1.One-year outcomes of a novel domestic transcatheter aortic valve system in severe aortic stenosis: a multicenter cohort study
Yuehuan LI ; Jiawei ZHOU ; Lai WEI ; Yingqiang GUO ; Liang MA ; Huiming GUO ; Xiangbin PAN ; Dongjin WANG ; Fanyan LUO ; Jue WANG ; Minxin WEI ; Deguang FENG ; Yingbin XIAO ; Liming LIU ; Jian′an WANG ; Jiangang WANG ; Haibo ZHANG
Chinese Journal of Surgery 2025;63(11):1052-1058
Objective:To examine the safety and effectiveness of a novel domestic transcatheter aortic valve system in addressing severe aortic valve stenosis.Methods:This prospective, multicenter, single-arm target-value clinical trial enrolled patients with severe aortic stenosis meeting inclusion criteria from 13 Chinese centers between July 2021 and April 2022. The primary endpoint was all-cause mortality at 1-year post-procedure. Secondary endpoints included safety outcomes (30-day all-cause mortality, 1-year major adverse cardiovascular events, device success) and efficacy parameters (transvalvular pressure gradient, paravalvular leak severity, New York Heart Association(NYHA)class improvement, and quality of life). Survival analysis was performed using the Kaplan-Meier analysis.Results:The study included 134 patients, 85 males and 49 females, with an age of (73.6±5.6)years (range: 65.1 to 91.8 years). Bicuspid aortic valve morphology was present in 59.7% (80/134). Device success rate was 99.3%, with one case converted to open surgery due to coronary obstruction. All-cause mortality was 0.8% (95% CI: 0.1% to 5.3%) at both 30-day and 1-year follow-up, significantly lower than the 25% target value ( P<0.01). Permanent pacemaker implantation rates remained 2.2% (3/134) at both timepoints. Stroke incidence was 0.7% (1/134) at 30 days and 1.5% (2/134) at 1 year. Myocardial infarction rates were 0.7% (1/134) at both intervals. The postoperative transvalvular pressure gradient of the aortic valve was (6.6±3.1) mmHg(1 mmHg=0.133 kPa) (range: 4 to 8 mmHg). Among the patients, 32 cases (23.9%) had mild paravalvular leakage, 4 cases (3.0%) had moderate paravalvular leakage, and no severe paravalvular leakage was observed. NYHA class Ⅰ and Ⅱ patients increased from 18.7% preoperatively to 99.3% postoperatively. Conclusion:The novel domestic transcatheter aortic valve system demonstrates satisfactory 1-year safety and efficacy outcomes in treating severe aortic stenosis.
2.Castor stent implantation combined with subclavian artery bypass grafting for the treatment of aortic arch lesions
Shuchun LI ; Min JIN ; Qing ZHOU ; Dongjin WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(12):1733-1737
Objective To explore the short- and mid-term efficacy of Castor single branch aortic stent combined with subclavian artery bypass grafting for the aortic arch lesions. Methods A retrospective analysis of the clinical data of patients with proximal anchor zone insufficiency aortic arch lesions treated with Castor stent combined with subclavian artery bypass grafting at the Department of Cardiac Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from August 2020 to November 2023 was performed. Results A total of 22 patients were included, including 19 males and 3 females, with an average age of (56±16) years. There were 18 patients of aortic dissection and 4 patients of aortic arch tumors. The success rate of surgical technique was 100.0%, and the average postoperative hospital stay for patients was (10±4) days. The median follow-up time was 20 months. During the follow-up period, there were no major complications such as endoleak, paraplegia, cerebral infarction, and renal insufficiency, and all patients had no readmissions. Conclusion For proximal anchor zone insufficiency aortic arch lesions, the treatment method of using a Castor stent branch placed in the left common carotid artery can effectively extend the anchor zone, avoid the huge trauma of open chest surgery, and achieve a good short- and mid-term efficacy.
3.One-year outcomes of a novel domestic transcatheter aortic valve system in severe aortic stenosis: a multicenter cohort study
Yuehuan LI ; Jiawei ZHOU ; Lai WEI ; Yingqiang GUO ; Liang MA ; Huiming GUO ; Xiangbin PAN ; Dongjin WANG ; Fanyan LUO ; Jue WANG ; Minxin WEI ; Deguang FENG ; Yingbin XIAO ; Liming LIU ; Jian′an WANG ; Jiangang WANG ; Haibo ZHANG
Chinese Journal of Surgery 2025;63(11):1052-1058
Objective:To examine the safety and effectiveness of a novel domestic transcatheter aortic valve system in addressing severe aortic valve stenosis.Methods:This prospective, multicenter, single-arm target-value clinical trial enrolled patients with severe aortic stenosis meeting inclusion criteria from 13 Chinese centers between July 2021 and April 2022. The primary endpoint was all-cause mortality at 1-year post-procedure. Secondary endpoints included safety outcomes (30-day all-cause mortality, 1-year major adverse cardiovascular events, device success) and efficacy parameters (transvalvular pressure gradient, paravalvular leak severity, New York Heart Association(NYHA)class improvement, and quality of life). Survival analysis was performed using the Kaplan-Meier analysis.Results:The study included 134 patients, 85 males and 49 females, with an age of (73.6±5.6)years (range: 65.1 to 91.8 years). Bicuspid aortic valve morphology was present in 59.7% (80/134). Device success rate was 99.3%, with one case converted to open surgery due to coronary obstruction. All-cause mortality was 0.8% (95% CI: 0.1% to 5.3%) at both 30-day and 1-year follow-up, significantly lower than the 25% target value ( P<0.01). Permanent pacemaker implantation rates remained 2.2% (3/134) at both timepoints. Stroke incidence was 0.7% (1/134) at 30 days and 1.5% (2/134) at 1 year. Myocardial infarction rates were 0.7% (1/134) at both intervals. The postoperative transvalvular pressure gradient of the aortic valve was (6.6±3.1) mmHg(1 mmHg=0.133 kPa) (range: 4 to 8 mmHg). Among the patients, 32 cases (23.9%) had mild paravalvular leakage, 4 cases (3.0%) had moderate paravalvular leakage, and no severe paravalvular leakage was observed. NYHA class Ⅰ and Ⅱ patients increased from 18.7% preoperatively to 99.3% postoperatively. Conclusion:The novel domestic transcatheter aortic valve system demonstrates satisfactory 1-year safety and efficacy outcomes in treating severe aortic stenosis.
4.Current state and progress of left subclavian artery revascularization in thoracic endovascular aortic repair
Wei XIE ; Xichun QIN ; Shuchun LI ; Min JIN ; Qing ZHOU ; Dongjin WANG ; Yunxing XUE
International Journal of Surgery 2022;49(7):499-504
Thoracic endovascular aortic repair has served as the predominant treatment approach for patients with thoracic aortic diseases. In order to ensure the successful release of the stent as well as a good proximal anchoring effect, it is necessary to preserve or reconstruct the left subclavian supply as much as possible. With the advance of various endovascular assistive technologies, different left subclavian artery revascularization techniques have gained widespread acceptance. So far, techniques include carotid-subclavian bypass or transposition, chimney grafts, fenestrations, branched aortic devices can reconstruct the left subclavian artery and other branch vessels on the arch. This article reviewed the present situation of left subclavian artery reconstruction and the selection of surgical methods of thoracic endovascular aortic repair.
5.Two staged hybrid abdominal aortic debranch procedure for thoracoabdominal aneurysm
Wei XIE ; Yunxing XUE ; Shuchun LI ; Min JIN ; Qing ZHOU ; Dongjin WANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2021;37(6):354-357
Objective:To investigate the short-term effects of staged hybrid abdominal aortic debranching technique in the treatment of thoracoabdominal aorta.Methods:From January 2018 to December 2018, 22 patients with thoracoabdominal aortic aneurysms underwent surgical treatment in Nanjing Drum Tower Hospital. Among them, 12 underwent staged hybrid abdominal aortic debranching (AAD), and 10 underwent traditional thoracoabdominal aortic replacement (TAR). AAD consisted of two phases: the first phase of surgery was mid-opening, Y-type artificial blood vessels replaced the lower abdominal aorta and bilateral common iliac arteries, and the abdominal aortic branches were reconstructed at the same time: right branch artificial blood vessels-right renal artery-left renal artery, the left branch artificial blood vessel-superior mesenteric artery-common hepatic artery; the second phase was endovascular repair anchoring normal and long-term normal aorta or artificial blood vessel. The clinical effected of two methods for the treatment of thoracoabdominal aortic aneurysms were compared and analyzed.Results:The overall mortality rate was 13.6%, and the mortality rate in the TAR group increased significantly (0 vs. 30%). The main cause was dissection (91.7% vs. 90.0%, P=0.895). Crawford classification was predominantly type Ⅱ in both groups(58.3% vs. 50.0%, P=0.082). The proportion of patients with Marfan syndrome in the TAR group was higher (30% vs. 0, P=0.046). The TAR group was significantly more drained 24 h after surgery [(355.0±199.2)ml vs. (1244.0±716.1)ml, P= 0.003]. The TAR group had a higher proportion of lung infections (40% vs. 0, P= 0.018). The average cost was higher in the AAD group [(28.4±8.3) ten thousands yuan vs. (19.3±10.4) ten thousands yuan, P= 0.033]. Conclusion:The staged hybrid abdominal aortic debranching technique can effectively treat thoracoabdominal aortic aneurysms. Compared with traditional thoracoabdominal aortic replacement, the surgical trauma is smaller but more expensive.
6.Double-jacket-wrapping root reconstruction method for proximal repair in acute type A aortic dissection
Yunxing XUE ; Qing ZHOU ; Jun PAN ; Hailong CAO ; Fudong FAN ; Dongjin WANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2021;37(4):212-215
Objective:To introduce a new method of root reconstruction for proximal repair of acute type A aortic dissection, and to retrospectively analyze its short-term efficacy.Methods:From January 2018 to October 2019, a total of 455 patients with acute Stanford type A aortic dissection received surgical treatment. Among them, 343 patients underwent double-jacket-wrapping(DJW) root reinforcement(11 patients underwent leaflet suspension), 81 patients underwent Bentall surgery, 15 Wheat operations, 12 untreated roots, and 4 David operations. Compared 343 patients who underwent double-jacket-wrapping root reconstruction and 81 patients who underwent Bentall surgery. The perioperative indicators and short-term survival of the two groups were compared.Results:No patients died intraoperatively. The 30-day mortality rate in the DJW group and the Bentall group were 10.5% and 7.4%, respectively( P=0.403); cardiopulmonary bypass time were(218.8±68.4) min and(240.2 ± 59.8), P=0.011; aortic clamp time were(150.6 ± 47.9) min and(181.3 ±45.6)min, P=0.000. There was no difference between the operation time and the deep hypothermia circulatory time between the two groups. The mean follow-up was(11.7±6.4) months. Seven and two follow-up deaths occurred in the DJW group and the Bentall group, respectively, and the cause of death was not related to the aortic root. The degree of aortic regurgitation after DJW was 0.7±0.5, which was significantly lower than that before surgery( P=0.000). Conclusion:Compared with Bentall surgery, DJW method is a safe and effective method for the repair of acute type A aortic dissection roots, which can obtain good perioperative and early curative effects.
7.Application of American milestone concept on standardized training for specialists in China: a case study of cardiothoracic surgery
Wenjie JI ; Fudong FAN ; Qing ZHOU ; Dongjin WANG
Chinese Journal of Medical Education Research 2020;19(1):22-26
This paper analyzed the current status of standardized training for specialists in China using American "milestone concept" and its competency training and assessment system for specialists as references. To achieve the goal of training high-standard and homogeneous cardiothoracic surgeons, a "milestone plan" focusing on the cultivation of diagnosis and treatment capacity of specialists, their mastery ability of medical knowledge, communication ability, professional ability, system-based clinical practice ability, practice-based learning ability and the ability of pursuing improvement was explored. In addition, daily assessment and summary assessment were carried out by means of self-evaluation, superior evaluation and peer evaluation. At the end, training of six core competencies and multi-dimensional evaluation system for cardiothoracic surgeons were constructed, which provided significant references to the construction of training and assessment system for specialists in China.
8.Surgical repair for ventricular septal defect induced by acute myocardial infarction
Yunxing XUE ; Qing ZHOU ; Haoshun ZHUANG ; Xiyu ZHU ; Dongjin WANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2020;36(4):218-221
Objective:To assess the association of time interval with surgical repair effects for patients with ventricular septal defect(VSD) following acute myocardial infarction(AMI).Methods:From January 2010 to December 2017, 14 patients with VSD induced by AMI have received surgical therapy in our department. The age of the entire group was (65.5±3.3) years with male percentage of 78.6%(11/14). VSDs were anterior apical in 10(71.4%) and posterior inferior in 4(28.6%) patients. Average size of VSD was(15.8±5.8)mm. We retrospectively reviewed the patients' clinical manifestations, surgical methods and outcomes. According to the time interval from AMI onset and operation, patients were divided into two groups, Group 1(9 cases) as more than one week and Group 2(5 cases) as less than one week. Comparing study was done and differences were analyzed.Results:All patients underwent concomitant coronary artery bypass graft surgery. The cardiopulmonary bypass time and aortic clamp time was(203.9±52.3)min and(152.4±44.8)min. The mortality rate was 14.3%(2/14), higher in Group 2 but no significant differences(20.0% vs 11.1%, P=1.000). Mechanical support(IABP and ECMO) were more common in Group 2, both in preoperative(IABP 80.0% vs 22.2%, P=0.091; ECMO 20.0% vs. 0, P=0.357) and intraoperative period(IABP 60.0% vs. 0, P=0.027; ECMO 40.0% vs. 0, P=0.110). Compared with Group 1, Group 2 revealed worse left ventricular function(LVEF 0.304±0.023 vs. 0.408±0.103, P=0.035), higher rate of urgent procedure(100% vs. 11.1%, P=0.003). No resistant shunt and death was found during follow-up. Conclusion:Surgery is an effective way to treat AMI with VSD. When the time from onset to surgery exceeds one week, the patient's hemodynamic condition is more stable and the operation is safer. Patients undergoing surgery within one week show more unstable hemodynamic status, and mechanical assistance supports can correct the hemodynamic status and improve perioperative success rate.
9.Surgical treatment strategy of acute Stanford A aortic dissection with coronary malperfusion
Zirun LU ; Fudong FAN ; Yunxing XUE ; Qiang WANG ; Qing ZHOU ; Dongjin WANG ; Jun PAN
Chinese Journal of Thoracic and Cardiovascular Surgery 2018;34(9):527-530
Objective To summarize the surgical treatment strategy of acute Stanford A aortic dissection with coronary malperfusion.Methods From January 2010 to November 2015,307 patients of acute Stanford A aortic dissection underwent operation were included.The mean age was (51.3 ± 13.0) years,ranged from 22 to 83.The BMI was (25.4 ± 3.7) kg/m2 and 239 (77.9%) were men.There were 210 (71.2%) with hypertension,9 (2.9%) with Marian syndrome,and 44 (14.3%) with cardiac tamponade.Coronary malperfusion was confirmed in 43(14.0%) patients with 34 in right coronary artery,5 in left coronary artery,and 4 in both.There were 26 type A,8 type B,9 type C in Neri system.We performed coronary ostia repair in 12 patients,Bentall in 16,coronary artery bypass grafting(CABG) in 9,and Bentall plus CABG in 6.CABG was also performed in 1 Bentall,1 aortic valve repair,and 5 ascending aorta replacement in 264 patients without coronary malperfusion.Results The rate of CABG,cardiopulmonary bypass(CPB) time,aorta cross-clamp time were significantly higher in patients with coronary malperfusion(P <0.01).The in-hospital mortality was 32.6% in patients with coronary malperfusion and 14.4% in patients without coronary malperfusion.Thus,coronary malperfusion significantly increased in-hospital mortality(P <0.01).The mean follow-up time was(19.2 ± 18.0) months with a 95% follow-up rate.The total follow-up survival rate is 97.5% and the rate of patients with coronary malperfusion is 100%.Multivariate logistic regression analysis shows that cardiac tamponade(OR =4.8,P <0.01) and CPB time(OR =1.0,P <0.01) was the independent risk factor of post-operation inhospital mortality of acute Stanford A aortic dissection.Conclusion Acute Stanford A aortic dissection with coronary malperfusion has a significantly high in-hospital mortality with the indeed need of revascularization of coronary arteries rapidly.The treatment strategy depends on the specific clinical condition.

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