DETERMINING BEST PRACTICE: REMOVAL OF FEMORAL ARTERIAL SHEATHS. Sarah Ashley Ford. Bachelor of Science Wofford College, May 2002

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1 DETERMINING BEST PRACTICE: REMOVAL OF FEMORAL ARTERIAL SHEATHS By Sarah Ashley Ford Bachelor of Science Wofford College, May 2002 Bachelor of Science University of South Carolina, May 2005 Submitted in Partial Fulfillment of the Requirements For the Degree of Doctor of Nursing Practice in Nursing Science College of Nursing University of South Carolina 2008 Accepted by: JoAnne Herman, PhD, RN, Chairman Stephanie Burgess, PhD, APRN-BC, FNP, Committee Member James Buggy, PhD, Dean of the Graduate School

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3 Acknowledgements I would like to thank JoAnne Herman, PhD for her guidance throughout this project as well as through the program. Thanks for your encouragement and understanding. I would also like to thank Dr. Stephanie Burgess for believing in me and pushing me to be a better student. ii

4 Abstract Percutaneous coronary intervention (PCI) is a key clinical tool for assessing and accessing the vasculature of the heart. In the United States over 1,000,000 PCIs take place yearly. PCI requires the insertion of a femoral artery sheath to gain access to the vasculature of the heart. On completion of the procedure, the femoral arterial sheath is removed. Physicians, nurses, and specially trained individuals can remove femoral artery sheaths. Many methods are employed to remove these sheaths including manual compression of the femoral artery, mechanical compression of the femoral artery, and vascular closure devices. An extensive literature search was completed to determine the best method of femoral arterial sheath removal. Outcomes that were analyzed were time to hemostasis, time to ambulation, and the rate of vascular complications. Based on the literature, vascular closure devices are the preferred method to remove femoral arterial sheaths. VCDs have the same rate of vascular complications as other methods and allow the patient to ambulate early. Based on these findings, a guideline was developed to guide practice. iii

5 Table of Contents Page Title Page... i Acknowledgements... ii Abstract... iii Chapter I. Introduction... 1 Background and Significance of the Problem...1 Manual Compression....2 Mechanical Compression...2 Vascular Closure Devices Complications....6 Purpose...8 Search Process...9 Summary...9 II. Analysis of the Literature Method of Literature Analysis...10 Analysis Conclusions III. Guideline for Femoral Arterial Sheath Removal iv

6 IV. Conclusions and Recommendations References Appendices A: Levels of Evidence B: Grades of Evidence C: Table of Evidence v

7 Chapter I: Introduction The purpose of Chapter I is to present the clinical problem and discuss the background and significance of the problem. During the discussion of the background, the different methods of femoral arterial sheath removal will be introduced. Complications that occur during and post femoral arterial sheath removal will also be discussed. PICO definitions will be outlined. The PICO question will be developed and then used to guide the search process. Background and Significance of the Problem Percutaneous coronary intervention (PCI) is a key clinical tool for assessing and accessing the vasculature of the heart. In the United States over 1,000,000 percutaneous coronary interventions take place yearly (Baim & Grossman, 2005; Chlan, Sabo, & Savik, 2005; Smith et al., 2006). PCI is a group of technologies that encompass balloon angioplasty, percutaneous transluminal coronary angioplasty, and coronary stent placement (Smith et al.). PCI requires the insertion of a femoral artery sheath to gain access to the vasculature of the heart. The sheath also provides support to the femoral artery during catheter exchanges. On completion of the procedure, the femoral arterial sheath is removed (Chlan, Sabo, & Savik; Jones & McCutcheon, 2003; Smith et al.). Physicians, nurses, and specially trained individuals can remove femoral artery sheaths (Axelberg & Mayer, 2000; Benson et al., 2005). The removal of femoral arterial sheaths has become a routine part of nursing care (Benson et al.; Capasso, Codner, Nuzzo- Meuller, Cox, & Bouvier, 2006; Chlan, Sabo, & Savik). 1

8 Many devices have been developed to aid in the discontinuation of the femoral arterial sheath and to reduce the incidence of complications. Complications that have occurred post sheath removal include formation of retroperitoneal bleeding, hematoma, pseudoaneurysm, arteriovenous fistula, thrombosis, infection, and vessel occlusion (Baim & Grossman, 2005; Chlan, Sabo, & Savik, 2005). Complications related to the removal of the arterial sheath occur at rates from 11% to 65% (Axelberg & Mayer, 2000; Balzer et al., 2007; Chlan, Sabo, & Savik; Jones & McCutcheon,2003). Manual compression. Manual compression at the femoral artery during removal is considered to be the gold standard for femoral arterial sheath removal (Axelberg & Mayer, 2000). The femoral artery is compressed with two or three fingers until hemostasis is obtained. Continuous direct pressure is required for fifteen to sixty minutes without obscuring distal pulses (Axelberg & Mayer; Dressler & Dressler, 2006; Shoulders-Odom, 2008; Walker, Cleary, & Higgins, 2001). The patient must remain in bed, supine for two to six hours post hemostasis. Hand and arm fatigue is a disadvantage of the manual compression technique (Axelberg & Mayer; Walker, Cleary, & Higgins). Advantages of manual compression include low cost and no specialized equipment (Walker, Cleary, & Higgins). Mechanical compression. Mechanical compression employs several different mechanisms to apply pressure on the artery to obtain hemostasis. These devices use the patient s pelvis as leverage. The FemStop device uses a small pneumatic pressure dome, a belt and a pump. The CompressAR system and QuicKlamp employ a C-clamp compression device (Benson et al., 2005; Dressler & Dressler, 2006; Jones & McCutcheon, 2003; Schickel et al., 2001). The C-clamp device consists of a hand 2

9 adjustable clamp that applies pressure to the artery. A transparent sterile disc is applied over the femoral artery puncture site until hemostasis is obtained (Schickel et al.; Walker, Cleary, & Higgins, 2001). After hemostasis is attained a pressure dressing is applied over the site. The advantages of mechanical compression devices are hands-free operation, decreased contact with blood, and controlled pressure. The disadvantages are that mechanical compression devices cannot be used on those patients who are obese, have severe peripheral vascular disease or femoral artery or femoral venous grafts (Shoulders- Odom, 2008). Vascular closure device. Vascular closure devices are an alternative to manual and mechanical compression to achieve hemostasis after PCI. Vascular closure devices can be categorized based on the mechanism of hemostasis, which includes collagen and collagen-like plugs, sutures, staples, and patches. Vascular closure devices are inserted by physicians immediately following the PCI procedure (Leeper, 2004). Collagen induces platelet aggregation and the release of coagulation factors which results in the formation of a clot. The collagen is degradable and is absorbed by granulocytes and macrophages (Axelberg & Mayer, 2000; Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005). VasoSeal, Angio-Seal, Duett, QuickSeal, and Sealgel are examples of collagen/collagen like vascular closure devices. VasoSeal delivers absorbable bovine collagen onto the external surface of the artery. Delivery is mediated through a pre-loaded syringe-like system. Trained physicians, nurses, and technicians have the ability to deploy the syringe. After deployment, gentle pressure is required until hemostasis is obtained. Once hemostasis is obtained, a sterile dressing is applied directly to the puncture site. The patients must 3

10 remain on bed-rest for 60 minutes (Axelberg & Mayer, 2000; Hamner, Dubois, & Rice, 2005; Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005; Schickel et al., 2001). Angio-Seal consists of three components: a small anchor, a bovine collagen sponge, and an absorbable suture. A sheath delivery system delivers the anchor to the interior wall of the artery. The suture is then used to pull the anchor and the collagen sponge together creating a seal (Axelberg & Mayer, 2000; Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005; Rastan et al., 2008). This device is deployed by a trained physician (Lasic, Nikolsky, Kesanakurthy, & Dangas). Duett is another sealing device that employs a procoagulant mixture of collagen and thrombin to achieve hemostasis. The Duett device is threaded into the sheath and a balloon is inflated. After the balloon is against the artery wall, the procoagulant mixture is delivered onto the extravascular surface of the artery to seal the puncture site (Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005). QuickSeal is a closure device that delivers a porcine gelatin sponge directly over the guidewire. This allows for extravascular closure of the artery (Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005). Sealgel is a fast-acting defibrinogenating agent that is administered at the arterial puncture site. Manual pressure is required for 10 minutes or more until hemostasis is obtained. Bed rest is recommended for twelve hours post procedure (Lefebvre et al., 2001). Perclose, X-SITE, and SuperStitch are examples of suture mediated vascular closure devices. The first suture-mediated device was Perclose. Perclose requires several steps to obtain hemostasis. First the introducer sheath is replaced by the Perclose device. Each Perclose device consists of three components: the closer, the cincher, and a knot 4

11 pusher. When the needle ports are located just within the lumen of the artery, the needles are deployed so that they are positioned within the lumen of the artery. The needles pass through the vessel wall and are collected by a barrel located in the shaft of the device outside of the artery wall. The barrel guides the needles and the sutures to the surface so that the ends of the suture can be retrieved. The sutures are then tied in a slipknot and pulled down tightly to close the puncture (Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005). X-SITE and SuperStitch work in a similar manner to the Perclose vascular closure device. The X-SITE consists of a suture attached to two needles and a knot pusher. The SuperStitich applies one non-absorbable suture to achieve closure (Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005). EVS Vascular Closure System and StarClose are staple mediated devices. The EVS Vascular Closure System is inserted through the delivery sheath to the puncture site. The trigger is activated and the staple expands to close the tissue of the vessel (Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005). The StarClose device closes the vessel with a star-shaped clip that is positioned against the wall of the artery. The clip is positioned against the wall of the artery at the puncture site and grasps the arterial tissue (Rastan et al., 2008). TheraSeal, Syvek Patch, Clo-Sur PAD, and D-Stat Dry are the final category of vascular closure devices. TheraSeal is a noninvasive technique to seal the puncture site. Ultrasound energy is applied and seals the puncture site through acoustic hemostasis (Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005). The Syvek Patch is also a noninvasive method of vascular closure. This is a sterile nonwoven pad of cellulosic polymer and 5

12 poly-n-acetyl glucosamine. The pad promotes vasoconstriction and local clot formation (Lasic, Nikolsky, Kesanakurthy, & Dangas). The Clo-Sur PAD is a soft wound dressing consisting of hydrophilic biopolymer polyprolate acetate. This device is positively charged and obtains hemostasis through electrical interference between erythrocytes (Balzer et al., 2007; Mlekusch, Dick, Haumer, Sabeti, 2006). D-Stat Dry is a wound dressing that is impregnated with thrombin. When the dressing is applied to the vascular access site, thrombin is released from the dressing causing the formation of a clot thus obtaining hemostasis. Manual pressure is required to achieve hemostasis with this method (Rastan et al., 2008). Complications Associated with Femoral Arterial Sheath Removal PCI has several associated complications. Complications include oozing, ecchymosis, hematoma, retroperitoneal hematoma, arterial occlusion, pseudoaneurysm, arteriovenous fistula, and infection (Dressler & Dressler, 2006; Lins, Guffey, VanRiper, & Kline-Rogers, 2006; Shoulders-Odom, 2008). Risk factors contributing to the development of vascular complications are advanced age, female gender, and a low body weight or obesity. Other factors that contribute to risk are comorbidities, certain medications, and procedural complications (Lins, Guffey, VanRiper, & Kline-Rogers). Oozing and ecchymosis are considered minor complications post PCI. Oozing can be resolved through continued manual pressure until the oozing has subsided. Ecchymosis is a common complication and is accompanied by pain and minor swelling. During the first twenty-four hours after the procedure, a warm compress may be applied 6

13 to the site to ease discomfort (Dressler & Dressler, 2006; Lins, Guffey, VanRiper, & Kline-Rogers, 2006; Shoulders-Odom, 2008). A hematoma is a collection of blood in the soft tissue and is identified by local swelling, hardness, and pain. Management of hematomas requires pressure to the groin, bed rest, and careful monitoring. A retroperitoneal hematoma is a major complication. This type of hematoma is characterized by back, flank or abdominal pain; hypotension; and a drop in hematocrit. Management of retroperitoneal hematomas is hydration, transfusion, and bed rest. This complication can be fatal if not recognized early (Dressler & Dressler, 2006; Lins, Guffey, VanRiper, & Kline-Rogers, 2006; Shoulders-Odom, 2008). Arterial occlusion occurs when a clot forms in the femoral artery. Symptoms of arterial occlusion are diminished pulse in the affected limb, pain, coolness, pallor, and paresthesia (Dressler & Dressler, 2006; Lins, Guffey, VanRiper, & Kline-Rogers, 2006; Shoulders-Odom, 2008). Pseudoaneurysm is a localized dissection or tear in the inner wall of the artery. Symptoms are a large painful hematoma at the site of access, a pulsatile mass, and a bruit or thrill in the groin. Treatment involves surgical repair, ultra-sound guided compression or ultrasound-guided thrombin injection (Dressler & Dressler, 2006; Lins, Guffey, VanRiper, & Kline-Rogers, 2006; Shoulders-Odom, 2008). Arteriovenous fistula is a direct communication between an artery and a vein and is characterized by a continuous bruit, swollen extremity, and claudication. Ultrasound is used to confirm diagnosis and treatment can include ultrasound-guided compression, 7

14 surgical repair or implantation of a stent (Dressler & Dressler, 2006; Lins, Guffey, VanRiper, & Kline-Rogers, 2006; Shoulders-Odom, 2008). Infection may occur at the groin site. Signs and symptoms of infection are redness, warmth, discomfort, and drainage. The incidence of infection is 1.5% (Dressler & Dressler, 2006; Shoulders-Odom, 2008). Ambiguity exists in determining which method of arterial sheath removal is the most effective. Inadequate hemostasis leads to vascular complications. Vascular complications may be costly, increase hospital time, and increase patient discomfort. The most effective method of femoral arterial sheath removal is one that decreases time to hemostasis, decreases bed-rest, decreases the rate of vascular complications, and decreases the amount of time the nurse must spend to obtain hemostasis. By finding the most effective method of femoral arterial sheath removal, complications can be reduced. This reduction in rates of complication will in turn decrease time of hospital stay, demands on nursing time, and patient discomfort related to prolonged bed-rest. Purpose The purpose of this paper is to analyze and synthesize the current research on femoral arterial sheath removal in adults. The literature was examined to determine if there is enough evidence to develop a practice guideline. Search Process The search process began by using the PICO format. The PICO format includes the following components: patient population, intervention of interest, comparison intervention, and outcome. This format is designed to yield the best and most relevant evidence. (Melynk & Fineout-Overholt, 2005). A question was developed to guide the 8

15 search process. The patient population of interest is adults undergoing PCI for diagnostic or interventional purposes. This also included adults who had femoral arterial sheaths for neuroradiological interventionsl. The intervention of interest is manual compression following femoral arterial sheath removal. Comparison interventions are mechanical compression and vascular closure devices. The outcome of interest is the best method of femoral arterial sheath removal. Best method is determined by the rate at which vascular complications occur, time to hemostasis (minutes), and time to ambulation (hours) with each method of femoral arterial sheath removal. The question was answered using published studies from several databases. Databases searched included MEDLINE, CINAHL Plus, Science Direct, EJS E-Journals, ProQuest Nursing and Allied Health Source, and Cochrane. These databases were chosen for the ability to retrieve full text. The PICO components were used in the subject headings to help guide the search. Studies over ten years old were not used. Summary PCI is a frequently used technology that permits the examination of the vasculature of the heart. The femoral artery is punctured with an introducer sheath to access the heart. Many methods of femoral arterial sheath removal exist. This paper was designed to create a practice guideline based on the best available evidence to help clinicians remove femoral arterial sheaths with the fewest complications. 9

16 Chapter II: Analysis of the Literature The purpose of Chapter II is to discuss the literature search. Inclusion and exclusion criteria will be outlined. The evidence will be placed into a table of evidence. Using the Scottish Collegiate Guidelines Network (SIGN), the literature will be analyzed for level of evidence and then graded. Analysis of the Literature The literature search was conducted from June 2008 through October Twenty-six articles were obtained through the search of the literature. Databases searched were MEDLINE, CINAHL Plus, Science Direct, EJS E-Journals, ProQuest Nursing & Allied Health Source, and Cochrane. Relevant articles were identified using the keywords percutaneous coronary intervention, sheath, and arterial sheath removal. Current literature lacks large-scale randomized clinical trials; therefore, experimental, quasi-experimental, and observational studies were included. Inclusion criteria included studies that were published within the last 10 years and were peer-reviewed. Exclusion criteria were studies that were published before 1999, not peer-reviewed, and articles that were not studies. Ten articles were rejected based on these criteria. 10

17 Method of Literature Analysis The Scottish Intercollegiate Guidelines Network (SIGN) is a network dedicated to improving the quality of health by developing and disseminating evidence-based guidelines. SIGN developed a system of determining levels of evidence (Appendix A) and grades of recommendations (Appendix B) for evidence based clinical guidelines. Reviews of all types of evidence were evaluated using the rating system from SIGN. The studies were placed into a table of evidence (Appendix C) for review and were assessed for quality and relevance. Grades were assigned based on the levels of evidence. Recommendations were then based on the strength of the evidence. Analysis Several methods are employed to obtain hemostasis, decrease time to ambulation, and decrease vascular complications following femoral arterial sheath removal. Ambiguity exists in which method is the most effective. The literature was reviewed and analyzed to determine which of these methods was the most effective and was; therefore, the best method. Manual Compression versus Mechanical Compression Manual compression is the gold standard for femoral arterial sheath removal. In the review of the literature, manual compression was often the control and mechanical compression was the intervention. The mechanical devices in these studies were FemStop, CompressAr, and QuicKlamp. Walker, Cleary and Higgins (2001) compared the FemStop device to manual pressure. Participants were placed in each group randomly and the outcome measured 11

18 was the incidence of vascular complications following the removal of the femoral arterial sheath. Time to hemostasis in minutes was the second outcome measured. To reduce bias, twelve nurses in the cardiac catheter laboratory experienced in sheath removal and assessment of the groin for complications were trained to use the observation form. The training was also done to enhance interrater reliability. Based on the study design, sample size, and methods, the level of evidence was determined to be 1-. In comparing FemoStop to manual compression, Walker, Cleary, and Higgins (2001) found that with the FemStop device the time to hemostasis was significantly longer than in the manual compression group (p-value= <0.001). Of the 274 participants, those in the FemStop device group had a higher incidence of hematoma formation. In this study, hematoma was defined as an accumulation of blood measuring greater than 2 cm wide. Similarly, Simon, Bumgarner, Clark, and Israel (1998) compared manual compression to the CompressAr device. A quasi-experimental design was used and consisted of a convenience sample of 998 patients. Outcomes measured were time to hemostasis and the incidence of vascular complications. Based on the study design, sample size, and methods, the level of evidence was determined to be 2+. Mean time to hemostasis was three minutes longer for the mechanical compression group (17.13 min) compared to the manual group (14.93 min). Both the manual compression group (3%) and the mechanical compression group (2%) had low incidence of vascular complications. The development of hematomas between the two groups was not statistically significant. Hematoma was defined as a palpable raised mass of blood greater 12

19 than 7.6 cm. Time to ambulation was not measured and was the same for the control group and for the intervention group. Mean time to ambulation was 4.8 +/- 2.1 hours. Juran et al. (1999) completed the SANDBAG (Standards of Angioplasty Nursing Techniques to Diminish Bleeding Around the Groin). This study was extensive with a sample size of 4010 and was a descriptive, correlational study. The results of this study were that the most significant factor to decrease vascular complications was to remove the sheath early, the type of pressure mechanism to achieve hemostasis, and the person and method to remove the sheath. No significant differences were found among two mechanical compression devices and manual compression. Based on the study design, sample size, and methods, the level of evidence was determined to be 2+. QuicKlamp, a mechanical device, has been shown to take longer to obtain hemostasis than manual compression, p-value=0.000 (Jones & McCutcheon, 2003).The mean time to hemostasis in the control group was 15 minutes compared to 29 minutes for the QuicKlamp group. In a randomized controlled trial, Jones and McCutcheon found that there was a significantly higher incidence in hematoma following manual compression than in mechanical compression, p-value= The time to ambulation was longer in those participants who received the intervention (median duration= 4 hours and 20 minutes) than those who had manual compression (median duration= 4 hours), p- value=0.001). Based on the study design, sample size, and methods, the level of evidence was determined to be 1-. Benson et al. (2005) and Chlan, Sabo, & Savik (2005) compared two mechanical compression devices (CompressAr and FemStop) to manual compression. In both of these studies manual compression resulted in the quickest time to hemostasis and fewer 13

20 vascular complications. Benson et al. (2005) found that with the mechanical compression devices a higher incidence of vascular complications occurred. Minor complications that occurred in both studies related to mechanical compression included hematoma, rebleeding, and ecchymosis. Both of these studies followed an experimental design. Benson et al. (2005) had a sample size of ninety participants who were randomly assigned to undergo one of the three methods of sheath removal. The independent variable was the method of sheath removal and dependent variable was vascular complications. To reduce variability in sheath removal, seven Registered Nurses removed all of the sheaths. Each of these nurses reviewed the procedures for sheath removal prior to the initiation of the study. The data collection tool was tested for content validity and interrater reliability prior to the study. Based on the study design, sample size, and methods, the level of evidence was determined to be 2+. Chlan, Sabo, and Savik (2005) randomly assigned 306 patients to receive the following interventions: FemStop, C-clamp, or manual compression. Outcomes measured by this study were perception of pain/discomfort prior to, during, and after compression and, time to hemostasis, and the incidence of vascular complications. A select group of nurses were trained to be involved in the study. The training included an education session, demonstration, and the nurses were then required to demonstrate their skills. Based on the study design, sample size, and methods, the level of evidence was determined to be 2+. In summary, all of these studies determined that manual compression is still the gold standard for obtaining hemostasis. Mechanical compression methods take longer 14

21 to reach hemostasis and have a higher rate of vascular complications. In most studies these differences were noted but were not always found to be statistically significant. Manual/Mechanical Compression versus Vascular Closure Devices Vascular closure devices were developed to decrease the amount of time to achieve hemostasis but as with all new products and technology the questions posed are Is this device safe? And Is this device effective?. Tron et al. (2003) compared the Perclose device, a suture-mediated vascular closure device, to manual compression. The sample size of 167 was randomized to have the intervention, Perclose, or manual compression of the femoral artery. Outcomes measured were mean time to hemostasis in minutes, incidence of vascular complications, and the post procedure length of stay in hours. Based on the study design, sample size, and methods, the level of evidence was determined to be 1-. In this study Tron et al. (2003) found that Perclose achieved hemostasis much faster than manual compression. Although hemostasis was achieved quickly with the Perclose device, the success rate was 93% compared to a success rate of 100% for manual compression. No statistically significant difference was found in the occurrence of vascular complications between the two methods. Also, no significant difference was detected in the length of hospital stay for the sample population between the two methods. Lefebvre et al. (2001) compared Sealgel, a collagen-based vascular closure device, to manual compression. The sample size consisted of 50 participants who underwent PCI or the coronary arteries. Outcomes measured were time to hemostasis in minutes and vascular complications. Based on the study design, sample size, and 15

22 methods, the level of evidence was determined to be 2-. Lefebvre et al. found that hemostasis was obtained at a faster rate with Sealgel. The vascular complication rate for Sealgel was 4% and was successfully delivered 98% of the time. When compared to mechlanical compression, Schickel, Adkisson, Miracle, and Cronin (1999) found that VasoSeal, a collagen plug device, resulted in a decreased time to hemostasis. Schickel, Adkisson, Miracle, and Cronin used a non-randomized, comparative design with a sample size of 176. Outcomes that were tracked were hemostasis time, ambulation time, discharge date and time, and vascular complications. The time to hemostasis is measured in minutes and in this study hemostasis was 5.6 minutes for the VasoSeal method and 29.2 minutes for the mechanical compression. Time to ambulation was significantly different between the groups. Those patients who received the VasoSeal closure device were able to ambulate after 1 hour; mean time to ambulation was 2.17 hours. The mean time to ambulation for the mechanical compression intervention was 4.75 hours, p-value= Another finding of this study was a much lower rate of complications in those patients who received the collagen plug, VasoSeal. The rate at which complications occurred for the mechanical compression intervention was 5.3% compared to 0% for the VasoSeal. Based on the study design, sample size, and methods the level of evidence was determined to be 2-. A prospective study was conducted by Peirot, Herbreteau, Bracard, Berge, and Cognard (2005) to assess the effect of using an arteriotomy closure device, Angio-Seal. The total number of participants was 119 and outcomes measured were time to hemostasis and incidence of complications. Out of the 119 subjects only two had a vascular complication. Neither subject required additional treatment. Sheaths were 16

23 withdrawn two minutes after completion of the procedure and in three patients additional manual compression was required to obtain hemostasis. The conclusion of this study is that Angio-Seal is safe to use. Based on the study design, sample size, and methods, the level of evidence was determined to be 2-. Rastan et al. (2008) evaluated three closure methods using a prospective, randomized study design. The three interventions were a collagen plug device, Angio- Seal, a clip, StarClose, and a wound dressing, D-Stat Dry. The study had a sample-size of 852 patients undergoing PCI. The outcome measured was vascular complication rate. D- Stat Dry was associated with a higher rate of vascular complications when compared to the other methods. There was no significant difference in rates of vascular complications between Angio-Seal and StarClose. Based on the study design, sample size, and methods the, level of evidence was determined to be 1+. Two studies (Balzer et al., 2007 & Mlekusch et al., 2006) compared the Clo-Sur PAD, a hemostatic wound dressing, to manual compression. Balzer et al. conducted a randomized controlled trial with a sample size of 60. The outcomes of interest in this study were time to hemostasis, time to ambulation, and vascular complications. Based on the study design, sample size, and methods, the level of evidence was determined to be 1+. Mlekusch et al. had a sample size of 206. In this randomized controlled trial, puncture-related and device-related complications, time to hemostasis, time to ambulation, and patient and physician discomfort were the outcomes of interest. Based on the study design, sample size, and methods, the level of evidence was determined to be

24 Comparison was made based on time to hemostasis, time to ambulation, and rate of vascular complications. Both studies found no difference in the rate of complications between the Clo-Sur PAD and manual compression. Significant differences were found in the time to hemostasis and the time to ambulation. With Clo-Sur PAD time to hemostasis was measured between 10 and 13 minutes while manual compression was 16 to 20 minutes to hemostasis. Length of bed-rest was 8 to 20 hours for the manual compression method and 2 to 6 hours for the Clo-Sur PAD method (Balzer et al., 2007 & Mlekusch et al., 2006). Nikolsky et al. (2004) conducted a meta-analysis to compare vascular closure devices to manual and mechanical compression methods. Based on the study design, sample size, and methods, the level of evidence was determined to be 1++. This metaanalysis found that the vascular complication rate for vascular closure devices to not be significantly different from conventional compression methods. The only difference was a higher rate of complications after PCI with the VasoSeal when compared to mechanical compression. Vascular closure devices can decrease the amount of time to obtain hemostasis. Lasic, Nikolsky, Kesanakurthy, and Dangas (2005) reviewed all of the vascular closure devices available and conducted a meta-analysis. Based on the study design, sample size, and methods, the level of evidence was determined to be 1+. The results of this metaanalysis did not differ from the meta-analysis done by Nikolsky et al. (2004). Both concluded that vascular closure devices are a safe alternative to manual and mechanical compression. 18

25 In summary, the comparison of vascular closure devices to conventional methods (manual and mechanical compression) found that the differences existed in the time to hemostasis but there was no overwhelming evidence of decreased vascular complications. The advantages of achieving hemostasis quickly are decreased time to ambulation and therefore less time in the direct care of physicians and nurses. Conclusions An analysis of the literature regarding femoral arterial sheath removal methods was carried out. The literature was reviewed between June 2008 and October Efforts were made to obtain all relevant, peer-reviewed articles from the previous ten years. The Scottish Intercollegiate Guidelines Network was consulted for rating the studies (see Appendices A and B) and then each study was placed into a table of evidence (See Appendix C). The practice guideline was then created based on the level of evidence. 19

26 Chapter III: Guideline for Femoral Arterial Sheath Removal The guideline for femoral arterial sheath removal is targeted to health care professionals who are likely to provide care to adults undergoing percutaneous coronary intervention. The guidelines and recommendations are based on meta-analyses, randomized clinical trials, experimental, and observational studies that are peer-reviewed. Vascular closure devices are recommended for femoral arterial sheath removal (Grade-A) The incidence of vascular complications ranges from 1-14% despite which method is used (Lins, Guffey, VanRiper, & Kline-Rogers, 2006). The evidence has shown no change in the rate of vascular complications for vascular closure devices when compared to manual compression. Vascular closure devices are safe and effective (Hamner, Dubois, & Rice, 2005; Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005) and have the added benefit of decreasing the time to hemostasis. As a result of a quicker hemostasis, the patient is able to discontinue bed rest sooner. Ambulation post procedure occurs sooner, and the patient is able to be discharged from the hospital or facility earlier than with manual and mechanical compression. Collagen-based and suture mediated vascular closure devices are the preferred vascular closure devices for femoral arterial sheath removal (Grade-A) Lasic, Nikolsky, Kesanakurthy, and Dangas (2005) and Nikolsky et al. (2004) both recommend collagen-based or suture-mediated closure methods. Collagen-based and suture-mediated closure devices have been available since the early 1990 s and have 20

27 undergone the most reliable testing (Lasic, Nikolsky, Kesanakurthy, & Dangas; Lins, Guffey, VanRiper, & Kline-Rogers, 2006). Collagen-based are favored for their ease of use and simple application. Perclose (suture-mediated device) is recommended when repeat vascular access will be needed in the following ninety days. Perclose allows for immediate access to the artery in the same groin (Lasic, Nikolsky, Kesanakurthy, & Dangas; Nikolsky, et al.; Tron, et al., 2003). VasoSeal, a collagen-based device, was shown to have worse outcomes than AngioSeal. Therefore AngioSeal is the preferred collagen-based vascular closure device (Lasic, Nikolsky, Kesanakurthy, & Dangas; Nikolsky, et al.). Vascular closure devices (VCDs) should not be used when contraindicated (Grade- A) VCDs are contraindicated in patients who are obese, in patients with double wall punctures and in patients who are allergic to any component of the VCD (Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005; Lins, Guffey, VanRiper, & Kline-Rogers, 2006) Schickel, Adkisson, Miracle, and Cronin (1999) state that contraindications for the use of VasoSeal are cases in which femoral sheaths larger than 8F are used; the distance from the skin to the femoral artery is greater than 6.5 cm; and in patients who are allergic to collagen or bovine products. Manual compression of the femoral artery should be used when VCDs are contraindicated (Grade-A) The evidence shows that manual compression is preferable to mechanical compression. Manual compression results in the quickest time to hemostasis and fewer vascular complications. Mechanical compression devices have a higher incidence of 21

28 vascular complications (Benson, et al.., 2005; Jones & McCutcheon, 2003). Walker, Cleary, and Higgins (2001) found that with the FemStop device the time to hemostasis was significantly longer than in the manual compression group (p-value= <0.001). Of the 274 participants, those in the FemStop device group had a higher incidence of hematoma formation. Similarly, Simon, Bumgarner, Clark, and Israel (1998) compared manual compression to the CompressAr device. Mean time to hemostasis was three minutes longer for the mechanical compression group compared to the manual group. Femoral arterial sheaths should be removed as soon as possible following percutaneous coronary intervention (PCI) (Grade-D) A risk factor for vascular complications following PCI is a long sheath-indwelling time (Lins, Guffey, VanRiper, & Kline-Rogers, 2006). This suggests that efforts be made to remove sheaths soon after the PCI is complete. Healthcare providers who remove femoral arterial sheaths should monitor closely for vascular complications following PCI (Grade-B) Complications related to the removal of the arterial sheath occur at rates from 11% to 65% (Axelberg & Mayer, 2000; Balzer et al., 2007; Chlan, Sabo, & Savik, 2005; Jones & McCutcheon, 2003). Vascular complications include oozing, ecchymosis, hematoma, retroperitoneal hematoma, arterial occlusion, pseudoaneurysm, arteriovenous fistula, and infection (Dressler & Dressler, 2006; Lins, Guffey, VanRiper, & Kline- Rogers, 2006; Shoulders-Odom, 2008). Risk factors contributing to the development of vascular complications are advanced age, female sex, and a low body weight or obesity. Other factors that contribute to risk are comorbidities, certain medications, and procedural complications (Lins, Guffey, VanRiper, & Kline-Rogers). 22

29 Complications may necessitate longer stays in the hospital and more complex, invasive procedures. Surgical repair and/or blood transfusions may be required (Lins, Guffey, VanRiper, & Kline-Rogers, 2006). 23

30 Chapter IV: Conclusions and Recommendations Outcome Recommendation Based on Analysis Percutaneous coronary intervention (PCI) is a key clinical tool for assessing and accessing the vasculature of the heart. In the United States over 1,000,000 percutaneous coronary interventions take place yearly (Baim & Grossman, 2005, Chlan, Sabo, & Savik, 2005, Smith, S. et al., 2006). After the PCI procedure is complete, the femoral sheath used to access the vasculature of the heart must be removed. Many devices have been developed to aid in the discontinuation of the femoral arterial sheath and to reduce the incidence of complications. The evidence has not shown a clear difference between the devices based on rates of vascular complications. Vascular closure devices (VCDs) have been distinguished from manual and mechanical compression devices by not having a greater incidence of vascular complications. With the use of VCDs, hemostasis is achieved more quickly than with other methods (Lasic, Nikolsky, Kesanakurthy, & Dangas, 2005; Nikolsky et al.., 2004). By obtaining hemostasis quickly, the amount of time spent on bed-rest is diminished. Decreased bed-rest leads to early patient mobilization and ambulation. Patients may be discharged from the hospital or facility the same day if no vascular complications develop. The advantages of faster hemostasis, discontinuation of bed-rest 24

31 and early mobilization are a decrease in patient discomfort and patient satisfaction (Nikolsky et al.., 2004). Implications of Outcomes and Guideline on Practice Healthcare providers have the obligation of providing the best care possible to their clients. In order to provide the best care, healthcare providers need to read and understand all of the literature available related to their area of expertise. The vast amount of literature available can be overwhelming. Reading all of this literature is a daunting task as well as time-consuming. Practice guidelines are developed on the best and most current literature to guide care. This guideline was developed to collect and analyze the applicable literature regarding femoral arterial sheath removal. By using this guideline, healthcare providers can use valuable time and energy on patient care instead of reading all of the literature. The guideline can also help the healthcare provider use the best method of femoral arterial sheath removal based on individual patients. Implication of Outcome and Guideline for Research Current literature lacks large randomized clinical studies. Much research remains to be done regarding femoral arterial sheath removal in adults. We need to know which method is the most reliable and has the lowest complication rates. Rates of complication for all methods have and incidence of 1-14%. Reducing the rates of complication will improve the safety of PCI. Research regarding the causes of complications and the interventions to decrease complications need to be conducted. As technology improves new vascular closure devices are being developed. Future studies should assess the safety of these new devices as well as the efficacy of these new devices. 25

32 General Recommendations Vascular closure devices are safe and effective in the removal of femoral arterial sheaths. As new devices and as generational advances are made, randomized clinical trials comparing these devices to manual compression need to be performed. If a vascular closure device cannot be used then manual compression is the best method. Tailoring care based on a patient s individual characteristics is also recommended. Summary Healthcare providers can provide the best care to their patients undergoing PCI by following the guideline. Using the guideline will help healthcare providers decrease complications and increase patient satisfaction. In addition to using the guideline, healthcare providers should tailor their interventions based on the individual characteristics. Randomized controlled trials with larger sample sizes need to be performed to strengthen existing evidence and to evaluate new vascular closure devices on the market. 26

33 References Axelberg, A. & Mayer, D. (2000). Arterial closure method: Pull, plug, or close. The American Journal of Nursing, 100(5), Baim, D. & Grossman, W. (2005). Diagnostic cardiac catheterization and angiography. In D. L. Kasper, A. S. Fauci, D. L. Longo, E. Braunwald, S. L. Hauser, & J. L. Jameson (Eds.), Harrison s principles of internal medicine (pp ). New York: McGraw-Hill. Balzer, J., Schwarz, J., Thalhammer, A., Eichler, K., Schmitz-Rixen, T., & Vogl, T. (2007). Postinterventional percutaneous closure of femoral access sites using the Clo-Sur PAD device: Initial findings. European Radiology, 17, Benson, L., Wunderly, D., Perry, B., Kabboord, J., Wenk, T., Birdsall, B., et. al. (2005). Determining best practice: Comparison of three methods of femoral sheath removal after cardiac interventional procedures. Heart & Lung, 34(2), Capasso, V., Codner, C., Nuzzo-Meuller, N., Cox, E., & Bouvier, S. (2006). Peripheral arterial sheath removal program: A performance improvement initiative. Journal of Vascular Nursing, 24(4), Chlan, L., Sabo, J., & Savik, K. (2005). Effects of three groin compression methods on patient discomfort, distress, and vascular complications following a percutaneous coronary intervention procedure. Nursing Research, 54(6),

34 Dressler, D. & Dressler, K. (2006). Caring for patients with femoral sheaths. American Journal of Nursing, 106(5), 64A-64H. Hamner, J., Dubois, E., & Rice, T. (2005). Predictors of complications associated with closure devices after transfemoral percutaneous coronary procedures. Critical Care Nurse, 25(3), Jones, T. & McCutcheon, H. (2003). A randomized controlled trial comparing the use of manual versus mechanical compression to obtain haemostasis following coronary angiography. Intensive and Critical Care Nursing, 19, Juran, N., Rouse, C., Smith, S., O Brien, M., et. al. (1999). Nursing interventions to decrease bleeding at the femoral access site after percutaneous coronary intervention. American Journal of Critical Care, 8(5), Lasic, Z., Nikolsky, E., Kesanakurthy, S., & Dangas, G. (2005). Vascular closure devices: A review of their use after invasive procedures. American Journal of Cardiovascular Drugs, 5(3), Leeper, B. (2004). Nursing outcomes percutaneous coronary interventions. Journal of Cardiovascular Nursing, 19(5), Lefebvre, J., Qanadli, S., Kacher, S., Aberkane, L., Rigaud, M., Lacombe, P., & Rocha, P. (2001). A new vascular sealant (Sealgel) to achieve rapid hemostasis after percutaneous angioplasty in anticoagulated patients: Clinical feasibility and preliminary results. European Radiology, 11(3),

35 Lins, S., Guffey, D., VanRiper, S., & Kline-Rogers, E. (2006). Decreasing vascular complications after percutaneous coronary interventions partnering to improve outcomes. Critical Care Nurse, 26(6), Melnyk, D. & Fineout-Overholt, E. (2005). Evidenced-based practice in nursing & healthcare: A guide to best practice. Philadelphia: Lippincott Williams & Wilkins. Mlekusch, W., Dick, P., Haumer, M., Sabeti, S., et al. (2006). Arterial puncture site management after percutaneous transluminal procedures using a hemostatic wound dressing (Clo-Sur P.A.D.) versus conventional manual compression: A randomized controlled trial. Journal of Endovascular Therapy, 13(1), Nikolsky, E., Mehran, R., Halkin, A., Aymong, E., Mintz, G., Lasic, Z., et al. (2004). Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: A meta-analysis. Journal of the American College of Cardiology, 44(6), Pierot, L., Herbreteau, D., Bracard, S., Berge, J., & Cognard, C. (2006). An evaluation of immediate sheath removal and use of the Angio-Seal vascular closure device in neuroradiological interventions. Neuroradiology, 48(1), Rastan, A., Sixt, S., Schwarzwälder, U., Schwarz, T., Frank, U., Bürgelin, K., et al. (2008). VIPER-2: A prospective, randomized single-center comparison of 2 different closure devices of femoral artery access sites. Journal of Endovascular Therapy, 15(1),

36 Schickel, S., Adkisson, P., Miracle, V., Cronin, S. et al. (1999). Achieving femoral artery hemostasis after cardiac catheterization: A comparison of methods. American Journal of Critical Care, 8(6), Schiks, I., Schoonhoven, L., Vergeugt, F., Aengevaeren, W., & Acterberg, T. (2007). Performance evaluation of arterial femoral sheath removal by registered nurses after PCI. European Journal of Cardiovascular Nursing, 6(3), Shoulders-Odom, B. (2008). Management of patients after percutaneous coronary interventions. Critical Care Nurse, 28(5), Simon, A., Bumgarner, S., Clark, K., & Israel, S. (1998). Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization. American Journal of Critical Care, 7(4), Smith, S., Feldman, T., Hirshfeld, J., Jacobs, A., Kern, M., King, S., et al. (2006). ACC/AHA/SCAI 2005 guideline update for percutaneous intervention. Cardiology, 113, Tron, C., Koning, R., Eltchaninoff, H., Douillet, R., Chassaing, S., Sanchez-Giron, C., et al. (2003). A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA. Journal of Interventional Cardiology, 16(3), Walker, S., Cleary, S., & Higgins, M. (2001). Comparison of the FemoStop device and manual pressure in reducing groin puncture site complications following coronary angioplasty and coronary stent placement. International Journal of Nursing Practice, 7,

37 Appendix A: Levels of Evidence 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1 Meta-analyses, systematic reviews or RCTs, or RCTs with a high risk of bias 2++ High quality systematic reviews of case-control or cohort studies or High quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal 2+ Well conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal 2 Case-control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal 3 Non-analytic studies, eg case reports, case series 4 Expert opinion 31

38 Appendix B: Grades of Recommendation A B C At least one meta-analysis, systematic review, or RCT rated as 1++ and directly applicable to the target population or A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+ directly applicable to the target population and demonstrating overall consistency of results A body of evidence including studies rated as 2++ directly applicable to the target population and demonstrating overall consistency of results or Extrapolated evidence from studies rated as 1++ or 1+ A body of evidence including studies rated as 2+ directly applicable to the target population and demonstrating overall consistency of results or Extrapolated evidence from studies rated as 2++ D Evidence level 3 or 4 or Extrapolated evidence from studies rated as 2+ 32