Postembolization Syndrome Research Articles

Comparative analysis of the efficacy and safety of endovascular and endoscopic interventions on the gonadal veins in the treatment of pelvic congestion syndrome

ObjectiveComparison of the efficacy and safety of endovascular and endoscopic interventions on the gonadal vein in the treatment of patients with pelvic congestion syndrome (PCS). MethodsWe evaluated the treatment outcomes in 95 patients with PCS who underwent endovascular embolization of gonadal veins (EEGV) (group 1, n = 67) or endoscopic resection of the gonadal veins (ERGV) (group 2; n = 28). A comparative analysis of the efficacy and safety of EEGV and ERGV in the treatment of PCS included assessments of their effects on pelvic venous pain, pelvic venous reflux, diameter of the pelvic veins, and restoration of daily activity, as well as treatment safety assessment. Clinical examinations and ultrasound studies of the pelvic veins were repeated at 1, 10, and 30 days, and 36 months after EEGV and ERGV. Pain was assessed using a visual analogue scale and the Von Korff questionnaire. ResultsA decrease in pelvic venous pain intensity was observed at 3.6 ± 1.4 days after EEGV and 2.5 ± 0.8 days after ERGV (P = .49 between the groups). At 1 month after the intervention, a complete relief of pelvic pain was reported by 52 and 25 patients in the EEGV and ERGV groups, respectively. The rates of valvular incompetence of the uterine veins were decreased from 85% in both groups at baseline to 3% in group 1 and 0% in group 2 at 36 months after the intervention, respectively. In the early postprocedural period, pain in the femoral or jugular vein puncture site was reported by eight patients (12%) who underwent EEGV (2.2 ± 0.7 scores). Postembolization syndrome was diagnosed in 13 patients (19.4%). After ERGV, all patients experienced pain in the area of the surgical wound, with a severity of 3.9 ± 0.5 scores. Hematoma at the puncture site of the main vein was observed in 6% of patients after EEGV. Protrusion of coils was identified in three patients (4.5%). The VTE incidence was four times greater in group 1 vs group 2 (14 vs 3 patients; P < .05). The relative risk of this complication after EEGV was 1.4 (95% confidence interval, 1.146-1.732). In two patients (7.1%) after the bilateral laparoscopic resection of the gonadal veins, an ileus developed. No complications of anesthesia were observed in either group. ConclusionsEndovascular and endoscopic techniques for decreasing blood flow through the gonadal veins are effective and safe in treating the PCS. The obvious advantages of EEGV are minimal injury and possibility to perform procedure under local anesthesia. The ERGV is associated with at least similar and, in some cases, even superior outcomes, in the terms of significantly (P < .05) shorter time to the postprocedural pain relief and avoiding postembolization syndrome.

Outcomes of transarterial chemoembolization (TACE) of the liver in patients with metastatic triple-negative breast cancer (TNBC).

e13107 Background: TACE is widely used in oncology in patients with metastasis in liver from GI tumors, meanwhile its opportunities in management pts with TNBC are unknown. The purpose of the study was to analyze the results of TACE of the liver metastases from TNBC. Methods: The study included 60 TNBC pts with unresectable liver metastases. 34 pts of the main group underwent chemotherapy including taxanes in standard regimens. After 6-12 chemotherapy cycles, the main group received 1-2 TACE procedures (doxorubicin 30 mg/m², 5-fluorouracil 600 mg/m², 10 ml of lipiodol and 1-2 ml of 300-500 µm HepaSphere microspheres). The control group (n = 32) received only 6-12 cycles of taxane-containing chemotherapy. Pts were aged 32-66 years, mean age in the main group 49.4, in controls 55 years. Primarily advanced breast cancer with unresectable liver metastases was diagnosed in 6 (17.6%) pts of the main group and in 5 (15.6%) controls. Progression after previous treatment was observed in 91.2% (31) main group and 90.6% (29) controls. Sizes of metastatic foci were 2.7-7.3 cm, average number 7.5. Bilobar metastases were most common. Liver metastases were own accompanied by metastases to the bones, intrathoracic lymph nodes, lungs and pleura. Obtained data were processed with software package “Statistica 7.0”. Results: Main group received a total of 46 TACE procedures performed for a maximal number of metastatic lesions, especially for those progressing after systemic therapy and the largest ones, when possible. Post-embolization syndrome after performing TACE, was observed in 60.86% (28) of cases, managed with conservative therapy for 2-7 days. Icterus was not observed. The tumor response rate was 94.1% in the main group vs. 80.6% in controls, with significant differences in PR (44.1% and 15.3% respectively, p &lt; 0.05). Median of duration treatment response was 13.4 months in the main group and 9.3 months in control group (p &lt; 0.05). CR was not achieved. Median follow-up was 17 months. 3-year disease-free survival was 63.2% in the main group and 43.8% in controls (p = 0.039). Conclusions: TACE resulted in better response to the therapy as well as improved disease-free survival in pts with TNBC. TACE is possible to be used to consolidate the achieved effect of the chemotherapy.

A prospective randomized controlled trial of selective transarterial chemoembolization using drug-eluting beads loaded with epirubicin versus selective conventional transarterial chemoembolization using epirubicin-lipiodol for hepatocellular carcinoma: The JIVROSG-1302 PRESIDENT study.

4518 Background: Transarterial chemoembolization (TACE) with selective catheterization into the segmental or subsegmental hepatic arteries supplying HCC is often performed to achieve the complete local control of HCC in the patients with a limited number of small sized nodules. To clarify which of TACE with drug-eluting beads loaded with epirubicin (DEB-TACE) or conventional TACE with epirubicin-lipiodol (cTACE) can achieve the complete response (CR) more frequently, we performed a randomized controlled trial of DEB-TACE vs. cTACE. Methods: Between March 2016 and May 2019, unresectable HCC patients with Child-Pugh class A or B who were scheduled to receive selective TACE were randomly assigned 1:1 to the DEB-TACE group and the cTACE group. The primary endpoint was the CR rate at 3 months, and the secondary endpoints were the CR rate at 1 month and rate of adverse events (AEs). The response and AEs were assessed according to the modified RECIST by an independent review committee and the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0., respectively. Results: A total of 200 patients (DEB-TACE, 99 patients; cTACE 101 patients) were enrolled from 22 Japanese institutions. The patient characteristics were well-balanced between the two groups. The median number of tumors was one in both groups and the median tumor size was 20.0 mm in the DEB-TACE group and 20.5 mm in the cTACE group. The table shows the CR rates and frequencies of AEs. The CR rates of cTACE at 3 and 1 months were significantly higher than those of DEB-TACE. The frequency of AEs (all grades), including pyrexia, malaise, increased serum total bilirubin (T-Bil) and increased serum alanine transaminase (ALT), was significantly higher in the cTACE group than in the DEB-TACE group. Conclusions: Selective cTACE appeared to have greater efficacy for local tumor control as compared to selective DEB-TACE, however, the frequencies of post-embolization syndromes were higher in the cTACE group than in the DEB-TACE group. Clinical trial information: UMIN000021250 . [Table: see text]

Prostatic Artery Embolization for Benign Prostatic Hyperplasia Treatment: A Russian Multicenter Study in More Than 1,000 Treated Patients.

Benign prostatic hyperplasia (BPH) is one of the most common diseases of the genitourinary system. The prevalence of BPH increases in men with advancing age. While transurethral resection of the prostate gland entails complications such as retrograde ejaculation, urinary incontinence, hematuria, urethral strictures, bladder neck sclerosis, and other adverse events, it is necessary to apply minimally invasive surgical methods such as superselective embolization of the prostatic arteries (PAE), particularly Proximal Embolization First Then Distal Embolization (PErFecTED). The data from 1,015 BPH patients who underwent endovascular surgery demonstrate the benefits of PErFecTED treatment during 24 months after surgery. Both Quality of Life score and International Prostate Symptom Score were around three times better in the PErFecTED group and remained stable during the entire observation period. However, the technique needs to be improved due to the high risk of postembolization syndrome.

Prostatic artery embolization versus transurethral resection of the prostate in management of benign prostatic hyperplasia.

BackgroundTransurethral resection of the prostate (TURP) is considered the gold standard surgical intervention for prostate size less than 80 g. Prostatic artery embolization (PAE) has been suggested as a minimally invasive interventional radiological procedure in the management of benign prostatic hyperplasia (BPH), especially by using the PErFecTED technique. We aim through our study to evaluate the efficacy and safety of PAE compared with those of monopolar transurethral resection of prostate (M-TURP) and bipolar transurethral resection of prostate (B-TURP) in treating lower urinary tract symptoms (LUTSs) secondary to BPH.MethodsWe randomized 60 patients into 3 equal groups representing M-TURP, B-TURP, and PAE. Patients were followed up at 1 and 6 months postoperatively with regard to the International prostate symptom score (IPSS) score; uroflowmetry; prostate volume by transrectal ultrasound; and postvoid residual urine.ResultsThe mean operative time was 59, 68, and 89 minutes for the M-TURP group, the B-TURP group, and the PAE group, respectively; only one patient, who represented 5% of the M-TURP group and 1.7% of the whole study population, developed transurethral resection syndrome. Four patients of the PAE group complained of postembolization syndrome, which represented 20% of the cases. Only two patients in our study, both belonging to the PAE group, developed acute urinary retention after catheter removal, representing 10% of the PAE group and 3.33% of the whole study population. The improvement in the IPSS score, the average uroflowmetry (Q-average) score, postvoid residual urine, and prostate volume reduction was noted in all groups, with more statistically significant improvement in each of the M-TURP and the B-TURP groups than in the PAE group.ConclusionPErFecTED technique is a novel way of embolization, with statistically significant improvement for patients complaining of LUTSs due to BPH in terms of improvement of IPSS, uroflowmetry, prostate size, and amount of postvoid residual urine, yet these results are still not comparable with either the results of M-TURP or B-TURP that still show more effective improvement.

Durability of partial splenic artery embolization on platelet counts for cancer patients with hypersplenism-related thrombocytopenia.

Partial splenic artery embolization (PSAE) has shown promise in increasing platelet counts in cancer patients with hypersplenism-related thrombocytopenia. The purpose of this study was to identify response predictors and to longitudinally evaluate PSAE efficacy and durability in a large cohort of cancer patients with hypersplenism-related thrombocytopenia. A single-institution, IRB-approved, HIPAA-compliant retrospective review of all PSAEs for thrombocytopenia between 2012 and 2015 was performed. Patients were classified as complete responders (CR, no platelet value < 100 × 109/L following PSAE), partial responders (PR, initial increase in platelets but subsequent decrease in platelets < 100×109/L), and non-responders (NR, platelets never > 100×109/L following PSAE). Of the 98 patients included in the study, 58 had CR (59%), 28 had PR (29%), and 12 patients had NR (12%). The percent splenic tissue embolized was significantly greater in the CR group compared to the PR group (P = 0.001). The percent volume of splenic tissue embolized was linearly correlated with the magnitude of platelet increase without a minimum threshold. At least one line of chemotherapy was successfully restarted in 97% of patients, and 41% of patients did not experience recurrence of thrombocytopenia for the duration of their survival. The major complication rate was 8%, with readmission following initial hospitalization for persistent "post-embolization syndrome" symptoms the most common. In cancer patients with hypersplenism-related thrombocytopenia, PSAE is a safe intervention that effects a durable elevation in platelet counts across a range of malignancies and following the re-initiation of chemotherapy.

Multicentre prospective study of drug-eluting bead chemoembolisation safety using tightly calibrated small microspheres in non-resectable hepatocellular carcinoma

PurposeTo assess the safety and tolerability of transarterial drug-eluting bead chemoembolisation (DEB-TACE) using tightly calibrated 100-μm microspheres in hepatocellular carcinoma (HCC). MethodThis multicentre prospective study included 131 patients with a 2-year follow-up. All patients had Child-Pugh scores ≤ B7, a good performance status, and Barcelona Clinic Liver Cancer stage A or B. Beads were loaded with 50 mg of doxorubicin per millilitre. Overall, 223 nodules were treated (mean size: 27.6 mm, average number of nodules per patient: 1.7). Toxicity was assessed using Common Terminology Criteria for Adverse Events 4.03 and response according to the modified Response Evaluation Criteria in Solid Tumours. The primary endpoint was safety. Secondary endpoints included technical success, post-embolisation syndrome (PES), local tumour response, and 2-year survival. ResultsA total of 214 DEB-TACE procedures were performed (mean per patient: 1.64), with a technical success rate of 97.6 % and a PES rate of 9.3 %. Major complications occurred in 6.8 % of patients and 4.1 % of procedures. There were no treatment-related deaths. Doxorubicin dose was an independent predictor of complications (p = 0.01). Four patients were lost to follow-up and 18 received liver transplants. Objective response rates were 74.6 %, 45.7 %, and 44.1 % at 6, 12, and 24 months, respectively. The cumulative 24-month overall survival rate was 55.96 %. Median survival was 22 months (interquartile range = 13–24). Co-morbidities and tumour response were independent predictors of survival (p = 0.0012 and 0.0052, respectively). Complications did not affect survival (p = 0.24). ConclusionsDEB-TACE with tightly calibrated 100-μm beads is safe and not associated with increases in biliary toxicity or complications. Tumour response and survival are in the expected range for chemoembolisation therapy. (Clinical trials ID: NCT02670122).

Renal Graft Embolization as a Treatment for Graft Intolerance Syndrome

BackgroundRenal graft intolerance syndrome is an inflammatory process that occurs in up to 40% of patients with graft loss. It is characterized by fever, graft pain, hematuria, and anemia. Traditionally, the treatment has been nephrectomy; however, this procedure is associated with high morbidity and mortality rates. As an alternative, graft embolization is associated with success rates of up to 92%. In this study, we describe the graft embolization experience of 1 center, its clinical outcomes and complications. MethodsAn observational, retrospective study was conducted. It included all patients with graft intolerance syndrome undergoing graft embolization between 2012 and 2018. The success of the procedure was defined by the resolution of the symptoms that motivated the embolization. ResultsWe found 12 cases of patients undergoing embolization. The time of presentation of the graft intolerance syndrome after admission to dialysis was 6 months (range, 0.6-13). The main clinical manifestation was pain in the area of the graft and macroscopic hematuria. Except for 1 patient, all continued with the immunosuppressive treatment regimen after graft loss for 4 months (range, 0.6-9), received antibiotics for 5.5 days (range, 2-14), and 10 patients received steroid treatment for 6.5 days (range, 5-10). The main complication, secondary to the procedure, was hematoma at the puncture site in 3 patients. Only 1 patient had postembolization syndrome, which resolved with steroid administration. Two patients required postembolization nephrectomy due to persistent renal blood flow and symptoms such as pain and hematuria. The average hospital stay was 5.5 days (range, 1-24). ConclusionsRenal graft embolization is an effective technique as a treatment strategy in patients with clinical signs of intolerance syndrome, with a success rate ≥83.3%, low morbidity, and short hospital stay; furthermore, it avoids the potential complications of a surgical nephrectomy. Graft infection should be ruled out before embolization, and the use of prophylactic antibiotics and steroid therapy is recommended to reduce the risk of postembolization syndrome and infectious complications.

Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases.

The liver is affected by two of the most common groups of malignant tumours: primary liver tumours and liver metastases from colorectal carcinoma or other extrahepatic primary cancers. Liver metastases are significantly more common than primary liver cancer, and long-term survival rate after radical surgical treatment is approximately 50%. However, R0 resection (resection for cure) is not feasible in the majority of people; therefore, other treatments have to be considered. One possible option is based on the concept that the blood supply to hepatic tumours originates predominantly from the hepatic artery. Transarterial chemoembolisation (TACE) of the hepatic artery can be achieved by administering a chemotherapeutic drug followed by vascular occlusive agents, and can lead to selective necrosis of the liver tumour while it may leave normal parenchyma virtually unaffected. This can also be performed without chemotherapy, which is called bland transarterial embolisation (TAE). To assess the beneficial and harmful effects of TAE or TACE compared with no intervention or placebo in people with liver metastases. We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, and four more databases (December 2019). We also searched two trials registers and the US Food and Drug Administration database (September 2019). Randomised clinical trials assessing beneficial and harmful effects of TAE or TACE compared with no intervention or placebo for liver metastases. We followed standard Cochrane methodological procedures. We extracted information on participant characteristics, interventions, study outcomes, study design, and trial methods. Two review authors independently extracted data and assessed risk of bias. We assessed the certainty of evidence with GRADE. We resolved disagreements by discussion. We included one randomised clinical trial with 61 participants (43 male and 18 female) with colorectal cancer with liver metastases: 22 received transarterial embolisation (TAE; hepatic artery embolisation), 19 received transarterial chemoembolisation (TACE; 5-fluorouracil hepatic artery infusion chemotherapy with degradable microspheres), and 20 received 'no active therapeutic intervention' as a control. Most tumours were synchronous, unresectable metastases involving up to 75% of the liver. Participants were followed for a minimum of seven months. The trial was at high risk of bias. Very-low-certainty evidence found inconclusive results for mortality at 44 months between the TAE and TACE versus no intervention groups (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.74 to 1.06; 61 participants). Local recurrence was reported in 10 participants without any details about the group allocation. Very-low-certainty evidence found little or no difference in mortality between the TAE and no intervention groups (RR 0.91, 95% CI 0.75 to 1.10; 42 participants). Median survival was 7 months from trial entry (range 2 to 44 months) in the TAE group and 7.9 months (range 1 to 26 months) in the control group, and 8.7 months after diagnosis (range 2 to 49 months) in the TAE group and 9.6 months (range 1 to 27 months) in the control group. The trial authors reported the differences were not statistically significant. There were no reported side effects in the control group. In the TAE group, 18 participants experienced short-term symptoms of 'post-embolisation syndrome', which were relieved with symptomatic treatment; one participant also had a local puncture site haematoma. Very-low-certainty evidence found little or no difference in mortality between the TACE and no intervention groups (RR 0.83, 95% CI 0.65 to 1.07; 39 participants). Median survival in the TACE group was 10.7 months (range 3 to 38 months) from trial entry, and 13.0 months (range 3 to 38 months) after diagnosis. The trial authors reported that differences between groups were not statistically significant. All participants experienced short-term nausea, with or without vomiting, immediately after treatment; one participant developed a wound infection, and one developed deep vein thrombosis. The trial did not measure failure to clear liver metastases, time to progression of liver metastases, tumour response measures, or health-related quality of life. Cancer Research Campaign, a non-profit organisation, provided a grant for the trial; Pharmacia Ltd. delivered the Port-a-Cath arterial delivery systems and degradable starch microspheres. We identified one ongoing trial comparing TACE plus chemotherapy versus chemotherapy alone in people with unresectable colorectal liver metastases who failed with first-line chemotherapy (NCT03783559). Based on one, small randomised trial at high risk of bias, the evidence is very uncertain about the effect of TAE or TACE versus no active therapeutic intervention on mortality for people with liver metastases as the true effect may be substantially different. The trial did not measure failure to clear liver metastases, time to progression of liver metastases, tumour response measures, or health-related quality of life. Short-term, minor adverse events were recorded in the intervention groups only. Large trials, following current standards of conduct and reporting, are required to explore the benefits and harms of TAE or TACE compared with no intervention or placebo in people with resectable and unresectable liver metastasis.

Abstract No. 396 Partial splenic artery embolization: a nonsurgical approach to hypersplenism

Partial splenic embolization (PSE) is a novel percutaneous interventional method and an alternative to open and laparoscopic splenectomy because of its minimally invasive nature and fewer complications. PSE can be particularly useful in high-risk surgical patients allowing preservation normal splenic function and thus avoiding the risk of infections. Retrospective study of 14 patients (8 males and 6 females) in the age group of 10 to 49 years with hypersplenism (massive splenomegaly and Platelet count 10000-60000) referred to IR department for partial splenic artery embolization between October 2013 and October 2018. Baseline data was documented. PSE was performed though transfemoral approach using PVA Particles (355 to 500 microns) sparing one or two sectors to retain 20- 30% of the blood supply and to achieve ∼70% splenic infarction. Intra-arterial gentamycin was given to all patients after splenic artery catheterization. Follow-up for splenic size and complete blood counts were done at one month and six months post procedure and were analyzed. All patients achieved a splenic infarction rate of more than 50% with a significant improvement in platelet count. All patients had a well-maintained splenic function. Post-embolization syndrome was noted in 8 patients which was managed conservatively. There were no major complications identified in any of the patients PSE is a safe and minimally invasive technique having a good long-term effect on the hematological parameters, minimal complications and preservation of normal splenic function.

3:27 PM Abstract No. 301 Drug-eluting beads transcatheter arterial chemoembolization is effective and well-tolerated in hepatocellular carcinoma patients with portal vein tumor thrombus

The aim of this study was to investigate the efficacy and safety of drug-eluting beads transcatheter arterial chemoembolization (DEB-TACE) and prognostic factors in hepatocellular carcinoma (HCC) patients with portal vein tumor thrombus (PVTT). 58 HCC patients with PVTT who received DEB-TACE treatment were included in this retrospective study, and the baseline characteristics were recorded. Treatment response was assessed at 4-6 weeks post treatment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST), Overall survival (OS) was calculated using the Kaplan–Meier method, and adverse events (AEs) were also recorded. Univariate and multivariate Cox regression analyses were used to evaluate the relevant clinical variables in predicting OS. The objective response rate (ORR) was 79.3% in terms of tumors and 44.8% in thrombi. The median PFS and OS of patients were 5.0 months and 9.0 months respectively. The cumulative survival rate at 3-, 6-, 9-, 12-, 18- and 24-month were 94.8%, 72.4%, 53.4%, 41.4%, 22.4% and 19.0%, respectively. In a stepwise multivariate Cox proportional hazards model, the higher Child-Pugh stage (HR = 2.279; 95% CI, 1.042–4.985, P = 0.039) and tumor burden (P = 0.008) were the significant predictors of poorer OS after adjustment for known risk factors. As to AEs, they were mainly transient elevated liver enzymes and postembolization syndrome, all of which were not severe. DEB-TACE is effective and well-tolerated in HCC patients with PVTT. The higher Child-Pugh stage and tumor burden are independent predictors for poorer OS.

Abstract No. 402 Prophylactic steroids for preventing post embolization syndrome after transcatheter arterial embolization for renal angiomyolipoma

Abstract No. 402 Prophylactic steroids for preventing post embolization syndrome after transcatheter arterial embolization for renal angiomyolipoma

4:12 PM Abstract No. 198 Transarterial embolization of liver cancer in a transgenic pig model

To develop a porcine model of liver cancer, which could be used to test new locoregional therapies. Liver tumors were induced in 14 Oncopigs (transgenic pigs with Cre-inducible p53 and Kras mutations) by using an adenovirus carrying the Cre-recombinase gene. The resulting tumors (n = 50) were characterized on multiphase contrast-enhanced CT, angiography, and necropsy. Transarterial embolization was performed using 40-120 micron or 100-300 micron Embospheres. Response to embolization was evaluated by mRECIST, and on pathology. Complications were determined based on daily clinical evaluation, laboratory results, imaging, and necropsy. Liver tumors developed at 50 of 58 sites (86%) that were inoculated. Average tumor size was 2.1 cm at 1 week. Histopathology revealed an invasive malignant neoplasm, with metastases to lymph nodes and peritoneum in some cases. H&E staining and immunohistochemistry showed poorly differentiated or undifferentiated tumors of undetermined origin, but features suggesting a biliary epithelial origin were seen in some cases. Neoplastic cells were accompanied by a major inflammatory component. 2 of 14 pigs only had inflammatory nodules without evidence of neoplasia. On multiphase CT, all tumors had a hypovascular center, and 18 of 50 (36%) had a hypervascular rim. After transarterial embolization, non-contrast CT showed retained contrast in the tumors. Follow-up contrast-enhanced scan showed a complete radiographic response in 3 of 3 pigs treated using 40-120 micron Embospheres, and 2 of 3 pigs treated using 100-300 micron Embospheres. One pig treated with 40-120 micron Embospheres developed postembolization syndrome (vomiting) requiring euthanasia. One pig treated with 100-300 micron Embospheres died during sedation for terminal imaging, and was found to have a large right pleural effusion, liver infarct, and progressive extrahepatic disease. Liver tumors can be induced in a transgenic pig, and can be successfully treated using bland embolization. This new model system could be used to develop the next generation of arterially directed therapies for primary or secondary liver cancer.

Abstract No. 403 Retrospective comparative study on the use of steroids to decrease postembolization syndrome in patients undergoing partial splenic embolization

Abstract No. 403 Retrospective comparative study on the use of steroids to decrease postembolization syndrome in patients undergoing partial splenic embolization

Nivolumab (NIVO) and drug eluting bead transarterial chemoembolization (deb-TACE): Preliminary results from a phase I study of patients (pts) with liver limited hepatocellular carcinoma (HCC).

525 Background: Regional therapies in HCC impact the immune microenvironment and may augment the effects of immune checkpoint inhibitors. Methods: This is a multicenter phase 1 study of NIVO and deb-TACE in unresectable HCC pts (BCLC Stage B) and Child Pugh A cirrhosis (NCT03143270). The primary objective is to assess safety. Secondary objectives include response rate by RECIST v1.1, progression-free and overall survival by Kaplan-Meier methodology, and blood/tumor immune correlates. A 3 + 3 design sequentially evaluates 3 cohorts of differing schedules of NIVO relative to deb-TACE. Deb-TACE (75mg of doxorubicin) is administered on Day 0. NIVO is dosed at 240mg IV every 14 days for 1 year (Cohort 1: NIVO begins day +14 after deb-TACE; Cohort 2, interrupted NIVO dosing begins at Day -28 but is held on the Day 0 then restarted on Day +14; Cohort 3, continuous NIVO dosing begins on Day -28 without interruption). Results: As of July 2019, 9 pts have been treated [median 65 years (range: 54-76), male (89%), viral (44%;1 HBV, 3 HCV), non-viral (56%;2 EtOH, 1 NASH, 2 unknown), prior resection (44%), prior regional therapy (44%), 3 pts in each cohort]. No cases of treatment related liver failure, dose-limiting toxicity, or Grade 5 adverse events (AEs) were observed. Grade ≥3 AEs possibly related to nivolumab, deb-TACE, or both included: transaminase elevation (1 pt: day 1 post TACE resolved in 7 days without treatment; 2 pts: ≥30 days post TACE resolved with steroids between 20-41 days), post-embolization syndrome (1 pt: resolved in 5 days), asymptomatic lipase increase (1 pt: resolved in 14 days), post-procedural groin hematoma (1 pt: resolved in 2 days). All 9 pts were evaluable for efficacy: 2 (22%) confirmed PR and 7 (78%) SD. 4/9 pts remain on study with SD or better—2 pts continue &gt; 18 months post embolization with durable PRs. 12 months OS rate was 71%. Ongoing correlates will be presented at a separate meeting. Conclusions: Nivolumab given at various times relative to deb-TACE appears safe and tolerable. Cohort 3 continues to accrue to provide a better estimate of safety and antitumor activity of the combination. Clinical trial information: NCT03143270.

Prognosis criteria of the severe postembolization syndrome in patients with uterine myoma

Recently specialists take an interest in organ-preserving methods of uterine fibroids treatment, one of which is uterine artery embolization (UAE). One of the method’s negative aspects is the severe postembolization syndrome (PES) development, requiring timely initiation of adequate treatment in order to avoid severe complications that could lead to the organ removal. The study was aimed to search for the prognostic criteria of the severe PES development during the preoperative period. The study included 81 UAE-treated women aged 19–50 with 7–17 week uterine myoma. The patients’ anthropometric measurements were used, as well as the skin microcirculation data obtained by laser Doppler flowmetry together with the occlusion test. Based on prognostic criteria, models with AUC (area under ROC curve) &gt; 0.8 were presented. According to the models, the anthropometric predictors of the severe PES were the following: age under 38.5 (p &lt; 0.05); BMI lower than 25 kg/m2 (р &lt; 0.05), and microcirculation value (M) prior to UAE below 9.55 PU (р = 0.001). Microvascular blood flow during the occlusion test indicate that the higher the oxygen consumption index (I), intravascular resistance (Rc), capillary blood flow reserve capacity in the models, the higher the risk of the severe PES development (p &lt; 0.05). Low alpha angle value obtained by the occlusion test (p = 0.003) as well as the UVLF value (p = 0.004) in the models also indicate the increased risk of severe PES. Multidimensional prognostic modelling admits to expect the severe PES development prior to UAE, which allows the doctor to prepare the woman for specific management and treatment.

Prognosis criteria of the severe postembolization syndrome in patients with uterine myoma

В последние годы проявляется интерес к органосохраняющим методам лечения миомы матки, одним из которых является эмболизация маточных артерий (ЭМА). Среди отрицательных сторон метода — развитие тяжелого постэмболизационного синдрома (ПЭС), требующего своевременного начала адекватного лечения с целью избежания грозных осложнений, способных привести к удалению органа. Целью исследования был поиск прогностических критериев развития тяжелого ПЭС в дооперационном периоде. В исследование вошла 81 женщина с миомой матки 7–17 недель в возрасте 19–50 лет, прошедшая лечение методом ЭМА. В работе использовали антропометрические данные пациенток и показатели кожной микроциркуляции, полученные методом лазерной допплеровской флоуметрии (ЛДФ) с проведением окклюзионной пробы (ОП). На основании прогностических критериев построены модели с AUC (область под графиком ROC кривой) &gt; 0,8. Антропометрические предикторы тяжелого ПЭС в моделях: возраст менее 38,5 лет (р &lt; 0,05); ИМТ менее 25 кг/м2 (р &lt; 0,05) и показатель микроциркуляции (М) до ЭМА — менее 9,55 пф. ед. (р = 0,001). Показатели микрокровотока в ОП свидетельствуют о том, что чем выше значения индекса потребления кислорода (I), внутрисосудистого сопротивления (Rc), резерва капиллярного кровотока (РКК) в моделях, тем выше риск развития тяжелой формы ПЭС (р &lt; 0,05). Низкие показатели угла альфа в ОП (р = 0,003) и эндотелиальных колебаний UVLF (р = 0,004) в моделях также ведут к повышенному риску развития тяжелого ПЭС. Многомерные прогностические модели позволят диагностировать развитие тяжелого ПЭС до проведения ЭМА и подготовить пациентку к определенному послеоперационному ведению и лечению.

Identifying predictors and evaluating the role of steroids in the prevention of post-embolization syndrome after transarterial chemoembolization and bland embolization.

BackgroundTransarterial chemoembolization (TACE) and bland embolization (TAE), performed for hepatocellular carcinoma (HCC), are often complicated by post-embolization syndrome (PES). There are limited data regarding the incidence of PES after TAE and the role of steroids in PES. We report the incidence of PES post TACE and TAE, identify predictors, and evaluate the role of steroids in PES.MethodsDemographic and clinical variables of patients who underwent embolization were collected and PES was identified. Risk factors for PES, TACE and TAE were derived by logistic regression. We compared patients who received dexamethasone to those who did not, regarding baseline characteristics, occurrence of PES, and hospital stay.ResultsA total of 171 patients, average age 60.5 years, underwent the procedure, 77.8% were male, and 87.7% had cirrhosis. Of these 171, 107 underwent TACE and 64 TAE. Dexamethasone was given to 106 (61.9%) patients, of whom 85 had TACE and 21 TAE. One hundred twenty-four patients (72.5%) developed PES. PES occurred in more patients who underwent TACE, 80 (74.7%) vs. 44 (68.7%), and resulted in a longer hospital stay (1.47 vs. 1.12 days, P=0.034). Predictive factors for PES included female sex (odds ratio [OR] 2.76, 95% confidence interval [CI] 1.04-7.34; P=0.041), and alcohol-related HCC (OR 3.14, 95%CI 1.42-6.95; P=0.005). Dexamethasone did not affect the length of hospital stay (1.43 vs. 1.29 days, P=0.422) or the rate of prolonged hospitalization (18.8% vs. 15.4%, P=0.561).ConclusionThere was no difference in the incidence of PES following TACE or TAE and the use of dexamethasone did not reduce the incidence of PES or the duration of hospital stay.

“The post-pulmonary syndrome - results of echocardiographic driven follow up after acute pulmonary embolism”

IntroductionThe concept of post Pulmonary Embolism syndrome includes various combinations of functional, haemodynamic or imaging abnormalities in patients after pulmonary embolism (PE). Although residual obstruction of pulmonary vascular bed is suggested to be a major cause of post Pulmonary Embolism syndrome (post-PE syndrome) other cardiopulmonary abnormalities can be responsible for functional impairment. Therefore, we analyzed the frequency of post-PE syndrome and its potential causes. Material and methodsWe report data of consecutive 845 PE survivors (468 F, aged 62 ± 18 yrs) who were anticoagulated, and followed for at least 6 months. All symptomatic subjects at follow up underwent diagnostic workup. Results35% (290/845) of PE survivors recovered functionally, while 65% patients reported a decreased exercise tolerance compatible with post-PE syndrome. One hundred and five symptomatic cases were lost to follow up. After diagnostic workup, chronic thromboembolic pulmonary hypertension (CTEPH) was diagnosed in 38 of 450 (8.4%) symptomatic subjects and chronic thromboembolic pulmonary disease (CTED) was diagnosed in 15/450 (3.3%) of them. Chronic heart failure with reduced ejection fraction (EF) was found in 6.9% (31/450) of patients and 154 patients (34.2%) had leftsided diastolic dysfunction. Valve heart disease was detected in 6.2% (28/450), atrial fibrillation in 31/450 (6.9%), Other causes of reduced exercise tolerance include coronary artery disease in 31/450 (6.9%), pulmonary disease 42/450 (9.3%), morbid obesity 15/450 (3.3%), neoplasms 15/450 (3.3%), psychiatric disorders 1%, rheumatoid disease 1%, anemia 1%. ConclusionsApproximately 65% of PE survivors report functional impairment, despite at least 6 months of anticoagulation. Persistent pulmonary artery thromboemboli resulting in CTEPH or CTED were detected in 7.2% of PE survivors and 11.8% of symptomatic patients. Leftsided diastolic dysfunction was the most prevalent echocardiographic abnormality, and remained the most common cause of functional limitation affected 34.2% of symptomatic cases.

Effect of palonosetron and dexamethasone administration on the prevention of gastrointestinal symptoms in hepatic arterial chemoembolization with epirubicin.

There are several studies on premedication to prevent postembolization syndromes which occurs after transcatheter arterial chemoembolization (TACE), but the medication to be used is still not established. This study aimed to examine the effect of palonosetron and dexamethasone on the prevention of gastrointestinal symptoms induced by TACE. Patients with hepatocellular carcinoma who were treated with TACE with epirubicin were retrospectively evaluated. The complete response rate of antiemetic drugs and incidence and severity of gastrointestinal symptoms were compared between the antiemetic group (AE group), which includes 51 patients prophylactically administered with palonosetron 0.75 mg and dexamethasone 9.9 mg intravenously before TACE on day 1 and dexamethasone 6.6 mg intravenously on days 2 and 3, and control group with 101 patients without antiemetic premedication. Complete response rate in the entire evaluation period was significantly higher in the AE group compared with that in the control group. In the acute phase, the incidence and severity of nausea, vomiting, and anorexia significantly decreased in the AE group, but only anorexia improved in the delay phase. Additionally, postembolization syndromes, such as abdominal pain and fever, were significantly attenuated in the AE group; however, constipation worsened in this group. Premedication of palonosetron and dexamethasone significantly prevents the incidence and reduces the severity of gastrointestinal symptoms especially in the acute phase. Further studies will be needed to determine the most recommended 5-HT3 antagonist or dosage of dexamethasone in establishing the optimal antiemetic regimen.