Comparison of Polyvinyl Alcohol Versus Combination of Lipiodol-Bleomycin Emulsion and NBCA-Lipiodol Emulsion for Renal Angiomyolipoma Embolization: A Prospective Randomized Study
Abstract
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BACKGROUND. Consensus is lacking regarding optimal embolic agents for transcatheter arterial embolization (TAE) of renal angiomyolipomas (AMLs).
OBJECTIVE. The purpose of our study was to compare the safety and efficacy of TAE with polyvinyl alcohol (PVA) and TAE with a combination of ethiodized oil (Lipiodol)-bleomycin emulsion and N-butyl cyanoacrylate (NBCA)-Lipiodol emulsion for the treatment of patients with large or symptomatic AMLs.
METHODS. This prospective study enrolled patients referred for TAE of a large (> 4 cm) or symptomatic renal AML from July 2007 to December 2018. Patients were randomized to undergo TAE using PVA particles or a combination of Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion. Patients underwent serial clinical follow-up visits and follow-up CT or MRI examinations after TAE. Outcomes were compared between groups.
RESULTS. Seventy-eight patients were enrolled. After exclusions, the analysis included 72 patients (15 men, 57 women; mean age, 35.0 years; 51 patients with hematuria, 66 patients with flank pain): 35 patients were randomized to treatment by PVA and 37 were randomized to treatment by a combination of Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion. Complete occlusion of all angiographically visible arterial supply was achieved in all patients. No major adverse event occurred in any patient. The mean follow-up after TAE was 77 ± 45 (SD) months (range, 37–180 months). The frequency of resolution of hematuria after initial TAE without recurrence was greater after treatment by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than by PVA (100.0% vs 80.0%, respectively; p = .03). At 12-month follow-up, the frequency of complete resolution of flank pain was higher after treatment by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than by PVA (100.0% vs 75.0%, p = .03). Mean reduction in AML volume at 36 months or longer after TAE versus at baseline was greater in patients treated by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than in those treated by PVA (98.0% vs 85.7%, respectively; p = .04). The frequency of complete response by modified RECIST (mRECIST) criteria at 36 months or longer after TAE was greater in patients treated by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than by PVA (94.6% vs 74.3%, p = .04). The rate of repeat TAE was higher among patients treated by PVA than among those treated by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion (25.7% vs 8.1%, p = .04).
CONCLUSION. Superior outcomes after TAE of AML were achieved using Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than using PVA.
CLINICAL IMPACT. TAE using a combination of Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion is a safe and effective treatment option for large or symptomatic AMLs.
TRIAL REGISTRATION. Chinese Clinical Trial Registry ChiCTR2100053296
HIGHLIGHTS
Key Finding
▪ TAE of AML using Lipiodol-bleomycin emulsion and NCBA-Lipiodol emulsion, compared with TAE using PVA, achieved higher frequency of hematuria resolution without recurrence (100.0% vs 80.0%), higher frequency of complete resolution of flank pain (100.0% vs 75.0%), greater AML volume reduction (98.0% vs 85.7%), and lower rate of repeat TAE (25.7% vs 8.1%).
Importance
▪ This prospective randomized study supports the safety and efficacy of TAE using a novel combination of Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion to treat large or symptomatic AMLs.
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References
1.
Caliò A, Brunelli M, Segala D, et al. Angiomyolipoma of the kidney: from simple hamartoma to complex tumour. Pathology 2021; 53:129–140
2.
Nason GJ, Morris J, Bhatt JR, et al. Natural history of renal angiomyolipoma favors surveillance as an initial approach. Eur Urol Focus 2021; 7:582–588
3.
Lee KH, Tsai HY, Kao YT, et al. Clinical behavior and management of three types of renal angiomyolipomas. J Formos Med Assoc 2019; 118:162–169
4.
Murray TE, Lee MJ. Are we overtreating renal angiomyolipoma: a review of the literature and assessment of contemporary management and follow-up strategies. Cardiovasc Intervent Radiol 2018; 41:525–536
5.
Bhatt JR, Richard PO, Kim NS, et al. Natural history of renal angiomyolipoma (AML): most patients with large AMLs > 4 cm can be offered active surveillance as an initial management strategy. Eur Urol 2016; 70:85–90
6.
Hatano T, Egawa S. Renal angiomyolipoma with tuberous sclerosis complex: how it differs from sporadic angiomyolipoma in both management and care. Asian J Surg 2020; 43:967–972
7.
Fernández-Pello S, Hora M, Kuusk T, et al. Management of sporadic renal angiomyolipomas: a systematic review of available evidence to guide recommendations from the European Association of Urology Renal Cell Carcinoma Guidelines Panel. Eur Urol Oncol 2020; 3:57–72
8.
Ribal MJ. Challenging already established statements on the therapy of renal angiomyolipoma. Eur Urol 2016; 70:91–92
9.
Ljungberg B, Albiges L, Abu-Ghanem Y, et al. European Association of Urology Guidelines on renal cell carcinoma: the 2019 update. Eur Urol 2019; 75:799–810
10.
Flum AS, Hamoui N, Said MA, et al. Update on the diagnosis and management of renal angiomyolipoma. J Urol 2016; 195:834–846
11.
Chapman D, Tyson M, Buckley B. Single-institution, retrospective review of elective and emergency embolization of renal angiomyolipoma. Can Urol Assoc J 2021; 15:E598–E602
12.
Lee S, Park HS, Hyun D, et al. Radiologic and clinical results of transarterial ethanol embolization for renal angiomyolipoma. Eur Radiol 2021; 31:6568–6577
13.
Sheth RA, Feldman AS, Paul E, Thiele EA, Walker TG. Sporadic versus tuberous sclerosis complex-associated angiomyolipomas: predictors for long-term outcomes following transcatheter embolization. J Vasc Interv Radiol 2016; 27:1542–1549
14.
Kiefer RM, Stavropoulos SW. The role of interventional radiology techniques in the management of renal angiomyolipomas. Curr Urol Rep 2017; 18:36
15.
Kuusk T, Biancari F, Lane B, et al. Treatment of renal angiomyolipoma: pooled analysis of individual patient data. BMC Urol 2015; 15:123
16.
Urbano J, Paul L, Cabrera M, Alonso-Burgos A, Gómez D. Elective and emergency renal angiomyolipoma embolization with ethylene vinyl alcohol copolymer: feasibility and initial experience. J Vasc Interv Radiol 2017; 28:832–839
17.
Sawada Y, Shimohira M, Hashizume T, et al. Transcatheter arterial embolization for renal angiomyolipoma using a micro-balloon catheter and a mixture of ethanol and Lipiodol. Cardiovasc Intervent Radiol 2017; 40:1933–1939
18.
Torkian P, Li J, Kaufman JA, Jahangiri Y. Effectiveness of transarterial embolization in treatment of symptomatic hepatic hemangiomas: systematic review and meta-analysis. Cardiovasc Intervent Radiol 2021; 44:80–91
19.
Yan JY, Zhang JL, Yuan K, et al. Transarterial embolisation with bleomycin and N-butyl-2-cyanoacrylate–Lipiodol mixture for symptomatic polycystic liver disease: preliminary experience. Clin Radiol 2019; 74:975.e11–975.e16
20.
Prigent FV, Guillen K, Comby PO, et al. Selective arterial embolization of renal angiomyolipomas with a N-butyl cyanoacrylate–Lipiodol mixture: efficacy, safety, short- and mid-term outcomes. J Clin Med 2021; 10:4062
21.
Comby PO, Guillen K, Chevallier O, et al. Endovascular use of cyanoacry-late-Lipiodol mixture for peripheral embolization: properties, techniques, pitfalls, and applications. J Clin Med 2021; 10:4320
22.
Northrup H, Aronow ME, Bebin EM, et al.; International Tuberous Sclerosis Complex Consensus Group. Updated international tuberous sclerosis complex diagnostic criteria and surveillance and management recommendations. Pediatr Neurol 2021; 123:50–66
23.
Dariushnia SR, Redstone EA, Heran MKS, et al. Society of Interventional Radiology quality improvement standards for percutaneous transcatheter embolization. J Vasc Interv Radiol 2021; 32:476.e1–476.e33
24.
Guo Y, Kapoor A, Cheon P, So AI, Lattouf JB, Jamal M. Canadian Urological Association best practice report: diagnosis and management of sporadic angiomyolipomas. Can Urol Assoc J 2020; 14:E527–E536
25.
Yamakado K, Tanaka N, Nakagawa T, Kobayashi S, Yanagawa M, Takeda K. Renal angiomyolipoma: relationships between tumor size, aneurysm formation, and rupture. Radiology 2002; 225:78–82
26.
Davenport MS, Neville AM, Ellis JH, Cohan RH, Chaudhry HS, Leder RA. Diagnosis of renal angiomyolipoma with Hounsfield unit thresholds: effect of size of region of interest and nephrographic phase imaging. Radiology 2011; 260:158–165
27.
Chan Park M, Park S, Kim SC, et al. Varying outcomes among patients with large angiomyolipomas according to the treatment method. Urol Int 2021; 105:680–686
28.
Hocquelet A, Cornelis F, Le Bras Y, et al. Long-term results of preventive embolization of renal angiomyolipomas: evaluation of predictive factors of volume decrease. Eur Radiol 2014; 24:1785–1793
29.
Villalta JD, Sorensen MD, Durack JC, Kerlan RK, Stoller ML. Selective arterial embolization of angiomyolipomas: a comparison of smaller and larger embolic agents. J Urol 2011; 186:921–927
30.
Murray TE, Doyle F, Lee M. Transarterial embolization of angiomyolipoma: a systematic review. J Urol 2015; 194:635–639
31.
Kato H, Kuwatsuru R, Inoue T, Okada S, Aida M, Yamashiro Y. Superselective transcatheter arterial embolization for large unruptured renal angiomyolipoma in lymphangioleiomyomatosis. J Vasc Interv Radiol 2018; 29:958–965
32.
Chick CM, Tan BS, Cheng C, et al. Long-term follow-up of the treatment of renal angiomyolipomas after selective arterial embolization with alcohol. BJU Int 2010; 105:390–394
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Submitted: September 29, 2022
Revision requested: October 14, 2022
Revision received: November 4, 2022
Accepted: November 22, 2022
Version of record online: December 7, 2022
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