal circuit with a hollow-fiber oxygenator (EL-2000 for pediatric use; Kurary Co. Ltd., Osaka, Japan) was preprimed, and the gas-exchange function was evaluated after 1 year of storage. EL-2000 has a dense polyolefin membrane with a surface area of 0.3 m2. When the bypass flow rates were 250, 500, 1,000, and 1,500 ml/min with 100% oxygen at the same flow rate as the bypass blood flow (namely, V/Q = 1) to the oxygenator, oxygen transport rates of the stored oxygenator were 19.6 +/- 0.3, 38.3 +/- 0.41, 64.4 +/- 0.9, and 76.4 +/- 2.7 ml/min (n = 5, mean +/- SD), respectively. PCO2 differences between pre- and postoxygenator blood (delta PCO2) were 18.6 +/- 1.4, 12.0 +/- 1.6, and 4.4 +/- 1.2 mm Hg at V/Q = 1 and the same bypass blood flow rates, respectively, excluding 1,500 ml/min, the data for which were excluded because of preparatory failure. PCO2 removal indices (defined as the ratio of delta PCO2 to PCO2 in preoxygenator blood) were 0.45 +/- 0.03, 0.29 +/- 0.12, and 0.10 +/- 0.03, respectively. Though the evaluation was done using only a single oxygenator, we feel strongly that the gas-exchange function of the preprimed dense-membrane hollow fiber oxygenator will be preserved even after 1 year of storage.     

Should the gas outlet port on membrane oxygenators be routinely scavenged during cardiopulmonary bypass?

Elimination of a volatile anesthetic agent administered prior to the start of bypass through the oxygenator has not been previously described. The purpose of this study was to determine the contamination risk from enflurane used before but not during cardiopulmonary bypass. Enflurane concentration was measured from the gas outlet port of a membrane oxygenator using infrared gas analysis in 11 cardiac surgical patients. The mean peak concentration at the gas outlet port in patients who had a final end-tidal concentration of < or = 0.3% was 0.08 +/- 0.04%, compared to 0.18 +/- 0.05% in patients with a final end-tidal concentration of more than 0.3%, P < 0.001. The elapsed time to reach peak concentration was 8.3 +/- 8.4 minutes, whereas the elapsed time from the peak concentration to 50% of the peak level was 63.1 +/- 25.1 minutes. At the time of peak enflurane release, a concentration of less than 2 ppm was measured at distances of 10 cm or less from the oxygenator gas outlet port in patients with an end-tidal enflurane of < or = 0.3%. In one patient with a final end-tidal enflurane of 1.1%, a contaminant level of 2 ppm could be measured at 95 cm from the oxygenator gas outlet port. This demonstrates that there is a potential risk of contamination from volatile anesthetics used immediately prior to extracorporeal circulation. Minimizing this risk may necessitate routine scavenging of the oxygenator, or simply avoiding increased concentrations of inhalation anesthesia before initiating cardiopulmonary bypass.     

A simple method to reduce the inspiratory oxygen fraction for high pulmonary blood flow patients in an operating room

BACKGROUND: Low inspired oxygen acutely increases pulmonary vascular resistance and decreases pulmonary-systemic blood flow ratio. We present a simple method to lower inspired oxygen fraction (FIO2<0.21) without supplemental nitrogen, during mechanical ventilation by an anesthesia machine. METHODS: After institutional approval, seven healthy adult volunteers and three infants (0-12 month old) scheduled for congenital heart surgery were enrolled in this study. All the infants were diagnosed with congestive heart failure because of high pulmonary blood flow and were thought to benefit from low FIO2. The volunteers performed spontaneous ventilation (fresh air flow rate=10 l.min(-1), tidal volume=600 ml, frequency=10 br.min(-1)). The infants were mechanically ventilated with air (fresh air flow rate=6 l.min(-1), tidal volume=10 ml.kg(-1), 1515%, fresh gas flow rates were increased to adjust FIO2 to 0.21. RESULTS: In all of the seven volunteers and three infants target FIO2 was achieved in <10 min. FIO2 was kept at 0.18+/-0.01 (SD) by calculated fresh air flow rates. In one infant, SpO2 decreased >15% 20 min after lowering FIO2, we had to discontinue this study, and increase fresh gas flow to ventilate the infant with FIO2 0.21. In the other two infants, FIO2 was maintained throughout the study. CONCLUSIONS: This simple and convenient method to decrease FIO2, has a utility in clinical situations, in which pulmonary vascular resistance is to be increased to improve systemic oxygen delivery in patients with high pulmonary blood flow during cardiac surgery.     

Clinical evaluation of the Sorin Synthesis oxygenator with integrated arterial filter

The use of arterial line filters has long been a standard of practice in the field of cardiopulmonary bypass. Sorin Biomedica has designed an adult hollow-fiber oxygenator that not only incorporates their Mimesys biomimicry coating technology but also has a 40-micron arterial filter as an integrated component of this unique membrane oxygenator. We did a prospective, randomized clinical trial of 54 Synthesis coated oxygenators and compared them with 54 uncoated Monolyth Pro oxygenators, the latter of which incorporated an external arterial line filter with a standard bypass loop There were few statistically significant differences found between the Synthesis group and the Monolyth group with regard to pressure differentials, hemodynamic resistance, and platelet drop. The Synthesis oxygenator did require less priming volume, but the amount was not significant. Platelet counts with the Phosphorylcholine coated Synthesis oxygenators, using crystalloid perfusates, was similar to our previously published data on platelet protection and Albumin perfusates. We conclude that the Sorin Synthesis oxygenator appears to have better flow characteristics than the Monolyth oxygenator, with the potential for lower priming volumes. The most clinically significant benefit comes from the elimination of the arterial filter bypass loop and the avoidance of inverting the arterial filter during priming.     

Clinical effects of membrane lung support for acute respiratory failure.

Extrapulmonary support in respiratory failure has become possible for prolonged periods with clinical application of the membrane lung oxygenator. The membrane lung may be perfused in a venovenous circuit, in which case it functions by prepulmonary venous oxygenation, or it may be pumped in venoarterial perfusion as partial or total cardiopulmonary bypass. Four patients were placed on venovenous membrane lung (GE-Peirce) perfusion for periods ranging from 6 to 112 hours. In oxygenating blood flows of less than 50% of the cardiac output, a viable PaO2 (mean, 52 mm Hg) was obtained in 2 patients with 60% FIO2, including 1 survivor who was weaned from the membrane lung. The remaining 2 patients had heart failure and insufficient venovenous membrane lung flows to improve systemic oxygenation (mean PaO2, 45 mm Hg on 100% FIO2). Four other patients were placed on venoarterial membrane lung (GE-DuaLung) bypass for 18 to 110 hours. With 40 to 85% of the cardiac output bypassed through the membrane oxygenator, immediate improvement was seen in systemic oxygenation (mean PaO2, 75 mm Hg), effective compliance (mean increase of 75%), and reduction in pulmonary hypertension (mean decrease, 15 mm Hg). These changes during bypass allowed the lungs to be put at rest with a decrease in FIO2 and positive end-expiratory pressures. This clinical experience indicates that venoarterial membrane lung bypass may be both supportive and therapeutic, decompressing the pulmonary circuit and maintaining systemic oxygenation. Membrane lung supported by either mode of perfusion has been shown to be clinically effective in patients suffering acute respiratory failure.     

Continuous measurement of oxygen consumption during cardiopulmonary bypass: description of the method and in vivo observations

BACKGROUND: Systemic oxygen consumption is not routinely measured during cardiopulmonary bypass, despite its potential benefits. We aimed to develop a noninvasive method to continuously measure oxygen consumption using respiratory mass spectrometry during hypothermic cardiopulmonary bypass in pigs. METHODS: Nine pigs weighing 18.5 (1.6) kg underwent hypothermic (32 degrees C) cardiopulmonary bypass for 180 minutes with 120 minutes of aortic cross clamping. An AMIS 2000 mass spectrometer (Innovision A/S, Odense, Denmark) was adapted for the on-line measurement of oxygen consumption by sampling the inlet and outlet gases of the membrane oxygenator together with measurement of the "expired" gas volume. RESULTS: Active cooling for 60 minutes reduced the venous blood temperature by 2.9 (0.8) degrees C and VO(2) by 0.70 (0.33) mL/kg/min. The 40-minute active rewarming restored the venous blood temperature by 4.4 (0.4) degrees C and oxygen consumption increased by 1.36 (0.33) mL/kg/min. There was wide interanimal variability, however, particularly at higher venous blood temperatures. Immediately after the release of aortic cross clamp, there was a noticeably acute increase in oxygen consumption in all the pigs (0.64 [0.21] mL/kg/min). CONCLUSIONS: A simple and safe adaptation of mass spectrometry allows continuous measurement of oxygen consumption during hypothermic cardiopulmonary bypass. The wide interindividual variations observed in this pilot study underscore the need to more accurately describe changes in oxygen consumption and how they are affected by temperature, oxygen delivery, and other interventions during cardiopulmonary bypass. As such, the technique may have an important role in clinical research and management of oxygen transport in patients undergoing cardiac surgery.     

Similarity of Clinical and Laboratory Results Obtained with Microporous Teflon Membrane Oxygenator and Bubble-Film Hybrid Oxygenator

For 80 elective clinical cardiopulmonary bypasses we alternately used either a commercial microporous Teflon membrane oxygenator or a commercial hybrid bubble-film oxygenator. Setup time was a little longer with the membrane unit (20 minutes), but priming volume (2,250 ml) was the same. No problems were encountered with the hybrid oxygenator. However, despite our monitoring of additional variables, including shim and inlet pressure and recirculation flow, gas exchange abnormalities were encountered in 5 patients on whom the membrane oxygenator was used; in 4 of these cases the abnormalities were encountered prior to our recognition of the potential for occasional internal shunting with this device.There were no hospital deaths. When the two groups, matched except for oxygenator selection, were compared, there were no significant differences clinically or hematologically. For cardiopulmonary bypass of 2 hours or less, both oxygenators studied are definite improvements over previous silicone membrane and high-gas-flow bubble oxygenators. However, lower cost and reduced complexity favor the hybrid oxygenator.     

Extracorporeal circulation in the fetal lamb. Effects of hypothermia and perfusion rate

The poor prognosis of certain cardiac abnormalities detected prenatally by echocardiography has led some investigators to consider intrauterine cardiac surgery. Investigation into the efficacy of open cardiac procedures in-utero will require techniques for safe and effective fetal extracorporeal circulation and myocardial protection. We performed cardiopulmonary bypass in 8 fetal lambs to assess the feasibility of fetal cardiopulmonary bypass. Four fetuses underwent studies at 37 degrees C (Group I) and 4 at 25 degrees C (Group II). The aorta was clamped and cold crystalloid cardioplegia administered. Perfusion was carried out for 10 minutes each at high (95 +/- 18 cc/kg/min), moderate (67 +/- 10 cc/kg/min), and low (49 +/- 8 cc/kg/min) flow rates while hemodynamic and blood gas measurements were made. Total time on bypass averaged 57 min in Group I and 75 min in Group II. Four fetuses were successfully weaned from bypass following the study period. Fetal pO2 and oxygen saturation was very low at all flow rates in Group II and at low flow rates in Group I, indicating poor function of the placenta as an oxygenator at 25 degrees C and at low flow rates during normothermia. Lambs undergoing bypass at 37 degrees C had a progressive rise in pCO2 levels as flow decreased, while pCO2 was relatively normal at all flow rates at 25 degrees C. These studies serve as a starting point for the development of techniques to allow intrauterine correction of experimentally produced fetal cardiac lesions.     

Laboratory evaluation of a new membrane oxygenator with a built-in hemoconcentrator

In order to facilitate the handling of cardiopulmonary bypass (CPB) and simplify the circuit, we have developed a new membrane oxygenator with a hemofiltration function. The hollow fiber units for gas exchange and hemofiltration were combined in concentric circles in a cylindrical housing. The total priming volume was 190 ml. Because we used a silicon-coated hollow fiber membrane for gas exchange, this oxygenator was completely resistant to serum leakage. The gas exchange and hemofiltration sections both have a blood-outside flow configuration. All blood flows in a radial direction from around the central core to the surrounding hollow fiber units, first to the hemofiltration portion and then to the gas exchange section. Filtered fluid was easily collected through a stopcock mechanism. The oxygen transfer rate was 312 ml/min at a blood flow rate of 6 L/min, and the ultrafiltration rate was 3.5 L/hour at a blood flow rate of 4 L/min with 25% hematocrit and 200 mmHg transmembrane pressure in an in vitro study. The pressure drop was 62 mmHg at a blood flow rate of 4 L/min. We found no adverse effects in an in vivo study using a mongrel dog. In conclusion, this durable combined device could achieve excellent and simplified hemoconcentration by having all the blood in the unit flow through the hemofiltration portion, and may be useful not only in CPB during open heart surgery, but also in extracorporeal membrane oxygenation.     

Oxygenation strategy and neurologic damage after deep hypothermic circulatory arrest. II. hypoxic versus free radical injury.

OBJECTIVES: Laboratory studies suggest that myocardial reperfusion injury is exacerbated by free radicals when pure oxygen is used during cardiopulmonary bypass. In phase I of this study we demonstrated that normoxic perfusion during cardiopulmonary bypass does not increase the risk of microembolic brain injury so long as a membrane oxygenator with an arterial filter is used. In phase II of this study we studied the hypothesis that normoxic perfusion increases the risk of hypoxic brain injury after deep hypothermia with circulatory arrest. METHODS: With membrane oxygenators with arterial filters, 10 piglets (8-10 kg) underwent 120 minutes of deep hypothermia and circulatory arrest at 15 degrees C, were rewarmed to 37 degrees C, and were weaned from bypass. In 5 piglets normoxia (PaO2 64-181 mm Hg) was used during cardiopulmonary bypass and in 5 hyperoxia (PaO2 400-900 mm Hg) was used. After 6 hours of reperfusion the brain was fixed for histologic evaluation. Near-infrared spectroscopy was used to monitor cerebral oxyhemoglobin and oxidized cytochrome a,a3 concentrations. RESULTS: Histologic examination revealed a significant increase in brain damage in the normoxia group (score 12.4 versus 8.6, P =.01), especially in the neocortex and hippocampal regions. Cytochrome a,a 3 and oxyhemoglobin concentrations tended to be lower during deep hypothermia and circulatory arrest in the normoxia group (P =.16). CONCLUSIONS: In the setting of prolonged deep hypothermia and circulatory arrest with membrane oxygenators, normoxic cardiopulmonary bypass significantly increases histologically graded brain damage with respect to hyperoxic cardiopulmonary bypass. Near-infrared spectroscopy suggests that the mechanism is hypoxic injury, which presumably overwhelms any injury caused by increased oxygen free radicals.     

Changes in red cell deformability associated with anaesthesia and cardiopulmonary bypass in open-heart surgery

Red cell deformability was observed during open-heart surgery in 59 patients. Deformability, assessed with a standard microfiltration method, was expressed as red cell filtration rate (RFR) in microliter/s. The mean preoperative value, 38.9 +/- 1.0 microliter/s, showed a generally falling tendency. The first significant decrease in mean RFR (by 18%) followed induction of general anaesthesia, and the second (by 15%) was seen 60 min after the start of cardiopulmonary bypass (CPB). The major decrease in RFR during CPB was found at the end of bypass, when it was reduced to 62% of the pre-CPB value. The percentage RFR reduction at the end of CPB showed significant correlation with 1) CPB duration (r = 0.49), 2) oxygen flow rate index (OFRI), i.e. flow/min in the bubble oxygenator/m2 bsa (r = 0.38), and 3) blood flow rate index (BFRI), i.e. average volume of blood pumped through the heart-lung machine/min CPB time/m2 bsa (r = 0.51).     

A fax-back oxygenator-perfusionist clinical performance data collection and statistical analysis method.

A method to collect clinical oxygenator performance data daily is described. At the end of a bypass procedure, the perfusionist fills in a fax-back form designed to automatically input patient-oxygenator performance data into a computer spreadsheet. Multiple blood gases, FiO2, gas and blood flow data, venous oxygenator blood inlet conditions (hemoglobin, O2 saturation, hematocrit and temperature), time on bypass and device manufacturer information are collected at the end of each cardiopulmonary bypass procedure at multiple institutions. A large sample database is created that allows multi-parametric analyses in regard to clinical practice, device performance, manufacturing consistency and patient requirements. The database and analyses facilitate institutional, manufacturer, and clinician benchmarking. Monthly reports to the clinicians give valuable feedback to improve oxygenator use and patient blood gas control. Reports to the device manufacturer provide information used to evaluate the clinical consequences of small changes in the manufacturing process.     

Influence of oxygenator type on the prevalence and extent of microembolic retinal ischemia during cardiopulmonary bypass. Assessment by digital image analysis

We have previously reported the occurrence of microembolic ischemia in the retina during cardiopulmonary bypass, as revealed by fluorescein angiography. This method has been extended by digital image analysis to include quantification of the extent of retinal ischemia and has been applied to a prospective comparative study of 64 patients undergoing elective coronary operations with either a bubble or a membrane oxygenator. Patients with diabetes or clinically evident cerebrovascular disease were excluded. Bypass procedures were standardized in all cases with pulsatile flow and a 40 microns arterial line filter (Pall EC Plus). Thirty patients had bypass with a bubble oxygenator (Harvey H1700) and 34 patients had bypass with a flat sheet membrane oxygenator (COBE CML). In each case retinal fluorescein angiograms were obtained preoperatively and 5 minutes before the end of bypass and were processed with a digital image analyzer (Context Vision GOP-302). Microembolic perfusion defects were identified by digital subtraction of preoperative and end-bypass angiograms and their total area was computed. Results. In the bubble oxygenator group retinal perfusion defects indicative of microembolism occurred in all 30 (100%) patients. In contrast, over half the patients in the membrane oxygenator group had normal retinal perfusion, and the prevalence of perfusion defects (44%; 70% confidence limits 34% to 54%) was significantly less than in the bubble group (p less than 0.001). In addition, those patients in the membrane group had significantly fewer lesions (median 0; 70% confidence limits 0 to 1) than patients in the bubble group (median 2; 70% confidence limits 2 to 2; p less than 0.001) and also had significantly smaller total areas of retinal ischemia (median 0 mm2; 70% confidence limits 0 to 0.16 mm2) than the bubble group (median 0.22 mm2; 70% confidence limits 0.21 to 0.27 mm2; p less than 0.001). There was no relationship between the extent of retinal ischemia and bypass time, arterial blood gas concentrations, volume of cardiotomy suction or donor blood returned to the pump, or recent medication with aspirin. Inferences. Digital image analysis of retinal fluorescein angiograms may provide a method of quantifying microembolic ischemia in the central nervous system during cardiopulmonary bypass. Flat sheet membrane oxygenation appears to provide significantly better protection against microembolic ischemia than bubble oxygenation.