1.Long-term outcomes of intravascular ultrasound-guided drug-eluting stents implantation in patients with acute coronary syndrome: ULTIMATE ACS subgroup
Xiaofei GAO ; Leng HAN ; Xuesong QIAN ; Zhen GE ; Xiangquan KONG ; Shu LU ; Jing KAN ; Guangfeng ZUO ; Junjie ZHANG ; Shaoliang CHEN
Chinese Journal of Cardiology 2024;52(2):137-143
Objective:To explore the long-term effects of intravascular ultrasound (IVUS) guidance on patients with acute coronary syndrome (ACS) undergoing drug-eluting stents (DES) implantation.Methods:Data used in this study derived from ULTIMATE trial, which was a prospective, multicenter, randomized study. A total of 1 448 all-comer patients were enrolled between 2014 August and 2017 May. Primary endpoint of this study was target vessel failure (TVF) at 3 years, including cardiac death, target-vessel-related myocardial infarction, and clinically-driven target vessel revascularization.Results:ACS was present in 1 136 (78.5%) patients, and 3-year clinical follow-up was available in 1 423 patients (98.3%). TVF in the ACS group was 9.6% (109/1 136), which was significantly higher than 4.5% (14/312) in the non-ACS group (log-rank P=0.005). There were 109 TVFs in the ACS patients, with 7.6% (43/569) TVFs in the IVUS group and 11.6% (66/567) TVFs in the angiography group (log-rank P=0.019). Moreover, patients with optimal IVUS guidance were associated with a lower risk of 3-year TVF compared to those with suboptimal IVUS results (5.4% (16/296) vs. 9.9% (27/273),log-rank P=0.041). Conclusions:This ULTIMATE-ACS subgroup analysis showed that ACS patients undergoing DES implantation were associated with a higher risk of 3-year TVF. More importantly, the risk of TVF could be significantly decreased through IVUS guidance in patients with ACS, especially in those who had an IVUS-defined optimal procedure.
2.Thirty-day Outcomes of First-in-man Implantation of a Novel Transcatheter Edge-to-edge Mitral Repair System in Patients With Severe Mitral Regurgitation
Kai XU ; Yan WANG ; Shaoliang CHEN ; Xiangbin PAN ; Ben HE ; Ruiyan ZHANG ; Bin WANG ; Junjie ZHANG ; Zhengbin ZHU ; Bin WANG ; Da ZHU ; Yaling HAN
Cardiology Discovery 2024;04(2):142-147
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.
3.Thirty-day Outcomes of First-in-man Implantation of a Novel Transcatheter Edge-to-edge Mitral Repair System in Patients With Severe Mitral Regurgitation
Kai XU ; Yan WANG ; Shaoliang CHEN ; Xiangbin PAN ; Ben HE ; Ruiyan ZHANG ; Bin WANG ; Junjie ZHANG ; Zhengbin ZHU ; Bin WANG ; Da ZHU ; Yaling HAN
Cardiology Discovery 2024;04(2):142-147
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.
4.Predictive value of XRCC1 Arg399Gln gene polymorphism in the adverse events and prognosis of postoperative SOX chemotherapy for advanced gastric cancer
Linhai ZHENG ; Jun QIAN ; Shaoliang HAN
Chinese Journal of Postgraduates of Medicine 2023;46(10):865-870
Objective:To investigate the predictive value of XRCC1 Arg399Gln gene polymorphism in the adverse events and prognosis of SOX chemotherapy for advanced gastric cancer after D2 resection.Methods:A total of 62 patients with advanced gastric cancer receiving Sox chemotherapy after D2 resection from January 2015 to April 2018 in Quzhou People′s Hospital were included and the baseline characteristics were collected retrospectively. Postoperative pathological specimens were used for genotyping of XRCC1 Arg399Gln gene variation. To analyze the relationship between the polymorphism of XRCC1 Arg399Gln in patients and the clinicopathological features and the occurrence of adverse chemotherapy reactions. Also, to evaluate the disease-free survival (DFS) and overall survival(OS) of patients in the different genotypes. Cox regression analysis was used to screen for prognostic risk factors.Results:The genotype distribution of XRCC1 Arg399Gln locus in 62 patients with gastric cancer was G/G in 35 cases (56.45%), G/A in 21 cases (33.87%) and A/A in 6 cases (9.68%). And the distribution frequencies of the three genotypes were in accordance with the hardy-weinberg equilibrium( P = 0.295). G/A and A/A genotypes were merged in the subsequent analysis. Comparison of baseline characteristics between the G/G genotype and G/A+A/A genotype showed no statistically significant differences (all P>0.05). Different genotypes had no significant differences in the adverse reactions of Sox chemotherapy after advanced gastric cancer surgery (all P>0.05). The median DFS of the G/G genotype was 45 months (95% CI 41.73 - 48.28), which was higher than G/A+A/A genotype 38 months (95% CI 35.71 - 40.29)( P = 0.047). Univariate Cox regression analysis showed that the polymorphism of XRCC1 Arg399Gln was risk factor for tumor recurrence in patients with advanced gastric cancer who received SOX chemotherapy after surgery ( RR = 2.178, 95% CI 1.078 - 4.402, P = 0.030). Multivariate Cox regression analysis showed that the polymorphism of XRCC1 Arg399Gln was independent risk factor for tumor recurrence in patients with advanced gastric cancer who received SOX chemotherapy after surgery ( RR = 2.581, 95% CI 1.242 - 5.363, P = 0.011). The median OS of G/G genotype and G/A+A/A genotype were 60 months (95% CI 57.81 - 62.19) and 55 months (95% CI 49.62 - 60.38). There was no significant difference in OS between G/G genotype and G/A+A/A genotype ( P = 0.202). Univariate regression analysis showed that the polymorphism of XRCC1 Arg399Gln wasn′t risk factor for death in patients with advanced gastric cancer who received SOX chemotherapy after surgery ( RR = 1.702, 95% CI 0.744 - 3.896, P = 0.208). Conclusions:The XRCC1 Arg399Gln gene polymorphism has no correlation with the adverse reactions of SOX chemotherapy after D 2 resection for advanced gastric cancer. But, the XRCC1 Arg399Gln G/G type is closely associated with the prognosis of patients, it has predictive value for better DFS.
5.Clinical characteristics and surgical treatment of enteric Behcet disease complicated with acute abdomen
Qingmiao ZHOU ; Rongjian WANG ; Jianbo HE ; Yu HE ; Yujun YU ; Chen WANG ; Shaoliang HAN
Chinese Journal of General Surgery 2020;35(6):455-459
Objective:To investigate the clinical characteristics and surgical treatment of enteric Behcet′s disease with acute abdomen.Methods:The clinical data and follow-up results of 9 patients with enteric Behcet′s disease with acute abdomen treated surgically were analyzed retrospectively.Results:All patients in this group had abdominal pain, with bloody stool in one case, failure to exhaust and defecation in 1 case. Physical examination revealed abdominal mass in 2 cases, peritonitis sign in 5 cases and tenderness of the right lower abdomen in 1 case. The causes of operation were pathological perforation of ileocecal region, pathological perforation of small intestine, acute appendicitis, ileum fistula, intestinal stenosis and obstruction and massive hemorrhage of lower digestive tract.In this group, laparotomy or laparoscopy were done in these cases, including ileocecal resection in 2 cases, partial resection of small intestine in 3 cases, laparoscopic appendectomy in 1 case and right colon colectomy in 3 cases. Incision infection occurred in 1 case, anastomotic leakage in 1 case and adhesive intestinal obstruction in 1 case occurred after operation. The median follow-up time of 8 cases was 7.5 years, and Behcet′s disease recurred in 4 cases, but no recurrence of enteric Behcet disease was found.Conclusions:Intestinal perforation, bleeding and obstruction are the main causes of intestinal Behcet′s disease with acute abdomen, and emergency surgery is an important means of treatment, moreover, nutrition support and drug therapy are the important supportive therapy to control this disease.
6.The diagnosis and treatment of primary abdominal cocoon
Xiaojiao RUAN ; Feng ZHOU ; Chen WANG ; Hanzhang HUANG ; Shaoliang HAN
Chinese Journal of General Surgery 2019;34(1):39-41
Objective To investigate the clinical characteristics,diagnosis and treatment of primary abdominal cocoon.Methods The clinical data of 16 cases of primary abdominal cocoon were reviewed and analyzed.Results Only in 2 cases in which correct preoperative diagnosis was estabished by CT scan.The other 14 cases were diagnosed during operation.Parts or all small intestines were covered with a layer of milky white dense fibrous thin membrane,formed mass-likely adhesion,and fibrous film attached to the mesenteric roots.Extensive adhesion existed in between intestines.The operation included lysis of peritoneal adhesion plus fibrous membrane excision in 14 cases,lysis of peritoneal adhesion plus fibrous membrane excision and segmental enterectomy in 2 cases,and in 2 cases appendectomy was done.There was no anastomotic leakage or other major complications except for wound infection in 1 case.All the patients were followed up from 3 months to 7 years with a median follow-up time of 3.6 years,and no recurrent cases were found.Conclusions Surgery is the main method for the treatment of abdominal cocoon with evident clinical symptoms,and the prognosis is largely fair.
7.Clinical diagnosis and treatment of Paget disease of breast
Yu HE ; Yujun YU ; Zengrong JIA ; Chen WANG ; Hanzhang HUANG ; Guoyu HUANG ; Shaoliang HAN
Chinese Journal of Postgraduates of Medicine 2019;42(8):697-700
Objective To investigate early diagnosis and treatment of Paget disease of breast. Methods The clinicopathological data of 26 cases of breast Paget disease in the First Affiliated Hospital of Wenzhou Medical University from January 1995 to June 2018 was analyzed. Results The main clinical manifestation of 26 patients was eczema like papillae in 19 cases (73.1%), and associated with nipple discharge in 9 cases (34.6% ) and breast mass in 6 cases (23.1% ). The diagnosis of this disease was based on curettage cytology in 4 cases (15.4% ), biopsy in 8 cases (30.8% ), and needle aspiration cytology or post resection pathological examination in 14 cases (53.8% ). Paget disease consisted of simple papillary Paget disease in 3 cases (11.5%), ductal carcinoma in 18 cases (69.2%) and invasive ductal carcinoma in 5 cases (19.2%). Pathological TNM staging was 0 stage in 19 cases (73.1%), stageⅠin 3 cases (11.5%), stageⅡin 2 cases (7.7%), stageⅢin 2 cases (7.7%) and no stage inⅣcase. In this group, 2 cases underwent radical mastectomy, 18 cases underwent modified radical mastectomy, 4 cases underwent simple mastectomy, and 2 cases underwent mastectomy combined with low axillary lymph node dissection and intraoperative rapid frozen examination. Fourteen patients received adjuvant chemotherapy with CEF(cyclophosphamide + pharmorubicin + tegafur)/EC (pharmorubicin + cyclophosphamide) + T(docetaxel) or TP(docetaxel + cis- platinum)regiment after operation, 2 cases were treated with trastuzumab targeted therapy and 5 cases with adjuvant radiotherapy. Twenty-five of 26 patients were followed up for 8-108 months except one patient lost in follow-up. The 5-year survival rate was 96.0% (24/25), and the 10-year survival rate was 52.0% (13/25). Conclusions The diagnosis of Paget disease of the breast depends on cytology or pathology, and multidisciplinary treatment based on surgery is judged of by tumor stage and coincident other types of breast cancer and axillary lymph node involvement.
8.Surgical treatment of Crohn disease
Chinese Journal of General Surgery 2019;34(7):565-567
Objective To investigate the surgical indication and surgical procedures for Crohn disease.Methods Clinical data of 47 cases with Crohn disease were retrospectively analyzed.Results The main clinical manifestations were abdominal pain (35 cases),diarrhea (16 cases),emaciation and fatigue(12 cases),abdominal mass (9 cases),intestinal obstruction (31 cases),intestinal adhesion (18 cases),intestinal perforation(8 cases),intestinal bleeding (1 1 cases),internal fistula (4 cases),abdominal abscess (4 cases).Preoperative enteroscopy was performed in 23 cases,and 7 cases were diagnosed as Crohn's disease.Operative procedures included colectomy in 15 cases,small bowel resection and intestinal adhesion lysis in 29 cases,ileostomy in 3 cases.Postoperative complications occurred in 13 cases,including incision dehiscence in 2 cases,intestinal fistula in 5 cases,there were 2 cases of stress ulcer,pulmonary infection in 1 case and short bowel syndrome in 1 case,early postoperative inflammatory bowel obstruction in 2 cases and death in 1 case.44 patients were followed-up,for an average of 6.8 years.Recurrence of Crohn's disease was found in 11 cases and canceration in 3 cases.Conclusions Surgery is still the mainstay for Crohn's disease,and close follow-up is important for disease recurrence and canceration.
9.Clinical features, diagnosis and treatment of abdominal lymphangioma
Feng ZHOU ; Hanzhang HUANG ; Chen WANG ; Xiaojiao RUAN ; Naxin LIU ; Shaoliang HAN
Chinese Journal of General Surgery 2018;33(5):369-371
Objective To investigate the clinicopathological features of abdominal lymphangioma and its diagnosis and treatment.Methods The clinical data of 37 patients with abdominal lymphangioma were analyzed retrospectively.Results The clinical presentations were slight abdominal distention and discomfort in 6 cases (16%),abdominal pain or lumbago in 13 cases (35%),found by health screening in 14 cases (38%) and abdominal mass in 4 cases (11%).Tumor located in retroperitoneal space in 20 cases,small bowel in 7 cases,colon mesentery in 4 cases,small mesentery in 2 cases,duodenum in 2 cases,stomach in one case and pancreas in one case.The surgical procedures were complete resection in 31 cases and incomplete resection in 6 cases.Except 3 cases lost to fol]ow-up,no recurrence was found during the postoperative follow-up period.Conclusions It is difficult to diagnose abdominal lymphangioma before operation,and complete resection of tumor is the first choice.
10.Clinical characteristics and surgical treatment for duodenal stromal tumor
Maosong CHEN ; Shaoliang HAN ; Caiyan PAN ; Kuan HE ; Yaoqing CAI ; Zuolin ZHOU ; Hanzhang HUANG
Chinese Journal of General Surgery 2017;32(7):561-564
Objective To investigate the clinical characteristics,surgical treatment and outcome for patients with duodenal stromal tumor.Methods Data of 40 patients with stromal tumor of duodenum were reviewed retrospectively.Results All patients received resection including local resection in 14 cases,segmental resection of the duodenum in 17 cases,and pancreaticoduodenectomy in 9 cases.38 cases were followed-up,and two were lost.The median follow-up was 59 months (range 3-240 mos).The 1,3,and 5-year overall survival rates were 92%,76% and 68%,respectively.No recurrence was found in very-low-risk tumor (n =1) and low-risk turmors (n =4).The 1,3,and 5-year overall survival rates for intermediate-risk tumors were 95%,80% and 70%,respectively;and those were 69 %,31%,and 0 for high-risk tumors,respectively.14 of 33 cases (42%) suffered from recurrence after radical resection for intermediate or high-risk tumors.33 postoperative cases received treatment with Imatinib (Glivec) for more than one year,and one case developed recurrence at 2.5 years after operation.4 patients with synchronous liver metastasis received palliative resection and Imatinib,and two survived more than 1 year.Conclusion Surgery is the first choice for duodenal stromal tumor,and Imatinib should be administered for high-risk disease after surgery.

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