Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials.
Despite advances in other aspects of cardiac catheterization, manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management. Suture-mediated closure may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial (STAND I) evaluated the 6Fr Techstar device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 515 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS). Major complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05). Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significantly shorter for suture-mediated closure. Suture-mediated closure of the arterial puncture site thus affords reliable immediate hemostasis and shortens the time to ambulation without significantly increasing the risk of local complications.
Baim
D S
DS
Beth Israel-Deaconess Medical Center and the Cardiovascular Data Analysis Center, Boston, Massachusetts 02215, USA. dbaim@bidmc.harvard.edu
Knopf
W D
WD
Hinohara
T
T
Schwarten
D E
DE
Schatz
R A
RA
Pinkerton
C A
CA
Cutlip
D E
DE
Fitzpatrick
M
M
Ho
K K
KK
Kuntz
R E
RE
D006328:Cardiac Catheterization / Q000379:methods*; D002408:Catheters, Indwelling; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000601:surgery*; D006488:Hemostasis, Surgical / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011677:Punctures; D012449:Safety; D013536:Suture Techniques; D016896:Treatment Outcome