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 observe the clinical effect of internal administration of Traditional Chinese Medicine (TCM) and external application of hot election bag combined with acupuncture on urinary retention after stroke with kidney qi deficiency type.Methods:A total of 106 patients admitted to Chengde Hospital of Traditional Chinese Medicine from January 2017 to December 2020 who met the inclusion criteria were randomly divided into 2 groups according to the random number table method, with 53 in each group. The control group was treated with conventional western medicine therapy and bladder function training, while the observation group was treated with TCM, acupuncture and external application on the basis of the control group. Both groups were treated for 28 days. Before and after treatment, TCM syndrome scores were performed, and the maximum urinary capacity and residual urine volume were recorded by abdominal B-ultrasound to evaluate the bladder function of the patients. The improvement time of urinary pain, first urination time, catheter indwelling time, length of hospital stay and adverse reactions during treatment were observed and recorded, and the clinical efficacy was evaluated.Results:The total effective rate was 96.2% (51/53) in the observation group and 84.9% (45/53) in the control group, and the difference between the two groups was statistically significant ( χ2=3.98, P=0.046). The residual urine volume of the observation group after treatment [(54.23±6.23) ml vs. (91.24±11.25) ml, t=20.95] was significantly lower than that of the control group ( P<0.01), and the maximum urinary bladder volume [(366.23±30.23) ml vs. (259.63±26.23) ml, t=19.39] was significantly higher than that of the control group ( P<0.01). After treatment, the TCM syndrome score of the observation group was significantly lower than that of the control group ( t=13.25, P<0.01), and the bladder function score of the observation group was significantly lower than that of the control group ( t=13.53, P<0.01). The improvement time of urinary pain, first urination time, catheter indwelling time and hospital stay in the observation group were significantly lower than those in the control group ( t=5.73, 17.91, 6.76, 9.67, all Ps <0.01). No adverse reactions occurred in the two groups during treatment. Conclusion:The combination of TCM, hot compress therapy and acupuncture plus routine therapy can treat the patients with urinary retention after stroke and kidney qi deficiency type with good bladder function, improved symptoms and fast recovery and safety.

Objective:To explore the efficacy of Matas test combined with endovascular intervention on patients with traumatic internal carotid-cavernous fistula.Methods:A retrospective case study was performed on 144 patients with traumatic internal carotid-cavernous fistula treated in our department from August 2012 to June 2018. The clinical symptoms, intraocular pressure and visual acuity data before and after surgery were counted, and the paired t test was used for statistical analysis. Logistic regression was performed to analyze factors affecting recurrence.Results:The main symptoms of traumatic internal carotid-cavernous fistula were proptosis, bulbar conjunctival hyperemia and cranial sound. Postoperative intraocular pressure was significantly lower than preoperative intraocular pressure [(11.13±2.97) mmHg vs. (22.37±6.64) mmHg] and postoperative visual acuity was significantly higher than preoperative visual acuity [(0.69±0.36) vs. (0.47±0.25)] and (both P<0.05). Postoperative intraocular pressure was an independent risk factor for recurrence within 3 months ( OR=0.357, 95% CI: 0.135-0.944, P=0.037), and the recurrence rate was 10.42%. Conclusions:Matas test combined with endovascular intervention in the treatment of traumatic internal carotid-cavernous fistula can effectively reduce intraocular pressure, improve visual acuity, and has a definite curative effect. It is one of the effective treatment methods for traumatic internal carotid-cavernous fistula.

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: To evaluate the impacts of an on-pump beating-heart versus an off-pump coronary artery bypass grafting (CABG) technique for surgical revascularization on the early clinical outcomes in patients with a left ventricular ejection fraction (EF) of 35% or less. Methods: A total of 216 consecutive patients with an echocardiographic estimated EF of 35% or less who underwent non-emergency, primary, isolated CABG from January 2010 to December 2014 at Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University were included in this study and were divided into either an OBCAB group (patients who received on-pump beating-heart CABG surgery, n=88) or an OPCAB group (patients who received off-pump CABG surgery, n=128). The early clinical outcomes were investigated and compared. The outcomes were compared between groups by t-test, χ² test or Fisher′s exact test, when appropriate. Results: No significant differences emerged between the two groups in baseline characteristics of the entire cohort except for more patients with diabetes and a larger left ventricular endo-diastolic diameter in the OBCAB group. Patients in the OBCAB group compared to the OPCAB group had a similar in-hospital mortality (3.4% vs. 4.7%, P= 0.741). Mean EF, as measured preoperatively and early postoperatively (before discharge), significantly improved from (31.0±2.8)% to (35.6±2.9)% (t=10.61, P=0.000) in the OBCAB group and from (31.0±2.9)% to (34.8±3.3)% (t=9.68, P=0.000) in the OPCAB group, respectively. The improvement of mean LVEF in the OBCAB group was significantly higher than that in the OPCAB group ((4.7±0.2)% vs. (3.6±0.3)%, t=29.53, P=0.000). Patients in the OBCAB group compared to the OPCAB group had a significant higher early postoperative EF ((35.6±2.9)% vs.(34.8±3.3)%, t=1.892, P=0.034) but shared a similar baseline EF ((31.0±2.8)% vs. (31.0±2.9)%, t=0.012, P=0.930). Patients in the OBCAB group compared to the OPCAB group received a greater number of grafts and an increased amount of drainage during the first 24 h (3.7±0.8 vs. 2.8±0.6, t=9.442, P=0.000; (715±187) ml vs. (520±148) ml, t=8.544, P=0.000, respectively), without evidence of worse in-hospital mortality or major postoperative morbidity. Conclusion The on-pump beating-heart technique may be an acceptable alternative to the off-pump technique for surgical revascularization in patients with an estimated EF of 35% or less.

Objective To explore the association between BMI and the risk of developing cardiac surgery associated acute kidney injury (CS-AKI),mortality of AKI and AKI requiring renal replacement therapy (AKI-RRT) after cardiac surgery.Methods Clinical data of patients undergoing cardiac surgery from January 2011 to December 2015 in Zhongshan Hospital of Fudan University were prospectively collected.Patients were divided into four groups according to BMI classification of Chinese population.Adjustment for selection bias was further assessed using propensity score method (PSM) to evaluate the role of BMI in the development of AKI.Results A total of 8442 patients were enrolled,among which 1092 patients successfully matched through PSM.The AKI incidences were respectively 30.3％,33.3％,38.6％ and 46.8％ in four BMI groups (P ＜ 0.01) before PSM.The AKI incidences were respectively 31.9％,35.2％,42.5％ and 42.9％ in four BMI groups (P=0.016) after PSM.The risk of developing AKI increased by 19.9％ as the BMI increased per 5 kg/m2 (95％ CI:1.070-1.344,P=0.002).The hospital mortality of patient (overall,AKI,AKI-RRT) in four groups was not statistically different after PSM (P ＞ 0.05),but overweight group always had the lowest mortality.Conclusions BMI is a risk factor for AKI after cardiac surgery,and the AKI incidence increases with increasing BMI in a certain range.

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.