Objective To investigate the species of sandflies and the prevalence of Leishmania infections in sandflies from selected areas of northern and northwestern China, so as to provide insights into identification of leishmaniasis vectors and assessment of epidemiological trends of leishmaniasis in China. Methods Sandfly samples were collected from Mentougou District of Beijing Municipality, Xiangning County in Linfen City of Shanxi Province, Ejin Banner in Alxa League of Inner Mongolia Autonomous Region, and Payzawat County of Karamay District of Karamay City, Gaochang District of Turpan City in Xinjiang Uygur Autonomous Region from July 2023 to July 2024. Approximately 100 intact female sandfly samples were randomly selected from each site and the species of sandflies was identified according to morphological characteristics and molecular assays. Female sandflies originating from the same habitat were grouped into pools of 10 individuals. Leishmania infection was detected using polymerase chain reaction (PCR) assay targeting the internal transcribed spacer 1 (ITS-1) gene, and the prevalence of Leishmania infection was calculated in sandflies from different sampling sites using the minimum infection rate (MIR) method. In addition, positive amplicons were sequenced and subjected to phylogenetic analysis. Results A total of 6 155 sandflies were collected from different environments at sampling sites across the six aforementioned regions from July 2023 to July 2024. Phlebotomus chinensis (96.00%) was the dominant sandfly species in Mentougou District, Beijing Municipality, with a small proportion of Ph. sergenti (4.00%), and only Ph. chinensis was found in Xiangning County, Linfen City, Shanxi Province. Ph. wui was the only sandfly species detected in Ejin Banner, Alxa League, Inner Mongolia Autonomous Region, and Payzawat County, Kashgar City, Xinjiang Uygur Autonomous Region, and Ph. caucasicus (97.70%) was the dominant sandfly species in Karamay District, Karamay City, Xinjiang Uygur Autonomous Region, with a small proportion of Ph. wui (2.30%), while Ph. alexandri was the only species in Gaochang District, Turpan City, Xinjiang Uygur Autonomous Region. A total of 40, 60, 34, 18, 18, and 22 pools of sandfly samples were tested from Mentougou District in Beijing Municipality, Xiangning County in Linfen City of Shanxi Province, Ejin Banner in Alxa League of Inner Mongolia Autonomous Region, Payzawat County in Kashgar City, Karamay District in Karamay City, and Gaochang District in Turpan City of Xinjiang Uygur Autonomous Region, respectively. L. infantum was detected in Ph. chinensis samples from Mentougou District in Beijing Municipality, and Xiangning County of Linfen City in Shanxi Province, with MIR of 0.25% to 1.00%, and L. donovani was detected in Ph. wui from Ejin Banner in Alxa League of Inner Mongolia Autonomous Region, and Payzawat County in Kashgar City of Xinjiang Uygur Autonomous Region, with MIR of 0.56% to 0.88%; however, no Leishmania infection was detected in Ph. caucasicus from Karamay District in Karamay City or Ph. alexandri from Gaochang District in Turpan City of Xinjiang Uygur Autonomous Region. Phylogenetic analysis showed that the Leishmania ITS-1 gene sequences obtained from Mentougou District in Beijing Municipality and Xiangning County in Linfen City of Shanxi Province were clustered into the same clade with the reference sequences of L. infantum ITS-1 gene, while the Leishmania ITS-1 gene sequences obtained from Ejin Banner in Alxa League of Inner Mongolia Autonomous Region and Payzawat County in Kashgar City of Xinjiang Uygur Autonomous Region were clustered into the same clade with the reference sequences of L. donovani ITS-1 gene. Conclusions There are variations in sandfly species in selected areas of northern and northwestern China, and variations in the species of Leishmania infecting sandflies. Improved surveillance of sandfly vectors and targeted control strategies with adaptations to geographical features and leishmaniasis vectors are recommended.

Objective:To explore the association between albumin-corrected serum calcium (ACSC) levels and 30-day all-cause mortality in patients hospitalized for community-acquired bacterial pneumonia (CABP).Methods:A secondary analysis was conducted on 1 899 patients with CABP from a Norwegian cohort study. The relationship between baseline ACSC levels and 30-day mortality was assessed using multivariable logistic regression models, adjusted for potential confounders.Results:A significant positive correlation was found between ACSC levels and 30-day mortality risk after adjusting for confounding variables ( OR=1.95, 95% CI=1.48-2.58). When ACSC levels were categorized into tertiles (T1-T3), a trend analysis revealed that the T2 and T3 groups had significantly higher mortality risks compared to the lowest tertile (T1), with odds ratios ( OR) and 95% confidence intervals ( CI) of 1.52(95% CI: 0.97-2.38) and 2.21 (95% CI: 1.44-3.39), respectively ( P for trend <0.001). Subgroup analyses demonstrated no significant interactions across predefined subgroups (all P for interaction > 0.05). Conclusions:In patients with CABP and admission ACSC levels of ≥8.6 mg/dL, higher ACSC levels were positively associated with an increased risk of 30-day mortality. These findings highlight the potential prognostic value of ACSC levels in CABP patients.

OBJECTIVE: To explore the risk factors affecting the prognosis of patients with sepsis complicated with acute pulmonary embolism, and to construct and validate a nomogram predictive model for in-hospital mortality risk. METHODS: Based on the American Medical Information Mart for Intensive Care (MIMIC-III, MIMIC-IV) databases, the data were collected on patients with sepsis complicated with acute pulmonary embolism from 2001 to 2019, including baseline characteristics, and vital signs, disease scores, laboratory tests within 24 hours of admission to the intensive care unit (ICU), and interventions. In-hospital mortality was the outcome event. The total samples were divided into training and testing sets in a 7:3 ratio by random sampling. Univariate Cox regression analysis was used to verify the impact of all variables on the risk of in-hospital mortality, thereby screen potential influencing factors. Subsequently, a stepwise bi-directional regression method was applied to select factors one by one, leading to the construction of a nomogram prediction model. Collinearity testing was used to demonstrate the absence of strong multicollinearity among the influencing factors in the nomogram prediction model. The discrimination of the nomogram model, sequential organ failure assessment (SOFA), and simplified pulmonary embolism severity index (sPESI) was evaluated using C-index in the test set. Receiver operator characteristic curve (ROC curve) was drawn to evaluate the predictive value of various models for in-hospital mortality in patients with sepsis complicated with acute pulmonary embolism. RESULTS: A total of 562 patients with sepsis complicated with acute pulmonary embolism were included, including 393 in the training set and 169 in the testing set. Univariate Cox regression analysis showed that 30 factors associated with in-hospital mortality in patients with sepsis complicated with acute pulmonary embolism. Through stepwise bi-directional regression, 12 variables were ultimately selected, including gender, presence of malignant tumors, body temperature, red cell distribution width (RDW), blood urea nitrogen (BUN), serum potassium, prothrombin time (PT), 24-hour urine output, mechanical ventilation, vasoactive drugs, warfarin use, and sepsis-induced coagulopathy (SIC). Collinearity testing indicated no strong multicollinearity among the influencing factors [all variance inflation factor (VIF) > 10]. A nomogram model was constructed using the 12 variables mentioned above. The nomogram model predicted the C-index and its 95% confidence interval (95%CI) of in-hospital mortality in patients with sepsis complicated with acute pulmonary embolism better than SOFA score and sPESI [0.771 (0.725-0.816) vs. 0.579 (0.519-0.639), 0.608 (0.554-0.663)]. The ROC curve showed that the area under the curve (AUC) and its 95%CI of the nomogram model were higher than those of the SOFA score and sPESI [0.811 (0.766-0.857) vs. 0.630 (0.568-0.691), 0.623 (0.566-0.680)]. These findings were consistently replicated in the internal validation of the testing set. In both the training and testing sets, Delong's test showed that the AUC of the nomogram model was significantly higher than the SOFA score and sPESI (both P < 0.05). CONCLUSION The nomogram model demonstrated good predictive effectiveness for the risk of in-hospital mortality in patients with sepsis complicated with acute pulmonary embolism, enabling clinicians to predict mortality risk in advance and take timely interventions to reduce mortality.
Humans ; Pulmonary Embolism/mortality* ; Hospital Mortality ; Nomograms ; Sepsis/complications* ; Prognosis ; Risk Factors ; Intensive Care Units ; Male ; Female ; Middle Aged ; Aged

OBJECTIVE: To construct machine learning prediction model for sepsis-associated encephalopathy (SAE), and analyze the application value of the model on early identification of SAE risk in elderly septic patients. METHODS: Patients aged over 60 years with a primary diagnosis of sepsis admitted to intensive care unit (ICU) from 2008 to 2023 were selected from Medical Information Mart for Intensive Care-IV 2.2 (MIMIC-IV 2.2). Demographic variables, disease severity scores, comorbidities, interventions, laboratory indicators, and hospitalization details were collected. Key factors associated with SAE were identified using univariate Logistic regression analysis. The data were randomly divided into training and validation sets in a 7 : 3 ratio. Multivariable Logistic regression analysis was conducted in the training set and visualized using a nomogram model for prediction of SAE. The discrimination of the model was evaluated in the validation set using the receiver operator characteristic curve (ROC curve), and its calibration was assessed using calibration curve. Furthermore, multiple machine learning algorithms, including multi-layer perceptron (MLP), support vector machine (SVM), naive bayes (NB), gradient boosting machine (GBM), random forest (RF), and extreme gradient boosting (XGB), were constructed in the training set. Their predictive performance was subsequently evaluated on the validation set. Taking the XGB model as an example, the interpretability of the model through the SHapley Additive exPlanations (SHAP) algorithm was enhanced to identify the key predictive factors and their contributions. RESULTS: A total of 2 204 septic patients were finally enrolled, of whom 840 developed SAE (38.1%). A total of 21 variables associated with SAE were screened through univariate Logistic regression analysis. Multivariable Logistic regression analysis showed that endotracheal intubation [odds ratio (OR) = 0.40, 95% confidence interval (95%CI) was 0.19-0.88, P < 0.001], oxygen therapy (OR = 0.76, 95%CI was 0.53-0.95, P = 0.023), tracheotomy (OR = 0.20, 95%CI was 0.07-0.53, P < 0.001), continuous renal replacement therapy (CRRT; OR = 0.32, 95%CI was 0.15-0.70, P < 0.001), cerebrovascular disease (OR = 0.31, 95%CI was 0.16-0.60, P < 0.001), rheumatic disease (OR = 0.44, 95%CI was 0.19-0.99, P < 0.001), male (OR = 0.68, 95%CI was 0.54-0.86, P = 0.001), and maximum anion gap (AG; OR = 0.95, 95%CI was 0.93-0.97, P < 0.001) were associated with an decreased probability of SAE, and age (OR = 1.05, 95%CI was 1.03-1.06, P < 0.001), acute physiology score III (APSIII; OR = 1.02, 95%CI was 1.01-1.02, P < 0.001), Oxford acute severity of illness score (OASIS; OR = 1.04, 95%CI was 1.03-1.06, P < 0.001), and length of hospital stay (OR = 1.01, 95%CI was 1.01-1.02, P < 0.001) were associated with an increased probability of SAE. A nomogram model was constructed based on these variables. In the validation set, ROC curve analysis showed that the model achieved an area under the ROC curve (AUC) of 0.723, and the calibration curve showed good consistency between the predicted probability of the model and the observed probability. Among the machine learning algorithms, including MLP, SVM, NB, GBM, RF, and XGB, the SVM model and RF model demonstrated relatively good predictive performance, with AUC of 0.748 and 0.739, respectively, and the sensitivity was both exceeding 85%. The predictive performance of the XGB model was explained through SHAP analysis, and the results indicated that APSIII score (SHAP value was 0.871), age (SHAP value was 0.521), and OASIS score (SHAP value was 0.443) were important factors affecting the predictive performance of the model. CONCLUSIONS The machine learning-based SAE prediction model exhibits good predictive capability and holds significant application value for the early identification of SAE risk in elderly septic patients.
Humans ; Machine Learning ; Aged ; Sepsis-Associated Encephalopathy ; Sepsis/complications* ; Intensive Care Units ; Logistic Models ; Middle Aged ; Male ; ROC Curve ; Female ; Bayes Theorem ; Nomograms ; Support Vector Machine ; Algorithms

Objective To investigate the genetic diversity of sandfly populations in endemic areas of visceral leishmaniasis in China, so as to provide references insights into management of visceral leishmaniasis and the vector sandflies. MethodsSixteen sampling sites were selected from main endemic foci of visceral leishmaniasis in China from June to September 2024, including Shanxi Province, Shaanxi Province, Henan Province, Gansu Province, Sichuan Province, and Xinjiang Uygur Autonomous Region. Sandflies were captured using light traps and manual aspirators from sheep pens, chicken coops, cave dwellings, bovinesheds, and pig pens at each sampling site. A single sandfly sample was washed in phosphate-buffered saline (PBS), and genomic DNA was extracted from sandfly samples. Cytochrome oxidase subunit 1 (COI) gene was amplified using PCR assay with universal primers, and analyzed and retrieved with the nucleotide sequence analysis tool (BLAST) software, and the sequence of COI gene was aligned with the ClustalX 1.83 and MEGA 7.0 software. The base composition and variation site of the COI gene sequence were analyzed using the software MEGA 7.0, and the number of haplotypes, total number of segregating sites, haplotype diversity, nucleotide diversity, and average nucleotide differences were calculated in the COI gene sequence using the software DnaSP 5.10, followed by Tajima’s D test for neutrality. Haplotypes were screened using the software DnaSP 5.10, and the haplotype network map of sandfly samples was plotted using the software Network 5.0. MEGA 7.0 software was employed for gene sequence editing and alignment, and calculation of genetic distances among sandfly species sampled from different regions, and a phylogenetic tree was built with a neighbor-joining method. Results A total of 466 sandflies were captured from 16 sampling sites in China from June to September 2024, and 430 gene sequences were yielded following PCR amplification and sequencing of the COI gene, with 652 to 688 bp in the length of amplification fragments. The captured sandfly samples were characterized as Phlebotomus chinensis, Sergentomyia squamirostris, Se. koloshanensis, Ph. sichuanensis, and Ph. longiductus following the COI gene sequence alignment in BLAST. A total of 251 haplotypes were identified in the 430 gene sequences from sandfly samples (50.5%), and the average haplotype diversity, nucleotide diversity and average number of nucleotide difference were 0.885, 0.257 and 160.761, respectively. The Tajima’s D values were -0.92 for sandfly populations from Yangquan City, Shanxi Province and -1.73 for sandfly populations from Sanmenxia City, Henan Province, and were all more than 0 for sandfly populations from other sampling sites. Haplotype analysis identified 50 haplotypes, which were classified into two haplogroups. Heplogroup 1 included 29 haplotypes, which had a high homology, and heplogroup 2 included 21 haplotypes. The average genetic distance was 0.000 to 0.604 among sandfly samples from different sampling sites, and phylogenetic analysis revealed that the five sandfly species were clustered into distinct clades, all with 100% clade confidence. Conclusions There is a high genetic polymorphism in the COI gene from five sandfly populations in main endemic foci of visceral leishmaniasis in China, and COI gene may serve as a marker gene for analysis of the genetic structure of sandfly populations.

Background and Aims:Laparoscopic transcystic bile duct exploration(LTCBDE)has become the preferred method for treating secondary bile duct stones due to its advantages of minimal trauma,fast recovery,and low complication rates.However,challenges remain in the dilation of the cystic duct,the insertion of the choledochoscope,and the exploration of the common hepatic duct and intrahepatic bile ducts.This study was performed to explore the clinical application and effectiveness of the programmed modified LTCBDE in the treatment of gallbladder stones combined with common bile duct stones.Methods:A retrospective analysis was conducted on the clinical data of 248 patients who underwent programmed modified LTCBDE at the Affiliated Suzhou Ninth Hospital of Soochow University from January 2018 to January 2024.The surgical strategies and treatment outcomes were summarized.Data from 913 patients who underwent laparoscopic common bile duct exploration(LCBDE)during the same period were also collected to compare surgical outcomes and postoperative complications between the two groups.Results:Through programmed surgical steps,the innovative"diaphragm"incision technique,and improved bile duct probe application,244 patients(98.4%)successfully underwent LTCBDE,while 4 patients were converted to LCBDE due to failure to insert a 4.9 mm choledochoscope through the cystic duct.After operation,1 patient(0.4%)had residual bile duct stones,which were successfully removed through T-tube tract stone extraction(this patient was converted to LCBDE during the procedure).Additionally,1 case of bile leakage and 1 case of abdominal infection(each 0.4%)occurred,both of which resolved with conservative treatment.No cases of intra-abdominal bleeding,bile duct stenosis,or bile duct injury were reported.The average operative time in the programmed modified LTCBDE group was comparable to that of the LCBDE group(85.2 min vs.88.0 min,P=0.398),but the postoperative hospital stay was significantly shorter(6.2 d vs.8.3 d,P<0.001),and the incidence of complications was lower(1.6%vs.4.7%,P=0.044).Conclusion:The programmed modified LTCBDE is a standardized,safe,and effective procedure with a low complication rate.It is worthy of further clinical promotion and application.

Background and Aims:Laparoscopic transcystic bile duct exploration(LTCBDE)has become the preferred method for treating secondary bile duct stones due to its advantages of minimal trauma,fast recovery,and low complication rates.However,challenges remain in the dilation of the cystic duct,the insertion of the choledochoscope,and the exploration of the common hepatic duct and intrahepatic bile ducts.This study was performed to explore the clinical application and effectiveness of the programmed modified LTCBDE in the treatment of gallbladder stones combined with common bile duct stones.Methods:A retrospective analysis was conducted on the clinical data of 248 patients who underwent programmed modified LTCBDE at the Affiliated Suzhou Ninth Hospital of Soochow University from January 2018 to January 2024.The surgical strategies and treatment outcomes were summarized.Data from 913 patients who underwent laparoscopic common bile duct exploration(LCBDE)during the same period were also collected to compare surgical outcomes and postoperative complications between the two groups.Results:Through programmed surgical steps,the innovative"diaphragm"incision technique,and improved bile duct probe application,244 patients(98.4%)successfully underwent LTCBDE,while 4 patients were converted to LCBDE due to failure to insert a 4.9 mm choledochoscope through the cystic duct.After operation,1 patient(0.4%)had residual bile duct stones,which were successfully removed through T-tube tract stone extraction(this patient was converted to LCBDE during the procedure).Additionally,1 case of bile leakage and 1 case of abdominal infection(each 0.4%)occurred,both of which resolved with conservative treatment.No cases of intra-abdominal bleeding,bile duct stenosis,or bile duct injury were reported.The average operative time in the programmed modified LTCBDE group was comparable to that of the LCBDE group(85.2 min vs.88.0 min,P=0.398),but the postoperative hospital stay was significantly shorter(6.2 d vs.8.3 d,P<0.001),and the incidence of complications was lower(1.6%vs.4.7%,P=0.044).Conclusion:The programmed modified LTCBDE is a standardized,safe,and effective procedure with a low complication rate.It is worthy of further clinical promotion and application.

Objective To investigate the value of derived neutrophil to lymphocyte ratio(dNLR)as a pre-dictive biomarker for immunotherapy response in advanced non-small cell lung cancer(NSCLC).Methods A total of 92 patients with advanced NSCLC who received anti-programmed cell death receptor(PD-1)combined therapy in the hospital from August 2018 to December 2019 were selected as the research objects.Peripheral blood samples were collected within 24 h before immunotherapy,complete blood cell count was measured,and dNLR was calculated.Patients with advanced NSCLC were treated with PD-1 inhibitors or combination regi-mens,and the response to immunotherapy was evaluated by objective response rate(ORR)and disease control rate(DCR).The receiver operating characteristic(ROC)curve was used to analyze the predictive value of dN-LR for the diagnosis and response to immunotherapy in advanced NSCLC.Multivariate Logistic regression model was used to analyze the relationship between dNLR and immunotherapy response in advanced NSCLC.Kaplan-Meier survival curve and Log-Rank test were used to analyze the overall survival(OS),progression-free survival(PFS)and disease-specific survival(DSS)of the low dNLR group and the high dNLR group.Re-sults The ORR and DCR of advanced NSCLC patients after immunotherapy were 32.61％and 65.22％,re-spectively,and the PFS and OS were 17.0(8.5,25.5)and 24.0(12.7,36.1)months,respectively.The dNLR of DCR group was lower than that of non-DCR group(P＜0.001).The dNLR of ORR group was lower than that of non-ORR group(P＜0.001).The area under the curve of dNLR for predicting DCR or ORR was 0.897(95％CI 0.829-0.965)and 0.874(95％CI 0.795-0.953),respectively.Multivariate Logistic regres-sion analysis showed that dNLR≥2.28 increased the risk of non-response to immunotherapy,and this inde-pendent relationship still existed after further adjustment for objective confounding factors(P＜0.05).Sur-vival curve results showed that patients with high dNLR had significantly shorter PFS,OS,and DSS(P＜0.05).Multivariate Cox regression analysis showed that high dNLR was an independent factor affecting the poor prognosis of patients with advanced NSCLC(P＜0.05).Conclusion High dNLR advanced NSCLC pa-tients are more difficult to benefit from immune therapy,and prognosis is worse.dNLR is promising as a pre-dictive biomarker for immunotherapy response in advanced NSCLC.

Objective To analyze the diagnosis status of negative etiological pulmonary tuberculosis test re-sults in Wuhan,and to provide scientific basis for improving the diagnosis strategy of etiological negative pul-monary tuberculosis.Methods From January 1 to February 28,2019,a total of 241 patients with negative eti-ological tuberculosis who were registered,reported and treated in 1 municipal and 2 district-level designated hospitals were selected.The medical record data,chest imaging examination and laboratory examination re-sults of the selected patients were reviewed and extracted,and the quality of etiological examination and ima-ging examination of patients with negative etiological pulmonary tuberculosis were analyzed.Results Among the 241 patients,88.8％(214/241)of the patients met the diagnostic criteria for negative etiological pulmona-ry tuberculosis,and 96.3％(232/241)of the patients had chest imaging examinations that were consistent with the original diagnostic results.Patients received sputum smear examination,sputum culture,and molecu-lar biology test accounted for 97.9％(236/241),73.9％(178/241)and 65.6％(158/241),respectively.Patients received anti-tuberculosis antibody test,tuberculin skin test,y-interferon release and diagnostic anti-infection treatment accounted for 54.8％(132/241),46.5％(112/241),26.1％(63/241),and 53.1％(128/241),respec-tively.The sputum culture detection rate of urban area was higher than those of central and remote urban are-as,the rate of central urban area was higher than that of remote urban areas,and the molecular biology detec-tion rate of urban area was higher than those of central and remote urban area,with statistical significance(P＜0.001).The detection rate of anti-tuberculosis antibody of urban area was lower than that of central ur-ban area,and the differences were statistically significant(P＜0.001).The rate of diagnostic anti-infective therapy of central urban area was higher than that of urban area and the remote urban area,and the rate in ur-ban area was higher than that of remote urban area,and the differences were statistically significant(P＜0.001).Conclusion It is necessary to further standardize the diagnosis of negative etiological pulmonany tu-berculosis of designated tuberculosis hospitals.The proportion of diagnostic anti-infection treatment and auxil-iary examination at the municipal level needs to be increased,and the frequency and items of laboratory etio-logical examination at the district level need to be increased.

Objectives::The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin ?-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods::The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention.Results::From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (>5 mmHg), with an effective orifice area of 2.57 cm 2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions::The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin ?-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.