Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices.
BACKGROUND
Vascular access site management is crucial to safe, efficient and comfortable diagnostic or interventional transfemoral percutaneous coronary procedures. Two new femoral access site closure devices, Perclose and Angio-Seal , have been proposed as alternative methods to manual compression (MC). We compared these two devices and tested them in reference to standard MC for safety, effectiveness and patient preference.


METHODS
Prospective demographic, peri-procedural, and late follow-up data for 1,500 patients undergoing percutaneous coronary procedures were collected from patients receiving femoral artery closure by MC (n = 469), Perclose (n = 492), or Angio-Seal (n = 539). Peri-procedural, post-procedural, and post-hospitalization endpoints were: 1) safety of closure method; 2) efficacy of closure method; and 3) patient satisfaction.


RESULTS
Patients treated with Angio-Seal experienced shorter times to hemostasis (p < 0.0001, diagnostic and interventional) and ambulation (diagnostic, p = 0.05; interventional, p < 0.0001) than those treated with Perclose. Those treated with Perclose experienced greater access site complications (Perclose vs. Angio-Seal, p = 0.008; Perclose vs. MC, p = 0.06). Patients treated with Angio-Seal reported greater overall satisfaction, better wound healing and lower discomfort (each vs. Perclose or vs. MC, all p < or = 0.0001). For diagnostic cath only, median post-procedural length of stay was reduced by Angio-Seal (Angio-Seal vs. MC, p < 0.0001; Angio-Seal vs. Perclose, p = 0.009). No difference was seen in length of stay for interventional cases.


CONCLUSIONS
Overall, Angio-Seal performed better than Perclose or MC in reducing time to ambulation and length of stay among patients undergoing diagnostic procedures. There was a higher rate of successful deployment and shorter time to hemostasis for Angio-Seal, and this was accomplished with no increase in bleeding complications throughout the follow-up. Additionally, Angio-Seal performed better than Perclose in exhibiting a superior 30-day patient satisfaction and patient assessment of wound healing with less discomfort.
Duffin
D C
DC
Division of Cardiology, LDS Hospital, 8th Avenue and C Street, Salt Lake City, Utah 84143, USA.
Muhlestein
J B
JB
Allisson
S B
SB
Horne
B D
BD
Fowles
R E
RE
Sorensen
S G
SG
Revenaugh
J R
JR
Bair
T L
TL
Lappe
D L
DL
D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000925:Anticoagulants / Q000627:therapeutic use; D003327:Coronary Disease / Q000150:complications / Q000628:therapy; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006487:Hemostasis / Q000502:physiology; D006489:Hemostatic Techniques / Q000295:instrumentation; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use; D015994:Incidence; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017060:Patient Satisfaction; D016491:Peripheral Vascular Diseases / Q000209:etiology / Q000523:psychology* / Q000628:therapy*; D011183:Postoperative Complications / Q000523:psychology / Q000628:therapy; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011677:Punctures / Q000295:instrumentation / Q000523:psychology; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D007140:Immunoglobulin Fab Fragments; D000077284:Abciximab