Till nowadays unipolar DDD pacemakers have been mainly used because of technological problems. But recently bipolar DDD pacemakers have been made and their usage is recommended because of the avoidance of far field noise detection. In this study the comparisons between unipolar and bipolar DDD pacemakers were done. There were no differences in the pacing and sensing thresholds. But from the aspects of myopotential interference and diaphragmatic twitch, bipolar system was superior to unipolar system. In case of myocardial leads unipolar system is simpler, because bipolar system needs 4 fixations of electrodes compared with 2 fixations in unipolar system. And the unipolar DDD pacemakers which generators locate in the abdominal wall can avoid myopotential interference. The DDD pacemaker which polarity could be externally programmed was very useful because the proper polarity could be selected in each case.

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Hetnodynamic superiority in DDD mode pacing was demonstrated both at rest and during exercise, campared with VVI mode. A higher A-V O₂ difference and serum lactate concentration indicating the presence of anaerobic state was observed during exercise in VVI mode. VVI mode showed a higher oxygen extraction ratio and insufficient increase in coronary flow during exercise. Left ventricular work for a given oxygen consumption was greater in DDD mode. The differences in herrodynamics and myocardial metabolism mode were related to the physiologic response of pacing rate and atrioventricular synchronicity during exercise in DDD mode.

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Long term survival was analized in 211 cases who underwent pacemaker implantation in our clinic by May, 1985. The actual survival rate of whole patients was 85% in 5 years follow up and 79% in 10 years follow up. The mortality rate in the follow up period was 16.1% (34 cases). The number of death due to cerebral vascular disease was 9 (26.5%).
The mortality rate with physiological pacing was 7.6% and with ventricular pacing was 22.5%. The mortality rate in old age group (older than 70 years of age) was not high compared with that in younger age group (younger than 70 years of age). There fore, pacemaker implantation should be recommended even in old age group.

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The activated carbon tip electrodes have been implanted in a group of 23 patients up to 5 years. 1) The initial stimulation threshold of the carbon tip electrode was reasonably low. Moreover, the chronic stimulation threshold of the unipolar carbon tip electrode has been maintained in significantly lower value than that of metal tip electrodes. 2) The carbon tip electrodes also showed less frequent dislodgement and less frequent sensing failure compared to the metal tip one. These results will promise to elongate a pacemaker longevity. 3) However, bipolar carbon tip electrodes showed significantly high chronic stimulation threshold compared to the unipolar one, although the initial stimulation threshold was reasonably low. This group will need further investigation to resolve it.

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The pacemaker insertion in a patient with a persistent left superior vena cava ( PLSVC ) presents many problems such as dislodgement of catheter tip, pacing and sensing failure, thrombosis of coronary sinus other than difficulty in the insertion of catheter tip.
We met two patients with PLSVC who could not be diagnosed as having PLSVC before operation. Anomalous position of catheter tip made us suspect the presence of PLSVC and it was confirmed by intraoperative angiography. Left subclavian puncture more lateral than usual made catheter insertion easier. Both right atrial and right ventricular pacing were successful with 60cm catheter which is inserted via PLSVC. For atrial pacing, J-shaped wire is not suitable because of difficulty in fixation.
Both of the two patients are doing well without any complication.

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The rate responsive pacemaker using respiratory rate as a sensor was implanted in 4 patients, 3 patients for ventricular pacing and one patient for atrial pacing. The level of exercise achieved with this system was higher than with a fixed ventricular pacing rate. The fluctuations in the ventricular paced rate during daily activities were documented by ambulatory monitoring. When DDD pacing is not indicated, the use of the rate responsive respiratory-dependent pacemaker allows more physiological pacing.

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Diaphragm pacemakers which can be controlled by the body temperature or the heart rate were developed. They were applied to mongrel dogs. The metabolic rate was increased by the administration of the 2-4-dinitrophenol. The physiological effectivity of the pacemakers were ascertained when the body temperature was below 38°C.

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The effect of temperature-sensitive pacemaker upon the pacing rate at the treadmill exercise was studied in animal experiment. During exercise, the blood temperature on both groups slowly elevated and reached the peak level at the end of running. The heart rate and cardiac output of normal dogs made the temporary and rapid increasing by emotional effect at the first 10 seconds, Exerpt for the initial change, the relations between blood temperature and heart or pacing rate appeared to be similar.

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An application of unipolar dual-chamber pacemaker to a single chamber pacing. Recent published studies have reported on clinical disadvantages of unipolar against bipolar configuration with regard to the susceptibility to skeletal myopotentials, muscle twitching, flexbibility, redundancy and so on. However, in Europacing-85, we have presented the unique unipolar single chamber pacing system with dual mode which automatically changes to VVI or VVT according to the level of the input signals and could overcome the proposed superiority of bipolar VVI pacing system.

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The experimental study of small-sized pump-oxygenator newly designed for infant was performed. Capiox a 08^R was used as a oxygenator, and PKS-Kidney^R was employed as a roller pump. Mongrel dogs, weighed 4 to 5 kg, were subjected to cardiopulmonary bypass usi ng this pump oxygenator for three hours. The priming volume was 300ml, and 140ml of blood as well as 60ml of additive drugs had to be given to the lines during the cardiopulmonary bypass of 3 hours. 100ml of uncollected cardioplegic solution was included to the circulating volume. This small-sized pump-oxygenator especially designed for the cardiac surgery in neonates and small infants is sufficient for 3 hours of cardiopulmonary bypass with 300ml of priming volume, but in clinical use it is safe to add some extra volume to the prime.

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23 patients less than three months were analyzed in terms of CPB. The results indicate that prolonged CPB, preoperative heart failure and complexity of the lesions affect the outcome. As the perfusion rate, 150ml/kg/min seemed adequate for the patients in this age group.

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We evaluated gas transfer performance of 0.6m²polypropylene hollow fiber oxygenator and sizes of some drainage catheters. Gas transfer performance of O₂ transfer and CO₂ removal were evaluated with effective pulmonary flow/total blood flow ratio (Q_p/Q_T), and arterio-venous CO₂ content difference/arterial CO₂ tension ratio (ΔCO₂ /PaCO₂). Sufficient O₂ transfer was obtained under oxygen-blood flow ratio (VA) was 1.0, but for CO₂ removal was necessary three times of oxygen flow. Some Catheters for drainaging were experimented. We obtained 300ml/min flow with a torocar catheter 8F. size, and 500ml/min flow with 10F. size under -100mmHg.

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In our department, we made use of 11 types of oxygenator, 6 were bubble type, the others were membrane type. Evaluation of oxygenator was held as follows.
1) Efficiency of gas transfer were shown to changes of PaO₂, PaCO₂ with V/Q being changed, O₂ transfer and Qp/Qt. 2) Efficiency of heat exchange 3) Platelet retension 4) hemolysis
As for platelet retension and hemolysis, membrane oxygenator were superior to bubble type.

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An Experimental study of the Effect of Microbubbles on Tissues. Currently the hollow fiber membrane oxygenator (Capiox II) is being used for about 70% of our open heart operations. No microbubble was detected in arterial line of this oxygenator by ultrasonic detector whereas many microbubbles were recorded in the case of bubble oxygenator. We compare HFO with BO as to the effects on blood and tissue microcirculation.
Fifteen mongrel dogs were divided into HFO group and BO group using BOS-5 oxygenator. After cessation of perfusion for 2 hours, they were observed for further 2 hours under artificial respiration. Blood gas, hemogram, plasma free hemoglobin and AT-III were measured 60 and 120 minutes during perfusion and 60 and 120 minutes after cessation of perfusion. Specimens of lung, heart, kidney, etc. were removed for microscopies to evaluate the effect of microbubbles upon tissue microcirculation. Blood gas data did not differ significantly between groups after perfusion. Platelet count was significantly higher (p<0.01) in HFO group at 120 min. after the establishment of ECC. Perivascular bleeding and edema in the specimen of lung and kidney were found in both groups, but spotty coagulation necrosis in heart muscle was found more in number in BO group.

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Bently hollow fiber oxygenator BOS CM40 was used for open heart surgery in 7 adult patients and compared with TMO in 8 patients. The following results were obtained. 1 Blood-gas analysis data of BOS showed higher PaO₂ and lower PaCO₂ than that of TMO with same condition.
2 At the end of bypass, platelet count in BOS showed lower value than that in TMO. But immunoglobulin was maintained well, complement value was higher than that in TMO throughout bypass, too. 3 Plasma free hemoglobin levels were almost same in BOS and TOM. 4 Oxygenator pressure drop in BOS showed slightly high compared to that in other plate membrane oxygenators.

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Five oxygenators (A: Travenol LPM 50, B: Shiley M-2000, C: Bentley BOS CM 40, D: Bentley BOS 105, E: Williairi Harvey H-1700) were evaluated in 54 patients. Continuous blood oxygen saturation (by Bentley Oxysat), PaCO₂, and gas to Lloodflow ratio (V/Q) were compared in each group after the temporary low flow state. Subnormal blood gas data was obtained in each group as follows; A: 70%, B: 60%, C: 44%, D: 33%, E: 30%. V/Q in C was significantly low but Sv02 below 70% was never recorded. BOS CM 40 seemed to be the choice for our current cardiopulmonary bypass. Oxysat was found to be a useful and reliable device to maintain safe conduct of cardiopulmonary bypass.

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A microporous polypropylene hollow fiber oxygenator was used in more than 600 cases of open heart surgery with safety. Gas exchange performances of the oxygenator were excellent. However, tendency of Pco₂ accumulation in the blood in the outlet of the oxygenator was observed at the end of the total CPB. Pulmonary shunting flow in the patients treated with a H. F. O. was greater than those with B. O. just after the operation. This might be due to the two pump system adopted in our extracorporeal circuits. But, recovery of the pulmonary function of the patients perfused with H. F. O. was more rapid than those with B. O.

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This new type hollow fiber oxygenator, in which blood flows outside of capillaries has the characteristics of lesser numbers and large bore size of microporous polypropylene fibers. Not only low prime volume (480ml) but also wide blood flow range (1-7L/min) provide suitability for a large patient population. In clinical study of 30 patients this lung provided adequate 02 and C02 transfer without time dependent deterioration in performance. No deleterious hematologic consequences were observed because of low surface membrane area which might decrease blood-material interaction. Platelet index (platelet counts/hematocrit) was not significantly decreased during bypass, and plasma free hemoglobin increasing rate was 0.33±0.22 mg/dl/min, which was low enough to maintain the stable serum haptoglobin value. The roller pump pulsatile flow is effective alternative of pulsatile assist device because of low transmembrane blood phase pressure gradient. Experimental pumpless arterial-venous shunt ECMO disclosed stable oxygenation capability during 13 hours. The present study indicates that the new type membrane oxygenator would be suitable for clinical application.

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The Maxima is an outside flow type membrane oxygenator. It contains heat exchanger and 2800 hollow fibers with an effective membrane surface area of 2.0m² The hollow fiber has 400μm inner diameter and 460μm outer diameter and its pore size is 0.03μm. The Maxima and Capiox II were applied for open heart surgery. In Maxima, paltelet count was significantly higher and plasma free hemoglobin was significantly lower than in Capiox II at 30, 60, and 90 minutes of cardiopulmonary bypass. Blood gas exchange was maintained stable within physiological limits throughout bypass in both oxygenators. At flow rate of 3.5l/min, mean pressure drop of 30mmHg in Maxima and 80mmHg in Capiox II was observed. As for protection of platelet, hemolysis and pressure drop, Maxima seems to be superior to Capiox II.

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A new parallel plate oxygenator “Shiley M-2000” was used on 10 patients, and compared to the bubble oxgenator (William Harvey H-1700) as to (1) Blood gas exchange (O₂ transfer rate, CO₂ transfer rate), (2) protective effects against blood injuries, Hemolysis.
Our clinical study represents the Superiority of “Shiley M-2000” above William Harvey H-1700 bubble oxygenator, especially of CO₂ transfer rate (171.0 ml/min), plasma free Hb producing rate (0.84mg/dl/min).
Our data show that Shiley M-2000 oxygenator is one of the artificial lungs with most satisfactory results in present use.

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Shiley M-2000 membrane oxygenator contains heat exchange and 2.3m₂ of microporous polypropylen membrane in parallel plate design. This membrane is used two Cellgard membrane, pore size 0.2×0.02μm and 0.4×0.04μm, which are placed cross one over the other. The element of Z-fold membrane are kept separated by the insertion of latticed polypropylene spacer in each gas and blood fold and provide bilevel crossflow. In vitro, the gas transfer performance and oxygenator resistance of M-2000 were proved to be better than those of CML, but heat exchange performance was lower than CML. Five clinical cases using M-2000 are compaired with the other four membrane oxygenator groups. There is no significant difference among four membrane oxygenators in the counts of platelet, white blood cell, microbubble and urine volume without plasma free hemoglobine, that is significantly low in CML.

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This clinical study was designed to compare Shiley M-2000 membrane oxygenator, Capiox II membrane oxygenator and Shiley 100A bubble oxygenator as to blood gas, platelet counts, β-TG changes and plasma free hemoglobin level during and after cardiopulmonary bypass (CPB). The following results were obtained.
1. O₂ transfer rate was higher in membrane oxygenator than Shiley 100A bubble oxygenator but other blood gas data such as PaCO₂, pH did not show any significant difference in three groups. 2. The change of platelet counts before and during CPB was no significant difference among these groups, however, patelet counts increased on the 1st post-operative day in the cases with membrane oxygenators. 3. There were no significant differences in β-TG value and plasma free hemoglobin levels among these three groups. These findings suggested that membrane oxygenators had more superiority than bubble oxygenator concerning to platelet counts. But thereafter, precise difference among hemolysis, β-TG could not be obtained in the clinical cases.

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We have developed hollowfiber oxygenator for ECMO using combined membrane. Microporesof hollowfibers were filled up with silica and fluoropolymer was coated on inner surface of hollowfibers. The performance of this oxygenator with 1.6m² of surface area, was an O2 transfer rate of 75ml/min and CO2 transfer rate of 83ml/min at a blood flow rate of 1500ml/min. Gas transfer of this oxygenator was stable and plasma leakage did not occur during 30 hours V-A bypass in dogs. Platelet count maintained 88% of the initial value at 30 hours point of V-A bypass. This oxygenator was found to be useful for ECMO prooedure, especially for ECCO2R.

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We have newly developed the extracapillary blood flow type hollow fiber oxygenator for clinical use in ECMO. Two types of oxygenator polypropylene hollow fiber (PPHF) and silicone hollow fiber (SHF) oxygenator have been developed. PPHF oxygenator probed highly efficient in gas transfer and minimam effects to the blood components. But it was thought to be inappropriate to use PPHF oxygenator in ECMO because of serum leakage in long term use. SHF oxygenator probed satisfactorily efficient in oxygen transfer in vitro. In conclusion, SHF oxygenator could have the utility for ECMO.

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We have originally developed a new model of ARI by injecting the seawater endotracheally. This method was proved to establish a stable state of ARI withwout depressing the cardiac function significantly. Using this model of dogs, venovenous bypass for ECMO (V-V ECMO) was carried out by changing ventilation-perfusion ratio (V/Q ratio) to 1.0, 2.0 and 3.0 at each bypass flow rate of 40%, 60% and 80% of pre-perfusion cardiac output. Changes in blood-gas and hemodynamics were evaluated at each condition to reveal the effects of V-V ECMO. Although little evaluation of PaO₂ was observed, significant reduction of PaCO₂ could be obtained even at a low bypass flow rate. It was considered that PaCO₂ coud be controlled not only by changing the bypass flow rate but also by alternating V/Q ratio. Since the circulatory derrangement would scarecely occur by V-V ECMO, this way of ECMO was considered clinically useful particularly for CO₂ removal.

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We made the new machine of extracorporeal lung assist (ECLA) with artificial membrane lung and prolonged veno-venous bypass to support gas exchanges for neonatal respiratory failure. Making up and down a pressure of water in a rigid plastic box including a small silicone reservoir, a blood intermittently comes in and out the reservoir via a thin wall single lumen catheter of segmented polyurethane inserted into the vein. Pneumatic pinch valves which are electrically controlled close and open the extracorporeal circuit to circulate the blood through a artificial membrane lung. In 18 pigs aged within 14 days, we tested the safty and efficacy of the apparatus. The blood priming volume was less than 220ml. The apparatus had bypass blood flow of 112ml/kg/min at maximum. By preventing of hemorrhage from surgical wound in cervical region with careful hemostasis and control of the rate of heparin infusion, the prolonged veno-venous bypass of seven days were successfully accomplished. This system of extracorporeal lungg assist may be clinically suitable for the neonatal respiratory failure.

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This study was performed by using dogs (2-9kg weight) to investigate the veno-venous bypass for respiratory support. Three type methods of ECMO consisted of veno-arterial (V-A) bypass and veno-venous (V-V) bypass (continuous flow and intermittent flow). After completion of these ECMO perfusion, oxygenation and hemodynamics were studied. The intermittent flow was obtained by inflation or deflation of the flexible chamber in which pump and reservior were combined in each. Flow rate of 30% of the cardiac output was maintained in this study. The difference of oxygenation and pressure of the femoral artery was not seen between V-A bypass and V-V bypass. Intermittent flow by V-V bypass increased slightly pressure of the pulmonary artery and right ventricle. This reason caused due to drainage and perfusion of the venous blood.

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Punpless extracorporeal membrane oxygenaration with mictroporous polypropylene hollow fiber lung (Capiox II) was used in treatment three pacients with respiratory distress due to hypercapnea. Improvement in blood gas data was significant and then clouding of conciusness was disapeared after ECMO.

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Studies were made on dogs with severe respiratory failure induced by transtracheal administration of Linoleic acid. The dogs were separated into the 4 groups: GI: respiratory failure GII: pumpless A-V bypass GIII: V-A bypass GIV: V-A bypass with administration of OP41483 (PGI₂ derivatives). The dogs in which ECMO was done maintained good blood gas and survived significantly longer than G-I. GIII survived significantly longer than GII. TxA₂ increased and PGI_2/TxA2 ratio decreased after Linoleic acid administration OP-41483 dilated the vessels of lung, and then intrinsic PGI₂ increased significantly and PGI₂/TxB₂ ratio increased following administration of OP-41483. But no significant difference was observed in survival time between GIII and GIV.

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We tried ECMO for 10 dogs which were included 2 different groups being under the 2 type of respiratory failures. The group I was under the circulatory and respiratory failure, and the group II was under the only respiratory failure. 2 or 3 small parts of the lung were removed in every 3 hours until 9th hour during ECMO, and were observed by the electron microscopy. In the group I several maximum changes were reaognized in the blood-air barrier, but in the group II the changes were minimal. Lung biopsy is available when you decide to start ECMO.

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The secondary flow induced in the serpentine tube membrane oxygenator with steady and pulsatile blood flow enables to augment the gas transfer performance as have been seen in our previous studies. However, there is still some uncertainty in the effect of geometrical conditions on the gas transfer performance in the serpentine tube. In this study the oxygen transfer performance with steady and pulsatile blood flow was investigated for the serpentine tube with well-defined geometrical conditions such as coiling ratio and circular angle for the curved portion. The results of gas transferevaluation indicate that the augmentation of oxygen transfer can be achieved in the, fairly wide conditions of nature of blood flow and tubing configurations.

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Gas exchange across the EVA capillary hollow fiber (CHF) was studied using a heparinless dialyzer (KF101, Kuraray) in animal experiments. The extracapillary space was perfused by oxygen saturated saline solution and CHFs were perfused by venous blood drained from an anesthesized dog. When the pressure difference between intra (Pi)-and extra (Pe)-hollow fiber was kept negative (Pi-Pe<0), standard venous blood at the flow rate of 50ml/min through this dialyzer could be quite oxygenated (500 Torr) and CO₂ was removed (10 Torr). This EVA liquid oxygenator can be cheaply used for ECMO without plasma leakage

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ECCO₂-R system including recirculation circuit was studied with low flow venovenous bypass for hypoventilated dogs. In view of arterial PCO₂ and hemodynamics, bypass flow set as 10% of cardiac output was effective when recirculation was combined.

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In vitro experiment, methylprednisolone inhibited complement activation via both pathways, especially alternative pathway. In clinical cardiopulmonary bypass, methylprednisolone significantly inhibited complement activation via alternative pathway.

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Transition of serum complement level was determined in 20 cardiac patients undergoing cardiopulmonary bypass, for better understanding of unphysiological entities in this artificial perfusion. No significant difference was noted in C3, C4, C5, CH50 level between the membrane and bubble oxygenator groups. C3a level in the bubble oxygenator group tended to be higher than that in the membrane group. The higher level in the former group was more prolonged than in the latter, Elevation of C5a level and neutropenia induced during cardiopulmonary bypass with the membrane oxygenator was more dominent than that induced with the bubble oxygenator. In conclusion, the followings would be suggested:1) C3a level is more intentively affected by the blood-oxygen interface than the blood material interaction, and2) C5a level and neutropenia are more strongly affercted by the blood-material interaction than the blood-oxygen interface.

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We compared three priming solutions; saline, lactated Ringer's solutions (LR) and acetated. Ringer's solution (AR), from hemodynamics and metabolism in haemodilution for two-hour cardiopulmonary bypass in 18 mongrel dogs.
Result 1) Hemodynamics: no significant difference in 3 groups.
2) Acid-base balance: no significant difference between LR group and AR group
3) Metabolism of lactate: no significant difference between LR group and AR group
4) %NEFA; decrease of releasing NEFA was observed in AR group (P<0.05)

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Extracorporeal circulation without blood priming in open heart surgery was studied to evaluate pre-operative hematocrit, body weight, ECC time, amount of blood transfusion, shift of hematocrit during ECC and post-BTF hepatitis. The following results were obtained: 1) There were no significant differences between the three groups as to pre-operative hematocrit and body weight. 2) ECC time is most important factor for possibility of non-blood priming ECC. 3) Non-blood priming ECC made it possible to decrease BTF volume and the occurrence of post-BTF hepatitis.

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Hemothorax ATS (Sorenson) is a very simple autotransfusion system, consisting of suction tube, canister, disposable liner assembly and suction regulator. We applied this system in 28 open heart surgery and 8 aneurysmal operations for clinical availability. This system was very easy to use, however, hemolysis was observed often, especially in surgery using cardiopulmonary bypass. This system was very useful especially in aneurysmal operation for reducing the amount of blood transfusion.

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10 mongrel dogs were divided into two groups and cardio-pulmonary-bypass was done, 5 dogs as a cnotrol group with use of Heparin (group H) and 5 dogs as a DBcAMP group (group D). DBcAMP was admistered by drip infusion of a rate of 0.01ml/kg/min just after start of CPB. The hemodynamic parameters, BGA, pyruvate and lactate didnt showed no significant changes, but the significant decrease of the whole blood aggregation and TXB₂ of the group D suggests that DBcAMP may preserve platelet function.

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The changes of blood coagulation and fibrinolysis during extra corporal circulation (ECC) were studied in 20 cases. Fibrinopeptid A, a sensitive and specific factor of blood coagulation activity, did not increased during ECC, but elevated after heparin neutralization with protamine. FDP increased remarkably during ECC. Antithrombin III, α₂ plasmin inhibiter, plasminogen and fibrinogen decreased during ECC. These data suggested that blood coagulation was well controled by heparin, but fibrinogenolysis was activated during ECC

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We have applyed blood component transfusion since 1979 to patients undergoing open heart surgery for preventing excessive postoperative bleeding. In addition to the use of platelet rich plasma and cryoprecipitate, we have recently introduced platelet transfusion using the technique of platelet pheresis. The total volume of platelets corresponding to 3, 500ml blood of adult male, which were obtained from single donor, was harvested 24 hours prior to the operation and transfused to the patient following cardiopulmonary bypass. By the use of platelet transfusion, the volume of postoperative blood loss and the volume of blood transfusion were singificantly reduced. However, an incidence of posttransfusion hepatitis (non-A, non-B type) was not reduced to the level of statistical significance.

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Comparison of Biopump and roller pump.
The qualitative and quantitative studies of platelet were performed to evaluate the difference of the effects of centrifugal pump and roller pump on platelet during short-term CPB with membrane oxygenator.
There was no significant difference between the two pump systems in regard to the levels of platelet loss and increase rate of βTG and PF 4.
It is considered that the degree of prebypass platelet aggregation of each patient rather contributes to the degree of the consumption of platelet during bypass.

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Twelve mongrel dogs were divided into 2 groups:6 dogs perfused with 110ml/kG/min. (G1), 6 dogs with 52ml/kg/min. (G2). They were studied in the aspects of circulatory conditions and prostanoids. These conclusion were obtained. 1: There was no significant difference between G1 and G2 in both carotid A. and renal A. flows, but as to femoral A. flow less in G2 than that of G1 significantly. 2:TXB₂ increased significantly in both carotid and renal A. in G1 compard with that of G2. These suggested that less CPB flow might bring more favorable condition in the aspects of vasoactive prostanoids.

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