Objective:To explore the surgical technique and results of three-dimensional aortic valve anatomic repair for bicuspid aortic valve (BAV) with aortic regurgitation (AR).Methods:This is a retrospective case series study. From August 2021 to December 2023, 130 consecutive patients with BAV-AR underwent aortic valve anatomic repair at the Department of Cardiothoracic Surgery, Zhongshan Hospital, Fudan University,and the data were retrospectively analyzed. There were 115 males and 15 females, aged (38.6±11.7) years (range: 15 to 67 years). All patients received modified aortic root reconstruction, to do three-dimensional root remodeling, including the basal ring, sinus of Valsalva and sino-tubular junction simultaneously. Perioperative and follow-up data were collected and analyzed. Comparisons between groups were performed using independent samples t-test, Wilcoxon paired signed-rank test, or χ2 test. Results:No patient transferred to valve replacement during the operation. The cardiopulmonary bypass time ( M(IQR)) was 109(34) minutes (range:67 to 247 minutes), and the aortic cross-clamp time was 76(26) minutes (range: 32 to 158 minutes). Preoperative transesophageal echocardiography showed 123 patients (94.6%) presented with moderate or severe regurgitation. Immediately postoperative transesophageal echocardiography showed no regurgitation in 22 patients (16.9%), trace regurgitation in 81 patients (62.3%) and mild regurgitation in 27 patients (20.8%). Follow up was completed in all patients, with a follow-up of 5.5(9.4) months (range: 0.1 to 27.6 months). No mortality was observed during follow-up. Echocardiography was obtained in 112 patients at the latest follow-up, including no regurgitation in 4 patients (3.6%), trace regurgitation in 58 patients (51.8%), mild regurgitation in 45 patients (40.2%), moderate regurgitation in 4 patients (3.6%), and severe regurgitation in 1 patient (0.9%). Conclusion:For patients with BAV-AR who have good valve quality and no severe aortic sinus dilation, the recent outcomes of three-dimensional anatomical repair technique, focusing on overall remodeling of the aortic root, are satisfactory.

Objective:To explore the surgical technique and results of three-dimensional aortic valve anatomic repair for bicuspid aortic valve (BAV) with aortic regurgitation (AR).Methods:This is a retrospective case series study. From August 2021 to December 2023, 130 consecutive patients with BAV-AR underwent aortic valve anatomic repair at the Department of Cardiothoracic Surgery, Zhongshan Hospital, Fudan University,and the data were retrospectively analyzed. There were 115 males and 15 females, aged (38.6±11.7) years (range: 15 to 67 years). All patients received modified aortic root reconstruction, to do three-dimensional root remodeling, including the basal ring, sinus of Valsalva and sino-tubular junction simultaneously. Perioperative and follow-up data were collected and analyzed. Comparisons between groups were performed using independent samples t-test, Wilcoxon paired signed-rank test, or χ2 test. Results:No patient transferred to valve replacement during the operation. The cardiopulmonary bypass time ( M(IQR)) was 109(34) minutes (range:67 to 247 minutes), and the aortic cross-clamp time was 76(26) minutes (range: 32 to 158 minutes). Preoperative transesophageal echocardiography showed 123 patients (94.6%) presented with moderate or severe regurgitation. Immediately postoperative transesophageal echocardiography showed no regurgitation in 22 patients (16.9%), trace regurgitation in 81 patients (62.3%) and mild regurgitation in 27 patients (20.8%). Follow up was completed in all patients, with a follow-up of 5.5(9.4) months (range: 0.1 to 27.6 months). No mortality was observed during follow-up. Echocardiography was obtained in 112 patients at the latest follow-up, including no regurgitation in 4 patients (3.6%), trace regurgitation in 58 patients (51.8%), mild regurgitation in 45 patients (40.2%), moderate regurgitation in 4 patients (3.6%), and severe regurgitation in 1 patient (0.9%). Conclusion:For patients with BAV-AR who have good valve quality and no severe aortic sinus dilation, the recent outcomes of three-dimensional anatomical repair technique, focusing on overall remodeling of the aortic root, are satisfactory.

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective:To investigate the effectiveness and safety of transcatheter closure of atrial septum defect(ASD) in adults using echocardiography as the only imaging tool.Methods:From April 2017 to August 2019, 118 patients with congenital atrial septum defect were treated by cardiac surgery in Zhongshan Hospital affiliated to Fudan University. There were 31 males and 87 females, aged 15-72 years old[mean(40.3±15.3) years old]. 117 cases of atrial septum defect were secondary foramen and 1 case was residual shunt after repair of atrial septum defect by transthoracic echocardiography. The patients with tricuspid insufficiency and pulmonary hypertension were followed up by transesophageal echocardiography.Results:The transcatheter closure of atrial septum defect(ASD) was successfully performed in 114 patients. 3 patients were successfully treated with right fourth intercostal small incision atrial defect occlusion due to the coaxial problem of occlusive device and atrial defect. One patient underwent repair of atrial septum defect during the correction of right ventricular injury. The selected size of occluder ranged from 12 mm to 38 mm. One case of ethmoidal orifice was successfully blocked with double occlusive device. There was no occlusive device displacement, no obvious residual shunt, peripheral vascular injury and other complications occurred in successful occlusive patients. 110 patients were directly transferred back to the general ward after extubation. The postoperative hospital stay was(2.3±1.1) days and the total hospitalization time was(4.5±1.7) days. There were 7 patients with tricuspid regurgitation above mild to moderate before operation, and 6 patients with tricuspid regurgitation decreased to mild regurgitation after occlusion. One month after operation, the pulmonary artery pressure of 51 patients with moderate and severe pulmonary hypertension decreased from(50.4±11.4)mmHg to(38.9±12.9) mmHg( P<0.05). The occlusive device was well fixed and no residual shunt was found. Conclusion:Transesophageal echocardiography guided transcatheter closure of atrial septum defect is not only safe and effective in adult cardiac surgery, but also can avoid radiation and contrast agent injury.

Objective To summarize the treatment decision-making strategy and its long-term efficacy for advanced elderly patients with severe valvular heart disease and clear indications for surgery.Methods Clinical data of 196 patients aged 75 years and older firmly diagnosed as severe valvular heart diseases were retrospectively analyzed.The patients were divided into the surgical group (a mean age of 77.4±2.0 years,n=126)and the conservative group(a mean age of 80.5±5.0 years,n =70).Factors affecting therapeutic decision-making were analyzed,and the differences in a long-term survival were compared between the two groups.Results The most common reason for choosing conservative treatment was the recommendation of the doctor giving a preliminary diagnosis and worrying about the high-risk surgery for the patients(62.9％,44/70).Only 26(37.1％)patients in the conservative group were evaluated by cardiac surgeons,among whom 12 (17.1％)patients were considered to have surgical contraindications,and 14 (20.0％) patients themselves or their family members chose conservative treatment for the fear of surgical risks.Patients in the operation group were mainly from the outpatient department of cardiac surgery,and only 8 (6.3 ％)cases were referred from department of internal medicine.Logistic regression analysis showed that female,chronic renal insufficiency,advanced age,pneumonia and emergency hospital admissions were independent predictors for the conservative option(P ＜0.01),while patients with isolated aortic valve disease tended to receive surgical treatment.Overall 5-year survival was higher in the surgical group than in the conservative group (76.4％ vs.39.9％,P ＜ 0.01).Cox regression analysis disclosed that the conservative treatment option was the single risk factor for long-term survival in all series.Conclusions Many factors affect the process of therapeutic decision-making for patients with severe valvular heart diseases,and a multidisciplinary collaboration is the best way for the optimal treatment strategy for those patients.

Objective The aim of the study was to compare the early and mid-term outcomes of isolate mitral valve repair through minimal invasive and median sternotomy approach .Methods From July 2009 to December 2015, 329 patients under-went minimal invasive isolated mitral valve repair through right thoracic approach at our institution .The mean age was(48 ±14) years(15-78 years), 202 patients(61.4％) were male and 137 patients(41.6％) were in NYHA class Ⅲ-Ⅳ.570 patients underwent isolate mitral valve repair through median sternotomy in the same period .Propensity score matching identify 248 pa-tient pairs with similar preoperative characteristics .Early and mid-term outcomes were compared between propensity-matched groups.Results After propensity matching, the mean cardiopulmonary bypass time[(91 ±27)min vs.(76 ±27)min, P<0.05] and aorta cross clamp time[(52 ±18)min vs.(43 ±15)min, P<0.05] were significantly longer in minimal invasive group.24 hours drainage volume was significantly less[(353 ±329)ml vs.(446 ±356)ml, P <0.05] and patients need transfusion was significantly fewer(22.2％ vs 31.5％, P<0.05) in minimal invasive group.Incidence of stroke, poor wound healing, renal failure requiring hemodialysis and tracheotomy were similar between the two groups(P>0.05).There were two in-hospital death in minimal invasive group(respiratory failure) and median sternotomy group(low cardiac output syndrome), respectively.Follow-up was 91％ complete and the mean follow-up time was(28 ±21) months(3-89 months).At 7 year after surgery, overall survival were 99％and 100％(P>0.05) in minimal invasive group and median sternotomy group, respective-ly.Freedom from reoperation were 100％ and 95％(P>0.05) and freedom from recurrent mitral regurgitation were 95％ and 90％(P>0.05).Conclusion Minimal invasive mitral valve repair was safe, effective and provide equivalent mid-term out-comes compared to median sternotomy approach .Minimal invasive surgery provided cosmetic benefits , decreased postoperative trauma.As the accumulation of clinical experience, complex repair is feasible through minimal invasive surgery.Adoption of minimal invasive surgery will increase the acceptance of early intervention strategy among asymptomatic MR patients and thus improve late outcomes and life quality .

Objective The aim of the study is to evaluate the early and long-term outcomes of mitral valve repair for degenerative mitral regurgitation.Methods From January 2003 to December 2015,clinical profiles of 1 903 patients with degenerative mitral regurgitation who underwent mitral valve repair at our institution were analyzed retrospectively.There were 1 312 males (68.9 ％) and 591 females (31.1％) the mean age was (54.2 ± 13.1) years.Early and long-term outcomes were summarized and risk factors for adverse events were assessed.Results There were 35 in-hospital deaths(1.8％) and in-hospital mortality for isolated mitral valve repair was 0.9％ (10/1 163).Perioperative complications included central nerve system complications(0.7％),respiratory failure requiring tracheotomy(1.8％),acute renal injury requiring hemodialysis(1.2％) and reoperation for bleeding(0.7 ％).NYHA function class Ⅲ-Ⅳ (OR =3.65),atrial fibrillation (OR =2.85) and ejection fraction ＜0.6(OR =2.34) were identified as independent risk factors for in-hospital mortality.12 years over follow-up,overall survival,freedom from reoperation for mitral valve and freedom from recurrent moderate/severe regurgitation were 85％ 、91％ and 75％,respectively.Age ＞ 60 years(HR =7.43),preoperative stroke(HR =6.51),ejection fraction ＜ 0.6 (HR =3.87),left ventricular end-systolic dimension ＞ 40 mm (HR =3.98) and pulmonary systolic pressure ＞ 50 mmHg (1 mmHg =0.133 kPa) (HR =2.85) were independent predictive factors for late death.Ejection fraction ＜ 0.6 (HR =4.01),left ventricular end-diastolic dimension ＞ 60 mm(HR =1.88),leaflet lesion involving anterior leaflet (HR =2.40) and residue mild regurgitation(HR =4.17) were independent predictors for late recurrent regurgitation.Leaflet lesion involving anterior leaflet(HR =2.40) and residue mild regurgitation (HR =3.35) were independent predictor for late reoperation for mitral valve.Conclusion Mitral valve repair is safe and effective in degenerative mitral regurgitation.Early surgical intervention for asymptomatic patients with preserved left ventricular function before onset of atrial fibrillation and pulmonary artery hypertension is associated with decreased incidence of adverse events and improved long-term outcomes.Early surgical intervention should be restricted in experienced high-volume centers.

Objective This research investigated the coagulation of critically ill patients for predicting the prognosis of 28 day in a university hospital emergency room.Methods A prospective investigation was done in the emergency room of Beijing Chao-Yang Hospital,Capital Medical University from June 2015 to May 2016,and 28-day mortality was recorded.Whole blood cell analysis,blood gas analysis and clotting test were done and repeated after patients in hospital.Results A total of 1 992 patients were enrolled,and divided into two groups:survival (n =1 522) and dead (n =470).No significant difference of age,gender,body mass index and disease composition were found between the two groups (P ＞0.05).APACHE Ⅱ of the survival and dead groups were (12.11 ±4.12) and (21.15 ± 5.55) respectively.D-dimer and platelet account of the dead group were M (Qr) 265 (0,718) μg/L and (208.16±89.87) × 109/L-1 respectively,significant differences were found between the two groups (P ＜ 0.05).Coagulation was found deteriorated progressively in the dead group,whereas improved in the survival group.The risk factors of poor prognosis,which were the increased APACHE Ⅱ and D-dimer,were detected by Logistic analysis and ROC curve,especially the D-dimer.Conclusions Coagulation abnormalities were found in the critically ill patients of emergency room.The increasing of D-dimer is one of the risk factors of poor prognosis.

Objective To evaluate the safety and effectiveness of a newly domestic bovine pericardium using a juvenile sheep model and to provide proof for clinical use.Methods Under the off-pump condition,8 domestic bovine pericardiums were implanted into the pulmonary artery and the descending aorta of 4 juvenile sheep as the trial group.As the control group,four imported bovine pericardiums were implanted into two juvenile sheep.Before the surgery,the juvenile sheep were given a physical examination and some laboratory tests.Ultrasonic cardiographs were taken after 1 month and 2 months of implantation.Sheep were sacrificed after 90 days and compared with the extent of endothelialization,inflammation and calcification of the two groups.Results (1) All the juvenile sheep survived without any complications.(2) Ultrasonic cardiograph showed the absence of leakage,thrombus,calcification,neoplasm or any structural deterioration.(3) Gross examination showed there was no intimal hyperplasia.The thickness and tenacity of all patches had no change compared with the pre-operation condition.All the patches showed smooth and pliable faces without degeneration,as well as absence of macroscopically calcification.(4) There was not any positive result in microbiological tests in both groups.The degree of inflammation,necrosis and calcification had no significant differencs between the two groups.Conclusions The data shows that the domestic bovine pericardium,a newly developed Chinese domestic-design and manufactured bovine pericardium,can exhibit long-term satisfactory safety and efficacy in the implantation of the pulmonary artery and the descending aorta of juvenile sheep.

Objective To evaluate laparoscopic radical cholecystectomy for T2 gallbladder cancers.Methods A retrospective analysis was made on 44 patients with pathology confirmed T2 gallbladder cancer undergoing laparoscopic vs open radical cholecystectomy.The clinicopathological and follow-up data were compared.Results Laparoscopic cholecystectomy was performed in 32 patients,the implantation metastasis rate of this approach has no statistical differences compared with the open cholecystectomy (P =1.000).26 patients underwent laparoscopic radical resection and the remaining 18 patients underwent open radical resection.There was no statistical difference in operation time (P =0.953),blood loss (P =0.193)and postoperative complications (P =1.000),but the laparoscopic radical resection group is superior to the open group on postoperative pain grading (P =0.022),ambulation time (P =0.000),nothing per mouth time (P =0.000) and length of hospital stay (P =0.048).The mean number of lymph nodes retrieved was 5 ±4 (range 1-12) in the laparoscopic radical group and 6 ± 3 (range 1-12) in the open group (P =0.983);the 1,3,5 year survival rates was 92.3％,70.3％,61.5％ and 92.3％,76.3％,69.3％,respectively(P =0.473).Conclusions Initial laparoscopic cholecystectomy does not increase the rate of seeding metastasis in the context of intact gallbladder carcinoma.Totall laparoscopic radical resection is feasible in selected T2 gallbladder cancer patients.