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Effectiveness and safety of manual hemostasis facilitated by the SyvekPatch with one hour of bedrest after coronary angiography using six-French catheters
Effectiveness and Safety of Manual Hemostasis Facilitated by the SyvekPatch With One Hour of Bedrest After Coronary Angiography Using Six-French Catheters Bruce L. Palmer, MD, D. Scott Gantt, DO, Mark E. Lawrence, DO, M. Hassan Rajab, PhD, MPH, and Gregory J. Dehmer, MD Manual hemostasis facilitated by a SyvekPatch with 1 hour of bedrest after coronary angiography using 6Fr catheters was evaluated in a study of 200 patients. There were no major adverse events and 2% minor adverse events, all of which were managed successfully with additional bedrest of 1 to 2 hours. The findings suggest that the 1-hour bedrest protocol using the SyvekPatch is safe and effective in low-risk patients. 䊚2003 by Excerpta Medica, Inc. (Am J Cardiol 2004;93:96 –97)
he effectiveness and safety of manual hemostasis with 2 hours of bedrest after coronary angiography T using 6Fr catheters has been reported. The Syvek1,2
Patch (Marine Polymer Technologies, Danvers, Massachusetts) is an external device that facilitates hemostasis after percutaneous arterial access for invasive procedures. The patch contains poly-N-acetyl glucosamine, a polysaccharide polymer produced by marine microalgae, which activates plasma clotting proteins and platelets as well as induces vasoconstriction via the release of endothelin-1.3,4 Nader et al5 reported their clinical experience in 636 diagnostic procedures using 4Fr to 6Fr catheters with 1.4% minor complications after hemostasis facilitated by a SyvekPatch, followed by their standard operating protocol for bedrest. We present the results of a similar protocol, but with 1 hour of bedrest after angiography using 6Fr catheters. This protocol may have value in managing patients undergoing coronary angiography, where successful outcomes, patient satisfaction, and potential improved catheterization laboratory efficiency are priorities. •••
During the study period, 764 patients qualified for outpatient coronary angiography based on current guidelines published by the American College of Cardiology and the Society for Cardiac Angiography and Interventions.6 From this cohort, 200 low-risk patients were assigned 1 hour of bedrest, whereas the remaining patients were assigned bedrest periods of 2 to 4 hours at the physician’s discretion. Those assigned to From the Department of Medicine (Division of Cardiology), Scott & White Hospital and Clinic, Temple, Texas; and The Texas A & M University System Health Science Center College of Medicine, College Station, Texas. Dr. Gantt’s address is: Division of Cardiology, Scott & White Clinic, 2401 South 31st Street, Temple, Texas 76508. E-mail: [email protected]. Manuscript received June 30, 2003; revised manuscript received and accepted August 28, 2003.
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©2003 by Excerpta Medica, Inc. All rights reserved. The American Journal of Cardiology Vol. 93 January 1, 2004
longer periods of bedrest generally had ⱖ1 of the following risk factors: multiple needle punctures of the artery, severe obesity, significant hypertension, peripheral vascular disease, increased age, or continued need for anticoagulants. After 1 hour of supine bedrest in the study group, the arterial access site was inspected and patients were encouraged to walk for an additional hour. All patients were evaluated for an adverse event before dismissal and were contacted by telephone 24 to 72 hours after discharge for evaluation of late events. Major adverse events were defined as rebleeding or hematoma requiring surgical intervention, pseudoaneurysm, retroperitoneal hematoma, arteriovenous fistula, arterial or venous thrombosis, infection, or the need for blood transfusion. Minor adverse events were defined as rebleeding or hematoma requiring additional compression or bedrest. The study population’s characteristics are listed in Table 1. Continuous variables are presented as mean ⫾ SD. Major and minor event rates are reported with 95% confidence intervals (CI). None of the 200 patients experienced a major adverse event (95% CI 0% to 1.5%); 2% of patients (95% CI 0.5% to 5.0%) had minor adverse events. In the 4 patients with minor adverse events, 2 occurred during bedrest and 2 with ambulation. All patients with minor adverse events were managed successfully with additional manual compression and extra bedrest of 1 to 2 hours. Patients without adverse events (98% of the study group) were discharged within 3 hours of completing angiography. Patients with minor adverse events were dismissed within 5 hours of the procedure. In the 564 patients excluded from the study protocol, 6 had a minor adverse event, 1 had retroperitoneal hemorrhage with a 3-g decrease in hemoglobin, and 1 developed a pseudoaneurysm. No patient required blood transfusion. •••
The incidence of access site complications is low after coronary angiography using manual compression of the arterial access site and bedrest of 4 to 6 hours.1,2,7–9 In an environment with increasing costs and decreasing reimbursements, the safe and efficient management of patients after outpatient coronary angiography is important. A method for decreasing bedrest time, thereby improving patient satisfaction and laboratory efficiency without increasing complications, would be ideal. Shorter bedrest periods have been achieved using smaller caliber catheters, radial artery access methods, and arterial closure devic0002-9149/04/$–see front matter doi:10.1016/j.amjcard.2003.08.077
TABLE 1 Patient Characteristics (n ⫽ 200) Variable Age (yrs) (range) Men Mean body mass index (kg/m2) (range) WHO classification (kg/m2) Normal range (18.5–24.9) Grade 1, overweight (25–29.9) Grade 2, overweight (30–39.9) Grade 3, overweight (⬎40) Creatinine (mg/dl) Systolic blood pressure (mm/Hg) (range) Diastolic blood pressure (mm/Hg) (range) Heparin (1,500–3,000 U intravenous bolus) Antiplatelets Aspirin Clopidogrel
61 ⫾ 12 (34–84) 104 (52%) 30 ⫾ 6 (19–54) 46 66 74 14 1.3 125 69 105
(23%) (33%) (37%) (7%) ⫾ 1.5 ⫾ 15 (92–168) ⫾ 10 (45, 99) (53%)
142 (71%) 3 (1%)
Values are expressed as mean ⫾ SD or number (%). WHO ⫽ World Health Organization.
es.10 –12 Visualization of the coronary anatomy is sometimes inadequate with small-caliber catheters and the radial artery method is not frequently used.13 Arterial closure devices can dramatically shorten bedrest time, but have a small incidence of unique and serious complications.14 This study demonstrates a protocol using 6Fr catheters for satisfactory coronary visualization, with a low occurrence of access site complications and shortened bedrest time. Compared with arterial closure devices that cost between $200 and $300, the SyvekPatch costs approximately $60. Although cost was not measured in this study, implementation of this protocol may increase the potential number of outpatient procedures completed in a standard workday. Patient satisfaction is improved with shorter periods of bedrest. Our study has several limitations. Patient assignment to 1 hour of bedrest was at the discretion of the physician and thus subject to bias. Based on the judgment of the operator, patients with multiple needle punctures of the artery, severe obesity, significant hypertension, peripheral vascular disease, increased age, or the need for continued use of anticoagulants were frequently excluded from this protocol and managed with longer periods of bedrest. This was a retro-
spective analysis of a small selected group. However, a randomized trial to demonstrate improved cost effectiveness or a significant reduction in vascular complications would require a study population in excess of 2,600 patients in a similar clinical setting.15 Further trials with a larger patient population are recommended. Acknowledgment: We acknowledge the dedication, professionalism, and hard work of our cardiac catheterization laboratory nurses, technicians, and secretaries, without whom this study would not have been possible.
1. Baum RA, Gantt DS. Safety of decreasing bedrest after coronary angiography. Cathet Cardiovasc Diagn 1996;39:230 –233. 2. Logemann T, Luetmer P, Kaliebe J, Olson K, Murdock DK. Two versus six hours of bedrest following left-sided cardiac catheterization and a meta-analysis of early ambulation trials. Am J Cardiol 1999;84:486 –488. 3. Cole DJ, Connolly RJ, Chan MW, Schwaitzberg SD, Byrne TK, Adams DB, Baron PL, O’Brien PH, Metcalf JS, Demcheva M, Vournakis J. A pilot study evaluating the efficacy of a fully acetylated poly-N-acetyl glucosamine membrane formulation as a topical hemostatic agent. Surgery 1999;126:510 –517. 4. Ikeda Y, Young LH, Vournakis JN, Lefer AM. Vascular effects of poly-Nacetylglucosamine in isolated rat aortic rings. J Surg Res 2002;102:215–220. 5. Nader RG, Garcia JC, Drushal K, Pesek T. Clinical evaluation of SyvekPatch in patients undergoing interventional, EPS and diagnostic cardiac catheterization procedures. J Invasive Cardiol 2002;14:305–307. 6. Bashore TM, Bates ER, Kern MJ, Berger PB, Laskey WK, Clark DA, O’Laughlin MP, Cusma JT, Oesterle S, Dehmer GJ, Popma JJ. American College of Cardiology/Society for Cardiac Angiography and Interventions clinical expert consensus document on cardiac catheterization laboratory standards. A report of the American College of Cardiology task force on clinical expert consensus documents. J Am Coll Cardiol 2001;37:2170 –2214. 7. Barkman A, Lunse C. The effect of early ambulation on patient comfort and delayed bleeding after cardiac angiogram: a pilot study. Heart Lung 1994;23: 112–117. 8. Keeling A, Taylor V, Nordt LA, Powers E, Fisher C. Reducing time in bed after cardiac catheterization (TIBS II). Am J Crit Care 1996;5:277–281. 9. Vlasic W, Almond D. Research-based practice: reducing bedrest following cardiac catheterization. Can J Cardiovasc Nurs 1999;10:19 –22. 10. Khoukaz S, Kern MJ, Bitar SR, Azrak E, Eisenhauer M, Wolford T, El-Shafei A. Coronary angiography using 4 Fr catheters with Acisted power injection: a randomized comparison to 6 Fr manual technique and early ambulation. Cathet Cardiovasc Interv 2001;52:393–398. 11. Silber S. 10 years of arterial closure devices: a critical analysis of their use after PTCA (in German). Z Kardiol 2000;89:383–389. 12. Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989;16:3–7. 13. Mehta H, Chatterjee T, Windecker S, Eberli FR, Fleisch M, Seiler C, Hess OM, Meier B. Four French catheters for diagnostic coronary angiography. Cathet Cardiovasc Intervent 2003;58:275–280. 14. Dangas G, Mehran R, Kokolis S, Feldman D, Satler LF, Pichard AD, Kent KM, Lansky AJ, Stone GW, Leon MB. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001;38:638 –641. 15. Krause P, Klein L. Utility of a percutaneous collagen hemostasis device: to plug or not to plug. J Am Coll Cardiol 1993;22:1280 –1282.
BRIEF REPORTS
97
he effectiveness and safety of manual hemostasis with 2 hours of bedrest after coronary angiography T using 6Fr catheters has been reported. The Syvek1,2
Patch (Marine Polymer Technologies, Danvers, Massachusetts) is an external device that facilitates hemostasis after percutaneous arterial access for invasive procedures. The patch contains poly-N-acetyl glucosamine, a polysaccharide polymer produced by marine microalgae, which activates plasma clotting proteins and platelets as well as induces vasoconstriction via the release of endothelin-1.3,4 Nader et al5 reported their clinical experience in 636 diagnostic procedures using 4Fr to 6Fr catheters with 1.4% minor complications after hemostasis facilitated by a SyvekPatch, followed by their standard operating protocol for bedrest. We present the results of a similar protocol, but with 1 hour of bedrest after angiography using 6Fr catheters. This protocol may have value in managing patients undergoing coronary angiography, where successful outcomes, patient satisfaction, and potential improved catheterization laboratory efficiency are priorities. •••
During the study period, 764 patients qualified for outpatient coronary angiography based on current guidelines published by the American College of Cardiology and the Society for Cardiac Angiography and Interventions.6 From this cohort, 200 low-risk patients were assigned 1 hour of bedrest, whereas the remaining patients were assigned bedrest periods of 2 to 4 hours at the physician’s discretion. Those assigned to From the Department of Medicine (Division of Cardiology), Scott & White Hospital and Clinic, Temple, Texas; and The Texas A & M University System Health Science Center College of Medicine, College Station, Texas. Dr. Gantt’s address is: Division of Cardiology, Scott & White Clinic, 2401 South 31st Street, Temple, Texas 76508. E-mail: [email protected]. Manuscript received June 30, 2003; revised manuscript received and accepted August 28, 2003.
96
©2003 by Excerpta Medica, Inc. All rights reserved. The American Journal of Cardiology Vol. 93 January 1, 2004
longer periods of bedrest generally had ⱖ1 of the following risk factors: multiple needle punctures of the artery, severe obesity, significant hypertension, peripheral vascular disease, increased age, or continued need for anticoagulants. After 1 hour of supine bedrest in the study group, the arterial access site was inspected and patients were encouraged to walk for an additional hour. All patients were evaluated for an adverse event before dismissal and were contacted by telephone 24 to 72 hours after discharge for evaluation of late events. Major adverse events were defined as rebleeding or hematoma requiring surgical intervention, pseudoaneurysm, retroperitoneal hematoma, arteriovenous fistula, arterial or venous thrombosis, infection, or the need for blood transfusion. Minor adverse events were defined as rebleeding or hematoma requiring additional compression or bedrest. The study population’s characteristics are listed in Table 1. Continuous variables are presented as mean ⫾ SD. Major and minor event rates are reported with 95% confidence intervals (CI). None of the 200 patients experienced a major adverse event (95% CI 0% to 1.5%); 2% of patients (95% CI 0.5% to 5.0%) had minor adverse events. In the 4 patients with minor adverse events, 2 occurred during bedrest and 2 with ambulation. All patients with minor adverse events were managed successfully with additional manual compression and extra bedrest of 1 to 2 hours. Patients without adverse events (98% of the study group) were discharged within 3 hours of completing angiography. Patients with minor adverse events were dismissed within 5 hours of the procedure. In the 564 patients excluded from the study protocol, 6 had a minor adverse event, 1 had retroperitoneal hemorrhage with a 3-g decrease in hemoglobin, and 1 developed a pseudoaneurysm. No patient required blood transfusion. •••
The incidence of access site complications is low after coronary angiography using manual compression of the arterial access site and bedrest of 4 to 6 hours.1,2,7–9 In an environment with increasing costs and decreasing reimbursements, the safe and efficient management of patients after outpatient coronary angiography is important. A method for decreasing bedrest time, thereby improving patient satisfaction and laboratory efficiency without increasing complications, would be ideal. Shorter bedrest periods have been achieved using smaller caliber catheters, radial artery access methods, and arterial closure devic0002-9149/04/$–see front matter doi:10.1016/j.amjcard.2003.08.077
TABLE 1 Patient Characteristics (n ⫽ 200) Variable Age (yrs) (range) Men Mean body mass index (kg/m2) (range) WHO classification (kg/m2) Normal range (18.5–24.9) Grade 1, overweight (25–29.9) Grade 2, overweight (30–39.9) Grade 3, overweight (⬎40) Creatinine (mg/dl) Systolic blood pressure (mm/Hg) (range) Diastolic blood pressure (mm/Hg) (range) Heparin (1,500–3,000 U intravenous bolus) Antiplatelets Aspirin Clopidogrel
61 ⫾ 12 (34–84) 104 (52%) 30 ⫾ 6 (19–54) 46 66 74 14 1.3 125 69 105
(23%) (33%) (37%) (7%) ⫾ 1.5 ⫾ 15 (92–168) ⫾ 10 (45, 99) (53%)
142 (71%) 3 (1%)
Values are expressed as mean ⫾ SD or number (%). WHO ⫽ World Health Organization.
es.10 –12 Visualization of the coronary anatomy is sometimes inadequate with small-caliber catheters and the radial artery method is not frequently used.13 Arterial closure devices can dramatically shorten bedrest time, but have a small incidence of unique and serious complications.14 This study demonstrates a protocol using 6Fr catheters for satisfactory coronary visualization, with a low occurrence of access site complications and shortened bedrest time. Compared with arterial closure devices that cost between $200 and $300, the SyvekPatch costs approximately $60. Although cost was not measured in this study, implementation of this protocol may increase the potential number of outpatient procedures completed in a standard workday. Patient satisfaction is improved with shorter periods of bedrest. Our study has several limitations. Patient assignment to 1 hour of bedrest was at the discretion of the physician and thus subject to bias. Based on the judgment of the operator, patients with multiple needle punctures of the artery, severe obesity, significant hypertension, peripheral vascular disease, increased age, or the need for continued use of anticoagulants were frequently excluded from this protocol and managed with longer periods of bedrest. This was a retro-
spective analysis of a small selected group. However, a randomized trial to demonstrate improved cost effectiveness or a significant reduction in vascular complications would require a study population in excess of 2,600 patients in a similar clinical setting.15 Further trials with a larger patient population are recommended. Acknowledgment: We acknowledge the dedication, professionalism, and hard work of our cardiac catheterization laboratory nurses, technicians, and secretaries, without whom this study would not have been possible.
1. Baum RA, Gantt DS. Safety of decreasing bedrest after coronary angiography. Cathet Cardiovasc Diagn 1996;39:230 –233. 2. Logemann T, Luetmer P, Kaliebe J, Olson K, Murdock DK. Two versus six hours of bedrest following left-sided cardiac catheterization and a meta-analysis of early ambulation trials. Am J Cardiol 1999;84:486 –488. 3. Cole DJ, Connolly RJ, Chan MW, Schwaitzberg SD, Byrne TK, Adams DB, Baron PL, O’Brien PH, Metcalf JS, Demcheva M, Vournakis J. A pilot study evaluating the efficacy of a fully acetylated poly-N-acetyl glucosamine membrane formulation as a topical hemostatic agent. Surgery 1999;126:510 –517. 4. Ikeda Y, Young LH, Vournakis JN, Lefer AM. Vascular effects of poly-Nacetylglucosamine in isolated rat aortic rings. J Surg Res 2002;102:215–220. 5. Nader RG, Garcia JC, Drushal K, Pesek T. Clinical evaluation of SyvekPatch in patients undergoing interventional, EPS and diagnostic cardiac catheterization procedures. J Invasive Cardiol 2002;14:305–307. 6. Bashore TM, Bates ER, Kern MJ, Berger PB, Laskey WK, Clark DA, O’Laughlin MP, Cusma JT, Oesterle S, Dehmer GJ, Popma JJ. American College of Cardiology/Society for Cardiac Angiography and Interventions clinical expert consensus document on cardiac catheterization laboratory standards. A report of the American College of Cardiology task force on clinical expert consensus documents. J Am Coll Cardiol 2001;37:2170 –2214. 7. Barkman A, Lunse C. The effect of early ambulation on patient comfort and delayed bleeding after cardiac angiogram: a pilot study. Heart Lung 1994;23: 112–117. 8. Keeling A, Taylor V, Nordt LA, Powers E, Fisher C. Reducing time in bed after cardiac catheterization (TIBS II). Am J Crit Care 1996;5:277–281. 9. Vlasic W, Almond D. Research-based practice: reducing bedrest following cardiac catheterization. Can J Cardiovasc Nurs 1999;10:19 –22. 10. Khoukaz S, Kern MJ, Bitar SR, Azrak E, Eisenhauer M, Wolford T, El-Shafei A. Coronary angiography using 4 Fr catheters with Acisted power injection: a randomized comparison to 6 Fr manual technique and early ambulation. Cathet Cardiovasc Interv 2001;52:393–398. 11. Silber S. 10 years of arterial closure devices: a critical analysis of their use after PTCA (in German). Z Kardiol 2000;89:383–389. 12. Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989;16:3–7. 13. Mehta H, Chatterjee T, Windecker S, Eberli FR, Fleisch M, Seiler C, Hess OM, Meier B. Four French catheters for diagnostic coronary angiography. Cathet Cardiovasc Intervent 2003;58:275–280. 14. Dangas G, Mehran R, Kokolis S, Feldman D, Satler LF, Pichard AD, Kent KM, Lansky AJ, Stone GW, Leon MB. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001;38:638 –641. 15. Krause P, Klein L. Utility of a percutaneous collagen hemostasis device: to plug or not to plug. J Am Coll Cardiol 1993;22:1280 –1282.
BRIEF REPORTS
97