June 06, 2017
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Consensus report defines outcomes criteria for surgery in unilateral primary aldosteronism

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Younger patients and women with unilateral primary aldosteronism are more likely to experience a favorable outcome after total adrenalectomy than men or older patients with the condition, according to a retrospective analysis from an international consensus group.

“Reported proportions of patients achieving clinical remission vary widely between centers; this variation is attributed to several underlying factors, such as background primary hypertension, age, longstanding primary aldosteronism, advanced renal failure or other comorbidities,” Tracy A. Williams, PhD, of the department of medical sciences at the University of Turin, Italy, and colleagues wrote. “However, heterogeneity might also reflect the absence of standardized criteria to classify outcomes of adrenalectomy for unilateral primary aldosteronism. As such, we hypothesized that standardized uniform outcome criteria applied across a large multicenter patient cohort might minimize the previously reported variation in outcome results.”

As part of the Primary Aldosteronism Surgical Outcome (PASO) study, Williams and colleagues from 28 centers across 12 countries retrospectively analyzed clinical and biochemical outcomes — defined as complete, partial or absent success — after adrenalectomy in unilateral primary aldosteronism. Data included patients diagnosed by adrenal venous sampling who underwent total adrenalectomy and had complete follow-up data. Researchers used the Delphi method to reach an international consensus for criteria for six outcomes of adrenalectomy for unilateral primary aldosteronism: complete success (remission); partial success (improvement) and absent success (persistence) for both clinical and biochemical outcomes, and recommendations for the time and interval of follow-up. Consensus was based on blood pressure, the use of antihypertensive drugs, plasma potassium and aldosterone concentrations, and plasma renin concentrations or activities.

For the international cohort analysis, researchers analyzed clinical data from 705 patients recruited between 1994 and 2015; 699 also had biochemical data.

Across the 12 centers, the proportions of patients achieving complete clinical success varied widely, a contrast to the high proportions of patients achieving complete biochemical success, according to the researchers. Within the cohort, 656 patients (94%) experienced complete biochemical success, whereas only 259 patients (37%) achieved complete clinical success; improvement in BP was achieved in a further 344 patients (47%).

“Baseline systolic [BP] was the only factor independently associated with complete biochemical success: patients with higher [BP] had an increased likelihood of complete success,” the researchers wrote. “Complete clinical success was associated with four variables: female sex, lower age, fewer antihypertensive medications as measured by defined daily dose, and absence of left ventricular hypertrophy.”

Women had a higher likelihood of complete clinical success when compared with men (OR = 2.25; 95% CI, 1.4-3.62), as well as clinical benefit, defined as complete plus partial clinical success (OR = 2.89; 95% CI, 1.49-5.59). Younger patients had a higher likelihood of complete clinical success (OR = 0.95 per extra year; 95% CI, 0.93-0.98) and clinical benefit (OR = 0.95 per extra year; 95% CI, 0.92-0.98). Higher levels of preoperative medication were associated with lower levels of complete clinical success, according to the researchers.

“The PASO consensus offers feasible criteria for the classification of outcomes of adrenalectomy for the treatment of unilateral primary aldosteronism,” the researchers wrote. “The variation in baseline characteristics of the cohort contributes to the wide variation in clinical outcomes. Younger patients and female patients have a higher chance of complete clinical success and clinical benefit. Screening should still be done in every individual fulfilling the guideline criteria because biochemical cure is by itself clinically important and because older women and men can also derive postoperative clinical benefit.” – by Regina Schaffer

Disclosure: One researcher reports a consulting agreement with Nihon Medi-Physics for preclinical studies related to imaging agents for adrenal glands.