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Trial-Based Hemolysis Modeling to Investigate Operating Modes of Continuous-Flow LVADs. 基于试验的溶血模型研究连续血流lvad的工作模式。
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-13 DOI: 10.1111/aor.70021
Patrick Borchers, Steffen Leonhardt, Marian Walter

Background: The influence of operating modes on pump-induced hemolysis in continuous-flow left ventricular assist devices (LVADs) can be assessed using computational fluid dynamics (CFD) simulations alongside power law models derived from shearing device experiments. However, this conventional method incurs high computational costs, limiting the exploration of diverse operating conditions and hindering online hemolysis prediction. This work presents a CFD-free and trial-based methodology for determining online-capable hemolysis models for continuous-flow LVADs.

Methods: The trial-based hemolysis model is based on a modified power law model, with parameters identified from LVAD hemolysis trials. The dynamic behavior is modeled using the Lagrangian approach. Specifically, this model was determined for the Sputnik1 LVAD and integrated with a lumped-parameter model of the LVAD-supported cardiovascular system. Subsequently, hemolysis was predicted across various operating modes and patient conditions.

Results: The RMSE and the R2 of the modified power law fit were 18.4 [%·mL/h] and 0.69, respectively. The relative error introduced by the Lagrangian approach was below 0.7%. For the Sputnik1, hemolysis decreased with reduced speed. Additionally, lower systemic resistance and diminished left ventricular contractility were associated with lower hemolysis, whereas speed modulation increased hemolysis across most profiles.

Discussion: The proposed hemolysis model allows to assess various LVAD operating modes and patient conditions, assisting in the selection of low-hemolysis treatment strategies. For Sputnik1 patients, it is advisable to maintain low pump speed and systemic resistance, while speed modulation should be reserved for those with low hemolysis markers. Integrating this model with online flow sensing would enable online hemolysis prediction.

背景:工作模式对连续血流左心室辅助装置(lvad)泵致溶血的影响可以通过计算流体动力学(CFD)模拟和剪切装置实验得出的幂律模型来评估。然而,这种传统方法的计算成本很高,限制了对各种操作条件的探索,也阻碍了在线溶血预测。这项工作提出了一种无cfd和基于试验的方法,用于确定连续血流lvad的在线溶血模型。方法:基于试验的溶血模型基于修正幂律模型,参数从LVAD溶血试验中确定。采用拉格朗日方法对其动力学行为进行了建模。具体来说,该模型是为Sputnik1 LVAD确定的,并与LVAD支持的心血管系统的集总参数模型相结合。随后,在不同的操作模式和患者条件下预测溶血。结果:修正幂律拟合的RMSE和R2分别为18.4[%·mL/h]和0.69。拉格朗日方法引入的相对误差小于0.7%。对于Sputnik1,溶血随着速度的降低而减少。此外,较低的全身阻力和左心室收缩力减弱与较低的溶血有关,而在大多数情况下,速度调节增加了溶血。讨论:提出的溶血模型允许评估各种LVAD操作模式和患者情况,有助于选择低溶血治疗策略。对于Sputnik1患者,建议保持较低的泵速和全身阻力,而对于溶血标志物较低的患者,应保留速度调节。将该模型与在线流量传感相结合,将实现在线溶血预测。
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引用次数: 0
In Vitro Calcification Evaluation of Polycarbonate Urethane-Impact of Production Processes. 聚碳酸酯聚氨酯的体外钙化评价——生产工艺的影响。
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-13 DOI: 10.1111/aor.70028
Jan Ritter, Christoph Schmitz, Stephan Rütten, Abdelhafid Aqil, Cécile Oury, Thomas Schmitz-Rode, Willi Jahnen-Dechent, Ulrich Steinseifer, Johanna C Clauser

Background: Heart valve diseases remain a leading cause of death in industrialized nations. Polycarbonate urethane (PCU) is a promising material for heart valve prostheses due to its biocompatibility and low calcification tendency. However, the impact of processing methods on calcification remains unclear.

Methods: PCU patches were fabricated via hot pressing or solution casting. Both groups (n = 3 each), along with bovine pericardium patches as positive controls (n = 3), were incubated for 10 weeks in a custom in vitro calcification fluid. Calcification, cytocompatibility, and material properties were assessed using light and electron microscopy, infrared spectroscopy, and gel permeation chromatography (GPC).

Results: Calcification was observed in hot-pressed PCU and control patches but not in solution-cast PCU. Both PCU types showed comparable cytocompatibility. Spectroscopy and GPC revealed chemical and structural changes in hot-pressed PCU, likely promoting calcification.

Conclusion: Hot pressing alters the chemical structure of PCU and increases its calcification propensity without affecting cytocompatibility. These findings highlight the importance of process control and in vitro screening during heart valve material development.

背景:心脏瓣膜疾病仍然是工业化国家死亡的主要原因。聚碳酸酯聚氨酯(PCU)具有良好的生物相容性和低钙化倾向,是一种很有前途的心脏瓣膜修复材料。然而,加工方法对钙化的影响尚不清楚。方法:采用热压或溶液铸造法制备PCU贴片。两组(每组n = 3),以及牛心包贴片作为阳性对照(n = 3),在定制的体外钙化液中孵育10周。使用光镜和电子显微镜、红外光谱和凝胶渗透色谱(GPC)评估钙化、细胞相容性和材料性能。结果:热压PCU和对照贴片均出现钙化现象,而液铸PCU无钙化现象。两种PCU类型的细胞相容性相当。光谱学和GPC揭示了热压PCU的化学和结构变化,可能促进了钙化。结论:热压可改变PCU的化学结构,增加其钙化倾向,但不影响细胞相容性。这些发现强调了过程控制和体外筛选在心脏瓣膜材料开发中的重要性。
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引用次数: 0
Vasoreactivity as a Measure of Kidney Viability During Ex Vivo Normothermic Machine Perfusion. 血管反应性是体外恒温机器灌注过程中肾脏活力的衡量指标。
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-13 DOI: 10.1111/aor.70033
Isa M van Tricht, Baran Ogurlu, Silke S M Wolfswinkel, Henri G D Leuvenink, Cyril Moers

Background: Normothermic machine perfusion (NMP) could serve as a platform to assess deceased-donor kidney viability before transplantation, yet it remains unclear which parameters indicate renal viability. As vascular integrity is important for adequate renal function after transplantation, this study aimed to investigate the influence of warm ischemic injury on vascular smooth muscle cell (VSMC) responsiveness to vasoactive drugs during NMP.

Methods: Fourteen porcine kidneys (n = 7 per group) were exposed to either 30 or 60 min of warm ischemia (WI), followed by 3.5 h of cold machine perfusion. After cold perfusion, kidneys underwent 4 h of NMP (37°C). During NMP, vasoactive drugs were sequentially infused into the renal artery at 30-min intervals, starting with epoprostenol (10 μg), followed by dopamine (1 mg), sodium nitroprusside (2 mg), acetylcholine (1 mg), norepinephrine (10 μg), and finally verapamil (2.5 mg).

Results: Renal blood flow during NMP changed significantly in both groups after administration of dopamine, acetylcholine, norepinephrine, and verapamil, but not following epoprostenol and sodium nitroprusside infusion. In kidneys subjected to 30 min of WI, the response to dopamine and norepinephrine was more pronounced, and oxygen consumption and blood pH were higher compared to kidneys that sustained 60 min of WI.

Conclusion: This study indicates that prolonged WI damage diminishes the contractility of VSMCs through the α-adrenergic receptors. Our findings suggest that the renal vascular responses to dopamine and norepinephrine, as well as decreased oxygen consumption and blood pH, could serve as objective indicators to quantify warm ischemic injury during renal NMP.

背景:常温机器灌注(NMP)可以作为移植前评估死亡供体肾脏活力的平台,但目前尚不清楚哪些参数表明肾脏活力。由于血管完整性对移植后肾功能的维持至关重要,本研究旨在探讨热缺血损伤对NMP过程中血管平滑肌细胞(VSMC)对血管活性药物反应性的影响。方法:取14只猪肾,每组7只,分别进行30min和60min的热缺血,然后进行3.5 h的冷机灌注。冷灌注后,肾脏进行4小时的NMP(37°C)。在NMP过程中,血管活性药物以30 min为间隔依次输注肾动脉,先给药丙烯醇(10 μg),再给药多巴胺(1 mg)、硝普钠(2 mg)、乙酰胆碱(1 mg)、去甲肾上腺素(10 μg),最后给药维拉帕米(2.5 mg)。结果:两组患者在给予多巴胺、乙酰胆碱、去甲肾上腺素和维拉帕米后,NMP期间肾血流量发生了显著变化,而在给予丙烯醇和硝普钠后,肾血流量无明显变化。与WI持续60分钟的肾脏相比,WI持续30分钟的肾脏对多巴胺和去甲肾上腺素的反应更为明显,耗氧量和血液pH值更高。结论:长时间WI损伤通过α-肾上腺素能受体降低VSMCs的收缩力。我们的研究结果表明,肾血管对多巴胺和去甲肾上腺素的反应,以及氧气消耗和血液pH值的降低,可以作为量化肾NMP过程中热缺血损伤的客观指标。
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引用次数: 0
Design and Hemolytic Performance of a Centrifugal Artificial Blood Pump. 离心人工血泵的设计与溶血性能。
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-09 DOI: 10.1111/aor.70030
Xuemin Liu, Qing Han, Shikui Zhao, Jiejie Shao, Peng Wang, Honghua Zhao

Purpose: Significant advances have been made in the design and manufacture of artificial blood pumps. However, blood compatibility issues such as hemolysis, thrombosis, and inflammation during the clinical use of artificial blood pumps have reduced their reliability. Among these issues, hemolysis problems can lead to acute kidney injury, hyperkalemia, and in severe cases, even serious threats to life. To address hemolysis problems, blood transfusion, reduction of blood pump speed, and medication to promote erythropoiesis are generally used. This study explores the hemolysis problem from the perspective of the essence of problem solving, that is, the design of the blood pump structure.

Methods: A new centrifugal pump UJN-1 was designed based on empirical design theory and the velocity coefficient method of traditional centrifugal pumps. We used the commercial software Fluent to compare the data obtained from our simulation of FDA benchmark blood pumps with the results of other researchers to validate the accuracy of our simulation method. Based on the CFD numerical simulation method, we evaluated the hemolytic performance of three centrifugal pumps: Revolution, PuraLev 200SU, and UJN-1. The hydraulic performance of the designed UJN-1 blood pump was experimentally verified.

Results: The UJN-1 could provide a blood flow rate of 4-6 L/min and a blood pressure of 120 mmHg at 2500 rpm. The CFD numerical simulation and experimental results of the designed artificial blood pump UJN-1 were compared and verified, and the results showed that the error was small. The hemolysis results of the Revolution pump, 200SU pump, and UJN-1 pump were 3.35 × 10-4%, 2.20 × 10-4%, and 1.49 × 10-4%, respectively. In a comparison of hemolysis among the three pumps, the UJN-1 pump had the lowest level of hemolysis.

Conclusion: This low hemolysis artificial blood pump design is important for long-term clinical use and high reliability of medical devices.

目的:人工血泵的设计和制造取得了重大进展。然而,在临床使用人工血泵时,血液相容性问题,如溶血、血栓形成和炎症,降低了其可靠性。在这些问题中,溶血问题可导致急性肾损伤、高钾血症,严重时甚至严重威胁生命。为了解决溶血问题,通常采用输血、降低血泵速度和促进红细胞生成的药物。本研究从解决问题的本质,即血泵结构设计的角度探讨溶血问题。方法:基于经验设计理论和传统离心泵的速度系数法,设计了一种新型离心泵UJN-1。我们使用商业软件Fluent将我们对FDA基准血泵的模拟得到的数据与其他研究人员的结果进行比较,以验证我们模拟方法的准确性。基于CFD数值模拟方法,对Revolution、PuraLev 200SU和UJN-1三种离心泵的溶血性能进行了评价。实验验证了所设计的UJN-1型血泵的水力性能。结果:UJN-1在2500rpm下可使血流速度达到4 ~ 6l /min,血压达到120mmhg。将所设计的人工血泵UJN-1的CFD数值模拟与实验结果进行对比验证,结果表明误差较小。Revolution泵、200SU泵和UJN-1泵的溶血效果分别为3.35 × 10-4%、2.20 × 10-4%和1.49 × 10-4%。在三种泵的溶血比较中,UJN-1泵溶血水平最低。结论:低溶血人工血泵设计对临床长期使用和医疗器械的高可靠性具有重要意义。
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引用次数: 0
Ultra-Long Polymyxin B Hemoperfusion and Its Effect on Vasopressor Dosage and Organ Dysfunction in Patients With Septic Shock Requiring High-Dose Norepinephrine: A Post Hoc Analysis of a Prospective Cohort Study. 超长多粘菌素B血液灌流及其对需要大剂量去甲肾上腺素的感染性休克患者血管加压剂剂量和器官功能障碍的影响:一项前瞻性队列研究的事后分析
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-09 DOI: 10.1111/aor.70025
Kyohei Miyamoto, Yu Kawazoe, Noriko Miyagawa, Hitoshi Yamamura, Yoshinori Ohta, Takuya Kimura, Yukitoshi Toyoda, Michihito Kyo, Tetsuya Sato, Masashi Kinjo, Masaki Takahashi, Junichi Maruyama, Hiroshi Matsuura, Kazunori Fukushima, Takeshi Morimoto

Background: Prolonged duration of polymyxin B hemoperfusion (PMX-HP) for septic shock is not widely investigated.

Methods: We used BEAT-SHOCK, a prospective registry including 309 adult patients with septic shock requiring high-dose norepinephrine (≥ 0.2 μg/kg/min). Our post hoc analysis included 82 patients that underwent PMX-HP, dichotomized into either the ultra-long PMX-HP group (first session duration ≥ 12 h; n = 53) or the non-ultra-long PMX-HP group (< 12 h; n = 29). The primary outcomes were changes in vasopressor/inotrope dosage, represented by vasoactive-inotropic score (VIS), and sequential organ failure assessment (SOFA) score from baseline to day 3.

Results: The median durations of the first PMX-HP session in the ultra-long and non-ultra-long PMX-HP groups were 1290 and 358 min, respectively. Their median baseline VIS was 38.3 (IQR 26.0-49.5) in the ultra-long group, 38.1 (IQR 30.9-55.6) in the non-ultra-long PMX-HP group. The median baseline SOFA score was 11 (IQR 9-13) in both groups. The changes in these scores from baseline to day 3 did not differ between them (adjusted difference -3.8 [95% confidence interval -9.0 to 11.3] for VIS and -0.0 [95% confidence interval -1.5 to 1.5] for SOFA score). The 90-day mortality rate was 24.7% in the ultra-long PMX-HP group and 21.1% in the non-ultra-long PMX-HP group (adjusted hazard ratio 1.35; 95% confidence interval 0.49-3.69).

Conclusions: Ultra-prolonged PMX-HP for ≥ 12 h was not associated with a greater reduction in vasopressor/inotrope dosage or improvement in organ dysfunction on day 3 than PMX-HP < 12 h in our patients with septic shock without endotoxin monitoring.

Trial registration: UMIN Clinical Trial Registry on 1 November 2019 (registration no. UMIN000038302).

背景:脓毒性休克中延长多粘菌素B血液灌流(PMX-HP)时间的研究尚未广泛。方法:我们采用BEAT-SHOCK,一项前瞻性登记,包括309例需要大剂量去甲肾上腺素(≥0.2 μg/kg/min)的脓毒性休克成年患者。我们的事后分析包括82例接受PMX-HP治疗的患者,将其分为超长时间PMX-HP组(首次治疗持续时间≥12小时;n = 53)和非超长时间PMX-HP组(结果:超长时间PMX-HP组和非超长时间PMX-HP组首次治疗的中位持续时间分别为1290分钟和358分钟)。他们的中位基线VIS在超长组为38.3 (IQR 26.0-49.5),在非超长PMX-HP组为38.1 (IQR 30.9-55.6)。两组中位基线SOFA评分均为11分(IQR 9-13)。这些评分从基线到第3天的变化在他们之间没有差异(VIS的调整差异为-3.8[95%置信区间-9.0至11.3],SOFA评分的调整差异为-0.0[95%置信区间-1.5至1.5])。超长PMX-HP组90天死亡率为24.7%,非超长PMX-HP组为21.1%(校正风险比1.35;95%可信区间0.49-3.69)。结论:与PMX-HP相比,超延长PMX-HP≥12小时与第3天血管加压剂/肌力药物剂量的减少或器官功能障碍的改善无关。UMIN000038302)。
{"title":"Ultra-Long Polymyxin B Hemoperfusion and Its Effect on Vasopressor Dosage and Organ Dysfunction in Patients With Septic Shock Requiring High-Dose Norepinephrine: A Post Hoc Analysis of a Prospective Cohort Study.","authors":"Kyohei Miyamoto, Yu Kawazoe, Noriko Miyagawa, Hitoshi Yamamura, Yoshinori Ohta, Takuya Kimura, Yukitoshi Toyoda, Michihito Kyo, Tetsuya Sato, Masashi Kinjo, Masaki Takahashi, Junichi Maruyama, Hiroshi Matsuura, Kazunori Fukushima, Takeshi Morimoto","doi":"10.1111/aor.70025","DOIUrl":"https://doi.org/10.1111/aor.70025","url":null,"abstract":"<p><strong>Background: </strong>Prolonged duration of polymyxin B hemoperfusion (PMX-HP) for septic shock is not widely investigated.</p><p><strong>Methods: </strong>We used BEAT-SHOCK, a prospective registry including 309 adult patients with septic shock requiring high-dose norepinephrine (≥ 0.2 μg/kg/min). Our post hoc analysis included 82 patients that underwent PMX-HP, dichotomized into either the ultra-long PMX-HP group (first session duration ≥ 12 h; n = 53) or the non-ultra-long PMX-HP group (< 12 h; n = 29). The primary outcomes were changes in vasopressor/inotrope dosage, represented by vasoactive-inotropic score (VIS), and sequential organ failure assessment (SOFA) score from baseline to day 3.</p><p><strong>Results: </strong>The median durations of the first PMX-HP session in the ultra-long and non-ultra-long PMX-HP groups were 1290 and 358 min, respectively. Their median baseline VIS was 38.3 (IQR 26.0-49.5) in the ultra-long group, 38.1 (IQR 30.9-55.6) in the non-ultra-long PMX-HP group. The median baseline SOFA score was 11 (IQR 9-13) in both groups. The changes in these scores from baseline to day 3 did not differ between them (adjusted difference -3.8 [95% confidence interval -9.0 to 11.3] for VIS and -0.0 [95% confidence interval -1.5 to 1.5] for SOFA score). The 90-day mortality rate was 24.7% in the ultra-long PMX-HP group and 21.1% in the non-ultra-long PMX-HP group (adjusted hazard ratio 1.35; 95% confidence interval 0.49-3.69).</p><p><strong>Conclusions: </strong>Ultra-prolonged PMX-HP for ≥ 12 h was not associated with a greater reduction in vasopressor/inotrope dosage or improvement in organ dysfunction on day 3 than PMX-HP < 12 h in our patients with septic shock without endotoxin monitoring.</p><p><strong>Trial registration: </strong>UMIN Clinical Trial Registry on 1 November 2019 (registration no. UMIN000038302).</p>","PeriodicalId":8450,"journal":{"name":"Artificial organs","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
The International Functional Electrical Stimulation Society: Highlights From the IFESS Conference at RehabWeek 2025. 国际功能性电刺激学会:2025年RehabWeek的IFESS会议亮点
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-09 DOI: 10.1111/aor.70019
Ken Yoshida, Matija Milosevic, Monica Perez, Ashraf S Gorgey, Erika G Spaich, Simona Ferrante
{"title":"The International Functional Electrical Stimulation Society: Highlights From the IFESS Conference at RehabWeek 2025.","authors":"Ken Yoshida, Matija Milosevic, Monica Perez, Ashraf S Gorgey, Erika G Spaich, Simona Ferrante","doi":"10.1111/aor.70019","DOIUrl":"https://doi.org/10.1111/aor.70019","url":null,"abstract":"","PeriodicalId":8450,"journal":{"name":"Artificial organs","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Differential Hypoxemia During Veno-Arterial Extracorporeal Organ Support: Its Impact on Mortality and Different Treatment Strategies. 静脉-动脉体外器官支持期间的差异低氧血症:对死亡率的影响和不同的治疗策略。
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-09 DOI: 10.1111/aor.70016
Anneke Neumann, Lina Serna Higuita, Jana Buob, Rafal Berger, Metesh Acharya, Aron-Frederik Popov

Objectives: Extracorporeal Life Support (ECLS) has evolved into an established treatment for severe cardiogenic shock. As most patients have residual antegrade left ventricular output toward the descending aorta that meets the retrograde blood flow from the arterial ECLS cannula, they may develop differential hypoxemia. The location of the mixing cloud is critical for coronary and brain oxygenation. We analyzed the effects of the development of differential hypoxemia on morbidity and mortality of ECLS patients. Moreover, we analyzed the impact of two different treatment options for this phenomenon, including the administration of beta-blockers and the provision of a supplementary arterial cannula, on survival.

Methods: We performed a retrospective review of patient demographics, outcomes, laboratory, and respiratory parameters during and after ECLS support for 76 ECLS patients treated at our institution.

Results: Overall, 38 ECLS patients developed differential hypoxemia. Treatment of this phenomenon included either the administration of beta-blockers (n = 18) or the introduction of a second arterial ECLS cannula (n = 20). There were no significant differences in median SOFA-Scores (Sequential Organ Failure Assessment Scores) between groups (p = 0.072; ECLS vs. ECLS with differential hypoxemia patients). Under all respiratory and laboratory values analyzed, only bilirubin levels were significantly different (p = 0.020). Development of differential hypoxemia was associated with significantly decreased survival rates (p = 0.05). Moreover, insertion of a second arterial ECLS cannula was a risk factor for mortality (OR: 3.68, 95% CI 1.18-11.47, p = 0.025).

Conclusions: Development of differential hypoxemia is associated with significantly increased mortality rates among ECLS patients and should therefore be prevented as far as possible. Non-invasive administration of beta-blockers seems to be the more effective treatment option for differential hypoxemia, as the introduction of a second arterial ECLS cannula was a risk factor for mortality.

目的:体外生命支持(ECLS)已发展成为严重心源性休克的既定治疗方法。由于大多数患者左心室输出液残留向降主动脉的顺行,与来自动脉ECLS插管的逆行血流相接,因此可能出现差别性低氧血症。混合云的位置对冠状动脉和脑氧合至关重要。我们分析了不同低氧血症的发展对ECLS患者发病率和死亡率的影响。此外,我们分析了两种不同的治疗方案对这种现象的影响,包括给药-受体阻滞剂和提供辅助动脉插管,对生存率的影响。方法:我们对我院76例ECLS患者在ECLS支持期间和之后的患者人口统计学、结果、实验室和呼吸参数进行了回顾性分析。结果:总体而言,38例ECLS患者出现了差别性低氧血症。这种现象的治疗包括给予-受体阻滞剂(n = 18)或引入第二动脉ECLS插管(n = 20)。各组间中位sofa评分(序贯器官衰竭评估评分)无显著差异(p = 0.072; ECLS vs差异低氧血症患者的ECLS)。在所有呼吸和实验室值分析中,只有胆红素水平有显著差异(p = 0.020)。差异性低氧血症的发生与生存率显著降低相关(p = 0.05)。此外,插入第二动脉ECLS套管是死亡率的危险因素(OR: 3.68, 95% CI 1.18-11.47, p = 0.025)。结论:不同低氧血症的发展与ECLS患者死亡率显著增加相关,因此应尽可能预防。由于引入第二动脉ECLS插管是死亡率的一个危险因素,无创给药β受体阻滞剂似乎是鉴别低氧血症更有效的治疗选择。
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引用次数: 0
Advances and Challenges in Artificial Womb for Respiratory Support in Extremely Low Gestational Age Neonates: A Narrative Review. 人工子宫用于极低胎龄新生儿呼吸支持的进展与挑战:综述。
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-09 DOI: 10.1111/aor.70026
Chuhan Huang, Shiqi Fei, Xiaoqian Zhang, Yongnan Li, Weina Pei

Background: Respiratory management of extremely low gestational age neonates (ELGANs) is a major challenge in neonatal intensive care, as they face high mortality and morbidity due to complications such as respiratory distress syndrome and bronchopulmonary dysplasia. Traditional respiratory support methods (e.g., mechanical ventilation) have limitations, potentially leading to adverse outcomes like chronic lung injury and intracranial hemorrhage. Artificial womb technology (AWT), based on extracorporeal membrane oxygenation (ECMO) principles, has emerged as a potential alternative by simulating the intrauterine environment to provide respiratory and circulatory support for ELGANs.

Methods: This narrative review systematically summarizes the development of AWT for respiratory support in ELGANs, analyzes its core technical principles (e.g., pumpless arteriovenous extracorporeal life support (V-A ECLS) and pump-driven veno-venous extracorporeal life support (V-V ECLS)), and explores key advancements and challenges in oxygenator design, anticoagulation strategies, cannulation techniques, and synthetic amniotic fluid regulation.

Results: Significant progress has been made in AWT over the past decade, with two main support modes (pumpless and pump-driven) developed, each showing advantages and disadvantages in gas exchange efficiency and animal model survival time. Improvements in oxygenator materials (e.g., hollow fiber membranes, polymethylpentene membranes) and miniaturized designs have optimized gas exchange and reduced priming volume. Advances in anticoagulation strategies (e.g., heparin alternatives, surface coating technologies) and monitoring systems (e.g., nano-sensors, near-infrared spectroscopy) have enhanced safety. Additionally, regulation of synthetic amniotic fluid composition and immunomodulatory mechanisms has preliminarily simulated the intrauterine environment, but issues such as intracranial hemorrhage and species-specific barriers in animal model translation remain.

Conclusions: AWT offers a new direction for respiratory support in ELGANs, but its clinical application requires addressing challenges in biocompatibility, long-term organ development monitoring, and ethical norms. With optimized system design, material innovation, and multimodal monitoring, AWT is expected to become a crucial tool for improving ELGANs' prognosis.

背景:极低胎龄新生儿(elgan)的呼吸管理是新生儿重症监护的主要挑战,因为他们由于呼吸窘迫综合征和支气管肺发育不良等并发症而面临高死亡率和发病率。传统的呼吸支持方法(如机械通气)存在局限性,可能导致慢性肺损伤和颅内出血等不良后果。人工子宫技术(AWT)基于体外膜氧合(ECMO)原理,通过模拟宫内环境为elgan提供呼吸和循环支持,已成为一种潜在的替代方案。方法:本文系统总结了AWT在elgan中用于呼吸支持的发展,分析了其核心技术原理(如无泵动静脉体外生命支持(V-A ECLS)和泵驱动静脉静脉体外生命支持(V-V ECLS)),并探讨了氧合器设计、抗凝策略、插管技术和合成羊水调节等方面的关键进展和挑战。结果:近十年来,AWT研究取得了重大进展,主要发展了两种支持模式(无泵和泵驱动),每种支持模式在气体交换效率和动物模型存活时间方面各有优缺点。氧合器材料(如中空纤维膜、聚甲基戊烯膜)的改进和小型化设计优化了气体交换并减少了起爆体积。抗凝策略(如肝素替代品、表面涂层技术)和监测系统(如纳米传感器、近红外光谱)的进步提高了安全性。此外,人工羊水成分的调节和免疫调节机制已经初步模拟了宫内环境,但动物模型翻译中存在颅内出血和物种特异性屏障等问题。结论:AWT为elgan的呼吸支持提供了新的方向,但其临床应用需要解决生物相容性、器官长期发育监测和伦理规范等方面的挑战。通过优化系统设计、材料创新和多模式监测,AWT有望成为改善elgan预后的关键工具。
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引用次数: 0
Optimization Studies of Robocasted Bioceramic Bone Scaffolds Using Analytical Hierarchy Process and TOPSIS. 基于层次分析法和TOPSIS的机械铸造生物陶瓷骨支架优化研究。
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-08 DOI: 10.1111/aor.70014
Umanath Puthillam, Jishita Ravoor, Renold Elsen Selvam, Deepan Karuppan, Balaji Bakthavachalam, Govind Purohit

Background: A bone scaffold is used to treat critical size bone defects and demands contradictory physical and mechanical properties. It is difficult to achieve the desirable properties using a single material, and composite materials are used to develop the scaffolds.

Methods: A combination of bioceramics such as hydroxyapatite (HAP), calcium silicate (CS), or calcium phosphate (CP) with different percentages of multiwalled carbon nanotubes (MWCNT) is used to develop the scaffolds using Robocasting 3D printing to treat the cancellous bone defects. The bioceramics will enhance the biocompatibility and bone regeneration of the scaffold while the MWCNT will improve the mechanical properties. Compressive strength, density, shrinkage, and porosity are selected as deciding factors, and the analytic hierarchy process (AHP) and technique for order of preference by similarity to ideal solution (TOPSIS) are used to identify the best composite materials for the required properties.

Results: The scaffolds are printed and sintered and observed that CS with 1 mass % of MWCNT sintered at 1200°C, HAP with 0.5 mass % of MWCNT sintered at 1100°C, and CP with 0.5 mass % of MWCNT sintered at 1200°C are the best bone scaffold options.

Conclusion: The ideal processing parameters for developing bioceramic bone scaffolds using the robocasting technique are identified and reported.

背景:骨支架用于治疗临界尺寸骨缺损,其物理和力学性能要求相互矛盾。使用单一材料很难达到理想的性能,因此采用复合材料来开发支架。方法:将羟基磷灰石(HAP)、硅酸钙(CS)、磷酸钙(CP)等生物陶瓷材料与不同比例的多壁碳纳米管(MWCNT)相结合,采用Robocasting 3D打印技术制备支架,用于治疗松质骨缺损。生物陶瓷将增强支架的生物相容性和骨再生能力,而MWCNT将改善支架的力学性能。选择抗压强度、密度、收缩率和孔隙率作为决定因素,并采用层次分析法(AHP)和理想溶液相似性偏好排序法(TOPSIS)来确定满足所需性能的最佳复合材料。结果:打印并烧结支架,观察到1200℃烧结1质量% MWCNT的CS、1100℃烧结0.5质量% MWCNT的HAP和1200℃烧结0.5质量% MWCNT的CP是最佳骨支架选择。结论:确定并报道了应用机器人铸造技术开发生物陶瓷骨支架的理想工艺参数。
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引用次数: 0
Clinical and Preclinical Evidence on a Novel Percutaneous Pulsatile Ventricular Assist Device (PulseCath): A Scoping Review. 一种新型经皮搏动性心室辅助装置(PulseCath)的临床和临床前证据:范围综述。
IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-08 DOI: 10.1111/aor.70022
Viviana Teresa Agosta, Jacopo D'Andria Ursoleo, Corrado D'Andria, Alice Bottussi, Fabrizio Monaco

Background: In recent decades, temporary mechanical circulatory support (tMCS) devices have garnered increasing interest for the treatment of cardiogenic shock. PulseCath-a pulsatile ventricular assist device-may address a critical unmet need within the tMCS array, offering an intermediate level of support between that of intra-aortic balloon pump (IABP) and more invasive tMCS devices (e.g., Impella and ECMO).

Methods: We conducted a systematic search of PubMed/MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, and Google Scholar databases to retrieve available clinical and preclinical in vivo data regarding the implantation of PulseCath.

Results: Five preclinical in vivo studies (38 animal models) and 16 clinical studies (386 patients) were identified and retrieved. When implanted in humans, PulseCath was mostly employed with a "pre-emptive" strategy, particularly in the context of high-risk percutaneous coronary interventions. However, cases reporting its "bail-out" deployment in instances of hemodynamic instability were also identified.

Conclusions: While the underreporting of adverse events and of PulseCath use as a bailout strategy across literature constrains a definitive evaluation of the device, preliminary findings suggest an apparent ease of use. Therefore, further research is warranted to better delineate which specific patient population would most likely benefit from the implantation of such a device. As such, the integration of underlying pathophysiological data, individualized risk assessment, and more robust clinical studies may potentially expand its use.

背景:近几十年来,临时机械循环支持装置(tMCS)在治疗心源性休克方面获得了越来越多的关注。pulsecath是一种脉动式心室辅助装置,可以解决tMCS阵列中一个关键的未满足需求,提供介于主动脉内球囊泵(IABP)和更具侵入性的tMCS装置(例如Impella和ECMO)之间的中间水平的支持。方法:系统检索PubMed/MEDLINE、EMBASE、Cochrane Central Register of Controlled Trials、Web of Science、Scopus和谷歌Scholar数据库,检索有关PulseCath植入的临床和临床前体内数据。结果:共检索到5项临床前体内研究(38只动物模型)和16项临床研究(386例患者)。当植入人体时,PulseCath大多采用“先发制人”的策略,特别是在高风险的经皮冠状动脉介入治疗的背景下。然而,在血流动力学不稳定的情况下,报告其“纾困”部署的病例也被确定。结论:虽然文献中对不良事件和PulseCath作为救助策略使用的少报限制了对该设备的明确评估,但初步发现表明其明显易于使用。因此,进一步的研究是有必要的,以更好地描述哪些特定的患者群体最有可能从植入这种装置中受益。因此,整合潜在的病理生理数据、个体化风险评估和更可靠的临床研究可能会扩大其应用范围。
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Artificial organs
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