ObjectiveTo investigate the early clinical results of MitraClip system in domestic patients. Methods We retrospectively analyzed the clinical data of 36 patients who underwent transcatheter edge-to-edge repair procedure using MitraClip system in Beijing Fuwai Hospital, Shenzhen Fuwai Hospital and Fuwai Yunnan Cardiovascular Hospital between January and June 2021. There were 24 males and 12 females, with a median age of 70 (47-86) years. Ten (27.8%) patients had 3+ mitral regurgitation (MR) and 26 (72.2%) patients had 4+ MR preoperatively. ResultsAll procedures were successfully performed. The reduction in MR was 2+ at least immediately after surgery, and 91.7% of patients had MR≤2+ at 3 days postoperatively. There was no statistical difference in left ventricular ejection fraction change postoperatively. Forward velocity and peak gradient of mitral valve were increased after the procedure. Mean gradient of mitral valve were increased at 3 days postoperatively than immediately after surgery (P<0.001). Two patients had acute pericardial effusion intraoperatively, and received pericardial puncture and drainage immediately. ConclusionMitraClip system has been applied well in domestic patients and can significantly improve MR. This sutdy has a good consistency with foreign studies, and the early results are satisfactory.
ObjectiveTo evaluate the safety and efficacy of transapical mitral valve repair with moderate-to-severe or severe mitral regurgitation (MR) by using LifeClip system. Methods We retrospectively analyzed the clinical data of 7 symptomatic patients with moderate-to-severe or severe MR who received transapical mitral valve repair by using the LifeClip system in our hospital from July to November 2021. There were 5 males and 2 females with an average age of 76.0±7.5 years. ResultsThere were 2 patients with degenerative MR and 5 patients with functional MR. All of the procedures were successful and 6 patients received 1 LifeClip while the other one patient received 2. The operation time was 135.7±46.9 min, the mechanical ventilation time was 12 (3, 14) h, and the hospital stay time was 18.1±4.1 d. No serious complications or death occurred during the perioperative or follow-up period. MR reduction by ≥2 grades was achieved in all the patients at the one-month follow-up. The classification of cardiac function was improved in varying degrees. Conclusion Transapical mitral valve repair using the LifeClip system shows good safety and efficacy for severe MR patients, and MR degree is significantly improved at early follow-up. However, the benefit of LifeClip should be validated in a larger sample size of Chinese population and through long-term follow-up.
ObjectiveTo utilize a rapid health technology assessment to evaluate the efficacy, safety and cost-effectiveness of the MitraClip device for patients with severe mitral regurgitation (MR). MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM and the CRD databases were electronically searched to collect clinical evidence and economic evaluations on the efficacy, safety and cost-effectiveness of the MitraClip device for patients with severe MR from inception to May 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies; then, descriptive analyses and data summaries were performed. ResultsA total of 33 studies, involving 4 HTA reports, 3 RCTs, 16 systematic reviews or meta-analyses, and 10 economic evaluations were included. In the evidence comparing MitraClip and surgery, most of the literature showed that the MitraClip group had higher postoperative residual MR, fewer blood transfusion events, and fewer hospital days. We found no significant treatment effects on 30-day adverse events and mortality, and the 1-year and above survival rate. In the evidence of MitraClip versus medical therapy alone, all included studies showed that MitraClip benefited mid-term and long-term survival and reduced the incidence of subsequent cardiac hospitalizations. Economic evaluations showed that the clinical benefits were cost-effective in the setting of their health service systems. ConclusionThe available high-grade clinical evidence shows that MitraClip is effective and safe to some extent, and has cost-effectiveness compared with traditional treatment in other countries. However, the real-world effectiveness and cost-effectiveness of the MitraClip need to be tested in the Chinese population and health-care setting.
Objective To investigate the effects of different types of tricuspid regurgitation, implantation positions, and device models on the treatment outcomes of K-Clip for tricuspid regurgitation using numerical simulations. Methods Three-dimensional reconstruction of the heart model was performed based on CT images. Two different regurgitation orifices were obtained by modifying the standard parameterized tricuspid valve leaflets and chordae tendineae. The effects of different K-Clip models at different implantation positions (posterior leaflet midpoint, anterior-posterior commissure, anterior leaflet midpoint, posterior septal commissure) were simulated using commercial explicit dynamics software Ls-Dyna. Conclusion For the two types of regurgitation in this study, clipping at the posterior leaflet midpoint resulted in a better reduction of the regurgitation orifice (up to 75% reduction in area). Higher clamping forces were required for implantation at the anterior leaflet midpoint and posterior septal commissure, which was unfavorable for the smooth closure of the clipping components. There was no statistical difference in the treatment outcomes between the 18T and 16T K-Clip components, and the 16T component required less clamping force. Therefore, the use of the 16T K-Clip component is recommended.
ObjectiveTo systematically evaluate the differences in efficacy and outcomes between patients with functional mitral regurgitation (SMR) and degenerative mitral regurgitation (DMR) treated with mitral edge-to-edge repair (TEER) using MitraClip. MethodsPubMed, EMbase, the Cochrane Library, Web of Science, China Biomedical Literature Database (CBM), CNKI, Wanfang database, and VIP database were searched in computer. Relevant literature from the database from its establishment to January 2024 was covered. Literature screening, data extraction, and risk of bias assessment for the included studies were performed independently by two researchers. Meta-analysis was performed using Stata18.0 software. ResultsFourteen papers were finally included, including 6 707 patients, including 4 161 patients in the SMR group and 2 241 patients in the DMR group. Meta-analysis results showed that patients in the SMR group had a higher 1-year all-cause mortality rate [OR=1.53, 95%CI (1.30, 1.81), P<0.01, I2=0%] and 1-year readmission rate for heart failure [OR=1.9, 95%CI (1.60, 2.26), P<0.01, I2=0%] after MitraClip treatment than the DMR group patients. Postoperative mitral transvalvular pressure difference [SMD=-0.47, 95%CI (-0.65, -0.30), P<0.01, I2=51%] was lower in patients in the SMR group than in those in the DMR group, and the incidence of subsequent secondary open-heart surgery [OR=0.41, 95%CI (0.20, 0.83), P=0.01, I2=0%] was lower in patients in the SMR group. ConclusionThe results of Meta-analysis showed that after MitraClip treatment, patients in the SMR group showed better efficacy in the short term, but the medium- and long-term efficacy was not as good as that of patients in the DMR group. The specific type of mitral regurgitation should be considered when choosing a MitraClip treatment strategy to more accurately predict efficacy and prognosis.
ObjectiveTo evaluate the feasibility of clipless laparoscopic cholecystectomy (LC) to patients with calculous cholecystitis in acute inflammation stage. Methods The clinical data of 169 patients with calculous cholecystitis in acute inflammation stage who underwent clipless LC from December 2008 to July 2010 were analyzed. ResultsAll patients were successfully operated by LC except one case who suffered from gallbladder perforation and a conversion to open surgery was performed. The operation time ranged from 25-70 min (mean 38 min). The blood loss ranged from 10-200 ml (mean 22 ml). Peritoneal drainage was done in 38 patients, and the drainage time ranged from 1-6 d (mean 1.8 d). The time to out-of-bed activity was at 2 h after operation and the hospitalization time was 3-7 d (mean 3.5 d). There was no complication such as bile duct injury, hemorrhage, billiary leakage, and intra-abdominal infection. ConclusionWith improvement of operator’s experiences and skills, the clipless LC becomes feasible and safe for patients with calculous cholecystitis in acute inflammation stage.
目的探讨在腹腔镜阑尾切除术（laparoscopic appendectomy，LA）中应用Lapro-Clip可吸收生物夹的优势。 方法回顾性分析2011年7月至2013年4月期间于秦皇岛市抚宁县人民医院微创外科施行LA术的294例阑尾炎患者的临床资料，对其效果进行分析和评价。 结果294例阑尾炎患者行LA术时，均采用Lapro-Clip可吸收生物夹（12 mm）处理阑尾及其系膜。所有患者术中出血均＜10 mL，手术时间13～48 min（平均24 min），住院时间为2～7 d（平均4 d）。术后均无切口感染、肠瘘、腹腔出血、粘连性肠梗阻等并发症发生。术后以电话随访294例，随访时间为3～12个月，平均6个月，均无腹胀、腹痛等并发症发生。 结论LA术中应用Lapro-Clip可吸收生物夹处理阑尾根部及其系膜的操作简单、安全，能节省手术时间。
ObjectiveTo systematically review the efficacy of MitraClip therapy in heart failure patients with mitral insufficiency. MethodsDatabases including PubMed, The Cochrane Library (Issue 11, 2014), EMbase, CBM, CNKI, VIP and WanFang Data were searched from October 2005 to October 2015 to collect before-after controlled studies about the efficacy of MitraClip therapy in heart failure patients with mitral insufficiency. Two reviewers independently screened literature, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.2 software. ResultsA total of 9 studies involving 782 patients were included. The results of meta-analysis showed that, compared with their conditions before treatment, patients after the MitraClip implantation had a declined NYHA class Ⅲ-Ⅳ ratio (RD=0.72, 95%CI 0.60 to 0.85, P<0.000 01), increased left ventricular ejection fraction (LVEF) (MD=-2.97，95%CI -5.06 to -0.89，P<0.005) and improved performance in 6 min walk-test (6-MWT) (MD=-88.73, 95%CI -157.16 to -20.31, P=0.01). ConclusionMitraClip therapy can, to a certain extent, improve the cardiac function of patients with heart failure and mitral insufficiency. However, further studies are needed to confirm its effects on improving the long-term survival of patients.
ObjectiveTo establish a mouse model of pressure overload-induced heart failure via suprasternal notch approach. MethodsMale mice were separated into a sham group and an experiment group. Through suprasternal notch approach, the aortic arch port between the origin of the right innominate and left common carotid arteries was partially clipped with tantalum clip, which had a remaining opening of 0.35 mm or 0.25 mm in diameter to cause progres-sively increased afterload. Echocardiography was performed 10 weeks after aortic arch clipped or sham surgery to deter-mine left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular posterior wall end-diastolic thickness (LVPWD), ejection fraction (EF) and fractional shortening (FS). After hemodynamic recordings were completed, mouse body weight (BW) and heart weight (HW) were measured for obtaining HW/BW ratio (mg/g). After heart function examination, mice blood sample was collected for evaluation of serum N-terminal pro-brain natriuretic peptide (NT-proBNP). At the end, part of left ventricular free wall was excised, and hematoxylin and eosin stain was made for histopathological examination. ResultsThe HW/BW, LVEDD and serum NT-proBNP significantly increased in the experiment group compared with those in the sham group (P < 0.01, respectively). The LVPWD, EF and FS significantly decreased compared with the sham group (P < 0.01, respectively). Histopathological examination showed malalignment and rupture of cardiac muscle fibers, hypertrophy and degeneration of myocardial cells, part of which had local or patchy necrosis in left ventricule postoperatively 10 weeks. ConclusionThe model of pressure overload-induced heart failure in mice established through suprasternal approach is simple, minimally invasive and reliable.