Femoral Artery Closure Device Research Articles

Access site complications in thoracic endovascular aortic repair

BackgroundPercutaneous access and use of vascular closure devices facilitate thoracic endovascular aortic repair (TEVAR) procedures during local anesthesia and allow immediate detection of signs of spinal ischemia. However, the very large bore access (usually ≥22F sheath) associated with TEVAR increases the risk of vascular complications. In this study, we sought to define the safety and feasibility of two percutaneous femoral artery closure devices during TEVAR, in terms of access site vascular complications and major, life-threatening, or fatal bleeding (≥major) within 48 hours. Access site vascular complications were defined as technical failure of vascular closure or later formation of pseudoaneurysm. MethodsFrom March 2010 to December 2022, 199 transfemoral TEVAR were performed at Helsinki University Central Hospital, Finland. We retrospectively categorized these into three groups, based on surgeon preference for the access technique and femoral artery closure method: (1) surgical cut-down and vessel closure, n = 85 (42.7%), (2) percutaneous access and vascular closure with suture-based ProGlide, n = 56 (28.1%), or (3) percutaneous access and vascular closure with ultrasound-guided plug-based MANTA, n = 58 (29.1%). The primary outcome measure was technical success of vascular closure and access site vascular complications during index hospitalization. Secondary outcome measures were ≥major bleeding, early mortality, and hospital stay. ResultsThe technical success rate was 97.6% vs 91.1% vs 93.1% for surgical cut-down, ProGlide, and MANTA, respectively (P = .213). The rate of access site vascular complication was 3.5% vs 8.9% vs 10.3%, respectively (P = .290), with two pseudoaneurysms detected postoperatively and conservatively managed in the MANTA group. The vascular closure method was not associated with increased risk of ≥major bleeding, early mortality, or hospital stay on univariate analysis. Predictors for ≥major bleeding after TEVAR in multivariable analysis were urgent procedure (odds ratio: 2.8, 95% confidence interval: 1.4-5.5; P = .003) and simultaneous aortic branch revascularization (odds ratio: 2.7, 95% confidence interval: 1.3-5.4; P = .008). ConclusionsIn this study, the technical success rates of the percutaneous techniques demonstrated their feasibility during TEVAR. However, the number of access site complications for percutaneous techniques was higher compared with open approach, although the difference was not statistically significant. In the lack of evidence, the safety of the new MANTA plug-based vascular closure for TEVAR warrants further investigation.

Femoral Artery Closure Devices vs Manual Compression During Cardiac Catheterization and Percutaneous Coronary Intervention

<h2>Abstract</h2><h3>Background</h3> Femoral arterial access remains widely used despite recent increase in radial access for cardiac catheterization and percutaneous coronary intervention (PCI). Various femoral artery closure devices have been developed and are commonly used to shorten vascular closure times, with variable rates of vascular complications observed in clinical trials. We sought to examine the rates of contemporary outcomes during diagnostic catheterization and PCI with the most common femoral artery closure devices. <h3>Methods</h3> We identified patients who had undergone either diagnostic catheterization alone (<i>n</i> = 14,401) or PCI (<i>n</i> = 11,712) through femoral artery access in the Indiana University Health Multicenter Cardiac Cath registry. We compared outcomes according to closure type: manual compression, Angio-Seal, Perclose, or Mynx. Access complications and bleeding outcomes were measured according to National Cardiovascular Data ​Registry standard definitions. <h3>Results</h3> The use of any vascular closure device as compared to manual femoral arterial access hold was associated with a significant reduction in vascular access complications and bleeding events in patients who underwent PCI. No significant difference in access-site complications was observed for diagnostic catheterization alone. Among closure devices, Perclose and Angio-Seal had a lower rate of hematoma than Mynx. <h3>Conclusions</h3> The use of femoral artery access closure devices is associated with a reduction in vascular access complication rates as compared to manual femoral artery compression in patients who undergo PCI.

Femoral in the Time of Radial

Femoral in the Time of Radial

Vascular Complications Among Patients Undergoing Trans-femoral Transcatheter Aortic Valve Implantation: Prostar vs ProGlide Parallel Technique.

Reliable femoral artery closure devices are essential for the success of trans-femoral Transcatheter Aortic Valve Implantation (TAVI) procedures. Accordingly, device choice might affect vascular complications and bleeding rates. This was a retrospective analysis, comparing vascular complication rates among patients who underwent trans-femoral TAVI with vascular access closure using either the ProGlide parallel suture or Prostar closure devices. We included 191 patients: 106 were treated with Prostar and 85 with ProGlide. The ProGlide group had higher rate of diabetes, chronic kidney disease, peripheral arterial disease, and significantly smaller femoral arteries that were treated via larger sheaths. Valve Academic Research Consortium (VARC)-2 major complications were similar between the groups. (4.7% for ProGlide vs 3.8% for Prostar, P=1), with similar incidence of closure device failure (2 vs 3, P=1). No differences were found after univariant analysis and propensity-score matching in the incidence of major and minor bleeding nor in the rate of in-hospital mortality between ProGlide and Prostar (4.7 vs 2.8%, P=.7, 1.2 vs 2.8%, P=.63, and 1.2 vs .0%, P=.45, respectively). Parallel suture technique using two ProGlide sutures showed comparable rates of vascular complications to the Prostar closure device in higher risk population of TAVI patients.

Contemporary Use and Outcomes of Arterial Closure Devices After Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

BackgroundArterial closure devices reduce the length of bedrest after invasive cardiac procedures via the femoral approach, but there are conflicting data on their association with major bleeding and vascular complications. We thus sought to evaluate the contemporary use of femoral arterial closure devices and their association with major bleeding among patients undergoing percutaneous coronary intervention.Methods and ResultsWe identified patients undergoing percutaneous intervention via the femoral approach within the Veterans Affairs Healthcare System from December 2004 through September 2018. The association between arterial closure device use and major bleeding was evaluated using both propensity matching and instrumental variable analyses, incorporating contrast‐induced nephropathy as a falsification end point. We identified 132 373 percutaneous coronary interventions performed by 681 operators, with closure device use increasing 1.2% each year (linear trend P<0.001). In a propensity‐matched cohort, closure devices were associated with a 1.1% reduction in periprocedural bleeding (95% CI, −1.5% to −0.6%). Closure devices were also associated with a numerical decrease in contrast‐inducted nephropathy that did not reach statistical significance (−0.6%; 95% CI, −1.3% to 0.1%). In an instrumental variable analysis of closure device use, there was no difference in the bleeding rate between those who received a closure device and those who did not (0.2%; 95% CI, −0.9% to 1.2%).ConclusionsArterial closure devices are associated with a reduction in major bleeding within a propensity‐matched cohort. This association dissipates in an instrumental variable analysis, highlighting some of the methodologic limitations of comparative effectiveness research in observational analyses.

Antegrade Common Femoral Artery Closure Device Use Is Safe and Associated With Decreased Complications

Antegrade access (AA) of the common femoral artery is often used for ipsilateral infrainguinal peripheral vascular intervention. However, the use of closure devices (CDs) for AA is still considered outside the instructions for use. We hypothesized that CD use for AA would not be associated with an increased odds of access site complications. The Vascular Quality Initiative was examined from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery AA. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether a CD was used or not. Hierarchical multivariable logistic regressions controlling for hospital-level variation were used to examine the independent association between CD use and access site complications while controlling for confounders meeting < .01 on univariate analyses for the outcome. A sensitivity analysis using coarsened exact matching was performed using factors different between treatment groups to reduce residual confounding. Overall, 11,562 cases were identified, and 5693 (49.2%) used a CD. Patients treated with a CD were less likely to be white (74.1% vs 75.2%), to have coronary artery disease (29.7% vs 33.4%), to use aspirin (68.7% vs 72.4%), and to be reversed with protamine (15.5% vs 25.6%; all P < .05). CD patients were more likely to be obese (31.6% vs 27.0%) and to have an elective operation (82.6% vs 80.1%), ultrasound-guided access (75.5% vs 60.6%), and larger access sheath (6.0F ± 1.0F vs 5.5F ± 1.0F; P < .05 for all). CD cases were less likely to develop any access site hematoma (2.55% vs 3.53%; P < .01) or a hematoma requiring reintervention (0.63% vs 1.26%; P < .01) and had no difference in access site stenosis or occlusion (0.30% vs 0.22%; P = .47) compared with no CD. On multivariable adjusted analysis, CD cases had significantly decreased odds for development of any access site hematoma (odds ratio, 0.75; 95% confidence interval, 0.59-0.95) and a hematoma requiring intervention (odds ratio, 0.56; 95% confidence interval, 0.38-0.81; Table I). A sensitivity analysis after coarsened exact matching confirmed these findings (Table II). In this nationally representative sample, CDs placed outside instructions for use for AA were safe and associated with lower odds of hematoma. CDs for AA may improve AA outcomes with a potential to decrease health care utilization associated with sheath removal.Table IUnmatched multivariable analysis of access complications comparing the use of closure devices (CDs)ComplicationOR95% CIP valueAny hematomaa0.750.59-0.95.02Hematoma requiring interventionb0.560.38-0.81<.01Stenosis or occlusionc1.430.60-3.39.41CI, Confidence interval; OR, odds ratio.Boldface entries indicate statistical significance (P < .05).aAdjusted for age, sex, elective operation, volume of contrast material used, history of diabetes, prior major amputation, prior inflow stent or angioplasty, and prior infrainguinal bypass.bAdjusted for age, sex, elective operation, congestive heart failure, and prior infrainguinal bypass.cAdjusted for elective operation and history of coronary artery bypass graft or percutaneous coronary intervention. Open table in a new tab Table IIMatcheda multivariable analysesComplicationOR95% CIP valueAny hematomab0.740.54-1.00.05Hematoma requiring interventionc0.540.29-0.99.05Stenosis or occlusiond0.970.28-3.42.96CI, Confidence interval; OR, odds ratio.aMatched for white, obese, coronary artery disease, congestive heart failure, aspirin use, history of coronary artery bypass graft or percutaneous coronary intervention, prior major amputation, prior inflow stent or angioplasty, prior infrainguinal bypass, elective operation, ultrasound-guided access, largest access sheath used, and heparin reversal with protamine.bAdjusted for age, sex, elective operation, volume of contrast material used, history of diabetes, prior major amputation, prior inflow stent or angioplasty, and prior infrainguinal bypass.cAdjusted for age, sex, elective operation, congestive heart failure, and prior infrainguinal bypass.dAdjusted for elective operation and history of coronary artery bypass graft or percutaneous coronary intervention. Open table in a new tab

Effectiveness of premedication protocol using intravenous fentanyl to reduce pain associated with femoral artery closure device placement

To test the effectiveness of a premedication protocol using intravenous bolus of 100 μg fentanyl to reduce pain associated with femoral artery closure device placement for neuro-endovascular procedures. The severity of pain associated with femoral artery closure device placement was analysed using a numerical rating scale score ranging from 0 (no pain) to 10 (most severe pain) in two cohorts of consecutive adult patients (n=118), those who were (n=64) or were not (n=54) treated with premedication protocol. The primary endpoints were the proportion of patients with excellent (score ≤1) and failed pain control (score ≥8). Stepwise logistic regression analysis was performed to identify the effect of premedication on pain control after adjustment for potential confounders. The median numerical pain rating score at femoral artery closure device placement was significantly lower in patients treated with premedication protocol compared with those who underwent closure without premedication (1 versus 5, p<0.001). There was a significantly higher rate of excellent (56.2% versus 14.8%, p<0.001) and good (68.7% versus 31.2%, p<0.001) pain control at closure device placement among patients treated with premedication protocol. None of the patients treated with premedication protocol reported failed pain control compared with 33.4% of those who underwent closure device placement without premedication. In the multivariate analysis, treatment with the premedication protocol was significantly associated with an increased rate of excellent pain control (odds ratio 2.3; 95% confidence interval 1.9-3.1). Premedication with intravenous fentanyl injection prior to femoral artery closure device placement can reduce the intensity of pain associated with closure.

Abstract 13431: Safety And Efficacy of Angioseal Deployment in Patients With Common Femoral Artery Access During Electrophysiological Procedures Performed With Uninterrupted Oral Anticoagulation

Introduction: Retrograde access is commonly used during EP procedures to access the aortic root as well as the LV. Many patients who undergo these procedures are under uninterrupted oral anticoagulation (OAC), therefore it is important to find a way to minimize arterial access-site complications. Hypothesis: Femoral arterial access closure devices can be safely used to achieve hemostasis after common femoral artery access in EP procedures performed with uninterrupted OAC. Methods: Consecutive patients who underwent femoral arterial access closure with the AngioSeal device in two centers were included in this retrospective analysis. All patients were systemically heparinized with ACT between 300 and 500 s. Success was defined as hemostasis achieved in &lt; 5 minutes. Results: Over a 2-year period, 62 patients underwent femoral arterial access closure. 52% were PVC/VT ablations, 40% AF (NCC), and 8% SVT (NCC/WPW). 53% of the patients were female, with a mean age of 59 ± 13 years and BMI 30.0 ± 5.2; sheath size was 8F for all. 40% on uninterrupted OAC (24% factor Xa inhibitors, 16% warfarin), whereas 23% were on ASA, 5% on dual antiplatelet therapy, and 32% were not receiving any antithrombotic therapy at the time of the procedure. In all patients with uninterrupted OAC, femoral arterial access was ultrasound-guided to ensure that the arteriotomy was located above the bifurcation but below the external iliac artery. Femoral arterial closure was successful in all, without any device-related complication. There were 2 (3%) access-related complications requiring prolonged hospitalization, both related to the additional venous access, as determined by ultrasound: 1 superficial bleeding in a patient with NCC tachycardia during AF ablation who was on uninterrupted rivaroxaban and 1 large hematoma in a patient who underwent VT ablation and was on ASA. The incidence of complications was not significantly different between patients with uninterrupted OAC compared to those with uninterrupted antiplatelet thereapy or no antithrombotic therapy (Fischer’s exact test P = NS). Conclusions: Common femoral artery access closure with the AngioSeal device is safe and effective in achieving hemostasis in patients undergoing EP procedures performed with uninterrupted OAC.

Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study

BACKGROUNDBleeding events after percutaneous coronary interventions (PCI) are associated with patients’ age, gender, and the presence of chronic kidney disease, antithrombotic treatment, as well as arterial access site. Patients being treated by PCI using radial access site are associated with an improved prognosis. However, the safety of femoral closure devices has never been compared to radial compression devices following PCI. Therefore, the aim of this study is to evaluate the safety of femoral closure compared to radial compression devices in patients treated by PCI envisaging access site bleedings as well as short- and long-term prognostic outcomes.METHODSThe Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study comparing 400 consecutive patients undergoing PCI either using radial compression devices (TR Band™) or femoral closure devices (Angio-Seal™) at the corresponding access site. The primary outcome consists of the occurrence of vascular complications at the arterial access site, including major bleedings as defined by common classification systems. Secondary outcomes consist of the occurrence of adverse cardiac events, including all-cause mortality, target lesion revascularization, and target vessel revascularization during 30 days and 12 months of follow-up.RESULTSStudy enrollment was initiated in February 2014. The enrollment phase is expected to last until May 2015.CONCLUSIONSThe FERARI study intends to comparatively evaluate the safety and prognostic outcome of patients being treated by radial or femoral arterial closure devices following PCI during daily clinical practice.

Rehabilitation Barriers Recognized in a Geriatric Patient after Cardiac Revascularization Procedure

ABSTRACTThe incidence of coronary heart disease is most prevalent among persons greater than 65 years of age (Fang et al., ). A cardiac catheterization is often required to confirm or evaluate the extent of the disease. Over 1 million inpatient cardiac catheterizations are performed annually in the United States, with approximately half of those patients needing a percutaneous cardiac intervention as a result of the catheterization findings. The use of larger catheters during this procedure may cause complications after removal of the catheter, and vascular access complications are a leading cause of morbidity, cost, and legal ramifications. One method to achieve hemostasis after a catheter is removed from the femoral artery is to mechanically close the puncture site with a femoral artery closure device (FACD) (Hamel, ). This case study describes how the complications of an FACD deployed after a coronary intervention created an impediment to progression of a geriatric patient's rehabilitation course. Opportunities to share lessons learned from this unexpected physiologic barrier are discussed, and consequences related to inadequate information at hand-off between institutions are described.

75 Celt ACD®, A Novel Stainless Steel Femoral Artery Closure Device, Reduces Time to Hemostasis, Patient Discomfort and Late Bruising Compared with Angio-seal™

IntroductionThe Celt ACD® (Kimal, Middlesex, U.K.) is a novel stainless steel vascular closure device (VCD). We conducted a prospective, non-randomised study to assess time to hemostasis, patient discomfort and vascular...

First human experience of thermal arterial closure

This study was designed to evaluate the efficacy and safety of the CardioDex arterial closure device, which is a novel femoral artery closure device used following percutaneous cardiac catheterization. Current devices utilized to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization include collagen plug and suture mediated devices, but are associated with significant vascular complications. The CardioDex closure device utilizes thermal energy to cause collagen shrinking and swelling and thereby, achieve hemostasis. The device was evaluated in a prospective nonrandomized single-center trial with patients undergoing 6F invasive cardiac procedures. Femoral artery puncture closure was performed immediately at completion of the procedure, followed by 3-4 minutes of manual compression. Time to hemostasis (TTH), time to ambulation (TTA), and short-term clinical follow-up data were collected. A total of 34 patients including 21 diagnostic and 13 interventional cases were evaluated. The median TTH was 3 min in diagnostic and 4 min in interventional cases. TTH was independent of activated clotting time (ACT). The median TTA was 2.75 hr and 3.37 hr in diagnostic and interventional groups, respectively. There were no major adverse events identified at 1 week and 30 day follow up. This first in human clinical experience with the CardioDex closure device demonstrates that in the small cohort studied, it is safe and effective in diagnostic cardiac catheterization and also in interventional cases on mild anticoagulation (mean ACT = 188 sec). It has the advantage of leaving no foreign material in the body following use.

Effectiveness of femoral arterial closure devices compared to traditional compression methods following femoral sheath removal: a systematic review

1The Heart Hospital Baylor Plano, Plano, TX, USA, 2Baylor Heart and Vascular Hospital, Dallas, TX, USA, 3Texas Christian University Center for Evidence Based Practice and Research: A Collaborating Center of the Joanna Briggs Institute

THERMAL GENERATED FEMORAL ARTERIAL CLOSURE: INITIAL EXPERIENCE WITH A NOVEL DEVICE

The aim of the study was to determine the safety and efficacy of a novel thermal femoral artery closure device (CardioDex; Caesarea, Israel). The device is comprised of a Nitinol anchor that is deployed via the existing introducer sheath, a battery power unit and a heating member inserted over the

Endovascular retrieval of a dislodged femoral arterial closure device with Alligator forceps

The Angio-Seal (St. Jude Medical, Minnetonka, Minn) is a frequently used percutaneous femoral artery closure device to obtain hemostasis after arterial catheterization. Separation and migration of the device, leading to distal embolization and limb-threatening ischemia necessitating emergency surgery, is reported but extremely rare. We present a unique case of successful endovascular bailout management of a dislocated Angio-Seal with use of an Alligator Tooth Retrieval forceps (Cook Medical, London, United Kingdom).

Effectiveness of femoral arterial closure devices compared to traditional compression methods following femoral sheath removal: A Systematic Review

Review Questions/Objectives The systematic review objective is to synthesise the best available research evidence related to the effectiveness of femoral arterial closure devices as compared to traditional compression methods post femoral sheath removal in the cardiovascular patient. The specific review question to be addressed is: • What effects do femoral arterial closure devices, as compared to traditional compression methods, have on outcomes post femoral sheath removal in the cardiovascular patient? Inclusion Criteria Types of participants This review will consider studies that included all types of cardiovascular adult patients (18+ years old) with post femoral sheath removal following endovascular procedures regardless of previous treatments. The femoral artery is preferable access site due to the larger diameter of the artery compared to the radial or brachial arteries. Due to the larger diameter of the femoral artery, time to hemostatis and complications are significantly different than that of the brachial or radial arteries.For accurate comparison, patients undergoing procedures using radial or brachial access will not be included. Types of interventions The interventions of interest are arterial closure devices and traditional compression methods used following femoral arterial sheath removal. Studies that compare arterial closure devices and compression methods post endovascular procedure will be included in this review. Similarly, studies that compare various compression methods post endovascular procedure will be included in this review. Studies that compare radial or brachial access to femoral access and hemostasis will not be included in this review to allow for accurate comparison. Femoral access has significantly differing times to hemostatis and complication rates than radial or brachial access. Types of outcome measures The primary outcome of interest is the difference in effectiveness of femoral arterial closure devices and traditional compression methods on patient outcomes. Studies meeting criteria for participants and intervention which include outcomes related to bleeding risks and vascular complications, such as hematoma, bleeding at the site, retroperitoneal bleeding, pseudoanuerysm, and AV-fistula creation will be considered for inclusion in this review. In addition, studies describing attainment of hemostasis following femoral sheath removal will be considered.

Limitations of closing percutaneous transthoracic ventricular access ports using a commercial collagen vascular closure device

Closed-chest access and closure of direct cardiac punctures may enable a range of therapeutic procedures. We evaluate the safety and feasibility of closing percutaneous direct ventricular access sites using a commercial collagen-based femoral artery closure device. Yorkshire swine underwent percutaneous transthoracic left ventricular access (n = 13). The access port was closed using a commercial collagen-based vascular closure device (Angio-Seal, St. Jude Medical) with or without prior separation of the pericardial layers by instillation of fluid into the pericardial space ("permissive pericardial tamponade"). After initial nonsurvival feasibility experiments (n = 6); animals underwent 1-week (n = 3) or 6-week follow-up (n = 4). In naïve animals, the collagen plug tended to deploy outside the parietal pericardium, where it failed to accomplish hemostasis. "Permissive pericardial tamponade" was created under MRI, and accomplished early hemostasis by allowing the collagen sponge to seat on the epicardial surface inside the pericardium. After successful closure, six of seven animals accumulated a large pericardial effusion 5 ± 1 days after closure. Despite percutaneous drainage during 6-week follow-up, the large pericardial effusion recurred in half, and was lethal in one. A commercial collagen-based vascular closure device may achieve temporary but not durable hemostasis when closing a direct left ventricular puncture port, but only after intentional pericardial separation. These insights may contribute to development of a superior device solution. Elective clinical application of this device to close apical access ports should be avoided.

Effectiveness of femoral arterial closure devices compared to traditional compression methods following femoral sheath removal: A Systematic Review

Effectiveness of femoral arterial closure devices compared to traditional compression methods following femoral sheath removal: A Systematic Review

MRI after implantation of a novel femoral closure device following intra-arterial catheterisation: implications for subsequent contrast-enhanced MR angiography

To assess MRI safety aspects and artefacts of a novel femoral artery closure device during contrast-enhanced MR angiography in patients following intra-arterial catheterisation. Ten consecutive patients underwent MRI within 24 h of coronary angiography and placement of a femoral artery closure device. We used a T2-weighted gradient-echo MRI sequence to measure the device-related artefact size in comparison with a phantom image, phase-contrast flow measurement proximal to, at the level of and distal to the device to quantify potential differences in flow velocity and contrast-enhanced 3D gradient-echo MR angiography to differentiate potential femoral artery stenosis from device-related artefacts. The mean size of the oval-shaped artefact was 8.4 x 6.6 mm (+/-1.0 x 0.8 mm) and was almost identical to the maximum artefact size of the phantom measurement (8.3 x 5.7 mm). Device placement did not result in an increased peak velocity (proximal 69 +/- 23 cm/s, at the level of 64 +/- 11 cm/s and distal to the device 63 +/- 12 cm/s, p = 0.67). The mean artefact penetration into the vessel lumen was 0.5 +/- 0.5 mm (percentage vessel narrowing 7.0 +/- 6%; range 0-16%). The MR conditional StarClose femoral artery closure device was used safely within 24 h of deployment at 1.5 T. Despite clip-related artefacts MR angiography will allow for easy differentiation of clip-related artefacts from high-grade atherosclerotic stenosis.

Femoral Artery Closure After Cardiac Catheterization

After diagnostic and interventional cardiac catheterization, femoral artery closure devices offer quicker time to hemostasis, ambulation, and discharge than does manual compression. Nurses should understand how femoral artery closure devices work, the potential vascular complications that may occur with their use, and the recommended time to ambulation and discharge.