[Early deambulation following cardiac catheterization by the use of 6 Fr Angio-Seal, a new hemostatic percutaneous puncture closure device].
OBJECTIVE
Efficacy of the hemostatic puncture closure 8 Fr Angio-Seal device for percutaneous puncture closure after a catheterism has been previously demonstrated, but the experience provided has been obtained with 8 Fr devices. At present the device has been modified and its size reduced to 6 Fr. In this pilot study we evaluate the efficacy of the new hemostatic 6 Fr Angio-Seal device and its safety when early deambulation post-diagnostic and/or therapeutic catheterization is established.


METHODS
Prospective study of 150 consecutive patients randomized either for application of the 6 Fr Angio-Seal device (group A; n = 75), in which early ambulation was indicated, or manual compression (group B; n = 75), with ambulation 12 h after cardiac catheterization. Basal data, including clinical and angiographic characteristics and previous treatment with heparin and platelet aggregation inhibitors were similar in both groups.


RESULTS
The time of hemostasia was significantly shorter in group A than in group B (118 +/- 210 s in A vs 1320 +/- 370 s in B; p (3/4) 0,001), and with early ambulation (3,1 +/- 0,4 h in A vs 12,3 +/- 3,1 h in B; p (3/4) 0,001) no local complications were observed.


CONCLUSIONS
The 6 Fr Angio-Seal hemostatic device diminished the hemostasia time and early ambulation could be achieved. In this pilot study no complications due to early movilization were observed, but the safety of the new hemostatic device after diagnostic or therapeutic catheterizations needs to be evaluated in greater series.
Díaz De La Llera
L S
LS
Hospital Universitario Virgen del Rocío y Clínica Infanta Luisa. Sevilla.
Fournier Andray
J A
JA
D020341:Absorbable Implants; D006328:Cardiac Catheterization; D005260:Female; D006488:Hemostasis, Surgical / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011677:Punctures; D013536:Suture Techniques; D013997:Time Factors; D016138:Walking