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

Background and Objectives: There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce. Methods: Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66). Results: No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs.62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59–32.64; p=0.01).In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342). Conclusions Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes.

Background and Objectives: There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce. Methods: Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66). Results: No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs.62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59–32.64; p=0.01).In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342). Conclusions Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes.

Background and Objectives: There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce. Methods: Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66). Results: No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs.62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59–32.64; p=0.01).In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342). Conclusions Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes.

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 evaluate the clinical efficacy of mitral valve transcatheter edge-to-edge repair (TEER) in patients with non-central degenerative mitral regurgitation (DMR).Methods:This retrospective study included patients with non-central DMR who underwent TEER at Fuwai Hospital between January 2021 and February 2024. Patients were categorized into two groups: the commissure-involved group and the non-commissure group, based on whether the mitral valve commissures were involved. Clinical data, surgical outcomes, and echocardiographic findings at 3 months postoperatively were collected and compared, and patients were followed up. The primary endpoint was the procedural success rate at discharge.Results:A total of 59 patients were included, aged (68.6±9.3) years, including 23 females (39%). In the overall study population, 78% (46/59) of patients had severe mitral regurgitation. Forty-two cases were in the non-commissure group, and 17 cases were in the commissure-involved group. Patients in the non-commissure group mainly had lesions in the A1/P1 region, while patients in the commissure-involved group mainly had lesions in the A3/P3 region. There was no significant difference in the procedural success rate at discharge (93% vs. 88%, P=0.95) and the incidence of postoperative complications (5% vs. 6%, P=1.00) between the two groups. Two patients in the commissure-involved group experienced single leaflet device attachment, with one of them requiring conversion to surgical mitral valve surgery; In the non-commissure group, two patients experienced single-valve clamping, and one of them was converted to surgical mitral valve surgery. The follow-up time of the entire cohort was (15.5±10.3) months. In the non-commissure group, 2 patients died and 2 were readmitted. While in the commissure-involved group, no patients died and only 1 patient was readmitted. Conclusion:TEER is an effective treatment for patients with non-central DMR involving the commissures, without increasing the incidence of postoperative complications.

Background and Objectives: There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce. Methods: Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66). Results: No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs.62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59–32.64; p=0.01).In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342). Conclusions Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes.

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 evaluate the clinical efficacy of mitral valve transcatheter edge-to-edge repair (TEER) in patients with non-central degenerative mitral regurgitation (DMR).Methods:This retrospective study included patients with non-central DMR who underwent TEER at Fuwai Hospital between January 2021 and February 2024. Patients were categorized into two groups: the commissure-involved group and the non-commissure group, based on whether the mitral valve commissures were involved. Clinical data, surgical outcomes, and echocardiographic findings at 3 months postoperatively were collected and compared, and patients were followed up. The primary endpoint was the procedural success rate at discharge.Results:A total of 59 patients were included, aged (68.6±9.3) years, including 23 females (39%). In the overall study population, 78% (46/59) of patients had severe mitral regurgitation. Forty-two cases were in the non-commissure group, and 17 cases were in the commissure-involved group. Patients in the non-commissure group mainly had lesions in the A1/P1 region, while patients in the commissure-involved group mainly had lesions in the A3/P3 region. There was no significant difference in the procedural success rate at discharge (93% vs. 88%, P=0.95) and the incidence of postoperative complications (5% vs. 6%, P=1.00) between the two groups. Two patients in the commissure-involved group experienced single leaflet device attachment, with one of them requiring conversion to surgical mitral valve surgery; In the non-commissure group, two patients experienced single-valve clamping, and one of them was converted to surgical mitral valve surgery. The follow-up time of the entire cohort was (15.5±10.3) months. In the non-commissure group, 2 patients died and 2 were readmitted. While in the commissure-involved group, no patients died and only 1 patient was readmitted. Conclusion:TEER is an effective treatment for patients with non-central DMR involving the commissures, without increasing the incidence of postoperative complications.

Objective To explore the method and feasibility of establishing patent ductus arteriosus (PDA) model in Bama miniature pig by using autologous jugular vein, and to provide a large animal model for the development of PDA occluder and the study of pulmonary hypertension associated with congenital heart disease. Methods Five male Bama miniature pigs weighing about 45 kg were selected to gain the PDA model of the autogenous jugular vein, which was fixed by glutaraldehyde and anastomosed between the ascending aorta and the main pulmonary artery. The patency of PDA was confirmed by echocardiography and angiocardiography immediately and one week after the operation. Two animals were selected to undergo transcatheter closure of PDA via femoral vein 1 week after the operation, and the rest were euthanized to obtain PDA and lung tissue for pathological examination. Results The PDA model was successfully established in all five animals with a success rate of 100.0%. Immediately and 1 week after the operation, echocardiography and angiography showed that PDA blood flow was unobstructed, and hematoxylin-eosin staining showed that PDA endothelialization was good. One week after the operation, two animals were successfully treated with transcatheter femoral vein occlusion. The pathological examination of lung tissue showed thickening of the intima and muscular layer of pulmonary arterioles, thickening of pulmonary interstitium and infiltration of neutrophils. Conclusion It is safe and feasible to establish a large animal model of PDA by using autogenous jugular vein anastomosis between the ascending aorta and the main pulmonary artery. The model can be used for the development of PDA interventional occlusive devices and the pathophysiological study of congenital heart disease-related pulmonary hypertension.