Immediate Ambulation Following Diagnostic Coronary Angiography Procedures Utilizing a Vascular Closure Device (The Closer‚Ñ¢)<br />

Achieving arterial hemostasis is a major factor limiting ambulation and hospital discharge among patients undergoing diagnostic cardiac catheterizations. Historically, manual or mechanical compression for 15–30 minutes coupled with an extended bed rest of 3–6 hours has been the standard of practice.1–8 Some studies support shorter ambulation times when 4, 5 or 6 French sheaths are utilized.4,9–12 Manual compression has been the standard by which recently introduced vascular hemostasis devices are judged with regard to efficacy, cost, complications and patient comfort.3,7,13–21 Manual compression techniques with subsequent bed rest may be associated with patient discomfort, especially for the elderly and for those patients with preexisting back and hip pain.2,3,13 In addition to the associated patient comfort issues, compression techniques are a time- and resource-intensive practice.13,18 Numerous studies have substantiated the use of various vascular closure devices to alleviate patient discomfort and improve resource utilization without increasing complication rates.13,22,23 Some institutions have begun routine use of closure devices in lieu of manual compression whenever feasible.13,18,23 There is a paucity of data available for the latest generation of suture-mediated closure devices, The Closer™ (Abbott Corporation, Redwood City, California).13 Therefore, the safety and efficacy of immediate ambulation after diagnostic angiography utilizing this latest generation of suture-mediated closure devices were studied. The role that operator experience played in the successful deployment of The Closer™ was also analyzed. Methods From December 1999 to January 2002, a total of 1,389 consecutive patients underwent diagnostic coronary angiography at Immanuel St. Josephs Hospital-Mayo Health System. After angiography, a total of 513 non-consecutive patients underwent vascular closure with The Closer™ device at physician discretion (Figure 1). Following device deployment, an immediate ambulation protocol was considered, which consisted of: 1. Following deployment of The Closer™, patients were allowed to self-transfer from the procedure table to a stretcher bed. 2. Patients were allowed to immediately sit upright in bed, stand, ambulate or use the restroom. 3. Outpatients were observed in the recovery room for 4 hours prior to discharge. 4. Inpatients were generally observed in the recovery room for 30–60 minutes prior to being transferred to their hospital room. Among the 513 patients undergoing vascular closure, twenty-six patients were excluded from the immediate ambulation protocol for the following reasons: International Normalized Ratio (INR) greater than 1.5, platelet count less than 100,000/mm3, concomitant femoral venous sheath, multiple arterial punctures during femoral artery access attempts, heavy sedation during the procedure, or acute myocardial infarction within 24 hours. The remaining 487 patients were included in the immediate ambulation protocol. A study coordinator collected all follow-up data and prospectively collected clinical and procedural data. Outpatients were followed at 24 hours or more, and inpatients were followed the next morning. Technique. Femoral artery access was achieved with an 18-gauge single-wall puncture needle. Arterial access was maintained with a 6 French (Fr) sheath. Six-Fr diagnostic coronary catheters were used. Hemostasis was achieved at physician discretion by vascular closure with The Closer™ (Figure 2), manual compression or C-clamp compression. All patients considered for vascular closure underwent femoral artery angiography to document appropriate anatomy for deployment. Patients were excluded from consideration for vascular closure if there was significant femoral artery tortuosity, severe femoral artery calcification, arterial access at or distal to the bifurcation of the superficial femoral artery and the profunda artery, or a major branch vessel in close proximity to the arterial access site. Definitions. Device deployment describes the time at which the suture knot was delivered. Device failure was defined as operator error or device malfunction resulting in failure to achieve immediate hemostasis or to achieve hemostasis after 2–5 minutes of light, manual compression. Immediate ambulation was defined as patients who entered the immediate ambulation protocol. Delayed ambulation was defined as any patient who had a successful device deployment, but required an additional 1–3 hours of bed rest prior to ambulation. Statistics. Continuous data are summarized as means ± standard deviation with one-way analysis of variance to test group differences. Discrete data are summarized as frequencies and group percentages and compared using Pearson’s Chi-squared test. Fisher’s Exact test gave similar results for variables with small cell counts. Results Among the 487 study patients eligible for the immediate ambulation protocol, a total of 434 (89%) were immediately ambulated, thirty-four (7%) underwent delayed ambulation, and 19 (4%) experienced device failure (Figure 1). Of the 34 patients requiring intermediate bed rest, ten had minor bleeding from the arterial access tract requiring 2–5 minutes of light compression and 24 were delayed secondary to physician preference for other reasons such as concomitant use of antithrombin or antiplatelet agents. Nineteen patients (4%) failed to achieve hemostasis. Baseline clinical characteristics of the immediate ambulation, delayed ambulation, and device failure subgroups were similar (Table 1). Antiplatelet and antithrombin utilization was not statistically different in each of the subgroups. The mean times to ambulation were 6.3 ± 2.4 minutes and 105.2 ± 55.3 minutes in the immediate ambulation and delayed ambulation subgroups, respectively. Complication rates were very low for both subgroups (Table 2). At follow-up, no patient developed hematoma > 4 cm, ipsilateral retroperitoneal bleed, arterio-venous fistula, pseudoaneurysm, access site infection or loss of distal pulses. No patients had lower extremity ischemia or required a blood transfusion. There were 4 recurrent femoral artery bleeds; three were in the immediate ambulation subgroup and 1 was in the delayed ambulation subgroup. The 3 recurrent femoral artery bleeds in the immediate ambulation subgroup all occurred during the post-procedure observation period (Table 3; patients A, B and C). All were successfully treated with manual compression without any additional vascular complications. One recurrent femoral artery bleed occurred in the delayed ambulation subgroup (Table 3; patient D). Patient D was an 81-year-old male who presented to the emergency department 6 days post-procedure with a recurrent femoral artery bleed requiring 20 minutes of manual compression to obtain hemostasis. The patient was also receiving enoxaparin (1 mg/kg subcutaneously every 12 hours) and warfarin (6 mg daily) post-procedure. The influence of operator experience on immediate ambulation, delayed ambulation and device failure is shown in Figure 3. Among the first 100 patients undergoing deployment of The Closer™, 82% underwent immediate ambulation, 12% underwent delayed ambulation and 6% experienced device failure. Among the subsequent 387 patients, 91% underwent immediate ambulation, 6% underwent delayed ambulation and 3% experienced device failure. Discussion This report describes 487 non-consecutive patient outcomes after deployment of The Closer™ to achieve hemostasis. The overall rate of hemostasis was 96%, but 4% of the patients failed to achieve hemostasis with The Closer™. Eighty-nine percent of the patients could be ambulated immediately (mean time, 6.3 ± 2.4 minutes) and 7% were ambulated after an intermediate bed rest (mean time, 105.2 ± 55.3 minutes). The only significant complications were 4 late recurrent femoral artery bleeds (0.8%). Operator experience did appear to be associated with increased successful device deployments and decreased device failures. As operator experience grew, our rate of immediately ambulated patients rose and our deployment failure rate fell. This may represent better patient selection and improved operator technique. Large-scale trials using manual compression have found the incidence of major access-site complications following cardiac catheterization to be between 0.22% and 1%.24–26 Collagen plug devices such as Angioseal™ (Kensey Nash Corporation, Exton, Pennsylvania) and Vasoseal™ (Datascope Corporation, Montvale, New Jersey) offer a shorter time to hemostasis and ambulation when compared to manual compression without a higher overall complication rate;16,20,24,25,27 however, serious complications including arterial thrombosis requiring urgent vascular surgery have been reported.28,29 The Duett™ procoagulant device (Vascular Solutions, Inc., Minneapolis, Minnesota) has been shown to provide shorter time to hemostasis with comparable success rates to manual compression.17,18 The overall complication rate with the Duett™ device is not significantly higher than manual compression, but the incidence of serious complications such as arterial occlusion is higher.30,31 Early designs of suture-mediated closure devices have also been shown to shorten time to hemostasis and ambulation without decreasing complications when compared to manual compression.7,13,22 While there is a great deal of evidence supporting the safety of the suture-mediated closure devices, this support is not unanimous. A large-scale study of over 1,100 patients utilizing an early version of the suture-mediated device after diagnostic angiography showed a higher complication rate when compared to manual compression.3 There are relatively few data available regarding immediate ambulation after deployment of the suture-mediated closure devices. Our study confirmed the safety and efficacy of utilizing a suture-mediated closure device after diagnostic cardiac catheterization. Moreover, we have extended the device’s utility to enable immediate ambulation after vascular closure. There are several study limitations that should be taken into consideration. Our study population is relatively small and from a single center. A larger scale, multicenter trial comparing different methods for achieving hemostasis would be required before generalizing our results. Also, a prospective, randomized controlled study design would have minimized bias. Femoral artery ultrasound was not performed routinely and was only ordered if clinically indicated, e.g., for a newly discovered bruit or pulsatile hematoma. It is conceivable that some clinically insignificant arterio-venous fistulas and pseudoaneurysms were missed. Conclusion We conclude that The Closer™ device can be safely and effectively used to immediately ambulate diagnostic angiography patients. We also noted that a learning curve existed when utilizing the device. Our complication rates compare favorably to historical rates utilizing manual compression.24–26,29 Acknowledgment. The authors would like to thank the staff of the Cardiac Catheterization Lab at Immanuel St. Josephs-Mayo Health System, and Mary Grams, RN, for their contributions.

1. Logemann T, Leutmer P, Kaliebe J, et al. Two versus six hours of bed rest following left-sided cardiac catheterization and a meta-analysis of early ambulation trials. Am J Cardiol 1999;84:486–488. 2. McCabe P, McPherson L, Lohse C, Weaver A. Evaluation of nursing care after diagnostic coronary angiography. Am J Crit Care 2001;10:330–340. 3. Kahn Z, Kumar M, Hollander G, Frankel R. Safety and efficacy of the Perclose suture-mediated closure device after diagnostic and interventional catheterization in a large consecutive population. Cathet Cardiovasc Intervent 2002;55:8–13. 4. Baum R, Gantt D. Safety of decreasing bed rest after coronary angiography. Cathet Cardiovasc Diagn 1996;39:230–233. 5. Keeling A, Taylor V, Nordt L, et al. Reducing time in bed after cardiac catheterization (TIBS II). Am J Crit Care 1996;5:277–281. 6. Hogan-Miller E, Rustad D, Sendelbach S, Goldenberg I. Effects of three methods of femoral site immobilization on bleeding and comfort after coronary angiogram. Am J Crit Care 1995;4:143–148. 7. Baim D, Knopf W, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: Results of the Suture To Ambulate aNd Discharge (STAND I and STAND II) trials. Am J Cardiol 2000;85:864–869. 8. Pooler-Lunse C, Barkman A, Bock B. Effects of modified positioning and mobilization of back pain and delayed bleeding in patients who had received heparin and undergone angiography: A pilot study. Heart Lung 1996;25:117–123. 9. Kern M, Cohen M, Talley J, et al. Early ambulation after 5 French diagnostic cardiac catheterization: Results of a multicenter trial. J Am Coll Cardiol 1990;15:1475–1483. 10. Steffenino G, Dellavalle A, Ribichini F, et al. Ambulation three hours after elective cardiac catheterization through the femoral artery. Heart 1996;75:477–480. 11. Wood R, Lewis B, Harber D, et al. Early ambulation following 6 French diagnostic left heart catheterization: A prospective randomized trial. Cathet Cardiovasc Diagn 1997;42:8–10. 12. Sola R, Pastore G, Stein B. Early ambulation after diagnostic cardiac catheterization: A 4 French study. J Invas Cardiol 2001;13:75–78. 13. Fleischhauer F, Stewart J. Effectiveness of suture mediated closure of vascular access sites following diagnostic and interventional catheterizations. Cath Lab Digest 2000;(Suppl):12–14. 14. Bogart M. Time to hemostasis: A comparison of manual versus mechanical compression of the femoral artery. Am J Crit Care 1995;4:149–156. 15. Simon A, Burngarner B, Clark K, Israel S. Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization. Am J Crit Care 1998;7:308–313. 16. Kussmaul W, Buchbinder M, Whitlow P, et al. Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: Results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol 1995;25:1685–1692. 17. Sanborn T, Gibbs H, Brinker J, et al. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol 1993;22:1273–1279. 18. Shrake K. Comparison of major complication rates associated with four methods of arterial closure. Am J Cardiol 2000;85:1024–1025. 19. Duffin D, Muhlestein J, Allison S, et al. Femoral arterial puncture management after percutaneous coronary procedures: A comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invas Cardiol 2001;13:354–362. 20. Brachmann J, Ansah M, Kosinski E, Schuler, G. Improved clinical effectiveness with a collagen vascular hemostasis device for shortened immobilization time following diagnostic angiography and percutaneous transluminal angioplasty. Am J Cardiol 1998;81:1502–1505. 21. Lehmann K, Heath-Lange S, Ferris S. Randomized comparison of hemostasis techniques after invasive cardiovascular procedures. Am Heart J 1999;138:1118–1125. 22. Mehta H, Fleisch M, Chatterjee T, et al. Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures. J Invas Cardiol 2002;14:9–12. 23. Gerkens U, Cattelaens N, Lampe E, Grube E. Management of arterial puncture site after catheterization procedures: Evaluating a suture-mediated closure device. Am J Cardiol 1999;83:1658–1663. 24. Babu S, Piccorelli G, Shah P, et al. Incidence and results of arterial complications among 16,350 patients undergoing cardiac catheterization. J Vasc Surg 1989;10:113–116. 25. Johnson L, Lozner E, et al. Coronary arteriography 1984–1987: A report of the registry of the society for cardiac angiography and intervention. Results and complications. Cathet Cardiovasc Diagn 1989;17:5–10. 26. Ricci M, Trevisani G, Pilcher D. Vascular complication of cardiac catheterization. Am J Surg 1994;167:375–378. 27. Aker U, Kensey K, Heuser R, et al. Immediate arterial hemostasis after cardiac catheterization: Initial experience with a new puncture closure device. Cathet Cardiovasc Diagn 1994;31:228–232. 28. Gonze M, Sternbergh W, Salartash K, Money S. Complications associated with percutaneous closure devices. Am J Surg 1999;178:209–211. 29. Eidt J, Habibipour S, Saucedo J, et al. Surgical complications from hemostatic puncture closure devices. Am J Surg 1999;178:511–516. 30. Silber S, Tofte A, Kjellevand T, et al. Final report of the European multi-center registry using the Duett vascular sealing device. Herz 1999;24:620–623. 31. Ellis S, Mooney M, Talley D, et al. Assessment of the safety and efficacy of the DUETT vascular hemostasis device: Final results of the Safe and Effective Vascular Hemostasis (SEAL) trial. Am Heart J 2002;143:612–619.