Objective:To explore the advantages of internet-based smart healthcare for full-cycle transcatheter edge-to-edge repair (TEER) management in reducing postoperative adverse events rate, improving cardiac function, and enhancing quality of life.Methods:This retrospective study enrolled patients with mitral regurgitation who underwent transcatheter TEER at Beijing Anzhen Hospital Valve Intervention Center between June 2021 and September 2023. Patients were classified into degeneration mitral regurgitation (DMR) and functional mitral regurgitation (FMR) according to etiology, with further stratification by enrollment period into usual care group (June 2021 to October 2022) and full-cycle management group (November 2022 to September 2023). The 1-year postoperative follow-up data were collected and compared between subgroups with the same etiology. Kaplan-Meier survival curves were plotted, and log-rank tests were used to compare the differences in major endpoint event-free survival rates between the two groups. Univariate and multivariate Cox regression and logistic regression analyses were performed to evaluate the impact of the full-cycle management system on patients′ outcomes.Results:A total of 130 patients were included, aged (72.0±8.6) years, including 82 (63%) males. DMR was identified in 84 cases (40 in the usual care group and 44 in the full-cycle management group), while FMR was observed in 46 cases (27 in the usual care group and 19 in the full-cycle management group). Kaplan-Meier analysis demonstrated higher 1-year major endpoint event-free survival rates in the full-cycle management group compared to the usual care group, though the difference was not statistically significant (log-rank P>0.05). Compared to the usual care group, the full-cycle management group showed significantly higher proportions of New York Heart Association classification Ⅰ-Ⅱ patients (DMR: 67% vs. 52%, P=0.031; FMR: 68% vs. 52%, P=0.021), greater 6-minute walking distances (DMR: (346.39±70.41) m vs. (294.11±60.47) m, P=0.012; FMR: (356.60±54.68) m vs. (318.55±39.02) m, P=0.004), and superior Kansas City Cardiomyopathy Questionnaire scores (DMR: 81.50 (74.50, 85.00) points vs. 71.00 (66.00, 82.25) points, P=0.014; FMR: 83.00 (76.00, 85.00) points vs. 74.00 (70.75, 80.00) points, P=0.030). Multivariate logistic regression confirmed the full-cycle management system as an independent predictor for the above improved outcomes (all P<0.05). Conclusion:Smart healthcare-based full-cycle management improves cardiac function and quality of life in mitral regurgitation patients after TEER, demonstrating lower rates of major endpoint events compared to usual care.

Objective:To explore the advantages of internet-based smart healthcare for full-cycle transcatheter edge-to-edge repair (TEER) management in reducing postoperative adverse events rate, improving cardiac function, and enhancing quality of life.Methods:This retrospective study enrolled patients with mitral regurgitation who underwent transcatheter TEER at Beijing Anzhen Hospital Valve Intervention Center between June 2021 and September 2023. Patients were classified into degeneration mitral regurgitation (DMR) and functional mitral regurgitation (FMR) according to etiology, with further stratification by enrollment period into usual care group (June 2021 to October 2022) and full-cycle management group (November 2022 to September 2023). The 1-year postoperative follow-up data were collected and compared between subgroups with the same etiology. Kaplan-Meier survival curves were plotted, and log-rank tests were used to compare the differences in major endpoint event-free survival rates between the two groups. Univariate and multivariate Cox regression and logistic regression analyses were performed to evaluate the impact of the full-cycle management system on patients′ outcomes.Results:A total of 130 patients were included, aged (72.0±8.6) years, including 82 (63%) males. DMR was identified in 84 cases (40 in the usual care group and 44 in the full-cycle management group), while FMR was observed in 46 cases (27 in the usual care group and 19 in the full-cycle management group). Kaplan-Meier analysis demonstrated higher 1-year major endpoint event-free survival rates in the full-cycle management group compared to the usual care group, though the difference was not statistically significant (log-rank P>0.05). Compared to the usual care group, the full-cycle management group showed significantly higher proportions of New York Heart Association classification Ⅰ-Ⅱ patients (DMR: 67% vs. 52%, P=0.031; FMR: 68% vs. 52%, P=0.021), greater 6-minute walking distances (DMR: (346.39±70.41) m vs. (294.11±60.47) m, P=0.012; FMR: (356.60±54.68) m vs. (318.55±39.02) m, P=0.004), and superior Kansas City Cardiomyopathy Questionnaire scores (DMR: 81.50 (74.50, 85.00) points vs. 71.00 (66.00, 82.25) points, P=0.014; FMR: 83.00 (76.00, 85.00) points vs. 74.00 (70.75, 80.00) points, P=0.030). Multivariate logistic regression confirmed the full-cycle management system as an independent predictor for the above improved outcomes (all P<0.05). Conclusion:Smart healthcare-based full-cycle management improves cardiac function and quality of life in mitral regurgitation patients after TEER, demonstrating lower rates of major endpoint events compared to usual care.

Objectives:To explore the effects of interatrial shunt on cardiac function and clinical prognosis of patients with heart failure with reduced ejection fraction(HFrEF). Methods:This study was a prospective single-arm study.From December 2021 to December 2022,15 consecutive patients with HFrEF from Beijing Anzhen Hospital were enrolled in this study.Interatrial shunt was performed with a D-Shant atrial shunt device.Right heart catheterization was performed before and immediately after device implantation,pulmonary capillary wedge pressure(PCWP),mean right atrial pressure(RAP),interatrial gradient pressure,mean pulmonary artery pressure,total pulmonary resistance(TPR),pulmonary vascular resistance(PVR),cardiac index(CI),and pulmonary/systemic blood flow ratio(Qp/Qs)were measured.Patients were followed-up for 12 months after procedure,changes in cardiac structure and function were evaluated by echocardiography.NYHA classification,6-minute walking distance(6MWD),and Kansas City cardiomyopathy questionnaire(KCCQ)were observed.All-cause mortality and rehospitalization for heart failure served as clinical endpoints. Results:Interatrial shunt procedure was successful in all patients.Compared with preoperative value,PCWP,interatrial gradient pressure,mean pulmonary artery pressure,and TPR were significantly decreased,while Qp/Qs was significantly increased immediately after procedure(all P<0.01).There were no significant changes in RAP,PVR,and CI post procedure(all P>0.05).There were no significant differences in shunt size,shunt velocity,and shunt pressure difference between postoperative immediately and at 12-months follow-up(all P>0.05).At 12 months,left ventricular ejection fraction was significantly higher than baseline level(P<0.05),and there were no significant changes in right atrial diameter and right ventricular fractional area change(both P>0.05).Compared with preoperative status,NYHA classification was improved,KCCQ score was increased,and the number of patients with 6MWD>450 m was increased at 12 months(all P<0.05).N-terminal pro-B-type natriuretic peptide value was significantly decreased at 12 months(P<0.05).No patient died during the 12-months follow-up period,and there were no device-related adverse events.Two patients experienced hospital readmission for heart failure. Conclusions:Implantation of interatrial shunt device could effectively improve hemodynamic parameters in patients with HFrEF and is related to significantly improved cardiac function at 12-months follow-up.

Objective::To evaluate the feasibility, safety, and effectiveness of a novel edge-to-edge mitral valve repair system (the NovoClasp system) in patients with severe mitral regurgitation.Methods::In this prospective, single-arm, first-in-human study conducted at Beijing Anzhen Hospital, data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system. The study candidates were patients exhibiting a mitral regurgitation severity of 3+ or more and were at high-risk or contraindicated for surgical intervention. Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes. Other safety and efficacy outcomes were prospectively assessed at device implantation, discharge, and 30 d, 6 months, and 12 months post-procedure.Results::Between October 1, 2021, and January 31, 2022, 11 patients were treated for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the NovoClasp system. All patients had a baseline New York Heart Association functional class of III-IV, with 7/11 exhibiting complex mitral valve disease. All patients achieved the primary endpoints of technical and device success, with a post-operative 30-d mitral regurgitation grade reduction to 2+ or lower, which was maintained at 12 months. One patient had minor bleeding and hematoma at the access site before discharge, and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge. No additional cases of death, adverse cerebral or cardiovascular events, or device-related complications was observed during the follow-up.Conclusion::This study suggested the potential feasibility and safety of the NovoClasp system, showing a promising technical and device success rate, along with a decrease in mitral regurgitation severity. A further pivotal study is needed to assess the procedural and long-term outcomes.

Objective::To evaluate the feasibility, safety, and effectiveness of a novel edge-to-edge mitral valve repair system (the NovoClasp system) in patients with severe mitral regurgitation.Methods::In this prospective, single-arm, first-in-human study conducted at Beijing Anzhen Hospital, data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system. The study candidates were patients exhibiting a mitral regurgitation severity of 3+ or more and were at high-risk or contraindicated for surgical intervention. Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes. Other safety and efficacy outcomes were prospectively assessed at device implantation, discharge, and 30 d, 6 months, and 12 months post-procedure.Results::Between October 1, 2021, and January 31, 2022, 11 patients were treated for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the NovoClasp system. All patients had a baseline New York Heart Association functional class of III-IV, with 7/11 exhibiting complex mitral valve disease. All patients achieved the primary endpoints of technical and device success, with a post-operative 30-d mitral regurgitation grade reduction to 2+ or lower, which was maintained at 12 months. One patient had minor bleeding and hematoma at the access site before discharge, and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge. No additional cases of death, adverse cerebral or cardiovascular events, or device-related complications was observed during the follow-up.Conclusion::This study suggested the potential feasibility and safety of the NovoClasp system, showing a promising technical and device success rate, along with a decrease in mitral regurgitation severity. A further pivotal study is needed to assess the procedural and long-term outcomes.

Objective     To analyze the echocardiographic characteristics of above grade 3+ mitral regurgitation (MR) patients by 3D transesophageal echocardiography (3D-TEE) in transcatheter edge-to-edge repair (TEER) and compare the intervention rate of TEER treatment in patients with different risk stratification. Methods     We retrospectively analyzed the clinical data of 91 patients with above grade 3+ MR in Anzhen Hospital between June 2021 and April 2022. There were 45 males and 46 females aged 66.5±15.9 years. According to pathogenesis, the patients were divided into different anatomical groups and risk stratification groups. There were 34 patients in a simple degenerative group (simple DMR group), 28 patietns in a complex disease group (Complex group), 14 patients in a simple ventricular  functional reflux group (simple VFMR group), 9 patients in a simple atrial functional reflux group (simple AFMR group), and 6 patients in a mixed functional reflux group (mixed FMR group). All patients were examined with a unified standard of transthoracic echocardiography (TTE) and 3D-TEE to compare the characteristic three-dimensional structural changes of the mitral valve in each group. According to the three partition strategy of preoperative anatomical evaluation of TEER, the risk stratification was conducted for the enrolled patients, which was divided into three regions from light to heavy: green area, yellow area, and red area. TEER treatment intervention rate of patients with different risk stratification was calculated. Results     Ant leaf angle and post leaf angle were negative in the simple DMR and Complex groups, and non-planar angle, prolapse height and prolapse volume were higher than those of the other groups (P=0.000). Ant leaf angle and post leaf angle were positive in the VFMR group and the mixed FMR group. Anterior and posterior (AP) diameter of valve ring (P=0.036), tenting height and tenting volume were higher than those of other groups (P=0.000).  AP diameter, tenting height and tenting volume were changed mildly in patients with simple AFMR. MR patients in red and yellow zone achieved a 28.1% TEER intervention rate. Conclusion     Standardized TTE and TEE examinations are crucial for the qualitative and quantitative diagnosis of MR in the echo core-lab. 3D-TEE mitral valve parameter can help determine the exact pathogenesis of MR and to improve the interventional rate of challenging MR patients.

Objective:To study the risk factors of acute kidney injury in patients with diabetic nephropathy and the prognostic value of urinary neutrophil gelatinase associated lipocalin (NGAL) .Methods:The data of 80 patients with diabetic nephropathy in the First Hospital of Shanxi Medical University from Mar. 2016 to Dec. 2020 were retrospectively studied. According to the random selection of numbers + artificial arrangement, they were divided into observation group and control group according to the presence or absence of acute kidney injury (AKI) . The observation group included patients with diabetic nephropathy complicated by acute kidney injury, and the control group included patients with diabetic nephropathy. The urinary albumin/creatinine ratio (ACR) , blood routine, left ventricular ejection fraction (LVEF) , NGAL, etc. were compared between the two groups. The correlation and influencing factors of acute kidney injury in patients with diabetic nephropathy and age, eGFR, severe infection, antibiotics, heart failure, respiratory failure, ACR, LVEF, and NGAL were studied. At the same time, the prognostic value of urinary NGAL was analyzed.Results:Single factor screening: There was no significant difference in gender or body weight between the two groups ( P>0.05) . However, there were differences in age, epidermal growth factor receptor (eGFR) , severe infection, antibiotics, heart failure, respiratory failure, ACR, LVEF, and NGAL ( P<0.05) . Correlation: Acute kidney injury in patients with diabetic nephropathy was very weakly correlated with gender, age, and body weight, moderately correlated with eGFR, heart failure, respiratory failure, ACR, and LVEF, and highly correlated with NGAL, severe infection, and antibiotics. Risk factors: The independent risk factors for acute kidney injury in patients with diabetic nephropathy included severe infection, eGFR, antibiotics, ACR, LVEF, and NGAL. The prognostic value of urinary NGAL: AUC=0.967, standard error 0.021, Youden index 0.967, sensitivity 0.967, specificity 1, and zero cutoff point 30.00. Conclusion:The main influencing factors of DN complicated with AKI are severe infection, eGFR, antibiotics, ACR, LVEF, NGAL, and urinary NGAL has prognostic value for DN complicated with AKI, and it is worthy of clinical application.

Objective: To investigate the feasibility and efficacy of percutaneous closure of paravalvuar leak (PVL) in patients after heart valve replacement surgery using Amplatzer vascular plug Ⅲ (AVP Ⅲ). Methods: In this retrospective study, consecutive PVL patients after heart valve replacement surgery receiving percutaneous closure with AVP Ⅲ in Beijing Anzhen hospital between March 2017 and October 2018 (n=21) were enrolled.The preoperative and intraoperative data and short-and mid-term outcome results were analyzed. Results: Theage of patients in this cohort was (54.9±11.7) years, and there were 12 (57.1%) male patients. There were 8 patients (38.1%) post mitral valve replacement, 4 patients (19.0%) post aortic valve replacement and 9 patients (42.9%) post double valves replacements.There were 14 cases (66.7%) of mitral valve PVL,6 cases (28.6%) of aortic valve PVL, and 1 case (4.8%) of double valves PVL.Successful device deployment was accomplished in 18 defects from 17 PVL patients. Technical successful rate of mitral valve PVL closure and aortic valve PVL closure was 12/15 and 6/7,respectively. One patient received surgical repair due to procedure-induced femoral pseudoaneurysm.There were 17 cases of severe PVL and 1 case of moderate PVL before procedure, and there were 2 cases of moderate PVL, 6 cases mild PVL, and PVL disappeared in 10 cases after procedure (P<0.01 vs. pre-procedure). The follow-up time was (8.3±4.7) months. There were 10 cases (58.8%) of New York Heart Association (NYHA) function grade Ⅲ and 7 cases (41.2%) of NYHA function grade Ⅳ before procedure, and there were 12 cases of NYHA function grade Ⅰ(70.6%) and 5 cases (29.4%) of NYHA function grade Ⅱ post procedure (P<0.01). Post procedure, there was no displacement of the occluder and heart valve movement was not affected,and there was no new hemolysis or hemolysis worsening. Conclusion Percutaneous closure of PVL in patients after heart valve replacement surgery with AVP Ⅲ is feasible, and associated with favorable short-and mid-term clinical outcomes.

Objective: To dynamically evaluate left ventricular perfusion, global and local functional changes during left ventricular aneurysm (LVA) formation and to explore the relationship between the size of LVA and LVEF, LVESV, LVEDV by gated99mTc-MIBI SPECT (GSPECT) and gated18F-FDG PET metabolic (GPET) imaging in experimental pigs. Methods: LVA model was established by occlusion of left circumlfex artery (LCX) and placing an Ameroid constrictor at the proximal end of left anterior descending artery (LAD) in a total of 16 Chinese mini-pigs. At the 1st, 4th and 8th weeks of surgery, the changes of total perfusion defect (TPD), LVA formation and LVEF, LVESV, LVEDV were dynamically evaluated by GSPECT and GPET; the relationships between the size of LVA and LVEF, LVESV, LVEDV were analyzed respectively.Results: There were 5 pigs died in surgery and 2 died at the 1st week of modeling. According to golden (pathological) standard, 9 animals successfully ifnished the dynamic imaging study. At the 1st week of (basic) modeling, 4 animals formed large LVA, 2 formed small LVA at the apex and 3 without LVA formation. At the 4th and 8th weeks of modeling, dynamic imaging presented that the animals with large LVA had gradually increased range and degree of perfusion defect, LVEDV, LVESV, while gradually decreased LVEF; the above indexes were relatively stable in animals with small or none LVA. In addition, the size of LVA was related to LVEF (r=-7.26), LVEDV (r=0.855) and LVESV (r=0.825), allP<0.05. Conclusion: In experimental pigs, at the beginning of LVA formation, large range and severe perfusion defect may cause large aneurysm, the LV functional damage and remodeling may gradually increase and the prognosis is poor; in contrast, the animals with small or none LVA have better prognosis and usually without ventricular remodeling; which implies that in acute phase of LVA formation, the size of aneurysm may predict the trend of global LV systolic function and remodeling at the early stage.