Methods:From February 2018 to January 2022, the clinical data of 1 123 patients who underwent Starclose vascular closure device, Angio-Seal and Exoseal vascular occlusion devices and Perclose ProGlide vascular suture device at femoral artery puncture hemostasis after neuro-intervention, in the Department of Interventional Radiology (Eastern District), The First Affiliated Hospital of Zhengzhou University, were retrospectively analyzed. The patients were divided into three groups based on the intervention method: the closure group (Starclose, n=271), the occlusion group (Angio-Seal, n=327 and Exoseal, n=352) and the suture group (ProGlide, n=173). Next, the hemostatic efficacy and complications associated with the three devices were analyzed and compared. Additionally, regression analysis was conducted to identify any relevant factors that may contribute to complications. Results:Three vascular hemostatic devices demonstrated effective hemostasis and the success rate were 92.6% in the closure group (Starclose), 93.4% in the occlusion group (Angio-Seal 93.0% and Exoseal 93.8%) and 89.6% in the suture group (ProGlide). There was no statistically significant difference( χ2=3.026, P=0.388). Single or multiple complications were observed in 102 patients (9.1%), including local oozing (16 cases in the closure group, 39 cases in the occlusion group, 13 cases in the suture group), local hematoma (14 cases in the closure group, 31 cases in the occlusion group, 11 cases in the suture group), pseudoaneurysm (13 cases in the closure group, 35 cases in the occlusion group, 10 cases in the suture group), local infection (2 cases in the closure group, 3 cases in the occlusion group, 1 case in the suture group). There were no statistically significant differences ( P>0.05). Moreover, serious complications such as femoral artery occlusion, embolus shedding and permanent nerve injury weren′t observed in the three groups. Multivariate logistic regression analysis revealed that overweight ( OR=1.562,95% CI 1.023—2.385, P=0.039), femoral artery with calcified plaque ( OR=1.934,95% CI 1.172-3.189, P=0.010), combined use of multiple antiplatelet drugs ( OR=1.769,95% CI 1.103—2.839, P=0.018), use of an 8F sheath( OR=2.824,95% CI 1.406—5.671, P=0.004) and the operator′s proficiency ( OR=0.508,95% CI 0.328—0.788, P=0.002) were the independent factors influencing complications, of which the first four were identified as risk-promoting factors for complications while the operator′s rich experience and high proficiency were the protective factors. Conclusions:Three hemostatic devices demonstrate effective hemostasis and comparable rates of complications at femoral artery puncture hemostasis after neuro-intervention. Overweight, femoral artery with calcified plaque, combined use of multiple antiplatelet drugs, use of an 8 F sheath and the operator′s proficiency were independent factors influencing complications.Ojective:To investigate the efficacy and complications associated with vascular suture, closure and occlusion devices at femoral artery puncture hemostasis after neuro-intervention.

Objective:To investigate the application value of optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in evaluating flow diverter (FD) apposition and endothelialization in aneurysm animal models, and analyze the effect of incomplete stent apposition (ISA) on aneurysm lumen healing and stent endothelialization.Methods:Lateral common carotid artery aneurysm models in swines were established by surgical method and then FD was implanted. Immediately after surgery, OCT and IVUS were used to evaluate the locations and degrees of ISA, and difference between these 2 methods in evaluating FD apposition was compared. DSA was performed at 12 weeks after surgery to evaluate the aneurysm occlusion (Kamran grading) and stent patency. OCT and IVUS were used again to observe the stent endothelial situation; by comparing with histopathologic results, effect of ISA on aneurysm healing and stent endothelialization was analyzed.Results:Lateral common carotid artery aneurysm models in 6 swines were established, and 6 Tubridge FDs were successfully implanted. Compared with IVUS (3 stents, 4 locus), OCT could detect more ISA (6 stents, 14 locus); and the vascular diameter change area (7 locus), aneurysm neck area (4 locus) and the head and tail of FD (3 locus) were the main sites of FD malapposition; average distance between stent wire and vessel wall was (560.14±101.48) μm. At 12 weeks after surgery, DSA showed that 1 patient had a little residual contrast agent at the aneurysm neck (Kamran grading 3), and the remaining 5 had complete aneurysm occlusion (Kamran grading 4). One FD had moderate lumen stenosis, and the other 5 FDs had lumen patency. OCT indicated mostly disappeared acute ISA; ISA proportion decreased to 21.4 % (3/14), including 2 in the aneurysm neck and 1 in the partial stent. Histopathological results showed bare stent woven silk, without obvious endothelial coverage; in one FD with luminal stenosis, intimal hyperplasia was mainly composed of vascular smooth muscle cells.Conclusion:In carotid artery aneurysm model with FD implantation, OCT can detect more ISA than IVUS; most acute ISA have good outcome at 12 th week of follow-up, while severe ISA can cause delayed FD endothelialization and delayed aneurysm occlusion.

Objective:Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap.Conclusion:Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.

Objective:Randomized controlled trials (RCT) usually have strict implementation criteria. The included subjects' characteristics of the conditions for the intervention implementation are quite different from the actual clinical environment, resulting in discrepancies between the risk-benefit of interventions in actual clinical use and the risk-benefit shown in RCT. Therefore, some methods are needed to enhance the extrapolation of RCT results to evaluate the real effects of drugs in real people and clinical practice settings.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:A total of 12 articles were included. Three methods in the included literature focused on: ①improving the design of traditional RCT to increase population representation; ②combining RCT Data with real-world data (RWD) for analysis;③calibrating RCT results according to real-world patient characteristics.Conclusions:Improving the design of RCT to enhance the population representation can improve the extrapolation of the results of RCT. Combining RCT data with RWD can give full play to the advantages of data from different sources; the results of the RCT were calibrated against real-world population characteristics so that the effects of interventions in real-world patient populations can be predicted.

Objective To explore the effect of nimodipine combined with minimally invasive puncture on neurological function,hemodynamics,and serum inflammatory factor levels in patients with hypertensive intracerebral hemorrhage(HICH).Methods A total of 108 patients with HICH treated at the Second Affiliated Hospital of Hebei North University from June 2019 to May 2022 were selected as the research subjects.They were divided into an observation group(n=55)and a control group(n=53)according to the treatment method.All patients in the two groups received minimally invasive puncture;on this basis,the patients in the observation group were treated with nimodipine for one month.The neurological deficit of patients in the two groups was evaluated by the National Institute of Health Stroke Scale(NIHSS)score before and after treatment.Before and after treatment,5 mL of fasting venous blood was taken from patients in the morning,and the serum was obtained by centrifugation.The serum levels of brain-derived neurotrophic factor(BDNF),neuron-specific enolase(NSE),C-reactive protein(CRP),tumor necrosis factor-α(TNF-α)and interleukin-6(IL-6)were detected by enzyme-linked immunosorbent assay.Ultrasonic transcranial Doppler blood flow analyzer was used to monitor the hemodynamic indexes such as mean blood flow velocity(Vm),resistance index(RI)and pulsitility index(PI)of patients in the two groups before and after treatment.The adverse reactions such as headache,dizziness,infection and rebleeding were recorded in the two groups after treatment.Results There was no statistically significant difference in the NIHSS score and serum NSE and BDNF levels between the two groups before treatment(P＞0.05).After treatment,the NIHSS score and serum NSE level of patients in the two groups were significantly lower than those before treatment,while the serum BDNF level was significantly higher than that before treatment(P＜0.05).After treatment,the NIHSS score and serum NSE level of patients in the observation group were significantly lower than those in the control group,while the serum BDNF level was significantly higher than that in the control group(P＜0.05).There was no statistically significant difference in the Vm,PI and RI between the two groups before treatment(P＞0.05).After treatment,the Vm and PI of patients in the two groups were significantly higher than those before treatment,while the RI was significantly lower than that before treatment(P＜0.05).After treatment,the Vm and PI of patients in the observa-tion group were significantly higher than those in the control group,while the RI was significantly lower than that in the control group(P＜0.05).There was no statistically significant difference in serum TNF-α,IL-6,and CRP levels between the two groups before treatment(P＞0.05).The levels of serum TNF-α,IL-6,and CRP of patients in the two groups after treatment were significantly lower than those before treatment(P＜0.05).After treatment,serum TNF-α,IL-6,and CRP levels of patients in the observation group were significantly lower than those in the control group(P＜0.05).The incidence of adverse reactions in patients in the control group and observation group was 7.55％(4/53)and 9.09％(5/55),respectively,and the difference in the incidence of adverse reactions between the two groups was not statistically significant(P＞0.05).Conclusion Nimodipine combined with minimally invasive puncture can effectively improve the blood perfusion rate of HICH patients,reduce the degree of inflammatory response,and alleviate the patients'neurological function damage.

Objective:To assess the efficacy and safety of overlapping braided carotid artery stent (Wallstent) implantation in large extracranial internal carotid artery aneurysms (15 mm≤diameter<25 mm) and giant ones (diameter≥25 mm).Methods:A retrospective study was performed; the clinical data of 23 patients with large or giant extracranial internal carotid artery aneurysms accepted overlapping Wallstent stent implantation in Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University from August 2015 to June 2023 were collected. Immediately after implantation, DSA was used to evaluate the retention of contrast agent within the aneurysms and high-resolution C-arm CT (HR-CBCT) was used to detect the apposition between the two stents and between the stents and inner wall of the blood vessel. Perioperative complications were recorded. Clinical follow-up was performed bi-monthly via outpatient visits or telephone, and modified Rankin scale (mRS) was used to assess the prognoses (mRS scores of 0-2 as good prognosis) at the last follow-up; aneurysm occlusion was evaluated in a 6-month follow-up by DSA and in-stent restenosis in a final imaging follow-up by DSA or CTA according to the OKM grading. Results:Twenty-two patients had successful overlapping implantation of 2 Wallstent stents; blood flow was restricted in one patient due to carotid artery dissection at the distal end of the aneurysm during stent implantation and restored after a Neuroform EZ stent and 2 Wallstent stent implantation from the distal-proximal lesion; technical success rate of 95.7% (22/23) was obtained. DSA immediately after implantation showed obvious contrast medium retention in all aneurysms. HR-CBCT indicated good stent apposition in 21 patients and mild incomplete stent apposition in 2. Clinical follow-up was finished in 23 patients, ranged 6-31 months (mean 11.5±6.3 months); all patients had good prognosis at the last follow-up. Imaging follow-up, including at least once DSA, was conducted for all patients, with intervals ranging from 6 to 15 months (mean 10.4±3.4 months); DSA 6 months after implantation showed complete aneurysm occlusion in 19 patients (OKM grading D) and a bit of residual contrast in 4 patients (OKM grading C); final imaging follow-up (DSA in 2 and CTA in 21) revealed in-stent stenosis in 2 patients (stenosis rates of 51% and 87%) with obvious improved stenosis after balloon angioplasty and patent stents in 21 patients without evidence of aneurysm opacification.Conclusion:Overlapping braided carotid artery stent (Wallstent) implantation is an effective and safe approach for managing large or giant extracranial carotid artery aneurysms.

Objective:To investigate the difference of dose distribution between intensity-modulated photon radiotherapy (IMRT) and intensity-modulated proton radiotherapy (IMPT) in patients with non-small cell lung cancer.Methods:The clinical data of 8 patients with stage Ⅱ-Ⅲ non-small cell lung cancer who received radiotherapy in Ion Medical center of the First Affiliated Hospital of University of Science and Technology of China from November 2020 to April 2022 were retrospectively analyzed. IMRT and IMPT radiotherapy plans were created for each patient separately, the main evaluation indicators were targeted area dose distribution parameters [homogeneity index (HI), conformity index (CI) and the percent volume of volume wrapped by 95% and 100% of prescription dose profile in the targeted area (V 95% and V 100%)], and the average dose (D mean) to the organ at risk and the percent volume of a certain relative biological effect (RBE) dose exposure [D mean, V 5 Gy(RBE) and V 20 Gy(RBE) of ipsilateral lung, D mean, V 5 Gy(RBE) and V 20 Gy(RBE) of bilateral lung, D mean, V 30 Gy(RBE) and V 40 Gy(RBE) of heart, maximum dose (D max) of spinal cord, and D mean of esophageal]. Results:In comparison with IMRT, IMPT reduced the levels of dose parameters in bilateral lung, ipsilateral lung, spinal cord, esophagus, and heart with statistically significant differences (all P < 0.05), especially in D mean of bilateral lung [(4.1±1.8) Gy (RBE) vs. (6.9±1.9) Gy (RBE)], V 5 Gy(RBE) [(15.9±7.1) % vs. (28.5±8.6)%], V 20 Gy(RBE) [(7.4±3.5)% vs. (10.1±3.5)%], and D mean of ipsilateral lung [(9.1±4.5) Gy (RBE) vs. (11.9±3.3) Gy (RBE)], all decreased significantly (all P < 0.001), but the differences in the levels of targeted area dose distribution parameters between them were not statistically significant (all P > 0.05). Conclusions:For patients with non-small cell lung cancer, IMPT is superior to IMRT in the protection of bilateral lung, ipsilateral lung, spinal cord, esophagus and heart.

Objective:To explore the stent apposition and safety of Neuroform EZ and Enterprise 2 stents in treatment of symptomatic intracranial atherosclerotic stenosis (sICAS), and their influencing factors for in-stent restenosis.Methods:A total of 143 sICAS patients treated by Enterprise 2 stents (implanted 143 Enterprise 2 stents, E2 group) and 202 patients treated by Neuroform EZ stents (implanted 202 Neuroform EZ stents, EZ group) were selected from Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University from January 2017 to January 2022. Stent apposition was evaluated based on reconstructive images of high-resolution flat detector CT. The complications 30 d after surgery and during 6-24 months of follow-up were recorded. Based on DSA or CTA 6 months after surgery, the patency of the two stents was evaluated. Univariate analysis and multivariate Logistic regression analysis were used to determine the independent risk factors for in-stent restenosis.Results:(1) Forty-nine patients had incomplete stent apposition (ISA) after stent release: 24 patients with ISA in E2 group (16.8%, 24/143; 15 of type I and 9 of type II) and 25 with ISA in the EZ group (12.4%, 25/202, 11 of type I and 14 of type II) were found, without statistical difference ( χ 2=1.334, P=0.248); however, ISA incidence in the EZ group (19.0% and 10.3%) was significantly lower than that in the E2 group (41.4% and 25.6%) when the diameter ratio of anterior and posterior vessels of the stenosis lesions≥1.30 or the angle of stent≥75° ( χ 2=4.228, P=0.040; χ 2=4.531, P=0.033). (2) Within 30 d of stenting, 17 patients developed neurological dysfunction-related complications: 8 patients in EZ group and 9 in E2 group were noted, without significant difference ( P=0.324). Clinical follow-up was obtained in 317 patients, and 20 patients developed long-term stroke associated with responsible lesion vessels: 12 patients in EZ group and 8 in E2 group were noted, without significant difference ( P=0.995). (3) Totally, 298 patients received imaging follow-up 6 months after surgery, and 65 patients developed in-stent restenosis: 36 patients in EZ group and 29 in E2 group were noted, without significant difference ( χ 2=0.309, P=0.578). Multivariate Logistic regression analysis showed that diabetes ( OR=2.714, 95% CI: 1.437-5.126, P=0.002), stent apposition ( OR=3.435, 95% CI: 1.223-9.652, P=0.019), lesion stenosis length ( OR=1.176, 95% CI: 1.065-1.300, P=0.001) and immediate postoperative residual stenosis ( OR=1.038, 95% CI: 1.004-1.074, P=0.029) were independent influencing factors for in-stent restenosis. Conclusions:Enterprise 2 and Neuroform EZ stents have high stent apposition and safety in sICAS treatment, but in cases with large diameter ratio of the anterior and posterior vessels of the stenosis lesions (diameter ratio≥1.30) or large angle of the stent (≥75°), Neuroform EZ stent has better stent apposition. Patients with diabetes, ISA, long lesion stenosis or high residual stenosis may trend to have in-stent restenosis.

Objective:To establish the carotid artery in-stent restenosis (ISR) models in Bama pigs after Neuroform EZ stent implantation, and observe and summarize their imaging and pathological characteristics.Methods:Thirteen healthy Bama pigs from Guangxi Province were chosen; carotid artery intima was injuried by balloon over-dilation; Neuroform EZ stents were implanted at the vascular injury sites to establish ISR models. Blood flow at areas accepted carotid artery stent implantation in Bama pigs was monitored by bedside color ultrasound every 2 weeks after surgery; once hemodynamic changes (acceleration or deceleration of the blood flow) in stents were detected, DSA, intravascular ultrasound (IVUS), optical coherence tomography (OCT) and high-resolution MRI (HR-MRI) were performed immediately. Bama pigs were then sacrificed and tissues at the stents were taken; HE staining was used to observe the pathological changes.Results:Thirteen Neuroform EZ stents were implanted into 13 Bama pigs after balloon over-dilation of the unilateral carotid arteries with a technical success rate of 100%. Hemodynamic changes in stents were detected in these 13 pigs (10 with acceleration and 3 with deceleration) at (12.46±3.57) weeks after stenting (ranged from 6-18 weeks); ISR of different degrees was found in all these 13 pigs by DSA with an average stenosis rate of (44.23±9.39)%. IVUS and OCT found that the main body of stents was covered by hyperplastic intima, and thickened intima resulted in local lumen stenosis; and obvious vascular wall enhancement in these lumens was shown on HR-MRI. HE staining showed rupture of intravascular internal elastic lamina and severely arterial intimal hyperplasia;and the hyperplastic intima was mainly composed of smooth muscle cells.Conclusion:Carotid artery ISR models in Bama pigs can be accurately and reliably established at approximately 12 weeks by tearing endovascular intima with balloon over-dilation and implanting Neuroform EZ stents, and multiple imaging and pathology methods confirm that ISR is caused by hyperplastic intima.

Objective:To compare the efficacies of Enterprise 1 stent and Enterprise 2 stent in treating symptomatic intracranial atherosclerotic stenosis (ICAS).Methods:From January 2018 to April 2021, 76 patients with symptomatic ICAS treated by Enterprise 2 stent (implanting Enterprise 2 stents, EP2 group) and 52 patients with symptomatic ICAS treated with Enterprise 1 stent (implanting Enterprise 1 stents, EP1 group) were chosen from Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University. DSA was performed immediately after stent implantation and residual vascular stenosis rate was analyzed and compared between the 2 groups. Stent apposition of the 2 groups were evaluated according to reconstruction images of high-resolution flat detector CT; patients were divided into incomplete stent apposition (ISA) group and complete stent apposition group, accordingly; their clinical data were compared. Multivariate Logistic regression was used to analyze the independent influencing factors for ISA. Incidences of perioperative complications and short-term in-stent restenosis (6 months after implantation) in the EP2 group and EP1 group were observed.Results:Intracranial stent was successfully implanted in all patients, with technical success rate of 100%. Significant difference was noted in EP1 group between pre-implanted vascular stenosis rate (80.85±12.14)% and post-implanted residual vascular stenosis rate ([21.44±8.11]%, P<0.05); significant difference was noted in EP2 group between pre-implanted vascular stenosis rate (81.83±12.85)% and post-implanted residual vascular stenosis rate ([21.53±7.76]%, P<0.05); no significant difference was noted in pre-implanted vascular stenosis rate, post-implanted residual stenosis rate, or angles of stent between EP1 group and EP2 group ( P>0.05). According to high-resolution flat detector CT scan, the ISA incidence in EP2 group (10.5%) was significantly lower than that in EP1 group (25.0%, P<0.05); compared with the complete stent apposition group, the ISA group had significantly higher post-implanted residual stenosis rate, higher proportions of patients with calcification at the stenosis, larger angles of stent, higher diameter ratio of anterior and posterior vessels of the stenosis lesions, and lower proportion of patients with Enterprise 2 stent implantation ( P<0.05). Multivariate Logistic regression analysis showed that the angle of stents, diameter ratio of anterior and posterior vessels of the stenosis lesions and Enterprise 2 stent implantation were independent influencing factors for stent apposition; and Enterprise 2 stent implantation was an proactive factor for complete stent apposition. Perioperative complication rate showed significant difference between EP1 group and EP2 group (1.3% vs. 7.7%, P<0.05). Short-term in-stent restenosis between EP2 group and EP1 group was significantly different (26.1% vs. 7.0%, P<0.05). Conclusion:Compared with Enterprise 1 stent, Enterprise 2 stent has better apposition, higher safety, and lower incidence of short-term in-stent restenosis, enjoying clinical application value in treating symptomatic ICAS.