Journal of Artificial Organs最新文献

{"title":"Psychological and socioeconomic impact of long-term home management on patients with left ventricular assist devices and their caregivers: a nationwide multicenter questionnaire survey.","authors":"Michiko Watanabe, Goro Matsumiya, Hiroki Kohno, Koichiro Kinugawa","doi":"10.1007/s10047-026-01569-4","DOIUrl":"10.1007/s10047-026-01569-4","url":null,"abstract":"<p><p>Left ventricular assist device (LVAD) therapy requires safe long-term home management supported by patients, caregivers, and healthcare systems. In Japan, continuous caregiver availability was historically required or strongly expected in LVAD home management, although this framework has recently been relaxed. We evaluated the psychological and socioeconomic burden experienced by LVAD patients and primary caregivers under this former 24-h caregiver-accompaniment framework. This cross-sectional, nationwide anonymous web-based questionnaire survey was conducted through 79 LVAD centers between April and July 2024. De-identified individual-level data from 184 patients and 136 primary caregivers were analyzed. Prespecified comparisons of depressive symptoms according to caregiver-accompaniment burden and work/study status were performed within each respondent group, and multivariable logistic regression was used to identify factors associated with depressive symptoms. Psychological burden related to caregiver accompaniment was reported by 83.7% of patients and 61.8% of caregivers. Not working or studying was reported by 44.0% and 31.6%, respectively. Depressive symptoms were reported in 36.4% of patients and 35.3% of caregivers. Depressive symptoms were more frequent among respondents with caregiver-accompaniment burden than among those without such burden in both patients (61/154 [39.6%] vs. 6/30 [20.0%]; p = 0.041) and caregivers (38/84 [45.2%] vs. 10/52 [19.2%]; p = 0.002), whereas depressive symptoms did not differ significantly according to work/study status. Under the former 24-h caregiver-accompaniment framework, Japanese LVAD households reported substantial psychological and socioeconomic burdens. These findings provide real-world baseline data for evaluating recent policy relaxation and for designing support systems that promote quality of life and social reintegration while maintaining safety.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13350110/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148421375","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":"Assessment of aortic insufficiency during Impella support as a bridge to durable left ventricular assist device implantation and its long-term progression.","authors":"Tomo Yoshizumi, Toru Kondo, Tomonari Uemura, Yasunari Hayashi, Shingo Kazama, Ryota Morimoto, Masato Mutsuga","doi":"10.1007/s10047-026-01570-x","DOIUrl":"10.1007/s10047-026-01570-x","url":null,"abstract":"<p><p>Impella is increasingly used as a bridge to durable left ventricular assist device (dLVAD) implantation in patients with advanced heart failure. However, Impella support may worsen aortic insufficiency (AI), raising concerns regarding both AI progression during support and subsequent late AI progression after dLVAD implantation. This study evaluated the impact of Impella bridging on AI progression and clinical outcomes after dLVAD implantation. This retrospective single-center study included 64 patients who underwent primary dLVAD implantation and consisted of three analyses. First, baseline characteristics, perioperative variables, and early postoperative outcomes were compared between the aortic valve (AV) Intervention (n = 12) and No AV Intervention (n = 52) groups at dLVAD implantation. Second, changes in AI severity during Impella support were evaluated in patients with preoperative Impella support (n = 19). Third, long-term outcomes were compared between the Impella Bridging (n = 14) and No Impella Bridging (n = 38) groups after excluding patients who underwent concomitant AV intervention. Preoperative clinical severity was generally comparable between the AV Intervention and No AV Intervention groups, although hospital mortality was higher in the AV Intervention group. AI severity worsened significantly during Impella support (p < 0.001), whereas AV intervention rates did not differ significantly according to preoperative Impella support status (p = 0.32). During long-term follow-up, no statistically significant association was observed between Impella bridging and subsequent AI progression or clinical outcomes. Impella support as a bridge to dLVAD implantation was associated with significant worsening of AI during support. Under the current treatment strategy, including careful assessment of AV function and selective concomitant AV intervention at dLVAD implantation, no statistically significant association was observed between prior Impella bridging and subsequent late AI progression or adverse clinical outcomes. However, given the significantly higher in-hospital mortality in the AV Intervention group, careful patient selection for concomitant AV intervention remains essential.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13332875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148387598","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 a novel anticoagulant and fibrinolytic management monitoring method during extracorporeal circulation using clot-fibrinolysis waveform analysis: the effects of anticoagulants on coagulation and fibrinolysis functions.","authors":"Sadanori Shimizu, Tomoko Matsumoto, Daiki Shimomura, Tomonori Soyama","doi":"10.1007/s10047-026-01565-8","DOIUrl":"10.1007/s10047-026-01565-8","url":null,"abstract":"<p><p>Clot-fibrinolysis waveform analysis (CFWA) enables the simultaneous assessment of coagulation and fibrinolytic functions within a short timeframe. We evaluated the effects of commonly used anticoagulants on coagulation-fibrinolysis balance using CFWA in anticoagulant-supplemented model plasma and explored its potential clinical application during extracorporeal circulation. Nafamostat mesylate (NM), unfractionated heparin (UFH), and low-molecular-weight heparin (LMWH) were added to normal plasma to establish each model. Coagulation function was assessed using clotting time (CT) and maximum clotting velocity (min1), whereas fibrinolytic function was evaluated using fibrinolysis onset time (FLT) and total fibrinolysis (EFP).Increasing NM concentrations prolonged CT and reduced min1 while prolonging FLT and decreasing EFP, indicating suppression of both coagulation and fibrinolysis. UFH prolonged CT and reduced min1 but shortened FLT and increased EFP, suggesting enhanced fibrinolytic susceptibility. LMWH produced milder anticoagulant effects with minimal influence on fibrinolytic parameters.As an exploratory clinical application, CFWA was applied to a patient undergoing hemodialysis with suspected heparin resistance and recurrent circuit clotting. CFWA detected persistent hypercoagulability despite prolonged APTT after high-dose UFH administration, providing additional functional information not captured by conventional coagulation tests.CFWA may provide a sensitive and comprehensive assessment of coagulation-fibrinolysis balance and serve as a complementary monitoring tool during extracorporeal circulation.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148352063","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":"Outcomes of donation after circulatory death heart transplant using normothermic regional perfusion: a systematic review and meta-analysis.","authors":"Miao He, Xiaoqian Zhang, Huizhen Li, Yanchun Zhang, Qiming Zhao, Xiangyang Wu, Yongnan Li, Weina Pei","doi":"10.1007/s10047-026-01568-5","DOIUrl":"10.1007/s10047-026-01568-5","url":null,"abstract":"<p><p>This systematic review and meta-analysis aim to synthesize evidence comparing normothermic regional perfusion (NRP) and direct procurement and perfusion (DPP) in donation after circulatory death (DCD) heart transplantation, providing evidence-based guidance for optimizing donor heart procurement and transplantation protocols. A systematic literature review was conducted following PRISMA guidelines. PubMed, Embase, the Cochrane Library, and the International Clinical Trials Registry Platform were systematically searched. Two reviewers independently applied eligibility criteria, evaluated quality, and extracted data. The primary outcome was the 30-day survival rate. The 30-day survival rates for NRP and DPP patients were 96.58% and 94.79%, respectively (odds ratio [OR]: 1.52, 95% confidence interval [CI] 1.06-2.17, P = 0.02). Severe primary graft dysfunction (PGD) rates for NRP and DPP patients were 7.90% and 14.03%, respectively (P = 0.002), while the combined rate of none/mild PGD was 86.36% and 85.84% for each group. The cumulative postoperative extracorporeal membrane oxygenation rate for NRP patients was 6.54%, compared to 17.18% for DPP patients (P = 0.0001). The postoperative intra-aortic balloon pump rate for NRP patients was 9.09%, compared to 17.78% for DPP patients (P = 0.35). NRP patients had a higher likelihood of being discharged home than DPP patients (P = 0.36), while NRP patients had a lower likelihood of being discharged from the intensive care unit than DPP patients (P = 0.71). NRP was associated with higher 30-day survival, which is a promising clinical approach in the application of DCD donor hearts.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148352020","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":"A potential survival benefit in coronary artery bypass grafting with micro-axial temporary pump recovery in patients with reduced left ventricular ejection fraction.","authors":"Anjeli Reyes Macaranas, Naoki Tadokoro, George T Tolis, Sary F Aranki, Asishana A Osho, Thoralf M Sundt, Eriberto Michel, David A D'Alessandro, Akinobu Itoh","doi":"10.1007/s10047-026-01564-9","DOIUrl":"10.1007/s10047-026-01564-9","url":null,"abstract":"<p><p>Coronary artery bypass grafting (CABG) with temporary micro-axial ventricular assist device (Impella, Johnson and Johnson, Danvers, MA, USA) for peri-operative recovery has been utilized among patients with reduced left ventricular ejection fraction (LVEF). We hypothesized that Impella recovery CABG would be associated with increased two-year survival, compared to traditional intra-aortic balloon pump (IABP) recovery CABG. 151 patients with low LVEF (≤ 25%) underwent on-pump CABG at our hospital system between July 2017 and March 2025. Patients who underwent CABG without mechanical assistance, had a cardiac arrest within 24 hours of CABG, prior organ transplantation, or chronic dialysis were excluded. Propensity score analysis matched patients with Impella recovery (n = 19) and IABP recovery CABG (n = 19), and Kaplan-Meier analysis compared two-year survival between these groups. Patients who received Impella recovery CABG had significantly greater two-year survival at 100% compared to the IABP group at 60.5% (95% CI 39.9-91.7%) (log-rank p = 0.01). Impella recovery was associated with greater aortic cross clamp (p = 0.02) and cardiopulmonary bypass (p < 0.001) times and longer ICU stays (p = 0.008). There were no significant differences in major postoperative complications, including re-exploration for bleeding, stroke, and renal failure. Our exploratory study found that Impella recovery CABG was associated with decreased mortality compared to IABP recovery among patients with reduced LVEF. Larger cohorts with longer follow-up are necessary to assess whether this advanced mechanical support method confers a meaningful survival benefit in this high-risk patient population.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148338671","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":"Hepatic artery aneurysm rupture into the biliary tract during long-term left ventricular assist device support successfully treated by transcatheter arterial embolization: a case report.","authors":"Fumika Haga, Takamasa Sato, Koji Owada, Satoshi Okochi, Ryo Ogawara, Keiichiro Endo, Fumiya Anzai, Yu Sato, Yoshiaki Katada, Yasuchika Takeishi","doi":"10.1007/s10047-026-01566-7","DOIUrl":"10.1007/s10047-026-01566-7","url":null,"abstract":"<p><p>Bleeding complications remain a major concern in patients supported by long-term left ventricular assist devices (LVADs). Although gastrointestinal bleeding is common, hemobilia due to rupture of a hepatic artery aneurysm is extremely rare. A 47-year-old man with end-stage heart failure underwent implantation of a continuous-flow LVAD as a bridge to transplantation and was maintained on long-term anticoagulation therapy. He developed anemia with abdominal pain and melena. Imaging at the first hospitalization revealed a hepatic artery aneurysm with suspected hemobilia. After temporary stabilization, he was readmitted with recurrent melena and abdominal pain. Subsequent imaging demonstrated rapid aneurysmal enlargement with rupture into the biliary tract. Emergency angiography followed by transcatheter arterial embolization using detachable coils and n-butyl cyanoacrylate achieved complete hemostasis while preserving hepatic arterial flow. Anticoagulation was resumed without thrombotic complications, and the patient subsequently underwent successful transplantation without recurrence. Hepatic artery aneurysm rupture into the biliary tract is a rare but life-threatening complication in patients receiving long-term LVAD support. Prompt multidisciplinary management and endovascular intervention are essential for favorable outcomes.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148338650","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":"Engineering brain organoids: from neurodevelopmental modeling to translational barriers.","authors":"Yusuke Nishimura","doi":"10.1007/s10047-026-01567-6","DOIUrl":"10.1007/s10047-026-01567-6","url":null,"abstract":"<p><p>Brain organoids have progressed from simple three-dimensional neuroepithelial aggregates to increasingly sophisticated systems that recapitulate key aspects of human neurodevelopment and disease. Despite rapid biological advances, their translational potential remains constrained by challenges in maturation, vascular integration, reproducibility, and scalable standardization. Recent innovations, including microfluidic perfusion platforms, synthetic extracellular matrices, vascularization strategies, and modular assembloid assembly, illustrate a shift from descriptive modeling to functionally integrated and experimentally controllable neural systems. However, increasing biological complexity introduces ethical and regulatory considerations that must be incorporated into translational research frameworks. These advances provide new opportunities to investigate human-specific developmental mechanisms and bridge the gap between in vitro modeling and in vivo neurobiology. Future progress will depend on balancing two complementary objectives: enhancing biological fidelity and improving experimental utility through increasingly controllable and design-driven organoid platforms with defined architecture, functionality, and reproducibility. In this context, brain organoids are emerging as bioengineered neural tissue systems that share important conceptual and technological foundations with next-generation artificial organ technologies. Continued advances in bioengineering, standardization, and systems-level integration are essential to maximize their translational impact on disease modeling, therapeutic testing, and regenerative neuroscience.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148294737","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":"Meta-analysis: percutaneous versus surgical VA-ECMO decannulation demonstrates no clear differences in most outcomes, with a signal toward lower infection.","authors":"Masashi Kawabori, Chris A Jackel, Jo-Ann Nugent, Anna Y Johnson, Tony Mangino, Jamel Ortoleva","doi":"10.1007/s10047-026-01562-x","DOIUrl":"10.1007/s10047-026-01562-x","url":null,"abstract":"<p><p>Venoarterial Extracorporeal Membrane Oxygenation (ECMO) is a life-support therapy for critical cardiac or respiratory failure, and decannulation requires arterial access closure. The traditional surgical repair is effective but carries risks inherent to invasive procedures. Percutaneous vascular access closure has been developed as a less invasive alternative, though direct comparative evidence has been limited. We performed a systematic review and meta-analysis of 10 studies published between 2011 and 2024, encompassing 1074 patients and comparing surgical closure versus percutaneous closure. Outcomes assessed included limb infection, ischemia, pseudoaneurysm, bleeding events, ECMO duration, and in-hospital mortality. Results demonstrated no statistically significant differences across most outcomes, including limb ischemia (OR = 0.79; 95% CI 0.44-1.40; p = 0.415), pseudoaneurysm (OR = 0.88; 95% CI 0.45-1.72; p = 0.704), bleeding events (OR = 0.48; 95% CI 0.08-2.82; p = 0.316), ECMO duration (Mean Difference = - 25.4711; 95% CI = - 63.7896-12.8474; p = 0.1639) and mortality (OR = 0.74; 95% CI 0.50-1.10; p = 0.134). In contrast, the pooled OR indicated a significant 94.1% decrease in odds of infection associated with percutaneous closure (OR = 0.06; 95% CI = 0.02-0.17; p = 0.002). No heterogeneity was identified (I² = 0%), and meta-regression results were non-significant, suggesting that the device type did not serve as a modifier (p = 0.23).Overall, this analysis reflects the current state of the literature and does not demonstrate consistent differences between percutaneous and surgical approaches across most outcomes. While percutaneous closure may be associated with lower odds of infection, this finding should be interpreted cautiously given the limited number and observational nature of the included studies. However, these results highlight that infection may be an important outcome to prioritize in future investigations. Larger, prospective investigations are needed to better define the comparative effectiveness and safety of these approaches.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148294765","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":"Does closed suction drainage reduce postoperative hematoma and muscle swelling after total hip arthroplasty? A retrospective comparative study using computed tomography.","authors":"Tomoki Asano, Keisuke Uemura, Ryo Higuchi, Sotaro Kono, Hirokazu Mae, Tetsuro Tani, Kazuma Takashima, Seiji Okada, Mitsuyoshi Yamamura, Hidetoshi Hamada","doi":"10.1007/s10047-026-01561-y","DOIUrl":"10.1007/s10047-026-01561-y","url":null,"abstract":"<p><strong>Purpose: </strong>Closed suction drainage has been used after total hip arthroplasty (THA) to prevent hematoma, muscle swelling, and complications, but its effectiveness remains controversial. This study evaluated the effects of drains on postoperative hematoma, muscle swelling, and clinical outcomes.</p><p><strong>Methods: </strong>A total of 168 patients who underwent unilateral cementless THA via the posterior approach for secondary hip osteoarthritis due to developmental dysplasia were retrospectively reviewed. Among them, 60 matched pairs, with and without drains, were selected using propensity score matching based on age, sex, body mass index, operative time, and femoral stem type. The primary outcome was the percentage increase in under-fascial area (UFA) measured on axial computed tomography at the teardrop level. UFA was used as a surrogate marker of postoperative hematoma and muscle swelling and was assessed preoperatively and on postoperative day 7. Secondary outcomes included postoperative estimated blood loss (PEBL), pain (assessed using the numeric rating scale), and laboratory parameters (albumin, hemoglobin, white blood cell count, creatine kinase, and C-reactive protein) on postoperative days 1, 4, 7, and 14.</p><p><strong>Results: </strong>The mean percentage increase in the UFA did not differ between groups (10.7% [no-drain] vs. 11.2% [drain], P = 0.63). No significant differences were found in the PEBL, numeric rating scale pain scores on day 3, or laboratory parameters beyond postoperative day 14.</p><p><strong>Conclusion: </strong>Closed suction drainage did not reduce the UFA increase or improve clinical outcomes after THA. The routine use of drains may not be warranted considering the absence of demonstrable benefits and potential risks.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13279490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148277492","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":"Effect of short-term early postoperative gait-training using a lightweight hip-assist device on walking-speed recovery after total knee arthroplasty: a pilot study.","authors":"Kenichi Yoshikawa, Hirotaka Mutsuzaki, Kazunori Koseki, Koichi Iwai, Yutaka Kohno","doi":"10.1007/s10047-026-01560-z","DOIUrl":"10.1007/s10047-026-01560-z","url":null,"abstract":"<p><p>Robot-assisted gait training may improve walking recovery after total knee arthroplasty (TKA). However, optimal intervention durations and early postoperative feasibility remain unclear. We evaluated a short-term, early postoperative gait-training program's effects on walking-speed recovery using a lightweight, hip-wearable assistive device. In this pilot study, patients who underwent TKA were allocated preoperatively to receive either HWA-01 gait training plus standard rehabilitation (HGT) or standard rehabilitation alone (control). HGT was delivered during postoperative weeks 1-3 (8-10 sessions; ≤ 20 min/session, excluding rest). Outcomes were assessed at baseline, 2, 4, and 8 weeks; generalized linear mixed models were used to analyze gait speed, knee function, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) outcomes, and Patient Acceptable Symptom State (PASS) achievement for self-selected walking speed (SWS) (≥ 1.2 m/s) was compared between groups. Forty patients (52 knees) were analyzed (HGT, 13 patients/13 knees; control, 29 patients/39 knees). Significant time × group interactions were observed at 2 weeks for SWS (p = 0.045) and maximum walking speed (p = 0.044), indicating an attenuation of the early postoperative walking-speed decline in the HGT group. At 4 weeks, more patients in the HGT group achieved the PASS threshold (p = 0.013). No significant group or interaction effects were observed for the range of motion, torque, or WOMAC outcomes. A 2-week, early postoperative HGT program using a lightweight hip-assist device may mitigate early walking-speed decline after TKA and promote earlier attainment of a patient-acceptable walking speed with favorable safety and tolerability.Trial registration: UMIN Clinical Trials Registry (UMIN-CTR), UMIN000054889, https://www.umin.ac.jp/ctr/ .</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":"29 3","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148258088","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}