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 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.

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.

Periarticular fracture of the shoulder is a common type of fractures in the elderly. Postoperative adverse events such as internal fixation failure, humeral head ischemic necrosis and upper limb dysfunction occur frequently, which seriously endangers the exercise and health of the elderly. Compared with the fracture with normal bone mass, the osteoporotic periarticular fracture of the shoulder is complicated with slow healing and poor rehabilitation, so the clinical management becomes more difficult. At present, there is no targeted guideline or consensus for this type of fracture in China. In such context, experts from Youth Osteoporosis Group of Chinese Orthopedic Association, Orthopedic Expert Committee of Geriatrics Branch of Chinese Association of Gerontology and Geriatrics, Osteoporosis Group of Youth Committee of Chinese Association of Orthopedic Surgeons and Osteoporosis Committee of Shanghai Association of Chinese Integrative Medicine developed the Chinese expert consensus on the diagnosis and treatment of osteoporotic periarticular fracture of the shoulder in the elderly ( version 2023). Nine recommendations were put forward from the aspects of diagnosis, treatment strategies and rehabilitation of osteoporotic periarticular fracture of the shoulder, hoping to promote the standardized, systematic and personalized diagnosis and treatment concept and improve functional outcomes and quality of life in elderly patients with osteoporotic periarticular fracture of the shoulder.

Objective:To investigate the clinical efficacy of full-endoscopic technique through the posterior cervical Delta large portal for the treatment of cervical spondylotic myelopathy and radiculopathy.Methods:The clinical data were analyzed retrospectively of the 15 patients who had been treated for cervical spondylotic myelopathy or radiculopathy at Orthopedics Department, Jiaxing Xiuzhou District People's Hospital from January 2020 to June 2021. There were 6 males and 9 females, aged from 54 to 76 years (average, 66.2 years). Responsible levels: 3 cases of C3, 4, 4 cases of C4, 5, 7 cases of C5, 6 and 1 case of C6, 7. They were all treated by full-endoscopic technique through the posterior cervical Delta large portal. The therapeutic efficacy was assessed by comparing the neck disability indexes (NDI) and Japanese Orthopaedic Association (JOA) cervical scores at preoperation, 1 and 3 months post-operation, and the last follow-up, and the modified MacNab scores at the last follow-up. The operative effects on cervical curvature and segmental stability were assessed by comparing the C2-7 cobb angles and operative ranges of motion (ROM) at preoperation, 1 and 3 months postoperation, and the last follow-up.Results:All cases completed their operation successfully. The operation time ranged from 56 to 82 min (average, 65.7 min), and the intraoperative blood loss from 10 to 30 mL (average, 20.7 mL). Tissue infection, intraspinal infection, dural tear, nerve root injury or perioperative anesthesia-related complications occurred in none of the patients. All patients were followed up for 6 to 18 months (average 10.8 months). The NDIs at 1 and 3 months post-operation, and the last follow-up (18.54%±3.06%, 14.96%±2.33%, and 12.89%±2.33%) were significantly lower than that before operation (34.19%±3.83%), and those at 3 months postoperation and the last follow-up significantly lower than that at 1 month postoperation ( P<0.05), but there was no significant difference between 3 months postoperation and the last follow-up in NDI ( P>0.05). The JOA scores at 1 and 3 months postoperation, and the last follow-up [(12.28±1.65), (13.30±1.57) and (13.54±1.41) points] were significantly higher than the preoperative value [(9.25±1.49) points] ( P<0.05), but there was no such a significant difference between postoperative time points ( P>0.05). Comparisons between preoperation, 1 and 3 months postoperation, and the last follow-up showed no significant difference in the C2-7 cobb angle or operative ROM ( P>0.05). The modified MacNab scores at the last follow-up resulted in 9 excellent, 5 good and 1 fair cases. Conclusion:In the treatment of cervical spondylotic myelopathy and radiculopathy, the full-endoscopic technique through the posterior cervical Delta large portal shows the advantages of limited invasion and complications, rapid recovery after operation, and little impact on the cervical curvature and segmental stability.

  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.

Objective:To evaluate the clinical effectiveness of thoracoscopic extended septal myectomy in elderly patients diagnosed with hypertrophic obstructive cardiomyopathy(HOCA).Methods:From April 2019 to August 2021, 36 elderly patients with HOCM who underwent septal myectomy were retrospectively analyzed, including 20 patients under thoracoscopy and 16 patients under median sternotomy.The surgical outcomes, echocardiography and follow-up results were compared between the two groups.Results:The number of intracardiac incisions in the Thoracoscopy group was significantly lower than that in the median thoracotomy group( P=0.001).Additionally, the ventilation time of ≤24 hours was higher in the thoracoscopy group compared to the median thoracotomy group(75.0% vs 31.2%, P=0.017).It is noteworthy that there were no deaths in the thoracoscopic group.However, one patient experienced left ventricular rupture during mitral valve replacement and had to be converted to median sternotomy.This patient also developed low cardiac output syndrome after the operation but was discharged smoothly.In the median sternotomy group, one patient died in the hospital, two patients developed low cardiac output syndrome, and one patient underwent re-sternotomy due to bleeding.Importantly, neither group experienced ventricular septal perforation or complete atrioventricular block.The number of intracardiac incisions in the thoracoscopy postoperative interventricular septal thickness was significantly reduced in both groups.In the thoracoscopic group, the interventricular septal thickness was(19.2±3.5)mm and(11.3±2.2)mm, with a t-value of 8.531 and a p-value of <0.001.In the median sternotomy group, the interventricular septal thickness was(19.9±3.9)mm and(13.1±2.6)mm, with a t-value of 5.664 and a p-value of <0.001.This reduction effectively relieved left ventricular outflow tract obstruction.In the thoracoscopic group, the left ventricular outflow tract obstruction decreased from(96.2±32.9)mmHg to(8.2±3.4)mmHg, with a t-value of 11.894 and a p-value of <0.001.In the median sternotomy group, the left ventricular outflow tract obstruction decreased from(83.2±40.9)mmHg to(13.3±19.3)mmHg, with a t-value of 5.997 and a p-value of <0.001.The patients in the thoracoscopic group were followed up for an average of(13.5±8.8)months, and no complications occurred.The patients in the median sternotomy group were followed up for an average of(15.8±9.4)months.One patient in this group underwent alcohol septal ablation for residual obstruction and developed complete atrioventricular block. Conclusions:Thoracoscopic extended myectomy in elderly patients with(HOCM)can achieve comparable therapeutic effectiveness and safety compared to the median sternotomy approach.This minimally invasive procedure is associated with shorter ventilation time and can also minimize the need for additional intracardiac incisions, especially when simultaneous mitral valve treatment is necessary.

Objective    To determine the clinical efficacy of transcatheter aortic valve replacement (TAVR) for severe aortic regurgitation (AR) combined with severe mitral regurgitation (MR). Methods    The clinical data of 13 patients who underwent TAVR due to severe AR combined with severe MR from March 2018 to September 2021 in our hospital were retrospectively analyzed, including 10 males and 3 females with a mean age of 72.54±2.35 years. The echocardiographic findings of all patients were compared preoperatively and postoperatively. Results    Surgeries were performed successfully in all patients without intraoperative death or conversion to sternotomy. The operation time was 118.15±11.42 min, intraoperative blood loss was 100.00 (75.00, 250.00) mL, and the length of hospital stay after surgery was 9.00 (4.50, 11.00) d. The mean follow-up duration was 10.00 (6.50, 38.50) months, during which there were 2 patients with mild to moderate AR, 6 with mild AR, and 5 with no AR; meanwhile, severe MR decreased significantly (P=0.001) even without active intervention, including 4 mild to moderate MR and 9 mild MR patients. Compared to preoperative indexes, the left atrial diameter [46.00 (41.00, 52.50) mm vs. 35.00 (34.00, 41.00) mm, P<0.001], left ventricular end-systolic diameter [45.00 (36.00, 56.00) mm vs. 35.00 (28.00, 39.00) mm, P=0.002] and left ventricular end-diastolic diameter (62.62±2.40 mm vs. 51.08±2.49 mm, P<0.001) showed a decreasing trend during the follow-up. Conclusion    In selected patients with severe AR combined with severe MR, TAVR alone improves AR and combined MR at the same time.