Staple-Mediated Vascular Closure
A novel percutaneous design of traditional surgical technology addresses the limitations of current vascular closure devices.
To view the figures and tables related to this article, please refer to the print version of our april issue, page 56.
Despite the recent introduction of vascular closure device (VCD) technology, vascular access site complications remain the leading source of morbidity after the approximately 7.5 to 8 million percutaneous catheter-based procedures performed annually worldwide.1 VCD trials consistently demonstrate increased patient satisfaction, early ambulation, and decreased hospital resource utilization as compared to manual compression.2,3 Unfortunately, these reports have not consistently demonstrated decreased complication rates, and current VCD technology has even created a new category of complications and treatments primarily involving infection and arterial thrombosis.4–8
LIMITATIONS OF CURRENT VCDs
Currently, only 10% to 15% of all catheter-based procedures performed worldwide utilize a VCD for access site hemostasis.1,2 Several potential limitations associated with current technology that limit widespread clinical VCD utilization are summarized in Table 1.
PERCUTANEOUS STAPLE TECHNOLOGY
Surgical metal staple technology has revolutionized traditional general, vascular, and cardiothoracic surgery for several decades and has proven safe, biocompatible, and cost effective. The Vascular Closure System (EVS) closure device (Angiolink Corporation, Taunton, MA) was specifically designed with the goal of being the ?ideal VCD? by addressing the limitations of current VCDs. The device uses well-known surgical and endovascular concepts, including biocompatibility, sterility, simplicity, and the ?anatomic purse-string effect? to achieve immediate, safe, secure, and cost-effective extraluminal femoral arteriotomy closure.
THE ANGIOLINK STAPLE
The device consists of three components:
1. A biocompatible titanium staple (Figure 1) with a 3-mm crown designed for deployment 1 mm above the vessel adventitia, and four staple legs, each with a distal pledget-flare designed to gather an autogeneous tissue pledget of femoral sheath, adventitia, and media for an autogeneous extraluminal closure (Figure 1).
2. A simple one-piece three-step introducer assembly containing an introducer, a dialator with a blood-marking lumen positioned 7 mm from the distal tip, and two small stabilization filaments designed to transiently deploy intraluminally maximizing vessel wall stabilization for staple deployment (Figure 1).
3. A trigger-activated staple deployment device (Figure 1). The staple and stapler utilize a unique proprietary deployment cycle design that allows initial staple expansion and advancement to gather autogeneous tissue prior to final staple closure, achieving an anatomic purse-string (Figure 2).
The arterial sheath is removed, and the dilator and introducer are introduced over a .035-inch guidewire through the overlying tissues until brisk bleeding is noted from the distal dialator port marking the depth of the arterial lumen. The guidewire is removed and the three-step introducer maneuver is performed, stabilizing the anterior vessel wall. The dilator is then removed, and the staple device is advanced through the introducer until the stapler reaches the level of the stabilized anterior vessel wall, where the system locks itself in place, which can be noted by an audible click. The staple, still housed sterile in the deployment device, is now located 1 mm to 2 mm above the adventitia. As the trigger is activated, the staple deployment cycle is performed, the stabilization filaments are retracted, and the introducer is removed all in the same final movement, having deployed the completely sterile staple to the arteriotomy site (Figure 2B).
ACHIEVING THE IDEAL VCD
Titanium has become the most common human metal implant material because of its superior properties of strength and pliability, biocompatibility and inertness, as well as cost effectiveness when compared to stainless steel, making it ideal for the intricate Angiolink staple design. Permanent braided sutures, collagen plugs, and other absorbable procoagulants used with current VCDs are noninert, highly reactive, and may be an etiologic factor in infection and arterial thrombosis.
The one-piece introducer assembly system has been designed for simplicity, uses cost-effective materials, and has a short learning curve. The staple remains sterile within the stapler housing and introducer until final deployment inside the body at the extraluminal vessel wall, much like the sterile deployment of a stent, therefore avoiding operator or skin contamination. The entire system is designed for single-operator use, and, with experience, the total operator closure time should be less than 60 seconds.
The purse-string suture closure concept is a well-known surgical technique used to close large arteriotomies in large vessels. The technique utilizes pledgets to gather only vessel adventitia and media at the arteriotomy edges, allowing for tissue approximation when the cannula is removed and the suture is tied. This results in immediate, secure, totally extraluminal vessel closure in the anticoagulated patient with pulsatile aortic blood flow. This extraluminal closure is accomplished without luminal narrowing; therefore, this device theoretically could be utilized in any vessel regardless of stick location, size, or anticoagulation status and could allow almost immediate ambulation (Figure 3).
The initial safety and efficacy experience with the first-generation Angiolink prototype was performed in Paraguay. A report of 89 patients yielded an overall closure success rate of 92.1%, a device closure success rate of 96.4%, a mean time to complete hemostasis 2.47 ± 1.42 minutes, and no complications at 24 hours or at 7-day ultrasound follow-up.9 Several prototype revisions and improvements have occurred since this original report, and approximately 400 deployments have been performed in Paraguay, with overall closure success rates of 96% to 97%, and a mean time to complete hemostasis of 1.55 ± 1.01 minutes, with no complications (R. Caputo, A. Ebner, personal communication, January 2003). A five-site US phase I trial will begin in April or May 2003. The specific design of the Angiolink staple may provide potential advantages over current VCDs (Table 2).
THE FUTURE POTENTIAL
Just as metal stent platform technology has revolutionized interventional cardiovascular care and metal staple technology has revolutionized traditional surgery, there is potential for management of access site hemostasis. Future designs of this device can be engineered both smaller and larger, and could accommodate >20F sheath sizes, making abdominal and thoracic aortic aneurysms and other larger sheath-based interventions totally percutaneous. Totally absorbable inert surgical staple technology already exists, and an absorbable Angiolink staple could easily address any concerns regarding reaccess or reentry with this first-generation staple technology. The current Angiolink staple has been designed to address the limitations of current vascular closure technology, and, therefore, may have the potential to significantly increase clinical VCD utilization.
David E. Allie, MD, is Director of Cardiothoracic and Endovascular Surgery at the Cardiovascular Institute of the South in Lafayette, Louisiana. He is a member of the Scientific Advisory Board for Angiolink, Corporation. Dr. Allie may be reached at (800) 582-2435; David.Allie@cardio.com.
Chris J. Herbert, RT, RCIS, is Director of Technology at the Cardiovascular Institute of the South in Lafayette, Louisiana. He is a research consultant for Angiolink Corporation. Mr. Herbert may be reached at (800) 582-2435; Chris.Herbert@cardio.com.
Craig M. Walker, MD, is Medical director of the Cardiovascular Institute of the South in Houma, Louisiana. He is a member of the Scientific Advisory Board for Angiolink Corporation. Dr. Walker may be reached at (800) 445-9676; Craig.Walker@cardio.com.
Ronald P. Caputo, MD, heads S.J.H. Cardiac Catheterization Associates in Syracuse, New York. He is Chairman and Chief Medical Officer of Angiolink Corporation. Dr. Caputo may be reached at (315) 448-6215; firstname.lastname@example.org.
1. Strategic growth opportunities in cardiovascular interventional treatment drives cardiology sector. American Health Consultants. BBI Newsletter. 2001;5:1-6.
2. Rogers EW, Doty WD, Stewart J. Significant improvements in patient care and cost savings resulting from percutaneous vascular surgery (PVS). J Cardiovasc Manag. 1999;10:13-17.
3. Duffin DC, Muhlestien JB, Allison SB, et al. 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. J Invas Cardiol. 2001;13:354-362.
4. Carey D, Martin JR, Moore CAQ, et al. Complications of femoral artery closure devices. Cathet Cardiovasc Intervent. 2001;52:3-7.
5. Dangas G, Mehran R, Kokolis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol. 2001;38:638-644.
6. Sanborn TA, Gibbs JJ, Brinker JA, et al. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol. 1999;22:1273-1279.
7. Pracyz JB, Wall TC, Langabough TC, et al. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol. 1998;81:970-976.
8. Meyerson SL, Feldman T, Desai TR. Angiographic access site complications in the era of arterial closure devices. Vasc Endovasc Surg. 2002;36:137-144.
9. Caputo RP, Ebner A, Grant WG, et al. Percutaneous femoral arteriotomy repair: initial experience with a novel staple closure device. J Invas Cardiol. 2002;14:652-656.