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A novel irradiation stent versus conventional irradiation stent for malignant dysphagia: A prospective randomized controlled trial.
Zhu, GY, Lu, J, Wang, C, Guo, JH
Journal of cancer research and therapeutics. 2021;(5):1261-1268
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Abstract
AIM: To evaluate whether a novel irradiation stent (NIS) could decrease the rate of recurrent dysphagia, compared to the conventional irradiation stent (CIS) in patients with malignant dysphagia. MATERIALS AND METHODS We performed an open-label randomized controlled trial of participants with malignant dysphagia. A total of 94 participants were parallelly allocated into the NIS group or the NIS group between April 2019 and April 2020. The primary endpoint was the rate of recurrent dysphagia. The secondary endpoints included technical success, clinical success, overall survival, and adverse events. RESULTS The technical success rate and the clinical success rate was 100.0% (47/47) in both groups. The median follow-up period was 189 days (range 14-422 days). Recurrent dysphagia was observed in 12.8% (6/47) of patients in the NIS group and 31.9% (15/47) in the CIS group (P = 0.026). Tissue/tumor growth occurred in 4 patients (8.5%) after NIS placement and 12 (25.5%) after CIS placement (P = 0.028). Stent migration occurred in 2 patients (4.3%) after NIS placement and 3 (6.4%) after CIS placement (P = 0.646). No food obstruction was found in both groups. The median overall survival was 177 days (95% confidence interval [CI] 139-214) in the NIS group and 168 days (95% CI 153-183) in the CIS group (P = 0.932). The incidence of severe adverse events was comparable between the two groups (21.3% vs. 17.0%, P = 0.600). CONCLUSIONS In patients with malignant dysphagia, compared with CIS, NIS could decrease the rate of tissue/tumor growth without increase the rate of stent migration and therefore decrease the rate of recurrent dysphagia.
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Reducing the cost of managing patients with atrial fibrillation undergoing percutaneous coronary intervention with stenting.
Mehran, R, Vogel, B, Levy, P
Journal of cardiology. 2021;(1):93-99
Abstract
Patients undergoing percutaneous coronary intervention (PCI) have an increased risk of both ischemic events and bleeding complications resulting from antithrombotic therapy. These events are particularly common in patients with a concomitant indication for oral anticoagulation, such as those with atrial fibrillation, and are associated with a substantial healthcare resource burden. Advances in procedural aspects of PCI have led to marked improvements in outcomes and a consequent reduction in the costs resulting from PCI-associated complications. Furthermore, recent randomized clinical trials have investigated the optimal antithrombotic strategy in the specific case of patients with atrial fibrillation undergoing PCI, leading to a shift toward the tailoring of antithrombotic therapy according to the patient's individual stroke and bleeding risks. Here we review these recent advances, with a particular focus on the improvements in antithrombotic strategies offered by the non-vitamin K antagonist oral anticoagulants.
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How Early Postoperative Urinary Tract Infections Affect Renal Graft Function at 1-Year Follow-up.
Warzyszyńska, K, Zawistowski, M, Karpeta, E, Dziewa, N, Kosieradzki, M
Transplantation proceedings. 2020;(8):2403-2408
Abstract
BACKGROUND Urinary tract infection (UTI) occurs in 21% of kidney recipients within the first 3 months after transplantation (KTx). It is associated with impaired graft function. Ureteral stent placement increases the occurrence of UTIs. The aim of this study was to assess the correlation between double-J placement, UTI incidence, and graft function. MATERIAL AND METHODS We conducted an observational study in 753 patients transplanted between 2010 and 2017 in compliance with the Helsinki Congress and the Istanbul Declaration. Recipients with preserved graft function at the 1-year follow-up were included. Medical records were searched for intraoperative double-J placement, UTI incidence, and estimated glomerular filtration rate (eGFR) on the 30th and 360th days post-transplant. Pretransplant hypothetical estimated GFR (heGFR) of each donor was calculated from donors' age and physiological age-dependent loss of functional nephrons. Spearman's correlation and linear regression analyses were applied. P < .05 was considered significant. RESULTS UTIs occurred in 239 (31.8%) patients. On the 30th day after KTx, eGFR was significantly lower in the UTI group (median, 39.5 vs 43.2; P < .01). A similar pattern was seen 1 year after KTx (47.5 vs 54.2; P < .01). Urinary stents were placed in 213 (28.3%) patients. UTIs occurred in 92 (43.2%) of them and in 147 (27.2%) of nonstented patients (odds ratio: 2; 95% confidence interval [CI], 1.5-2.8; P < .01). Median donor heGFR was 105.8 mL/min/1.73 m2, whereas median donor Modification of Diet in Renal Disease (MDRD) GFR was 64.2 mL/min/1.73 m2. A moderate correlation between age-adjusted heGFR and 1-year transplant function (r = .47) was noted. CONCLUSIONS UTIs in the early post-transplant period decreased 1-year eGFR by 4 to 5 mL/min/1.73 m2. UTIs occurred twice as often when a urinary stent was placed.
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Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a multicenter, placebo controlled, double blind, randomized clinical trial.
Torrecilla, C, Fernández-Concha, J, Cansino, JR, Mainez, JA, Amón, JH, Costas, S, Angerri, O, Emiliani, E, Arrabal Martín, MA, Arrabal Polo, MA, et al
BMC urology. 2020;(1):65
Abstract
BACKGROUND Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks. METHODS A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 - none; 3 - global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events. RESULTS The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. CONCLUSIONS Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation. TRIAL REGISTRATION This trial was registered at www.clinicaltrials.gov under the name "Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent" with date 2nd November 2017, code NCT03343275, and URL.
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Triple versus double antithrombotic therapy in patients with atrial fibrillation and stent implantation: a meta‑analysis of randomized trials.
Grajek, S, Olasińska-Wiśniewska, A, Michalak, M, Ritter, SS
Kardiologia polska. 2019;(9):837-845
Abstract
BACKGROUND Appropriate double (DT) and triple (TT) antithrombotic therapy in patients with atrial fibrillation and stent implantation is unclear. AIM: The aim of the study was to perform a meta‑analysis of studies comparing DT and TT in patients with atrial fibrillation and stent implantation. METHODS Of the 450 reports, 5 randomized trials were included in the meta‑analysis: WOEST, ISAR‑REACT, PIONEER AF‑PCI, RE‑DUAL PCI, and AUGUSTUS, with a total of 9931 patients. RESULTS Treatment efficacy, as assessed by the incidence of major adverse cardiac events, did not differ significantly between both therapeutic strategies: 8.98% for DT vs 8.71% for TT (odds ratio [OR], 1.02; 95% CI, 0.86-1.21). The incidence of hemorrhagic complications was significantly lower in patients treated with DT than TT (13.1% and 21.0%, respectively; OR, 0.57; 95% CI, 0.47-0.70). In over 90% of patients, DT included clopidogrel along with an oral anticoagulant (non-vitamin K antagonist oral anticoagulant or vitamin K antagonist). CONCLUSIONS The results of our meta‑analysis are clearly in line with the current trend of the fastest possible reduction in the use of TT in favor of DT. Almost half lower risk of hemorrhagic complications during DT compared with TT, with similar efficacy of the 2 strategies, provides an argument for the wider use of DT in patients with AF and stent implantation.
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Emerging Technologies in Flow Diverters and Stents for Cerebrovascular Diseases.
Karsy, M, Guan, J, Brock, AA, Amin, A, Park, MS
Current neurology and neuroscience reports. 2017;(12):96
Abstract
PURPOSE OF REVIEW Stents and flow diverters have revolutionized the treatment of cerebrovascular disease. Guglielmi coils, flexible microcatheters, and first-generation intracranial stents, such as Neuroform (Stryker Neurovascular) and Enterprise stents (Codman/DePuy-Synthes), have paved the way for the development of the Pipeline Embolization Device (PED) (ev3/Covidien/Medtronic) and other endovascular approaches. RECENT FINDINGS This review discusses the historical development of flow diverter technologies from the PED to similar devices, such as the Surpass stent (Stryker Neurovascular), the Flow-Redirection Endoluminal Device (FRED; MicroVention, Inc.), the SILK stent (Balt Extrusion), and the p64 Flow Modulation Device (Phenox). In addition, the potential use of drug-eluting stents and various bioresorbable scaffolds (e.g., poly-L-lactic acid, magnesium), new developments in stent material (e.g., thin-film nitinol), design (e.g., biocompatible polymers, embedded microcircuitry, flow models), and potential applications for flow diverters will be considered. Endovascular treatment of cerebrovascular disease is rapidly advancing via continued development of new technology.
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Preoperative Belladonna and Opium Suppository for Ureteral Stent Pain: A Randomized, Double-blinded, Placebo-controlled Study.
Lee, FC, Holt, SK, Hsi, RS, Haynes, BM, Harper, JD
Urology. 2017;:27-32
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Abstract
OBJECTIVE To investigate whether the use of a belladonna and opium (B&O) rectal suppository administered immediately before ureteroscopy (URS) and stent placement could reduce stent-related discomfort. METHODS A randomized, double-blinded, placebo-controlled study was performed from August 2013 to December 2014. Seventy-one subjects were enrolled and randomized to receive a B&O (15 mg/30 mg) or a placebo suppository after induction of general anesthesia immediately before URS and stent placement. Baseline urinary symptoms were assessed using the American Urological Association Symptom Score (AUASS). The Ureteral Stent Symptom Questionnaire and AUASS were completed on postoperative days (POD) 1, 3, and after stent removal. Analgesic use intraoperatively, in the recovery unit, and at home was recorded. RESULTS Of the 71 subjects, 65 had treatment for ureteral (41%) and renal (61%) calculi, 4 for renal urothelial carcinoma, and 2 were excluded for no stent placed. By POD3, the B&O group reported a higher mean global quality of life (QOL) score (P = .04), a better mean quality of work score (P = .05), and less pain with urination (P = .03). The B&O group reported an improved AUASS QOL when comparing POD1 with post-stent removal (P = .04). There was no difference in analgesic use among groups (P = .67). There were no episodes of urinary retention. Age was associated with unplanned emergency visits (P <.00) and "high-pain" measure (P = .02) CONCLUSION B&O suppository administered preoperatively improved QOL measures and reduced urinary-related pain after URS with stent. Younger age was associated with severe stent pain and unplanned hospital visits.
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First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis.
Suwannasom, P, Sotomi, Y, Corti, R, Kurz, DJ, Roffi, M, von Birgelen, C, Buzzi, S, Zucker, A, Dijkstra, J, Wykrzykowska, JJ, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2017;(17):2118-2127
Abstract
AIMS: In preclinical studies, a bare metal cobalt-chromium stent with an active surface oxide layer modification (BMSmod) has been shown to inhibit neointimal hyperplasia effectively. We sought to assess both the clinical safety and feasibility of the BMSmod. METHODS AND RESULTS In this prospective, non-randomised, first-in-man multicentre study, a total of 31 patients with de novo coronary lesions, reference lumen diameters of 2.5-3.5 mm and lesion length ≤16 mm, were enrolled. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at baseline and six-month follow-up. Primary angiographic and OCT endpoints included in-stent late lumen loss (LLL) and mean neointimal thickness at six months. The device-oriented composite endpoint (DoCE), defined as cardiac death, myocardial infarction not clearly attributable to a non-intervention vessel, and clinically indicated target lesion revascularisation (CI-TLR), was analysed according to the intention-to-treat principle. In 31 patients (33 lesions), the procedural success rate was 93.5%. At six months, angiographic LLL was 0.91±0.45 mm and binary angiographic restenosis occurred in 23.3% of lesions. Out of 33 lesions, OCT was performed in 27 lesions at both time points. Mean neointimal thickness amounted to 348±116 µm. At six months, the DoCE was 19.4% due to the occurrence of CI-TLR in five patients (including one late definite stent thrombosis of a non-study stent). CONCLUSIONS In contrast to previous preclinical pathophysiological work, the BMSmod did not prevent neointimal hyperplasia in a first-in-man clinical setting.
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Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy.
Gibson, CM, Pinto, DS, Chi, G, Arbetter, D, Yee, M, Mehran, R, Bode, C, Halperin, J, Verheugt, FW, Wildgoose, P, et al
Circulation. 2017;(4):323-333
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BACKGROUND Patients with atrial fibrillation who undergo intracoronary stenting traditionally are treated with a vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT), yet this treatment leads to high risks of bleeding. We hypothesized that a regimen of rivaroxaban plus a P2Y12 inhibitor monotherapy or rivaroxaban plus DAPT could reduce bleeding and thereby have a favorable impact on all-cause mortality and the need for rehospitalization. METHODS Stented subjects with nonvalvular atrial fibrillation (n=2124) were randomized 1:1:1 to administration of reduced-dose rivaroxaban 15 mg daily plus a P2Y12 inhibitor for 12 months (group 1); rivaroxaban 2.5 mg twice daily with stratification to a prespecified duration of DAPT of 1, 6, or 12 months (group 2); or the reference arm of dose-adjusted VKA daily with a similar DAPT stratification (group 3). The present post hoc analysis assessed the end point of all-cause mortality or recurrent hospitalization for an adverse event, which was further classified as the result of bleeding, a cardiovascular cause, or another cause blinded to treatment assignment. RESULTS The risk of all-cause mortality or recurrent hospitalization was 34.9% in group 1 (hazard ratio=0.79; 95% confidence interval, 0.66-0.94; P=0.008 versus group 3; number needed to treat=15), 31.9% in group 2 (hazard ratio=0.75; 95% confidence interval, 0.62-0.90; P=0.002 versus group 3; number needed to treat=10), and 41.9% in group 3 (VKA+DAPT). Both all-cause death plus hospitalization potentially resulting from bleeding (group 1=8.6% [P=0.032 versus group 3], group 2=8.0% [P=0.012 versus group 3], and group 3=12.4%) and all-cause death plus rehospitalization potentially resulting from a cardiovascular cause (group 1=21.4% [P=0.001 versus group 3], group 2=21.7% [P=0.011 versus group 3], and group 3=29.3%) were reduced in the rivaroxaban arms compared with the VKA arm, but other forms of rehospitalization were not. CONCLUSIONS Among patients with atrial fibrillation undergoing intracoronary stenting, administration of either rivaroxaban 15 mg daily plus P2Y12 inhibitor monotherapy or 2.5 mg rivaroxaban twice daily plus DAPT was associated with a reduced risk of all-cause mortality or recurrent hospitalization for adverse events compared with standard-of-care VKA plus DAPT. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01830543.
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The Evolution and Current Utility of Esophageal Stent Placement for the Treatment of Acute Esophageal Perforation.
Herrera, A, Freeman, RK
Thoracic surgery clinics. 2016;(3):305-14
Abstract
Esophageal stent placement was used primarily for the treatment of malignant strictures until the development of a new generation of biomaterials allowed the production of easily removable, occlusive stents in 2001. Since then, thoracic surgeons have gained experience using esophageal stents for the treatment of acute esophageal perforation. As part of a hybrid treatment strategy, including surgical drainage of infected spaces, enteral nutrition, and aggressive supportive care, esophageal stent placement has produced results that can exceed those of traditional surgical repair. This review summarizes the evolution of esophageal stent use for acute perforation and provides evidence-based recommendations for the technique.