• Title/Summary/Keyword: Medical Device Management

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Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting for Revascularization of Left Main Coronary Artery Disease

  • Sangwoo Park;Seung-Jung Park;Duk-Woo Park
    • Korean Circulation Journal
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    • v.53 no.3
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    • pp.113-133
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    • 2023
  • Owing to a large-jeopardized myocardium, left main coronary artery disease (LMCAD) represents the substantial high-risk anatomical subset of obstructive coronary artery disease. For several decades, coronary artery bypass grafting (CABG) has been the "gold standard" treatment for LMCAD. Along with advances in CABG, percutaneous coronary intervention (PCI) has also dramatically evolved over time in conjunction with advances in the stent or device technology, adjunct pharmacotherapy, accumulated experiences, and practice changes, establishing its position as a safe, reasonable treatment option for such a complex disease. Until recently, several randomized clinical trials, meta-analyses, and observational registries comparing PCI and CABG for LMCAD have shown comparable long-term survival with tradeoffs between early and late risk-benefit of each treatment. Despite this, there are still several unmet issues for revascularization strategy and management for LMCAD. This review article summarized updated knowledge on evolution and clinical evidence on the treatment of LMCAD, with a focus on the comparison of state-of-the-art PCI with CABG.

A Design of Secure Communication for Device Management Based on IoT (사물인터넷 기반 디바이스 관리를 위한 안전한 통신 프로토콜 설계)

  • Park, Jung-Oh;Choi, Do-Hyeon;Hong, Chan-Ki
    • Journal of Convergence for Information Technology
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    • v.10 no.11
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    • pp.55-63
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    • 2020
  • The IoT technology is a field that applies and converges the technologies in the existing industrial environment, instead of new technologies. The IoT technology is releasing various application services converged with other industries such as smart home, healthcare, construction, and automobile, and it is also possible to secure the work efficiency and convenience of users of IoT-based technologies. However, the security threats occurring in the IoT-based technology environment are succeeding to the vulnerability of the existing wireless network environment. And the occurrence of new and variant attacks in the combination with the ICT convergence environment, is causing damages. Thus, in the IoT technology-based environment, it would be necessary to have researches on the safe transmission of messages in the communication environment between user and device, and device and device. This thesis aims to design a safe communication protocol in the IoT-based technology environment. Regarding the suggested communication protocol, this thesis performed the safety analysis on the attack techniques occurring in the IoT technology-based environment. And through the performance evaluation of the existing PKI-based certificate issuance system and the suggested communication protocol, this thesis verified the high efficiency(about 23%) of communication procedure. Also, this thesis verified the reduced figure(about 65%) of the issued quantity of certificate compared to the existing issuance system and the certificate management technique.

Management of Acute Fulminant Myocarditis Using a Left Ventricular Assist Device - A case report - (좌심실 보조장치를 이용한 전격성 심근염의 치료 - 1례 보고 -)

  • Kang, Shin-Kwang;Park, Sang-Soon;Na, Myung-Hoon;Yu, Jae-Hyeon;Lim, Seung-Pyung;Lee, Young;Seong, In-Whan
    • Journal of Chest Surgery
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    • v.34 no.6
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    • pp.490-493
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    • 2001
  • A 17 year-old high school girl was admitted for anterior chest pain. Pulmonary edema and circulatory collapse progressed in spite of the medical treatment and intra-aortic balloon pump. Left ventricular assist device(LVAD, Bio-Pump, Medtronic Bio-Med, USA) was instituted under the impression of acute fulminant myocarditis. The inlet cannula was inserted in the left atrium(LA) via left submammary anterior thoracotomy. Biopsy was taken from left atrial appendage. The outlet cannula inserted to the left femoral artery using PTFE cuff. After 158 hours of extracorporeal circulation, LVAD was able to be weaned successfully with nearly normalized LV motion on echocardiogram, Coxsakievirus was identified with immunochemistry and serum neutralization test. She was discharged without any heart failure symptoms after 23 days of hopitalization.

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Clinical Feature of Iatrogenic Vascular Injury (의인성 혈관 손상의 임상적 고찰)

  • Kim, Su-jin;Lee, Tae-seung
    • Journal of Trauma and Injury
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    • v.21 no.2
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    • pp.128-135
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    • 2008
  • Purpose: As the care of surgical patients becomes increasingly complex and catheter-based techniques are more frequently applied, the pattern of iatrogenic vascular injuries may be increasing. Major vascular injuries can jeopardize a patient's life or limb survival. The purpose of this study was to examine the current etiology and prognosis for iatrogenic vascular injuries. Methods: We reviewed medical records of 29 cases of iatrogenic vascular injury that were treated Seoul National University Bundang Hospital between October 2003 and October 2008. We studied clinical variables including demographics, cause of injury, clinical presentations, management and prognosis. Results: The mean age was 60.8 years (range: 25-86), and the male to female ratio was 1.9 : 1. The causes of injuries were operation related complication in 18 cases (62.1%), endovascular intervention and diagnostic angiography in 11 cases (37.9%). The types of vascular injury were partial severance in 14 cases, pseudoaneurysm in 8, arteriovenous fistula (AVF) in 3, thrombosis in 2, complete severance in 2. Especially, device related complication including percutaneous closing device were occurred in 9 and the others came from inadvertent physician's procedure. Primary repair were done in 12 cases, end-to-end anastomosis in 5, interposition graft in 4, ligation in 2, patch angioplasty in 1, peudoaneurysm excision and arteriorrhaphy in 1, hematoma evacuation in 1, and endovascular repair in 3. There were 2 cases of mortality, one of them due to hemorrhagic shock and the other due to septic shock. Conclusion: Proper selection of treatment modalities should be important to have better outcome according to the type of injury as well as anatomical location. Each physician should be familiar to new device as well as patient's topographical feature. Immediate referral to vascular specialist is also essential to reduce morbidity.

Adverse Events in Total Artificial Heart for End-Stage Heart Failure: Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE)

  • Min Choon Tan;Yong Hao Yeo;Jia Wei Tham;Jian Liang Tan;Hee Kong Fong;Bryan E-Xin Tan;Kwan S Lee;Justin Z Lee
    • International Journal of Heart Failure
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    • v.6 no.2
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    • pp.76-81
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    • 2024
  • Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions: Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

Respiratory signal analysis of liver cancer patients with respiratory-gated radiation therapy (간암 호흡동조 방사선치료 환자의 호흡신호분석)

  • Kang, dong im;Jung, sang hoon;Kim, chul jong;Park, hee chul;Choi, byung ki
    • The Journal of Korean Society for Radiation Therapy
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    • v.27 no.1
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    • pp.23-30
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    • 2015
  • Purpose : External markers respiratory movement measuring device (RPM; Real-time Position Management, Varian Medical System, USA) Liver Cancer Radiation Therapy Respiratory gated with respiratory signal with irradiation time and the actual research by analyzing the respiratory phase with the breathing motion measurement device respiratory tuning evaluate the accuracy of radiation therapy Materials and Methods : May-September 2014 Novalis Tx. (Varian Medical System, USA) and liver cancer radiotherapy using respiratory gated RPM (Duty Cycle 20%, Gating window 40% ~ 60%) of 16 patients who underwent total when recording the analyzed respiratory movement. After the breathing motion of the external markers recorded on the RPM was reconstructed by breathing through the acts phase analysis, for Beam-on Time and Duty Cycle recorded by using the reconstructed phase breathing breathing with RPM gated the prediction accuracy of the radiation treatment analysis and analyzed the correlation between prediction accuracy and Duty Cycle in accordance with the reproducibility of the respiratory movement. Results : Treatment of 16 patients with respiratory cycle during the actual treatment plan was analyzed with an average difference -0.03 seconds (range -0.50 seconds to 0.09 seconds) could not be confirmed statistically significant difference between the two breathing (p = 0.472). The average respiratory period when treatment is 4.02 sec (${\pm}0.71sec$), the average value of the respiratory cycle of the treatment was characterized by a standard deviation 7.43% (range 2.57 to 19.20%). Duty Cycle is that the actual average 16.05% (range 13.78 to 17.41%), average 56.05 got through the acts of the show and then analyzed% (range 39.23 to 75.10%) is planned in respiratory research phase (40% to 60%) in was confirmed. The investigation on the correlation between the ratio Duty Cycle and planned respiratory phase and the standard deviation of the respiratory cycle was analyzed in each -0.156 (p = 0.282) and -0.385 (p = 0.070). Conclusion : This study is to analyze the acts after the breathing motion of the external markers recorded during the actual treatment was confirmed in a reproducible ratios of actual treatment of breathing motion during treatment, and Duty Cycle, planned respiratory gated window. Minimizing an error of the treatment plan using 4DCT and enhance the respiratory training and respiratory signal monitoring for effective treatment it is determined to be necessary.

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Usability Study on Public Access Defibrillator (공공설치용 자동제세동기의 사용성 연구)

  • Oh, Young-Jin
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.32 no.1
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    • pp.61-66
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    • 2009
  • Usability study of the CU Medical "i-PAD" AED was conducted to validate the usability of the device, primarily focused on the trained user as well as the utility of the training material. Comparing these results of the trained participants to those obtained by Callejas et al. (2004), who studied video-trained users of two commercially available Philips AEDs (FR2 and HS1) using a male manikin only, the participants in this study were more successful (100% vs. 85.7%-FR2 vs. 88.9%-HS1) and faster to shock (58.5s-i-PAD vs. 91s-FR2 vs. 90s-HS1). While the focus of this study was on validating ease of use for trained bystanders, the results of the untrained condition showed that, from a usability perspective, these devices perform as well as any other AEDs already approved and available for purchase for untrained bystander use, as evidenced by the comparison to various published research results.

A Study on the Selection of Strategic Industry in Gyeonggi Province (경기도 지역 전략산업 선정에 관한 시론적 연구)

  • Kim, Shin-Pyo
    • Journal of Industrial Convergence
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    • v.12 no.2
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    • pp.16-23
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    • 2014
  • The aim of this study is to find the strategic industries that fulfills the on-site demands of the Gyeonggi province region related to the advancement and development of the local industries. As the results of the analysis, the 4 major strategic industries in the Gyeonggi province region were determined to be (1) electronic component, computer, visual, acoustic and telecommunication equipment manufacturing, (2) pulp, paper and paper product manufacturing, (3) medical substances and pharmaceutical product manufacturing, and (4) rubber and plastic product manufacturing. The industry of concordance between the 4 major strategic industry of the Gyeonggi province determined in this Study and the 13 future growth engine industry of Korea was the area of intelligent semiconductor. Accordingly, it was analyzed that there is a need to strategically cultivate the electrical and electronic telecommunication device industry, which is ranked the $1^{st}$among the strategic industries of Gyeonggi province by generating synergic effects with the policy of the government for nurturing of intelligent semiconductor industry.

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A Study on the Development Methodology of Intelligent Medical Devices Utilizing KANO-QFD Model (지능형 메디컬 기기 개발을 위한 KANO-QFD 모델 제안: AI 기반 탈모관리 기기 중심으로)

  • Kim, Yechan;Choi, Kwangeun;Chung, Doohee
    • Journal of Intelligence and Information Systems
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    • v.28 no.1
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    • pp.217-242
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    • 2022
  • With the launch of Artificial Intelligence(AI)-based intelligent products on the market, innovative changes are taking place not only in business but also in consumers' daily lives. Intelligent products have the potential to realize technology differentiation and increase market competitiveness through advanced functions of artificial intelligence. However, there is no new product development methodology that can sufficiently reflect the characteristics of artificial intelligence for the purpose of developing intelligent products with high market acceptance. This study proposes a KANO-QFD integrated model as a methodology for intelligent product development. As a specific example of the empirical analysis, the types of consumer requirements for hair loss prediction and treatment device were classified, and the relative importance and priority of engineering characteristics were derived to suggest the direction of intelligent medical product development. As a result of a survey of 130 consumers, accurate prediction of future hair loss progress, future hair loss and improved future after treatment realized and viewed on a smartphone, sophisticated design, and treatment using laser and LED combined light energy were realized as attractive quality factors among the KANO categories. As a result of the analysis based on House of Quality of QFD, learning data for hair loss diagnosis and prediction, micro camera resolution for scalp scan, hair loss type classification model, customized personal account management, and hair loss progress diagnosis model were derived. This study is significant in that it presented directions for the development of artificial intelligence-based intelligent medical product that were not previously preceded.

Association of Congestive Heart Failure and Death with Ankylosing Spondylitis : A Nationwide Longitudinal Cohort Study in Korea

  • Bae, Ki Hwan;Hong, Je Beom;Choi, Yoon Jin;Jung, Jin Hyung;Han, In-Bo;Choi, Jung Min;Sohn, Seil
    • Journal of Korean Neurosurgical Society
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    • v.62 no.2
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    • pp.217-224
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    • 2019
  • Objective : We attempted to discover that Ankylosing spondylitis (AS) has a comprehensive relationship with congestive heart failure and death. Methods : We used a nationwide database managed by the Korean National Health Insurance Service from 2010 to 2014. Twelve thousand nine hundred eighty-eight patients with a diagnosis of AS and 64940 age- and sex- stratified matching subjects without AS were enrolled in the AS and control groups. Incidence probabilities of 6 years congestive heart failure and death in each group were calculated. The Cox proportional hazard regression analysis was used to estimate the hazard ratio. We divided the AS and control groups into subgroups according to sex, age, income, and comorbidities. Results : During the follow-up period, 102 patients (0.79%) in the AS group and 201 patients (0.32%) in the control group developed congestive heart failure (p<0.0001). In addition, 211 (1.62%) subjects in the AS group died during the follow-up period compared to 639 (0.98%) subjects in the control group (p<0.0001). The adjusted hazard ratio of congestive heart failure and death in the AS group was 2.28 (95% confidence interval [CI], 1.80-2.89) and 1.66 (95% CI, 1.42-1.95), respectively. The hazard ratios of congestive heart failure and death were significantly increased in all of the subgroups. Conclusion : The incidence rates of congestive heart failure and death were increased in AS patients.