ObjectiveTo explore the effect and safety of surgical treatment for hypertrophic obstructive cardiomyopathy (HOCM) with mitral regurgitation (MR) through right mini-thoracotomy.MethodsFrom January 2008 to June 2018, 54 patients with HOCM and moderate-to-severe MR underwent modified Morrow procedure and edge-to-edge mitral valvuloplasty through right mini-thoracotomy, including 31 males and 23 females, with an average age of 47.1±12.6 years. All patients had systolic anterior motion (SAM) phenomenon. Preoperative left ventricular outflow tract pressure gradient (LVOTPG) was 93.6±32.8 mm Hg, interventricular septum thickness (IVST) was 24.8±2.8 mm.ResultsSurgeries in all patients were completed successfully. No early death or interventricular septal perforation occurred. One (1.9%) patient received permanent pacemaker implantation due to the complete atrial-ventricular block. At discharge, postoperative LVOTPG (18.1±6.2 mm Hg) and IVST (14.5±2.1 mm) were significantly decreased compared with the preoperative values (P<0.05). No MR or SAM was observed in all patients. The follow-up time was 6-132 months, and during this period, no death, MR or SAM occurred. The average LVOTPG was 19.4±5.7 mm Hg, and the average IVST was 14.2±1.5 mm.ConclusionMorrow procedure and edge-to-edge mitral valvuloplasty through right mini-thoracotomy is a safe and effective method for treatment of HOCM with moderate-to-severe MR.
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.
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+).
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 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.
Mitral regurgitation is the most common heart valvular disease at present. In the past, mitral regurgitation was mainly treated by surgical mitral valve repair or replacement. However, with the progress of transcatheter interventional techniques and instruments in recent years, transcatheter mitral valve interventional therapy has gradually shown its advantages and benefited patients. The purpose of this article is to review the progress of transcatheter mitral valve intervention in this year, and to provide prospects for the future of transcatheter mitral valve treatment.
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.
Objective To compare the differences of transcatheter edge-to-edge repair (TEER) between trans-apical and trans-femoral groups in the treatment of mitral regurgitation. Methods A retrospective study was conducted on the patients who underwent TEER surgery at Tianjin Chest Hospital from February 2023 to October 2024. Patients were divided into two groups based on the surgical approach: trans-apical approach group and trans-femoral approach group. Baseline conditions, perioperative and postoperative 6-month survival status, and echocardiographic follow-up indicators were collected and compared between the groups. The primary endpoint indicators were all-cause mortality and device success rate. Secondary endpoint indicators included catheterization duration, heart failure readmission rate, and incidence of moderate or greater mitral regurgitation. Results A total of 33 patients were included, with 16 in the trans-femoral approach group and 17 in the trans-apical approach group. The average age was (69.85±7.86） years, and 17 patients (51.5%) were male. There were no statistically significant differences between the two groups in demographic characteristics, STS scores, comorbidities (except for diabetes), and laboratory tests. The proportion of patients with preoperative heart function≥grade Ⅲ was higher in the trans-apical approach group (88.2% vs. 43.8%, P=0.007), and the left ventricular end-diastolic diameter was smaller [(58.41±7.13）mm vs. (65.81±11.58) mm, P=0.033]. The catheterization operation time was shorter in the trans-apical approach group [40.00 (30.00, 61.00) min vs. 74.00 (56.25, 108.25) min, P=0.002]. There were no statistically significant differences between the two groups in all-cause mortality, device success rate, and heart failure readmission rate. Conclusion TEER surgeries via different approaches might have the same safety and efficacy. The trans-apical TEER surgery is simpler to operate, has a shorter learning curve, and is easier for beginners to master.
Echocardiography is an important imaging technique in mithal valve transcatheter edge-to-edge 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 male patient aged 67 years with successful mitral valve TEER under the real-time guidance of Multivue technology, and summarizes the key points of this technology.
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.