• Title/Summary/Keyword: Artificial heart

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A Study on Safety and Performance Evaluation of Smart All-in-one Cardiopulmonary Assist Device (스마트올인원 심폐순환보조장치의 안전성 및 성능평가에 관한 연구)

  • Park, Junhyun;Ho, YeJi;Lee, Yerim;Lee, Duck Hee;Choi, Jaesoon
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.197-205
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    • 2019
  • The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

Effect of Individualized Exercise Program for Preventing Metabolic Syndrome among IT Company Office Workers (IT 기업 사무직 근로자의 대사증후군 예방을 위한 맞춤형 운동프로그램의 효과)

  • Kyungun Bae;Sung Hyun You;Dabi Shin;Yuncheol Ha;Hongmin Kim;Byungchan Pak;Hyosang Kim;Shinae Park
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.34 no.1
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    • pp.77-84
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    • 2024
  • Objectives: Interventions promoting physical exercise and healthy habits in workplaces have been shown to be effective in reducing risk factors for metabolic syndrome. This study was conducted to examine the effects of an individualized conditioning exercise program of IT company office workers with or at higher risk of metabolic syndrome. Methods: A total of 444 IT company office workers with or at higher risk of metabolic syndrome participated in a 3-month conditioning exercise program. Body composition data using bioelectrical impedance analysis and cardiopulmonary data using cardiopulmonary exercise testing from 53 individuals (mean age: 34.8 ± 7.1 years, sex : 21% female, height : 170.4 ± 6.8 cm, weight : 75.2±12.2 kg, body mass index : 25.8±3.3 kg/m2) who have successfully completed pre-test, intervention, and post-test were analyzed. The 12 weeks intervention encompassed: (1) health counseling (2) supervised exercise(endurance-based, aerobic exercise, or circuit training once a week for 50 minutes at heart rate reserve(HRR) of 77-95%) (3) self-directed exercise and biweekly health screening checks. Results: The results indicated a significant decrease in body weight, body fat mass and body mass index, respectively. Moreover, VO2peak, AT VO2 and AT Time significantly improved, respectively. Resting blood pressure(SBP/DBP) showed positive changes but were not statistically significant. We observed the correlation between characteristics of participants and rate of changes in cardiopulmonary outcomes of participants, there are no significant correlation. These results indicate positive changes in body composition and cardiorespiratory fitness parameters following individualized conditioning exercise program. Conclusions: Individualized workplace exercise program for preventing metabolic syndrome can lead to improvements in body composition and cardiorespiratory fitness.

Mitral Valve Repair for Congenital Mitral Regurgitation in Children (선천성 승모판막 페쇄부전증이 있는 소아에서 승모판막 성형술에 대한 임상적 고찰)

  • Kim, Kun-Woo;Choi, Chang-Hyu;Park, Kook-Yang;Jung, Mi-Jin;Park, Chul-Hyun;Jeon, Yang-Bin;Lee, Jae-Ik
    • Journal of Chest Surgery
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    • v.42 no.3
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    • pp.292-298
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    • 2009
  • Background: Surgery for mitral valve disease in children carries both technical and clinical difficulties that are due to both the wide spectrum of morphologic abnormalities and the high incidence of associated cardiac anomalies. The purpose of this study is to assess the outcome of mitral valve surgery for treating congenital mitral regurgitation in children. Material and Method: From 1997 to 2007, 22 children (mean age: 5.4 years) who had congenital mitral regurgitation underwent mitral valve repair. The median age of the patients was 5.4 years old and four patients (18%) were under 12 months of age. 15 patients (68%) had cardiac anomalies. There were 13 cases of ventricular septal defect, 1 case of atrial septal defect and 1 case of supravalvar aortic stenosis. The grade of the preoperative mitral valve regurgitation was II in 4 patients, III in 15 patients and IV in 3. The regurgitation was due to leaflet prolapse in 12 patients, annular dilatation in 4 patients and restrictive leaflet motion in 5 patients. The preoperative MV Z-value and the regurgitation grade were compared with those obtained at follow-up. Result: MV repair was possible in all the patients. 19 patients required reduction annuloplasty and 18 patients required valvuloplasty that included shortening of the chordae, papillary muscle splitting, artificial chordae insertion and cleft closure. There were no early or late deaths. The mitral valve regurgitation after surgery was improved in all patients (absent=10, grade I=5, II=5, III=2). MV repair resulted in reduction of the mitral valve Z-value ($2.2{\pm}2.1$ vs. $0.7{\pm}2.3$, respectively, p<0.01). During the mid-term follow-up period of 3.68 years, reoperation was done in three patients (one with repair and two with replacement) and three patients showed mild progression of their mitral reguration. Conclusion: our experience indicates that mitral valve repair in children with congenital mitral valve regurgitation is an effective and reliable surgical method with a low reoperation rate. A good postoperative outcome can be obtained by preoperatively recognizing the intrinsic mitral valve pathophysiology detected on echocardiography and with the well-designed, aggressive application of the various reconstruction techniques.

The Long-term Clinical Result of St. Jude Mechanical Valve Replacement (St. Jude 기계판막 치환술의 장기 임상성적)

  • 배윤숙;정성철;김우식;정승혁;유환국;이정호;김병열
    • Journal of Chest Surgery
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    • v.36 no.5
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    • pp.321-328
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    • 2003
  • Background: The St. Jude Medical prosthesis is one of the popularly used artificial prosthesis, therefore the National Medical Center reports the long-term clinical results of patients who underwent prosthetic valve replacement with St. Jude medical valve for 18 years. Material and Method: Between January, 1984 and June, 2002, a series of 163 consecutive patients who had Implanted St. Jude prosthesis at the National Medical Center were reviewed. Mean age was 42.9$\pm$15.1 years and male to female ratio was 69:94. The operative procedure comprised of 87 MVR, 30 AVR, 45 DVR, and 1 TVR. The reoperative procedure comprised of 21 MVR, 2 AVR, and 14 DVR. Follow-up rate was 96.9%, and cumulative follow-up was 823.8 patient-years. Result: Early mortality rate was 7.9% (13 patients), late mortality rate was 8.7% (13 patients) and late mortality due to valve related complication was 47% (7 patients). Actual survival rate at 10 and 18 years were 91.7$\pm$2.1% and 91.0$\pm$1.9%. Linearized Incidence was as follows: thromboembolism, 1.09%/ patient-year; anticoagulant related hemorrhage, 0.36%/patient-year; valve thrombosis, 0.24%/patient-year; paravalvular leakage, 0.12%/patient-year; and prosthetic bacterial endocarditis, 0.12%/patient-year linearized incidence of over all valve related complication was 1.94%/patient-year. Freedom from valve related complication at 10 and 18 years were 89.1$\pm$3.3% and 88.4$\pm$3.9%. Freedom from valve related death at 10 and 18 years were 95.1$\pm$1.2% and 95.1$\pm$1.0%. Valve related complication was related the age of patient, especially anticoagulant related hemorrhage was more common in patients over 60 years of age. Valve related complication, death were higher in DVR than AVR or MVR, and valve related death was higher in reoperation. There was no relationship between valve related complication or death and implant valve of size. Conclusion: The long-term clinical results of patients implanted with St. Jude Mechanical prosthesis was quite satisfactory with a low incidence of valve related complication and mortality.

A Study on the Manufacture of the Artificial Cardiac Tissue Valve (생체판의 제작 및 실험)

  • Kim, Hyoung-Mook;Song, Yo-Jun;Sohn, Kwang-Hyun
    • Journal of Chest Surgery
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    • v.12 no.4
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    • pp.383-394
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    • 1979
  • Treatment of valvular heart disease with valve replacement has been one of the most popular procedures in cardiac surgery recently. Although, first effort was directed toward the prosthetic valve, it soon became popular that bioprosthesis, the valvular xenograft, was prefered in the majority cases. Valvular xenograft has some superiority to the artificial prosthetic valve in some points of thromboembolism and hemolytic anemia, and it also has some inferiority of durability, immunologic reaction and resistance to Infection. Tremendous efforts were made to cover the inferiority with several methods of collection, preservation, and valve mounting of the porcine valve or pericardium of the calf, and also with surgical technique of the valvular xenograft replacement. Auther has collected 320 porcine aortic valves immediately after slaughter, and aortic cusps were coapted with cotton balls in the Valsalva sinuses to protect valve deformity after immersion in the Hanks' solution, and oxidation, cross-linking and reduction procedures were completed after the proposal of Carpentier in 1972. Well preserved aortic valves were suture mounted in the hand-made tissue valve frame of 19, 21, and 23 mm J.d., and also in the prosthetic vascular segment of 19 mm Ld. with 4-0 nylon sutures after careful trimming of the aortic valves. Completed valves were evaluated with bacteriologic culture, pressure tolerance test with tolerane gauge, valve durability test in the saline glycerine mixed solution with tolerance test machine in the speed of 300 rpm, and again with pathologic changes to obtain following results: 1. Bacteriologic culture of the valve tissue in five different preservation method for two weeks revealed excellent and satisfactory result in view of sterilization including 0.65% glutaraldehyde preservation group for one week bacteriologic culture except one tissue with Citobacter freundii in 75% ethanol preserved group. 2. Pressure tolerance test was done with an apparatus composed of V-connected manometer and pressure applicator. Tolerable limit of pressure was recorded when central leaking jet of saline was observed. Average pressure tolerated in each group was 168 mmHg in glutaraldehyde, 128 mmHg in formaldehyde, 92 mmHg in Dakin's solution, 48 mmHg in ethylene oxide gas, and 26 mmHg in ethanol preserved group in relation to the control group of Ringer's 90 mmHg respectively. 3. Prolonged durability test was performed in the group of frame mounted xenograft tissue valve with 300 up-and-down motion tolerance test machine/min. There were no specific valve deformity or wearing in both 19, 21, and 23 mm valves at the end of 3 months (actually 15 months), and another 3 months durability test revealed minimal valve leakage during pressure tolerance test due to contraction deformity of the non-coronary cusp at the end of 6 months (actually 30 months) in the largest 23 mm group. 4. Histopathologic observation was focussed in three view points, endothelial cell lining, collagen and elastic fiber destructions in each preservation methods and long durable valvular tolerance test group. Endothel ial cell lining and collagen fiber were well preserved in the glutaraldehyde and formaldehyde treated group with minimal destruction of elastic fiber. In long durable tolerance test group revealed complete destruction of the endothelial cell lining with minimal destruction of the collagen and elastic fiber in 3 month and 6 month group in relation to the time and severity. In conclusion, porcine xenograft treated after the proposal of Carpentier in 1972 and preserved in the glutaraldehyde solution was the best method of collection, preservation and valve mounting. Pressure tolerance and valve motion tolerance test, also, revealed most satisfactory results in the glutaraldehyde preserved group.

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Twenty-one Year Experience with Right Ventricle to Pulmonary Artery Conduit Interposition (우심실-폐동맥 간 도관 이식술의 21년간의 경험)

  • Kwak, Jae-Gun;Yoo, Jae-Suk;Kim, Yong-Jin;Kim, Woong-Han;Lee, Jeong-Ryul
    • Journal of Chest Surgery
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    • v.41 no.4
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    • pp.417-422
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    • 2008
  • Background: The aim of this study is to evaluate the long term results of creating various right ventricle to pulmonary artery conduits for treating complex congenital heart disease. Material and Method: Between June 1986 and July 2006, we retrospectively reviewed 245 patients who underwent reconstruction of the right ventricular outflow tract with various kinds of conduits. 410 operations were done in 245 patients, the mean age at operation was $3.2{\pm}4.9$ years (range: 7 days$\sim$45 years) and the mean body weight was $12.5{\pm}8.7\;kg$ (range: $2.4\sim76.3\;kg$). Result: We used the following conduits: Polystan conduit, Shelhigh conduit, Carpenter-Edward conduit, Dacron graft with an artificial valve, valveless Gore Tex vascular graft, homograft and hand-made bovine or autologous pericardial conduit. The mean follow up duration was $6.3{\pm}5.2$ years. Redo operation for RV-PA conduit dysfunction was performed in 131 patients, a second redo was done in 31 and a third redo was done in 3. The reoperation free rates were 67.3%, 48.5% and 39.4% for 5 years, 10 years and 15 years, respectively. The homograft showed the best durability, followed by the Dacron graft with artificial valve and the Carpentier-Edward conduit. The larger sized conduit showed better durability. Conclusion: The homograft showed lowest reoperation rate and a smaller size of conduit showed the highest reoperation rate. The reoperation rate for the RV-PA conduit was about 35% at 5 years, so it is mandatory to develop the more durable conduit for RV outflow.

A Study on the Appearance Characteristic of Landscape Elements and Symbolic Elements Implied in Tablets - Focus on Korean Damyang Garden and Chinese Suzhou Garden - (편액에 함의된 경관 및 상징요소의 출현특성 - 한국의 담양원림과 중국의 소주원림을 중심으로 -)

  • Ham, Kwang-Min;Li, Shu-Hua;Zhang, Ya-Ping;Mitani, Toru;Zhang, Jun-Hua
    • Journal of the Korean Institute of Traditional Landscape Architecture
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    • v.34 no.4
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    • pp.78-88
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    • 2016
  • The comparative analysis result of appearance characteristic of landscape elements and symbolic elements implied by the tablets on the 16th century's Korean Damyang garden and Chinese Suzhou garden is as follows. First, among the landscape elements implied in the tablets, appearance rate of botanical factors appeared high in the gardens of both areas. Damyang garden displayed bamboo grove and natural forest around the garden, while Suzhou garden displayed artificial mountain(假山) created artificially and a variety of plants including lotus, bamboo, and pine surrounding it were associated with the significance of the tablets. On the other hand, climatic/celestial elements including the rain, wind, and the moon were associated with the tablets of Damyang garden, while the artificial factors such as the building, bridge, and book, etc. were mostly were associated with the tablets of Suzhou garden. Second, among the symbolic elements included in the tablets, ethical personality which is the basic virtue of a noble man(聖人), was the universal characteristic of the meditation world of the garden in both areas. However, a will for political stability was mostly associated with the tablets of Damyang garden, while the retrospect heart for the immortal was mostly associated with the signboard in Suzhou garden. It was concerned with political ideal and the thought of Confucianism respectively. Third, the symbolic elements that appeared frequently in the tablets of Damyang garden, "Ethics" and "Political stability", were associated with the scene atmosphere created by the climatic elements and celestial elements. On the contrary, the symbolic elements which most frequently appeared in the tablets of Suzhou garden, "Ethics", was associated with the symbolic significance of the plant. The invisible space of gardens was expanded by tablets in both areas.

Christian Education for Human Spirit Transformation (인간 영의 변형을 위한 기독교교육)

  • Woo, Ji Yeon
    • Journal of Christian Education in Korea
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    • v.66
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    • pp.413-437
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    • 2021
  • Humans are created as spiritual beings that can relate to God. However, when a human spirit refuses to transform through confronting God, it experiences a crisis. A spiritual crisis results from disconnecting with God, who is the ultimate foundation, but we humans try to overcome such absence through accomplishments and efforts. In this technological age, the ethics issues of AI (Artificial Intelligence), robots, and cloning are related to anthropology. The development of the mind, heart, and logic cannot suggest a basis for destruction and confusion as much as the development of the world. In fact, education focused on the human mind cannot be considered holistic. Mind, together with thought, will, and belief, plays a crucial role in making choices and leading a human life. So it is actively studied in other domains other than Christian education. However, although the human spirit takes care of some territory of humanity, unlike the mind, it can neither be partial nor fragmentary. Instead, it manages the transformation that influences the core of human life. Therefore, Christian education must clearly concentrate on the spirit rather than on other human elements, intentionally concerning spiritual transformation through encounters with God. In other words, Christian education is the passage connecting a human spirit to God's presence at work, which enables us to understand the human being as a whole. For this, we must put our efforts to increase the chances of encountering God through Christian education. While "Encounter" requires both parties' interaction, "Transformation" stresses God as the main agent and His proactive nature. I also want to emphasize "worship" as the opportunity to communicate and experience God in our daily lives. By examining the preparation and the process of the spiritual transformation of humans, this paper would offer a theological foundation for continued transformation of the human spirit in the faith community, rather than personal experience or conviction.

Application of a Single-pulsatile Extracorporeal Life Support System for Extracorporeal Membrane Oxygenation -An experimental study - (단일 박동형 생명구조장치의 인공폐 적용 -실험연구-)

  • Kim, Tae-Sik;Sun, Kyung;Lee, Kyu-Baek;Park, Sung-Young;Hwang, Jae-Joon;Son, Ho-Sung;Kim, Kwang-Taik;Kim. Hyoung-Mook
    • Journal of Chest Surgery
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    • v.37 no.3
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    • pp.201-209
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    • 2004
  • Extracorporeal life support (ECLS) system is a device for respiratory and/or heart failure treatment, and there have been many trials for development and clinical application in the world. Currently, a non-pulsatile blood pump is a standard for ECLS system. Although a pulsatile blood pump is advantageous in physiologic aspects, high pressure generated in the circuits and resultant blood cell trauma remain major concerns which make one reluctant to use a pulsatile blood pump in artificial lung circuits containing a membrane oxygenator. The study was designed to evaluate the hypothesis that placement of a pressure-relieving compliance chamber between a pulsatile pump and a membrane oxygenator might reduce the above mentioned side effects while providing physiologic pulsatile blood flow. The study was performed in a canine model of oleic acid induced acute lung injury (N=16). The animals were divided into three groups according to the type of pump used and the presence of the compliance chamber, In group 1, a non-pulsatile centrifugal pump was used as a control (n=6). In group 2 (n=4), a single-pulsatile pump was used. In group 3 (n=6), a single-pulsatile pump equipped with a compliance chamber was used. The experimental model was a partial bypass between the right atrium and the aorta at a pump flow of 1.8∼2 L/min for 2 hours. The observed parameters were focused on hemodynamic changes, intra-circuit pressure, laboratory studies for blood profile, and the effect on blood cell trauma. In hemodynamics, the pulsatile group II & III generated higher arterial pulse pressure (47$\pm$ 10 and 41 $\pm$ 9 mmHg) than the nonpulsatile group 1 (17 $\pm$ 7 mmHg, p<0.001). The intra-circuit pressure at membrane oxygenator were 222 $\pm$ 8 mmHg in group 1, 739 $\pm$ 35 mmHg in group 2, and 470 $\pm$ 17 mmHg in group 3 (p<0.001). At 2 hour bypass, arterial oxygen partial pressures were significantly higher in the pulsatile group 2 & 3 than in the non-pulsatile group 1 (77 $\pm$ 41 mmHg in group 1, 96 $\pm$ 48 mmHg in group 2, and 97 $\pm$ 25 mmHg in group 3: p<0.05). The levels of plasma free hemoglobin which was an indicator of blood cell trauma were lowest in group 1, highest in group 2, and significantly decreased in group 3 (55.7 $\pm$ 43.3, 162.8 $\pm$ 113.6, 82.5 $\pm$ 25.1 mg%, respectively; p<0.05). Other laboratory findings for blood profile were not different. The above results imply that the pulsatile blood pump is beneficial in oxygenation while deleterious in the aspects to high pressure generation in the circuits and blood cell trauma. However, when a pressure-relieving compliance chamber is applied between the pulsatile pump and a membrane oxygenator, it can significantly reduce the high circuit pressure and result in low blood cell trauma.

Transformation of Adult Mesenchymal Stem Cells into Cardiomyocytes with 5-azacytidine: Isolated from the Adipose Tissues of Rat (성체 백서의 지방조직에서 추출한 중간엽 줄기세포의 5-azacytidine을 이용한 심근세포 분화 유도)

  • Choe Ju-Won;Kim Yong-In;Oh Tae-Yun;Cho Dai-Yoon;Sohn Dong-Suep;Lee Tae-Jin
    • Journal of Chest Surgery
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    • v.39 no.7 s.264
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    • pp.511-519
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    • 2006
  • Background: Loss of cardiomyocytes in the myocardial infarction leads to regional contractile dysfunction, and necrotized cardiomyocytes in infracted ventricular tissues are progressively replaced by fibroblasts forming scar tissue. Although cardiomyoplasty, or implantation of ventricular assist device or artificial heart was tried in refractory heart failure, the cardiac transplantation was the only therapeutic modality because these other therapeutic strategies were not permanent. Cell transplantation is tried instead of cardiac transplantation, especially bone marrow is the most popular donated organ. But because bone marrow aspiration procedure is invasive and painful, and it had the fewer amounts of cellular population, the adipose tissue is recommended for harvesting of mesenchymal stem cells. Material and Method: After adipose tissues were extracted from abdominal subcutaneous adipose tissue and intra-abdominal adipose tissue individually, the cellular components were obtained by same method. These cellular components were tried to transformation with the various titers of 5-azacytidine to descript the appropriate concentration of 5-azacytidine and possibility of transformation ability of adipose tissue. Group 1 is abdominal subcutaneous adipose tissue and Group 2 is intra-abdominal adipose tissue-retroperitoneal adipose tissue and omentum. Cellular components were extracted by collagenase and $NH_4Cl$ et al, and these components were cultured by non-induction media - DMEM media containing 10% FBS and inducted by none, $3{\mu}mol/L,\;6{\mu}mol/L,\;and\;9{\mu}mol/L$ 5-azacytidine after the 1st and 2nd subculture. After 4 weeks incubation, tile cell blocks were made, immunostaining was done with the antibodies of CD34, heavy myosin chain, troponin T, and SMA. Result: Immunostaining of the transformed cells for troponin T was positive in the $6{\mu}mol/L\;&\;9{\mu}mol/L$ 5-azacytidine of Group 1 & 2, but CD34 and heavy myosin chain antibodies were negative and SMA antibody was positive in the $3{\mu}mol/L\;&\;6{\mu}mol/L$ 5-azacytidne of Group 2. Conclusion: These observations confirm that adult mesenchymal stem cells isolated from the abdominal subcutaneous adipose tissues and intra-abdominal adipose tissues can be chemically transformed into cardiomyocytes. This can potentially be a source of autologous cells for myocardial repair.