Percutaneous suture-mediated closure of femoral access sites deployed through the procedure sheath: initial clinical experience with a novel vascular closure device.
The objective of this study was to assess the initial safety and feasibility of a novel suture-mediated device for closure of femoral access sites immediately after diagnostic or interventional cardiac catheterization. In a prospective study, 150 patients (mean age, 61.5 years; 109 male) underwent femoral access closure with a novel suture closure device (Superstitch, Sutura) immediately after diagnostic (n = 106) or interventional (n = 44) catheterization procedures, independently of the coagulation status. All patients were monitored for 24 hr after the procedure. The closure device was successfully deployed in 92% of patients. Immediate hemostasis was achieved in 77% of patients with no differences between patients undergoing diagnostic catheterization or coronary interventions (79% vs. 73%; P = 0.659). After 2 min of additional light manual compression, hemostasis was achieved in 92% of patients. There was one major complication requiring vascular surgery (0.7%). The novel suture closure device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.
Eggebrecht
Holger
H
Department of Cardiology, Center of Internal Medicine, University Hospital Essen, Essen, Germany.
Naber
Christoph
C
Woertgen
Uta
U
Ringe
Sonia
S
Konorza
Thomas F M
TF
Schmermund
Axel
A
von Birgelen
Clemens
C
Haude
Michael
M
Kroeger
Knut
K
Erbel
Raimund
R
Baumgart
Dietrich
D
D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects*; D002408:Catheters, Indwelling / Q000009:adverse effects*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006331:Heart Diseases / Q000175:diagnosis* / Q000601:surgery*; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000209:etiology* / Q000517:prevention & control*; D011183:Postoperative Complications; D011446:Prospective Studies; D013536:Suture Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D013997:Time Factors