INTRODUCTION: Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD. METHODS: In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging. RESULTS: A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline. CONCLUSIONS: Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies. REGISTRATION ClinicalTrials.gov , NCT07034222.
Humans ; Alzheimer Disease/drug therapy* ; Male ; Female ; Aged ; Middle Aged ; Cognitive Dysfunction/drug therapy* ; Aged, 80 and over ; Amyloid beta-Peptides/metabolism* ; Biomarkers ; East Asian People

Objective:To compare the clinical efficacy of endoscopic posterior transforaminal lumbar interbody fusion (Endo-PTLIF) and minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) in the treatment of single-segment lumbar degenerative diseases.Methods:A retrospective analysis was conducted on the clinical data of 56 patients with single-segment lumbar degenerative diseases treated at Xiuzhou District People's Hospital between September 2020 and March 2023. Patients were divided into two groups based on the surgical approach: the Endo-PTLIF group (24 cases, 11 males and 13 females; mean age: 56.5±8.4 years, range: 43-72 years) and the MIS-TLIF group (32 cases, 10 males and 22 females; mean age: 54.5±10.4 years, range: 37-73 years). Perioperative parameters, visual analog scale (VAS) scores for pain, Oswestry disability index (ODI), lumbar lordosis (LL), disc height (DH), and dural sac cross-sectional area (DSCA) were compared between the two groups.Results:No significant differences were observed between the two groups in baseline characteristics, preoperative VAS, ODI, LL, DH, or DSCA ( P>0.05). However, the operative time in the Endo-PTLIF group (173.9±12.3 minutes) was significantly longer than in the MIS-TLIF group (136.5±19.5 minutes, P<0.05). Similarly, the Endo-PTLIF group required more fluoroscopy exposures (15.9±1.8) than the MIS-TLIF group (13.0±1.6, P<0.05). In contrast, intraoperative blood loss in the Endo-PTLIF group (68.9± 12.9 ml) was significantly lower than in the MIS-TLIF group (126.7±35.4 ml, P<0.05). Additionally, the Endo-PTLIF group had a shorter hospital stay [7.00 (6.25, 7.75) days] compared to the MIS-TLIF group [10.00 (9.25, 11.00) days, P<0.05]. At one week and one month postoperatively, the Endo-PTLIF group had significantly lower back pain VAS scores [2.00 (2.00, 3.00) and 2.00 (2.00, 2.00), respectively] and a lower ODI (25.83%±3.83%) compared to the MIS-TLIF group [3.00 (2.25, 4.00), 2.50 (2.00, 3.00), and 30.09%±4.02%, respectively; P<0.05]. Beyond one month postoperatively, there were no significant differences in leg pain VAS scores between the groups, and back pain VAS and ODI showed no significant differences after six months ( P>0.05). At the final follow-up, the excellent and good rates, according to MacNab criteria, were 95.8% in the Endo-PTLIF group and 93.8% in the MIS-TLIF group, with no significant difference ( P>0.05). At 12 months postoperatively, both groups showed significant improvements in LL, DH, and DSCA compared to preoperative values ( P<0.05), but there were no significant differences between the two groups ( P>0.05). The fusion rates were 96% in the Endo-PTLIF group and 94% in the MIS-TLIF group, with no significant difference ( P>0.05). Complications included one case of dural tear in the Endo-PTLIF group, and one case of dural tear and one case of incision infection in the MIS-TLIF group. Conclusion:Endo-PTLIF achieves comparable clinical efficacy to MIS-TLIF in the treatment of single-segment lumbar degenerative diseases, with the added advantages of reduced intraoperative blood loss and faster postoperative recovery.

Objective:To compare the clinical efficacy of endoscopic posterior transforaminal lumbar interbody fusion (Endo-PTLIF) and minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) in the treatment of single-segment lumbar degenerative diseases.Methods:A retrospective analysis was conducted on the clinical data of 56 patients with single-segment lumbar degenerative diseases treated at Xiuzhou District People's Hospital between September 2020 and March 2023. Patients were divided into two groups based on the surgical approach: the Endo-PTLIF group (24 cases, 11 males and 13 females; mean age: 56.5±8.4 years, range: 43-72 years) and the MIS-TLIF group (32 cases, 10 males and 22 females; mean age: 54.5±10.4 years, range: 37-73 years). Perioperative parameters, visual analog scale (VAS) scores for pain, Oswestry disability index (ODI), lumbar lordosis (LL), disc height (DH), and dural sac cross-sectional area (DSCA) were compared between the two groups.Results:No significant differences were observed between the two groups in baseline characteristics, preoperative VAS, ODI, LL, DH, or DSCA ( P>0.05). However, the operative time in the Endo-PTLIF group (173.9±12.3 minutes) was significantly longer than in the MIS-TLIF group (136.5±19.5 minutes, P<0.05). Similarly, the Endo-PTLIF group required more fluoroscopy exposures (15.9±1.8) than the MIS-TLIF group (13.0±1.6, P<0.05). In contrast, intraoperative blood loss in the Endo-PTLIF group (68.9± 12.9 ml) was significantly lower than in the MIS-TLIF group (126.7±35.4 ml, P<0.05). Additionally, the Endo-PTLIF group had a shorter hospital stay [7.00 (6.25, 7.75) days] compared to the MIS-TLIF group [10.00 (9.25, 11.00) days, P<0.05]. At one week and one month postoperatively, the Endo-PTLIF group had significantly lower back pain VAS scores [2.00 (2.00, 3.00) and 2.00 (2.00, 2.00), respectively] and a lower ODI (25.83%±3.83%) compared to the MIS-TLIF group [3.00 (2.25, 4.00), 2.50 (2.00, 3.00), and 30.09%±4.02%, respectively; P<0.05]. Beyond one month postoperatively, there were no significant differences in leg pain VAS scores between the groups, and back pain VAS and ODI showed no significant differences after six months ( P>0.05). At the final follow-up, the excellent and good rates, according to MacNab criteria, were 95.8% in the Endo-PTLIF group and 93.8% in the MIS-TLIF group, with no significant difference ( P>0.05). At 12 months postoperatively, both groups showed significant improvements in LL, DH, and DSCA compared to preoperative values ( P<0.05), but there were no significant differences between the two groups ( P>0.05). The fusion rates were 96% in the Endo-PTLIF group and 94% in the MIS-TLIF group, with no significant difference ( P>0.05). Complications included one case of dural tear in the Endo-PTLIF group, and one case of dural tear and one case of incision infection in the MIS-TLIF group. Conclusion:Endo-PTLIF achieves comparable clinical efficacy to MIS-TLIF in the treatment of single-segment lumbar degenerative diseases, with the added advantages of reduced intraoperative blood loss and faster postoperative recovery.

Objective To summarize and analyze the preliminary clinical outcomes of the KokaclipTM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation (DMR). Methods This study was a single-arm, prospective, single-group target value clinical trial that enrolled patients who underwent the KokaclipTM transcatheter edge-to-edge repair (TEER) system for DMR in the Department of Heart Surgery of Guangdong Provincial People's Hospital, Guangdong Cardiovascular Institute from June 2022 to January 2023. Differences in the grade of mitral regurgitation (MR) during the perioperative and follow-up periods were compared, and the incidences of adverse events such as all-cause death, thoracotomy conversion, reoperation, and severe recurrence of MR during the study period were investigated. Results The enrolled patient population consisted of 14 (50.0%) females with a mean age of 70.9±5.4 years. Twenty-eight (100.0%) patients were preoperatively diagnosed with typeⅡ DMR, with a prolapse width of 12.5 (11.0, 16.1) mm, a degree of regurgitation 4+ leading to pulmonary venous reflux, and a New York Heart Association cardiac function class≥Ⅲ. All patients completed the TEER procedure successfully, with immediate postoperative improvement of MR to 0, 1+, and 2+ grade in 2 (7.1%), 21 (75.0%), and 5 (17.9%) patients, respectively. Mitral valve gradient was 2.5 (2.0, 3.0) mm Hg. Deaths, thoracotomy conversion, or device complications such as unileaflet clamping, clip dislodgement, or leaflet injury were negative. Twenty-eight (100.0%) patients completed at least 3-month postoperative follow-up with a median follow-up time of 5.9 (3.6, 6.8) months, during which patients had a mean MR grade of 1.0+ (1.0+, 2.0+) grade and a significant improvement from preoperative values (P<0.001). There was no recurrence of ≥3+ regurgitation, pulmonary venous reflux, reoperation, new-onset mitral stenosis, or major adverse cardiovascular events. Twenty-two (78.6%) patients’ cardiac function improved to classⅠorⅡ. Conclusion The domestic KokaclipTM TEER system has shown excellent preliminary clinical results in selected DMR patients with a high safety profile and significant improvement in MR. Additional large sample volume, prospective, multicenter studies, and long-term follow-up are expected to validate the effectiveness of this system in the future.

Total hip arthroplasty(THA)is an effective treatment for elderly femoral neck fractures,mid-to late-stage femoral head necrosis,and end-stage hip osteoarthritis.However,serious complications such as aseptic loosening of the prosthesis,peripheral fractures,and dislocation of the prosthesis still exist following THA,which makes the selection of the appropriate hip prosthesis type and placement position before THA an important challenge for surgeons.Currently,the commonly used preoperative planning methods for THA mainly rely on static images from two-dimensional(2D)X-ray or three-dimensional(3D)computed tomography(CT),which fail to adequately consider the hip joint in weight-bearing as well as motion,lumbar-hip joint changes,and prosthetic impingement during motion.Recently,the dual fluoroscopic imaging system,as a new in-vivo,dynamic radiological imaging technology,provides comprehensive and accurate dynamic 3D data for THA preoperative planning.However,the technical process and expert consensus on preoperative 3D planning of THA using a dual fluoroscopic imaging system have not yet been established,which affects the promotion and application of this technology.In light of the above,national orthopaedic experts and related professional representatives discussed and proposed seven consensus issues,and the'expert recommendation rate'and'strong recommendation rate'were obtained through a questionnaire survey on the recommendations of the participating experts.This consensus aims to provide guidance and reference for the standardised application of preoperative 3D planning of THA using the dual fluoroscopic imaging system.

Total hip arthroplasty(THA)is an effective treatment for elderly femoral neck fractures,mid-to late-stage femoral head necrosis,and end-stage hip osteoarthritis.However,serious complications such as aseptic loosening of the prosthesis,peripheral fractures,and dislocation of the prosthesis still exist following THA,which makes the selection of the appropriate hip prosthesis type and placement position before THA an important challenge for surgeons.Currently,the commonly used preoperative planning methods for THA mainly rely on static images from two-dimensional(2D)X-ray or three-dimensional(3D)computed tomography(CT),which fail to adequately consider the hip joint in weight-bearing as well as motion,lumbar-hip joint changes,and prosthetic impingement during motion.Recently,the dual fluoroscopic imaging system,as a new in-vivo,dynamic radiological imaging technology,provides comprehensive and accurate dynamic 3D data for THA preoperative planning.However,the technical process and expert consensus on preoperative 3D planning of THA using a dual fluoroscopic imaging system have not yet been established,which affects the promotion and application of this technology.In light of the above,national orthopaedic experts and related professional representatives discussed and proposed seven consensus issues,and the'expert recommendation rate'and'strong recommendation rate'were obtained through a questionnaire survey on the recommendations of the participating experts.This consensus aims to provide guidance and reference for the standardised application of preoperative 3D planning of THA using the dual fluoroscopic imaging system.

Objective     To analyze the clinical efficacy and survival outcome of totally thoracoscopic redo mitral valve replacement and evaluate its efficiency and safety. Methods     The clinical data of patients with totally thoracoscopic redo mitral valve replacement in Guangdong Provincial People’s Hospital between 2013 and 2019 were retrospectively analyzed. Survival analysis was performed using the Kaplan-Meier method. Univariate and multivariate Cox regression analyses were used to determine the risk factors for postoperative death. Results     There were 48 patients including 29 females and 19 males with a median age of 53 (44, 66) years. All the procedures were performed successfully with no conversion to median sternotomy. A total of 15, 10 and 23 patients received surgeries under non-beating heart, beating heart and ventricular fibrillation, respectively. The in-hospital mortality rate was 6.25% (3/48), and the incidence of early postoperative complications was 18.75% (9/48). Thirty-five (72.92%) patients had their tracheal intubation removed within 24 hours after the operation. The 1- and 6-year survival rates were 89.50% (95%CI 81.30%-98.70%) and 82.90%(95%CI 71.50%-96.20%), respectively. Age>65 years was an independent risk factor for postoperative death (P=0.04). Conclusion     Totally thoracoscopic redo mitral valve replacement is safe and reliable, with advantages of rapid recovery, reducing blood transfusion rate, reducing postoperative complications and acceptable long-term survival rate. It is worthy of being widely popularized in the clinic.

Objective    To investigate the surgical strategies and clinical efficacy of transmitral septal myectomy in the treatment of recurrent left ventricular outflow tract obstruction (LVOTO) after alcohol septal ablation. Methods    The clinical data of patients with recurrent LVOTO after alcohol septal ablation from July 2020 to July 2021 in the Department of Cardiac Surgery, Guangdong Provincial People's Hospital were retrospectively analyzed. Patients were preoperatively evaluated by echocardiography, cardiac magnetic resonance imaging, cardiac computed tomography, 3D modeling and printing technology. A personalized surgical strategy was preoperatively developed according to multimodality imaging assessment, while visual exploration was performed on the digital model and simulated surgical resection was performed on the printed model. Results     Two female patients were enrolled, aged 62 years and 64 years, respectively. Totally endoscopic transmitral extended myectomy was successfully performed on both patients with aortic cross-clamping time of 96 min and 85 min, respectively. LVOTO was relieved immediately (subaortic peak pressure gradient decreased from 100 mm Hg to 4 mm Hg and from 84 mm Hg to 6 mm Hg, respectively) and the mitral regurgitation significantly improved after the procedure. No patient had complete atrioventricular block or required permanent pacemaker implantation. The patients were discharged uneventfully without postoperative complications. Conclusion    Personalized totally endoscopic transmitral extended myectomy combined with multimodality imaging assessment and 3D modeling and printing has an acceptable clinical effect in patients with recurrent LVOTO after alcohol septal ablation. The procedure can precisely resect the hypertrophic septal myocardium while avoiding serious complications such as septal perforation or complete atrioventricular block.

We reported a 26-year-old male who was diagnosed with apical hypertrophic cardiomyopathy with left ventricular aneurysm. The location of the hypertrophic myocardium and the extent of resection were accurately assessed preoperatively using 3D modeling and printing technology. Myectomy was performed via transapical approach, and the intraoperative exploration was consistent with the description of the preoperative 3D modeling. The patient underwent the surgery successfully without any complications during the hospitalization, and the cardiopulmonary bypass time was 117 min, the aortic cross-clamping time was 57 min, and the hospital stay time was 7 d. The postoperative echocardiography demonstrated left ventricular cavity flow patency. This case provides a reference for the management of patients with apical hypertrophic cardiomyopathy.

  Objective  To understand the current status of surgical treatment for hemophilia osteoarthropathy (HO) in China.  Methods  Using an online questionnaire, select domestic hospitals that partici-pated in the compilation of the 'Guideline for perioperative management of hemophilia patients undergoing orthopaedic surgery in China ', in addition to members of the National Joint Surgery Group, and the Orthopedic Branch of the Chinese Medical Association for targeted investigation and analysis.  Results  A total of 17 domestic hospitals were included, all of which were general hospitals. Hospitals that started HO surgery treatment before 2000 accounted for 35.29%. A total of 3057 surgical cases of HO were reported by those hospitals. The most commonly performed surgical procedures were hip and knee joint replacement. The most commonly used coagulation factor replacement regimen was recombinant coagulation factor preparation. Ten hospitals reported finding patients with transfusion-related infectious diseases. Bleeding and hematoma formation were the most frequently reported surgical complications. Excessive length of hospital stay and high economic costs were the most frequently reported problems.  Conclusions  Surgical treatment for HO in 17 hospitals is mainly carried out in some large comprehensive medical centers in the eastern region. Compared with the patient base, the popularity and number of surgeries are still relatively insufficient. It is necessary to further standardize the treatment system by standardizing factor replacement and strengthening rehabilitation to improve surgical treatment outcomes.