• Journal of Chest Surgery
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• v.50 no.5
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• pp.363-370
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• 2017

Background: Extracorporeal life support (ECLS) is widely used in refractory heart or lung failure, and the demand for inter-facility transportation on ECLS is expanding. However, little is known about post-transportation outcomes, the clinical safety of such transportation, or the characteristics of the transported patients. Methods: This was a retrospective review of a 3-year, single-institution experience with inter-facility ECLS transport, as well as a comparative analysis of clinical outcomes with those of in-house patients. We also analyzed the risk factors for hospital mortality in the entire ECLS population using univariate and multivariate analyses to investigate the effects of transport. Results: All 44 patients were safely transported without adverse events. The average travel distance was 178.7 km, with an average travel time of 74.0 minutes. Early survival of the transported group seemed to be better than that of the in-house group, but the difference was not statistically significant (70.5% vs. 56.6%, p=0.096). The incidence of complications was similar between the 2 groups, except for critical limb ischemia, which was significantly more common in the transported group than in the in-house group (25.0% vs. 8.1%, p=0.017). After adjusting for confounders, being part of the transported group was not a predictor of early death (adjusted odds ratio, 0.689; p=0.397). Conclusion: Transportation of patients on ECLS is relatively safe, and the clinical outcomes of transported patients are comparable to those of in-house ECLS patients. Although matched studies are required, our study demonstrates that transporting patients on ECLS did not increase their risk of hospital mortality after adjustment for other factors.

• Journal of Chest Surgery
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• v.54 no.2
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• pp.99-105
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• 2021

Background: The number of heart transplantations (HTx) is increasing annually. Due to advances in medical and surgical support, the outcomes of HTx are also improving. Extracorporeal circulatory life support (ECLS) provides patients with decompensated heart failure a chance to undergo HTx. A medical approach involving collaboration among experienced experts in different fields should improve the outcomes and prognosis of ECLS-bridged HTx. Methods: From December 2003 to December 2018, 1,465 patients received ECLS at Samsung Medical Center. We excluded patients who had not undergone HTx or underwent repeated transplantations. Patients younger than 18 years were excluded. We also excluded patients who received an implantable durable left ventricular assist device before HTx. In total, 91 patients were included in this study. A multidisciplinary team approach began in March 2013 at our hospital. We divided the patients into 2 groups depending on whether they were treated before or after implementation of the team approach. Results: The 30-day mortality rate was significantly higher in the pre-ECLS team group than in the post-ECLS team group (n=5, 18.5% vs. n=2, 3.1%; p=0.023). The 1-year survival rate was better in the post-ECLS team group than in the pre-ECLS team group (n=57, 89.1% vs. n=19, 70.4%; p=0.023). Conclusion: We found that implementing a multidisciplinary team approach improved the outcomes of ECLS-bridged HTx. Team-based care should be adapted at HTx centers that perform high-risk HTx.

• Journal of Chest Surgery
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• v.40 no.8
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• pp.569-573
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• 2007

A 3 month old female baby, who had been diagnosed with right atrial isomerism associated with total anomalous pulmonary venous return (TAPVR), a functional single ventricle and major aortopulmonary collateral arteries (MAPCA), underwent left MAPCA unifocalization and left Blalock-Taussig shunt (3.5 mm) at 3 months of age. The post-operative course was complicated by pulmonary venous congestion, and the drainage site of the TAPVR was found to be stenotic on echocardiography. We performed sutureless repair of the TAPVR along with unifocalization of the right MAPCA. She was put on an extracorporeal membrane oxygenator for 8 days after the 2nd operation, and she was able to come off the oxygenator with the placement of a central shunt (3 mm). She developed tracheal stenosis, which was presumably due to longstanding endotracheal intubation, and she then underwent tracheostomy. She was discharged to home on day 104 after the 1st operation, and she has been followed up for 2 months in a good clinical condition.

• Journal of Chest Surgery
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• v.37 no.1
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• pp.1-10
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• 2004

Background: Currently, the cardiopulmonary machine with non-pulsatile pumps, which are low in internal circuit pressure and cause little damage to blood cells, is widely used. However, a great number of experimental studies shows that pulsatile perfusions are more useful than non-pulsatile counterparts in many areas, such as homodynamic, metabolism, organ functions, and micro-circulation. Yet, many concerns relating to pulsatile cardiopulmonary machines, such as high internal circuit pressure and blood cell damage, have long hindered the development of pulsatile cardiopulmonary machines. Against this backdrop, this study focuses on the safety and effectiveness of the pulsatile cardiopulmonary machines developed by a domestic research lab. Material and Method: The dual-pulsatile cardiopulmonary bypass experiment with total extracorporeal circulation was conducted on six calves, Extracorporeal circulation was provided between superior/inferior vena cava and aorta. The membrane oxygenator, which was placed between the left and right pumps, was used for blood oxygenation. Circulation took four hours. Arterial blood gas analysis and blood tests were also conducted. Plasma hemoglobin levels were calculated, while pulse pressure and internal circuit pressure were carefully observed. Measurement was taken five times; once before the operation of the cardiopulmonary bypass, and after its operation it was taken every hour for four hours. Result: Through the arterial blood gas analysis, PCO2 and pH remained within normal levels. PO2 in arterial blood showed enough oxygenation of over 100 mmHg. The level of plasma hemoglobin, which had total cardiopulmonary circulation, steadily increased to 15.87 $\pm$ 5.63 after four hours passed, but remained below 20 mg/㎗. There was no obvious abnormal findings in blood test. Systolic blood pressure which was at 97.5$\pm$5.7 mmHg during the pre-circulation contraction period, was maintained over 100 mmHg as time passed. Moreover, diastolic blood pressure was 72.2 $\pm$ 7.7 mmHg during the expansion period and well kept at the appropriate level with time passing by. Average blood pressure which was 83$\pm$9.2 mmHg before circulation, increased as time passed, while pump flow was maintained over 3.3 L/min. Blood pressure fluctuation during total extracorporeal circulation showed a similar level of arterial blood pressure of pre-circulation heart. Conclusion: In the experiment mentioned above, pulsatile cardiopulmonary machines using the doual-pulsatile structure provided effective pulsatile blood flow with little damage in blood cells, showing excellence in the aspects of hematology and hemodynamic. Therefore, it is expected that the pulsatile cardiopulmonary machine, if it becomes a standard cardiopulmonary machine in all heart operations, will provide stable blood flow to end-organs.

• Journal of computational fluids engineering
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• v.20 no.2
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• pp.88-95
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• 2015

Blood pump analysis process includes both mechanical and bio-mechanical aspects. Since a blood pump is a mechanical device, it has to be mechanically efficient. On the other hand, blood pumps function is sensitively related to the blood recirculation; hence, bio-factors such as hemolysis and thrombosis become important. This paper numerically investigates the mechanical and bio-mechanical performances of the Rotaflow in the extracorporeal membrane oxygenation(ECMO), Ventricular Assist Device(VAD), and full-load conditions. The operational conditions are defined as(400[mmHg], 5[L/min.]), (100[mmHg], 3[L/min.]), and (600[mmHg], 10[L/min.]) for ECMO, VAD, and full-load conditions, respectively. The results are presented and analyzed from the mechanical aspect via performance curves, and from bio-mechanical aspect via focusing on hemolytic characteristics. Regions of top and bottom cavities show recirculation in both ECMO and VAD condtions. In addition, Eulerian-based calculation of modified index of hemolysis(MIH) has been investigated. The results demonstrate that the VAD condition has the least risk of hemolysis among the others, while the full-load condition has the highest risk.

• Neonatal Medicine
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• v.25 no.3
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• pp.102-108
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• 2018

Purpose: Congenital diaphragmatic hernia (CDH) is rare but potentially fatal. The overall outcome is highly variable. This study aimed to identify a simple and dynamic parameter that helps predict the mortality of CDH patients in real time, without invasive tests. Methods: We conducted a retrospective chart review of 59 CDH cases. Maternal and fetal information included the gestational age at diagnosis, site of defect, presence of liver herniation, and lung-to-head ratio (LHR) at 20 to 29 weeks of gestational age. Information regarding postnatal treatment, including the number of days until surgery, the need for inhaled nitric oxide (iNO), the need for extracorporeal membrane oxygenation (ECMO), and survival, was collected. The highest respiratory severity score (RSS) within 24 hours after birth was also calculated. Results: Statistical analysis showed that a younger gestational age at the initial diagnosis (P<0.001), a lower LHR (P=0.001), and the presence of liver herniation (P=0.003) were prenatal risk factors for CDH mortality. The RSS and use of iNO and ECMO were significant factors affecting survival. In the multivariate analysis, the only remaining significant risk factor was the highest preoperative RSS within 24 hours after birth (P=0.002). The area under the receiver operating characteristic curve was 0.9375, with a sensitivity of 91.67% and specificity of 83.87% at the RSS cut-off value of 5.2. The positive and negative predictive values were 82.14% and 92.86%, respectively. Conclusion: Using the RSS as a prognostic predictor with simple calculations will help clinicians plan CDH management.

• Journal of Chest Surgery
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• v.46 no.1
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• pp.41-48
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• 2013

Background: We present our 12-year experience of pulmonary thromboendarterectomy in patients with chronic thromboembolic pulmonary hypertension. Materials and Methods: Between January 1999 and March 2011, 16 patients underwent pulmonary thromboendarterectomy. Eleven patients (69%) were classified as functional class III or IV based on the New York Heart Association (NYHA) classification. Seven patients had a history of inferior vena cava filter insertion, and 5 patients showed coagulation disorders. Pulmonary thromboendarterectomy was performed during total circulatory arrest with deep hypothermia in 14 patients. Results: In-hospital mortality and late death occurred in 2 patients (12.5%) and 1 patient (6.3%), respectively. Extracorporeal membrane oxygenation support was required in 4 patients who developed severe hypoxemia after surgery. Thirteen of the 14 survivors have been followed up for 54 months (range, 2 to 141 months). The pulmonary arterial systolic pressure and cardiothoracic ratio on chest radiography was significantly decreased after surgery ($76{\pm}26$ mmHg vs. $41{\pm}17$ mmHg, p=0.001; $55%{\pm}8%$ vs. $48%{\pm}3%$, p=0.003). Tricuspid regurgitation was reduced from $2.1{\pm}1.1$ to $0.7{\pm}0.6$ (p=0.007), and the NYHA functional class was also improved to I or II in 13 patients (81%). These symptomatic and hemodynamic improvements maintained during the late follow-up period. Conclusion: Pulmonary thromboendarterectomy for chronic thromboembolic pulmonary hypertension shows good clinical outcomes with acceptable early and long term mortality.

• Journal of Chest Surgery
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• v.43 no.3
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• pp.312-315
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• 2010

Infection of both native and prosthetic vessels in the groin is a very serious disease because of recurrent arterial rupture and sepsis, which can cause death. The successful treatment of groin infection, including infection of the femoral artery, requires extensive excision of the infected tissues and restoration of the circulation where the infected area is isolated. Here we describe a case of obturator bypass in a patient with infected femoral artery rupture that occurred after extracorporeal membrane oxygenation for myocarditis and severe heart failure.

• Communications for Statistical Applications and Methods
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• v.24 no.6
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• pp.561-581
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• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• Journal of Chest Surgery
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• v.34 no.4
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• pp.356-360
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• 2001

일시적 혹은 단기간의 심폐보조는 여러 형태의 심부전에서 널리 이용되어 왔다. 이 중 체외막산소화장치는 고식적 치료에 반응없는 환자에서 주로 사용되는데, 소아에서는 자주 이용되어 왔으나 성인에서는 그 적응증이 명확하지 않았으며 결과도 만족스럽지 못했다. 환자는 승모판 협착증을 가진 32세의 여자로 제왕절개술후 발생한 폐부종으로 내원하였다. 내원시 환자는 쇽상태로 강심제, 폐혈관확장제, 이뇨제등에 반응이 없었다. 우측 대퇴정-동맥캐뉼라를 통하여 14시간동안 체외막산소화장치를 이용하였으며, 환자상태는 가동 즉시 호전을 보였다. 이후 양측판막치환술을 시행하였고 수술 후에도 체외막산호화장치를 지속하였다. 체외막산호화장치는 수술시간을 포함하여 모두 62시간동안 가동하였으며, 이탈(weaning)은 안정된 혈류역학, 호전된 폐부종, 기저질환의 교정등을 통하여 성공적으로 이루어졌다. 환자는 판막수술 후 30일째 특별한 합병증없이 퇴원하였다.