For patients with moderate-to-severe functional mitral regurgitation (FMR) who continue to experience heart failure symptoms despite optimized medical and device therapy, transcatheter mitral valve edge-to-edge repair (TEER) is increasingly becoming a reliable treatment option. With the continuous research and development and improvement of TEER-related devices, there are currently dozens of domestically developed TEER devices undergoing clinical trials in China. In this study, we report the first case of a patient with severe FMR treated with the X-Clip? TEER system. The patient, a 60-year-old male, suffered FMR attributed to dilated cardiomyopathy. Preoperative transthoracic echocardiography showed severe mitral regurgitation (4+). He underwent percutaneous repair using the X-Clip? system, and immediate postoperative ultrasound showed mild mitral regurgitation. At the 1-month follow-up, the patient’s symptoms and New York Heart Association (NYHA) functional class improved, and a follow-up transthoracic echocardiogram showed mild mitral regurgitation (1+).
Objective To investigate the feasibility and early efficacy of transapical transcatheter aortic valve replacement (TAVR) combined with transcatheter mitral valve edge-to-edge repair (TEER) in patients with high-risk aortic valve lesions combined with severe mitral regurgitation. Methods The clinical data of patients who underwent "one-stop" transapical TAVR+TEER in our hospital from August 2022 to October 2023 were retrospectively analyzed. Results Five patients were collected, including 3 males and 2 females with a mean age of 66.6±1.8 years. Four patients had aortic valve insufficiency combined with mitral regurgitation and one had aortic valve stenosis and insufficiency combined with mitral regurgitation. All patients successfully completed transapical TAVR+TEER, and the immediate postoperative echocardiographic results revealed that none of them had more than mild perivalvular leakage and mitral regurgitation, and the prosthetic valves were in good position and function. At 1 week postoperatively, echocardiographic results showed 5 patients with no displacement of the prosthetic valve, detachment of the mitral clip, or damage to the leaflets. At 1 month postoperatively, cardiac function was improved to varying degrees in 4 patients, and 1 patient died of multiorgan failure. At 2 months postoperatively, 1 patient died of cerebrovascular accident, and at 3 months postoperatively the echocardiographic results of the remaining 3 patients revealed that there was no more than mild perivalvular leakage or mitral regurgitation, and the patients' postoperative cardiac function and daily life ability were significantly improved. Conclusion In high-risk aortic valve lesions combined with severe mitral regurgitation, "one-stop" transapical TAVR+TEER is feasible with favorable early efficacy and safety.
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 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.
Transcatheter mitral valve edge-to-edge repair (TEER) has become an important treatment opinion for patients with severe mitral regurgitation (MR) at high risk for surgery. The devices and procedural techniques of TEER are complex and require excellent team cooperation. However, there is still a lack of standardized clinical pathways in China. Based on the latest evidence, the expert group wrote this clinical pathway to guide and optimize TEER therapy in clinical practice. It demonstrates the following key issues of clinical concern: (1) TEER team building; (2) preoperative clinical evaluation of TEER patients; (3) imaging assessment before TEER procedure; (4) standardized procedures for TEER; (5) TEER for complex MR; (6) the standard process of perioperative comprehensive management; and (7) full life-cycle rehabilitation and follow-up. This clinical pathway might be helpful to facilitate the standardized development of TEER therapy and application, and promote the improvement of management and life quality for patients with MR.
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.
Over the past 20 years, transcatheter mitral valve edge-to-edge repair (TEER) has become an important treatment option for patients with severe mitral regurgitation (MR) who are at high surgical risk. Initially, several landmark clinical studies established the basis of TEER for primary and secondary MR, but they only involved clinically stable patients with appropriate mitral valve anatomy. With the increasing experience of interventional therapy, the iteration of equipment and the improvement of intraoperative imaging technology, the scope of use of TEER has been continuously expanded, and its indications have been continuously expanded to more complex mitral valve lesions and clinical situations. Therefore, in clinical practice, selecting the appropriate device according to the individual anatomical characteristics of the patient can minimize MR and complications, thereby optimizing immediate and long-term prognosis. This article mainly introduces the pathogenesis and related mechanisms of MR, the main TEER devices and their clinical evidence, the limitations of TEER, and the future development direction.
Transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR) is known as M-TEER. Its strengths include: precise targets and fewer implants; simple and clear principles for catheterization; originating from dependable medical concepts and broad applicability. Furthermore, TEER offers advantages in real-time hemodynamic and effectiveness measurement throughout the procedure over surgical edge-to-edge repair (SEER). When it comes to patients with degenerative mitral regurgitation , M-TEER should aim to deliver more optimum procedural outcomes. In functional mitral regurgitation, a modest transvalvular gradients or moderate residual shunt can be tolerated with M-TEER, which reduces the risk of problems and has no bearing on the patient's prognosis.
Objective To investigate the surgical method and short-term effectiveness of arthroscopy edge-to-edge #-shaped suture in the treatment of the complete radial tear of the lateral meniscus body. Methods The clinical data of 13 patients with complete radial tear of lateral meniscus body between May 2020 and August 2023 were retrospectively analyzed. There were 10 males and 3 females, aged 15-38 years (mean, 24.2 years). There were 11 cases of acute injury and 2 cases of chronic injury, with time from injury to admission ranging from 2 days to 5 months. All patients had tenderness in the lateral joint space, and 2 patients with chronic injury had positive McMurray’s sign. All patients were treated with arthroscopic edge-to-edge #-shaped suture technique. The knee joint activity and tenderness in the lateral joint space were detected, and the healing of the incision and the occurrence of complications were observed. X-ray films and MRI of the knee joint were performed to evaluate joint degeneration and meniscus healing. Lysholm score, International Knee Documentation Committee (IKDC) subjective score, Tegner score, and visual analogue scale (VAS) score were used to evaluate the functional recovery before and after operation. Results The operation time ranged from 46 to 100 minutes (mean, 80.08 minutes). All the incisions healed by first intention, and no complication such as intraoperative vascular and nerve injury or postoperative infection occurred. All 13 patients were followed up 20-59 months (mean, 29.3 months). All patients had no limitation of knee extension and flexion. One patient with chronic injury continued to have tenderness in the lateral space of the knee joint, while the remaining patients had no tenderness, swelling, and locking in the lateral space. Immediate postoperative MRI of knee joint showed continuous recovery of the lateral meniscus. At last follow-up, no degenerative changes were observed in X-ray films of knee joint. Except for 1 patient with chronic injury, the MRI of the other patients showed the healing performance after lateral meniscus suture. Lysholm score, IKDC subjective score, Tegner score, and VAS score all significantly improved when compared with those before operation (P<0.05). Conclusion The edge-to-edge #-shaped suture technique can effectively repair the complete radial tear of the lateral meniscus body, and the short-term effectiveness is satisfactory.
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.