Objective    To explore the treatment outcome of carotid endarterectomy combined with vertebral artery transposition in patients with severe stenosis to occlusion of the vertebral artery V1 segment and the ipsilateral carotid artery. Methods    From June 2017 to September 2020, patients with severe stenosis to occlusion of the vertebral artery V1 segment and the ipsilateral carotid artery treated with carotid endarterectomy combined with vertebral artery transposition in Fuwai Hospital were retrospectively analyzed. Results    Finally 12 patients were enrolled, including 10 males and 2 females with an average age of 67.8±6.0 years. Twelve patients were successfully operated and the follow-up time was 1-3 years. The stenosis degree of the V1 segment of the vertebral artery decreased from 83.5%±11.8% to 24.9%±14.3% (P<0.001). The stenosis degree of carotid artery decreased from 85.6%±11.0% to 0% (P<0.001). Postoperative follow-up showed that the symptoms of symptomatic patients before surgery improved. The 1-year and 3-year patency rates were 100.0%, and there were no peripheral nerve injury complications, perioperative deaths or strokes. Conclusion    Carotid endarterectomy combined with vertebral artery transposition can treat ipsilateral carotid artery  stenosis and vertebral artery stenosis at the same time, improve blood supply to the brain, improve patients' symptoms and has high promotion value.

Objective    To investigate the treatment of modified vertebral-carotid transposition (VCT) in patients with severe stenosis or occlusion at V1 segment of vertebral artery. Methods    A retrospective study of 13 patients with severe stenosis or occlusion at V1 segment of vertebral artery treated by modified VCT in our hospital from October 2016 to December 2018 was done. There were 10 males and 3 females with an average age of 70.5±7.1 years. Results    The operation was successful in this series of patients. The follow-up duration was 1-3 years. The stenosis degree of the V1 segment of the vertebral artery decreased from 86.8%±7.5% to 17.4%±14.5%. All patients achieved remission of symptoms after the surgery. Temporary peripheral nerve injury occurred in 6 patients. Four patients with neurological complications relieved during follow-up. The patency rate was 100.0% at postoperative 1 and 3 years. There was no perioperative death, stroke or re-intervention. Conclusion    Modified VCT can precisely restore the distal blood flow of patients with severe stenosis or occlusion at V1 segment of vertebral artery, and relieve their symptoms.

Early phase trials refer to the early exploratory stage of transferring drug development into clinical trials. With China's strong encouragement for innovative drug research and development and enterprises vigorous investment, a large number of innovative drugs have entered early clinical trials. Early phase trials are generally based on innovative diagnosis and treatment mechanisms, pharmaceutical technology and drug delivery methods. Their research design are complex and diverse, and the new technology such as computer simulation are also widely used in the early phase trial process. These aspects are major challenges for the scientific and ethical review of early phase trials. Based on the characteristics of early phase trials, this article analyzes the ethical issues in early clinical trials such as risk uncertainty, therapeutic misunderstanding, subject compensation, breakthrough treatment, etc., and puts forward ethical countermeasures and suggestions.

Objective    To investigate the efficacy of subclavian-carotid transposition (SCT) in treating patients with proximal subclavian artery occlusive diseases who were unable to be intervened, such as failure of intervention, congenital malformation and unwillingness to intervention. Methods    A retrospective review of 19 patients with proximal subclavian artery occlusion who underwent SCT from May 2016 to December 2018 was done. There were 14 males and 5 females with an average age of 54.05±17.34 years. The advantages and disadvantages of SCT in the treatment of proximal subclavian artery occlusion were analyzed. Results    All patients achieved immediate remission of symptoms after surgery. The stenosis degree of the proximal subclavian artery decreased from 100.0%±0.0% to 12.7%±10.1% after surgery. The average blood pressure difference between the unaffected side and the affected side decreased from 11.95±10.60 mm Hg to 0.89±5.75 mm Hg (P<0.01). Peripheral nerve injury occurred in 7 (36.8%) patients. The in-patient cost of subclavian artery occlusion patients who received subclavian artery interventional therapy in our hospital during the corresponding period was 3 392.12 yuan higher than that of the SCT group in average (if eliminating the patients whose cost was far from the average value, the cost of interventional therapy was 4 812.01 yuan higher than that of the SCT group in average). During 1-3 years' follow-up, 6 patients with neurological complication relieved. One- and three-year patency rates were 100.0%. No perioperative stroke, death or re-operation happened. Conclusion    SCT is an ideal process for the patients with subclavian artery occlusion who cannot accept subclavian artery interventional therapy.

The general characteristics, outcomes and risk factors of the patients with aortic dissection (AD) were evaluated in a single medical center. From January 2002 to December 2008, 284 patients with AD were treated and followed-up at our institution, including 105 cases of type A AD and 179 cases of type B AD. The patients in each type were divided into three groups according to management: medical treatment group (A or B), open surgery group (A or B), and stent-graft group (A or B). The characteristics and follow-up outcomes were compared between the groups or subgroups. The results showed that there was significant difference in the prognosis for type A AD between medical treatment group and open surgery group, but there was no significant difference in the prognosis for type B AD between medical treatment group and stent-graft group. Independent risk factors of follow-up mortality for patients with type A AD included a history of atherosclerosis (HR, 3.807; 95% confidence interval [CI], 1.489 to 7.611; P=0.003), in-hospital hypotension/shock (HR, 4.687; 95% CI, 1.846 to 11.900; P=0.001), in-hospital myocardial ischemia or infarction (HR, 3.734; 95% CI, 1.613 to 8.643; P=0.002), pleural effusion (HR, 2.210; 95% CI, 1.080 to 4.521; P=0.030), branch vessel involvement (HR, 2.747; 95% CI, 1.202 to 6.278; P=0.016) and surgical treatment (HR, 0.177; 95% CI, 0.063 to 0.502; P=0.001). And there were insignificant independent predictors for mortality of the patients with type B AD. It was concluded that there were significant differences in characteristics and one year mortality between type A AD and type B AD, but after one year, there was no significant difference in the mortality and complications of them. There were several discordant risk factors of AD, such as female gender, age, thrombus, abrupt onset of pain that were considered as the risk factors in some papers. And there was no definite risk factor of mortality in this study in the patients with type B AD.

Intravenous leiomyomatosis (IVL) is a rare benign neoplasm which originates from the smooth muscle cells and is usually confined to the pelvic venous system. Rarely, intracaval and intracardiac extension has been described. Death can occur as a result of intracardiac involvement. We reported 4 cases of IVL with right heart involvement (intracardiac leiomyomatosis, ICL). Three of them suffered recurrent sudden syncope, and the other one was totally asymptomatic. All of them were successfully treated through one-stage operation under extracorporeal circulation.

The general characteristics,outcomes and risk factors of the patients with aortic dissection (AD) were evaluated in a single medical center.From January 2002 to December 2008,284 patients with AD were treated and followed-up at our institution,including 105 cases of type A AD and 179 cases of type B AD.The patients in each type were divided into three groups according to management:medical treatment group (A or B),open surgery group (A or B),and stent-graft group (A or B).The characteristics and follow-up outcomes were compared between the groups or subgroups.The results showed that there was significant difference in the prognosis for type A AD between medical treatment group and open surgery group,but there was no significant difference in the prognosis for type B AD between medical treatment group and stent-graft group.Independent risk factors of follow-up mortality for patients with type A AD included a history of atherosclerosis (HR,3.807; 95％ confidence interval [CI],1.489 to 7.611; P=0.003),in-hospital hypotension/shock (HR,4.687; 95％ CI,1.846 to 11.900;P=0.001),in-hospital myocardial ischemia or infarction (HR,3.734; 95％ CI,1.613 to 8.643; P=0.002),pleural effusion (HR,2.210; 95％ CI,1.080 to 4.521; P=0.030),branch vessel involvement (HR,2.747;95％ CI,1.202 to 6.278; P=0.016) and surgical treatment (HR,0.177; 95％ CI,0.063 to 0.502; P=0.001).And there were insignificant independent predictors for mortality of the patients with type BAD.It was concluded that there were significant differences in characteristics and one year mortality between type A AD and type B AD,but after one year,there was no significant difference in the mortality and complications of them.There were several discordant risk factors of AD,such as female gender,age,thrombus,abrupt onset of pain that were considered as the risk factors in some papers.And there was no definite risk factor of mortality in this study in the patients with type B AD.

Intravenous leiomyomatosis (IVL) is a rare benign neoplasm which originates from the smooth muscle cells and is usually confined to the pelvic venous system.Rarely,intracaval and intracardiac extension has been described.Death can occur as a result of intracardiac involvement.We reported 4 cases of IVL with right heart inyolvement (intracardiac leiomyomatosis,ICL).Three of them suffered recurrent sudden syncope,and the other one was totally asymptomatic.All of them were successfully treated through one-stage operation under extracorporeal circulation.

To find out which biomaterial had the best biocompatibility, we compared the acute phase reaction of common biomaterials preparing for vascular grafts with the material of polyurethane modified by silk fibroin (SF-PU(1:1)). After transplanted the materials of dacron, polyterafluoroethylene (e-PTFE), polyurethane (PU), SF-PU(1:1) in rat muscle for one week, we studied the influence of different biomaterials on the histocompatibility by using rat acute toxicity test, test of local reaction in muscle, tissue section staining, WBC and PLT count. As a result, dacron had the worst histocompatibility. The other biomaterials had slight local inflammatory reaction. The WBC and PLT was nearly the same with the blank except dacron. e-PTFE, pure PU and SF-PU(1:1) had the better histocompatibility than traditional dacron. Especially SF-PU(1:1) had the best histocompatibility. Because of the better physical properties and histocompatibility of SF-PU( 1:1), the prospect of preparing small-diameter vascular grafts with SF-PU was cheerful.
Acute-Phase Reaction ; Animals ; Biocompatible Materials ; Blood Vessel Prosthesis ; Blood Vessel Prosthesis Implantation ; instrumentation ; Female ; Fibroins ; chemistry ; Implants, Experimental ; Macromolecular Substances ; chemistry ; Male ; Materials Testing ; methods ; Muscle, Skeletal ; physiology ; Polyurethanes ; chemistry ; Prosthesis Design ; Random Allocation ; Rats ; Rats, Sprague-Dawley

In this study, a novel polyurethane membrane, modified by superfine silk-fibroin powder, was prepared for small-diameter vascular grafting. Scanning electron microscopy, transmission electron microscopy, and histological examination were applied to evaluate histocompatibility of this polyurethane membrane. The polyurethane membrane was compared with polytetrafluoroethylene material. A pseudomembrane and gap formed between polytetrafluoroethylene and the surrounding tissues, and no cells infiltrated or grew into the polytetrafluoroethylene material. On the contrary, superfine silk-fibroin powder/polyurethane blend membrane merged tightly with the surrounding tissues without gaps, and cells infiltrated and grew into the material. Moreover, the negative effects of superfine silk-fibroin powder/polyurethane blend membrane on cells were less than those of its polytetrafluoroethylene counterpart. Our findings indicated that the superfine silk-fibroin powder/polyurethane blend membrane has better histocompatibility than polytetrafluoroethylene membrane. It is concluded that the superfine silk-fibroin powder/polyurethane blend membrane is a promising biomaterial for small-diameter prosthesis.