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 environmental microbiological and physical monitoring parameters between the temporary extended medical area and the normal area during the flexible allocation of ward, summarize the rule and find the potential risk points of infection control. Methods From April 10th to 23rd, 2023, prospective environmental microbial monitoring and physical parameter monitoring were carried out in a ward of Zhongnan Hospital of Wuhan University, and the monitoring results under different scenarios were compared and analyzed. Results In general, the carbon dioxide (CO2) concentration, particulate matter 2.5 (PM2.5) concentration, temperature, and relative humidity in the temporary medical area were better than those in the inpatient rooms (P<0.05), but there was no statistically significant difference in the amount of microorganisms detected on the surface of environmental objects or the hands of medical staff (P>0.05). After the start of the temporary medical area, the amount of microorganisms detected on the surface of environmental objects, CO2 concentration, and temperature in the inpatient rooms were higher than those in the temporary medical area (P<0.05), the PM2.5 concentration in the inpatient rooms was lower than that in the temporary medical area (P<0.05), and there was no statistically significant difference in the amount of microorganisms detected on the hands of medical staff or relative humidity between the two areas (P>0.05). Compared with those in the same area when the temporary medical area was not started, in the inpatient rooms after the start, the amount of microorganisms detected in the air, CO2 concentration, temperature, and relative humidity were lower (P<0.05), the amount of microorganisms detected on the surface of environmental objects and PM2.5 concentration were higher (P<0.05), and there was no statistically significant difference in the amount of microorganisms detected on the hands of medical staff between the two periods (P>0.05); in the temporary medical area after the start, the PM2.5 concentration was higher (P<0.05), the CO2 concentration and temperature were lower (P<0.05), and the differences in the relative humidity and amounts of microorganisms detected on the surface of environmental objects and the hands of medical staff between the two periods were not statistically significant (P>0.05). Regardless of whether the temporary medical area was activated or not, Filamentous fungi had the highest detection rates in air samples, and Staphylococcus epidermidis had the highest detection rates in both environmental surface samples and medical staff hand samples. Conclusion A series of environmental risks such as environmental microbial load and poor ventilation caused by temporary medical areas should be paid attention to.
Objective A prospective study was conducted to investigate the feasibility and effectiveness of three-dimensional printed in vitro guide plates assisted hip arthroscopy in the treatment of Cam-type femoroacetabular impingement (FAI). Methods The clinical data of 25 patients with Cam-type FAI who met the selection criteria between December 2016 and September 2022 were collected. There were 13 males and 12 females with an average age of 42 years (range, 19-66 years). The disease duration ranged from 3 to 120 months, with an average of 22.2 months. The preoperative range of internal rotation-external rotation was (28.70±4.50)°, α angle was (69.04±0.99)°, visual analogue scale (VAS) score was 6.5±0.2, and modified Harris hip score (HHS) was 50.5±0.7. All patients were treated with hip arthroscopy assisted by three-dimensional printed in vitro guide plate. The occurrence of complications was observed postoperatively, α angle of the affected hip joint was measured on Dunn X-ray film, and the glenoid labrum injury was observed by MRI. The percentage of overlap between the Cam plasty area and the preoperative simulated grinding area was calculated by three-dimensional CT+reconstruction. The effectiveness was evaluated by VAS score and modified HHS score. ResultsPostoperative dorsalis pedis numbness occurred in 1 case, and the symptoms disappeared after 1 month of conventional drug treatment such as neurotrophy. Two cases of perineal skin injury occurred, and healed after symptomatic treatment. There was no male erectile dysfunction, deep incision infection, pulmonary embolism, or other serious complications occurred. The percentage of overlap between the Cam plasty area and the preoperative simulated grinding area was 81.6%-95.3%, with an average of 89.8%. All 25 patients were followed up 6-12 months, with an average of 8 months. At last follow-up, the range of internal rotation-external rotation was (40.10±2.98)°, α angle was (43.72±0.84)°, VAS score was 1.8±0.2, and the modified HHS score was 72.1±1.3, which significantly improved when compared with preoperative ones (P<0.05). ConclusionThe treatment of Cam-type FAI with three-dimensional printed in vitro guide plates assisted hip arthroscopy is safe and feasible, and can achieve good effectiveness.