Antecubital versus femoral approach for adrenal venous sampling in the patients with primary aldosteronism: a randomized controlled trial.

IMPORTANCE

Femoral vein access used to be the traditional approach for adrenal venous sampling (AVS) procedures, whereas antecubital vein access is the newly developed approach. Until now, no randomized trial for comparison of two approaches has been carried out.

OBJECTIVE

To compare the success rate, safety, and procedural parameters of AVS via an antecubital approach versus femoral approach.

DESIGN

This randomized clinical trial (RCT) was conducted between January 2022 and December 2023. The patients with primary aldosteronism (PA) aged 18-60 years were randomly assigned to femoral vein access group (FV) or antecubital vein access group (AV). The intention-to-treat analysis included all randomized patients.

PARTICIPANTS

A total of 675 patients aged 18-60 years old with hypertension that were at increased risk for PA were screened, 183 of whom were confirmed with PA. Twenty-nine patients were excluded due to refusal of AVS, decline of participating in this trial, or contraindication to AVS. A total of 154 patients were recruited in this trial.

INTERVENTION: Patients were randomly assigned to undergo AVS via femoral approach or antecubital approach.

MAIN OUTCOMES AND MEASURES: The primary end point was the success rate of bilateral AVS. Secondary end points included the success rate of right, left sampling, procedure duration, fluoroscopy time, contrast volume, incidence of complications, and postsurgical outcomes.

RESULTS

From January 2022 to December 2023, totally 154 patients with PA were randomized to FV group (77cases, mean age, 47.8 ± 8.1 years; 26 females [33.8%]) and AV group (77cases, mean age, 49.2 ± 8.6 years; 30 females [39%]). The baseline characteristics for the two groups were well balanced ( P > 0.05). There were no significant differences in the success rate of bilateral (89.6% vs 92.2%, P = 0.58),right (94.8% vs 97.4%, P = 0.68), and left (94.8% vs 94.8%, P = 1.00) sampling between two groups. The incidence of complications did not differ between the two groups (2.6% vs 0, P = 0.477). The incidence of arterial mis-puncture was significantly higher in FV group than that in AV group (0% vs 9.1%, P = 0.02). The fluoroscopy time and contrast volume did not significantly differ between two groups. The procedure duration in AV group was significantly shorter than that of FV group (18.0 [IQR, 15.0-23.0] versus 20.0 [IQR, 17.0-25.5], P = 0.011). There was no significant difference in the proportion of patients who achieved complete clinical success (50.0% vs 45.9%, P = 0.725) and complete biochemical success (92.1% vs 91.9%, P = 1.000) after adrenalectomy between FV group and AV group.

CONCLUSION AND RELEVANCE: The trial showed AVS via AV approach or FV approach did not lead to significant differences in success rate and incidence of complications, as well as postsurgical outcomes. However, AV approach was associated with shorter procedure duration, no arterial mis-puncture and earlier ambulation after the procedure, which make it a better alternative to FV approach.