PVA enema ameliorates DSS-induced acute colitis in mice.

BACKGROUND: Ulcerative colitis (UC) represents a clinically challenging condition characterized by persistent damage to the colonic epithelial mucosa as the principal pathological feature. Polyvinyl alcohol (PVA) solution, primarily composed of glue, is a biodegradable polymer material that has found utility in the medical field. This research endeavors to investigate the therapeutic potential of PVA water solution in ameliorating UC in mice. METHODS: UC was induced in 48 C57BL/6 mice by administering 2.5% DSS in their diet for 6 days. Mice were treated with different concentrations of PVA (0.1 mg/ml PVA, 0.3 mg/ml PVA, 1 mg/ml PVA, 3 mg/ml PVA, 10 mg/ml PVA) enemas (n = 6). Disease Activity Index (DAI) and histologic score were evaluated for inflammation degree. Furthermore, mouse colon organoids were cultured, which were used to assess the effects of PVA on expansion in vitro. RESULTS: PVA aqueous solutions (1 mg/ml and 3 mg/ml) were able to alleviate the DAI in mice. By DAY 6, there was a significant 3/5-fold decrease in DAI within the 1 mg/ml PVA group (p = 0.02). Histopathology scores demonstrated improvements, while the levels of inflammatory factors in the intestinal mucosal tissue were reduced. Additionally, it was confirmed that PVA could promote the expansion of colonic organoids in vitro. CONCLUSIONS: In summary, our investigation has yielded findings indicating that PVA holds the potential to ameliorate symptoms associated with colitis in murine subjects afflicted by DSS-induced colitis, primarily through its facilitation of intestinal stem cell expansion. This study might provide a new candidate for the clinical treatment of ulcerative colitis.

Comparison of n-butyl-2-cyanoacrylate and polyvinyl alcohol particles for bronchial artery embolisation in primary lung cancer: a retrospective cohort study.

BACKGROUND: Bronchial artery embolisation (BAE) is an effective treatment option to control haemoptysis in primary lung cancer. However, no studies have investigated optimal embolisation material for BAE in lung cancer patients. Thus, this study aimed to compare the safety and efficacy of BAE performed using n-butyl-2-cyanoacrylate (NBCA) and polyvinyl alcohol (PVA) particles in primary lung cancer patients to determine which embolic material is better for patients with haemoptysis. METHODS: This retrospective study was approved by the institutional review board, and consent was waived. The rates of hemostasis, complications, procedure time, dose-area product, and haemoptysis-free survival were retrospectively compared between primary lung cancer (non-small cell [n = 111] and small cell [n = 11]) patients who underwent BAE using NBCA (n = 58) or PVA particles (n = 64) between January 2004 and December 2019. Predictors of recurrent haemoptysis were analysed using the Cox proportional hazard regression model. RESULTS: Among 122 patients (mean age, 66 ± 10 years; range 32-86 years; 103 men), more patients in the NBCA group (81.0%; 47 of 58) achieved complete hemostasis than did patients in the PVA group (53.1%; 34 of 64) (P = 0.002). No major complications were observed in either group. The procedure time (36.4 ± 21.6 vs. 56.3 ± 27.4 min, P < 0.001) was shorter, and the dose-area product (58.6 ± 64.0 vs. 233.5 ± 225.0 Gy*cm2, P < 0.001) was smaller in the NBCA group than in the PVA group. The median haemoptysis-free survival was 173.0 in the NBCA group compared with 20.0 days in the PVA group (P < 0.001). The PVA use (P < 0.001) and coagulopathy (P = 0.014) were independent predictors of shortened haemoptysis-free survival. CONCLUSION: BAE using NBCA showed significantly superior initial hemostasis with longer haemoptysis-free survival, shorter procedure time, and reduced radiation dose than BAE using PVA particles. The PVA use and coagulopathy were independent predictors of recurrent haemoptysis. TRIAL REGISTRATION: Retrospectively registered.

In vivo safety assessment, biodistribution and toxicology of polyvinyl alcohol microneedles with 160-day uninterruptedly applications in mice.

Dissolving microneedles (DMNs) are widely used in drug delivery systems since they are based on one-step application, which is simple and convenient for patients, especially for the patients such as diabetes who need daily or long-term self-administration. In general, the matrix materials of DMNs are water-soluble materials that can release the encapsulated drugs gradually by dissolving in the skin without generating sharp needle waste. However, the matrix materials of DMNs will also leave in the skin after application. Thus, it is vital to evaluate whether the matrix material of DMNs dissolved in the skin will cause health risks such as toxicity to the body or some skin-related complications to patients who frequent or long-term administration. In this work, PVA, as one of the typical matrix materials of DMNs, was selected to prepare the DMNs to research the safety of PVA-based MNs to the body after being dissolved in the skin. Briefly, in a 160 - days trial, the healthy mice were daily administrated by PVA MNs. The results showed that PVA materials mainly accumulated in the skin tissues of mice after dissolving and the concentration of PVA in the insertion sites gradually decreased and was almost undetectable at 6 days after administration. The observation of general conditions, blood hematological analysis and histological examinations of the mice demonstrated that the PVA-based MNs do not cause appreciable toxicity to the healthy mice after daily insertion in a 160 - days trial. Altogether, these results encourage further studies of PVA MNs for biomedical applications and support translation of PVA-based DMNs from pre-clinical development into clinical trials.

Early Failures of Polyvinyl Alcohol Hydrogel Implant for the Treatment of Hallux Rigidus.

BACKGROUND: The purpose of this study was to evaluate the clinical and radiological outcomes following a polyvinyl alcohol hydrogel implant in the treatment of hallux rigidus. METHODS: A retrospective cohort study investigating patients treated with a polyvinyl alcohol hydrogel implant for hallux rigidus was performed. Clinical outcomes were evaluated with the Foot and Ankle Outcomes Score (FAOS) and visual analog scale (VAS) score at the final follow-up. Plain radiographs were assessed postoperatively. Eleven patients (11 feet) with a mean follow-up of 20.9 months (range, 14-27 months) were included. The mean age was 60.3 years. RESULTS: All FAOS subscales showed pre- to postoperative improvements, but there was no statistical significance in all subscales. The mean VAS score showed improvement from 4.1 to 3.0 (P = .012). On postoperative plain radiographs, implant subsidence was observed 60% (6/10) at 4 weeks after surgery and 90% (9/10) at the final follow-up. Fifty percent (5/10) showed radiologic lucency around the implant. Forty percent (4/10) had erosion of the proximal phalanx of the great toe. Four patients (36%) reported no improvement following surgery at the final follow-up, which were considered as failures. Three patients required additional surgery related to the implants. An additional patient is waiting to revise the implant. CONCLUSION: Our current cohort study demonstrated a high failure rate with the polyvinyl alcohol hydrogel implant in patients with hallux rigidus. Significant radiologic subsidence with lysis around the implant, erosion of the proximal phalanx countersurface, and implant wear are harbingers for concern in the long term. LEVEL OF EVIDENCE: Level IV, case series.

Novel high-strength thromboresistant poly(vinyl alcohol)-based hydrogel for vascular access applications.

Adherence of proteins, cells, and microorganisms to the surface of biomaterials used for vascular access contribute to device failure by thrombosis, occlusions, and infections. Current technologies for inhibiting these complications are limited to coatings and additives that are limited in duration of efficacy and often induce adverse side effects. In this work, we developed a novel composite hydrogel structure comprising of a porous poly(vinyl alcohol) (PVA) that is impregnated with poly(acrylic acid) (PAA) and heat treated to create a physically cross-linked high-strength hydrogel material. The swelling and mechanical properties can be controlled by the temperature and duration of heat treatment to increase the cross-link density of the matrix. The heat treated composite PVA/PAA hydrogel exhibits both the mechanical strength and durability of thermoplastic polyurethanes (TPUs) and the inherently non-thrombogenic surface functionality of PVA-based hydrogels without the use of chemical cross-linking agents. The composite hydrogels were found to maintain their mechanical integrity and surface functionality after accelerated aging in a simulated-use in vitro model for 162.5 days real-time equivalent. Relative to commercial catheter materials, the composite PVA/PAA hydrogel exhibited up to an average of 97% reduction in platelet adhesion when exposed to an in vitro blood loop model and a lower rate of tip occlusion due to thrombosis. This high-strength thromboresistant hydrogel could have a major impact as a novel biomaterial for use in vascular access applications to improve patient health.

Intra-arterial EmboCept S® and DC Bead® effectively inhibit tumor growth of colorectal rat liver metastases.

BACKGROUND: Intra-arterial therapy with embolics is established for the treatment of malignancies of the liver. However, there are no studies comparing the different effects of various embolics used in clinical practice. Herein, we analyzed the effect of 3 different embolics on tumor growth in a rat model of colorectal liver metastases. METHODS: Eight days after subcapsular implantation of 5 × 105 colorectal cancer cells (CC531) in the left liver lobe of WAG/Rij rats were randomized into 4 groups (n = 8) and underwent intra-arterial hepatic therapy. Animals received either EmboCept S®, DC Bead® or Lipiodol® Ultra-Fluid. Animals of the control group received a comparable amount of saline. Tumor growth was measured on day 8 and 11 using a three-dimensional 40 MHz ultrasound device. On day 11 tumor and liver tissue were removed for histological and immunohistochemical analyses. RESULTS: On day 11 animals of the control group showed a tumor growth of ~ 60% compared to day 8. Application of Lipiodol Ultra-Fluid® did not significantly influence tumor growth (~ 40%). In contrast, treatment with EmboCept S® or DC Bead® completely inhibited tumor growth. Of interest, application of EmboCept S® did not only completely inhibit tumor growth but even decreased tumor size. Immunohistochemical analysis showed a significant increase of necrotic areas within the tumors after application of EmboCept S® and DC Bead® compared to Lipiodol® Ultra-Fluid. CONCLUSION: The present study demonstrates that an intra-arterial therapy with EmboCept S® and DC Bead®, but not Lipiodol® Ultra-Fluid, results in a complete inhibition of rat colorectal liver metastatic growth.

Characterization of a novel polyvinyl alcohol/chitosan porous hydrogel combined with bone marrow mesenchymal stem cells and its application in articular cartilage repair.

BACKGROUND: Different substances are combined to compensate for each other's drawbacks and create an appropriate biomaterial. A novel Polyvinyl alcohol (PVA)/chitosan (CS) porous hydrogel was designed and applied to the treatment of osteochondral defects. METHODS: Hydrogels of various PVA/CS ratios were tested for physiochemical and mechanical properties in addition to cytotoxicity and biocompatibility. The hydrogels with the best PVA/CS ratio were used in the animal study. Osteochondral defects were created at the articular cartilage of 18 rabbits. They were assigned to different groups randomly (n = 6 per group): the osteochondral defect only group (control group), the osteochondral defect treated with hydrogel group (HG group), and the osteochondral defect treated with hydrogel loaded with bone marrow mesenchymal stem cells (BMSCs) group (HG-BMSCs group). The cartilage was collected for macro-observation and histological evaluation at 12 weeks after surgery. RESULTS: The Hydrogel with PVA/CS ratio of 6:4 exhibited the best mechanical properties; it also showed stable physical and chemical properties with porosity and over 90% water content. Furthermore, it demonstrated no cytotoxicity and was able to promote cell proliferation. The HG-BMSCs group achieved the best cartilage healing. CONCLUSIONS: The novel PVA/CS porous composite hydrogel could be a good candidate for a tissue engineering material in cartilage repair.

Transarterial Chemoembolization of Hepatocellular Carcinoma Using Radiopaque Drug-Eluting Embolics: How to Pursue Periprocedural Cross-Sectional Imaging?

PURPOSE: To compare different imaging techniques (volume perfusion CT, cone-beam CT, and dynamic gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid-enhanced dynamic contrast-enhanced MR imaging with golden-angle radial sparse parallel MR imaging) in evaluation of transarterial chemoembolization of hepatocellular carcinoma (HCC) using radiopaque drug-eluting embolics (DEE). MATERIALS AND METHODS: MR imaging and CT phantom investigation of radiopaque DEE was performed. In the clinical portion of the study, 13 patients (22 HCCs) were prospectively enrolled. All patients underwent cross-sectional imaging before and after transarterial chemoembolization using 100-300 µm radiopaque DEE. Qualitative assessment of images using a Likert scale was performed. RESULTS: In the phantom study, CT-related beam-hardening artifacts were markedly visible at a concentration of 12% (v/v) radiopaque DEE; MR imaging demonstrated no significant detectable signal intensity changes. Imaging obtained before transarterial chemoembolization showed no significant difference regarding tumor depiction. Visualization of tumor feeding arteries was significantly improved with volume perfusion CT (P < .001) and cone-beam CT (P = .002) compared with MR imaging. Radiopaque DEE led to significant decrease in tumor depiction (P = .001) and significant increase of beam-hardening artifacts (P = .012) using volume perfusion CT before versus after transarterial chemoembolization. Greater residual arterial tumor enhancement was detected with MR imaging (10 HCCs) compared with volume perfusion CT (8 HCCs) and cone-beam CT (6 HCCs). CONCLUSIONS: Using radiopaque DEE, the imaging modalities provided comparable early treatment assessment. In HCCs with dense accumulation of radiopaque DEE, treatment assessment using volume perfusion CT or cone-beam CT may be impaired owing to resulting beam-hardening artifacts and contrast stasis. Dynamic contrast-enhanced MR imaging may add value in detection of residual arterial tumor enhancement.

Bronchial Artery Embolization for Hemoptysis in Primary Lung Cancer: A Retrospective Review of 84 Patients.

PURPOSE: To evaluate the safety and efficacy of bronchial artery embolization (BAE) in patients with primary lung cancer-related hemoptysis and to identify factors associated with hemoptysis-free survival. METHODS: Data from 84 patients with primary lung cancer (non-small cell [n = 74] and small cell [n = 10]) who underwent BAE from 1997 to 2018 for the management of hemoptysis were retrospectively reviewed. Of these, 53 patients had stage IV lung cancer. The hemoptysis volume prior to initial BAE was trivial (blood-tinged sputum) in 21 patients, moderate (< 300 mL per 24 hours) in 34 patients, and massive (> 300 mL per 24 hours) in 29 patients. RESULTS: Technical success, defined as the ability to selectively embolize the abnormal vessel, was achieved in 83 patients (98.8%), and clinical success was achieved in 69 (82.1%) patients. Polyvinyl alcohol particles were used to embolize in 51 patients, gelfoam in 15 patients, and gelfoam plus microcoils in 17 patients. Hemoptysis recurred in 20 patients (23.8%) during follow-up. The median hemoptysis-free survival and overall survival periods were both 61 days. In the clinical-success and clinical-failure groups, the median overall survival period was 99 and 9 days, respectively (P < .001). In multivariable analysis, massive hemoptysis (P = .012) and cavitary lung mass (P = .019) were predictive factors for shortened hemoptysis-free survival. CONCLUSIONS: BAE is a safe and effective approach to control hemoptysis, although the prognosis in primary lung cancer patients presenting with hemoptysis is generally poor. Massive hemoptysis and cavitary lung mass are significant predictors of shortened hemoptysis-free survival.

Transradial left gastric artery embolization to treat severe obesity: A pilot study.

BACKGROUND: Bariatric surgery is currently the only effective treatment with long-lasting results to treat severe obesity. OBJECTIVES: We performed a pilot study to evaluate the feasibility, safety and efficacy of percutaneous distal embolization of the left gastric artery (LGA) using a transradial approach. METHODS AND RESULTS: We recruited seven severely obese male patients (mean age 48 ± 7 years) referred for diagnostic coronary angiography. Mean baseline weight was 160 ± 27 kg and body mass index was of 52 ± 8 kg/m2 . We successfully injected 300-500 µm polyvinyl alcohol particles using 5Fr catheters and all distal LGA were occluded at the end of procedures. Mean procedure duration was 24 ± 13 min and mean fluoroscopy time was 10 ± 5 min. Six patients reported mild transient epigastric discomfort, which resolved with proton pump inhibitors. At 2 months, the average weight loss was of 7 ± 6 kg (median loss: -10 kg [-2, -11]), 6 ± 12 kg (median loss: -9 kg [-16, +4]) at 6 months and 13 ± 17 kg (median loss: -11 kg [0, -25]) up to 12 months after index procedures. CONCLUSION: Percutaneous transradial LGA embolization appears to be a promising technique to reduce the obesity burden. Randomized trials are required to further delineate the risk/benefit ratio, potential clinical indications and long term results.

Polyvinyl alcohol-iodine induced corneal epithelial injury in vivo and its protection by topical rebamipide treatment.

Periocular povidone-iodine (PI) and polyvinyl alcohol-iodine (PAI) have had a major role in the prevention of endophthalmitis. The purpose of this study was to investigate the corneal epithelial toxicity of PAI in a rabbit eye model using corneal resistance (CR) measurement, which is a good indicator of cell barrier function. Rabbit eyes were administered PAI solution at 4-, 6-, 8-, or 16-fold dilution with physiological saline solution (saline) or saline alone (control), to the conjunctival sac with/without wash-out with saline. Corneal epithelial injury assessed by fluorescein staining and the CR ratio was measured at 10 minutes (min) to 96 hours (h) after the initial administration. Histological observation was performed in the eyes following the PAI or control administrations. At 120 min after administration of PAI solution, the CR ratio was decreased and superficial punctate keratopathy (SPK) was significantly increased in each of the PAI-administered groups compared to the control. Recovery of CR and SPK after administration of 6- or 8-fold dilution of PAI was significantly delayed in eyes that were not subsequently washed with saline compared with eyes that were. Pre- or post-instillation of 2% rebamipide ophthalmic suspension significantly reduced PAI induced-SPK and -decrease of CR ratio. The CR method was able to accurately and quantitatively evaluate fine corneal epithelial injury. It is suggested that eyes should be washed with saline solution after administration of PAI solution or the instillation of rebamipide to prevent or reduce corneal epithelial injury.

Comparison of Clinical Outcomes of Prostatic Artery Embolization with 50-µm Plus 100-µm Polyvinyl Alcohol (PVA) Particles versus 100-µm PVA Particles Alone: A Prospective Randomized Trial.

PURPOSE: To evaluate the safety and efficacy of prostatic artery embolization (PAE) using the combination of 50-µm and 100-µm polyvinyl alcohol (PVA) particles versus 100-µm PVA particles alone in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Over a 5-year period, 120 patients treated with PAE for lower urinary tract symptoms (LUTS) secondary to BPH were randomized to undergo embolization with 50-µm plus 100-µm PVA particles (group A) or 100-µm PVA particles alone (group B). Mean follow-up time was 34 months (range, 12-57 mo). There were no differences between groups regarding baseline data. Primary outcome measurements included change in International Prostate Symptom Score (IPSS) and incidence of adverse events. Secondary outcome measurements included procedure-associated pain, prostate ischemia measured on magnetic resonance (MR) imaging 1 week after PAE, and changes over time in quality of life (QOL) questionnaire, peak urinary flow rate (Qmax), postvoid residual (PVR) volume, prostate volume (PV), prostate-specific antigen (PSA) level, and International Index of Erectile Function (IIEF) were evaluated. Recurrence of LUTS following PAE was defined as relief of LUTS temporally but increased IPSS ≥ 8 or QOL score ≥ 3 or decrease in Qmax to < 7 mL/s. RESULTS: Mean follow-up periods were 35 months ± 22 in group A and 33 months ± 25 in group B (P = .629). No differences between groups regarding procedural details, pain scores, or adverse events were noted (P > .05). At 24 month of follow-up, patients in group A had a greater decrease in mean IPSS (18.7 ± 12.5 vs 14.8 ± 13.5), QOL score (3.7 ± 1.5 vs 2.4 ± 1.8), Qmax (10.5 mL ± 9.5 vs 6.8 mL ± 5.0), PVR (92.0 mL ± 75.0 vs 60.0 mL ± 55.0), and PV (37.0 mL ± 19.5 vs 25.5 mL ± 15.0) compared with patients in group B (P < .05 for all). Mean ratios of prostate ischemic volume at 1 week after PAE were 70% ± 20 in group A and 41% ± 25 in group B (P = .021); mean PSA levels at 24 hour after PAE were 92.5 ng/mL ± 55.0 in group A and 77.5 ng/mL ± 45.0 in group B (P = .031); LUTS recurrence rates were 3.6% in group A and 14.6% in group B (P = .024). The mean IIEF-5 was not significantly different from baseline in either group. CONCLUSIONS: PAE with 50-µm plus 100-µm PVA particles resulted in greater improvement in clinical and imaging outcomes and no significant differences in adverse events compared with 100-µm PVA particles alone.

Intraarterial Lidocaine for Pain Control in Uterine Artery Embolization: A Prospective, Randomized Study.

PURPOSE: To assess efficacy of two different techniques of lidocaine injection in the uterine arteries to reduce pain following uterine artery embolization (UAE) for leiomyomas. MATERIALS AND METHODS: This prospective randomized single-blinded study was performed with 60 patients enrolled between November 2014 and December 2015 equally randomized to 3 arms. Group A received 10 mL lidocaine 1% (100 mg) mixed with polyvinyl alcohol particles (355-500 µm). Group B received the same dose of lidocaine injected after embolization. Group C was a control group. Pain was assessed on a 100-point visual analog scale at 4, 7, and 24 hours after the procedure. Narcotic agent dose to 24 hours was recorded. Outcomes were examined by analysis of variance and pairwise comparison. Leiomyoma infarction was assessed with magnetic resonance imaging 3 months after the procedure. RESULTS: Technical success rate of UAE was 100%. Mean pain score at 4 hours was significantly lower in the lidocaine groups (group A, 28.6; group B, 35.8) compared with the control group (59.4; P = .001). Pain scores at 7 and 24 hours were not statistically different among the 3 arms. The mean in-hospital narcotic agent dose was significantly lower in both lidocaine groups than in the control group (group A, 8.5 mg [P = .002]; group B, 11.1 mg [P = .03]; group C, 17.4 mg). There were no adverse events related to the use of lidocaine. The number of patients with complete infarction of leiomyomas at 3 months was significantly lower in group A at 38.9% (group B, 77.8%; group C, 75%; P = .0451). CONCLUSIONS: Lidocaine injected in the uterine arteries reduced postprocedural pain and narcotic agent dose after UAE. There were more cases of incomplete necrosis when lidocaine was mixed with the particles.

[Clinical effect of polyvinyl alcohol particles combined with chemoembolization in treatment of hepatocellular carcinoma complicated by hepatic arteriovenous shunt and related and prognostic factors].

Objective: To investigate the clinical effect of polyvinyl alcohol (PVA) particles combined with chemoembolization using chemotherapeutic agents or chemotherapeutic agents lipiodol emulsion (CALE) in the treatment of hepatocellular carcinoma (HCC) complicated by hepatic arteriovenous shunt (HAVS) and related prognostic factors. Methods: A retrospective analysis was performed for the clinical data of 133 patients with HCC complicated by HAVS. HAVS was classified into slow-flow HAVS, intermediate-flow HAVS, and high-flow HAVS, which were treated with 300-500µm, 500-710µm, and 710-1000µm PVA particles, respectively. The patients with slow-flow and intermediate-flow HAVS underwent embolization with PVA combined with chemotherapeutic agents followed by CALE, while those with high-flow HAVS underwent the treatment with PVA combined with chemotherapeutic agents alone. The survival time, progression-free survival time, and postoperative complications were followed up and analyzed. The Kaplan-Meier method was used to calculate cumulative survival rate and the Cox proportional hazards model was used to determine prognostic factors. Results: The median overall survival (OS) of 133 patients was 9.1 months, and the 6-, 12-, and 24-month survival rates were 73.7%, 36.2%, and 10.2%, respectively. The median OS of slow-flow group (36 patients), intermediate-flow group (58 patients), and high-flow group (39 patients) were 7.3, 9.1, and 10.8 months, respectively. And the 6- and 12-month survival rates were 69.2%/19.0%, 72.4%/39.2%, and 77.8%/42.7%, respectively. There was no significant difference in survival time between the patients with different types of HAVS (χ2= 2.865,P= 0.239). The incidence rates of postoperative gastroesophageal variceal bleeding and acute liver failure were 1.1% and 0.4%, respectively. The results of Cox regression analysis showed that preoperative alpha-fetoprotein level≥400 ng/ml (HR= 2.105,P= 0.006) was an independent risk factor, while multiple embolizations (HR= 0.482,P= 0.011), tumor remission (HR= 0.431,P= 0.041), and multimodality therapy (HR= 0.416,P= 0.004) were independent protective factors. Conclusion: PVA particles combined with chemotherapeutic agents or CALE is safe and effective in the treatment of HCC complicated by HAVS. Patients with multiple embolizations, tumor remission, and multimodality therapy tend to have good prognosis, while those with a high level of alpha-fetoprotein before embolization often have poor prognosis.

Efficacy and safety of a cationic emulsion in the treatment of moderate to severe dry eye disease: a randomized controlled study.

PURPOSE: To evaluate the efficacy and safety of a preservative-free cationic emulsion (CE) with a 0.18% hyaluronate sodium (HS) solution in patients with moderate to severe dry eye disease (DED) with keratitis or keratoconjunctivitis. METHODS: Eighty-five patients were randomized (1:1) in this multicenter, prospective, reference-controlled, parallel-group, investigator-masked study to receive CE (n = 44) or HS (n = 41). Clinical signs and symptoms were assessed over 3 months. The primary efficacy endpoint was noninferiority of CE to HS in change from baseline of ocular surface staining (OSS) score at 1 month. RESULTS: In the per protocol (PP) set and full analysis set (FAS), CE showed a similar and noninferior (p<0.0001) improvement in OSS scores compared with HS at 1 month (PP: -2.5 ± 1.3 vs -1.9 ± 1.6; FAS: -2.2 ± 1.5 vs -2.0 ± 1.8 for CE vs HS). Other clinical signs of DED similarly improved in both groups. In the FAS, global symptoms score of ocular discomfort was significantly better with CE compared with HS at 1 month (-14.8 ± 17.3 vs -7.6 ± 14.2; p = 0.0469), including greater alleviation of itching (-14.8 ± 21.2 vs -1.7 ± 19.7; p = 0.0100) and eye dryness (-21.9 ± 28.3 vs -8.4 ± 21.4; p = 0.0016). Similar trends were observed at 3 months for itching and eye dryness. Investigator global efficacy assessment and quality of life scores for eye pain and driving favored CE at 3 months. Incidence of adverse events was low in both treatment groups. CONCLUSIONS: CE was similar to HS with regards to safety and efficacy for objective signs but was superior to HS in improving DED symptoms in patients with moderate to severe DED.

Comparison of polyvinyl alcohol and tris-acryl gelatin microsphere materials in embolization for symptomatic leiomyomas: a systematic review.

OBJECTIVE: Use systematic reviews and meta-analyses to assess the effect of polyvinyl alcohol and tris-acryl gelatin microsphere materials in leiomyoma embolization for symptomatic leiomyomas. MATERIAL AND METHODS: We included randomised controlled studies published before January 2015 comparing polyvinyl alcohol and tris-acryl gelatin microsphere materials in uterine leiomyoma embolization for women with symptomatic leiomyomas. The main outcome measures included change of overall quality of life, change of overall symptom severity, changes of uterine and leiomyoma volumes, leiomyoma infarction rate, treatment failure and complications. RESULTS: A total of six randomized controlled studies from 335 studies accounting for 351 women with leiomyomas were identified in this meta-analysis. Compared to polyvinyl alcohol, tris-acryl gelatin microsphere showed a significant benefit in improving the overall quality of life and in reducing uterine volume at three and six months, in reducing overall symptom severity at 6 and 12 months, and furthermore in reducing treatment failure. In addition, tris-acryl gelatin microsphere could significantly reduce leiomyoma volume and decrease <90% complete leiomyoma infarction rate at three months. There were no differences in pain severity, other post-procedural symptoms or medication use in the two groups. CONCLUSIONS: A better effect of tris-acryl gelatin microsphere in leiomyoma embolization for patients with symptomatic leiomyoma.

Comparison of Clinical Outcomes following Glue versus Polyvinyl Alcohol Portal Vein Embolization for Hypertrophy of the Future Liver Remnant prior to Right Hepatectomy.

PURPOSE: To report outcomes after portal vein embolization (PVE) and right hepatectomy in patients receiving embolization with N-butyl cyanoacrylate (NBCA) glue + central AMPLATZER Vascular Plug (AVP; glue group) or polyvinyl alcohol (PVA) particles ± coils (PVA group). MATERIALS AND METHODS: Between March 2008 and August 2013, all patients having PVE with NBCA + AVP or PVA ± coils before right hepatectomy were retrospectively reviewed; 85 patients underwent PVE with NBCA + AVP (n = 45) or PVA ± coils (n = 40). The groups were compared using Mann-Whitney U and χ2 tests. RESULTS: Technical success of embolization was 100%. Degree of hypertrophy (16.2% ± 7.8 vs 12.3% ± 7.62, P = .009) and kinetic growth rate (3.5%/wk ± 2.0 vs 2.6%/wk ± 1.9, P = .016) were greater in the glue group versus the PVA group. Contrast volume (66.1 mL ± 44.8 vs 189.87 mL ± 62.6, P < .001) and fluoroscopy time (11.2 min ± 7.8 vs 23.49 min ± 11.7, P < .001) were significantly less during the PVE procedure in the glue group. Surgical outcomes were comparable between groups, including the number of patients unable to go onto surgery (P = 1.0), surgical complications (P = .30), length of hospital stay (P = .68), and intensive care unit admissions (P = .71). There was 1 major complication (hepatic abscess) in each group after PVE. CONCLUSIONS: PVE performed with NBCA + AVP compared with PVA ± coils resulted in greater degree of hypertrophy of the future liver remnant, less fluoroscopic time and contrast volume, and similar complication rates.

Peripheral Blood Regulatory T-Cell and Type 1 Helper T-Cell Population Decrease after Hepatic Artery Embolization.

PURPOSE: To evaluate changes in T-cell populations in peripheral blood after bland hepatic artery embolization (HAE). MATERIALS AND METHODS: Bland HAE was performed in 12 patients to treat primary (n = 5) or metastatic (n = 7) liver tumors, using microspheres and polyvinyl alcohol (n = 8) or microspheres alone (n = 4). Patient peripheral blood samples were collected within 1 month before HAE, within 1 week after HAE (early period after HAE), and 2-8 weeks after HAE (follow-up period). Peripheral blood populations of cytotoxic T lymphocytes, CD4(+) T cells, type 1 helper T cells (Th1) and type 2 helper T cells (Th2), and regulatory T cells (Treg) were evaluated using flow cytometry. Changes in T-cell populations before and after bland HAE were compared using paired t tests. RESULTS: Peripheral blood CD4(+) T-cell populations decreased significantly in the early period after HAE (44.0% ± 2.2 to 34.4% ± 3.6, P < .01) and in the follow-up period (44.0% ± 2.2 to 36.3% ± 3.0, P < .01). Among the individual CD4(+) T-cell subtypes, Treg (2.5% ± 0.3 to 1.7% ± 0.2, P < .02) and Th1 (8.1% ± 1.8 to 5.6% ± 1.6, P < .02) decreased significantly in the early period after HAE only. The presence of extrahepatic disease was associated with decreasing Treg (P < .04). CONCLUSIONS: After HAE, the peripheral blood T-cell environment is changed with decreases in Treg and Th1.

Embolisation for life-threatening haemoptysis complicated by systemic artery-pulmonary circulation shunts.

SETTING: Tertiary referral centre. OBJECTIVE: To retrospectively observe the characteristics of bronchial angiograms in the setting of systemic artery-pulmonary circulation shunts (SPS), and to evaluate the safety and effectiveness of bronchial artery embolisation (BAE) for these patients with life-threatening haemoptysis. DESIGN: The records of life-threatening haemoptysis patients with SPS who presented to a tertiary referral centre from January 2009 to March 2014 were reviewed. RESULTS: SPS consisted of bronchial artery-pulmonary artery shunt (AAS) in 30 cases, bronchial artery-pulmonary vein shunt (AVS) in 4 cases, non-bronchial systemic artery-pulmonary circulation shunt (n-BPS) in 7 cases and more than one type of SPS in 4 cases (AAS and AVS in 3 cases, three types of SPS in 1 case). BAE using polyvinyl alcohol (PVA) was successful in 97.8% (44/45) of the patients. Cumulative rates of freedom from recurrence at 1 month, 1 year and 2 years were respectively 97.8%, 93.2% and 85.4%. No major procedure-related complications occurred. No significant differences were found in recurrence rates or cumulative haemoptysis control rates among patients with different types of SPS complications (P = 0.55 and 0.46, respectively). CONCLUSION: BAE with PVA was safe and effective for life-threatening haemoptysis complicated by SPS.