Lab Management and Patient Satisfaction Improved with Cardiva Catalyst™ Assisted Manual Compression

Achieving vascular closure after diagnostic or interventional angiography continues to be a challenging process for catheterization laboratory staff and patients alike. Use of manual compression is time-consuming and often uncomfortable for patients, although it remains the “gold standard” for safety and cost. Use of vascular closure devices (VCDs) promises immediate closure, but complication rates can be higher and complications more severe than with manual compression,1–6 and patient comfort can suffer when VCDs are deployed. An optimal approach to achieving hemostasis and vascular closure would combine the safety of manual compression and the time-saving benefit of VCDs while maintaining patient comfort and decreasing time to ambulation.7,8 Experience at Stone Oak Center for Angiography & Interventions in San Antonio, Texas, is showing that the Cardiva Catalyst™ (Cardiva Medical, Mountain View, California) meets these criteria. Preliminary patient satisfaction survey results from Affiliated Surgeons of Rockford corroborate this experience at Stone Oak. Experience at Stone Oak Cath Lab Stone Oak Center for Angiography & Interventions is an outpatient cath lab that treats up to 10 patients per day. The lab has a high proportion of patients with diabetes and those on renal dialysis. Senior Clinical Director, Charlotte Merritt, RN knows that the lab’s success depends on getting patients ambulating as quickly as possible without complications. The lab has used the Catalyst device in conjunction with manual compression in over 300 patients, with no groin complications, heart attacks or hospitalizations. “I was skeptical to start with,” Charlotte said, “but I’ve seen the Catalyst used in patients with an activated clotting time (ACT) > 400 seconds, and we’ve been able to close the access site. We have deployed the Catalyst in patients who have received bivalirudin, and we know first-hand that it works. It is the safest, most effective and efficient combination we have available.” The Catalyst system is designed to be used with manual compression to facilitate both the intrinsic and extrinsic coagulation cascades, thereby reducing the duration of manual compression. The device is introduced through the sheath after catheterization. The low-profile, flexible nitinol disc is opened inside the vessel and brought back to the arteriotomy site parallel to the sheath removal, sealing the arteriotomy site temporarily and enabling tissue tract recoil as well as activation of the coagulation cascade. The surface of the Catalyst, directly adjacent to the arteriotomy site and tissue tract, is negatively charged to further stimulate the contact activation (intrinsic pathway) response and encourage platelet adherence at the site (Figure 1). The Catalyst wire coating also includes a positively-charged chitosan compound that has been shown to enhance platelet adhesion and aggregation through the tissue factor (extrinsic) pathway.9 Therefore, the device applies coagulation-promoting agents directly at the arteriotomy site. By encouraging this rapid coagulation response, the Catalyst ‘jump-starts’ the patient’s coagulation cascade, causing fibrin to be formed more quickly, platelets to adhere more effectively, and hemostasis to be achieved more readily. Charlotte reported that they perform both coronary and peripheral vascular procedures at Stone Oak, and “we don’t want to deploy a product that could compromise the vascular system. The quickest way to get patients off the table is to avoid device complications post procedure. We don’t want patients with no pulse, infection, or a collagen plug shoved into the artery.” Before coming to Stone Oak, Charlotte worked in a very busy cath lab where a collagen-based VCD was regularly deployed to achieve immediate vascular closure. “Catalyst sales representatives came into the lab, but we just didn’t have time to learn to use this new device,” she recalls. “Then we started having problems with the VCD we were using. There was a period of about 6 months where three patients had to be sent for surgery due to complications from the closure device they had received. This represented a significant cost both to the patient and the hospital.” “Then, a member of my family needed to come into the lab to undergo a cardiac catheterization and ultimately a coronary intervention,” she continued. “I asked the doctor not to use the collagen-based VCD in my family member, but to use a Catalyst instead. That’s when we started looking at the Catalyst for other patients in the lab. I was frustrated with our patients going through painful device deployment and complications. After a successful procedure with no complications, there is no reason why we should end the case with a complicated and painful closure device. We can feel good about not leaving a foreign object in the groin.” The experience at Stone Oak has shown that patients are able to ambulate and are discharged sooner when the Catalyst is used in conjunction with manual compression. Shorter times to ambulation, combined with fewer complications than with other VCDs, translate into a better experience for patients and cath lab staff alike. Shorter hold-times translate into better patient comfort and fewer repetitive stress or back injuries for the cath lab staff. “We are seeing fewer carpal tunnel problems among our staff members since we began using the Catalyst to decrease our hold times,” Charlotte noted. “Lab throughput has really improved and patients are having better experiences after their procedures.” Stone Oak’s experience of increased patient satisfaction is borne out by recent survey results from a randomized study conducted by Affiliated Surgeons of Rockford. Rockford Patient Satisfaction Study The Rockford Patient Satisfaction Study gathered information on pain during Catalyst device deployment, manual compression, and bed rest from 274 patients who were randomized into groups receiving manual compression alone versus Catalyst-assisted manual compression. The study was conducted from January 26, 2007 to May 1, 2008 in the interventional radiology suite where approximately three peripheral angiographic patients are treated each day. A linear analogue scale analysis measurement10–12 was used for the evaluation of patient satisfaction during Catalyst deployment and during the postprocedural compression period. This linear scale was based on those used for subjective information input in numerous oncological trials. Study Design. The Rockford study found an overwhelming improvement in patient satisfaction ratings when the Catalyst device was used. The vast majority of patients included in the Rockford study preferred the Catalyst over manual compression (over 88%). A very large number of patients included in this study (78%) were known to suffer from peripheral vascular or coronary artery disease and had already undergone previous angiographic procedures. Because of their past experience, these patients were already aware of various compression techniques (including manual compression and the use of a clamp) and closure devices. After these repeat patients experienced deployment of the Catalyst during their procedure, they refused to enter the study if they found they had been randomized into the manual compression arm of the protocol. This patient preference quickly led to a decrease in our recruitment numbers and an obvious bias in the study. The bias was created primarily because of two issues. First, because the patients excluded from the study based on their preference for the Catalyst device had vascular disease as described above, they tended to have higher risk access sites due to the presence of atheromatous plaques and scarring. As a result, lower-risk patients participated in the study. Second, patients who had previously undergone endovascular interventions who specifically selected the Catalyst were for the most part older than the patients included in the study, thus skewing the age demographics in the study cohort. The main reason patients preferred the Catalyst device was because of the shorter time needed for groin compression and significantly lower overall pressure. These two factors significantly decreased the pain and discomfort experienced by the patients during compression. In addition, a lower incidence of vasovagal reactions was noted during compression following the use of the Catalyst device. For the reasons outlined above, the study was changed with proper institutional review board approval during the patient recruitment phase, and the redesigned evaluation was primarily concerned with patient satisfaction. Study Outcomes. There were no increases in the rate or severity of puncture site-related complications in this study. In fact, there did appear to be a significant decrease in the severity of these complications when compared with a retrospective review of patients performed earlier at our institution whose puncture site closure was managed with a clamp. With the Catalyst device there were no significant puncture site complications requiring targeted treatment or need for a longer hospital stay. Nearly all of the complications observed with the Catalyst involved the occurrence of small, limited hematomas. No fistulae or pseudoaneurysms were observed. We were able to decrease the overall force of compression required to complete the closure of the arterial (common femoral artery) access site with the use of the Catalyst device. We were also able to significantly decrease compression time using the Catalyst when compared with manual compression protocols. Conclusions and Limitations. In this study, our center was able to decrease the time to ambulation following arterial vascular procedures with the use of the Catalyst device, an outcome clearly noted in comparison with our manual compression protocols. This decrease was not always significant, due in large part to the organization of nursing schedules on the medical floors in our community hospital. Nurses were sometimes unavailable to ambulate the patient at the required time and to adequately note these results on the trial protocol forms. This problem seemed to occur more frequently when the patient’s immediate postprocedural follow up did not take place in one of the dedicated endovascular units, but rather in one of the hospital’s medical and surgical wards, which is often the case in community hospitals. Despite the inability to consistently reduce time to discharge or ambulation, our study showed a significantly higher patient satisfaction rate with the Catalyst. Disclosures. Dr. Capasso is a member of Cardiva Medical’s medical advisory board and is an occasional member of the company’s speaker’s bureau. Dr. Longo is a medical writing consultant with Cardiva Medical, Inc. Bernadette Longo, PhD, can be contacted at: blongo@umn.edu

1. Lehmann KG, Heath-Lange SJ, Ferris ST. Randomized comparison of hemostasis techniques after invasive cardiovascular procedures. Am Heart J 1999;138:1118–1125. 2. Amin FR, Yousufuddin M, Stables R, et al. Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the Angio-Seal device vs. the FemoStop device. Intnl J Cardiol 2000;76:235–240. 3. Pershad A, Stevenson J. Closure devices are not benign: Case closed or artery closed? J Invasive Cardiol 2004;16:608–609. 4. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and meta-analysis. JAMA 2004;291:350–357. 5. Tiesenhausen K, Tomka M, Allmayer T, et al. Femoral artery infection associated with a percutaneous arterial suture device. Vasa 2004;33:83–85. 6. Tavris D, Dey S, Albrecht-Gallauresi B, et al. Risk of local adverse effects following cardiac catheterization by hemostasis device use. Phase II. J Invasive Cardiol 2005;17:644–650. 7. Allie DE, Hebert CJ, Walker CM, Caputo RP. Vascular access site hemostasis: “An endovascular surgeon’s perspective.” Manual compression may not be benign! Cath Lab Digest 2004;12:6–14. 8. Jones T, McCutcheon H. Effectiveness of mechanical compression devices in attaining hemostasis after femoral sheath removal. Am J of Crit Care 2002;11:155. 9. Fisher TH, Bode AP, Demcheva M, et al. Hemostatic properties of glucosamine-based materials. J Biomed Mater Res A 2007;80:167–174. 10. Myles PS, Urquhart N. The linearity of the visual analogue scale in patients with severe acute pain. Anaesth Intensive Care 2005;33:686–687. 11. Myles PS, Troedel S, Boquest M, Reeves M. The pain visual analogue scale: Is it linear or nonlinear? Anaesth Analg 2000;91:248–249. 12. Locke DE, Decker PA, Sloan JA, et al. Validation of single-item linear analogue scale assessment of quality of life in neuro-oncology patients. J Pain Symptom Manage 2007;34:628–638.