Alpha-gal syndrome: when treatment of hypovolemic shock can lead to anaphylaxis.

Delayed anaphylaxis after ingestion of red meat because of galactose-alpha-1,3-galactose (alpha-gal) syndrome has increased in recent years. The mechanism involves an immunoglobulin E reaction to alpha-gal, a molecule found in mammalian meat, dairy products, medications and excipients containing mammalian-derived components, and tick salivary glycans. Sensitization occurs due to the bite of a lone star tick and the transmission of alpha-gal molecules into person's bloodstream. We describe a case of alpha-gal syndrome with severe food, drug, and perioperative allergy in which anaphylaxis with hypovolemic shock occurred immediately after an emergency surgical procedure, when a gelatin-containing drug was injected. This case study confirms that the clinical manifestations of alpha-gal syndrome could be different depending on the route of administration, with immediate reactions if an alpha-gal-containing drug is injected and delayed type allergic manifestations occurring several hours after oral intake. The purpose of this report is to highlight the importance of risk communication in case of exposure to medical products and surgical procedures of patients with alpha-gal syndrome and to encourage drug manufacturers to indicate clearly the origin of excipients in product literature.

Decreased Bleeding-Related Adverse Events Using Track Embolization with Gelatin Sponge Slurry after Percutaneous Liver Biopsy: A Propensity Score-Matched Study.

PURPOSE: To evaluate the effectiveness of track embolization using gelatin sponge slurry in percutaneous ultrasound (US)-guided liver biopsy. MATERIALS AND METHODS: Among the 543 patients who underwent percutaneous US-guided liver biopsies between September 2018 and August 2021, 338 who did not undergo track embolization and 105 who underwent track embolization were included in the analysis. All procedures were performed with 18-gauge coaxial core biopsy needles. Patients' laboratory data were reviewed. Patients in both groups were subdivided into the following 2 groups: (a) those with targeted biopsy for a focal liver lesion and (b) those with nontargeted biopsy for a liver parenchyma. Moreover, postbiopsy events, such as transfusion and transarterial embolization, were assessed. To minimize selection bias, propensity score matching (PSM) was performed. RESULTS: After PSM, all factors that could affect bleeding risk were well-matched and well-balanced between the 2 groups (P > .474). In the non-track embolization group, 17 (16.2%) patients experienced major or minor bleeding-related adverse events (AEs). In contrast, in the track embolization group, only 5 (4.8%) patients experienced major or minor bleeding-related AEs, which was significantly lower than that in the non-track embolization group (P = .007). All 5 (4.8%) cases of major bleeding-related AEs were observed in the non-track embolization group (P = .024). CONCLUSIONS: In this study, a retrospective analysis was performed using PSM for percutaneous US-guided liver biopsy. Track embolization using gelatin sponge slurry is significantly superior in the prevention of bleeding-related AEs after US-guided liver biopsy.

Evaluating the Safety and Effectiveness of Quick-Soluble Gelatin Sponge Particles for Genicular Artery Embolization for Chronic Knee Pain Associated with Osteoarthritis.

PURPOSE: To evaluate the effectiveness and safety of genicular artery embolization (GAE) using quick-soluble gelatin sponge particles (QS-GSPs) to alleviate chronic knee pain associated with osteoarthritis. MATERIALS AND METHODS: This retrospective study included 71 patients (97 procedures, including 26 patients for both knees) who underwent GAE to treat osteoarthritic knee pain between August 2019 and January 2022. QS-GSPs were used for all the procedures. Technical success was defined as the embolization of at least 1 feeding artery. Clinical outcomes were evaluated using a 10-point visual analog scale (VAS). Clinical success was defined as a decrease in the VAS score of >50%. RESULTS: The technical success rate was 100% (97 of 97). The mean VAS scores at baseline, immediately after TAE, and at 1 day, 1 week, 1 month, 3 months, and 6 months after TAE were 6.3, 4.3, 5.0, 3.0, 2.9, 2.9, and 2.8, respectively. The clinical success rate was 72% (70 of 97 patients) at 6 months. No major adverse events were reported, and temporary skin color change (50.5%, 49 of 97) and hematoma at the puncture site (10.3%, 10 of 97) were observed. CONCLUSIONS: GAE using QS-GSPs had a high technical success rate and was considered safe. Clinical outcomes using QS-GSPs were comparable with those of existing materials.

Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy.

OBJECTIVE: This study aimed to measure safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule (DARE-VVA1) among postmenopausal women with moderate-to-severe vulvovaginal atrophy. METHODS: This was a randomized, placebo-controlled, double-blind, phase 1/2 study of DARE-VVA1, in four doses (1, 5, 10 and 20 mg). RESULTS: Seventeen women were enrolled and 14 completed the 8-week treatment. DARE-VVA1 was safe. All adverse events were of mild or moderate severity and distributed similarly among active and placebo groups. Plasma tamoxifen concentrations were highest among women using DARE-VVA1 20 mg, but the maximum mean (standard deviation) plasma tamoxifen concentrations on day 1 (2.66 ± 0.85 ng/ml) and day 56 (5.69 ± 1.87 ng/ml) were <14% of those measured after one oral tamoxifen dose. Active study product users had significant decreases from pre-treatment baseline in vaginal pH and proportion of vaginal parabasal cells (p = 0.04 for both endpoints), with women randomized to the 10 mg or 20 mg dose experiencing the largest treatment impact. The severity of vaginal dryness and dyspareunia decreased significantly from baseline with active study product use (p = 0.02 for both endpoints). CONCLUSIONS: DARE-VVA1 is safe and results in minimal systemic exposure to tamoxifen. Preliminary efficacy data support further development of this product.

Long-term volume reduction in renal angiomyolipomas embolized by gelatin sponge particles with or without supplementary microcoil embolization.

OBJECTIVE: To examine the effect of supplementary microcoil embolization on the long-term progression of angiomyolipomas embolized using gelatin sponge particles (GSPs). METHODS: This retrospective study included 29 unruptured angiomyolipomas in 25 patients, treated by complete embolization and radiological follow-up for ≥3 years. Embolization was performed using GSPs and supplementary microcoils. Supplementary microcoil embolization affecting >90% of the tumor vasculature was defined as microcoil embolization. Tumor volumes pre- and post-embolization were measured by computed tomography or magnetic resonance imaging. RESULTS: Eleven tumors received supplementary microcoil embolization and 18 tumors did not. Relative tumor reduction at >3 years post-embolization was significantly greater in tumors with supplementary microcoil embolization compared with tumors without microcoil embolization (81% ± 8% vs. 55% ± 29%). Fourteen tumors tended to show volume regrowth and the volumes of the remaining 15 tumors continued to decline. Tumors without supplementary microcoil embolization were more likely to show volume regrowth during follow-up than tumors with supplementary microcoil embolization (78% vs. 0%, respectively). CONCLUSIONS: When using a combination of GSPs and microcoils, supplementary microcoil embolization should be carried out to ensure maximum long-term reduction in tumor volume in patients with angiomyolipomas.

Perioperative Gelatin Use Is Associated With Increased Complication Rates and Does Not Prevent Postoperative Fluid Overload in Patients Undergoing Elective Cardiac Surgery.

OBJECTIVES: The benefit of using gelatin solution in cardiac surgery is still controversial. Previous data suggested adverse interactions of gelatin infusion with acute kidney injury (AKI) or coagulopathy. The purpose of this study was to evaluate the association between perioperative gelatin use and fluid overload (FO), hemodynamic stability, and outcomes compared to crystalloid-based fluid management. DESIGN: A retrospective study design. SETTING: At a single-center tertiary university setting. PARTICIPANTS: Propensity score-matched cohort study of 191 pairs of patients scheduled for cardiac surgery. INTERVENTIONS: Patients received either gelatin + crystalloid or pure crystalloid-based perioperative fluid management. The primary outcomes were the frequency of FO and hemodynamic stability defined by the vasoactive-inotropic score. Postoperative complications and 3-year survival were analyzed also. MEASUREMENTS AND MAIN RESULTS: Patients who received gelatin experienced more frequent postoperative FO than controls (11.0% v 3.1%, p = 0.006) despite comparable hemodynamic stability in both groups. Gelatin administration was linked with a higher rate of postoperative complications, including blood loss, AKI, and new-onset postoperative atrial fibrillation. Use of gelatin infusion resulted in an adjusted odds ratio of 1.982 (95% CI 1.051-3.736, p = 0.035) for developing early postoperative AKI. This study confirmed a dose-dependent relationship between gelatin infusion and AKI. Thirty-day mortality and 3-year survival were similar in the groups. CONCLUSIONS: Gelatin administration versus crystalloid fluid management showed a significant association with a higher rate of FO and an increased risk for early postoperative AKI in a dose-dependent manner.

Síndrome de alfa-gal. Alergia a carne roja y gelatina / Alpha-gal syndrome. Allergy to red meat and gelatin

Introducción El síndrome de alfa-gal es una alergia alimentaria potencialmente grave producido por la presencia de IgE específica para alfa-gal. El objetivo de este estudio es describir nuestra serie de 13 pacientes. Material y métodos Estudio retrospectivo de pacientes diagnosticados entre 2016 y 2017. Se realizaron pruebas cutáneas con extracto comercial y gelaspan así como determinación de IgE específica para alfa-gal y diferentes tipos de carne. Resultados Se analizó a 13 pacientes diagnosticados de síndrome de alfa-gal, 9 de ellos con anafilaxia, de los cuales 6 habían sido diagnosticados de anafilaxia idiopática. Todos presentaron prueba cutánea con gelaspan positiva, y no así con los extractos comerciales, cuyos resultados fueron menos concluyentes. Conclusiones Creemos que la anafilaxia idiopática puede esconder pacientes con síndrome de alfa-gal. La prueba cutánea con gelaspan es más útil que los extractos comerciales (AU)

Introduction Alpha-gal syndrome is a potentially severe food allergy caused by the presence of alpha-gal-specific IgE. The aim of this study is to describe our series of 13 patients. Material and methods This work is a retrospective study of patients diagnosed in 2016 and 2017. Skin tests were performed with commercial extract and gelaspan as well as specific IgE determination for alpha-gal and different types of meat. Results Thirteen patients diagnosed with alpha-gal syndrome were analyzed; 9 of them had anaphylaxis, 6of whom had been diagnosed with idiopathic anaphylaxis. All had a positive skin test with gelaspan, though this was not true with the commercial extracts, whose results were less conclusive. Conclusions We believe that a diagnosis of idiopathic anaphylaxis may prevent the identification of patients with alpha-gal syndrome. The gelaspan skin test is more useful than commercial extracts (AU)

Management of Symptomatic Vascularized Retained Products of Conception by Proximal Uterine Artery Embolization with Gelatin Sponge Torpedoes.

PURPOSE: To evaluate the effectiveness and safety of temporary proximal uterine artery embolization (UAE) for the treatment of highly vascularized retained products of conception (RPOCs). MATERIALS AND METHODS: This retrospective analysis included women who underwent treatment for vaginal bleeding after abortion, miscarriage, or delivery, with highly vascularized RPOCs detected by Doppler ultrasound (US) (ie, presence of an enhanced myometrial vascularity, a low resistance index of <0.5, and a peak systolic velocity of ≥0.7 m/s). A unilateral or bilateral embolization with torpedoes of gelatin foam was performed. From November 2017 to January 2021, 24 women with a median age of 30 years (interquartile range, 26.0-34.5 years) with symptomatic highly vascularized RPOCs were included. Clinical success was defined as bleeding arrest between the UAE and 1-month follow-up. Technical success was defined as the complete obstruction of at least 1 uterine artery supplying vascular abnormalities. The safety of the procedure according to the classification of the Society of Interventional Radiology and evolution of lesions on US were also reported. RESULTS: Technical success was achieved in all 24 (100%) patients, with bilateral arterial embolization in 19 (79%) patients and unilateral embolization in 5 (21%) patients. Clinical success was achieved in all 24 (100%) patients. Five patients still had uterine retention at the 1-month follow-up, including 2 patients with highly vascularized RPOCs. Two patients benefited from hysteroscopy, and 3 had noninvasive management. Four minor adverse events were reported (1 patient had infectious endometritis and 3 patients had a postembolization syndrome). CONCLUSIONS: Proximal UAE with torpedoes of gelatin foam is safe and effective for the management of symptomatic highly vascularized RPOCs.

Intraoperative Anaphylaxis to the Bovine Flowable Gelatin Matrix: A Report of 2 Cases.

CASE: We present 2 cases of life-threatening intraoperative anaphylaxis to the bovine flowable gelatin matrix during pediatric spinal deformity surgery for kyphoscoliosis. Both patients had no known bovine or gelatin allergies. Anaphylaxis occurred shortly after pressurized injection into the first cannulated pedicle tract and was successfully treated with epinephrine, diphenhydramine, and methylprednisolone infusion. The allergic reaction was confirmed with tryptase levels and serum-specific immunoglobulin E for beef, pork, bovine collagen, and porcine collagen. CONCLUSION: In patients with beef, pork, or gelatin intolerance, a significant atopic history or childhood vaccine reaction, preoperative allergy consultation, and testing should be performed to prevent this life-threatening complication.

Clinical application of gelatin sponge microparticles-transcatheter arterial chemoembolization combined with synchronous antigen-presenting dendritic cell sequential reinfusion for treatment of advanced large liver cancer: A single-center, prospective, non-randomized, controlled trial.

ABSTRACT: To assess the clinical efficacy and safety of gelatin sponge microparticles-transcatheter arterial chemoembolization (GSMs-TACE) plus synchronous antigen-presenting dendritic cell (DC) sequential reinfusion for advanced large liver cancer (LC).Patients with large LC were assigned to the experimental (combined sequential DC therapy) or control group. All patients received standardized GSMs-TACE. In the experimental group, 60 mL of peripheral blood was collected for in vitro culture of DCs (10-14 days). Then, intravenous reinfusion was conducted 3 times within 10, 20, and 30 days after surgery. Adverse reactions during the treatment were recorded and evaluated. The overall survival, transcatheter arterial chemoembolization frequency, and physical score (PS) were calculated.The median survival time of the experimental group was significantly longer than that of the control group. There were significant differences in median progression-free survival between the 2 groups (P < .05) and the objective effective rate at 1 and 6 months and 1 year (P < .05), but not 2 years (P > .05). The PSs of 2 groups were significantly improved at 1 month after GSMs-TACE, with more obvious improvement in the experimental group (P < .05).GSMs-TACE plus synchronous DC sequential reinfusion significantly prolonged the median survival time, improved the tumor response rate and PS, prolonged progression-free survival, and reduced intervention frequency. GSMs-TACE plus synchronous DC sequential reinfusion treatment is suitable for comprehensive treatment of patients with advanced larger LC in China.

Gelatin and the risk of acute kidney injury after cardiac surgery.

BACKGROUND: Gelatin has been used as a plasma volume expander because of its ability to preserve intravascular volume more effectively than crystalloids. However, gelatin may have detrimental effects on kidney function and increase the risk of acute kidney injury (AKI). METHOD: We investigated by retrospective analysis of prospectively collected data whether the administration of 4% succinyl gelatin is associated with an increased risk of AKI after cardiac surgery. We compared two propensity score-matched groups of 1,187 patients (crystalloid group and gelatin group). RESULTS: The incidence of AKI was similar in both groups (gelatin 21% and crystalloid 20%) (p = 0.414). The incidence of moderate AKI (8% vs. 6%) was higher in the gelatin group, but there was no difference in mild or severe AKI. Postoperative serum creatine on the first (70 vs. 70 µmol L-1 , p = 0.689) or fourth (71 vs. 70, p = 0.313) postoperative day was similar between groups and there was no difference in the need for new renal replacement therapy (p = 0.999). Patients in the gelatin group received less crystalloids (2080 ml vs. 4130 ml, p = 0.001) and total fluids (3760 ml vs. 4180 ml, p = 0.001), their fluid balance was less positive (p = 0.001) and they required less vasoactive and inotropic medication (p = 0.001). Gelatin was not associated with increased mortality compared to the crystalloid group. CONCLUSION: Gelatin was not associated with AKI after cardiac surgery.

Alpha-gal syndrome. Allergy to red meat and gelatin.

INTRODUCTION: Alpha-gal syndrome is a potentially severe food allergy caused by the presence of alpha-gal-specific IgE. The aim of this study is to describe our series of 13 patients. MATERIAL AND METHODS: This work is a retrospective study of patients diagnosed in 2016 and 2017. Skin tests were performed with commercial extract and gelaspan as well as specific IgE determination for alpha-gal and different types of meat. RESULTS: Thirteen patients diagnosed with alpha-gal syndrome were analyzed; 9 of them had anaphylaxis, 6 of whom had been diagnosed with idiopathic anaphylaxis. All had a positive skin test with gelaspan, though this was not true with the commercial extracts, whose results were less conclusive. CONCLUSIONS: We believe that a diagnosis of idiopathic anaphylaxis may prevent the identification of patients with alpha-gal syndrome. The gelaspan skin test is more useful than commercial extracts.

Serum CD203c+ Extracellular Vesicle Serves as a Novel Diagnostic and Prognostic Biomarker for Succinylated Gelatin Induced Perioperative Hypersensitive Reaction.

Background: Perioperative hypersensitivity reaction (HR) is an IgE-FcϵRI-mediated hypersensitivity reaction with degranulation and activation of mast cells and basophils. Several studies have focused on assessing the degranulation and activation of mast cells and basophils to diagnose and predict the prognosis of drug induced HR. However, it is challenging to isolate sufficiently pure mast cells and basophils from human sources to investigate. Effective biomarkers to assess mast cells and basophils activation in vivo could potentially have high diagnostic and prognostic values. In the present study, we investigated EVs pelleted from serum in patients with succinylated gelatin induced HR. Methods: Extracellular vesicles (EVs) were isolated using a total exosome isolation kit and ultracentrifugation, characterized by Western blot, transmission electron microscopy, and nanoparticle tracking analysis. Basophils were isolated from fresh peripheral blood by negative selection using Basophil Isolation Kit II. Human mast cell line was stimulated with IL4. The expression levels of proteins related to the hypersensitive response were evaluated by Western blotting and flow Cytometer. Histamine and tryptase levels were tested using a commercial ELISA kit, and gene expression of inflammatory mediators was evaluated by qRT-PCR. The receiver operating characteristic (ROC) curve was used to evaluate the specificity and sensitivity of biomarker in predicting HR. Results: The concentration of EVs and protein expression level of CD63, FcϵRI, CD203c and tryptase were significantly (p< 0.05) increased in HR samples. The expression level of mast cell/basophil specific CD203c were significantly increased in EVs derived from serum and basophils of HR patients, and the CD203c+-EVs production in mast cells is dramatically increased in the presence of IL4, which positively correlated with histamine, tryptase and inflammatory mediators. Moreover, the ROC curve of EVs concentration and CD203c expression indicated that CD203c+-EVs had a strong diagnostic ability for HR. Conclusion: Serum CD203c+-EVs serves as a novel diagnostic and prognostic biomarker for HR.

Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis.

BACKGROUND: Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintain adequate tissue oxygenation. The right choice of fluids to be used for plasma volume replacement (colloid or crystalloid solutions) is still a matter of debate, and large trials investigating the use of colloid solutions containing gelatine are missing. This study aims to investigate the efficacy and safety of plasma volume replacement using either a combined gelatine-crystalloid regime (1:1 ratio) or a pure crystalloid regime. METHODS: This is a prospective, controlled, randomized, double-blind, international, multicentric phase IV study with two parallel groups that is planned to be conducted at European intensive care units (ICUs) in a population of patients with hypovolaemia in severe sepsis/septic shock. A total of 608 eligible patients will be randomly assigned to receive either a gelatine-crystalloid regime (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG, in a 1:1 ratio) or a pure crystalloid regime (Sterofundin® ISO) for plasma volume replacement. The primary outcome is defined as the time needed to achieve HDS. Plasma volume replacement will be target-controlled, i.e. fluids will only be administered to volume-responsive patients. Volume responsiveness will be assessed through passive leg raising or fluid challenges. The safety and efficacy of both regimens will be assessed daily for 28 days or until ICU discharge (whichever occurs first) as the secondary outcomes of this study. Follow-up visits/calls will be scheduled on day 28 and day 90. DISCUSSION: This study aims to generate evidence regarding which regimen-a gelatine-crystalloid regimen or a pure crystalloid regimen-is more effective in achieving HDS in critically ill patients with hypovolaemia. Study participants in both groups will benefit from the increased safety of target-controlled plasma volume replacement, which prevents fluid administration to already haemodynamically stable patients and reduces the risk of harmful fluid overload. TRIAL REGISTRATION: The European clinical trial database EudraCT 2015-000057-20 and the ClinicalTrials.gov Protocol Registration and Results System ClinicalTrials.gov NCT02715466 . Registered on 17 March 2016.

Gelatin-Containing Vaccines for Varicella, Zoster, Measles, Mumps, and Rubella Induce Basophil Activation in Patients with Alpha-Gal Syndrome.

BACKGROUND: The alpha-gal syndrome (AGS) describes a new type I allergy entity to the carbohydrate epitope galactose-α-1,3-galactose (alpha-gal), which is mainly found in mammalian food products (e.g., beef, pork, and venison). Apart from meat products, alpha-gal can also be found in products containing gelatin of bovine or porcine origin. Recent case reports pointed to severe anaphylaxis in patients suffering from AGS after vaccination with vaccines containing hydrolyzed gelatin. It was the objective of this study to evaluate if basophil activation tests (BATs) performed with such vaccines were positive in patients with AGS. METHODS: BAT was performed with different dilutions of a gelatin-containing measles, mumps, and rubella (MMR) live vaccine; an attenuated varicella (V) vaccine; an attenuated V-zoster (VZ) vaccine; a MMR live vaccine not containing gelatin (non-gelatin MMR vaccine) in 2 patients with confirmed AGS, 2 patients highly suspicious for AGS, and 2 healthy individuals without any previous medical history for allergies. RESULTS: All patients showed strongly positive results for all gelatin-containing vaccines (MMR vaccine, V vaccine, and VZ vaccine). Non-gelatin MMR vaccine was negative. The 2 healthy controls did not show any basophil activation. CONCLUSIONS: Gelatin-containing vaccines should be administered with caution or avoided in patients with AGS because of their high potential to activate basophils indicating a risk for anaphylaxis. Also, BAT is a useful additional tool when it comes to screening for potentially high-risk alpha-gal-containing drugs.

Review of topical gelatin-based haemostatic agents; an insidious culprit of intraoperative anaphylaxis?

BACKGROUND: An under-recognized complication of gelatin-based haemostatic agents is their potential to cause anaphylactic reactions. This review aims to collate and analyse case in the literature of intraoperative anaphylaxis secondary to locally applied haemostatic agents. METHODS: An electronic search was performed on databases Medline, Embase, Pubmed and ProQuest. A total of 7671 articles were reviewed from title and abstract. After exclusion criteria and duplicates removed, 19 articles with 21 cases were included for analysis. Data extracted from each of the articles included patient demographics, haemostatic agent used, surgery type, known allergies and any objective evidence of hypersensitivity post anaphylactic episode, that is tryptase levels, IgE levels, skin prick testing. RESULTS: Fifty-seven percent of cases involved patients <18 years of age; 57% of cases involved spinal surgery; 100% of cases displayed objective evidence of hypersensitivity (tryptase levels, bovine or porcine IgE levels, or skin prick testing). Thirty-three percent of patients had exposure preoperatively to a known agent causing anaphylaxis or allergy which would preclude the use of a gelatin-based haemostat. These products included vaccines, spam meats, red meat, Jell-O and CollaPlug. Gelatin-based haemostat agents included Floseal, Gelfoam, Surgiflo, fibrin glue, Avitene, haemofibrine sponge, topical bovine thrombin and thrombin-soaked gelatin. CONCLUSION: Increased awareness of allergy to gelatin-based haemostats for surgical and anaesthetic is imperative, with 33% of cases having a known contraindication to gelatin-based haemostat. This review highlights important aspects in the pre-operative patient history and post-event patient investigation that could assist anaesthetists and surgeons in the prevention of future events.

Superior Rectal Artery Embolization with Tris-Acryl Gelatin Microspheres: A Randomized Comparison of Particle Size.

PURPOSE: To evaluate the safety and efficacy of superior rectal artery embolization (SRAE) with different-sized tris-acryl gelatin microspheres in symptomatic hemorrhoidal disease (HD). MATERIALS AND METHODS: Forty-two patients (male, 30; female, 12; median age, 45 years) with symptomatic HD (2 grade I, 8 grade II, 17 grade III, and 15 grade IV) were divided into 3 experimental arms (500-700 µm, 700-900 µm, and 900-1,200 µm groups; each had 14 patients) in a prospective randomized style to perform SRAE. Follow-up was performed by rectoscopy, clinical examination, and questionnaires. The primary outcome measure was the clinical success rate at 12 months. Secondary outcome measures were technical success rate, recurrence rate, procedure-related mortality, procedure-related complications, and any outcome changes between particle sizes. RESULTS: No procedure-related deaths or major morbidities were observed. There was a 54% minor complication rate (n = 23/42) in the treated zone: 45% sustained small superficial ulcerations (n = 19/42), 7% small rectosigmoid junction ulcerations (n = 3/42), and 2% small fibrotic scar tissue (n = 1/42). The clinical success rate was 93%. Of the groups, the best French bleeding score decrease was obtained in the 900-1,200 µm group. There were improvements in the quality of life score and visual analogue scale score after the SRAE procedure, although not in the Goligher score. No recurrent disease was observed. CONCLUSIONS: SRAE with tris-acryl gelatin microspheres for symptomatic HD is a safe and efficient treatment, with results favoring the use of larger microspheres.

Safety and Efficacy of Arterially Directed Liver Therapies in the Treatment of Hepatic Metastatic Ovarian Cancer: A Retrospective Single-Institution Study.

PURPOSE: To evaluate the safety and efficacy of 2 locoregional therapies (LRTs) including hepatic artery embolization (HAE) and transarterial radioembolization (TARE) in the treatment of patients with metastatic ovarian cancer to the liver. MATERIAL AND METHODS: From October 2010 to May 2019, the data of 15 consecutive patients (median age, 54 years ± 9.8; range, 35-78 years) with hepatic metastatic ovarian cancer who were treated with either HAE (n = 6; 40%) or TARE (n = 9; 60%) were reviewed. The most common histopathologic type was epithelial ovarian carcinoma (80%). The most common chemotherapy regimens used prior to embolization included carboplatin, paclitaxel, cisplatin, and bevacizumab. Patients received a mean of 4 lines ± 3 (range, 1-9) of chemotherapy. All patients with serous carcinoma were resistant to platinum at the time of embolization. Indications for embolization were progression of disease to the liver while receiving chemotherapy in 14 (93.3%) patients and palliative pain control in 1 patient. RESULTS: The overall response rates at 1, 3, and 6 months were 92.4%, 85.6%, and 70%, respectively. Median overall survival from the time of LRT was 9 (95% confidence interval [CI], 4-14) months. Median local tumor progression was 6.4 months ± 5.03 (95% CI, 3.3-9.5). No grade 3-5 adverse events were detected in either group. CONCLUSIONS: HAE and TARE were well tolerated in patients with metastatic ovarian cancer to the liver and possibly ensured prolonged disease control in heavily treated, predominantly in patients resistant to platinum. Larger numbers are needed to verify these data.