Comparison of BARD®LIFESTREAM™ Covered Balloon-Expandable Stent Versus GORE® VIABAHN™ Covered Self-Expandable Stent in Treatment of Aortoiliac Obstructive Disease: Study Protocol for a Prospective Randomized Controlled Trial(NEONATAL Trial)

Background Covered stent has become one of the mainstream therapies for aortoiliac obstructive disease (AIOD), with higher patency rate compared to bare metal stent. Covered balloon-expandable (CBE) stent can be placed more accurately with higher radial support force, while covered self-expanding (CSE) stent has greater elasticity and higher trackability. However, there is no level I evidence regarding the comparison safety and efficacy between the CSE stent and CBE stent in AIOD up to date. Therefore, this study aims to compare the efficacy and safety of CBE stent (BARD®LIFESTR`EAM™) and CSE stent (GORE® VIABAHN™) in AIOD. Methods This trial is a prospective, single center, paralleled, non-inferiority, randomized controlled trial. A total of 106 patients will be enrolled and these patients will be randomized to either the CBE stent group or CSE stent group. The primary end point of the study is occurrence of Target Lesion Revascularization (TLR) at 12 months after the intervention. Discussion To our knowledge, the NEONATAL trial is the first RCT to compare CBE and CSE stent in AIOD patients. The results of clinical trials may contribute to establishing a strategic guideline for choosing the optimal type of covered stent in treatment of AIOD patients. Trial registration: ChiCTR2100046734; Registered on 27 May, 2021 in Chinese Clinical Trials Registry.

Analysis of Use of Percutaneous Nephrostomy and Ureteral Stenting in Management of Ureteral Obstruction

Introduction and objectives: The basic aim of the study is to analyze the use of percutaneous nephrostomy and ureteral stenting in management of ureteral obstruction. Methodology of the study: This cross sectional study was conducted at Department of Urology, UCM, University of Lahore during January 2019 to October 2019. This study was done with the permission of ethical committee of hospital. There were 110 patients who selected for this study analysis. Enrollment criteria consisted of the need for unilateral or bilateral upper urinary tract diversion for at least 6 months. Either a PCN tube or an internal ureteral stent (e.g., double-J stent) was used for ureteral obstructions of various etiologies. Results: There were 110 patients with mean age 60 years in this study. There were 66 patients with ureteral stents and 44 (40%) with PCN tubes. A smaller elevation in serum creatinine was noted in the PCN group (0.21 vs. 0.78 mg/dL, p = 0.03). Nine of 86 (10.4%) double-J stents were converted to PCN tubes during the study period. Residual hydronephrosis after decompression was more common in the stent group than in the PCN group (65.2% vs. 27.2%, p = 0.01). Conclusion: It is concluded that Urinary diversion or decompression using PCN produced better preservation of renal function and lower incidences of complications in our study. Key words: PCN, Hydronephrosis, Urinary, Renal, Function

Comparison of Conservative and Surgical Treatments in Symptomatic Pregnancy Hydronephrosis

<b><i>Objectives:</i></b> This study aimed to evaluate the factors affecting the treatment choice in pregnant women with symptomatic hydronephrosis. <b><i>Methods:</i></b> Hospital records of pregnant women who visited our clinic due to symptomatic hydronephrosis between December 2010 and December 2020 were analysed retrospectively. Patients were divided into 2 groups: conservative and surgical (JJ stent) treatment groups. Age, gestational week, primipara, trimester, visual analogue scale (VAS), and preterm birth rates as well as clinical, laboratory, and ultrasonography findings were compared between the groups. <b><i>Results:</i></b> The study included 227 pregnant women (conservative treatment group, 133; JJ stent group, 94). Age, gestational week, primipara, trimester, hydronephrosis side, fever, pyelonephritis, pyuria, preterm labour and abortion, as well as blood urea nitrogen, creatinine, C-reactive protein, and white blood cell levels did not differ significantly between the groups (<i>p</i> &#x3e; 0.05). In the JJ stent group, VAS, creatinine value, culture positivity rate, degree of hydronephrosis, and renal pelvis anterior-posterior (AP) diameter were significantly higher than those in the conservative treatment group (<i>p</i> &#x3c; 0.05). The cut-off value for renal pelvis AP diameter was 16.5 mm in the first 2 trimesters and 27.5 mm in the third trimester. <b><i>Conclusions:</i></b> Surgical treatment should not be delayed in pregnant women who do not respond to conservative treatment and have impaired renal function and grade 3–4 hydronephrosis. Early surgical intervention is necessary in patients with a renal pelvis AP diameter of &#x3e;16.5 mm in the first 2 trimesters and &#x3e;27.5 in the third trimester.

Self-Radiopaque Markers Guiding Physician-Modified Fenestration (S-Fenestration) in Aortic Arch Endovascular Repair

Backgrounds and Objectives: Thoracic endovascular aortic repair (TEVAR) has currently become the “first-line choice” for descending aortic pathologies. For pathologies located at the aortic arch, TEVAR with physician-modified fenestration (PMF) has been gained popularity as an alternative choice. However, stent fenestration is an experience-dependent technique and comes with possible adverse events such as misalignment. This study aims to introduce the self-radiopaque PMF (SF), which uses the radiopaque marker as a guiding indicator.Methods: This is a single-center retrospective study of 125 patients who underwent the SF-TEVAR in Second Xiangya Hospital from December 2015 to December 2020. Data include basic clinical information and technique records of SF-TEVAR with follow-up results.Results: According to the SF-TEVAR protocol, we have performed the procedures on 125 patients and obtained an instant success rate of 98.4%. A total of 140 aortic stent-grafts and 44 bridging stents have been implanted in this study. The operation time is 64.6 ± 19.3 min, X-ray exposure time (from first digital subtraction angiography (DSA) to last DSA) is 25.6 ± 14.3 min, and contrast volume is 82.2 ± 22.6 ml. The success rate of PMF alignment is 98.4%. One bailout stent-graft was implanted into the left subclavian artery (LSA) by the chimney technique (0.8%). One fenestration was successfully and immediately corrected after misalignment (0.8%). Large simultaneous fenestration was performed in six patients (4.8%) for the left common carotid artery (LCCA) and LSA and in two patients (1.6%) for IA, LCCA, and LSA. One hundred twenty-two out of 125 patients' LSAs have been kept patent by the technique during the follow-up. The bridging stent group consists of 44 patients who received LSA stents, while the non-bridging stent group includes the other 81 patients. Type I endoleak has occurred in seven patients (5.6%) 1 week after the procedure. During follow-up (23 ± 18 months), survival rate is 95.7% and branch artery patent rate is 97.4%.Conclusions: The SF-TEVAR technique, which utilizes the radiopaque marker in stent-graft as an indication for PMF in TEVAR, seems a likely safe, effective, and efficient procedure that brings acceptable survival rate and branch artery patency rate. SF-TEVAR serves as a progressive alternative method to keep the branch artery patent in aortic arch endovascular reconstruction.

Preventive Effect of Biodegradable Stents On Biliary Stricture And Fibrosis After Biliary Anastomosis In A Porcine Model

The aim of this animal study was to evaluate the preventive effect of novel biodegradable stents (BS) on biliary stricture and fibrosis after duct-to-duct (DD) biliary anastomosis. Ten mini-pigs were allocated to the control group (n = 5) and or the stent group (n = 5). The common bile duct was exposed through surgical laparotomy, and then resected transversely. In the stent group, a 4 mm or 6 mm polydioxanone/magnesium sheath core BS was inserted according to the width of the bile duct, followed by DD biliary anastomosis. In the control group, DD biliary anastomosis was performed without BS insertion. In the stent group, stents were observed without deformity for up to four weeks in all animals. Eight weeks later, histopathologic examination revealed that the common bile duct of the anastomosis site was relatively narrower in circumference in the control group compared to the stent group. The degree of fibrosis in the control group was more marked than in the stent group (3.84 mm vs. 0.68 mm, respectively, p < 0.05). Our study showed that novel BS maintained their original shape and radial force for an adequate time and then disappeared without adverse events.

Endovascular Therapy of Anterior Circulation Tandem Occlusions: Pooled Analysis From the TITAN and ETIS Registries

Background and Purpose: Endovascular therapy for tandem occlusion strokes of the anterior circulation is an effective and safe treatment. The best treatment approach for the cervical internal carotid artery (ICA) lesion is still unknown. In this study, we aimed to compare the functional and safety outcomes between different treatment approaches for the cervical ICA lesion during endovascular therapy for acute ischemic strokes due to tandem occlusion in current clinical practice. Methods: Individual patients’ data were pooled from the French prospective multicenter observational ETIS (Endovascular Treatment in Ischemic Stroke) and the international TITAN (Thrombectomy in Tandem Lesions) registries. TITAN enrolled patients from January 2012 to September 2016, and ETIS from January 2013 to July 2019. Patients with acute ischemic stroke due to anterior circulation tandem occlusion who were treated with endovascular therapy were included. Patients were divided based on the cervical ICA lesion treatment into stent and no-stent groups. Outcomes were compared between the two treatment groups using propensity score methods. Results: A total of 603 patients were included, of whom 341 were treated with acute cervical ICA stenting. In unadjusted analysis, the stent group had higher rate of favorable outcome (90-day modified Rankin Scale score, 0–2; 57% versus 45%) and excellent outcome (90-day modified Rankin Scale score, 0–1; 40% versus 27%) compared with the no-stent group. In inverse probability of treatment weighting propensity score–adjusted analyses, stent group had higher odds of favorable outcome (adjusted odds ratio, 1.09 [95% CI, 1.01–1.19]; P =0.036) and successful reperfusion (modified Thrombolysis in Cerebral Ischemia score, 2b-3; adjusted odds ratio, 1.19 [95% CI, 1.11–1.27]; P <0.001). However, stent group had higher odds of any intracerebral hemorrhage (adjusted odds ratio, 1.10 [95%, 1.02–1.19]; P =0.017) but not higher rate of symptomatic intracerebral hemorrhage or parenchymal hemorrhage type 2. Subgroup analysis demonstrated heterogeneity according to the lesion type (atherosclerosis versus dissection; P for heterogeneity, 0.01), and the benefit from acute carotid stenting was only observed for patients with atherosclerosis. Conclusions: Patients treated with acute cervical ICA stenting for tandem occlusion strokes had higher odds of 90-day favorable outcome, despite higher odds of intracerebral hemorrhage; however, most of the intracerebral hemorrhages were asymptomatic.

Effectiveness of a Novel Covered Stent without External Thread Fixation for Anastomotic Leakage after Total or Proximal Gastrectomy for Gastric Cancer

A thread-fix stent entails long hospitalization and patient discomfort. We aimed to evaluate the efficacy of a novel stent with silicone-covered outer double layers without external fixation (Beta stent) for anastomotic leakage after total or proximal gastrectomy. The outcomes were compared between gastric cancer patients who underwent stent placement using a thread-fix stent between 2014 and 2015 (Thread-Fix Group) and those who received a Beta stent in the succeeding period until October 2018 (Beta Stent Group). The Beta Stent Group (n = 14) had a significantly higher leakage healing rate by the first stent placement (92.9% vs. 53.8%; p = 0.021) and had a shorter hospitalization period (median: 16 days vs. 28 days; p = 0.037) than the Thread-Fix Group (n = 13). Further, 50% of the Beta stent patients received outpatient management until stent removal. Stent maintenance duration was significantly longer in the Beta Stent Group (median, 28 days vs. 18 days; p = 0.006). There was no significant between-group difference in stent-related complications except for stent migration (7.1% (Beta Stent Group) vs. 0% (Thread-Fix Group), p = 0.326). In conclusion, the Niti-S Beta stent is an effective treatment for anastomotic leakage from total or proximal gastrectomy for gastric cancer. Stent maintenance is possible without hospitalization.

Study on the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction

background Drug-coated balloon (DCB) is a new technology that has emerged in recent years and has been proven to be effective and safe in the treatment of in-stent restenosis. The purpose of this article is to observe the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction. method We selected 80 patients admitted to the hospital for STEMI from January 2018 to December 2019. The subjects were randomly divided into a Yinyi (Liaoning) Biotech Bingo Drug Coated Balloon treatment group (balloon group, n = 38) and a drug-eluting stent (DES) treatment group (stent group, n = 42). Patients were followed up to understand the incidence of major adverse cardiovascular events (MACE) at 1 month, 6 months and 1 year after surgery. Coronary angiography was rechecked 1 year after surgery to understand the late lumen loss (LLL) in the two groups. result During the one-year follow-up, the LLL of the target lesion in the balloon group was -0.12±0.46 mm, while the target lesion in the stent group was 0.14±0.37 mm ( P <0.05). Within 1 year, the incidence of MACE in the balloon group was 11%, while the incidence of MACE in the stent group was 12%. There was no significant difference between the two groups. in conclusion When PCI is used for STEMI, only DCB therapy is safe and effective, and has shown good clinical effects during a one-year follow-up period.

Contemporary Results of Carotid Artery Stenting Using Low-Profile Dual-Metal Layer Nitinol Micromesh Stents in Relation to Single-Layer Carotid Stents

Purpose: To evaluate patients characteristics, procedural details, perioperative outcomes, and midterm results of carotid artery stenting (CAS) performed with the Roadsaver/Casper stent (Terumo Corp, Tokyo, Japan) as compared to concurrent patients treated with other commercially available carotid stents. Materials and Methods: This is a single-center, retrospective, nonrandomized study including 200 consecutive patients who underwent a total of 205 elective CAS procedures due to severe internal carotid artery stenosis between April 2015 and December 2018. Procedural data and outcomes for patients treated with the Roadsaver/Casper stent implantation (100 procedures, in 97 patients) vs first-generation carotid stents implantations (90 procedures, in 88 patients) were compared. Fifteen patients were treated with CGuard carotid stent (InspireMD, Tel Aviv, Israel), and outcomes were reported separately. Primary endpoints were the occurrence of major adverse cerebrovascular events (MACE), including death, ipsilateral stroke, and transitory ischemic attack (TIA). Secondary endpoints were the rate of intrastent stenosis, the need for reintervention, and the occurrence of adverse cardiovascular events, including myocardial infarction, arrhythmias, and need for inotropic support. Results: No difference in demographics and preoperative risk factors were observed between patients treated with and without the Roadsaver/Casper stent. The mean procedure time was shorter in the Roadsaver/Casper group (40.7±16.9 vs 49.4±27.3 minutes; p=0.008), while radial percutaneous access was more frequent (24% vs 5%; p<0.001). The rate of stroke/TIA/death at 30 days was 3% in the Roadsaver group vs 1% in the first-generation stent group (p=0.623). The primary patencyrate was 100% and 93.4% at 1- and 3-year of follow-up in the Roadsaver/Casper groupand 99% and 94.3% in the other stent group, respectively (p=0.95). Conclusions: In this real-world cohort of patients undergoing CAS, the Roadsaver/Casper stent was used to treat more symptomatic and vulnerable carotid plaques as compared to other carotid stents. Nevertheless, patients treated with this low-profile dual-layer micromesh stent showed low events rates at both 30 days and follow-up, similar to that observed for other stents.

Stenting versus balloon angioplasty alone in patients with below-the-knee disease: A propensity score-matched analysis

Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA.