{"title":"Artificial blood vessels-clinical development of TEVG.","authors":"Manabu Itoh, Keiji Kamohara, Koichi Node, Koichi Nakayama","doi":"10.1007/s10047-025-01508-9","DOIUrl":"10.1007/s10047-025-01508-9","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"308-316"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144142663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development of transcatheter implantable autologous tissue-engineered pulmonary valves using in-body tissue architecture.","authors":"Yasushi Sato, Yusuke Inoue, Takeshi Terazawa, Tomoki Nagayoshi, Kazuto Fujimoto, Isao Shiraishi, Kensuke Takamatsu, Kunihiro Ohta, Yoshiaki Takewa","doi":"10.1007/s10047-025-01507-w","DOIUrl":"10.1007/s10047-025-01507-w","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"393-401"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144150160","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}
{"title":"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.","authors":"Tasuku Hada, Toru Hifumi, Shutaro Isokawa, Yasumasa Tsukamoto, Norihide Fukushima, Norio Otani","doi":"10.1007/s10047-025-01502-1","DOIUrl":"10.1007/s10047-025-01502-1","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"354-364"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143997581","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}
Leonardo Spatola, Antonio Granata, Maria D'Amico, Gaspare Oddo, Alessia Gambaro
{"title":"Hemadsorption with CytoSorb®: focus on the latest experiences in cardiac surgery patients.","authors":"Leonardo Spatola, Antonio Granata, Maria D'Amico, Gaspare Oddo, Alessia Gambaro","doi":"10.1007/s10047-024-01485-5","DOIUrl":"10.1007/s10047-024-01485-5","url":null,"abstract":"<p><p>Cardiac surgery patients are potentially exposed to an acute inflammatory host response with a huge release of both pro- and anti-inflammatory cytokines both through intrinsic (e.g., tissue damage, endothelial injury) and extrinsic (e.g., anesthesia, extracorporeal circuits) mechanisms. Current standard of care therapy includes several invasive supportive treatments such as mechanical ventilation, continuous renal replacement therapy, ECMO, and/or cardiopulmonary bypass which may be responsible for an important inflammatory response. The inflammatory cytokine levels and hemodynamic status following these artificial treatments along with the current standard therapy are not always well controlled and may lead to worsened acute clinical conditions with prolonged in-hospital length of stay and increased mortality. In these settings, the administration of hemadsorption therapy with CytoSorb® has been supported by the successful results in several clinical studies as it has shown improvement of both the inflammatory profile and the hemodynamic vascular status of the patients. Therefore, in this narrative review, we summarized and discussed the current scientific literature on the role of CytoSorb<sup>®</sup> treatment in case of cardiac surgery. According to the current evidences, the raised inflammatory levels and both inotropic and vasopressor requests in cardiac surgery patients need more tailored therapies and, in this contest, the hemadsorption with CytoSorb<sup>®</sup> could play a pivotal role, especially on heart transplant patients. Furthermore, CytoSorb is currently the only hemadsorption sorbent authorized and efficiently applied for removing anticoagulant agents such as ticagrelor or rivaroxaban in patients undergoing cardiac surgery, to reduce perioperative bleeding complications and should be considered in high-risk patients.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"317-328"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872151","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}
{"title":"ECMO-weaning facilitated by neurally adjusted ventilatory assist (NAVA): a case for principal clarification.","authors":"F Heinold, O Moerer, L O Harnisch","doi":"10.1007/s10047-024-01484-6","DOIUrl":"10.1007/s10047-024-01484-6","url":null,"abstract":"<p><p>The use of veno-venous extracorporeal membrane oxygenation (VV-ECMO) has become increasingly prevalent, particularly in respiratory disease pandemics such as H1N1-influenza and SARS-CoV-2. This surge has emphasized the importance of clear therapy recommendations, improved accessibility to ECMO technology, established ECMO teams, and structured networks to ensure access to specialized care throughout the course of the disease for patients with severe ARDS. Although the initiation criteria for VV-ECMO are well defined, treatment strategies while on ECMO regarding e.g., ventilator management or ECMO weaning strategies remain variable and with lack of consensus. NAVA (Neurally Adjusted Ventilatory Assist), as an assisted mechanical ventilation modality, offers real-time electromyographic feedback, which has been shown to enhance prolonged weaning processes from mechanical ventilation. We present a case of penetrating thoracic trauma complicated by ARDS, successfully managed with VV-ECMO. NAVA was employed to monitor and facilitate ECMO. This approach integrates ECMO weaning with ventilation settings, considering both gas exchange lung function, such as carbon dioxide removal, and respiratory mechanics in the form of neuromuscular coupling. This is a new approach to VV-ECMO weaning. More research is planned to validate the efficacy of this method in conjunction with additional parameters, such as diaphragm activity evaluated sonographically in a randomized design. This case underscores the potential of NAVA in VV-ECMO weaning, offering a promising avenue for optimizing patient care and outcomes.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"462-467"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373675/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142818138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Elucidation of the mechanism of precipitate formation on mixing nafamostat mesylate solution with dialysate.","authors":"Iori Okamoto, Koichiro Oji, Otoka Nakashima, Yoka Shu, Hisatsugu Takahara, Hitoshi Suzuki, Hitoshi Muguruma","doi":"10.1007/s10047-025-01500-3","DOIUrl":"10.1007/s10047-025-01500-3","url":null,"abstract":"<p><p>This study clarifies the reagent preparation and administration conditions that lead to precipitation when nafamostat mesylate salt (NM) solution is mixed with dialysate. The objective is to elucidate the mechanism of precipitation. It was observed that the Carbostar<sup>®</sup> dialysate forms a precipitate immediately after mixing with the NM solution, whereas Kindaly<sup>®</sup> and Subpac<sup>®</sup> dialysates form a precipitate after approximately 30 min. This variance is attributed to the pH adjusters used: citric acid for Carbostar<sup>®</sup>, acetic acid for Kindaly<sup>®</sup>, and hydrochloric acid for Subpac<sup>®</sup>. As trivalent negative ions, citrate ions promote faster precipitation compared to acetic acid and hydrochloric acid, which are monovalent ions. Nafamostat acetate and nafamostat chloride salts are soluble, while nafamostat citrate is poorly soluble, leading to differences in precipitation timing. The bicarbonate ion's pK<sub>a</sub> value is 6.1, meaning precipitation does not occur if the pH is lowered below 6.1 using acetic acid or hydrogen chloride as pH adjusters. The solubility product of nafamostat bicarbonate is 8.1 × 10<sup>-7</sup> (mol/L)<sup>3</sup>, making precipitation inevitable under dialysis conditions ([nafamostat<sup>2+</sup>] = 5 mg/mL (9.2 mM), [HCO<sub>3</sub><sup>-</sup>] = 35 mM). The primary precipitate component is nafamostat bicarbonate salt. Although NM is initially water-soluble, it undergoes chemical transformation into a poorly soluble salt through ion exchange from mesylate ions to bicarbonate ions within the dialysate, resulting in precipitation. Based on these findings, we propose conditions to avoid precipitation.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"423-430"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803246","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}
{"title":"Progress of extracorporeal centrifugal pumps for mechanical circulatory supports.","authors":"Tomonori Tsukiya","doi":"10.1007/s10047-024-01492-6","DOIUrl":"10.1007/s10047-024-01492-6","url":null,"abstract":"<p><p>This review traces the evolution of centrifugal blood pumps in mechanical circulatory support (MCS) systems. Initially met with concerns over blood damage and thrombus formation, centrifugal pumps have become crucial components in ventricular assist devices (VADs) and extracorporeal membrane oxygenation (ECMO) due to their simplified drive mechanisms and adaptability. This paper outlines three generations of centrifugal pump development: first-generation pumps with sealing components, second-generation pumps utilizing pivot bearings, and third-generation pumps employing contactless bearings. Each iteration addressed previous limitations, particularly regarding thrombus formation and durability. Current regulatory challenges surrounding the duration of pump use in MCS are examined, highlighting the discrepancy between approved usage times and clinical needs. This paper notes ongoing efforts to extend approved use periods, citing examples of pumps cleared for extended use in various jurisdictions. This historical perspective provides insights into the technological advancements that have enhanced the safety, efficacy, and durability of centrifugal blood pumps in MCS applications.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"281-287"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949357","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}
Lajos Szentgyorgyi, Samuel Henry Howitt, Heather Iles-Smith, Bhuvaneswari Krishnamoorthy
{"title":"Sedation management and processed EEG-based solutions during venovenous extracorporeal membrane oxygenation: a narrative review of key challenges and potential benefits.","authors":"Lajos Szentgyorgyi, Samuel Henry Howitt, Heather Iles-Smith, Bhuvaneswari Krishnamoorthy","doi":"10.1007/s10047-025-01494-y","DOIUrl":"10.1007/s10047-025-01494-y","url":null,"abstract":"<p><p>Extracorporeal membrane oxygenation (ECMO) is an established technique for managing severe cardiorespiratory failure. However, it is invasive and requires profound analgo-sedation during initiation and often throughout the therapy. Managing sedation in venovenous (VV) ECMO patients is particularly challenging due to the impact of ECMO circuits on pharmacokinetics and specific patient requirements. This can lead to unpredictable sedative effects and require multiple drugs at higher doses. Additionally, sedation is usually managed with traditional scoring methods, which are subjective and invalid during neuromuscular blockade. These uncertainties may impact outcomes. Recent clinical practice increasingly focuses on reducing sedation to enable earlier physiotherapy and mobilisation, particularly in patients awaiting transplants or receiving mechanical circulatory support. In this context, processed electroencephalogram-based (pEEG) sedation monitoring might be promising, having shown benefits in general anaesthesia and intensive care. However, the technology has limitations, and its benefits in ECMO practice have yet to be formally evaluated. This review provides insights into the challenges of ECMO sedation, including pharmacokinetics, unique ECMO requirements, and the implications of inadequate sedation scores. Finally, it includes a brief overview of the practicality and limitations of pEEG monitoring during VV-ECMO, highlighting a significant research gap.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"293-307"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143582287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Current status and prospects of genetically modified porcine-to-human cardiac xenotransplantation.","authors":"Takuji Kawamura, Shunsuke Saito, Takura Taguchi, Daisuke Yoshioka, Ai Kawamura, Yusuke Misumi, Takashi Yamauchi, Shuji Miyagawa, Shigeru Miyagawa","doi":"10.1007/s10047-025-01504-z","DOIUrl":"10.1007/s10047-025-01504-z","url":null,"abstract":"<p><p>Cardiac xenotransplantation utilizing genetically modified pigs presents a promising avenue for treating end-stage heart failure, a leading cause of mortality worldwide. This paper delineates the current landscape of heart failure treatment in Japan, emphasizing the limitations of existing therapies such as heart transplantation and implantable left ventricular assist devices. It discusses the history and advancements in the development of genetically modified pigs for xenotransplantation, highlighting recent breakthroughs and challenges. The manuscript also addresses the specific challenges facing the implementation of xenotransplantation in Japan, including the selection of suitable genetically modified pigs, ensuring organ safety, patient selection criteria, transplantation protocols, and immunosuppression strategies. Drawing from international experiences and ongoing research efforts, the paper emphasizes the potential of xenotransplantation while acknowledging the hurdles that must be overcome for widespread clinical adoption.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"348-353"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373663/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144016237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Learning from history to improve the performance of blood purification devices and dialysis membranes: from engineering points of view.","authors":"Kiyotaka Sakai, Takehiro Miyasaka","doi":"10.1007/s10047-024-01489-1","DOIUrl":"10.1007/s10047-024-01489-1","url":null,"abstract":"<p><p>Abel JJ, Rowntree LG and Turner BB (Baltimore Trio) proposed the concept of vividiffusion and developed a vividiffusion apparatus in 1912. In a 1914 paper, they laid out the most important rule of device design. We named this rule an ART law taken from the initials of the Baltimore Trio. The ART law means that a blood purification device with a shape that can secure as large a dialysis membrane area as possible for as small a volume of blood filling as possible will achieve high dialysis performance. Rather than using 8 mm inner diameter collodion tubes in the original vividiffusion apparatus, the solution to the device shape that fits this rule is to hold down the tube from both top and bottom to make it as flat as possible, or if it is a flat membrane, to bring two flat membranes as close together as possible, and in the case of tubes and hollow fibers, to make their inner diameter as small as possible of approximately 200 μm. In other words, the dialysis performance is greatly improved by narrowing the blood flow path. This is exactly the ART law, predicting the shape of today's blood purification devices.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":" ","pages":"329-335"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005929","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}