Device Update I: The Angio-Seal Device: A Current State Assessment of Changing Clinical Practice

Methods for achieving hemostasis in patients undergoing angiographic catheterization vary from one medical center to another. Manual pressure and mechanical compression are still widely used, as well as patches and other closure aids. However, a growing number of medical centers are taking advantage of the benefits of vascular closure technology. The Angio-Seal STS Plus Platform (St. Jude Medical/Daig, Minnetonka, MN) plays a significant role in this growing trend, enabling earlier mobility and discharge of patients for efficient use of hospital staff and resources. With the healthcare industry’s increasing shortage of qualified professionals and growing financial restrictions, these benefits are proving valuable to many cath labs. Perspectives on Post-Angiographic Catheterization Management For decades, the standard of care for management of the femoral artery puncture site post-percutaneous angiographic catheterization and sheath removal was manual pressure. Achieving hemostasis after femoral arterial sheath removal requires a knowledgeable, trained health care professional to apply manual pressure for up to 20-30 minutes. This method can be effective; but it can be very uncomfortable for the patient and outcomes may be affected by the experience and proficiency of the health care professional. Additionally, the patient may be required to remain immobile for six hours or more. Depending on the procedure and the patient’s coagulation status, the time in which it is safe to remove the procedure sheath and allow the patient to regain mobility can vary greatly. For the last twenty to twenty-five years, many health care professionals have used an alternative hemostasis method to manual pressure mechanical compression devices. However, in the mid-to-late 1990s, the FDA approved release of several vascular closure devices, including the Angio-Seal Hemostatic Puncture Closure Device (HPCD), later renamed the Angio-Seal vascular closure device. This period marked the beginning of a new approach to femoral site management following catheterization procedures. In this article, we will continue our focus on post-angiographic catheterization management, following the path of the Angio-Seal device, and looking at why it has been incorporated in many cardiac catheterization labs. We’ll also review what advantages the device offers both clinicians and patients. About Angio-Seal The Angio-Seal STS and STS Plus allow closure to be completed on the cath lab table. In addition, recent labeling changes for the 6F Angio-Seal device include clinical data which demonstrate the safety and efficacy of patient ambulation in less than 20 minutes and discharge one hour after ambulation. An economic model created by the accounting firm Deloitte and Touche* has also shown cost benefits for hospitals when clinical protocols are changed to reflect device capabilities. These changes have been without sacrifice to patient comfort or safety. In fact, patients often express greater satisfaction due to earlier ambulation and discharge. *Economic model commissioned by St. Jude Medical, August 2003. How Does the Angio-Seal Device Work? Following the removal of the procedural sheath, Angio-Seal achieves hemostasis at the femoral arteriotomy without the aid of external pressure to the groin. It quickly seals by sandwiching the arteriotomy between its two primary structures, a co-polymer anchor and extra-vascular collagen sponge. These components form a mechanical barrier at the arteriotomy and are absorbed via normal physiologic responses of the body, reducing the potential for excessive scarring and fibrosis of the artery associated with non-absorbable materials. In January 2002, the Angio-Seal STS Platform was introduced in the United States. Building on the existing technology, the STS Platform adds a self-tightening suture and a secure cap. The Self-Tightening Suture (STS) allows device deployment to be completed at the end of the catheterization procedure, while the patient is still on the table. This suture is a surgical slipknot known as a Roeder Knot and is significant to the performance of the STS Platform. Angio-Seal STS Plus: Clinical Pathways Utilization of Angio-Seal STS and STS Plus versus manual compression in eligible patients following angiographic catheterization offers the following benefits to physicians, cath lab staff, nurses, patients and hospital administrators:

1. Can free up physical space in the cath lab holding and recovery area. Greater patient throughput combined with greater lab productivity can potentially increase the number of procedures performed without adding extra personnel or hours of overtime. In addition, most patients can be transferred immediately to their room or a designated outpatient recovery area. The recovery period can take place in a recliner rather than in a hospital bed. 2. Physician satisfaction. Many doctors feel they have greater control of the procedure with the Angio-Seal STS and STS Plus since the suture is cut and the puncture site is dressed before the patient is moved from the table. 3. More efficient use of personnel. Many labs are experiencing staff shortages and are in need of methods to improve better utilization of their staff. Angio-Seal eliminates the need for delayed sheath pulling and manual or mechanical pressure to achieve hemostasis. 4. Most patients can be managed and monitored safely and cost-effectively in designated outpatient recovery areas. The nurses assigned to these areas are familiar with the protocols and physician directives for patient assessment, education, mobilization, ambulation, and discharge preparation. 5. Allows earlier mobilization and ambulation. Recovery times and even time to discharge may potentially be reduced without compromising patient outcomes. Clinical data supports the safety and efficacy of early ambulation and discharge for patients who have received a 6F Angio-Seal STS or STS Plus following a diagnostic procedure. 6. Patient comfort. Patients often experience little or no groin and back discomfort.

Conclusion Vascular closure technology provides an optimal avenue for health care professionals and administrators seeking post angiographic catheterization methods beyond manual compression. The Angio-Seal STS and STS Plus start with sealing and securing the arteriotomy. Patients can be rapidly moved to a nursing care division commensurate with their current condition and medical history. The clinical effectiveness of Angio-Seal can facilitate patient ambulation in less than 20 minutes and discharge one-hour post ambulation.emmmar5.gifPatients receiving a 6F Angio-Seal STS device following diagnostic catheterization procedures may be ambulated in less than 20 minutes and discharged one hour post-ambulation. Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications. St. Jude Medical Angio-Seal Vascular Closure product family, including the Millennium, STS and STS Plus platforms, is indicated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8F Angio-Seal device and a 6 French or smaller procedural sheath for the 6F Angio-Seal device. The Angio-Seal STS and STS Plus platform devices are also indicated for use to allow patients who have undergone diagnostic angiography to ambulate safely as soon as possible after sheath removal and device placement, as well as to allow patients who have undergone an interventional procedure to ambulate safely after sheath removal and device placement. Possible adverse events for vascular closure devices include, but are not limited to: bleeding or hematoma, AV Fistula or pseudoaneurysm, infection, allergic reaction, foreign body reaction, inflammation or edema. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Carol Emmett and Fred Kuelker disclose an employment affiliation with St. Jude Medical.

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