Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal® Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study

To intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal® vascular closure device (VCD) and manual compression (MC) in a prospective study design. Patients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal®-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)]. Results were analyzed in a cross-over design. 48 patients (29 male, median age 62.5 (32–88) years) were included. An ExoSeal®-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0–15) vs. 10 (0–80) and 0 (0–75) vs. 25 (0–90), respectively (p