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.
To analyze the effectiveness of anterior cruciate l igament (ACL) reconstruction with preserving the remnant ACL by allograft l igament. Methods Between January and July in 2008, 97 patients underwent ACL reconstruction with the allograft l igament. On the basis of the ACL’s condition, patients were divided into 2 groups. In the trial group (patients having remnant ACL, n=38), there were 27 males and 11 females with an average age of 24.3 years (range, 16-43 years); of them, 8 cases compl icated by menicus injury and 13 cases by Outbridge I degree cartilage injury; the time from injuryto operation was 3-20 weeks (mean, 8.6 weeks). In the control group (patients having no remnant ACL, n=59), there were 35 males and 24 females with an average age of 27.8 years (range, 18-48 years); of them, 16 cases compl icated by menicus injury and 23 cases by Outbridge I degree cartilage injury; the time from injury to operation was 4-44 weeks (mean, 12.7 weeks). All injuries were caused by sports in 2 groups. All patients had positive anterior drawer test and positive Lackman test. Before operation and 3, 8, 9, 15 months after operation, the function of the knee joint was evaluated by the International Knee Documentation Committee (IKDC) scale and Lysholm score. KT-2000 arthrometer was used to evaluate knee laxity. Results All incisions healed primarily, and no intraarticular infection occurred. Thirty-seven cases and 57 cases were followed up 15 months in the trial group and the control group, respectively. Knee instabil ity disappeared; the patients showed negative anterior drawer test and negative Lackman test. By the evaluation of KT-2000, the joint sl ippage of 2 groups were less than 2 mm at 3 and 6 months after operation, but it was more than 2 mm in 2 cases of the trial group and in 3 cases of the control group at 9 months after operation; and it was no change in the trial group and 2.5-4.0 mm (mean, 3.4 mm) in the control group at 15 months after operation. Both the IKDC scale and Lysholm score were higher in the trial group than in the control group 3 months after operation, but the differences were not significant (P gt; 0.05). Both the IKDC scale and Lysholm score were
Objective To discuss the effectiveness of breast reconstruction with dual plane prosthesis implantation or anterior pectoralis prosthesis implantation under endoscopy by using prospective comparative study, in order to provide a reference for clinical surgical selection. Methods A total of 54 female patients with breast cancer admitted between January 2023 and December 2023 and met the selection criteria were selected as research subjects. According to the random number table, 54 patients were divided into trial group and control group with 27 cases in each. The patients in the trial group and control group were treated with dual plane prosthesis implantation and anterior pectoralis prosthesis implantation for breast reconstruction after glandular resection under endoscopy, respectively. There was no significant difference between the two groups (P>0.05) in the terms of age, body mass index, affected side, breast clinical stages, molecular typing, disease duration, breast volume of healthy side, breast ptosis of affected side, and preoperative Breast-Q score (social mental health, sexual health, breast satisfaction, chest somatic health). The operation-related indicators (operation time, total volume of drainage within 7 days after operation, extubation time, and hospital stay), occurrence of complications, breast reconstruction efficacy related indicators (transverse and longitudinal distance difference), and the pre- and post-operative differences (change values) of Breast-Q scores for each item were compared between the two groups. Results There was no significant difference in operation time, total volume of drainage within 7 days after operation, extubation time, and hospital stay between the two groups (P>0.05). All patients of the two groups were followed up 3-12 months (mean, 6.3 months). Three patients (11.11%) in trial group and 5 patients (18.52%) in control group experienced complications, and there was no significant difference in the occurrence of complications (P>0.05). At 7 days after operation, the transverse and longitudinal distance differences were significantly less in trial group than in control group (P<0.05). The Breast-Q scores of the two groups at 7 days after operation were significantly higher in all items than those before operation (P<0.05), but there was no significant difference in all change values between the two groups (P>0.05). ConclusionFor patients with breast cancer, comparison of breast reconstruction with anterior pectoralis prosthesis implantation, breast reconstruction with dual plane prosthesis implantation has better breast reconstruction effectiveness and higher safety.
Objective To discuss the feasibility and clinical outcomes of fast-track (FT) surgery for elderly patients (≥70 years) with colorectal carcinoma. Methods Between November 2007 and January 2009, 103 elderly patients were analyzed prospectively, who were divided into FT group and traditional group randomly. All 103 patients had completed the entire study. Postoperative complications and early rehabilitations were studied and compared. In addition, completion of FT courses was recorded. Results ① In early rehabilitation, the time of first ambulation was (1.96±0.89) d and (2.92±1.43) d, oral intaking was (2.41±0.92) d and (3.62±1.40) d, and first flatus was (3.88±1.05) d and (4.52±1.29) d in the FT group and the traditional group, respectively. The early rehabilitation indexes in the FT group were significantly earlier than those in the traditional group (Plt;0.05). ② Postoperative hospital stay was (9.27±1.87) d and (12.75±7.05) d in the FT group and the traditional group, respectively, in the FT group which was shorter than that in the traditional group (Plt;0.05). ③ The mortality rate and readmission rate was 0 on 2 weeks after operation in two groups. ④ The total morbidity rate was 11.76% (6/51) in the FT group, in the traditional group was 28.85% (15/52), there was significant difference between two groups (Plt;0.05), while there was no significant difference in general complications and surgical complications between two groups (Pgt;0.05).Conclusions FT surgery for elderly patients with colorectal carcinoma is feasible and could enhance recovery, cut down morbidity rate and shorten postoperative hospital stay. If the FT courses are more completed, the clinical outcomes could be better.
Objective To explore the difference in effectiveness between a dynamic rehabilitation protocol and a traditional static rehabilitation protocol after the treatment of acute Achilles tendon rupture with channel assisted minimally invasive repair (CAMIR) technique through a prospective comparative trial, aiming to provide a reference for clinically selecting a feasible treatment regimen. Methods Patients with acute Achilles tendon rupture admitted between June 2021 and June 2022 were included in the study, with 60 patients meeting the selection criteria. They were randomly divided into a dynamic rehabilitation group (n=30) and a static rehabilitation group (n=30) using a computer-generated random number method. There was no significant difference in baseline data such as gender, age, body mass index, smoking history, injured side, cause of injury, and disease duration between the two groups (P>0.05). After Achilles tendon anastomosis by using CAMIR technique, the dynamic rehabilitation group implemented early partial weight-bearing training with the assistance of an Achilles heel boot and controlled ankle joint exercises for 6 weeks, while the static rehabilitation group maintained a non-weight-bearing status during this period. Complications in both groups were recorded. At 3 and 6 months after operation, the Achilles tendon total rupture score (ATRS) was used to evaluate the degree of functional limitation of the Achilles tendon in the affected limb, and the 12-Item Short Form Health Survey (SF-12 scale) was used to assess the patients’ quality of life, including physical component summary (PCS) and mental component summary (MCS) scores. Results No sural nerve injury occurred during operation in both groups. All patients were followed up 12-18 months (mean, 14 months). The dynamic rehabilitation group had significantly higher ATRS scores at 3 and 6 months after operation compared to the static rehabilitation group (P<0.05). At 3 months after operation, the dynamic rehabilitation group had significantly lower PCS, MCS, and SF-12 total scores compared to the static rehabilitation group (P<0.05). At 6 months, all quality of life scores in the two groups were similar (P>0.05). Two cases (6.6%) in the dynamic rehabilitation group and 5 cases (16.7%) in the static rehabilitation group developed complications, with no significant difference in incidence of complications (P>0.05). Conclusion For acute Achilles tendon rupture, the dynamic rehabilitation protocol after Achilles tendon anastomosis by using CAMIR technique can improve early functional recovery and maintains comparable safety and effectiveness compared to static rehabilitation.
目的 研究银离子联合水凝胶敷料和传统敷料对术后感染伤口的治疗作用。方法 对我院普外科行手术治疗后伤口发生感染的患者进行前瞻性研究，随机纳入新型敷料组（银离子联合水凝胶）和传统敷料组，收集患者一般基线资料，比较2组的创面愈合率、创面愈合时间及换药费用。结果 根据纳入和排除标准，最终新型敷料组纳入42例患者，传统敷料组纳入58例患者，2组患者基线资料一致（P＞0.05）。治疗6d后的创面愈合率新型敷料组明显高于传统敷料组（P＜0.05）；创面愈合时间新型敷料组明显短于传统敷料组（P＜0.05）；换药费用2组间比较差异无统计学意义（P＞0.05）。结论 银离子联合水凝胶敷料具有较好的控制伤口感染、促进伤口的生长及促进伤口愈合的作用。
Objective To prospectively verify the accuracy and reliability of the diagnostic model of obstructive sleep apnea (OSA), including the probability model and disease severity model, and to explore a simple and cost-effective method for screening of OSA. Methods A total of 996 patients who underwent polysomnography in Zigong Fourth People’s Hospital(590 cases) and West China Hospital of Sichuan University(406 cases) were consecutively and prospectively included as the research subjects. Firstly, the OSA diagnostic model was used for the diagnostic test; then polysomnography was performed; Finally, taking polysomnography as the gold standard, the sensitivity, specificity, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and area under the ROC curve of OSA diagnostic model were calculated, and the reliability analysis of the model’s results was carried out. Results The sensitivity, specificity and accuracy of the OSA diagnostic model were 76.38%(595/779), 83.41%(181/217) and 77.91%(776/996) respectively, the positive predictive value is 94.29%, negative predictive value is 45.49%, positive likelihood ratio is 4.604, negative likelihood ratio is 0.283; and the area under the ROC curve was 0.866. The reliability analysis of OSA diagnostic model showed that there was no significant difference in the bias comparison of AHI; the intra-class correlation coefficient(ICC) between AHI in the OSA diagnostic model and AHI in polysomnography was 0.659, with a relatively strong consistency degree; the intra-class correlation coefficient between the lowest SpO2 in the OSA diagnostic model and the lowest SpO2 in polysomnography was 0.563, with a moderate consistency degree. Conclusions The OSA diagnostic model can better predict the probability of illness and assess the severity of the disease, which is helpful for the early detection, diagnosis and treatment of OSA. The OSA diagnostic model is suitable for popularization and application in primary hospitals and when polysomnography is not available in time.
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.
Objective To compare the postoperative anorectal pressure after procedure for prolapse and hemorrhoids (PPH) and Milligan-Morgan hemorrhoidectomy (MMH) in treatment of patients with mixed hemorrhoid of Ⅲ-degree. Methods In total of 112 patients with mixed hemorrhoid of Ⅲ-degree who underwent PPH (n=60) or MMH (n=52) in The First Affiliated Hospital of Xinjiang Medical University between March 2014 to March 2015 were prospectively enrolled, the type of surgery was according to patients’ individual choice. In 6 months after operation, all patients under-went the examination of anorectal manometry which including rectal anal inhibitory reflex, rectal resting pressure, anal resting pressure, maximal anal contractive pressure, and anal canal length of high pressure belt. Results In 6 months after operation, the positive rate of rectal anal inhibitory reflex 〔88.3% (53/60) vs. 61.5% (32/52)〕 , anal resting pressure 〔(56.42± 2.25) mm Hg vs. (46.31±2.58) mm Hg〕, and anal canal length of high pressure belt 〔(3.35±0.12) cm vs. (2.29±0.23) cm〕 of PPH group were all significantly higher than those of MMH group (P＜0.05), but there was no statistical significance between PPH group and MMH group in rectal resting pressure 〔(5.51±1.26) mm Hg vs. (5.39±1.85) mm Hg〕 and maximal anal contractive pressure 〔(156.64±9.78) mm Hg vs. (155.32±8.53) mm Hg〕, P>0.05. Conclusion PPH and MMH are all effective to treat mixed hemorrhoids of Ⅲ-degree, but PPH is more positive in protection of anal function.