A Poly-N-acetyl Glucosamine Hemostatic Dressing for Femoral Artery Access Site Hemostasis (Full title below)

A Poly-N-acetyl Glucosamine Hemostatic Dressing for Femoral Artery Access Site Hemostasis (Full title below)
A Poly-N-acetyl Glucosamine Hemostatic Dressing for Femoral Artery Access Site Hemostasis (Full title below)
A Poly-N-acetyl Glucosamine Hemostatic Dressing for Femoral Artery Access Site Hemostasis (Full title below)
Pages: 
35 - 39
Author(s): 

David Mego, MD, Melody Thomas, LPN, Jeff Stewart, MD, William Rollefson, MD, Patrick Flaherty, DO,
Bruce Murphy, MD, PhD, Paul Ribeiro, MD

A Poly-N-acetyl Glucosamine Hemostatic Dressing for Femoral Artery Access Site Hemostasis after Percutaneous Coronary Intervention: A Pilot Study

ABSTRACT: Background. Arterial puncture closure devices have improved time to hemostasis and ambulation after percutaneous coronary intervention (PCI) relative to traditional manual compression, though complication rates for both methods leave room for improvement. In a pilot registry, the authors evaluated a topical hemostatic dressing containing poly-N-acetyl glucosamine (p-GlcNAc) post PCI in fully anticoagulated patients. Methods and Results. In 100 patients undergoing PCI via the common femoral artery in the short-stay unit, the p-GlcNAc hemostatic dressing was applied with 15 minutes of manual compression at arterial access sites after arterial sheath removal. Procedural antiplatelet and anticoagulation therapies were aspirin, clopidogrel and bivalirudin. Patients were observed during 2 hours of bed rest and attempted to ambulate 2 hours post hemostasis. Effectiveness was assessed based on times to hemostasis and ambulation. Data were stratified by time elapsed since bivalirudin bolus or discontinuation of infusion (30 minutes, > 30–60 minutes, > 60 minutes). Mean time to hemostasis was 15.5 minutes. Mean time from hemostasis to ambulation was 2.08 hours; 87% of patients ambulated at 2 hours. Sheaths were removed at a mean 40.38 minutes after discontinuing bivalirudin. Anticoagulation status (as assessed by time since discontinuation of bivalirudin) did not influence time to hemostasis or ambulation. There was a single major complication (pseudoaneurysm), two minor rebleeds requiring additional manual compression, and 1 hematoma > 5 cm. Conclusions. This p-GlcNAc topical hemostatic dressing safely achieved hemostasis at arterial access sites and early ambulation, even with nearly immediate sheath removal after PCI with systemic anticoagulation using bivalirudin.

J INVASIVE CARDIOL 2010;22:35–39

Key words: catheterization, hemostasis, arteries, registries

By recent estimates, 1 million percutaneous coronary interventions (PCI) are performed annually in the United States; the worldwide estimate is approximately 2 million.1 This noninvasive coronary revascularization procedure has greatly curtailed the need for open cardiac surgery and the subsequent care of large sternal incisions. With the increase in PCI procedures, however, have come an increase in therapeutic arterial puncture and the subsequent need to achieve hemostasis at these sites after arterial sheath removal. The current options for achieving hemostasis at femoral artery access sites after coronary catheterization include traditional manual or mechanical compression, an array of arterial puncture closure devices (APCDs), and a handful of topical hemostatic dressings. Manual or mechanical compression is time-consuming, labor-intensive and costly in terms of in-hospital observation during the extended period of immobilization required.
Although APCDs have been shown to reduce time to hemostasis and ambulation compared with manual compression,2–7 these devices may be associated with higher complication rates than manual compression.5,7–9 Topically applied hemostasis dressings, which are used after diagnostic catheterization, have not been widely adopted for interventional catheterization procedures due to concerns regarding their ability to achieve hemostasis in the presence of higher levels of systemic anticoagulation and platelet inhibition. When these topical products have been used in PCI, it has been standard practice to delay sheath removal until the activated clotting time (ACT) has fallen below 180 seconds.

The research demonstrating faster times to hemostasis, ambulation, and ultimately discharge with APCDs compared with manual compression is substantial.2–7 However, implanting intravascular device components is not without potential risks, including acute complications related to placement (e.g., hematoma, pseudoaneurysm, leg ischemia, occlusion), longer-term clinical implications (e.g., residual foreign body components), infection, and the ability to re-stick or re-use APCDs in the same arterial regions.5,7–16

A topical, noninvasive approach to PCI access-site management that rapidly induces hemostasis biochemically, rather than mechanically, may be capable of providing the shorter times to hemostasis and ambulation associated with APCDs without the potential for vascular complications when arterial plugs or suture devices are used. Hemostasis dressings containing procoagulant agents, such as chitosan or polyprolate acetate, are used effectively to achieve hemostasis in traumatic wounds and hemorrhage,17 hemodialysis puncture site bleeding,18 and arterial puncture site hemostasis following diagnostic and peripheral intervention in which levels of systemic anticoagulation and platelet inhibition are lower than in PCI.19–21 Furthermore, these hemostatic pads have only been effective with ACTs less than 170–180 seconds and associated postprocedure ambulation times are in the 6- to 8-hour range.21,22 For procoagulant hemostatic dressings to equal APCDs in terms of clinical effectiveness, they would need to be usable immediately post procedure in the presence of substantial systemic anticoagulation and platelet inhibition and allow for 2-hour ambulation.

A novel vascular-access hemostasis system containing poly-N-acetyl glucosamine (p-GlcNAc) fibers, a unique material purified from a marine diatom,23 has been shown effective for achieving hemostasis in diagnostic24,25 and interventional cardiac catheterization,26,27 severe visceral injuries in coagulopathic patients28 and elective small-bowel surgery.29 Rates of major and minor vascular complication have been low and comparable to those reported for manual compression.24,25,27

We evaluated times to hemostasis and ambulation with a topical, p-GlcNAc fiber-containing, vascular-access hemostasis dressing after PCI in fully anticoagulated patients.

Methods

Patient selection. Patients undergoing interventional cardiac catheterization via the common femoral artery between October 16, 2007 and June 10, 2008, were eligible for this prospective, single-arm pilot registry at the Arkansas Heart Hospital in Little Rock, Arkansas. Enrollment was conducted on consecutive days that the research nurse coordinating the study was working in the catheterization laboratory. Eligible patients were those > 18 years of age treated in the short-stay unit whose catheterization procedures were performed via the common femoral artery (access confirmed by fluoroscopy) using a 6 Fr or 7 Fr arterial sheath. Patients were excluded from participation in this study for the following reasons: history of severe peripheral vascular disease (lower extremity vascular bypass or peripheral angioplasty/stent procedures or ankle/brachial index < 0.4), arterial access at that same arterial site < 30 days prior to the index procedure, arterial access in profunda or superficial femoral arteries, body mass index > 40, systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg, activated clotting time (ACT) > 300 seconds, or difficult access requiring multiple sticks with the introducer needle.

The study protocol was approved by the Western Institutional Review Board. Written informed consent was obtained from all patients prior to starting the index procedure.

Device description. The topical hemostasis system (SyvekEXCEL®, Marine Polymer Technologies, Danvers, Massachusetts) evaluated in this study employs a polysaccharide, p-GlcNAc-, which is purified from a marine diatom and is both protein-free and nonallergenic. The long (80–100 µm) and thin (~ 0.10–0.15 µm) fibers contain individual p-GlcNAc polymer molecules in a parallel orientation held together in a unique beta-crystalline formation by means of hydrogen bonding.23 The hemostasis system consists of a sterile, 3 x 4 cm, lyophilized pad of p-GlcNAc on foam backing (Figure 1). A reusable Plexiglas® handle and disposable polypropylene support structure are used to apply the dressing with compression. A Tegaderm® transparent adhesive bandage is applied over the p-GlcNAc dressing after hemostasis is achieved and left in place for 24 hours.

Study procedure. Per standard PCI protocol, aspirin ≥ 80 mg orally and a clopidogrel loading dose of ≥ 300 mg were administered prior to the index procedure in patients not already taking clopidogrel. A bivalirudin bolus (75 mg/kg body weight up to a maximum 75 mg) was administered at the start of the procedure. Bivalirudin infusion during the procedure was at the operator’s discretion.

The interventional cardiac catheterization procedure was performed according to standard practice. Post procedure, an arteriogram through the arterial sheath was performed to determine the access site in the common femoral artery. Arterial sheaths were pulled at 30 minutes post bivalirudin discontinuation or the earliest possible time thereafter, provided the patient had been transferred to the recovery area. At the time of sheath pull, the p-GlcNAc hemostasis dressing was applied with 15 minutes of manual compression. If the site continued to bleed, cycles of manual compression were repeated until hemostasis was achieved. Patients were observed during 2 hours of bed rest and attempted to ambulate at 2 hours post hemostasis, at which time the arteriotomy site was evaluated for hematoma formation or other complications.

Catheterization nurses involved with arterial sheath removal received training from the manufacturer’s clinical representative regarding application of the p-GlcNAc hemostasis dressing after sheath removal in highly anticoagulated patients. The two-part training consisted of a 45-minute classroom module and several sheath pulls under the observation of either the research nurse in charge of the study or the manufacturer’s clinical sales representative (formerly a radiology technician), both of whom have extensive experience with arterial sheath removal.

Study assessments. Effectiveness of the p-GlcNAc hemostasis dressing was assessed based on time to hemostasis, time to ambulation and the proportion of patients who ambulated at 2 hours. Data were stratified by time elapsed since bivalirudin bolus or discontinuation of infusion (30 minutes, > 30–60 minutes, or > 60 minutes). Because bivalirudin has been shown to produce a predictable dose response, continuous ACT monitoring with bivalirudin is not required.30 Safety was evaluated based on major and minor complication rates. Major complications were defined as surgical vascular repair or ultrasound-guided compression (for pseudoaneurysm, arterial-venous fistula or laceration), femoral nerve injury (sensory or motor), blood transfusion related to a groin complication, groin infection requiring intravenous antibiotics and/or prolonged hospitalization, thrombosis or loss of distal pulses. Minor complications included rebleed from the puncture site that required additional compression and hematoma > 5 cm.

Statistical analysis. This single-arm registry was designed to assess the safety and feasibility of using a p-GlcNAc dressing to achieve hemostasis in heavily anticoagulated patients following PCI. As such, formal power calculations were not performed. Patient, procedural, and outcome variables were summarized using descriptive statistics for continuous variables (e.g., mean, standard deviation) and frequency tables or proportions for discrete variables. The authors had full access to the data and take responsibility for its integrity. All authors have read and agree to the manuscript as written.

Results


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