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Differences between xenotransplantation and allogeneic kidney transplantation: the current situation and future challenges in Japan. 异种移植和异体肾移植的区别:日本的现状和未来的挑战。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-05-02 DOI: 10.1007/s10047-025-01506-x
Soichi Matsumura, Yoichi Kakuta, Yoko Maegawa-Higa, Shota Fukae, Ryo Tanaka, Shigeaki Nakazawa, Kazuaki Yamanaka, Shuji Miyagawa, Norio Nonomura

Kidney transplantation is the only curative option for patients with chronic renal failure, significantly improving their survival and quality of life. However, this treatment remains limited by the shortage of organ donors. The shortage of kidney donors remains a serious problem all over the world, and is particularly severe in Japan. While advancements in immunosuppressive therapies and histocompatibility testing have improved outcomes in allogeneic kidney transplantation, the rising number of dialysis patients has worsened the gap between the demand for and supply of suitable donor organs. In response to this pressing need, xenotransplantation has gained attention as a promising alternative solution. Recent progress driven by gene-editing technologies, including CRISPR-Cas9, has facilitated the development of genetically modified pigs suitable for potential human transplantation. This review provides an overview of the key differences in immune response and infection risks between xenogeneic and allogeneic kidney transplants. In addition, it comprehensively examines the challenges and potential of xenogeneic kidney transplantation from multiple perspectives, including differences in immunosuppressive therapies between allogeneic and xenogeneic transplantation. We also discuss the feasibility of xenogeneic kidney transplantation as a solution to the organ shortage in Japan and present directions for addressing challenges toward clinical application. We hope this review will provide valuable insights into the potential of xenogeneic kidney transplantation as a new treatment option for chronic renal failure and contribute to efforts to address the donor shortage problem in Japan.

肾移植是慢性肾功能衰竭患者唯一的治疗选择,可显著提高患者的生存率和生活质量。然而,这种治疗仍然受到器官捐献者短缺的限制。肾脏捐献者的短缺仍然是世界各地的一个严重问题,在日本尤为严重。虽然免疫抑制疗法和组织相容性测试的进步改善了异体肾移植的结果,但透析患者数量的增加加剧了合适供体器官的需求和供应之间的差距。针对这一迫切需求,异种移植作为一种有希望的替代解决方案而受到关注。包括CRISPR-Cas9在内的基因编辑技术推动了最近的进展,促进了适合潜在人类移植的转基因猪的发展。本文综述了异种和同种异体肾脏移植在免疫反应和感染风险方面的主要差异。此外,它还从多个角度全面探讨了异体肾移植的挑战和潜力,包括异体肾移植和异体肾移植在免疫抑制治疗方面的差异。我们还讨论了异种肾移植作为解决日本器官短缺的可行性,并提出了应对临床应用挑战的方向。我们希望这篇综述将为异种肾移植作为慢性肾功能衰竭的新治疗选择的潜力提供有价值的见解,并有助于解决日本供体短缺的问题。
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引用次数: 0
A novel blood volume monitoring approach in a venous reservoir using a laser displacement sensor for blood surface distance measurement. 一种利用激光位移传感器测量血液表面距离的静脉血容量监测新方法。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-05-16 DOI: 10.1007/s10047-025-01505-y
Shinichi Fukuhara, Ken-Ichiro Yamamoto

A venous reservoir (VR) is crucial for safe blood volume regulation during cardiopulmonary bypass (CPB) procedures. Currently, blood volume measurement in VRs relies heavily on visual inspection, which limits its accuracy and responsiveness. In this paper, a method that leverages a laser displacement sensor for blood surface distance change detection in VRs with high accuracy and simplicity is proposed. It enables precise, non-contact, real-time measurements for displacement and position analysis of blood surface. Hard-shell VRs maintain a constant relationship between blood volume and blood surface height. Therefore, we measured the blood surface distance and the distance between the sensors. The findings of this study demonstrate that blood volume correlates with the distance measured from the blood surface to the sensor, showing clear "blood surface distance-volume characteristic" curves specific to each VR. Experimental results confirm excellent reproducibility and low variability, even under different conditions, such as blood dilution and varying ambient light. In addition, the blood volume dynamic behavior during CPB can be captured with measurements that are in good agreement with theoretical predictions. Our findings confirm the potential of blood volume estimation based on blood surface distance measurements, making it a promising alternative for real-time blood volume monitoring during CPB. Integrating this method into CPB systems could improve safety, prevent air embolisms, and improve fluid management, paving the way for more precise and automated circulating blood volume control.

在体外循环(CPB)过程中,静脉储血池(VR)对安全的血容量调节至关重要。目前,vr中的血容量测量严重依赖于视觉检测,这限制了其准确性和响应性。本文提出了一种利用激光位移传感器进行vr血液表面距离变化检测的方法,该方法精度高,操作简单。它能够精确、非接触、实时测量血液表面的位移和位置分析。硬壳vr在血容量和血表面高度之间保持恒定的关系。因此,我们测量了血液表面的距离和传感器之间的距离。本研究的结果表明,血容量与从血液表面到传感器的距离相关,显示出每个VR特有的清晰的“血表面距离-体积特征”曲线。实验结果证实,即使在不同的条件下,如血液稀释和不同的环境光,也具有出色的再现性和低变异性。此外,CPB期间的血容量动态行为可以通过与理论预测很好地一致的测量来捕获。我们的研究结果证实了基于血表面距离测量的血容量估计的潜力,使其成为CPB期间实时血容量监测的有希望的替代方案。将这种方法集成到CPB系统中可以提高安全性,防止空气栓塞,改善流体管理,为更精确和自动化的循环血容量控制铺平道路。
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引用次数: 0
Fouling process of hemodiafiltration membranes by hemodialysis and hemodiafiltration therapy. 血液透析及血液滤过治疗对血液滤过膜的污染过程。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-02-27 DOI: 10.1007/s10047-025-01497-9
Yoshihiro Tange, Masashi Kawakami, Shingo Takesawa

During hemodialysis, proteins, such as albumin and globulin, are deposited on the dialysis membrane surface, causing fouling that affects solute removal and biocompatibility. This study aimed to measure the filtration coefficient as an index of dialysis membrane conditions in hemodialysis, pre-dilution online hemodiafiltration, and intermittent infusion hemodiafiltration modes using two different hemodiafiltration membranes ex vivo. The filtration coefficients of hemodiafiltration membranes in hemodialysis, pre-dilution online hemodiafiltration, and intermittent infusion hemodiafiltration modes were continuously measured for 123 min using 2 L bovine blood, which was adjusted with 32% hematocrit and 6.5 g/dL of total proteins. Polysulfone and cellulose triacetate were used as test membrane materials, and both membrane structures were asymmetric. The first fouling step was observed 20 s after filtration of both polysulfone and cellulose triacetate membranes in each mode. Thereafter, the filtration coefficient recovered in the pre-dilution online hemodiafiltration mode. However, it plateaued in the cellulose triacetate membrane and decreased in the polysulfone membrane. A flushing effect of the intermittent infusion hemodiafiltration mode was observed in both the cellulose triacetate and polysulfone membranes. The differences in fouling steps in each of the three modes-hemodialysis, pre-dilution online hemodiafiltration, and intermittent infusion hemodiafiltration-can be identified by continuously measuring filtration coefficient values.

在血液透析过程中,蛋白质,如白蛋白和球蛋白,沉积在透析膜表面,造成污染,影响溶质的去除和生物相容性。本研究旨在体外测量两种不同血液滤膜在血液透析、预稀释在线血液滤膜和间歇输注血液滤膜模式下的过滤系数作为透析膜状况的指标。采用2 L牛血,以32%的红细胞比容和6.5 g/dL的总蛋白为调节因子,连续测量血液透析、预稀释在线血液滤过和间歇输注血液滤过模式下血液滤过膜的滤过系数123 min。以聚砜和三醋酸纤维素为试验膜材料,两种膜结构均为不对称膜。聚砜膜和三醋酸纤维素膜在每种模式下过滤20 s后观察到第一个污染步骤。之后,过滤系数在预稀释在线血液滤过模式下恢复。然而,它在三醋酸纤维素膜中趋于稳定,在聚砜膜中下降。在三醋酸纤维素膜和聚砜膜中观察到间歇输注血液滤过方式的冲洗效果。通过连续测量过滤系数值,可以确定三种模式(血液透析、预稀释在线血液滤过和间歇输注血液滤过)中污垢步骤的差异。
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引用次数: 0
Silk-elastin sponge is effective for burn therapy after surgical debridement. 丝弹性蛋白海绵是外科清创后烧伤的有效治疗方法。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-02-28 DOI: 10.1007/s10047-025-01496-w
Yoshitaka Matsuura, Katsuya Kawai, Shingo Kawabata, Kazuo Noda, Eiichi Sawaragi, Naoki Morimoto

Silk-elastin is an artificial protein that helps promote wound healing. The present study was performed to examine the effect of silk-elastin on burns using an animal model. Partial- and full-thickness burns were applied to the back of rats using a metal device. And the necrotic tissue was excised via surgical debridement and dressing materials were applied. Two groups, namely, the silk-elastin sponge and control groups, were established in the case of deep partial-thickness burns and full-thickness burns, respectively. Tissue samples from the partial-thickness burn model obtained at the 5th day and the 7th day after debridement were analyzed. The length of epithelization in the tissue sample and wound healing rate were evaluated on macro-photographs. And tissue samples from the full-thickness burn model obtained at the 7th day and 14th day after debridement were analyzed. The area of granulation, length of epithelization, and number of vessels in the tissue sample and wound healing rate were evaluated on macro-photographs. The silk-elastin group showed a better wound healing rate and superior epithelization and granulation and angiogenesis in comparison to control group. And our findings on day 14 in full-thickness burn suggest a potential difference in the quality of scars. Silk-elastin sponge can help promote burn wound healing after debridement. This new material can accelerate epithelization, granulation, and neoangiogenesis at the early stage after application with less dressing change. We believe that silk-elastin is a good material for use in topical burn therapy. And the new material may reduce scar forming after healed.

丝绸弹性蛋白是一种人工蛋白质,有助于促进伤口愈合。本研究采用动物模型研究了丝弹性蛋白对烧伤的影响。用金属装置对大鼠背部进行部分和全层烧伤。手术清创切除坏死组织,应用敷料。在深度部分厚度烧伤和全厚度烧伤情况下,分别建立丝弹性蛋白海绵组和对照组。对清创后第5天和第7天部分厚度烧伤模型的组织样本进行分析。用宏观照片评价组织标本上皮长度和创面愈合率。并对清创后第7天和第14天全层烧伤模型的组织样本进行分析。在宏观照片上评估肉芽的面积,上皮的长度,组织样本中的血管数量和伤口愈合率。与对照组相比,丝弹性蛋白组创面愈合率更高,上皮、肉芽和血管生成也更好。我们在全层烧伤第14天的研究结果表明,疤痕的质量可能存在差异。丝弹性海绵可促进烧伤创面清创后的愈合。这种新材料可以在应用后的早期加速上皮、肉芽形成和新生血管生成,减少敷料更换。我们认为丝弹性蛋白是一种很好的材料,用于局部烧伤治疗。新材料可以减少愈合后疤痕的形成。
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引用次数: 0
The first case of central Y-Y extra-corporeal membrane oxygenation system in a pediatric patient. 第一例中央Y-Y体外膜氧合系统在儿科患者。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-02-16 DOI: 10.1007/s10047-024-01490-8
Kazuki Tanimoto, Shigemitsu Iwai, Motoki Komori, Naoki Tadokoro, Satsuki Fukushima, Hajime Ichikawa

The mechanical circulatory support (MCS) for pediatric patients with severe acute heart failure and poor pulmonary conditions is challenging. Herein, we report the first pediatric case of successfully treated by central Y-Y extra-corporeal membrane oxygenation (ECMO). A 10-year-old boy weighing 35 kg with a body surface area of 1.11 m2 was transferred to our institution in cardiac arrest with ongoing cardiopulmonary resuscitation using intra-aortic balloon pump and peripheral ECMO inserted at the previous hospital. Then, MCS system was converted to central ECMO with left heart drainage due to severe pulmonary congestion and the anticipation of long-term MCS. After 3 days, we converted it to central Y-Y ECMO because of concern about intracavitary thrombus formation due to poor pulmonary conditions. After four more days, the pulmonary conditions were improved, and we converted the MCS system into left ventricular assist device (LVAD) system. He is awaiting the heart transplantation eligibility review in a stable condition. Central Y-Y ECMO system can be used as a bridge to decision also for a pediatric patient with acute severe heart failure and poor pulmonary conditions.

机械循环支持(MCS)的儿科患者严重急性心力衰竭和不良肺条件是具有挑战性的。在此,我们报告第一例成功治疗中央Y-Y体外膜氧合(ECMO)的儿科病例。一名10岁男孩,体重35 kg,体表面积1.11 m2,因心脏骤停转至我院,在原医院使用主动脉内球囊泵和外周ECMO进行心肺复苏。然后,由于严重的肺充血和对长期MCS的预期,MCS系统转换为左心引流的中央ECMO。3天后,由于担心肺部状况不佳导致腔内血栓形成,我们将其转为中央Y-Y ECMO。再过4天,肺部状况有所改善,我们将MCS系统转换为左心室辅助装置(LVAD)系统。他目前情况稳定,正在等待心脏移植资格审查。中央Y-Y ECMO系统也可用于急性严重心力衰竭和肺部状况不佳的儿科患者的决策桥梁。
{"title":"The first case of central Y-Y extra-corporeal membrane oxygenation system in a pediatric patient.","authors":"Kazuki Tanimoto, Shigemitsu Iwai, Motoki Komori, Naoki Tadokoro, Satsuki Fukushima, Hajime Ichikawa","doi":"10.1007/s10047-024-01490-8","DOIUrl":"10.1007/s10047-024-01490-8","url":null,"abstract":"<p><p>The mechanical circulatory support (MCS) for pediatric patients with severe acute heart failure and poor pulmonary conditions is challenging. Herein, we report the first pediatric case of successfully treated by central Y-Y extra-corporeal membrane oxygenation (ECMO). A 10-year-old boy weighing 35 kg with a body surface area of 1.11 m<sup>2</sup> was transferred to our institution in cardiac arrest with ongoing cardiopulmonary resuscitation using intra-aortic balloon pump and peripheral ECMO inserted at the previous hospital. Then, MCS system was converted to central ECMO with left heart drainage due to severe pulmonary congestion and the anticipation of long-term MCS. After 3 days, we converted it to central Y-Y ECMO because of concern about intracavitary thrombus formation due to poor pulmonary conditions. After four more days, the pulmonary conditions were improved, and we converted the MCS system into left ventricular assist device (LVAD) system. He is awaiting the heart transplantation eligibility review in a stable condition. Central Y-Y ECMO system can be used as a bridge to decision also for a pediatric patient with acute severe heart failure and poor pulmonary conditions.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"468-472"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143433230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Why is organ transplantation from cardiac death donors necessary in Japan? An important strategy for heart transplantation in severe donor shortage. 为什么日本需要心脏死亡供体的器官移植?严重供体短缺的心脏移植的重要策略。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-02-13 DOI: 10.1007/s10047-025-01493-z
Hikaru Matsuda

Brain-dead donor (DBD) is the basis for most organ transplants and has been the exclusive method of choice for heart transplantation (HTx). However, the severe shortage of donors has been the common problem worldwide, especially in Japan. Meanwhile, the number of donors after cardiac (circulatory) death (DCD) has increased rapidly in the last 10 years, especially in Europe, thus expanding the donor pool. This strategy has been introduced in HTx since 2014, starting in Australia and the United Kingdom, with acceptable results. In most DCD, organs are removed under withdrawal of life support (WLST), which is called controlled DCD (cDCD). In Japan, we should consider introducing cDCD to supplement DBD, which is compromised by the shortage of donors. In this setting of cDCD, ethical and regulatory arguments arise as to the definition of human death and how to deal with WLST in organ donation. From a regulatory point of view, cDCD has been misunderstood as requiring a separate legislative development, and to dispel this misconception is the important message of this report. The development of an ex vivo machine perfusion system is another issue to start cDCD HTx as well as other organs. This paper outlines the issues involved in the introduction of cDCD for heart transplantation in Japan.

脑死亡供体(DBD)是大多数器官移植的基础,也是心脏移植的唯一选择方法。然而,捐助者的严重短缺一直是世界范围内的共同问题,特别是在日本。同时,心脏(循环)死亡(DCD)后的供体数量在过去10年中迅速增加,特别是在欧洲,从而扩大了供体池。自2014年以来,HTx就开始采用这种策略,从澳大利亚和英国开始,效果尚可。在大多数DCD中,器官是在生命维持系统(WLST)的撤销下被移除的,这被称为控制性DCD (cDCD)。在日本,我们应该考虑引入cDCD,以补充因捐助者不足而受到损害的DBD。在cDCD的背景下,关于人类死亡的定义以及如何处理器官捐赠中的WLST,出现了伦理和监管方面的争论。从监管的角度来看,cDCD被误解为需要单独的立法发展,而消除这种误解是本报告的重要信息。体外机器灌注系统的开发是启动cdcdhtx以及其他器官的另一个问题。本文概述了在日本心脏移植中引入cDCD所涉及的问题。
{"title":"Why is organ transplantation from cardiac death donors necessary in Japan? An important strategy for heart transplantation in severe donor shortage.","authors":"Hikaru Matsuda","doi":"10.1007/s10047-025-01493-z","DOIUrl":"10.1007/s10047-025-01493-z","url":null,"abstract":"<p><p>Brain-dead donor (DBD) is the basis for most organ transplants and has been the exclusive method of choice for heart transplantation (HTx). However, the severe shortage of donors has been the common problem worldwide, especially in Japan. Meanwhile, the number of donors after cardiac (circulatory) death (DCD) has increased rapidly in the last 10 years, especially in Europe, thus expanding the donor pool. This strategy has been introduced in HTx since 2014, starting in Australia and the United Kingdom, with acceptable results. In most DCD, organs are removed under withdrawal of life support (WLST), which is called controlled DCD (cDCD). In Japan, we should consider introducing cDCD to supplement DBD, which is compromised by the shortage of donors. In this setting of cDCD, ethical and regulatory arguments arise as to the definition of human death and how to deal with WLST in organ donation. From a regulatory point of view, cDCD has been misunderstood as requiring a separate legislative development, and to dispel this misconception is the important message of this report. The development of an ex vivo machine perfusion system is another issue to start cDCD HTx as well as other organs. This paper outlines the issues involved in the introduction of cDCD for heart transplantation in Japan.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"288-292"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143407749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of hybrid thoracic endovascular aortic repair for aortic arch diseases on life expectancy. 主动脉弓疾病混合胸血管内主动脉修复术对预期寿命的影响。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-04-24 DOI: 10.1007/s10047-025-01503-0
Tomoaki Kudo, Toru Kuratani, Ryoto Sakaniwa, Yoshiki Sawa, Shigeru Miyagawa

This study aimed to investigate whether the efficacy of proximal landing zones (LZs) 0, 1, and 2 in hybrid thoracic endovascular aortic repair (TEVAR) without cardiopulmonary bypass (CPB) in elderly patients can broaden aortic arch surgical eligibility from the perspective of a lifetime loss. From April 2008 to March 2020, 254 patients who underwent LZs 0, 1, and 2 hybrid TEVAR without CPB were enrolled (zone 0 in 41, zone 1 in 82, and zone 2 in 131 patients). The patients had a median age of 73 years, with a median follow-up period of 5.8 years. The median operative time was 172 min, the median postoperative hospital stay was 11 days, and the discharge rate to home was 95.3%. The survival rate, aorta-related death-free rate, and aortic events-free rate at 10 years were 72.8%, 97.0%, and 88.5%. A multivariable Cox proportional hazard regression analysis showed that age (p < 0.001), preoperative stroke (p = 0.042), and an occurrence of 30-day aortic events (p = 0.022) were significant risk factors for all-cause death. The lifetime loss for 75, 80, 85, and ≥ 90-year-old patients at the time of surgery was 0.2, 0.1, 0, and 0 years. Despite the high risk of surgical management of aortic arch diseases, this study revealed that LZs 0, 1, and 2 hybrid TEVAR without CPB in ≥ 75-year-old patients can be expected to result in a life expectancy similar to the standard life expectancy. Advanced age alone should not exclude surgical treatment for patients with arch diseases.

本研究旨在探讨近端着落区(LZs) 0、1和2在不经体外循环(CPB)的混合型胸廓血管内主动脉修复(TEVAR)中的疗效是否能从终身损失的角度拓宽主动脉弓手术的资格。从2008年4月到2020年3月,254例接受LZs 0、1和2混合型TEVAR无CPB的患者入组(41例为0区,82例为1区,131例为2区)。患者的中位年龄为73岁,中位随访时间为5.8年。手术时间中位数为172 min,住院时间中位数为11 d,出院率为95.3%。10年生存率、主动脉相关无死亡率和主动脉事件无发生率分别为72.8%、97.0%和88.5%。多变量Cox比例风险回归分析显示,年龄(p
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引用次数: 0
Artificial blood vessels-clinical development of TEVG. 人工血管- TEVG的临床发展。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-05-26 DOI: 10.1007/s10047-025-01508-9
Manabu Itoh, Keiji Kamohara, Koichi Node, Koichi Nakayama

The market for small-diameter vascular grafts (< 6 mm) used in cardiac and vascular surgery has not yet been fully established, as stable long-term patency has not been achieved. This paper focuses on the clinical development of tissue-engineered vascular grafts (TEVGs), especially those that have progressed to clinical trials, and introduces their current status with historical background and future directions. This review was created based on a translation of the Japanese review first reported in the Japanese Journal of Artificial Organs in 2023 (vol. 52, no. 3, pp. 161-166), with some modifications.

小直径血管移植市场(
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引用次数: 0
Development of transcatheter implantable autologous tissue-engineered pulmonary valves using in-body tissue architecture. 采用体内组织结构的经导管植入式自体组织工程肺瓣膜的研制。
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-05-26 DOI: 10.1007/s10047-025-01507-w
Yasushi Sato, Yusuke Inoue, Takeshi Terazawa, Tomoki Nagayoshi, Kazuto Fujimoto, Isao Shiraishi, Kensuke Takamatsu, Kunihiro Ohta, Yoshiaki Takewa

Transcatheter pulmonary valve implantation (TPVI) is a minimally invasive procedure used to treat pulmonary valve dysfunction in congenital heart disease. However, the limited durability of xenogeneic bioprosthetic valves is a significant concern. Tissue-engineered heart valves (TEHVs) have emerged as a promising alternative. We developed an autologous TEHV, Biovalve, using an in-body tissue architecture technology based on tissue encapsulation. In this study, we aimed to develop stent-integrated Biovalves (stent Biovalves) that can be applied to TPVI. We designed an asymmetric hourglass-shaped stent and a caged mold specifically for TPVI. The stent was fixed inside the mold by placing it on a core rod and covering it with an outer cage. After subcutaneous implantation of the molds with stents for 2 months, the molds with formed tissue were harvested and removed to obtain the stent Biovalve. The stent struts were completely covered with dense collagen. The stent Biovalve demonstrated intact insertion and deployment via the catheter and was successfully implanted in the goat pulmonary valve location. No complications such as stenosis, regurgitation, or translocation occurred post-implantation, with about 6 months of survival without anticoagulant therapy, excellent biocompatibility, and potential antithrombotic properties. There were no significant findings of thrombus or calcification in the excised Biovalve, and cell migration from the host tissue indicated ongoing tissue remodeling. Utilizing a novel mold with an outer cage ensures stent integration, enabling Biovalve production regardless of stent shape. This study presents a promising strategy to address the challenges of transcatheter heart valve implantation.

经导管肺动脉瓣植入术(TPVI)是一种用于治疗先天性心脏病肺动脉瓣功能障碍的微创手术。然而,异种生物假体瓣膜的有限耐用性是一个值得关注的问题。组织工程心脏瓣膜(tehv)已成为一种有前途的替代方案。我们开发了一种自体TEHV, Biovalve,使用基于组织封装的体内组织结构技术。在本研究中,我们旨在开发可应用于TPVI的支架集成生物瓣膜(stent biovalve)。我们专门为TPVI设计了一个不对称沙漏形支架和一个笼状模具。将支架固定在模具内,将其放置在芯棒上,并用外笼覆盖。将模具与支架皮下植入2个月后,取出已形成组织的模具,获得支架Biovalve。支架支架完全被致密的胶原蛋白覆盖。Biovalve支架通过导管完整地插入和部署,并成功植入山羊肺动脉瓣位置。植入后未发生狭窄、反流或易位等并发症,无抗凝治疗存活约6个月,具有良好的生物相容性和潜在的抗血栓特性。在切除的Biovalve中没有明显的血栓或钙化,并且来自宿主组织的细胞迁移表明正在进行的组织重塑。利用带有外笼的新型模具确保支架的集成,使Biovalve生产无论支架形状如何。本研究提出了一个有希望的策略来解决经导管心脏瓣膜植入的挑战。
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引用次数: 0
Survey on Japanese emergency physicians' awareness of advanced mechanical circulatory support upgrade therapy for patients with out-of-hospital cardiac arrest receiving extracorporeal cardiopulmonary resuscitation. 日本急诊医师对院外心脏骤停接受体外心肺复苏患者先进机械循环支持升级疗法认知的调查
IF 1.3 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-09-01 Epub Date: 2025-04-14 DOI: 10.1007/s10047-025-01502-1
Tasuku Hada, Toru Hifumi, Shutaro Isokawa, Yasumasa Tsukamoto, Norihide Fukushima, Norio Otani

Destination therapy (DT) using an implantable left ventricular assist device (i-LVAD) in Japan has expanded treatment options for patients with out-of-hospital cardiac arrest (OHCA) receiving extracorporeal cardiopulmonary resuscitation (ECPR). However, achieving hemodynamic stabilization and improved peripheral organ perfusion is essential. In patients with OHCA, percutaneous mechanical circulatory support (MCS) devices may be inadequate in some cases, necessitating surgical MCS. Despite the growing importance of MCS upgrading, awareness among Japanese emergency physicians remains unclear. We aimed to assess awareness of advanced MCS upgrading strategies in refractory patients after ECPR. A nationwide survey of 293 emergency and critical care centers in Japan assessed awareness of i-LVAD therapy after ECPR. The questionnaire collected data on demographics, LVAD strategy recognition, MCS upgrade practices, and barriers. Of 90 facilities (31%) that responded, 87 (30%) consented to using their responses in the analysis. Awareness of DT was 59.8%. Notably, 66.7% and 70.1% of the respondents recognized that MCS upgrading could lead to i-LVAD treatment and heart transplantation, respectively. The major barrier to MCS upgrade therapy was the facility's inability to implement it. DT awareness was similar between IMPELLA-registered and non-registered facilities, but i-LVAD indication recognition was higher in IMPELLA-registered facilities (78.0% vs. 51.4%, P = 0.009). The low survey response rate suggests limited MCS upgrade awareness among Japanese emergency physicians. Although facilities recognize pathways to i-LVAD and transplantation, barriers to their implementation persist. IMPELLA-registered facilities showed higher i-LVAD indication recognition, reflecting their accessibility to LV unloading devices and connections with backup hospitals.

在日本,使用植入式左心室辅助装置(i-LVAD)的目的治疗(DT)扩大了接受体外心肺复苏(ECPR)的院外心脏骤停(OHCA)患者的治疗选择。然而,实现血流动力学稳定和周围器官灌注改善是必不可少的。在OHCA患者中,经皮机械循环支持(MCS)装置在某些情况下可能不够,需要手术MCS。尽管MCS升级的重要性日益增加,但日本急诊医生的意识仍不清楚。我们的目的是评估ECPR后难治性患者对先进MCS升级策略的认识。一项对日本293个急诊和重症护理中心的全国性调查评估了ECPR后i-LVAD治疗的认识。问卷收集了人口统计、LVAD策略识别、MCS升级实践和障碍方面的数据。在回应的90家机构(31%)中,87家(30%)同意在分析中使用他们的回答。DT知晓率为59.8%。值得注意的是,66.7%和70.1%的受访者分别认识到MCS升级可能导致i-LVAD治疗和心脏移植。MCS升级治疗的主要障碍是医院无法实施。在impella注册和未注册的设施之间,DT认知度相似,但在impella注册的设施中,i-LVAD适应症认知度更高(78.0% vs. 51.4%, P = 0.009)。较低的调查回复率表明,日本急诊医生对MCS升级的认识有限。虽然医院已经识别了i-LVAD和移植的途径,但实施的障碍仍然存在。impella注册的医院对i-LVAD适应症的认可度较高,这反映了它们对LV卸载设备的可及性以及与后备医院的联系。
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引用次数: 0
期刊
Journal of Artificial Organs
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