• Journal of Chest Surgery
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• 제57권2호
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• pp.184-194
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• 2024

Background: Left ventricular assist devices (LVADs) are widely employed as a therapeutic option for end-stage heart failure. We evaluated the outcomes associated with centrifugal-flow LVAD implantation, comparing 2 device models: the Heartmate 3 (HM3) and the Heartware Ventricular Assist Device (HVAD). Methods: Data were collected from patients who underwent LVAD implantation between June 1, 2015 and December 31, 2022. We analyzed overall survival, first rehospitalization, and early, late, and LVAD-related complications. Results: In total, 74 patients underwent LVAD implantation, with 42 receiving the HM3 and 32 the HVAD. A mild Interagency Registry for Mechanically Assisted Circulatory Support score was more common among HM3 than HVAD recipients (p=0.006), and patients receiving the HM3 exhibited lower rates of preoperative ventilator use (p=0.010) and extracorporeal membrane oxygenation (p=0.039). The overall early mortality rate was 5.4% (4 of 74 patients), with no significant difference between groups. Regarding early right ventricular (RV) failure, HM3 implantation was associated with a lower rate (13 of 42 [31.0%]) than HVAD implantation (18 of 32 [56.2%], p=0.051). The median rehospitalization-free period was longer for HM3 recipients (16.9 months) than HVAD recipients (5.3 months, p=0.013). Furthermore, HM3 recipients displayed a lower incidence of late hemorrhagic stroke (p=0.016). In the multivariable analysis, preoperative use of continuous renal replacement therapy (odds ratio, 22.31; p=0.002) was the only significant predictor of postoperative RV failure. Conclusion: The LVAD models (HM3 and HVAD) demonstrated comparable overall survival rates. However, the HM3 was associated with a lower risk of late hemorrhagic stroke.

• Journal of Chest Surgery
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• 제57권3호
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• pp.315-318
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• 2024

The HeartWare Ventricular Assist Device (HVAD) was widely used for mechanical circulatory support in patients with end-stage heart failure. However, there have been reports of a critical issue with HVAD pumps failing to restart, or experiencing delays in restarting, after being stopped. This case report describes 2 instances of HVAD failure-to-restart during heart transplantation surgery and routine outpatient care. Despite multiple attempts to restart the pump using various controllers and extensions, the HVAD failed to restart, triggering a hazard alarm for pump stoppage. In one case, the patient survived after receiving a heart transplantation, while in the other, the patient died immediately following the controller exchange. These cases highlight the rare but life-threatening complication of HVAD failure-to-restart, underscoring the importance of awareness among clinicians, patients, and caregivers, and adherence to the manufacturer's guidelines and recommendations for HVAD management.

• Journal of Chest Surgery
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• 제54권6호
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• pp.543-546
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• 2021

A 55-year-old woman who had received an implantable left ventricular assist device 3 months earlier presented with dyspnea and a low-flow alarm of the device. Computed tomography and log-file analysis of the device system suggested inflow cannula obstruction. Since the patient had cardiogenic shock due to pump failure, venoarterial extracorporeal membrane oxygenation (ECMO) was initiated. With ECMO, surgical exchange of the pump was considered. However, the obstruction spontaneously resolved without surgical intervention. It turned out that an obstructive thrombus was washed out by rebooting the pump. Moreover, the thrombus was embolized in the patient's left subclavian artery. The patient underwent heart transplantation 4 months after the pump obstruction accident and continued to do well.

• The Korean journal of internal medicine
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• 제34권1호
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• pp.11-43
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• 2019

Heart failure (HF) is an important cardiovascular disease because of its increasing prevalence, significant morbidity, high mortality, and rapidly expanding health care cost. The number of HF patients is increasing worldwide, and Korea is no exception. There have been marked advances in definition, diagnostic modalities, and treatment of HF over the past four decades. There is continuing effort to improve risk stratification of HF using biomarkers, imaging and genetic testing. Newly developed medications and devices for HF have been widely adopted in clinical practice. Furthermore, definitive treatment for end-stage heart failure including left ventricular assist device and heart transplantation are rapidly evolving as well. This review summarizes the current state-of-the-art management for HF and the emerging diagnostic and therapeutic modalities to improve the outcome of HF patients.

• Journal of Chest Surgery
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• 제53권6호
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• pp.368-374
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• 2020

Background: The extracorporeal ventricular assist device (e-VAD) system is designed for left ventricular support using a permanent life support console. This study aimed to determine the impact of temporary e-VAD implantation bridging on posttransplant outcomes. Methods: We reviewed the clinical records of 6 patients with the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1, awaiting heart transplantation, who were provided with temporary e-VAD from 2018 to 2019. The circuit comprised a single centrifugal pump without an oxygenator. The e-VAD inflow cannula was inserted into the apex of the left ventricle, and the outflow cannula was positioned in the ascending aorta. The median follow-up duration was 8.4±6.9 months. Results: After e-VAD implantation, lactate dehydrogenase levels significantly decreased, and Sequential Organ Failure Assessment scores significantly improved. Bedside rehabilitation was possible in 5 patients. After a mean e-VAD support duration of 14.5±17.3 days, all patients were successfully bridged to transplantation. After transplantation, 5 patients survived for at least 6 months. Conclusion: e-VAD may reverse end-organ dysfunction and improve outcomes in INTERMACS I heart transplant patients.

• Journal of Magnetics
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• 제22권2호
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• pp.344-351
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• 2017

Wireless magnet pumps are used in medical applications and are particularly useful as artificial heart ventricular assist devices (VADs). To investigate wireless operation of magnetic pumps, we fabricated three types of magnetic impellers using bonded magnets by blending magnetic powders of SmFeN, NdFeB, and Sr-ferrite. We investigated the magnetic properties of the fabricated magnetic impellers, which are driven by the application of magnetic coupling with an external driving magnet or external coil system, without a driving motor, shaft, or mechanical bearings. The use of wireless magnetic pumps is therefore not complicated by critical issues of size, heat, and vibration, which are very important issues for blood pumps. The magnetic properties of the impellers, such as their rotational speed, driving torque and hydrodynamic performance, determine their wireless driving ranges. We conducted performance evaluations of the impeller's magnetic wireless manipulation, heat, and vibration. In addition, we carried out an animal test to confirm the suitability of the wireless magnetic pumps for use as biventricular assist devices (BiVADs).

• 대한의용생체공학회:의공학회지
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• 제40권5호
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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.

• Korean Circulation Journal
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• 제53권7호
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• pp.452-471
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• 2023

The Korean Society of Heart Failure (KSHF) Guidelines provide evidence-based recommendations based on Korean and international data to guide adequate diagnosis and management of heart failure (HF). Since introduction of 2017 edition of the guidelines, management of advanced HF has considerably improved, especially with advances in mechanical circulatory support and devices. The current guidelines addressed these improvements. In addition, we have included recently updated evidence-based recommendations regarding acute HF in these guidelines. In summary, Part IV of the KSHF Guidelines covers the appropriate diagnosis and optimized management of advanced and acute HF.

• Journal of Chest Surgery
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• 제32권5호
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• pp.428-432
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• 1999

배경: 전기적인 자극에 의하여 골격근의 피로현상이 극복됨으로써 골격근을 심장보조장치에 이용할 수 있게 되었다. 인공심장이나 심실보조기구는 에너지원의 전원장치가 크고 거추장스러운 단점이 있어 아직 해결해야될 문제이다. 반면 골격근을 이용한 심실보조장치는 에너지원으로 환자 자신의 골격근 수축력을 이용할 수 있는 장점이 있어 이의 임상응용 가능성을 제시하고자 한다. 대상 및 방법: 8예의 광배근을 이용하여 골격근 심실의 모형을 만들었다. 물이 담긴 라텍스 주머니를 골격근이 한바퀴 반 감싸도록 고안하였고 골격근의 수축압력은 연결된 관을 통하여 변환기에 기록되도록 하였다. 전극은 흉배신경 주위에 설치한 후 Itrel 7420 박동기에 연결하였다. 프로그래머로 박동기를 조절하였으며 3.0Volt, cyclic burst, 0.31초 on time, 6.0초 off time의 자극을 주었다. 라텍스 주머니 내에 액체의 양을 25cc 씩 증가시키면서 전부하의 변화에 따른 골격근 심실의 박출량과 압력 및 수축력을 측정하였다. 결과: 골격근 심실의 전부하가 0인 경우 일회박출량은 76.3ml 이고, 전부하가 점차 증가함에 따라 일회박출량이 감소하는 경향을 보였다. 전부하가 75cc 이상이 되면 일회박출량은 70ml 이하로 감소하는 양상을 볼 수 있었다. 압력을 측정한 결과도 전부하가 75cc 이하인 경우 정상의 혈압과 비슷한 107mmHg 이상의 혈압을 보이고 있으나 전부하가 100cc 이상 증가하는 경우 혈압이 100mmHg 이하로 감소하는 것을 볼 수 있었다. 또한 최대의 골격근 수축력은 50cc의 전부하에서 16.6 W/kg의 힘을 분출하였다. 결론: 골격근 심실은 전부하의 변화에 따라 정상 심장보다도 강한 박출량과 압력의 변화를 관찰할 수 있었으며 임상 응용의 가능성을 볼 수 있었다.

• 한국섬유공학회:학술대회논문집
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• 한국섬유공학회 2003년도 가을 학술발표회 논문집
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• pp.55-58
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• 2003

Segmented polyurethanes have been widely used for various commercial and experimental blood-contacting and tissue-contacting applications such as vascular prostheses, blood pumps, heart valves, pacemaker lead wire insulation, catheters, artificial hearts, and cardiac assist devices due to their generally favorable physical and mechanical properties, as well as fairly good biocompatibility and antithrombogenicity characteristics. (omitted)