Mitral regurgitation (MR) is the most common valvular heart disease, however, majority of patients are not suitable for open heart surgery due to comorbidity such as organ and heart dysfunction. Transcatheter edge-to-edge mitral valve repair has become an effective treatment option for high-risk patients with MR. Two patients were enrolled in this study inlcuding one 60-year degenerative mitral regurgitation patient and one 72-year functional mitral regurgitation patient. Transcatheter repair procedure was successfully done for the two patients without postoperative complication.
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 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.
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 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 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.
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.
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.
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.
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+).