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Commentary
“You Can’t Keep a Good Man (or Woman) Down”
March 2006
There has been an impressive decrease in the incidence of vascular complications following cardiac catheterization in recent years;1 however, excess bleeding from the access site, hematoma, arteriovenous fistula and arterial pseudoaneurysm formation continue to lengthen patients’ hospital stay and affect morbidity. After diagnostic left heart catheterization from the femoral artery, hemostasis has traditionally been achieved through manual compression with the fingertips over the arterial pulse. Many operators act on anecdotal evidence when determining the duration of patient bed rest following arterial sheath removal. Some support the notion that 3 minutes of manual pressure per catheter French size is sufficient for hemostasis while 1 hour of bed rest per French size is necessary to maintain hemostasis; however, statements such as these are largely untested. Advances in the use of arterial closure devices have helped reduce the duration of patient bed rest following sheath removal;2–5 however these devices contribute to increased health care costs and it remains unclear whether closure devices actually reduce complication rates.6 Protocols for duration of manual compression and bed rest following sheath removal vary widely across centers. In truth, there is a lack of sufficient data with which to construct universal guidelines seeking to minimize vascular complications and patient discomfort while improving efficiency in the catheterization lab and potentially reducing costs.
The study by Gall et al. published in this issue of the Journal of Invasive Cardiology7 demonstrates a low incidence of vascular complications in patients undergoing diagnostic left heart catheterization who receive mechanical compression for 30 minutes over the femoral artery after sheath removal followed by only 60 minutes of seated bed rest. The authors report a 0.1% incidence of minor bleeding following this protocol and a 0.2% rate of femoral artery pseudoaneurysm formation. A total of 987/1,000 (98.7%) of patients treated via this protocol were successfully discharged home the day of the procedure and there were no cases of complications following discharge. Although there was no control group in this study, these results compare favorably to the existing literature in which patients have adhered to longer bedrest protocols of 2–6 hours and have experienced complications at a rate of 1.6%–19%.8–11 While inadequate compression of the femoral artery has been linked to postcatheterization complications,1 the results of this study in which the Femostop® was used for mechanical compression can likely be generalized to cases in which manual compression is utilized, as the two methods have previously been demonstrated to be equal in efficacy.12 The authors report in this study that complications (notably hematoma formation) were more common in obese patients (11/13 patients with complications had BMI > 25) and in women (2.6% vs. 0.6%). While increased vascular complications have previously been reported in women,13–16 an increased risk has not previously been described for obese patients.
Nursing shortages, decreasing insurance reimbursement, and increased cost of new catheter and device technology are issues in the catheterization laboratory and trends toward early ambulation protocols reflect the growing importance of efficiency in the catheterization laboratory as a means to improve patient satisfaction and throughput. Furthermore, a protocol such as the one described by Gall et al. utilizing only 30 minutes of supine bedrest followed by 60 minutes of seated bedrest might significantly reduce patient discomfort following catheterization procedures, particularly in patients with back or neck pain or volume overload and orthopnea.
In our attempts to maximize efficiency and patient turnover in the catheterization laboratory, it is vital to remember that patient safety is the most important factor to consider when making decisions regarding early ambulation and early hospital discharge. Protocols outlining shortened durations of bedrest must be carefully scrutinized before being put to widespread use. Previously, 2.5 hour bedrest protocols have been demonstrated to be safe in small studies.8,9 The study by Gall et al. demonstrates the safety of an early ambulation protocol requiring only 30 minutes of supine bedrest followed by 60 minutes of seated bed rest. At our institution, the use of smaller diameter (4 and 5 French) arterial sheaths during uncomplicated diagnostic cardiac catheterization has increased, and one can postulate that the duration of bedrest may be further reduced in this setting without compromising patient safety.
Further study is needed to evaluate ideal strategies in patients undergoing coronary interventional procedures, as anticoagulant and antiplatelet agent administration, longer duration of procedures, and generally larger diameter arterial sheaths during these procedures significantly increase the incidence of vascular complications.17,18 Future randomized trials will need to clarify the ideal roles of closure devices and manual pressure in managing arterial access sites. Further investigation of complication rates in women and obese patients might justify the use of modified protocols for these patient groups to ensure safety. Potentially, a strategy of manual pressure and early ambulation may prove to be an extremely safe and cost-efficient method to handle patients undergoing diagnostic femoral arterial catheterization.
1 Babu SC, Piccorelli GO, Shah PM, et al. Incidence and results of arterial complications among 16,350 patients undergoing cardiac catheterization. J Vasc Surg 1989;10:113–116. 2. Baim DS, Knopf WD, 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. 3. Kapadia SR, Raymond R, Knopf W, et al. The 6Fr Angio-Seal arterial closure device: Results from a multimember prospective registry. Am J Cardiol 2001;87:789–791, A788. 4. SEAL Trial Study Team. 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. 5. Bhatt DL, Raymond RE, Feldman T, et al. Successful “pre-closure” of 7Fr and 8Fr femoral arteriotomies with a 6Fr suture-based device (the Multicenter Interventional Closer Registry). Am J Cardiol 2002; 89:777–779. 6. 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. 7. Gall S, Tarique A, Natarajan A, Zaman AG. Rapid Ambulation after coronary angiography via femorral artery access: A prospective study of 1000 patients. J Invasive Cardiol 2006;18:106–108. 8. Pollard SD, Munks K, Wales C, et al. Position and Mobilisation Post-Angiography Study (PAMPAS): A comparison of 4.5 hours and 2.5 hours bed rest. Heart 2003;89:447–448. 9. Wood RA, Lewis BK, Harber DR, et al. Early ambulation following 6 French diagnostic left heart catheterization: A prospective randomized trial. Cathet Cardiovasc Diagn 1997;42:8–10. 10. Lim R, Anderson H, Walters MI, et al. Femoral complications and bed rest duration after coronary arteriography. Am J Cardiol 1997;80:222–223. 11 . Kern MJ, Cohen M, Talley JD, et al. Early ambulation after 5 French diagnostic cardiac catheterization: Results of a multicenter trial. J Am Coll Cardiol 1990;15:1475–1483 12. Simon A, Bumgarner B, Clark K, et al. Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization. Am J Crit Care 1998;7:308–313. 13 . Chiu JH, Bhatt DL, Ziada KM, et al. Impact of female sex on outcome after percutaneous coronary intervention. Am Heart J 2004;148:998–1002. 14. Perings SM, Kelm M, Jax T, et al. A prospective study on incidence and risk factors of arteriovenous fistulae following transfemoral cardiac catheterization. Int J Cardiol 2003;88:223–228. 15 . Kelm M, Perings SM, Jax T, et al. Incidence and clinical outcome of iatrogenic femoral arteriovenous fistulas: Implications for risk stratification and treatment. J Am Coll Cardiol 2002; 40:291–297. 16 . Knight CG, Healy DA, Thomas RL. Femoral artery pseudoaneurysms: risk factors, prevalence, and treatment options. Ann Vasc Surg 2003;17:503–508. 17 . Omoigui NA, Califf RM, Pieper K, et al. Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I). J Am Coll Cardiol 1995; 26:922–930. 18. Mandak JS, Blankenship JC, Gardner LH, et al. Modifiable risk factors for vascular access site complications in the IMPACT II Trial of angioplasty with versus without eptifibatide. Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis. J Am Coll Cardiol 1998;31:1518–1524.