Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Objective To analyze the clinical characteristics of stiff left atrial syndrome (SLAS) after Mei mini maze procedure for atrial fibrillation (AF), and to explore its risk factors and treatments. Methods We retrospectively analyzed the clinical data of the patients who underwent Mei mini maze procedure in Xinhua Hospital between 2010 and 2020. According to whether SLAS occurred in the early postoperative period, patients were divided into a SLAS group and a non-SLAS group. The basic data, perioperative echocardiogram and laboratory test indexes of the two groups were compared. Results A total of 1 056 patients were collected. There were 672 (63.6%) males with an average age of 63.6±9.3 years, including 489 patients with persistent AF and 567 patients with paroxysmal AF. Fourteen (14/1 056, 1.3%) patients developed SLAS, with an average occurrence time of 2.1±1.1 days after the surgery. The average follow-up time of the whole group was 21.4±7.8 months. Two patients in the SLAS group developed SLAS again after discharge, and the occurrence time was 3 weeks and 4 weeks after the operation, respectively; while no SLAS occurred after discharge in the non-SLAS group. Diabetes and small preoperative left atrial diameter were risk factors for SLAS after surgery. Patients with SLAS had a good prognosis after adequate diuretic therapy. Conclusion The incidence of SLAS after Mei mini maze procedure for AF is low, and it mostly occurs in the early postoperative period. After adequate diuretic treatment, the prognosis is good.

Objective     To investigate the left ventricular reverse remodeling (LVRR) in patients with aortic valve insufficiency with reduced ejection fraction (AIrEF) and aortic valve insufficiency with preserved ejection fraction (AIpEF) after transcatheter aortic valve replacement (TAVR). Methods    The clinical and follow-up data of patients who underwent TAVR in the Department of Cardiothoracic Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from 2018 to 2021 were retrospectively analyzed. According to the guideline, the patients with left ventricular ejection fraction<55% were allocated to an AIrEF group, and the patients with left ventricular ejection fraction≥55% were allocated to an AIpEF group. Results    A total of 50 patients were enrolled. There were 19 patients in the AIrEF group, including 15 males and 4 females with a mean age of 74.5±7.1 years. There were 31 patients in the AIpEF group, including 19 males and 12 females with a mean age of 72.0±4.8 years. All patients underwent TAVR successfully. Echocardiographic results showed that TAVR significantly promoted LVRR in the patients. Significant LVRR occurred in the early postoperative period (the first day after the surgery) in both groups. It remained relatively stable after the LVRR in the early postoperative period (the first day after surgery) in the AIpEF patients, while it continued to occur in the early postoperative period (the first day after surgery) to three months after the surgery in the AIrEF patients, and then remained relatively stable. Compared to preoperative values, AIrEF patients had a reduction in the average left ventricular end-diastolic volume index and left ventricular end-systolic volume index by 16.8 mL/m2 (P=0.003) and 8.6 mL/m2 (P=0.005), respectively, and the average left ventricular end-diastolic diameter index and end-systolic diameter index decreased by 2.5 mm/m2 (P=0.003) and 1.9 mm/m2 (P=0.003), respectively on the first day after the surgery. In comparison to the first day after the surgery, AIrEF patients experienced an average increase of 12.1% in the left ventricular ejection fraction three months after the surgery (P<0.001). Conclusion    TAVR has achieved good therapeutic effects in patients with aortic valve insufficiency, significantly promoting the LVRR in patients, and has better curative effects in AIrEF patients.

Objective: To analyze the clinical characteristics of children with Burkitt lymphoma (BL) and to summarize the mid-term efficacy of China Net Childhood Lymphoma-mature B-cell lymphoma 2017 (CNCL-B-NHL-2017) regimen. Methods: Clinical features of 436 BL patients who were ≤18 years old and treated with the CNCL-B-NHL-2017 regimen from May 2017 to April 2021 were analyzed retrospectively. Clinical characteristics of patients at disease onset were analyzed and the therapeutic effects of patients with different clinical stages and risk groups were compared. Survival analysis was performed by Kaplan-Meier method, and Cox regression was used to identify the prognostic factors. Results: Among 436 patients, there were 368 (84.4%) males and 68 (15.6%) females, the age of disease onset was 6.0 (4.0, 9.0) years old. According to the St. Jude staging system, there were 4 patients (0.9%) with stage Ⅰ, 30 patients (6.9%) with stage Ⅱ, 217 patients (49.8%) with stage Ⅲ, and 185 patients (42.4%) with stage Ⅳ. All patients were stratified into following risk groups: group A (n=1, 0.2%), group B1 (n=46, 10.6%), group B2 (n=19, 4.4%), group C1 (n=285, 65.4%), group C2 (n=85, 19.5%). Sixty-three patients (14.4%) were treated with chemotherapy only and 373 patients (85.6%) were treated with chemotherapy combined with rituximab. Twenty-one patients (4.8%) suffered from progressive disease, 3 patients (0.7%) relapsed, and 13 patients (3.0%) died of treatment-related complications. The follow-up time of all patients was 24.0 (13.0, 35.0) months, the 2-year event free survival (EFS) rate of all patients was (90.9±1.4) %. The 2-year EFS rates of group A, B1, B2, C1 and C2 were 100.0%, 100.0%, (94.7±5.1) %, (90.7±1.7) % and (85.9±4.0) %, respectively. The 2-year EFS rates was higher in group A, B1, and B2 than those in group C1 (χ²=4.16, P=0.041) and group C2 (χ²=7.21, P=0.007). The 2-year EFS rates of the patients treated with chemotherapy alone and those treated with chemotherapy combined with rituximab were (79.3±5.1)% and (92.9±1.4)% (χ²=14.23, P<0.001) respectively. Multivariate analysis showed that stage Ⅳ (including leukemia stage), serum lactate dehydrogenase (LDH)>4-fold normal value, and with residual tumor in the mid-term evaluation were risk factors for poor prognosis (HR=1.38,1.23,8.52,95%CI 1.05-1.82,1.05-1.43,3.96-18.30). Conclusions: The CNCL-B-NHL-2017 regimen show significant effect in the treatment of pediatric BL. The combination of rituximab improve the efficacy further.
Adolescent ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Burkitt Lymphoma/drug therapy* ; Child ; Disease-Free Survival ; Female ; Humans ; Lactate Dehydrogenases ; Lymphoma, B-Cell/drug therapy* ; Male ; Prognosis ; Retrospective Studies ; Rituximab/therapeutic use* ; Treatment Outcome

Objective    To summarize the clinical data and efficacy of surgical treatment of aortic periannular abscess. Methods    The clinical data of 35 aortic periannular abscess patients admitted to our hospital from January 2009 to June 2019 were retrospectively analyzed, including 21 males and 14 females, aged 36 to 67 (53.0±12.3) years. Among them, there were 14 patients of native aortic valve endocarditis and 21 patients of prosthetic valve endocarditis (16 patients of mechanical valve and 5 patients of biological valve). Preoperative blood cultures were positive in 15 patients, including 8 patients of Staphylococcus aureus, 2 patients of Staphylococcus epidermidis, 3 patients of Streptococcus grass green, 1 patient of Pseudomonas aeruginosa, and 1 patient of Enterococcus. Results    Eleven patients underwent emergency or urgent surgery. Thirty patients underwent aortic valve replacement, and 5 patients underwent modified Cabrol surgery to replace the aortic root. Early postoperative complications included 1 patient of bleeding, 8 patients of low cardiac output syndrome, 5 patients of renal insufficiency, 10 patients of respiratory insufficiency, 3 patients of tracheotomy, 8 patients of pulmonary infection and 1 patient cerebrovascular accident. The postoperative follow-up period was 6 to 120 (53.6±20.8) months. During the follow-up, 4 patients died and 4 patients were lost. No infection recurred during the follow-up. Perivalval leakage occurred in 3 patients, and one patient underwent occlusion 12 months following the procedure. The survival curve indicated that the 1-year survival rate was 85.5%, and the 5-year survival rate was 67.3%. Conclusion    Although the lesions of periannular abscesses are complicated and critical, effective perioperative antibiotic treatment, individualized surgical timing, and appropriate surgical strategies can significantly reduce mortality and achieve better results.

Objective    To summarize the experience and efficacy of "one-stop" left atrial appendage clipping (LAAC) combined with transcatheter aortic valve replacement (TAVR) for patients with atrial fibrillation (AF) and aortic valve disease. Methods     From April 2018 to March 2021, 16 patients with AF and severe aortic valve disease underwent "one-stop" LAAC and TAVR in our department. All patients had long-standing persistent AF. There were 10 males and 6 females with an average age of 77.2±6.2 years. CHA2DS2-VASc score was 4.4±0.8 points, and HAS-BLED score was 3.5±0.7 points. Results    All patients successfully underwent "one-stop" LAAC combined with TAVR. There was no death during perioperative and follow-up periods. The length of the left atrial appendage base measured during the operation was 37.8±3.5 mm. The types of atrial appendage clip were 35 mm (n=3), 40 mm (n=8) and 45 mm (n=5). The time required for clipping the left atrial appendage (from skin cutting to skin suturing) was 25.7±3.8 min. There was no stroke or bleeding of important organs during the perioperative period. The average hospital stay was 6.8±2.0 d. The follow-up time was 19.6±10.1 months, during which there was no patient of cerebral hemorrhage or cerebral infarction. During the administration of warfarin, 2 patients had subcutaneous ecchymosis and 1 patient had gingival bleeding. Conclusion    "One-stop" LAAC combined with TAVR can be safely and effectively used to treat AF and aortic valve disease patients with high risk of thromboembolism and anticoagulant bleeding. The early and middle-term curative effect is satisfactory.

The rapid spread of carbapenemase-producing Klebsiella pneumoniae(cpKP)poses seri-ous threats to public health;however,the underlying genetic basis for its dissemination is still unknown.We conducted a comprehensive genomic epidemiology analysis on 420 cpKP isolates col-lected from 70 hospitals in 24 provinces/autonomous regions/municipalities of China during 2009-2017 by short-/long-read sequencing.The results showed that most cpKP isolates were categorized into clonal group 258(CG258),in which ST11 was the dominant clone.Phylogenetic analysis revealed three major clades including the top one of Clade 3 for CG258 cpKP isolates.Additionally,carbapenemase gene analysis indicated that blaKPC was dominant in the cpKP isolates,and most blaKPC genes were located in five major incompatibility(Inc)groups of blaKPC-harboring plasmids.Importantly,three advantageous combinations of host-blaKPC-carrying plasmid(Clade 3.1+3.2-IncFⅡpHN7A8,Clade 3.1+3.2-IncFⅡpHN7A8:IncR,and Clade 3.3-IncFⅡpHN7A8:InCpA1763-KPC)were identified to confer cpKP isolates the advantages in both genotypes(strong correlation/coevolution)and phenotypes(resistance/growth/competition)to facilitate the nationwide spread of ST11/CG258 cpKP.Intriguingly,Bayesian skyline analysis illustrated that the three advanta-geous combinations might be directly associated with the strong population expansion during 2007-2008 and subsequent maintenance of the population of ST11/CG258 cpKP after 2008.We then examined drug resistance profiles of these cpKP isolates and proposed combination treatment regimens for CG258/non-CG258 cpKP infections.Thus,the findings of our systematical analysis shed light on the molecular epidemiology and genetic basis for the dissemination of ST11/CG258 cpKP in China,and much emphasis should be given to the close monitoring of advantageous cpKP-plasmid combinations.

Objective    To summarize the experience of treating adult recurrent pectus excavatum without plate turnover. Methods    Twenty-seven patients with recurrent pectus excavatum treated by thoracoscopy-assisted placement without plate turnover from 2010 to 2019 in our hospital were enrolled. There were 23 males and 4 females with the age of 3-29 (12.81±7.79) years at the first operation, and 18-29 (21.74±3.56) years at this operation. Incision of 2-3 cm at bilateral axillary midline of the deepest point of pectus excavatum was made, and an auxiliary incision under xiphoid process was adopted according to the intraoperative situation. Results    All patients underwent thoracoscopy-assisted correction of pectus excavatum without bar turnover, and subxiphoid incision was performed in 11 patients. Twenty-five patients had one bar placed, and two patients required two bars. The operation time was 28-45 (33.00±6.44) min. Postoperative Haller index (2.95±0.40) was improved compared with preoperation (4.63±1.03). The postoperative hospital stay was 4-6 (4.00±0.32) day. All patients were followed up for 1-8 years. Complications included poor wound healing in 1 patient, and steel wire fracture and displacement in 1 patient. There was no plate rotation or bar displacement. Fourteen patients removed the bar 29-84 (40.36±13.93) months after the placement. Haller index was improved to 2.43-3.61 (2.86±0.35) during removal of steel plate. Untill June 2020, there was no recurrence of pectus excavatum. Conclusion    The treatment of adult recurrent pectus excavatum without plate turnover is satisfactory, and the protection of intercostal muscle and firm fixation is the key to ensure the success of operation and long-term effects.

The minimally invasive cardiovascular surgery developed rapidly in last decades. In order to promote the development of minimally invasive cardiovascular surgery in China, the Chinese Minimally Invasive Cardiovascular Surgery Committee (CMICS) has gradually standardized the collection and report of the data of Chinese minimally invasive cardiovascular surgery since its establishment. The total operation volume of minimally invasive cardiovascular surgery in China has achieved substantial growth with a remarkable popularization of concepts of minimally invasive medicine in 2019. The data of Chinese minimally invasive cardiovascular surgery in 2019 was reported as a paper for the first time, which may provide reference to cardiovascular surgeons and related professionals.

Objective    To investigate the technique and efficacy of left atrial appendage (LAA) occlusion during off-pump coronary artery bypass grafting (OPCABG) in elderly patients with coronary artery disease (CAD) and atrial fibrillation (AF). Methods    From 2013 to 2018, 84 elderly patients with CAD and AF with reduced left ventricular ejection fraction (LVEF< 50%) underwent OPCABG in our department. There were 54 males and 30 females at age of 70-82 years. They were divided into a left atrial appendage (LAA) occlusion group (n=56) and a non-LAA occlusion group (n=28). Postoperative antithrombotic therapy: the LAA occlusion group was given warfarin + aspirin + clopidogrel “triple antithrombotic therapy” for 3 months after operation, then was changed to aspirin + clopidogrel “dual antiplatelet” for long-term antithrombotic; the non-LAA occlusion group was given warfarin + aspirin + clopidogrel “triple antithrombotic” for long-term antithrombotic after operation. The clinical effectiveness of the two groups was compared. Results    All patients underwent the surgery successfully. There were 56 patients in the LAA occlusion group, including 44 patients of LAA exclusion and 12 patients of LAA clip. The time of LAA occlusion was 3 to 8 minutes. There was no injury of graft vessels and anastomotic stoma. Early postoperative death occurred in 2 patients (2.4%). There was no statistical difference between the two groups in postoperative hospital stay (P=0.115). Postoperative LVEF of the two groups significantly improved compared with that before operation (P<0.05). There was no stroke or bleeding in important organs during hospitalization. During follow-up of 1 year, no cerebral infarction occurred in both groups, but the incidence of bleeding related complications in the LAA occlusion group was significantly lower than that in the non-LAA occlusion group (3.6% vs. 18.5%, P=0.036). Conclusion    For elderly patients with CAD and AF with reduced LVEF, LAA occlusion during OPCABG can effectively reduce the risk of stroke and bleeding related complications, and without increasing the risk of surgery.