Single Operator Deployment of Vasoseal ES®: The Experience of Skaggs Community Health Center

Vascular sealing devices have made their way into most cath labs in North America. Technology and development in this arena continues to improve and expand the horizons of hemostasis management. Patient comfort, efficiency, and cost-effectiveness are just a few of the reasons for the development of these devices. Although the techniques and equipment used vary among the different devices, the goal is the same: rapid hemostasis. The Skaggs Community Health Center cath lab opened in June of 1999. We are a one-unit diagnostic and interventional cath lab, with 2 RNs and 3 technologists, and an annual volume of 1200 procedures. We decided to use a vascular sealing device for all patients without contraindications. This decision was based first on patient comfort (shortening time to ambulation), second on efficiency (since we pull our own sheaths, it shortens time to hemostasis) and third, on cost effectiveness (decreased length of stay, less staff time utilized for hemostasis, etc.). We also decided to perform closure with 100% tech deployment. We felt that since the techs are exposed to more procedures day-in and day-out, and would have more deployments to perform than the multiple physicians, that competency and success would be higher with tech deployment. The decision was made to use Angio-Seal (St. Jude Medical, Minnetonka, MN). This decision was based on several reasons: ease of deployment, no manual pressure required, and the patient could immediately be transferred to a stretcher (once deployed and cover applied to maintain sterility of the site). We evaluated the Vasoseal VHD® (Datascope Corporation, Mahwah, NJ) but did not use it as much because it required two operators, manual pressure time, and the need to always measure the depth of the artery (which we forgot most of the time, so we couldn’t deploy it anyway). After a few months, Datascope introduced the Vasoseal ES®, and we decided to evaluate it. The physicians liked the idea of having a device that did not leave anything deployed in the artery. The Vasoseal ES eliminated the need to measure the depth of the needle, but still recommended two operators for deployment. After a short evaluation, our facility decided go to primary use of Vasoseal ES. Upon implementation of Vasoseal ES at our facility, a complaint surfaced immediately from our physicians. They were now having to assist by holding manual pressure during the deployment of the Vasoseal ES, whereas before, as soon as the procedure was over, they left the table to begin charting and the scrub would deploy the Angio-Seal device. The resulting request was that the circulator mask and glove to assist in Vasoseal ES deployment while the physician charted. This was immediately identified as inefficient because the circulator would usually be giving a report during deployment, so it was annoying and more costly (we had to provide sterile gloves, cap, and mask for the circulator). It is at this time that the idea for single deployment was generated, and since then we have successfully deployed over 1000 Vasoseal ES devices using the single operator technique. The remainder of this article will describe how we do single operator deployment and provide our current protocol for patients receiving a Vasoseal ES. The two most important aspects to successful single operator deployment are patient selection and experience of the operator. Patient Selection. The only criteria we impose in addition to the manufacturer’s recommendations is that the operator is able to occlude the artery using only their middle and ring fingers (Fig. 1). Typically this will exclude heavier patients, hypertensive patients, and/or aortic insufficiency patients from the selection process. Again, much of the selection process relies on the operator’s experience, technique and comfort level. Supplies and Equipment. We have all supplies nearby and ready to go. We usually gather a stack of 4 x 4s, a syringe of 2% lidocaine, bioclusive dressing (Tegaderm®), and both remove the entire Vasoseal ES system from the packaging and lay it out to provide ease on access. Note: Even though this is a single operator technique, it’s important to always have another staff member within shouting distance. This is our standard practice whether we are using Vasoseal or manual hold for hemostasis. Procedure. Upon completion of procedure, determine whether or not the patient is a candidate for single operator deployment. Figure 1 and 2 show two different ways of holding pressure with the middle ring fingers. Figure 1 shows applying occlusive pressure just utilizing your fingers, and Figure 2 shows taking two 4 x 4s, quarter folding them to make a wedge that is placed directly over the artery. One of the authors uses this technique in order to assist with occlusive pressure. Depending on how well occlusive pressure is sustained, you can potentially get a small hematoma prior to even putting in the device. As a result, it’s important to make sure you have very good occlusive pressure. Most of us use the left hand or occlusive hand, whichever one you’re holding pressure with. The biggest size of hematoma we’ve had is about a half-dollar size. It’s easily evacuated with manual pressure. Once you determine you are capable of maintaining occlusive pressure by utilizing the techniques above, you are ready to begin deployment. The process is the same as it is with two people, but demonstrating the little techniques to achieve it are helpful. As you see in Figure 3, once you have inserted the Temporary Arteriotomy Locator® (TAL) to the white indicator, begin holding occlusive pressure with your left hand. As you maintain positioning of the TAL with the right forefinger and thumb, remove the sheath with your right middle and ring fingers. This takes a little practice and manual dexterity. Just maintain occlusive pressure and slowly work the sheath back and out. Use the right hand to withdraw the TAL to the green line. Then, as shown in Figure 4, use your right hand to maintain position while advancing the TAL in order to deploy the J-tip locator. Once the J-tip is deployed, use your right hand to withdraw until a slight resistance is met. Remember, these are the same steps as used in the deployment with two operators; it is only the manipulation that is different. Now, while trapping the TAL against the patient with your left hand, advance the tissue dilator and Vasoseal sheath onto it. Don’t forget to maintain occlusive pressure while doing so. Now that the dilator and sheath are threaded on, grasp the TAL with your right hand and the dilator with your left forefinger and thumb. Advance the dilator until the white marker is seen. Maintain that position and advance the Vasoseal using the same technique until the black marker is seen. With your right hand, disengage the J-tip on the TAL. Support the Vasoseal sheath with your left forefinger and thumb. Remove the TAL and tissue dilator. While maintaining support with your left hand, deploy the collagen cartridge as you would normally. At our facility, we inject a small amount of 2% lidocaine (left over from the beginning of the case) in between the deployment of the two collagen cartridges. It is our belief that this serves two purposes: 1) It aids in softening the collagen; 2) It provides additional local anesthetic to decrease deployment and post cath site discomfort. Conclusion. Single operator deployment of Vasoseal ES is a safe, efficient way to obtain rapid hemostasis. The obstacle in having to use two people to deploy the device can be overcome by employing this technique. We have utilized the single operator deployment technique successfully in over 1000 patients without any complications related to the single operator deployment aspect. The key ingredients to success are experienced staff, proper patient selection, and willingness to learn. In the coming months, we will be converting to Elite, the latest generation VasoSeal product from Datascope. Elite has a new sponge collagen which expands rapidly and provides an extravascular mechanical seal of the arteriotomy. Single operator deployment has allowed quicker turnaround by freeing up staff to perform other duties. It has also increased the skill level of our staff by demanding good manual pressure technique. If you have any questions, please contact Chris LaRose at (417) 335-7325

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