Adverse events during the diagnostic work-up for primary aldosteronism.

OBJECTIVE: The diagnostic work-up for primary aldosteronism (PA) involves multiple steps with potential for adverse events (AEs). The aim of this study was to identify the frequency and nature of AEs with medication adjustment during screening and associated with subsequent confirmatory and subtyping tests. METHODS: Electronic health records of 545 patients with hypertension tested for PA were retrospectively evaluated for AEs under a multicenter cohort study. The study involved multiple procedures, starting with the plasma aldosterone:renin ratio, usually after medication adjustment. Positive screening tests were followed by a saline suppression test (SST) and, if PA was thereby confirmed, by adrenal venous sampling (AVS). RESULTS: Among 545 patients screened for PA, medication adjustment was carried out in 447 (82%). AEs occurred in 36% (163/447) of the patients with medication adjustment and 2% (2/98) of those without. In the group with medication adjustment, there was one fatality, 14 (3%) required emergency care and eight (2%) hospitalization, while 94 (21%) required further medical counseling. Blood pressure dysregulation was the most frequent AE. Higher systolic blood pressure and higher initial antihypertensive medication requirements were associated with increased risk of AEs. AEs associated with the SST occurred in 5 of 267 (2%) patients, including one requiring hospitalization. AEs associated with AVS occurred in 5% (6/119) of patients, including one requiring cardiopulmonary resuscitation for asystole. CONCLUSIONS: Mild AEs are commonly associated with medication adjustment during screening for PA. Severe AEs with hospitalization or death are rare. AEs are also relatively rare during confirmatory and subtyping studies.