Treatment of gastric varices with cyanoacrylate complicated by systemic embolization.

Acute gastric variceal bleeding is a life-threatening condition that could be effectively treated with endoscopic cyanoacrylate injection diluted with lipiodol. The mixture acts as a tissue adhesive that polymerizes when in contact with blood in a gastric varix. This work reports a patient that presented to the emergency department with upper gastrointestinal bleeding due to acute variceal bleeding, who developed systemic embolization following cyanoacrylate injection therapy. This complication culminated in cerebral, splenic and renal infarctions with a fatal outcome. Systemic embolization is a very rare, but the most severe complication associated with endoscopic cyanoacrylate injection and should be considered in patients undergoing this treatment.

Comparison of Radiofrequency Ablation and Cyanoacrylate Closure for Large-Diameter Great Saphenous Vein Insufficiency.

BACKGROUND: To compare radiofrequency ablation (RFA) and cyanoacrylate closure (CAC) for large-diameter great saphenous vein (GSV) insufficiency between diameters of 12 and 16 mm. METHODS: This study is a single-center retrospective study. Subjects who underwent endovenous treatment with RFA (Group A) or CAC (Group B) for GSV insufficiency between June 2015 and June 2021 who were followed up for at least 2 years were included in the study. Subjects who had a 12-mm to 16-mm target vessel diameter and subjects with grade 3 and grade 4 reflux were included. Subjects' demographic data (age, sex), body mass indices, clinical, etiological, anatomic, pathophysiologic classification, GSV diameter, reflux grade, target vessel length, preoperative venous clinical severity score (VCSS), procedural time, postoperative first-day pain scores, postoperative 14th-day patient satisfaction scale, and postoperative complications were noted. In follow-up, subjects were evaluated with duplex ultrasonography and VCSS at 1, 6, 12, and 24 months. RESULTS: In total, 142 subjects were included (n = 71 for both groups). The mean GSV diameter was 13.21 ± 1.00 for Group A and 13.51 ± 0.97 for Group B. The groups did not differ in terms of age, sex, body mass index, clinical, etiological, anatomic, pathophysiologic classification, GSV diameter, reflux grade, target GSV length, preoperative VCSS, complications, postoperative 24-hr pain status or postoperative 14-day patient satisfaction scale (P > 0.05 for all comparisons). The procedure time was significantly shorter in Group B (34.68 ± 4.22 min for Group A vs. 22.59 ± 4.5 min for Group B, P = 0.001). In the 1-month and 6-month Duplex ultrasonography of the subjects, partial closure and patency rates in Group B were significantly higher than those in Group A (P = 0.003 and P = 0.025, respectively). At the 12-month and 24-month evaluation, closure rates did not show a statistically significant difference between the groups (P = 0.056 and P = 0.090, respectively). Preoperative and 1-month VCSS measurements did not show a statistically significant difference between groups (P > 0.05 for all comparisons). The 6-month, 12-month, and 24-month VCSS measurements of Group A were significantly higher than those in Group B. (P = 0.043, P = 0.009 and P = 0.002, respectively). CONCLUSIONS: Both RFA and CAC were found to be effective in the treatment of large-diameter GSV incompetency. The complication rates were similar between the 2 techniques. CAC had a shorter procedure time. Although the closure rates in the early postoperative period were better in the RFA group, long-term follow-up demonstrated similar patency rates. The functional results in the long-term follow-up were better in the RFA group.

Hypersensitivity reactions following vein closure therapy with venasealTM (n-butyl- 2-cyanoacrylate).

VenaSealTM is composed of a cyanoacrylate adhesive compound often utilized for chronic venous stasis treatment. Rare case reports of hypersensitivity reactions to this compound exist. We present the first case of dermatographism and angioedema after utilization of VenaSealTM successfully treated via high dose antihistamines. We also present a case of type IV hypersensitivity to VenaSealTM, a cyanoacrylate, occurring in a patient with known meth(acrylate) allergy indicating a possible cross reactivity between these acrylate groups.

[Recurrent Bacteremia after Cyanoacrylate Sclerotherapy of Ectopic Duodenal Varices]. / Bacteriemias Recorrentes após Escleroterapia de Varizes Ectópicas Duodenais com Cianoacrilato.

Sclerotherapy with N-butyl-2-cyanoacrylate is the first-line endoscopic approach for gastric and ectopic variceal bleeding, but it can be associated with local or systemic complications. Episodes of transient bacteremia after the procedure are frequent, but documented cases of recurrent bacteremia are rare. The authors report a 47-year-old female patient with liver cirrhosis who underwent duodenal sclerotherapy with cyanoacrylate after upper gastrointestinal bleeding. Subsequently, she developed five episodes of bacteremia with unknown origin. A definitive diagnosis of recurrent bacteremia due to cyanoacrylate was only possible after an exhaustive study to exclude other infectious foci. This case highlights a rare complication in an unusual topography (ectopic varices) and with a high number of episodes of bacteremia. A multidisciplinary management was paramount due to the patient's high surgical and anesthetic risk, comorbidities, and surgical aggressiveness.

A escleroterapia com N-butil-2-cianoacrilato é a abordagem endoscópica de primeira linha nas hemorragias por varizes gástricas ou ectópicas, podendo estar associada a complicações locais ou sistémicas. São frequentes situações de bacteriemia transitória após o procedimento, mas são raros os casos documentados de bacteriemias recorrentes. O caso relata uma doente de 47 anos com cirrose hepática submetida a esclerose de varizes duodenais com cianoacrilato após hemorragia digestiva alta. Posteriormente, desenvolveu cinco episódios de bacteriémia sem foco evidente. O diagnóstico definitivo de bacteriemias recorrentes com ponto de partida no cianoacrilato só foi possível após estudo exaustivo para excluir outros focos infeciosos. Este caso evidencia uma complicação rara, numa topografia também incomum (varizes ectópicas) e com um elevado número de episódios de bacteriémia. Destaca-se a importância de uma abordagem multidisciplinar para gerir esta doente, tendo em conta as comorbilidades, o elevado risco anestésico e a agressividade cirúrgica para extração do foco infecioso.

899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure.

OBJECTIVE: The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies. METHODS: The Total Product Life Cycle (TPLC) database of the US Food and Drug Administration (FDA), the Database of Adverse Event Notifications (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the Yellow Card database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed. Three Freedom of Information (FOI) requests had to be submitted to the MHRA to obtain data. RESULTS: The TPLC contained 899 reports which included 13 cases of death, 7 strokes, 211 thromboembolic events, and 482 immune reactions. The DAEN recorded three reportable adverse events, and the MHRA recorded seven adverse incidents including one death. CONCLUSION: CAC is associated with serious adverse events including death. These events are under-reported in the medical literature and only sub-optimally reported to the regulatory agencies.

The Novel Surgical Technique in the Cyanoacrylate Closure for Incompetent Great Saphenous Veins.

OBJECTIVE: The current Instructions for Use (IFU) of cyanoacrylate closure (CAC) is to start initial injection with the catheter tip positioned 5 cm distal to the sapheno-femoral junction (SFJ) to prevent endovenous glue-induced thrombosis (EGIT). However, this defensive design is responsible for the relatively long stump length. Although clinical studies on the long-term recurrence rate are still lacking, the long stump length can predict a higher long-term recurrence rate compared to other surgical methods. The author developed a novel surgical technique that can overcome the weakness of CAC, and the initial outcomes of this technique are described in this article. METHODS: This study retrospectively reviewed 25 great saphenous vein (GSV) in 20 patients who underwent CAC for incompetent GSV at our hospital. The procedure from puncturing the GSV to insertion of the catheter is the same as the conventional method. Place the catheter tip 2-3 cm below the SFJ before cyanoacrylate injection. After confirming the position of the SFJ with the longitudinal view of the ultrasound, press the GSV directly above the SFJ transversely with the second to fifth fingertips of the left hand. Then, the ultrasound probe is placed against the distal part of the fingertips, and CA injection is performed while GSV is monitored in real time. RESULTS: The mean stump length immediately after surgery was 19.3 (± 7.8) mm, with a range of .0-38.4 mm. The mean stump length after 1 week was 12.3 (± 7.4) mm and the range was .1-35.4 mm. The mean stump length after 1 month was 15.4 (± 10.1) mm, and the range was .0-35.4 mm. There was no case with EGIT or recanalization. CONCLUSIONS: The author confirmed the possibility of safely reducing stump length with this novel surgical technique, and expect that this method can help overcome the weakness of CAC.

Outcomes of Cyanoacrylate Closure Versus Radiofrequency Ablation for the Treatment of Incompetent Great Saphenous Veins.

BACKGROUND: Evaluation of the efficacy and safety of cyanoacrylate closure (CAC) for treating incompetent great saphenous veins (GSVs) compared to radiofrequency ablation (RFA). METHODS: In this prospective, randomized controlled study, 248 symptomatic subjects with incompetent GSVs were assigned to either CAC or RFA. The primary end point, complete closure of the target GSV, was determined using a duplex ultrasound examination. RESULTS: In this study, 248 patients (mean age 33.64 ± 8.06 years including 71% women) were treated with either CAC (n = 128) or RFA (n = 120) between August 2018 to May 2022. As a follow-up, after a 1-month duration, the closure rates were 128/128 at the CAC and 154/158 at the RFA. At month 24, closure rates were 122/128 at CAC and 146/158 at RFA. Apart from phlebitis and pigmentation, the incidences of bruising, skin burn, and paresthesia were lower in the CAC group compared to the RFA group. The mean procedural times were shorter for CAC. The satisfaction level with the treatment was moderately higher among CAC patients than RAF patients. CONCLUSIONS: This study suggests that Cyanoacrylate glue closure of the GSV and RFA are effective techniques for managing primary varicose veins. Cyanoacrylate glue closure of the GSV appears to have a lower rate of complications and higher satisfaction levels, rapid return to normal activities, and improved procedure time without the need for perivenous tumescent anesthesia and postprocedure compression stockings when compared to RFA.

Cyanoacrylate glue as part of a new bundle to decrease neonatal PICC-related complications.

A "bundle" is defined as a combination of evidence-based interventions that, if followed collectively and reliably, improve patient outcomes. The aim of this quasi-experimental study, conducted in a level-III NICU in Belgium, was to assess the impact of central line dressing and maintenance bundle implementation on the rate of catheter-related mechanical complications. We performed a quality improvement (QI) project. Prior to bundle implementation, neonatal PICC lines were secured by Steri-Strip® and occlusive dressing. We implemented a new PICC bundle consisting of the use of glue, sutureless device (Griplock®), and a transparent dressing to secure the catheter to the skin. We compared the rate of infections, mechanical complications, and dislocations before and after bundle implementation (periods 1 and 2, respectively). The use of glue resulted in a significantly decreased rate of central line-associated bloodstream infection (CLABSI) (p < 0.001), dislocations, and mechanical complications (p < 0.0001). During period 2, there was a significant increase for the average number of days the catheter stayed in place (p < 0.05). We did not observe catheter breakage or patient skin irritations attributable to the use of glue (not even in ELBW infants). CONCLUSION: The implementation of the new bundle to secure neonatal PICCs in our NICU was associated with a significant reduction in CLABSI and dislodgment rates, without glue-related complications. Active surveillance of CVC placement procedure, positioning, and management, as well as analysis of related complications is crucial for improving patient safety. Continuous implementation of up-to-date central line bundles based on best practice recommendations is a key for quality improvement in NICUs. WHAT IS KNOWN: • Stable vascular access is crucial in the NICU. Neonatal PICC securement issues can have serious consequences and are associated with device failure. WHAT IS NEW: • Catheter securement with tissue adhesive is safe and effective in reducing failure and complication rates in the neonatal population.

Complications of cyanoacrylate adhesive closure therapy in chronic venous insufficiency: A single center, single-surgeon study.

OBJECTIVES: In this study, we present the complication data of patients we treated for chronic venous insufficiency (CVI) with cyanoacrylate adhesive closure (CAC) therapy for 2 years. METHODS: Complications of 382 CAC procedures performed by the same surgeon were reviewed retrospectively. RESULTS: Independent of patients, depending on the payment system of the state; two hundred twenty-three (58.4%) of 382 procedures were performed using the Venex system, and the Variclose system was used in 159 (41.6%) patients. A phlebitis-like reaction occurred in 46 (12%) patients, induration in 18 (4.7%) patients, hyperpigmentation in five (1.3%) patients, abscesses in four (1%) patients, cellulitis in three (0.8%) patients, and granuloma in one (0.3%) patient. In addition, as serious complications, deep vein thrombosis (DVT) developed in three patients and pulmonary embolism in one of these patients. Interestingly, temporary blindness was also observed in one patient. CONCLUSIONS: Although CAC therapy is a reliable method, its complications should not be ignored. Its use by experienced surgeons reduces the risk of complications.

Type IV Hypersensitivity Reaction after Cyanoacrylate Venous Closure.

BACKGROUND: Nonthermal endovenous closure techniques are routinely utilized to treat superficial axial venous reflux. Cyanoacrylate closure is a safe and effective modality implemented for truncal closure. However, an adverse reaction of type IV hypersensitivity (T4H), unique to cyanoacrylate, is a known risk. This study aims to evaluate the real-world incidence of T4H and examine risk factors that may predispose its development. METHODS: A retrospective review between 2012- and 2022 was performed at four tertiary US institutions to examine patients who underwent cyanoacrylate vein closure of their saphenous veins. Patient demographics, comorbidities, CEAP (Clinical [C], Etiological [E], Anatomical [A], and Pathophysiological [P]) classification, and periprocedural outcomes were included. The primary endpoint was development of T4H post procedure. Logistic regression analysis for risk factors predictive of T4H was performed. Variables with a P-value of <0.05 were deemed significant. RESULTS: 595 patients underwent 881 cyanoacrylate venous closures. Mean age was 66.2 ± 14.9, and 66% of patients were female. There were 92 (10.4%) T4H events in 79 (13%) patients. Oral steroids were administered to 23% for persistent and/or severe symptoms. There were no systemic allergic reactions to cyanoacrylate. Multivariate analysis revealed younger age (P = 0.015), active smoking status (P = 0.033), and CEAP 3 (P < 0.001) and 4 (P = 0.005) classifications as independent risk factors associated with development of T4H. CONCLUSIONS: This real-world multicenter study shows the overall incidence of T4H to be 10%. CEAP 3 and 4 patients of younger age and smokers predicted a higher risk of T4H to cyanoacrylate.

Incidence and Clinical Impact of Endovenous Glue-Induced Hypersensitivity Among Patients Who Underwent Endovenous Cyanoacrylate Ablation Procedures: A Registry-Based Cohort Study.

BACKGROUND: The characteristics of endovenous glue-induced hypersensitivity (EGIH) remain unclear. OBJECTIVE: To assess the clinical impacts on patients with EGIH after endovenous cyanoacrylate-glue ablation (CA). MATERIALS AND METHODS: A prospectively designed endovenous CA-specific registry was created, and a total of 335 limbs from 173 patients who underwent endovenous CA were enrolled for a cohort study. RESULTS: Symptomatic EGIH was observed in 55 (31.8%) patients. Beyond the target vein area, systemic side effects were noted in 5.8% of the treated patients after CA. The median onset time was 13 postoperative days (range: 1-35 days). The median duration was 7 days, but about 10.9% of the affected patients experienced symptoms lasting longer than 4 weeks. In the EGIH and non-EGIH groups, significant improvements in venous clinical severity score and Chronic Venous Insufficiency Quality of Life Questionnaire-14 scores were observed 3 months postoperatively. The development of EGIH did not affect the postoperative patient-reported satisfaction scores ( p = .524). CONCLUSION: EGIH is observed in a substantial proportion of patients. The side effects do not affect the clinical outcomes and patient-reported outcome measures. Further studies are required on the detailed pathogenesis and definition of EGIH.

Clinical outcomes of clip-assisted endoscopic cyanoacrylate injection versus conventional endoscopic cyanoacrylate injection in treating gastric varices with a gastrorenal shunt.

BACKGROUND AND STUDY AIMS: The optimal treatment for gastric varices (GVs) is a topic that remains definite for this study. This study compared the clinical outcomes of clip-assisted endoscopic cyanoacrylate injection (clip-ECI) to conventional endoscopic cyanoacrylate injection (con-ECI) for the treatment of GVs with a gastrorenal shunt. PATIENTS AND METHODS: Data were collected retrospectively in five medical centers from 2015 to 2020. The patients were treated with con-ECI (n = 126) or clip-ECI (n = 148). Clinical characteristics and procedural outcomes were compared. Patients were followed until death, liver transplantation or 6 months after the treatment. The primary outcome was rebleeding, and the secondary outcome was survival. RESULTS: There were no significant differences in age, sex, etiology, shunt diameter and Child-Pugh classification between the two groups. Fewer GVs obliteration sessions were required in the clip-ECI group than in the con-ECI group (p = 0.015). The cumulative 6-month rebleeding-free rates were 88.6% in the clip-ECI group and 73.7% in the con-ECI group (p = 0.002). The cumulative 6-month survival rates were 97.1% in the clip-ECI group and 94.8% in the con-ECI group (p = 0.378). CONCLUSIONS: Compared with con-ECI, clip-ECI appears more effective for the treatment of GVs with a gastrorenal shunt, which required less sessions and achieved a higher 6-month rebleeding-free rate.

Cyanoacrylate glue reactions: A systematic review, cases, and proposed mechanisms.

OBJECTIVE: Cyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein closure. However, great need exists to elucidate further the types of specific adverse reactions that cyanoacrylate glue can cause for better patient selection and to minimize these events. In the present study, we systematically reviewed the literature to identify the types of reported reactions. In addition, we explored the pathophysiology contributing to these reactions and proposed the mechanistic pathway with inclusion of actual cases. METHODS: We searched the literature for reports of reactions following cyanoacrylate glue use in patients with venous diseases between 2012 and 2022. The search was performed using MeSH (medical subject headings) terms. The terms included cyanoacrylate, venous insufficiency, chronic venous disorder, varicose veins, vein varicosities, venous ulcer, venous wound, CEAP (clinical, etiologic, anatomic, pathophysiologic), vein, adverse events, phlebitis, hypersensitivity, foreign body granuloma, giant cell, endovenous glue-induced thrombosis, and allergy. The search was limited to the literature reported in English. These studies were evaluated for the type of product used and the reactions noted. A systematic review, in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) method, was performed. Covidence software (Melbourne, VC, Australia) was used for full-text screening and data extraction. Two reviewers reviewed the data, and the content expert served as the tiebreaker. RESULTS: We identified 102, of which, 37 reported on cyanoacrylate use other than in the context of chronic venous diseases and were excluded. Fifty-five reports were determined appropriate for data extraction. The adverse reactions to cyanoacrylate glue were phlebitis, hypersensitivity, foreign body granuloma, and endovenous glue-induced thrombosis. CONCLUSIONS: Although cyanoacrylate glue closure for venous reflux is generally a safe and clinically effective treatment choice for patients with symptomatic chronic venous disease and axial reflux, some adverse events could be specific to the properties of the cyanoacrylate product. We propose mechanisms for how such reactions can occur based on histologic changes, published reports, and case examples; however, further exploration is necessary to confirm these theories.

Short peripheral intravenous catheter securement with cyanoacrylate glue compared to conventional dressing: A randomized controlled trial.

BACKGROUND: Short peripheral intravenous catheters (PIVCs) fail prior to completion of therapy in up to 63% of hospitalizations. This unacceptably high rate of failure has become the norm for the most common invasive procedure in all of medicine. Securement strategies may improve PIVC survival. METHODS: We conducted a prospective, single-site, parallel, two-arm randomized controlled investigation with a primary outcome of catheter failure comparing securement with standard semi-permeable dressing and clear tape (SPD) to standard semipermeable dressing and clear tape with cyanoacrylate glue (SPD + CG). Adult emergency department patients with a short PIVC and anticipated hospital duration ⩾ 48 h were enrolled and followed until IV failure or completion of therapy for up to 7 days. Secondary outcomes included complications and cost comparisons between groups. Primary outcome was assessed by intention to treat and per protocol analyses. FINDINGS: 350 patients were enrolled between November 2019 and October 2020. PIVC survival for SPD + CG was similar to SPD group with the absolute risk difference of IV failure in the intention-to-treat (-5.8%, p = 0.065) population and improved in the per protocol (-8.1%, p = 0.04) population, respectively. Kaplan-Meier survival analysis indicated there was a significant benefit of the SPD + CG at greater than 2 days of hospitalization (p = 0.04). Prior to 48 h, there was no survival enhancement to either group (p = 0.98) in the intention to treat population. In a multivariable analysis with piecewise Cox regression, when the IV was functional greater than 48 h, the risk of IV failure in the SPD + CG was 43% less than the SPD group (adjusted hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.34 to 0.97; p = 0.04). Cumulative cost related to IV during hospitalization was similar between groups with a lower incremental rescue cost in the SPD + CG group. INTERPRETATION: SPD combined with cyanoacrylate glue provides similar benefit to patients compared to SPD alone and potentially improves short PIVC survival when the IV was inserted >48 h. As this strategy is cost neutral, it could be considered in admitted patients, particularly those with longer anticipated hospital durations.

Un cuerpo extraño inusual de cianoacrilato en el oído. Presentación de un caso clínico y revisión de la literatura / An unusual cyanoacrylate foreign body in the ear. Presentation of a clinical case and literature review

El pegamento basado en cianoacrilato posee una gran capacidad de adherencia a los tejidos, representando un problema cuando se encuentra en el oído externo debido a sus características anatómicas particulares. Se presenta un caso clínico de cuerpo extraño de cianoacrilato que ocluye el conducto auditivo externo y el tímpano, alterando la audición. Se describen los hallazgos y los intentos de extracción utilizando las alternativas terapéuticas descritas en la literatura, sin obtener resultados positivos, debiendo recurrir a la extracción quirúrgica. Además, se presentan detalles del procedimiento y los resultados. El paciente recupera la audición y la normalidad anatómica.

Cyanoacrylate-based glue has a great capacity for adhering to tissue, which is a problem when it is placed in the ear canal due to the anatomy of this structure. A clinical case of a cyanoacrylate foreign body occluding the external auditory canal and the tympanic membrane is presented. The therapeutics alternatives described in the literature used in the case failed, so, it was surgically removed by drilling the glue. Details of the procedure and results are presented. The patient recovers the hearing and anatomical normality.

Occlusion of the Great and Small Saphenous Vein Using Copolymeric Glue Based on N-Butyl Cyanoacrylate and Methacryloxy Sulfolane.

We present the preliminary results of a longitudinal observational study aimed at evaluating the effectiveness and safety at different short- and long-term follow-ups of vascular occlusion of the great saphenous vein (GSV) and small saphenous vein (SSV) affected by severe pathological reflux, using an innovative modified cyanoacrylate surgical glue composed of N-butyl cyanoacrylate and methacryloxy sulfolane (NBCA+MS). Ninety patients, prospectively recruited for 1 year, underwent the study with EcoColor-Doppler (ECD) to evaluate the maximum diameters of the GSV and SSV in the orthostatic position and the reflux time (RT). An RT greater than 0.5 s was considered pathologic. Clinical, etiology, anatomy, and pathophysiology (CEAP) assessment was used for the complete evaluation of each patient in the study. All the patients were treated by NBCA+MS glue to obtain vein occlusion and observed before treatment (baseline; T0), within 6 h after treatment (T1), 1 month after treatment (T2), 3 months after treatment (T3), 6 months after treatment (T4), and 1 year after treatment (T5). Chi-square (χ) analysis was performed to evaluate the effectiveness and safety of the treatment. All the patients participated in the entire duration of the study. Complete occlusion was maintained in 100% of patients at T1, 98.9% at T2 and T3, and 97.8% at T4 and T5 (p < 0.001). None of the patients suffered from post-surgical thrombosis. No blue hyperpigmentation, or paresthesia was observed during the entire observation period. Immediately after treatment, 7.7% of patients needed painkillers; 1 week after treatment, 100% of patients returned to normal life. Vascular occlusion of the great or small saphenous vein using NBCA+MS glue is a safe procedure with persistent benefits after a 1 year follow-up. This procedure can be performed with local anesthesia, allowing a quick return to normal life. Thanks to its low invasiveness, the treatment is not painful.