The VasoSeal Collagen Device

One center’s experience with VasoSeal.

By John Goodwin, MD
 

Vascular closure devices play an increasingly important role in a busy interventional practice. Safety, patient convenience, and hospital costs combine to drive their usage. We are no different at the Vascular Center of Baptist Hospital in East Tennessee. Our initial experience was with the use of a suture-mediated closure device. Although this method provided effective hemostasis, it was poorly accepted by our referring vascular surgeons who complained about subsequent surgery at the site because of the resulting tissue reaction. We currently use VasoSeal (Datascope Corporation, Mahwah, NJ) for vascular closure.

THE DEVICE
VasoSeal is an extravascular closure device that achieves hemostasis via collagen-mediated thrombotic closure at the puncture site. Nothing is left behind in the artery and there is no need to enlarge the puncture for delivery. There are no limitations as to vessel size, and the presence of existing disease does not preclude its use. Fluoroscopy is not needed to confirm access site location. Several studies have documented both its effectiveness and safety.

VasoSeal is currently on three different platforms: ES, VHD, Low Profile, and the newly introduced Elite ES. The ES is intended for 5 to 8F punctures, the VHD for 8F and smaller, and the Low Profile for 4F and 5F access. The Elite ES indicates the use of new collagen technology, which provides a rapid mechanical seal. The ES requires no predeployment measurements. Both the Low Profile and VHD systems come with a needle depth indicator kit, which allows different volumes of collagen to be delivered based on the length of the tissue tract. Each of these devices can be easily deployed in less than 1 minute. The mechanics of the deployment technique are quickly and easily learned. After some experience, the needle depth indicator kit can usually be bypassed as one becomes adept at estimating tissue tract length.

THE PROCESS
In our laboratory, we use the Low Profile system with diagnostic cases and the ES after interventional procedures. To deploy the Low Profile system, a guidewire is introduced into the indwelling catheter, which is subsequently removed. Upstream manual compression is applied by an assistant. The VasoSeal tissue dilator is advanced over the wire and through the tissue tract until there is blood return or until the skin marker on the dilator is flush with the skin surface. Occasionally, there is resistance as the dilator passes through the fascia and the dermatotomy may need to be enlarged and/or gentle dissection of the tract performed with use of a hemostat. Blood return through the dilator does not always occur because of the device’s small size, so it is important to observe the skin marker and not be too aggressive in advancing the dilator. The low profile of the dilator does allow it to enter the artery. If this happens, it is easily recognized by a significant decrease in resistance during dilator advancement and flush of blood through the dilator. If this occurs, the dilator, which is 6F, is removed, and hemostasis is either achieved by manual compression or use of the ES device. Once the Low Profile dilator is in proper position, the VasoSeal sheath is advanced over the dilator to the level of a clearly marked line, and the wire and dilator are then removed. Occlusive upstream compression is necessary at this time. The collagen delivery cartridge is then inserted into the sheath and the collagen is deployed by means of a plunger. Manual compression is relaxed at this time, and, if there is additional bleeding, a second collagen plug is inserted. The sheath is then removed from the tissue tract, and gentle, nonocclusive pressure is maintained for 15 to 30 seconds while it is determined if adequate hemostasis has been achieved. The entire procedure usually takes less than 1 minute and is not uncomfortable for the patient. A sterile dressing is applied and the patient is moved to a stretcher. The patient’s head is allowed to be elevated up to 45º immediately. The patient is able to ambulate after 1 hour of bedrest and is discharged shortly thereafter.

The technical aspects of deploying the ES device are similar; however, deployment with the ES device is performed over an arteriotomy locator (included in the kit) that acts as a guidewire and obviates the need for premeasurement, allowing for safe, accurate extravascular collagen deployment.

COMMENTARY
VasoSeal has continued to further develop and improve their products. As mentioned previously, they have recently introduced Elite ES. Elite ES is more sponge-like, primarily achieves hemostasis mechanically rather that physiologically, and has much greater absorption capacity. The deployment components have also been redesigned to be more ergonomically friendly.
VasoSeal has been a successful vascular closure device in our practice. It has resulted in a decreased use of hospital resources in our patient population. Our patients like the convenience and comfort afforded by its use and there has been acceptance of its use by our referring physicians. Its use has also led to increased safety of procedures performed in our anticoagulated, in-patient population. All of this has been achieved with no increase in groin complications.

John Goodwin, MD, practices at the East Tennessee Baptist Hospital, Knoxville, Tennessee. He does not hold a financial interest in any of the products mentioned herein. Dr. Goodwin may be reached at (865) 549-4219; jrgood421@aol.com.

 

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