The Outcomes of Primary Aldosteronism Patients in the AVIS-2 Study

Abstract

Background: Adrenal venous sampling (AVS) is the key test recommended by guidelines for primary aldosteronism (PA) patients seeking surgical cure, but its clinical outcomes have never been determined in large scale trials. Methods: We created a large multicentre international registry of individual AVS studies carried out at major referral centres worldwide to determine the clinical outcomes of this test. Findings. We analysed 1625 consecutive individual AVS studies performed between 2000 and 2015 in 19 tertiary referral centres located in Asia, Australia, Europe and North America. AVS, which was successful in 80.1% of all cases, allowed identification of lateralization of PA in only 45.5%, according to criteria in use at each centre. Adrenalectomy was performed in 41.8% of the patients and cured arterial hypertension, two-fold more frequently in women than men (p<0.001). When AVS-guided, surgery provided a higher rate of cure of hypertension than when non-AVS-guided (40.0 vs 30.5%, p=0.027). Overall, patients treated with medical therapy exhibited a higher rate of persistent hypokalaemia requiring potassium supplementation (4.9% vs 2.3%; p<0.01) and needed more antihypertensive medications (p<0.001). Interpretation: The low rate of adrenalectomy and cure of hypertension in PA patients seeking surgical cure indicate suboptimal use of AVS. Given the better outcomes of AVS-guided surgical decision-making, these results call for actions to improve the diagnostic use of this test that is key for referring PA patients for adrenalectomy. Trial Registration Number: The AVIS was registered at clinicaltrials.gov number NCT01234220. (The original protocol of AVIS-2, which started in 2012 as an observational multicentre study of individual consecutive AVS studies performed worldwide, was registered at clinicaltrials.gov (NCT01234220), and thereafter slightly amended to reach the target recruitment number of 1500 patients PA patients submitted to AVS.) Funding Statement: This study was supported in part by research grants to GPR from FORICA (The FOundation for advanced Research In Hypertension and CArdiovascular diseases) and the Societa Italiana dell’Ipertensione Arteriosa and from the Else Kroner-Fresenius-Stiftung to M.R. Declaration of Interests: The authors state: There is no conflict of interest and financial disclosure to be disclosed. Ethics Approval Statement: All procedures were carried out according to the Helsinki Declaration. The protocol of the study was approved by the Ethics Committee of both coordinating and participating centres.