Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia: REALIZE-K Design and Baseline Characteristics.

BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) improve outcomes in patients with heart failure and reduced ejection fraction (HFrEF). However, MRAs are often underused because of hyperkalemia concerns. OBJECTIVES: The purpose of this study was to assess whether sodium zirconium cyclosilicate (SZC), a nonabsorbed crystal that traps and rapidly lowers potassium, enables MRA use in patients with HFrEF and prevalent hyperkalemia (or at high risk). METHODS: REALIZE-K is a prospective, double-blind, placebo-controlled trial in patients with HFrEF (NYHA functional class II-IV; left ventricular ejection fraction ≤40%), optimal therapy (except MRA), and prevalent hyperkalemia (or at high risk). During the open-label run-in, all participants underwent protocol-mandated spironolactone titration (target: 50 mg daily); those with prevalent (cohort 1) or incident (cohort 2) hyperkalemia during titration started SZC. Participants achieving normokalemia while on spironolactone ≥25 mg daily were randomized to continuing SZC or matching placebo for 6 months. The primary composite endpoint was proportion of participants with optimal response (normokalemia, on spironolactone ≥25 mg daily, no rescue for hyperkalemia [months 1-6]). RESULTS: Of 365 patients (run-in), 202 were randomized. Baseline characteristics included mean age 70 years, prevalent comorbidities (78% estimated glomerular filtration rate <60 mL/min/1.73 m2, 38% atrial fibrillation/flutter), high N-terminal pro B-type natriuretic peptide (median 1,136 pg/mL), and high HFrEF therapy use (64% sacubitril/valsartan, 96% beta-blocker, 42% sodium glucose co-transporter 2 inhibitor). At randomization, 78% were receiving spironolactone 50 mg daily. CONCLUSIONS: REALIZE-K is the first trial to evaluate whether SZC can enable rapid and safe MRA optimization and long-term continuation in patients with HFrEF and prevalent/high risk of hyperkalemia. (Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients with Symptomatic HFrEF Receiving Spironolactone; NCT04676646).

Rare association between giant-cell aortitis and giant-cell aortic valvulitis.

Giant cell arteritis (GCA) is a type of chronic vasculitis that affects medium and large-caliber arteries, frequently related to aortic involvement and, consequently, to aneurysm formation. However, associated valvulitis with giant cells is uncommon. We describe the case of a 50-year-old female patient with aortic aneurysm and valvular insufficiency, whose anatomopathological examination revealed giant-cell aortic valvulitis associated with giant cell aortitis.

Impact of COVID-19 Pandemic in a Brazilian High-Volume Aortic Center.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic brought an unprecedented lack of control of what was to come. The intent of this document is to provide a balance of how much was ceased to be done for patients with aortic disease, to assess the mortality of these patients, and to show what happened to those who became COVID-19 positive during their hospitalization. METHODS: From April 1st to July 31st 2020, the worst period of the pandemic in São Paulo, Brazil, the Institute's aortic surgical patients operated on were evaluated and those were compared with patients operated during the same period in 2019. RESULTS: In 2019, 88 surgeries were performed; most of them were elective (66 [75%]), 10 were urgent, and 12 were emergency surgeries. In 2020, during the COVID-19 pandemic, we operated on only 31 patients, being 74.2% non-elective surgeries (P<0,001). There was a higher mortality for patients operated on during the pandemic surge of COVID-19 (P<0,001), but it was not specifically related to infected patients. CONCLUSION: The COVID-19 pandemic had an impact on surgical volume and outcome of patients with aortic disease, although it did not directly increase mortality.