Transcatheter Arterial Embolization with N-Butyl Cyanoacrylate for Nonvariceal Upper Gastrointestinal Bleeding in Hemodynamically Unstable Patients: Results and Predictors of Clinical Outcomes

PurposeTo assess the safety, efficacy, clinical outcomes, and prognostic factors associated with transcatheter arterial embolization (TAE) with N-butyl cyanoacrylate (NBCA) for nonvariceal upper gastrointestinal (GI) hemorrhage in hemodynamically unstable patients.Materials and MethodsBetween January 2008 and December 2012, 49 hemodynamically unstable patients (systolic blood pressure < 90 mm Hg and ongoing transfusion requirement) underwent emergency TAE with NBCA for nonvariceal upper GI bleeding and were included in the study. The technical (cessation of extravasation) and clinical (no residual bleeding within 7 d) success rates, incidence of ischemic complications, and clinical and technical predictors of recurrent bleeding within 30 days were analyzed.ResultsThe technical and clinical success rates were 98% and 71%, respectively. There were no ischemic bowel complications; one patient experienced hepatic infarction with elevated liver enzymes. The incidence of major complications was 2%. The incidence of rebleeding within 30 days was 39%. Hematologic malignancies (P = .017), coagulopathy (P = .003), steroid pulse therapy (P = .025), and the absence of NBCA in the target lesions (P = .003) were associated with recurrent bleeding.ConclusionsNBCA embolization can be safely performed in hemodynamically unstable patients with active nonvariceal upper GI bleeding. The clinical factors associated with rebleeding might influence the clinical outcome.     

Safety and Efficacy of Transcatheter Arterial Embolization for Lower Gastrointestinal Bleeding: A Single-center Experience with 112 Patients

PurposeTo assess the safety and efficacy of transcatheter arterial embolization for lower gastrointestinal bleeding (LGIB) and to determine the prognostic factors that affect clinical outcome.Materials and MethodsAll patients diagnosed with LGIB by angiography at a single institution from April 2006 to January 2013 were included in a retrospective study. The rates of technical success, early recurrent bleeding, major complications, clinical success, and in-hospital mortality for transcatheter arterial embolization were determined. The influence of possible prognostic factors on the outcome was analyzed.ResultsA total of 112 patients were included (36 with small-bowel LGIB, 36 with colon LGIB, and 40 with rectal LGIB). N-butyl cyanoacrylate (NBCA) was the embolic agent for 84 patients (75.0%), whereas gelatin sponge pledgets (n = 20), microcoils (n = 2), polyvinyl alcohol particles with adjunctive gelatin sponge pledgets (n = 1), and blood clots (n = 1) were used in the other patients. The technical success rate was 96.4%. For the entire group, the rates of early recurrent bleeding, major complications, clinical success, and in-hospital mortality were 17.4%, 4.6%, 74.5%, and 25.0%, respectively. These were 15.2%, 4.8%, 75.3%, and 26.2%, respectively, in the NBCA group. Hematologic malignancy, immobilization status, and coagulopathy were significant prognostic factors for clinical outcomes.ConclusionsTranscatheter arterial embolization is a safe and effective treatment for LGIB. NBCA could be used as a primary embolic agent for this procedure.     

Transcatheter Arterial Embolization for Secondary Postpartum Hemorrhage: Outcome in 52 Patients at a Single Tertiary Referral Center

PurposeTo assess the safety and efficacy of transcatheter arterial embolization (TAE) for the management of secondary postpartum hemorrhage (PPH) and to determine the factors associated with the clinical outcomes.Materials and MethodsA retrospective analysis of 52 patients (mean age, 31.6 y; range, 25–40 y) undergoing TAE for secondary PPH was performed. Clinical data, including maternal characteristics, delivery details, embolization details, and transfusion requirements, were obtained. Univariate analyses were performed to determine the factors related to clinical outcomes.ResultsThe major cause of bleeding was retained placental tissue (44.2%; 23 of 52). Actively bleeding foci were observed in 25 (48.1%) patients. Technical and clinical successes were achieved in 100% and 90.4% (47 of 52) of patients, respectively. Gelatin sponge particles with (n = 10) or without (n = 38) permanent embolic materials, such as microcoils or N-butyl cyanoacrylate, were most commonly used (92.3%; 48 of 52), whereas permanent embolic materials alone were used in 7.7% (4 of 52) of patients. In five patients, embolization failed, and these patients were managed by hysterectomy (n = 3), repeat TAE (n = 1), or conservative management (n = 1). Bleeding control was eventually achieved in all five patients. No maternal risk factors were related to clinical results. The median and mean follow-up periods were 3 months and 12.6 months (range, 1–62 mo). Regular menstruation resumed in all 44 patients with available follow-up, and 5 of the patients became pregnant.ConclusionsTAE for secondary PPH is safe and effective and showed technical and clinical success in 100% and 90.4% of patients, respectively. Approximately half of these patients showed a positive bleeding focus, and the use of permanent embolic materials was also common.     

Transcatheter Arterial Chemoembolization with Doxorubicin-Eluting Superabsorbent Polymer Microspheres in the Treatment of Hepatocellular Carcinoma: Midterm Follow-up

PurposeTo investigate prospectively the safety, tolerability, and efficacy of transarterial chemoembolization using superabsorbent polymer (SAP) microspheres loaded with doxorubicin for the treatment of hepatocellular carcinoma (HCC).Materials and MethodsDuring the years 2006–2011, 64 patients underwent 144 transarterial chemoembolization with SAP microspheres procedures. Most of the patients were staged as Barcelona Clinic Liver Cancer class B (65%). The most frequent underlying liver diseases were hepatitis C (35%) and alcoholic liver disease (28%) resulting in Child-Pugh A (73.4%) or Child-Pugh B (17%) liver cirrhosis. Tumor response was assessed using modified Response Evaluation Criteria in Solid Tumors with magnetic resonance (MR) imaging performed 4–6 weeks after each procedure.ResultsSerious adverse events (n = 9) were ischemic or infectious in nature. Transarterial chemoembolization with SAP microspheres resulted in objective response rates of 67.5%, 44.5%, and 25% after first, second, and third sessions. There were 16 patients (25%) who underwent orthotopic liver transplantation after transarterial chemoembolization with SAP microspheres, of whom 2 experienced recurrent disease. During a median follow-up time of 14 months (range, 2–55 mo), 26 patients (40.5%) died. Median overall and transplant-free survivals were 20.5 months (95% confidence interval, 13.2–27.7) and 18 months (95% confidence interval, 14.2–21.8), respectively.ConclusionsTransarterial chemoembolization with SAP microspheres has an excellent safety profile in cirrhotic patients, even in the presence of advanced liver disease (Child-Pugh B) or advanced stages of HCC. This treatment produced meaningful tumor response rates as assessed by MR imaging.     

Treatment of Acute Hemoptysis by Bronchial Artery Embolization with the Liquid Embolic Agent Ethylene Vinyl Alcohol Copolymer

PurposeTo determine the technical and clinical success of bronchial artery embolization (BAE) with the liquid embolic agent ethylene vinyl alcohol (EVOH) copolymer in patients with acute hemoptysis.Materials and MethodsThirty-four patients (25 male; mean age, 58 y; range, 13–78 y) who underwent BAE with EVOH were retrospectively reviewed. Reasons for acute hemoptysis included lung cancer (44%), pulmonary metastases (12%), bronchiectasis (21%), arteriovenous malformation (5%), tuberculosis (6%), aspergilloma (3%), acute respiratory distress syndrome (3%), anticoagulant overdose (3%), and scar tissue (3%). Technical and clinical success of BAE were retrospectively assessed.ResultsEmbolization was technically successful in 94% of patients. Additional embolization material was needed in 4 patients (12%). The immediate clinical success rate was 94% (32 of 34); in 2 patients (6%), hemoptysis recurred immediately after the intervention or could not be stopped. Periinterventional minor complications included headache (n = 1), fever (n = 1), and acute renal failure (n = 1). During follow-up (mean, 8.8 mo), 5 patients had a recurrence of hemoptysis (15%).ConclusionsThe use of EVOH copolymer for BAE in patients with acute hemoptysis is technically successful and safe and has a good clinical outcome with a low number of recurrences.     

Targeting and Recanalization after Embolization with Calibrated Resorbable Microspheres versus Hand-cut Gelatin Sponge Particles in a Porcine Kidney Model

PurposeTo report on polyethylene glycol hydrogel-based resorbable embolization microspheres (REM) that were synthesized to resorb in < 24 hours, before inflammation and vascular remodeling, to achieve a complete arterial recanalization and to compare targeting and recanalization of REM of 300–500 µm, 500–700 µm, and 700–900 µm with hand-cut gelatin sponge particles (GSP).Materials and MethodsEight pigs underwent polar renal artery embolization with REM or GSP. Angiograms were obtained before embolization and 10 minutes and 7 days after embolization before pigs were sacrificed to determine the occlusion level, the percentage of occlusion, and the recanalization rate for each product. The distribution of embolic material was assessed in pathology, and infarction rate of the kidneys was measured.ResultsREM of 300–500 µm occluded more distal vessels than REM of 500–700 µm and 700–900 µm. At day 7, the recanalization rate was complete for the larger REM, whereas it was about 60% for the two smaller sizes. REM were completely degraded, with no residual material or inflammation. GSP occluded more proximal arteries than REM of 700–900 µm, were partly degraded at day 7, and were accompanied by a foreign body reaction in proximal and distal arteries. GSP recanalized at 79%. The infarction rate was higher with the two smaller sizes of REM and with GSP than with the largest REM.ConclusionsREM of different sizes targeted different occlusion levels in kidney arteries. GSP provided an extended occlusion level without actual targeting. Regardless of embolic material used, angiographic recanalization of renal arteries depended on the extent of necrosis. REM of 700–900 µm demonstrated the lowest infarction rate and the best recanalization rate.     

Ethylene-Vinyl Alcohol Copolymer Endobiliary Obliteration of Hepatic Segments in a Patient with Isolated Bile Leaks

A 54-year-old woman with a symptomatic giant hepatic hemangioma underwent an extended left hepatic trisegmentectomy complicated by 250–350 mL/d postoperative bilious drainage. After 5 months of therapy, drainage was unabated, and the patient was no longer a surgical candidate. Sinography revealed three distinct isolated bile duct leaks involving segments 6, 7, and 8. Endobiliary segmentectomy was achieved by obliterating the isolated systems with ethylene-vinyl alcohol copolymer (Onyx; ev3, Plymouth, Minnesota) during three fluoroscopic procedures. Bilious leaks were successfully eliminated, and compensatory hypertrophy of noninvolved liver occurred. At 2 years from the last embolization procedure, the patient remained asymptomatic with no bilious leak.     

Pediatric Abdominal and Pelvic Trauma: Safety and Efficacy of Arterial Embolization

PurposeAlthough transcatheter embolization is a well established technique to treat adults in the trauma setting, evidence is lacking in the pediatric population. This study assesses the safety and efficacy of arterial embolization for blunt abdominal and pelvic trauma in the pediatric population.Materials and MethodsA retrospective review of abdominal and pelvic angiograms in 97 pediatric patients with blunt trauma was conducted over an 11-year period. Abdominal angiography and embolization was performed for ongoing hepatic, renal, splenic, or nonvisceral retroperitoneal injury. Pelvic angiography was performed in the setting of pelvic fracture with ongoing pelvic hemorrhage. Complications and clinical success rates of these procedures were assessed.ResultsOf the 97 pediatric patients who underwent angiography for acute abdominal or pelvic trauma, 54 (56%) required embolization involving 62 separate sites. Injury severity score greater than 15 was present in 94% of patients. Targets of embolization included the pelvis (n = 39), liver (n = 8), kidney (n = 7), spleen (n = 6), and retroperitoneum (n = 2). Effective hemorrhage control was achieved in 47 patients (87%). Overall mortality rate was 22% (12 of 54), with most deaths related to traumatic brain injury. Five complications occurred in four patients (7%), including three major complications (hepatic abscess, bile leak, and urinary incontinence).ConclusionsAngiography and embolization is relatively safe and potentially effective in the setting of abdominal and pelvic trauma in the pediatric population. Angiography with embolization should be considered in the treatment algorithm for this patient population.     

Preoperative Transcatheter Arterial Chemoembolization of Hepatoblastoma in Infants

PurposeTo evaluate the effect of preoperative transcatheter arterial chemoembolization of hepatoblastoma in infants.Materials and MethodsClinical data of 21 infants with hepatoblastoma treated between July 2008 and July 2012 in a single hospital were retrospectively analyzed. After preliminary diagnosis, surgical resection was performed in 9 infants (group I), and transcatheter arterial chemoembolization was performed in 12 infants (group II) before conventional resection. Surgical resection was performed when the tumor bulk appeared sufficiently reduced after transcatheter arterial chemoembolization alone or transcatheter arterial chemoembolization following chemotherapy in cases of pulmonary metastases.ResultsTumor shrinkage ranged from 25%–91% with a mean reduction of 69% (t = 3.816, P = .003) in group II. α-Fetoprotein levels were markedly decreased from 49%–99% with a mean level of 95% (t = 4.871, P = .000) in group II. Specimens in group II showed massive necrosis with a mean percentage of 72% with no significant treatment-related toxicity. In group II, the surgical time was significantly shorter (t = 3.438, P = .003), intraoperative blood loss was considerably less (t = 3.459, P = .003), and the weight of the resected liver was significantly less (t = 3.785, P = .001). Of 21 patients, 16 survived for 50 months without recurrence.ConclusionsTranscatheter arterial chemoembolization effectively reduced tumor volume, decreased α-fetoprotein, and reduced intraoperative hemorrhage. It represents a safe and effective adjuvant bridge to successful surgery for hepatoblastoma in infants.     

Prospective,Randomized Study of Coil Embolization versus Surefire Infusion System during Yttrium-90 Radioembolization with Resin Microspheres

PurposeTo compare standard coil embolization versus the use of an antireflux microcatheter (ARM) in patients undergoing planning angiography before selective internal radiation therapy (SIRT).Materials and MethodsA prospective, single-center trial was performed in which 30 patients were randomly assigned to undergo SIRT with coil embolization or the use of an ARM. The coil group underwent detachable coil embolization of nontarget vessels, and the ARM group underwent infusion of macroaggregated albumin with use of an ARM system, without coil embolization. Single-photon emission computed tomography (CT)/CT was then performed to assess for nontarget distribution. The primary endpoint was fluoroscopy time during planning angiography. Secondary endpoints included deployment time, total procedure time, radiation dose–area product, contrast agent used, and adverse events. Endpoints were evaluated during planning angiography and SIRT.ResultsOver a 9-month period, 30 consecutive patients were randomized at a 1:1 ratio between coil embolization and ARM groups. Technical success rates were 100% in both groups. Mean fluoroscopy time was significantly reduced in the ARM group versus the coil embolization group (1.8 min [range, 0.4–4.9 min] vs 6.0 min [range, 1.9–15.7 min]; P = .002). The planning procedure time (P < .001), deployment time (P < .001), dose–area product (P = .04), and amount of contrast agent used (P < .001) were also significantly less in the ARM group than in the coil embolization group. No nontarget distribution was detected in either group. There was no difference between groups in dose delivered on the day of SIRT (P = .71). There were no major or minor adverse events at 30 days.ConclusionsThe use of an ARM during planning angiography can significantly reduce fluoroscopy time, procedure time, and radiation dose.     

A Novel Resorbable Embolization Microsphere for Transient Uterine Artery Occlusion: A Comparative Study with Trisacryl-Gelatin Microspheres in the Sheep Model

PurposeTo evaluate angiographic recanalization, inflammatory reaction, and uterine damage after sheep uterine artery embolization (UAE) with a novel calibrated resorbable embolization microsphere (REM) and compare the results with control nonresorbable microspheres.Materials and MethodsSix hormonally artificially cycled sheep underwent bilateral UAE until stasis with either REM or trisacryl-gelatin microspheres (TGMS). At 7 days, control angiograms were obtained to assess the residual vascularization at arterial and parenchymal phases. The animals were then sacrificed for analysis of the presence of microspheres, inflammatory foreign body reaction, and surface areas of uterine damage.ResultsMean volume of microspheres injected per uterine artery (UA) or per animal did not differ between groups. At day 7, the flow was normal for six of six UAs that received embolization with REM versus only three of six UAs with TGMS (P = .0455, χ² test). Uterine parenchymography showed no defects in six UAs in the REM group versus five defects in six UAs in the TGMS group (P = .0060, χ² test). No REM or residual fragments of microspheres were observed on histologic analysis. TGMS were observed in tissues and accompanied by a mild inflammatory response. Necrosis rates were not significantly different between the two products, either in endometrium (REM 23.5% ± 28.8% [median 8.1%] vs TGMS 21.8% ± 23.7% [median 14.6%]) or in myometrium (REM 8.2% ± 22.7% [median 0.0%] vs TGMS 8.8% ± 20.8% [median 0.9%]). Endometrium alteration rate was lower with REM than with TGMS (39.7% ± 25.7% [median 34%] vs 60.6% ± 27.1% [median 71%]; P = .0060, Mann-Whitney test). Myometrium alteration rates were not significantly different between REM (45.7% ± 37.1% [median 63.0%]) and TGMS (37.8% ± 34.0% [median 19.1%]).ConclusionsAt 1 week after sheep UAE with REM, the recanalization was complete, the microspheres were completely degraded, and there was no remnant inflammatory response.     

Calibrated Bioresorbable Microspheres: A Preliminary Study on the Level of Occlusion and Arterial Distribution in a Rabbit Kidney Model

PurposeTo assess the level of occlusion and arterial distribution of calibrated bioresorbable microspheres (BRMS-I and BRMS-II) compared with tris-acryl gelatin microspheres (TGMS) after renal embolization.Materials and MethodsSix rabbits underwent renal embolization with 100–300 µm BRMS-I and TGMS; three rabbits received partial occlusion (group 1, n = 3), and three rabbits received total occlusion (group 2, n = 3). Four other rabbits received 100–300 µm BRMS-II (with higher cross-linking density than BRMS-I) in the left kidneys reaching total occlusion (group 3, n = 4). Coronal sections of the kidneys were histologically analyzed. Ease of injection, microsphere deformation, vessel sizes, and arterial distribution were assessed.ResultsThe injection of BRMS-I, BRMS-II, and TGMS through microcatheters went smoothly without any clogging. In group 1, BRMS identification was easier than TGMS. In group 2, both BRMS-I and TGMS were observed in all three arterial levels (interlobar, arcuate, and interlobular arteries) without a significant difference (P = .84). BRMS-I were not significantly different from TGMS in the mean diameter of vessels occluded (197 µm ± 23 vs 158 µm ± 21, P = .25) or the microsphere deformation (8.85% ± 0.53% vs 11.80% ± 0.64%, P = .071). In group 3, the arterial distribution of BRMS-II was significantly different from BRMS-I and TGMS (P < .0001).ConclusionsIn occluding arteries, 100–300 µm BRMS-I were not significantly different from 100–300 µm TGMS. Arterial distribution of BRMS can be influenced by their cross-linking density.     

The Role of Accessory Obturator Arteries in Prostatic Arterial Embolization

In 9 of 491 patients (1.8%) who underwent prostatic arterial embolization (PAE) for benign prostatic hyperplasia from March 2009–November 2013, prostatic arteries arose from the external iliac artery via an accessory obturator artery (AOA). Computed tomography angiography performed before the procedure identified the variant and allowed planning before the procedure. The nine AOAs were catheterized from a contralateral femoral approach. Bilateral PAE was technically successful in the nine patients. There was a mean decrease in international prostate symptom score of 6.5 points and a mean prostate volume reduction of 15.1% (mean follow-up, 4.8 mo) in the nine patients.     

Transcatheter Arterial Chemoembolization for Advanced Hepatocellular Carcinoma with Portal Vein Invasion: Safety,Efficacy, and Prognostic Factors

PurposeTo evaluate the safety and efficacy of transarterial chemoembolization and to identify the prognostic factors associated with survival in patients with hepatocellular carcinoma (HCC) and portal vein (PV) invasion.Materials and MethodsFrom January 2006 to March 2012, 50 patients with HCC invading into the PV (Barcelona Clinic Liver Cancer stage C) were treated with transarterial chemoembolization. The parenchymal tumor and PV tumor were confirmed by multidetector computed tomography (CT) and angiography. There were 14 patients with right PV tumor, 12 patients with left PV tumor, and 24 patients with main PV tumor. The response was evaluated by multidetector CT using Response Evaluation Criteria in Solid Tumors. Patients with residual tumors received repeated transarterial chemoembolization every 6–8 weeks unless the patients achieved complete remission or developed contraindications.ResultsThe median survival period of the entire group was 6.2 months (range, 1.7–50.9 mo), and the overall response rate was 42% (21 of 50 patients). The 6-month, 12-month, 24-month, and 36-month survival rates were 54%, 22%, 10%, and 8%. There were no instances of 30-day mortality or acute liver failure related to transarterial chemoembolization. The median survival of the 21 responders was 10.5 months, and the median survival of the 29 nonresponders was 5.5 months (P < .001). In both univariate and multivariate analyses, only the response to transarterial chemoembolization (hazard ratio = 0.25, P < .001) and the absence of ascites (hazard ratio = 0.24, P = .01) were significant prognostic factors.ConclusionsTransarterial chemoembolization is a safe and effective treatment for HCC with major PV invasion. The response to transarterial chemoembolization and the ascites status were the most significant predictive factors for prolonged survival.     

Transcatheter CT Arterial Portography and CT Hepatic Arteriography for Liver Tumor Visualization during Percutaneous Ablation

PurposeTo evaluate the feasibility of combining transcatheter computed tomography (CT) arterial portography or transcatheter CT hepatic arteriography with percutaneous liver ablation for optimized and repeated tumor exposure.Materials and MethodsStudy participants were 20 patients (13 men and 7 women; mean age, 59.4 y; range, 40–76 y) with unresectable liver-only malignancies—14 with colorectal liver metastases (29 lesions), 5 with hepatocellular carcinoma (7 lesions), and 1 with intrahepatic cholangiocarcinoma (2 lesions)—that were obscure on nonenhanced CT. A catheter was placed within the superior mesenteric artery (CT arterial portography) or in the hepatic artery (CT hepatic arteriography). CT arterial portography or CT hepatic arteriography was repeatedly performed after injecting 30–60 mL 1:2 diluted contrast material to plan, guide, and evaluate ablation. The operator confidence levels and the liver-to-lesion attenuation differences were assessed as well as needle-to-target mismatch distance, technical success, and technique effectiveness after 3 months.ResultsTechnical success rate was 100%; there were no major complications. Compared with conventional unenhanced CT, operator confidence increased significantly for CT arterial portography or CT hepatic arteriography cases (P < .001). The liver-to-lesion attenuation differences between unenhanced CT, contrast-enhanced CT, and CT arterial portography or CT hepatic arteriography were statistically significant (mean attenuation difference, 5 HU vs 28 HU vs 70 HU; P < .001). Mean needle-to-target mismatch distance was 2.4 mm ± 1.2 (range, 0–12.0 mm). Primary technique effectiveness at 3 months was 87% (33 of 38 lesions).ConclusionsIn patients with technically unresectable liver-only malignancies, single-session CT arterial portography–guided or CT hepatic arteriography–guided percutaneous tumor ablation enables repeated contrast-enhanced imaging and real-time contrast-enhanced CT fluoroscopy and improves lesion conspicuity.     

Recanalization of Chronic Total Occlusions of the Superior Mesenteric Artery in Patients with Chronic Mesenteric Ischemia: Technical and Clinical Outcomes

PurposeTo evaluate the safety and outcomes of endovascular recanalization of chronic total occlusions (CTOs) of the superior mesenteric artery (SMA) in patients with chronic mesenteric ischemia (CMI).Materials and MethodsA single-institution retrospective review was performed of 47 consecutive patients (18 male, 29 female) who underwent endovascular stent placement for CTOs of the SMA between February 2006 and November 2012. All patients had symptoms of CMI. Procedural and follow-up data were collected for assessment of technical success, safety, and outcome.ResultsTechnical success was achieved in 41 of 47 patients (87%). Forty-two of the 47 procedures were performed from a femoral approach. Fifteen patients underwent concurrent revascularization of the celiac artery. All patients who underwent successful recanalization reported symptomatic improvement. Kaplan–Meier analysis revealed primary freedom from symptomatic recurrence of 95% at 12 months and 78% at 24 months. Symptomatic recurrence was observed in seven patients, all of whom underwent successful assisted or secondary endovascular procedures. Secondary freedom from symptomatic recurrence rates were 100% at 12 months and 88% 24 months. There were three (7%) minor access-related complications and no major complications.ConclusionsEndovascular stent-assisted recanalization of chronic SMA occlusions is safe and effective, with an acceptable rate of technical success and excellent midterm clinical outcomes.     

Comparison of Polyvinyl Alcohol Microspheres and Tris-Acryl Gelatin Microspheres for Uterine Fibroid Embolization: Results of a Single-Center Randomized Study

PurposeTo assess the efficacy of two embolic agents in the treatment of symptomatic uterine leiomyomas.Materials and MethodsA randomized, prospective, single-center study enrolled 60 women with symptomatic uterine leiomyomas. Uterine artery embolization (UAE) with spherical polyvinyl alcohol (SPVA) microspheres (n = 30; 700–900 μm and 900–1,200 μm; near-stasis or stasis endpoint) and tris-acryl gelatin (TAG) microspheres (n = 30; 500–700 μm; “pruned-tree” endpoint) was performed. Infarction rates were calculated for the dominant tumor and for small (< 2 cm) and large (> 2 cm) nondominant tumors. The primary endpoint was tumor infarction at 24 hours measured by contrast-enhanced magnetic resonance imaging assessed by a blinded reviewer.ResultsBaseline characteristics were similar between groups. The primary endpoint was similar in both treatments (≥ 91% dominant tumor infarction; SPVA. 86.2%; TAG, 93.3%, P = .35). Complete infarction (100%) was also similar between arms at 24 hours and 3 months. Symptom severity was reduced and quality of life improved equally at 3 and 12 months in each treatment group. Complications were minor in both groups.ConclusionsUterine leiomyoma infarction at 24 hours and 3 months after treatment with SPVA or TAG microspheres was comparable when using near-stasis as a procedural endpoint with SPVA microspheres. Symptom relief was maintained for as long as 12 months for both embolic agents.