Objectives::The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin ?-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods::The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention.Results::From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (>5 mmHg), with an effective orifice area of 2.57 cm 2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions::The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin ?-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

Objectives::The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin ?-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods::The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention.Results::From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (>5 mmHg), with an effective orifice area of 2.57 cm 2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions::The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin ?-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

Objective To explore the feasibility and safety of kidney transplantation for pre-sensitized infants using deceased donors and summarize the relevant literature reports .Methods A second kidney transplantation was successfully performed for an 8-month-old pre-sensitized girl in July 2017 .She had a low level of donor specific antibody (DSA ) against human leucocyte antigen (HLA ) B62 due to severe acute rejection (AR) after her first kidney transplantation .For desensitization , plasmapheresis and intravenous immunoglobulin plus anti-CD20 antibodies were offered on operative day .Clinical data and outcomes were retrospectively analyzed .Results Renal graft regained immediate function after transplantation .Preformed DSA could be detected at 1 week .However ,there was no de novo DSA .At 1 year post-transplantation ,preformed DSA turned negative .During a follow-up period of 2 years ,renal graft showed an excellent function with a serum creatinine of 31 μmol/l and eGFR of 110 ml/min/1 .73m2 .No AR episode or proteinuria occurred .DSA stayed negative .Simultaneously physical development also caught up .Her height of 93 cm tall and weight of 13 .5 kg at month 24 & 8 months corresponded to normal grow th curve of her age .Conclusions Pre-sensitized infant could tolerate desensitization therapy well and achieve satisfactory outcomes .With surgical precisions and optimized managements ,kidney transplantation provides excellent renal functions and survivals for infants with organs from deceased donors .

Objective To evaluate the efficacy of tigecycline plus prolonged high-dose meropenem infusion in the prevention and treatment of early carbapenem-resistant Klebsiella pneumoniae (CRKP) infection after renal transplantation .Methods From January 2016 to December 2018 ,clinical data were retrospectively analyzed for 13 renal transplant recipients with graft-carried CRKP .The relevant clinical data included treatments and outcomes of grafts and recipients .KPC-2 gene was the only resistance gene detectable in all isolates of CRKP . Among 13 CRKP positive recipients ,there were positive cultures of graft preservation solution ,recipient blood & urine (n=1) , positive cultures of graft preservation solution & urine (n=1) ,positive cultures of graft preservation solutions & peri-graft drainage (n=3) ,continuous positive cultures of peri-graft drainage more than twice (n= 3) and positive culture of graft preservation solution (n= 5).All patients received tigecycline plus prolonged high-dose meropenem infusion-based antibiotics .Results Five patients with CRKP positive in preservation solution were successfully prevented from infection after a treatment period of (12 .4 ± 2 .1)days .Among another 8 cases ,additional topical medications (n= 3) and surgical debridement (n= 1) were used .It took a median time of 16 (7～60) days until a negative culture and the total antibiotic treatment course was 20 (10～93) days .The average hospitalization duration was (50 ± 35) days .During a median follow-up period of 25 (6～28) months ,there was no onset of renal arterial rupture ,graft nephrectomy or death .The survival rate was 100％ for recipients and 92 .3％ for grafts .Conclusions For post-transplant infections due to graft-carried KPC-2 producing CRKP ,rapid diagnostics and tigecycline plus prolonged high-dose meropenem infusion may optimize clinical outcomes by decreasing the rate of graft nephrectomy and the recipient mortality .

Objective To investigate the value of continuous renal replacement therapy (CRRT) coupled with minimally invasive ultrasound-guided percutaneous transhepatic gallbladder drainage (PTGD) for the treatment of severe acute biliary pancreatitis.Methods Hospitalized patients with severe acute biliary pancreatitis were recruited from the intensive care unit (ICU) of the Mfiliated Hospital of Qingdao University from June 2010 to June 2015,and divided into conventional CRRT alone group (n =30) and CRRT + PTGD group (n =30).Comparisons of postoperatively symptoms (time required for abdominal pain relief,time consumed for,gastrointestinal decompression),laboratory findings (WBC,PLT,PCT,CRP,AMS,TBIL,ALT,ALB,Lac) and acute physiology and chronic health evaluation score (APACHE Ⅱ,Balthazar CT,MODS) were carried out between two groups.The occurrence of complications (ARDS,abdominal infection,bile leakage,abdominal hemorrhage,intestinal injury,catheter translocation,catheter dislocation) was observed.The differences in duration of ventilator support,the length of stay in ICU,and fatality rate were compared between the two groups.Results Compared with the conventional CRRT alone group,the postoperative symptoms were significantly relieved,and time required for abdominal pain relief and time consumed for gastrointestinal decompression were evidently shortened in the CRRT + PTGD group (P ＜ 0.05).There were statistically significant differences in laboratory findings (WBC,PLT,PCT,CRP,AMS,TBIL,ALT) between two groups (P ＜ 0.05).The differences in APACHE Ⅱ,Balthazar CT and MODS score between the two groups also presented statistical significance (P ＜ 0.05).The comparisons of the duration of ventilator support [(6.1 ± 1.3) d vs.(9.5 ± 1.4) d] andthe length of stay [(15.7 ± 1.1) dvs.(21.1 ± 2.5) d] between thetwo groups revealed statistical significance (P ＜ 0.05).Conclusions CRRT coupled with PTGD for the treatment of severe acute biliary pancreatitis can effectively eliminate the inflammatory mediators and toxins from patients.On this basis,the coupled therapy with gallbladder puncture and drainage is capable of decompressing the biliary tract,improving liver function,effectively relieving clinical symptoms,minimizing the changes of laboratory findings an,d APACHE Ⅱ score,and thereby optimizing the prognosis of patients.

Objective To analyze the safety of renal transplant from donors with primary central nervous system (CNS) tumors.Methods We retrospectively analyzed the clinical data of 33 donors with primary CNS tumors and the 63 corresponding renal recipients between January 2013 and December 2016 in Tongji Hospital.Results The mean period from diagnosis as primary CNS tumor to donation was about (21.8± 46.4) months (range:0.5 to 192.0 months).The pathological classification of these tumors included gliomas,meningioma,medulloblastoma,etc.Besides,there were 10 donors with high-grade CNS malignancies.Eleven donors have ever been through at least one of the four treatments (craniotomy,V-P/V-A shunt,radiotherapy and chemotherapy),14 donors have undergone none,and the clinical data of rest were unavailable.All the 63 recipients got well renal function after transplant.During an average follow-up of (15.9 ± 8.2) months (range:2.7 to 35.5 months),one recipient got donor-derived rhabdoid tumor 4 months posttransplant,underwent comprehensive treatments,including allograft nephrectomy,radiotherapy,chemotherpy and returned to hemodialysis,while the 62 cases got no donor-derived tumors.Conclusion Tumor transmission of renal allograft from donors with primary CNS tumors is inevitable but with low risk,which means this kind of donors can be used with careful assessment,full informed consent and good balance between wait-list death and tumor transmission.

Objective To investigate the feasibility and safety of the single kidney transplantation from pediatric donors to adult recipients.Methods From May 2013 to January 2017,a total of 50 single kidney transplants from pediatric donation after citizen death (DCD) donors of age between 3 to 12 years to adult recipients were performed and the data were summarized.Results The average age of donors was 6.4 ± 2.5 years with an average donor weight of 19.1 ± 5.9 kg,and the average kidney length was 6.3 ± 0.6 cm.For the 50 adult recipients,the average age was 38.5 ± 12.1 years,the average body weight was 56.1 ± 13.1 kg,and the number of female patients was 26 (52％).All except 3 of these patients were transplanted for the first time.Delayed graft function (DGF) was observed in 15 patients (30％).The average value of eGFR among all the patients was rapidly increased in the first 3 months after transplantation and then steadily increased to (82.3 ± 13.4) mL· min-1·1.73 m-2 at 1 st year,followed by (83.8 ± 22.5) mL· min-1·1.73 m-2 at 2nd year.Four renal grafts developed acute rejection (8％),and 3 of them were successfully reversed by the treatment.Pulmonary infection occurred in 4 recipients,and 2 died.During a follow-up period of 19 months,uncensored grafts survival was 94％,and patients survival was 96％.Conclusion Excellent intermediate-term transplant outcome can be achieved by using single kidneys from pediatric donors elder than 3 years,which may shorten the waiting time in adult recipients and alleviate the contradictions in the absence of suitable pediatric recipients.

Objective By using optical coherence tomography (OCT) to evaluate the vascular neointimal hyperplasia and the stent strut coverage degree in patients with acute myocardial infarction (AMI) and in patients with stable angina (SA) one year after receiving drug-eluting stent (DES) implantation, and to compare the clinical results between the two groups. Methods A total of 39 patients, who received DES implantation due to coronary heart disease, including AMI (n=16, AMI group) and SA (n=23, SA group), during the period from March 2011 to July 2012, were enrolled in this study. One year after DES implantation, coronary angiography and OCT reexaminations were performed in all patients. The neointimal hyperplasia (NIH) thickness, NIH area, NIH volume, strut coverage and apposition rate were determined with OCT. The results were compared between the two groups. Results OCT measuring results showed that the mean NIH thickness of AMI group and SA group was ( 66 . 8 ± 20 . 7 ) mm and ( 121 . 6 ± 135 . 7 ) mm respectively (P=0.022); the NIH volume ratio were 5.66%±3.18% and 11.88%±8.22% respectively (P=0.005); the percentage of cross-section with NIH thickness over 100 μm was 22.56%±23.99% and 40.14%± 30.01% respectively (P=0.034); and the percentage of overall stent strut coverage was 89.27%±6.40% and 93.42%±7.03% respectively (P=0.007). All the above mentioned data of AMI group were obviously lower than those of SA group. Conclusion After DES implantation, the intimal repair, intimal hyperplasia and stent strut coverage in AMI patients are poorer.

Objective To investigate the possible inhibition effect of a domestic novel drug-eluting balloon(DEB), such as controlling the vascular stenosis and reducing the intimal hyperplasia, on obstructive peripheral arterial disease (PAD) of lower extremity. Methods Male New Zealand rabbits (weighted 2.5-3.0 kg) were used for this study. Mustang bare metal stents (BMS) were separately implanted at both the proximal and distal site of abdominal aorta to establish the PAD models in rabbits. Bare balloon (PTA group) or drug-eluting balloon (DEB group) was separately used to dilate the stent segment of the aorta. The animals were sacrificed 28 days after the treatment. The aorta stent specimens were collected and sent for pathologic examination. Using Masson staining method the degree of intimal hyperplasia was estimated and the expression level of paclitaxel-targeted β-tubulin was determined with immunohistochemical method. The results were compared between the two groups. Results Morphologically, both the degree of intimal hyperplasia and the vascular stenosis rate in DEB group were significantly lower than those in PTA group. Meanwhile, immunohistochemical examination of paclitaxel-targeted β-tubulin indicated that its expression level in DEB group was obviously higher than that in PTA group. Conclusion This experimental study indicates that the domestic novel DEB has potential inhibition effect in respect of controlling the loss of lumen as well as reducing the intimal hyperplasia. This novel DEB carries excellent property, suggesting the possibility to use DEB in clinical treatment of PAD.