title: Percutaneous suture-mediated closure of femoral access sites deployed through the procedure sheath: initial clinical experience with a novel vascular closure device.
abstract: 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.
authors.affiliation: Department of Cardiology, Center of Internal Medicine, University Hospital Essen, Essen, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Eggebrecht
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.forename: Uta
authors.initials: U
authors.lastname: Woertgen
authors.forename: Sonia
authors.initials: S
authors.lastname: Ringe
authors.forename: Thomas F M
authors.initials: TF
authors.lastname: Konorza
authors.forename: Axel
authors.initials: A
authors.lastname: Schmermund
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.forename: Knut
authors.initials: K
authors.lastname: Kroeger
authors.forename: Raimund
authors.initials: R
authors.lastname: Erbel
authors.forename: Dietrich
authors.initials: D
authors.lastname: Baumgart
mesh_terms: 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