The Angio-Seal Device

The internal fixation of external collagen closure devices is an increasingly popular means of vascular closure.

By Robert J. Applegate, MD
 

Since its clinical introduction in Europe in 1994,1 the Angio-Seal Vascular Closure Device (St. Jude Medical, St. Paul, MN) has grown substantially in popularity, due in large part to its rapid deployment and effective hemostasis under a wide variety of clinical conditions.

CHARACTERISTICS
The Angio-Seal hemostatic puncture closure device is a completely bioabsorbable closure system (Figure 1).2 It sandwiches the arterial puncture site between an intra-arterial polymer anchor and an extravascular wad of collagen, both of which are joined together by bioabsorbable suture. The anchor is composed of a polylactide and polyglycolide copolymer that is nonthrombogenic and maintains structural integrity during the initial placement. The anchor is resorbed in a process that is physically complete at approximately 30 days and chemically complete at approximately 90 days postprocedure (Kadar Belle, PhD, oral communication, October 2002). Embedded in the anchor is a completely absorbable synthetic polymer suture. The other end of the suture is housed in a delivery mechanism that allows tension to be placed on the anchor while the extravascular collagen wad is delivered from the delivery sheath to a position on top of the arteriotomy. Since introduction of the original model in 1994, the device has undergone significant modification, which has resulted in easier, more consistent deployment of the device. The Angio-Seal device can be deployed using a 6 or 8F closure system that permits closure of arteries up to 9F.

CLINICAL RESULTS
The clinical effectiveness of closure devices should be considered in terms of their effect on clinical outcomes, time to ambulation, and patient satisfaction. The Angio-Seal closure device favorably affects all three of these areas. Clinical outcomes using the Angio-Seal device have been reported in a variety of circumstances.3-6 In general, closure success rates have been reported in excess of 90% to 95%.

We retrospectively evaluated our outcomes using the Angio-Seal device in patients who had undergone percutaneous coronary intervention, and anticoagulation with both unfractionated heparin and abciximab.4 We were able to achieve closure success in 97% of patients. Closure failure may be due to device pullout (uncommon with recent design modifications), inability to deliver the collagen wad, or ineffective hemostasis despite successful deployment of the device due to bleeding at other arteriotomy sites. Complications or adverse outcomes after use of the device are uncommon. In our previously cited experience, minor or major vascular adverse events occurred in only 1.9% of patients. However, we avoid placing closure devices in small caliber arteries, as well as heavily calcified or diseased arteries, in which similar outcomes may not be observed. There are multiple retrospective evaluations of clinical outcomes, but very few randomized clinical trials evaluating different devices head-to-head exist. There are no data that prove one clinical device is superior to another in reducing vascular complications.

In a recent study, patients were randomized after diagnostic catheterization to either manual closure or Angio-Seal.7 Time to hemostasis was 0.9 ± 3.0 minutes with Angio-Seal, compared to 17.0 ± 8.0 minutes with manual, and time to ambulation was 1.4 ± 0.8 hours after Angio-Seal, compared to 6.6 ± 6.0 hours with manual compression.

Recent experience indicates that even more rapid ambulation can be achieved after closure with the Angio-Seal.8 Ultimately, the decision concerning when to allow a patient to ambulate after treatment with a closure device should be determined by practice needs and experience. Patient satisfaction after closure device use has been difficult to quantify, but Duffin et al9 prospectively evaluated patient satisfaction in a large group of patients after manual closure, as well as closure by two different closure devices. In the group of patients who were treated with an Angio-Seal device, patient satisfaction was reported to be higher, while patient discomfort and poor wound healing were extremely low, both in the hospital and at the 30-day follow-up.

THE DEVICE OF CHOICE
At our institution, we are committed to closure device use because we believe it provides optimal care and comfort for our patients. Although we use several different devices, the Angio-Seal device is the workhorse in our laboratory for several reasons. First, if a sheath can be placed into an artery, the Angio-Seal device can almost always be used to close the arteriotomy. Placement of the device is less subject to obstruction by scar tissue in the groin or other factors such as obesity compared to other devices. Second, the average deployment time using the Angio-Seal device is consistently less than 1 minute and facilitates a rapid transition of a successful catheterization or intervention to the nursing unit for recovery. Third, our data suggest that when successfully deployed, vascular outcomes are reduced by using the closure device. Fourth, our experience indicates that of all the available devices, Angio-Seal seems to be the one most preferred by our patients. Patients who have previously visited our catheterization laboratory often ask us to complete their procedures with a closure device. Finally, we believe that although there is an intra-arterial component to the Angio-Seal device, the closure system is completely bioabsorbable, and thus, it places the patient at low risk for long-term adverse sequelae, including serious endovascular infections.

Robert J. Applegate, MD, is Professor of Cardiology and Director of Cardiac Catheterization Laboratory, Section of Cardiology at Wake Forest University School of Medicine in Winston-Salem, North Carolina. He does not hold a financial interest in any product or company mentioned herein. Dr. Applegate may be reached at (336) 716-2718; bapplega@wfubmc.edu.

1. de Swart H, Dijkman L, Hofstra L, et al. A new hemostatic puncture closure device for the immediate sealing of arterial puncture sites. Am J Cardiol. 1993;72:445-449.
2. Nash J, Evans D. The “Angio-Seal” hemostatic puncture closure device. Concept and experimental results. Herz. 1999;24:597-606.
3. Aker UT, Kensey KR, Heuser RR, et al. Immediate arterial hemostasis after cardiac catheterization: initial experience with a new puncture closure device. Cathet Cardiovasc Diagn. 1994;31:228-232.
4. Applegate RJ, Grabarczyk MA, Little WC, et al. Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol. 2002;40:78-83.
5. Sesana M, Vaghetti M, Albiero R, et al. Effectiveness and complications of vascular access closure devices after interventional procedures. J Invas Cardiol. 2000;12:395-399.
6. 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;38:638-641.
7. Ward SR, Casale P, Raymond R, et al. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol. 1998;81:569-572.
8. McNulty EJ, Reynolds D, Bernal D, et al. Immediate ambulation and discharge within one hour following diagnostic cardiac catheterization. Circulation. 2002;106(suppl):II-692.
9. Duffin DC, Muhlestein JB, Allison SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compressions and two different vascular closure devices. J Invasiv Cardiol. 2001;13:354-362.

 

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