Society of Interventional Radiology Research Reporting Standards for Prostatic Artery Embolization

Abstract

Prostatic artery embolization (PAE) is a promising alternative to traditional surgical options for treatment of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) (1Abt D. Hechelhammer L. Mullhaupt G. et al.Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial.Br Med J. 2018; 361: k2338Crossref PubMed Scopus (155) Google Scholar, 2Abt D. Mullhaupt G. Mordasini L. et al.Outcome prediction of prostatic artery embolization: post hoc analysis of a randomized, open-label, non-inferiority trial.BJU Int. 2019; 124: 134-144Crossref PubMed Scopus (29) Google Scholar, 3Antunes A.A. Carnevale F.C. da Motta Leal Filho J.M. et al.Clinical, laboratorial, and urodynamic findings of prostatic artery embolization for the treatment of urinary retention related to benign prostatic hyperplasia. 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Angiographic findings during repeat prostatic artery embolization.J Vasc Interv Radiol. 2019; 30: 645-651Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar, 19de Assis A.M. Moreira A.M. Carnevale F.C. et al.Effects of prostatic artery embolization on the dynamic component of benign prostate hyperplasia as assessed by ultrasound elastography: a pilot series.Cardiovasc Intervent Radiol. 2019; 42: 1001-1007Crossref PubMed Scopus (12) Google Scholar, 20de Assis A.M. Moreira A.M. de Paula Rodrigues V.C. et al.Prostatic artery embolization for treatment of benign prostatic hyperplasia in patients with prostates > 90 g: a prospective single-center study.J Vasc Interv Radiol. 2015; 26: 87-93Abstract Full Text Full Text PDF PubMed Scopus (115) Google Scholar, 21du Pisanie J. Abumoussa A. Donovan K. Stewart J. Bagla S. Isaacson A. 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Prostate artery embolisation: an initial experience from an Indian perspective.Pol J Radiol. 2018; 83: e554-e559Crossref PubMed Scopus (4) Google Scholar, 42Smith C. Craig P. Taleb S. Young S. Golzarian J. Comparison of traditional and emerging surgical therapies for lower urinary tract symptoms in men: a review.Cardiovasc Intervent Radiol. 2017; 40: 1176-1184Crossref PubMed Scopus (9) Google Scholar, 43Stewart J.K. Isaacson A.J. Clinical outcomes following prostatic artery embolization in patients with bladder diverticula.J Vasc Interv Radiol. 2019; 30: 1633-1635Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar, 44Tapping C.R. Boardman P. Prostatic artery embolization (PAE) in catheter-dependent patients with large prostatic (BPH) glands (>90 cc): early intervention essential.Acta Radiol. 2019; 60: 1562-1565Crossref PubMed Scopus (5) Google Scholar, 45Torres D. Costa N.V. Pisco J. Pinheiro L.C. Oliveira A.G. Bilhim T. 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Zhang G.D. et al.Prostatic arterial embolization for the treatment of lower urinary tract symptoms due to large (>80 mL) benign prostatic hyperplasia: results of midterm follow-up from Chinese population.BMC Urol. 2015; 15: 33Crossref PubMed Scopus (76) Google Scholar, 49Wang M.Q. Zhang J.L. Xin H.N. et al.Comparison of clinical outcomes of prostatic artery embolization with 50-mum plus 100-mum polyvinyl alcohol (PVA) Particles versus 100-μm PVA particles alone: a prospective randomized trial.J Vasc Interv Radiol. 2018; 29: 1694-1702Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar, 50Wang X.Y. Zong H.T. Zhang Y. Efficacy and safety of prostate artery embolization on lower urinary tract symptoms related to benign prostatic hyperplasia: a systematic review and meta-analysis.Clin Interv Aging. 2016; 11: 1609-1622Crossref PubMed Scopus (29) Google Scholar). However, as with any developing area of investigation, there is a need to assemble consistent high-quality data that clarify the role of that therapy and allow for systematic analyses of multiple studies (51Golzarian J. Antunes A.A. Bilhim T. et al.Prostatic artery embolization to treat lower urinary tract symptoms related to benign prostatic hyperplasia and bleeding in patients with prostate cancer: proceedings from a multidisciplinary research consensus panel.J Vasc Interv Radiol. 2014; 25: 665-674Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar). The objective of this Reporting Standards document is to define a consistent nomenclature and terminology with which investigators can communicate the results of PAE trials to facilitate subsequent comparisons of published techniques, embolic materials, patient populations, and outcomes. The intent is to systematize the reporting of PAE data so that higher levels of evidence can be sought. Reporting Standards are not intended to validate or recommend technical aspects of PAE, but to promote transparent, detailed, and uniform reporting of relevant data. Reporting Standards may also have value in the nontrial setting in highlighting important aspects of clinical care. These recommendations are made in addition to the checklists of items found in the Standards for Reporting of Diagnostic Accuracy Studies Guidelines, Animal Research: Reporting of In Vivo Experiments Guidelines, Strengthening the Reporting of Observational Studies in Epidemiology Statement, and Consolidated Standards of Reporting Trials Guidelines (52Begg C. Cho M. Eastwood S. et al.Improving the quality of reporting of randomized controlled trials. The CONSORT statement.JAMA. 1996; 276: 637-639Crossref PubMed Google Scholar, 53Cohen J.F. Korevaar D.A. Altman D.G. et al.STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration.BMJ Open. 2016; 6e012799Crossref PubMed Scopus (979) Google Scholar, 54Kilkenny C. Browne W.J. Cuthill I.C. Emerson M. Altman D.G. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research.PLoS Biol. 2010; 8e1000412Crossref PubMed Scopus (4737) Google Scholar, 55von Elm E. Altman D.G. Egger M. Pocock S.J. Gøtzsche P.C. Vandenbroucke J.P. STROBE InitiativeThe Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.J Clin Epidemiol. 2008; 61: 344-349Abstract Full Text Full Text PDF PubMed Scopus (5706) Google Scholar). Most PAE studies have been single-arm studies; controlled and comparative trials are needed and are also under way. Appendix A of the Enhancing the Quality and Transparency of Health Research Network reporting guidelines (56Simera I. Moher D. Hirst A. Hoey J. Schulz K.F. Altman D.G. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network.BMC Med. 2010; 8: 24Crossref PubMed Scopus (304) Google Scholar) describes several shortcomings of contemporary health research reporting in general, some of which can be found in the current PAE literature. BPH is a histologic diagnosis that refers to smooth muscle and epithelial cell proliferation within the prostatic transition zone. LUTS include storage and/or voiding symptoms, which may not necessarily be related to BPH. Storage symptoms include frequency and nocturia, while voiding symptoms include difficulty initiating micturition and weak stream. BPH has been described as an etiology of LUTS through direct bladder outlet obstruction and through increased smooth muscle tone. The American Urological Association (AUA) defines bladder outlet obstruction as obstruction to the bladder outlet from all causes. Several terms have been used to describe LUTS in men, including prostatism, prostate enlargement, BPH, or clinical BPH. Because LUTS may have an etiology unrelated to the prostate, the term “LUTS independent of BPH” has been introduced. LUTS secondary to BPH is a meaningful descriptor of LUTS secondary to prostatic hyperplasia. Alternatively, the term “benign prostatic obstruction” (BPO) can be used when obstruction of the bladder outlet is confirmed by pressure-flow studies or is highly suspected from flow rates in the presence of an enlarged gland. PAE candidates should have a diagnosis of LUTS secondary to BPH as defined by the AUA 2018 BPH Management Guidelines (57Foster H.E. Barry M.J. Dahm P. et al.Surgical management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline.J Urol. 2018; 200: 612-619Crossref PubMed Scopus (196) Google Scholar). Complicated LUTS include etiologies and symptoms other than BPH, such as LUTS in the presence of suspicious digital rectal examination (DRE) findings, hematuria, abnormal prostate-specific antigen (PSA) level, pain, infection, palpable bladder, or neurologic disease (57Foster H.E. Barry M.J. Dahm P. et al.Surgical management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline.J Urol. 2018; 200: 612-619Crossref PubMed Scopus (196) Google Scholar). Studies should report whether history and physical examination (including DRE) were performed. Documentation of medical therapy, including dosages, frequencies, duration of therapy, and medication washout periods, if any, for BPO should be described for every patient. Surgical history, including previous urological and pelvic interventions, should be reported. The use of continuous or intermittent catheterization and the duration of symptoms should be reported. A validated self-administered questionnaire such as the International Prostate Symptom Score (IPSS) or the AUA Symptom Index should be used to subjectively assess symptoms. The quality of life component should be independently reported from those questionnaires. Investigators may consider assessment with other validated questionnaires (such as the Expanded Prostate Cancer Index Composite or the BPH Impact Index). Although other validated questionnaires may be of value, the IPSS and the AUA Symptom Index are recommended for clinical trials (58Barry M.J. Fowler Jr., F.J. O’Leary M.P. et al.The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association.J Urol. 1992; 148: 1549-1557Crossref PubMed Scopus (2795) Google Scholar,59Wei J.T. Dunn R.L. Litwin M.S. Sandler H.M. Sanda M.G. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer.Urology. 2000; 56: 899-905Abstract Full Text Full Text PDF PubMed Scopus (1184) Google Scholar). A urinalysis to evaluate for hematuria, proteinuria, pyuria, or other pathologic conditions should be obtained as a routine screening laboratory examination before PAE. In 2018, the US Preventive Services Task Force provided a negative, grade-D recommendation for PSA screening for men older than 70 years of age and a grade-C recommendation for PSA-based screening on a case-by-case basis for men aged 55–69 years (60Grossman D.C. Curry S.J. Bibbins-Domingo K. et al.US Preventive Services Task ForceScreening for prostate cancer: US Preventive Services Task Force Recommendation Statement.JAMA. 2018; 319: 1901-1913Crossref PubMed Scopus (79) Google Scholar). The decision to screen patients for prostate cancer should be based on DRE findings and on individual patients’ clinical indications and risk factors. The AUA recommends that findings suggesting prostate cancer, such as DRE results, prostate biopsy findings, hematuria, or elevated PSA level, indicate referral to a urologist for evaluation before treatment. Investigators should report PSA if obtained. Recommended demographic, anamnestic, and laboratory data are provided in Table 1.Table 1Recommended Data CollectionDemographic Data Age and race Patient weight and BMI Score of validated self-administered questionnaire (eg, IPSS, IIEF) Medical therapies for LUTS/BPH (including washout periods) Prior nonmedical therapy for LUTS/BPH Comorbid conditions (including cardiac history, recent surgery, hospitalizations) History of sexual dysfunction Presence of acute or chronic urinary retentionLaboratory Data Urinalysis PSA (or PSA density), if obtained Results of prostate biopsies, if obtainedObjective data Qmax PVR Invasive urodynamic testingBMI = body mass index; IIEF = International Index of Erectile Function; IPSS = International Prostate Symptom Score; LUTS = lower urinary tract symptoms; PSA = prostate-specific antigen; PVR = postvoid residual; Qmax = peak urinary flow. Open table in a new tab BMI = body mass index; IIEF = International Index of Erectile Function; IPSS = International Prostate Symptom Score; LUTS = lower urinary tract symptoms; PSA = prostate-specific antigen; PVR = postvoid residual; Qmax = peak urinary flow. Objective assessment of patients with LUTS can be performed with a wide variety of invasive or noninvasive means (61Lenherr S.M. Clemens J.Q. Urodynamics: with a focus on appropriate indications.Urol Clin North Am. 2013; 40: 545-557Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 62Mehdizadeh J.L. Leach G.E. Role of invasive urodynamic testing in benign prostatic hyperplasia and male lower urinary tract symptoms.Urol Clin North Am. 2009; 36: 431-441.vAbstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 63Nitti V.W. Pressure flow urodynamic studies: the gold standard for diagnosing bladder outlet obstruction.Rev Urol. 2005; 7: S14-S21PubMed Google Scholar); the interpretation of these studies is beyond the scope of this document. Noninvasive tests include measurement of peak urinary flow (Qmax) and postvoid residual (PVR). These noninvasive tests are useful in the initial diagnostic assessment and to measure treatment response (57Foster H.E. Barry M.J. Dahm P. et al.Surgical management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline.J Urol. 2018; 200: 612-619Crossref PubMed Scopus (196) Google Scholar). Invasive tests include filling cystometrography, abdominal leak point pressure, voiding cystometrography, static cystography, pelvic floor electromyography, and voiding cystourethrography, which measure the relative contribution of the individual components of the lower urinary tract (bladder, bladder outlet, and prostate) to LUTS and lower urinary tract function. Invasive urodynamic testing should be considered when the history and examination findings suggest that LUTS may be multifactorial or nonprostatic. Because the etiology of LUTS can be related to a number of different entities (such as detrusor overactivity, nocturnal polyuria, neurogenic bladder dysfunction, urinary tract infections, or malignancy) known as “complicated LUTS” (57Foster H.E. Barry M.J. Dahm P. et al.Surgical management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline.J Urol. 2018; 200: 612-619Crossref PubMed Scopus (196) Google Scholar), it is important that men considered for PAE undergo a thorough evaluation of their LUTS, preferably in conjunction with a urologist. The AUA 2018 surgical management guidelines (57Foster H.E. Barry M.J. Dahm P. et al.Surgical management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline.J Urol. 2018; 200: 612-619Crossref PubMed Scopus (196) Google Scholar) recommend PVR assessment before surgical intervention for LUTS caused by BPH and pressure-flow studies if the diagnosis of obstruction is uncertain. Nevertheless, these measures are routinely reported in high-level urologic trials, and consistent, continued reporting in the PAE literature is strongly suggested (64Cornu J.N. Ahyai S. Bachmann A. et al.A systematic review and meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic obstruction: an update.Eur Urol. 2015; 67: 1066-1096Abstract Full Text Full Text PDF PubMed Scopus (487) Google Scholar, 65Homma Y. Kawabe K. Tsukamoto T. et al.Estimate criteria for efficacy of treatment in benign prostatic hyperplasia.Int J Urol. 1996; 3: 267-273Crossref PubMed Scopus (77) Google Scholar, 66Jiang Y.L. Qian L.J. Transurethral resection of the prostate versus prostatic artery embolization in the treatment of benign prostatic hyperplasia: a meta-analysis.BMC Urol. 2019; 19: 11Crossref PubMed Scopus (31) Google Scholar, 67Lepor H. Landmark studies impacting the medical management of benign prostatic hyperplasia.Rev Urol. 2003; 5: S28-S35PubMed Google Scholar, 68McConnell J.D. Roehrborn C.G. Bautista O.M. et al.Medical Therapy of Prostatic Symptoms (MTOPS) Research GroupThe long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.N Engl J Med. 2003; 349: 2387-2398Crossref PubMed Scopus (1612) Google Scholar, 69Omar M.I. Lam T.B. Alexander C.E. et al.Systematic review and meta-analysis of the clinical effectiveness of bipolar compared with monopolar transurethral resection of the prostate (TURP).BJU Int. 2014; 113: 24-35Crossref PubMed Scopus (77) Google Scholar, 70Thomas J.A. Tubaro A. Barber N. et al.A multicenter randomized noninferiority trial comparing GreenLight-XPS laser vaporization of the prostate and transurethral resection of the prostate for the treatment of benign prostatic obstruction: two-yr outcomes of the GOLIATH Study.Eur Urol. 2016; 69: 94-102Abstract Full Text Full Text PDF PubMed Scopus (177) Google Scholar). Recommended objective data collection details are provided in Table 1. There are no consensus recommendations on the optimal imaging modality that should be used for evaluation before PAE. Investigators have advocated the use of computed tomographic (CT) angiography and magnetic resonance (MR) imaging before PAE for anatomic mapping and prostate volume measurement (17de Assis A.M. Maciel M.S. Moreira A.M. et al.Prostate zonal volumetry as a predictor of clinical outcomes for prostate artery embolization.Cardiovasc Intervent Radiol. 2017; 40: 245-251Crossref PubMed Scopus (27) Google Scholar,71Bilhim T. Pisco J.M. Rio Tinto H. et al.Prostatic arterial supply: anatomic and imaging findings relevant for selective arterial embolization.J Vasc Interv Radiol. 2012; 23: 1403-1415Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar,72Martins Pisco J. Pereira J. Rio Tinto H. Fernandes L. Bilhim T. How to perform prostatic arterial embolization.Tech Vasc Interv Radiol. 2012; 15: 286-289Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar). Although the AUA 2018 Guidelines (57Foster H.E. Barry M.J. Dahm P. et al.Surgical management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline.J Urol. 2018; 200: 612-619Crossref PubMed Scopus (196) Google Scholar) suggest that clinicians should consider assessment of prostate volume by imaging, measurement of prostate volume by imaging is logical before PAE, as it may provide a useful outcome parameter that can be analyzed for determination of patient selection, and is routinely reported in urologic BPO studies (64Cornu J.N. Ahyai S. Bachmann A. et al.A systematic review and meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic obstruction: an update.Eur Urol. 2015; 67: 1066-1096Abstract Full Text Full Text PDF PubMed Scopus (487) Google Scholar,69Omar M.I. Lam T.B. Alexander C.E. et al.Systematic review and meta-analysis of the clinical effectiveness of bipolar compared with monopolar transurethral resection of the prostate (TURP).BJU Int. 2014; 113: 24-35Crossref PubMed Scopus