Cath Lab News from the Deep South: Results of a Clinical Beta Site Study with a New Vascular Closure Device

East Alabama Medical Center (EAMC), which opened in 1952, is a 352-bed (314 inpatient beds and a 38-bed skilled nursing facility) located in Opelika, Alabama, serving Lee County and at least five surrounding counties (Chambers, Macon, Randolph, Russell and Tallapoosa). The EAMC Cardiac Cath Lab EAMC offers numerous services to the community, and one of these services is the cardiac catheterization lab, which opened in 1985. There are many experienced people in leadership positions in the cath lab, allowing it to run smoothly: Denise Crowe, Director of Cardiovascular Services; Rita Harman, Manager of Invasive Cardiology and Cath Obs.; Tanya Rice, Outcomes Coordinator; Riley Belcher, Cath Lab Coordinator. However, the true stars are our 8 registered nurses, 20 cardiovascular techs and our 8 highly skilled cardiologists.

"State-of-the-art equipment and innovative products are certainly important for a cath lab to be successful, but the key is hard-working, highly skilled staff; and our staff is outstanding whether they are working on a daily basis or responding to a critical situation." Rita Harman, Manager

EAMC has three labs and one EP lab, all of which are fully equipped with diagnostic technology, including intravascular ultrasound (IVUS). Within the next few months, the cath lab will be installing and using the Vericis® Physiolog Hemodynamic Monitoring System (Camtronics Medical Systems, Hartland, WI). All types of diagnostic and interventional procedures, including PTCA/stenting, PTA, PTCRA, DCA, and AngioJet® (Possis, Inc., Minneapolis, MN), are performed daily, averaging 27 per day. Our volume of procedures has continued to increase with the addition of several new cardiologists. We currently have 7 invasive cardiologists (4 are interventionalists, 6 handle implantable devices) and 1 non-invasive cardiologist. In 2002, our cardiologists performed 4,722 diagnostic procedures and 1,499 interventional procedures. We are also very fortunate to have two cardiothoracic surgeons available for emergencies. EAMC began performing open-heart surgeries in 1987. The EAMC Cardiac Outpatient Observation Unit (Cath Obs) Adjacent to the cath lab, EAMC has a 13-bed cardiac Outpatient Observation Unit (Cath Obs). Patients are admitted here for their procedures, and it is also where patients are transferred after the procedures and later discharged to their homes. The patients with outpatient procedures scheduled (diagnostic and interventional) will go home the same day, unless an overnight stay is required. Care is provided in specialized step-down units. Once discharged home, the patients participate in a rehabilitation program, which offers exercise programs as well as educational information tailored to meet the needs of each patient. Cath Obs is staffed by 7 nurses and 5 multi-care techs. Some of the cardiologists will allow sheaths to be pulled in Cath Obs, allowing for easy flow of patients and providing convenience to the physicians, patients and families. 2 Vascular Closure Research Studies The cardiologists at EAMC use several devices for vascular closure, including: VasoSeal (Datascope Corp., Mahwah, NJ); Perclose (Abbott Vascular Devices, Redwood City, CA); SyvekPatch® (Marine Polymers Technologies, Inc., Danvers, MA). In 2000, EAMC participated in a research study with Datascope Corporation, evaluating early discharge using VasoSeal ES. We enrolled 121 patients in this study, which allowed patients out of bed in one hour and patients to be discharged in two hours. The purpose of the evaluation was to monitor the hemostasis times to determine if there was any difference among patient groups or procedural variations. Initial results showed 90% of patients achieving hemostasis in less than one minute, both in challenging patients as well as routine angiography patients. There was no difference in the delivery method or the times to hemostasis among the groups. We again had an opportunity to work with Datascope in February of 2003. A beta site evaluation was conducted with Dr. William Ross Davis and Dr. John W. Mitchell using the new Elite vascular closure device. At that time, the FDA had approved the device; however, Elite had not yet been launched. About Elite Elite uses a new proprietary collagen, which expands rapidly when exposed to fluid. The deployment technique uses only one plug, and the collagen conforms to the tissue tract and does not distort or displace tissue, thus creating a mechanical seal at the arteriotomy site. Elite is fully extravascular and does not leave components behind in the artery. The collagen is almost completely absorbed by the body within 30 days. The device is safe for patients with peripheral vascular disease (PVD). (VasoSeal devices are the only devices approved by the FDA for patients with PVD.) Elite can also be used for patients who are highly anticoagulated. The EAMC Beta Site Evaluation The Elite beta site evaluation at EAMC involved twenty patients over a three-day period in February 2003. Ten patients underwent diagnostic procedures and ten patients underwent interventional procedures. Sixteen patients achieved arterial hemostasis in less than 30 seconds. A total of 18 patients (90%) achieved hemostasis within one minute. In two cases, hemostasis was not achieved within one minute. However, it can be attributed to the fact that these cases were training cases and the primary emphasis was on proper deployment method. In one of these cases, the patient was on coumadin with an INR of 1.3 and the device still provided immediate hemostasis. As a standard practice, ACTs are not drawn before sheaths are removed, unless warranted. (Note: Ambulation time was not addressed in the study because it was not an endpoint and the 1-hour ambulation time wasn't to be changed. The study was for educational information.) This study included a small sample population of 10 diagnostic and 10 interventional patients, and further study is needed. However, our results indicated that the Elite device provided a rapid seal, reducing time to hemostasis and resulting in positive patient outcomes for both diagnostic and interventional procedures.

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