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The 2020 Italian Society of Arterial Hypertension (SIIA) Practical Guidelines for the Management of Primary Aldosteronism

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The 2020 Italian Society of Arterial Hypertension (SIIA) Practical Guidelines for the Management of Primary Aldosteronism International Journal of Cardiology Hypertension 5 (2020) 100029 Contents lists available at ScienceDirect International Journal of Cardiology Hypertension journal homepage: www.journals.elsevier.com/international-journal-of-cardiology-hypertension/ Review Article The 2020 Italian Society of Arterial Hypertension (SIIA) practical guidelines for the management of primary aldosteronism Gian Paolo Rossi a,*, Valeria Bisogni a, Alessandra Violet Bacca b, Anna Belfiore c, Maurizio Cesari a, Antonio Concistre d, Rita Del Pinto e, Bruno Fabris f, Francesco Fallo g, Cristiano Fava h, Claudio Ferri e, Gilberta Giacchetti i, Guido Grassi j, Claudio Letizia d, Mauro Maccario k, Francesca Mallamaci l, Giuseppe Maiolino a, Dario Manfellotto m, Pietro Minuz h, Silvia Monticone n, Alberto Morganti o, Maria Lorenza Muiesan p, Paolo Mulatero n, Aurelio Negro q, Gianfranco Parati r, Martino F. Pengo r, Luigi Petramala d, Francesca Pizzolo h, Damiano Rizzoni p, Giacomo Rossitto a,s, Franco Veglio n, Teresa Maria Seccia a a Clinica dell'Ipertensione Arteriosa, Department of Medicine - DIMED, University of Padua, Italy b Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy c Clinica Medica "A. Murri", Department of Biomedical Sciences and Human Oncology, University of Bari Medical School, Bari, Italy d Department of Translational and Precision Medicine, Unit of Secondary Arterial Hypertension, "Sapienza" University of Rome, Italy e University of L'Aquila, Department of Life, Health and Environmental Sciences, San Salvatore Hospital, L'Aquila, Italy f Department of Medical Sciences, Universita degli Studi di Trieste, Cattinara Teaching Hospital, Trieste, Italy g Department of Medicine, DIMED, Internal Medicine 3, University of Padua, Italy h Department of Medicine, University of Verona, Policlinico "G.B. Rossi", Italy i Division of Endocrinology, Polytechnic University of Marche, Ancona, Italy j University of Milano-Bicocca, Italy k Endocrinology, Diabetology, and Metabolism, Department of Medical Sciences, University of Turin, Turin, Italy l CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy m UO Medicina Interna, Ospedale Fatebenefratelli Isola Tiberina, Rome, Italy n Hypertension Unit, Division of Internal Medicine, Department of Medical Sciences, University of Turin, Italy o Centro Fisiologia Clinica e Ipertensione, Ospedale Policlinico, Universita Milano, Milan, Italy p Clinica Medica, Department of Clinical and Experimental Sciences, University of Brescia, Italy q Department of Medicine, Center for Hypertension, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy r Department of Medicine and Surgery, University of Milano-Bicocca and Istituto Auxologico Italiano, IRCCS, Milan, Italy s University of Glasgow, Institute of Cardiovascular and Medical Sciences, Glasgow, UK ARTICLE INFO ABSTRACT Keywords: Background and aim: Considering the amount of novel knowledge generated in the last five years, a team of Primary aldosteronism experienced hypertensionlogists was assembled to furnish updated clinical practice guidelines for the manage- Hypertension ment of primary aldosteronism. Guidelines Methods: To identify the most relevant studies, the authors utilized a systematic literature review in international Diagnosis databases by applying the PICO strategy, and then they were required to make use of only those meeting pre- Treatment defined quality criteria. For studies of diagnostic tests, only those that fulfilled the Standards for Reporting of Diagnostic Accuracy recommendations were considered. Results: Each section was jointly prepared by at least two co-authors, who provided Class of Recommendation and Level of Evidence following the American Heart Association methodology. The guidelines were sponsored by the Italian Society of Arterial Hypertension and underwent two rounds of revision, eventually reexamined by an External Committee. They were presented and thoroughly discussed in two face-to-face meetings with all co- authors and then presented on occasion of the 36th Italian Society of Arterial Hypertension meeting in order * Corresponding author. DIMED –Clinica dell’Ipertensione Arteriosa, University Hospital, via Giustiniani, 2; 35126, Padova, Italy. E-mail address: [email protected] (G.P. Rossi). https://doi.org/10.1016/j.ijchy.2020.100029 Received 9 March 2020; Accepted 7 April 2020 Available online 15 April 2020 2590-0862/© 2020 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by- nc-nd/4.0/). G.P. Rossi et al. International Journal of Cardiology Hypertension 5 (2020) 100029 to gather further feedbacks by all members. The text amended according to these feedbacks was subjected to a further peer review. Conclusions: After this process, substantial updated information was generated, which could simplify the diagnosis of primary aldosteronism and assist practicing physicians in optimizing treatment and follow-up of patients with one of the most common curable causes of arterial hypertension. 1. Introduction (essential) hypertension because they are never screened for PA. Accordingly, they remain exposed lifelong to the detrimental effects of Primary aldosteronism (PA) is the most common, but probably the hyperaldosteronism. least identified cause of endocrine arterial hypertension. This is partly After publication of the last guidelines [1,2], many important because of the diffuse misconception that it is extremely rare and partly studies have appeared in this field, which can justify changes of because hypokalemia, one of its clinical hallmarks, nowadays often lacks. practice in the clinical management of PA. Hence, we have assigned Therefore, many PA patients are mislabeled as being affected by primary the task to prepare updated guidelines for the screening, subtyping, Development of PICO strategy focused on the different sections (see Supplemental Material – Table 1) Systematic search of Database (e.g. PubMed) From the beginning of me From 2016 N = 6,517 N = 770 N = 1,225 relevant papers Grading and scoring of papers according to quality Exclusion of N = 1,019 papers because non pernent or review or poor quality Drafting of the manuscript sections Review and editing Independent assessment by External Review Committee (ERC) Joint presentation during the 36th SIIA meeting Final draft Further revision by the ERC Submission Fig. 1. Main steps followed in the preparation of the Guidelines. 2 G.P. Rossi et al. International Journal of Cardiology Hypertension 5 (2020) 100029 and treatment of PA to a panel of renowned hypertensionlogists (Fig. 1). Highlights Class of Level of To this aim, they were asked to follow the overall methodology Recommendation Evidence describedindetailintheSupplementalMaterial,whichissumma- PA entails a heterogeneous group of IA rized here. After identification of relevant publications in the litera- common sporadic forms and rarer familial ture with the PICO strategy [3](Table 1 of Supplemental Material), forms. they were requested to grade and select only high-quality papers as a Its prevalence varies according to the IB cohort of hypertensive patients studied, on basis for advice/recommendation (Fig. 1) and to grade their sugges- the whole between 5.9% and 20%. tions by Class of Recommendation and Level of Evidence following an Familial forms are rare and mostly IA internationally accepted methodology (Table 2 of Supplemental Ma- characterized by autosomal dominant terial)[4]. transmission. Sporadic forms comprise surgically IA These guidelines also adopted an unprecedented strategy for the curable unilateral causes (aldosterone- evaluation of accuracy of diagnostic tests: they considered only studies producing adenoma and unilateral that fulfilled the STARD recommendations, which require a gold stan- hyperplasia) and medically treatable dard as reference (Figs. 1 and 2 of Supplemental Material)[5]. This was bilateral adrenal hyperplasia. judged to be necessary for PA, because a continuum exists between this Despite the high prevalence of PA only II B 1–2% of hypertensive patients are condition and low-renin essential hypertension [6], which means that screened for it. many hypertensive patients with only borderline elevated, or even normal plasma aldosterone concentration (PAC) have a high aldosterone-renin-ratio (ARR) owing to low-renin and cannot be attrib- uted with certainty to one group or the other. Hence, when assessing 3. Case detection accuracy of diagnostic tests the only useable “gold reference” for PA, i.e. the subtypes that can be unambiguously diagnosed, entail the unilateral 3.1. When and how to perform the screening forms, i.e. aldosterone-producing adenoma (APA) and unilateral hyper- plasia (UAH), which can be defined conclusively based on pathology, and Table 1 summarizes the conditions in which the diagnostic work-up follow-up examination [7], and the familial forms for which genetic tests for PA is recommended (Class of Recommendation II, Level of Evi- exist. dence B). An observational study, however, suggested that PA can follow fi 2. De nition and prevalence of primary aldosteronism Table 1 Categories of patients where the screening for primary aldosteronism is PA is a heterogeneous group of familial and sporadic disorders recommended. characterized by hypertension secondary to overproduction of aldoste- Condition Description rone that seems autonomous from renin. Sporadic PA are the most common forms and are caused by APA,
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