Transcatheter edge-to-edge repair (TEER) originated from surgical edge-to-edge repair. MitraClip is the first mature TEER device, and the TEER based on MitraClip is far ahead of many transcatheter mitral valve repair (TMVr) technologies in terms of safety, effectiveness and popularity, so it is named separately in the latest guidelines. The TEER has the following advantages: consistent with basic medical principles, few implants, precise target, less invasive and repeatable. However, there are also some shortcomings, such as the relatively complex design of transfemoral device, target single and relatively narrow indications. At present, the main clinical data of TEER are mainly from the clinical practice of MitraClip. Based on the three-year outcomes of COAPT study, both 2020 ACC/AHA guideline and 2020 ACC expert consensus decision pathway on the management of mitral regurgitation recommend in patients with chronic heart failure with left ventricular dysfunction and severe mitral regurgitation in nonresponders to medicine treatment. Edward's PASCAL, another TEER device, has two models. Among the domestic TEER devices, the ValveClamp of Hanyu medical technology has many distinct advantages, such as simple operation, large clamping area, high clamping efficiency and no need of X-ray. DragonFly, another domestic TEER device, has also completed its feasibility study. There are five trends of TEER in the future: further expansion of indications, combination with other interventional techniques, repeatable operations, transcatheter mitral valve replacement after TEER, and continuous improvement and innovation of equipment.
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.
Transcatheter edge-to-edge repair (TEER) is at present a well established interventional procedure for the treatment of mitral regurgitation (MR). Echocardiography is an essential imaging modality for peri-interventional assessment of TEER. Pre-procedural echocardiographic assessments, which include grading of MR severity, determining MR etiology and mechanisms, and analyzing mitral valve morphology, helps to determine patient eligibility and plan the procedure. Echocardiography is also indispensable in intra-procedural guidance, such as atrial septum puncture, advancing the device to the target position, and leaflets capture. In addition, echocardiography is important in immediate result evaluation, complication detection and patient follow up after the procedure.
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.
Echocardiography is an important imaging technique in transcatheter edge-to-edge mithal valve repair (TEER). During the operation, mitral leaflets capture and clamping have the highest requirements for ultrasound image quality and should be performed under the guidance of high-quality commissural view. However, standard commissural view cannot be obtained in some patients due to cardiac enlargement, transposition or limited esophageal acoustic window. In this condition, the optimal view can be obtained by Multivue technology. This paper reports a case of successful mitral valve TEER under the real-time guidance of Multivue technology, and summarizes the key points of this technology.
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.