Vascular closure devices: the second decade

Vascular closure devices (VCDs) introduce a novel means for improving patient comfort and accelerating ambulation after invasive cardiovascular procedures performed via femoral arterial access. Vascular closure devices have provided simple, rapid, and reliable hemostasis in a variety of clinical settings. Despite more than a decade of development, however, VCD utilization has neither been routine in the U.S. nor around the world. Their limited adoption reflects concerns of higher costs for cardiac procedures and a lack of data confirming a significant reduction in vascular complications compared with manual compression. Recent data, however, suggest that VCD are improving, complication rates associated with their use may be decreasing, and their utilization may improve the process of care after femoral artery access. Challenges in the second decade of VCD experience will include performing definitive randomized trials, evaluating outcomes in higher-risk patients, and developing more ideal closure devices.     

Vascular closure devices: the second decade.

Vascular closure devices (VCDs) introduce a novel means for improving patient comfort and accelerating ambulation after invasive cardiovascular procedures performed via femoral arterial access. Vascular closure devices have provided simple, rapid, and reliable hemostasis in a variety of clinical settings. Despite more than a decade of development, however, VCD utilization has neither been routine in the U.S. nor around the world. Their limited adoption reflects concerns of higher costs for cardiac procedures and a lack of data confirming a significant reduction in vascular complications compared with manual compression. Recent data, however, suggest that VCD are improving, complication rates associated with their use may be decreasing, and their utilization may improve the process of care after femoral artery access. Challenges in the second decade of VCD experience will include performing definitive randomized trials, evaluating outcomes in higher-risk patients, and developing more ideal closure devices.     

“To close or not to close?” When should vascular closure devices be used after cardiac catheterization procedures?

• Vascular closure devices (VCD) appear to be safe when compared to manual compression or surgical closure.
• VCDs’ main advantage seems to stem from lower time to hemostasis (TTH) and time to mobilization.
• In anticoagulated patients with 6‐Fr femoral sheaths, the new Celt ACT VCD, which uses a stainless‐steel permanent implant, seems to be safe and decreases TTH when compared to manual pressure.

     

Simplified swift and safe vascular closure device deployment without a local arteriogram: Single center experience in 2074 consecutive patients

ObjectiveVascular closure devices (VCDs), such as the Angio-Seal, a three-component hemostatic plug, have greatly facilitated the routine clinical practice in the catheterization laboratory. The manufacturer recommends a local angiogram before Angio-Seal deployment. However, from the outset, we employed a simplified routine of deploying this VCD, i.e. without use of local angiography.MethodsThe Angio-Seal was employed without a preceding femoral arteriogram over 8 years in 2074 consecutive patients, 72% presenting with acute coronary syndromes and subjected to coronary angiography (n = 1032) or PCI n = 1042) via a transfemoral approach with use of heparin and dual antiplatelet therapy.ResultsDeployment of the VCD was successful in 99.4%. Complete hemostasis was obtained in 98% of cases. In 14 patients, Angio-Seal deployment failed. Mean time for placement of Angio-Seal was <1 min, to-hemostasis 1 min, and to-mobilization 3 h. Only 3 (0.15%) patients had a major complication with vessel occlusion that required emergent vascular surgery with a successful outcome. Two patients developed a local pseudoaneurysm treated with ultrasonography-guided compression. Six small and 4 large inguinal hematomas (one requiring blood transfusion) and 5 cases of retroperitoneal bleeding (one requiring blood transfusion) were recorded.ConclusionDeployment of Angio-Seal without use of local angiography was efficacious and safe, characterized by a high success rate of deployment and hemostasis with few correctable complications in a large patient cohort undergoing transfemoral catheterization for PCI and non-PCI procedures under anticoagulation and antiplatelet drug therapy. VCD reduced the time-to-hemostasis and time-to-mobilization and minimized the incidence of complications.     

Review of vascular closure devices

BACKGROUND: Vascular access-site complications are an important cause of morbidity following catheterization procedures. Manual compression is the "gold standard" in achieving hemostasis of an arteriotomy site; however, manual compression is limited by the need to interrupt anticoagulation, prolonged bed rest, patient discomfort and time demands for healthcare providers. Vascular closure devices (VCDs) improve patient comfort, free medical staff resources and shorten the time needed for hemostasis, ambulation and discharge. However, the safety of VCDs remains in question and they may increase the risks of infection and leg ischemia. Compared with manual compression, the rate of major complications appears to be increased with VasoSeal, decreased with Angio-Seal and decreased in diagnostic cases with Perclose. The safety of VCDs cannot be assumed due to "class effect," and nearly all individual trials are underpowered to detect differences in complication rates, so the safety of other individual VCDs is unclear. In the absence of puncture site-related risk factors, VCDs as a whole appear to have little influence on complication rates, and patients at high baseline risk for bleeding due to clinical factors may benefit from these devices. Screening with femoral angiography prior to VCD placement and avoidance of VCDs in the presence of puncture site-related risk factors might reduce the risk of vascular complications. This review describes the mechanism, efficacy and safety of VCDs including hemostasis pads, the FemoStop, Clamp Ease, Mynx, Duett, FISH, Boomerang, ExoSeal, Starclose, VasoSeal, Angio-Seal and Perclose devices.     

冠状动脉介入治疗术后Angio-Seal血管封堵器的应用研究

目的比较经股动脉冠脉介入术后应用Angio-Seal血管封堵器（VCD）与徒手压迫止血法（MC）的临床疗效。方法将186例患者随机分成VCD及MC两组各93例。VCD组应用Angio-seal血管封堵器,MC组采用人工徒手压迫,观察止血成功率、止血时间、肢体制动时间以及并发症。结果VCD组止血时间、加压包扎时间和肢体制动时间较MC组显著缩短,差异有统计学意义（P〈0.01）,3例于VCD置入后仍然有明显出血,均给予徒手加压15min左右成功止血。MC组4例也由于患者肥胖,股动脉位置较深,徒手压迫止血时间〉20min,仍然有明显出血,继续压迫止血10～20min后成功止血。两组止血成功率间差异无统计学意义（P〉0.05）,并发症的发生率VCD组明显低于MC组,差异有统计学意义（P〈0.01）。结论应用VCD安全有效的,且可以明显降低止血、制动时间和并发症发生率,尤其适用于一些穿刺处并发症高危患者或不能耐受长时间制动的患者。     

Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices

BACKGROUND: Vascular access site management is crucial to safe, efficient and comfortable diagnostic or interventional transfemoral percutaneous coronary procedures. Two new femoral access site closure devices, Perclose and Angio-Seal , have been proposed as alternative methods to manual compression (MC). We compared these two devices and tested them in reference to standard MC for safety, effectiveness and patient preference. METHODS: Prospective demographic, peri-procedural, and late follow-up data for 1,500 patients undergoing percutaneous coronary procedures were collected from patients receiving femoral artery closure by MC (n = 469), Perclose (n = 492), or Angio-Seal (n = 539). Peri-procedural, post-procedural, and post-hospitalization endpoints were: 1) safety of closure method; 2) efficacy of closure method; and 3) patient satisfaction. RESULTS: Patients treated with Angio-Seal experienced shorter times to hemostasis (p < 0.0001, diagnostic and interventional) and ambulation (diagnostic, p = 0.05; interventional, p < 0.0001) than those treated with Perclose. Those treated with Perclose experienced greater access site complications (Perclose vs. Angio-Seal, p = 0.008; Perclose vs. MC, p = 0.06). Patients treated with Angio-Seal reported greater overall satisfaction, better wound healing and lower discomfort (each vs. Perclose or vs. MC, all p < or = 0.0001). For diagnostic cath only, median post-procedural length of stay was reduced by Angio-Seal (Angio-Seal vs. MC, p < 0.0001; Angio-Seal vs. Perclose, p = 0.009). No difference was seen in length of stay for interventional cases. CONCLUSIONS: Overall, Angio-Seal performed better than Perclose or MC in reducing time to ambulation and length of stay among patients undergoing diagnostic procedures. There was a higher rate of successful deployment and shorter time to hemostasis for Angio-Seal, and this was accomplished with no increase in bleeding complications throughout the follow-up. Additionally, Angio-Seal performed better than Perclose in exhibiting a superior 30-day patient satisfaction and patient assessment of wound healing with less discomfort.     

Early discharge using five french guiding catheter for transfemural coronary stenting: a feasibility and safety study (EDU 5Fr study)

This study assessed the safety and efficacy of early discharge after percutaneous coronary intervention (PCI) using 5Fr guiding catheters with a femoral approach in 100 patients undergoing elective coronary stenting. Patients were treated with aspirin and thienopyridines for 72 hours before PCI, and unfractionated heparin 70 IU/kg (< or = 5,000 IU) intravenously after arterial puncture. PCI was performed by femoral access using 5Fr guiding catheters and immediate postprocedural arterial sheath removal. Patients were discharged within 8 to 12 hours. No closure devices were used. Early discharge using 5Fr catheters was successful in 97% of cases. No deaths, myocardial infarction, or vascular complications occurred at 24 hours and 30 days.     

Vascular access site complications with the use of closure devices in patients treated with platelet glycoprotein IIb/IIIa inhibitors during rescue angioplasty.

The objective of this study was to evaluate the effectiveness of two different closure devices in patients undergoing rescue percutaneous coronary intervention (PCI) using IIb/IIIa inhibitors and to compare it with patients undergoing elective PCI. One hundred sixty-two patients undergoing rescue PCI treated with IIb/IIIa inhibitors underwent vascular access site closure (6 Fr Perclose, n = 92, or 6 Fr Angioseal, n = 70). Vascular complications were compared with a sex- and age-matched group (n = 100) of patients undergoing manual compression after sheath removal and a similar group of patients undergoing elective PCI (n = 196). The incidence of access site complications was not significantly different between the three groups undergoing rescue PCI and was not higher than in patient receiving GP IIb/IIIa inhibitors without fibrinolysis (RR = 0.95; 95% CI = 0.88-1.01). In patients undergoing rescue PCI and receiving IIb/IIIa inhibitors, closure devices allow early sheath removal and are associated with similar outcomes compared with manual compression and elective PCI regardless of the type of closure device used.     

新型血管封堵器在心导管术后应用120例观察

目的评价新一代血管封堵器Angio-Seal STS在冠状动脉造影及介入术后股动脉封闭中的应用价值。方法对重庆医科大学附属第一医院心内科2004-09—2005-12收治的298例病人,分为血管封堵器A组(120例)和人工压迫B组(178例),观察止血成功率、止血时间、卧床时间及血管性并发症。结果A组在止血时间、卧床时间及腰背痛不适上明显低于B组(P<0·05)。在止血成功率、腹股沟皮下血肿及血管迷走神经反射方面两组差异无显著性(P>0·05)。结论Angio-Seal STS血管封堵器对股动脉穿刺点能快速、有效地止血,缩短卧床时间,且不增加血管性并发症。Angio-Seal STS特点是自身紧闭式缝合,无须已往使用Angio-Seal后放置的弹簧。     

Complications with Angio‐Seal™ Vascular Closure Devices Compared with Manual Compression after Diagnostic Cardiac Catheterization and Percutaneous Coronary Intervention

Objectives

This study assessed and compared vascular complications in CATHs and PCIs using an Angio‐Seal? vascular closure device (VCD) versus manual compression (MC).

Methods

Secondary data analysis of a population‐based multiyear cohort database was conducted to compare femoral access‐related vascular outcomes in cardiac procedures using VCD and MC between May 1, 2006 and December 31, 2010. The primary outcome was any vascular complication. Propensity score adjusted analysis was conducted to reduce bias associated with covariate imbalance between the groups compared.

Results

Of the 11,897 procedures, 7,063 (59.4%) used a VCD. Vascular complications occurred in 174/8,796 (2.0%) of CATHs and 82/3,004 (2.7%) of PCIs. In the CATH sample, the odds of vascular complication were 57% lower if a VCD was used (OR = 0.43, 95% CI 0.31–0.60). For the PCI sample, the risk was 49% lower if a VCD was used (OR = 0.51, 95% CI 0.31–0.81).

Conclusions

A low incidence of vascular complications was observed with the use of an Angio‐Seal VCD relative to MC for both procedures.

     

Prophylactic Retrograde Distal Common Femoral Access as a Bail-out Strategy in Patients with Increased Risk for Femoral Access Complication During Transfemoral Aortic Valve Replacement

ObjectiveSeveral patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) have complex peripheral arterial disease (PAD) that increases risk of vascular complications and failure of vascular closure device (VCD). Endovascular bailout of failed VCD is performed through contralateral femoral access. Further due to multiple different anatomic reasons the contralateral femoral access and “up and over” approach is unavailable for endovascular bailout of the VCD failure. We evaluated a novel bailout technique of obtaining an additional access in ipsilateral common femoral artery (CFA) or superficial femoral artery (SFA) distal to the main CFA access used for TAVR device.MethodsWe prospectively identified patients who were at high risk for VCD failure and had unavailable contralateral CFA approach from the pre-TAVR evaluation with multislice CT angiography. The data was collected prospectively for the TVT registry and retrospectively reviewed. All patients had an additional distal access obtained in the CFA or proximal SFA under direct fluoroscopy guidance after achieving main CFA access for TAVR. Using an inner 0.021″ micro-dilator from the 4-Fr micropuncture mini stick max access kit (AngioDynamics, Marlborough, MA) and a 200 cm long 0.018″ wire, the distal access was secured in place through the TAVR procedure. After completing the TAVR if the VCD gained successful hemostasis, the 0.021″ dilator was removed with manual pressure. If the VCD failed to achieve hemostasis, the distal access was upsized to a 7 Fr sheath for carrying out endovascular repair of the TAVR access. If the distal access was upsized to 7 Fr, that access was treated with VCD. The patients were monitored for acute in-hospital complication and followed for 6 months.ResultsDuring 2017 & 2018, 97.4% of 186 TAVRs were performed via femoral approach at our center. Six patients met the criteria for high-risk access and non-availability of the contralateral “up and over” approach. Of the 6 patients enrolled in this prospective study, 3 required endovascular management of TAVR access because of failed VCDs and were treated with covered stents using the distal ipsilateral access. The remaining 3 patients had successful use of VCDs for the TAVR access and the prophylactic access with 0.021″ dilator was managed with manual pressure. None of the six patients suffered any further vascular complication or bleeding. At the 6-month follow up no vascular complications or clinically driven events were identified from the TAVR access or additional distal ipsilateral access.ConclusionThis novel technique of prophylactic ipsilateral distal femoral access can provide an alternative bailout strategy for patients at high risk of closure device failure and unavailable contralateral femoral approach during transfemoral TAVR.     

Comparison of Angioseal and Manual Compression in Patients Undergoing Transfemoral Coronary and Peripheral Vascular Interventional Procedures

Vascular closure devices (VCDs) were introduced in the early 1990s with the goal of limiting the time, labor, bed rest, and patient discomfort associated with manual compression (MC) for hemostasis after cardiovascular interventions. However, its advantage over MC has not been extensively studied after interventional procedures. The aim of this study was to do prospective, randomized study comparing the safety and efficacy of the Angio-Seal (AS) to that of MC in patients undergoing transfemoral coronary and peripheral vascular interventional procedure.A prospective, randomized trial was undertaken on consecutive series of patients admitted to King Fahd Hospital of the University for transfemoral coronary and peripheral vascular interventional procedures over 1 year. The study was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving AS with those undergoing MC. All patients were on antiplatelets and received heparin during the procedure.During the study period, 160 patients were included, 80 in each group. There was a significant difference in mean time to hemostasis in minutes (15.83 ± 1.63 minutes for MC and 0.42 ± 0.04 minutes for the AS; p < 0.001), time to ambulation in minutes (280 ± 15 for MC and 120 for AS; p = 0.04) and in minor complications (33.8% in MC vs. AS 5%; p < 0.001). However, the major complication rate did not significantly differ between the two groups (0% in AS vs. 2.5% in MC; p = 0.15).AS was found to achieve rapid closure of the femoral access site safely in patients undergoing coronary and peripheral vascular interventional procedures under antiplatelets and systemic heparinization.     

Vascular Closure Devices in Acute Coronary Syndromes: From Arbitrary to a Necessity?

Vascular closure devices (VCDs) were initially developed to improve access site hemostasis and allow for earlier ambulation in patients undergoing diagnostic catheterization and percutaneous coronary intervention (PCI). Though initially thought to be beneficial, large meta-analysis has shown conflicting data regarding whether VCDs alter access site bleeding in a variety of clinical settings. One area of particular interest for the adoption of VCDs has been in the setting of acute coronary syndromes (ACS) in which multiple antiplatelet strategies are often employed leading to a high risk of bleeding. Bleeding in ACS has been shown to be a powerful independent predictor of 30-day mortality. Recently, investigators have reported that VCDs reduce access site bleeding in the setting of ACS. In our review, we use several selected representative clinical trials to provide a historical account for the use of VCDs. We also provide for a review of data as it relates to access site bleeding in ACS along with analysis showing that VCDs may potentially provide for reductions in bleeding and vascular complications in patients with ACS undergoing PCI.     

Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention 1998-2003.

OBJECTIVES: To evaluate the adjusted risk of vascular complications after manual compression and vascular closure devices for femoral artery access site management in a large contemporary cohort, using propensity score analysis. BACKGROUND: Vascular closure devices (VCD) allow early ambulation after cardiac procedures involving femoral artery access, but whether the benefit of use of vascular closure devices (VCD) is offset by reduced safety in contemporary practice remains uncertain. Methods: Twenty one thousand eight hundred and forty one consecutive diagnostic cardiac catheterization (n = 13,124) and percutaneous coronary intervention procedures (n = 8,717) performed via a femoral access at a single site (WFUBMC) between 1998 and 2003 were evaluated. VCD's were used based on operator preference. Propensity to receive a vascular closure device (VCD) was calculated. The relative incidence of vascular complications was evaluated by logistic regression models, using the propensity score as a covariate. RESULTS: Overall, the unadjusted incidence of any vascular complication was 1.3% for VCD use and 1.4% for manual compression, p = NS. The propensity score-adjusted odds ratio for any vascular complication comparing VCD (n = 8,707) to manual compression (n = 13,034) was 0.86 (0.67-1.11) for all procedures, 0.80 (0.53-1.21) for diagnostic procedure, and 0.90 (0.65-1.26) for interventional procedures. CONCLUSIONS: In this large single-center, contemporary observational study, the risk-adjusted occurrence of vascular complications following VCD use for femoral artery access management is not increased by VCD use. Thus, in the current era, the benefit of VCD use is not offset by reduced safety.     

Collagen Plug Vascular Closure Devices and Reduced Risk of Bleeding with Bivalirudin Versus Heparin Plus Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Non ST‐Segment Elevation Myocardial Infarction

Introduction

In ISAR‐REACT‐4 (abciximab and heparin vs. bivalirudin for non‐ST‐elevation myocardial infarction [NSTEMI]), bivalirudin reduced the risk of bleeding after percutaneous coronary intervention (PCI) compared with unfractionated heparin plus abciximab (UFH + abciximab). Vascular closure devices (VCDs) may also prevent bleeding complications, and thus attenuate the benefit of bivalirudin. This analysis examined whether there exists an interaction on bleeding between VCDs and bivalirudin versus UFH + abciximab after PCI.

Methods

Patients with NSTEMI were randomly assigned to either receive UFH + abciximab or bivalirudin for PCI. The use of a VCD after femoral access was left to the operator's discretion. The effect of randomized treatment in patients who received a VCD was compared to that in patients with manual compression of the femoral access site. The primary end‐point of this analysis was the 30‐day incidence of ISAR‐REACT‐4 major bleeding.

Results

A total of 1,711 patients were enrolled in this analysis. Among the 365 (21.3%) patients receiving a VCD, 188 (51.5%) were treated with UFH + abciximab and 177 (48.5%) with bivalirudin. ISAR‐ REACT‐4 major bleeding was higher with UFH + abciximab than with bivalirudin, independent of whether a VCD was used (4.8% vs. 2.3% with VCD and 4.6% vs. 2.7% without VCD, Pint = 0.76). There were also no interactions between randomized treatment and VCDs with respect to any of the ischemic end‐points or net clinical outcome (Pint > 0.56).

Conclusions

In patients undergoing PCI for NSTEMI, the reduction of major bleeding by bivalirudin compared with UFH + abciximab was not affected whether a VCD was used.

     

Early clinical experience with the 6 French Angio-Seal device: immediate closure of femoral puncture sites after diagnostic and interventional coronary procedures.

The objective of this study was to assess the early safety and efficacy of the novel 6 Fr Angio-Seal device for routine clinical use after diagnostic cardiac catheterization and coronary angioplasty. In a prospective study, we used the 6 Fr Angio-Seal device in 180 consecutive patients (131 male, 49 female, mean age 60.7 years) for closure of femoral arterial puncture sites immediately after diagnostic (n = 108) or interventional (n = 72) coronary procedures independent of the coagulation status. All patients were monitored for 24 hr after the procedure and followed for 30 days. The closure device was successfully deployed in 95.4% after diagnostic catheterization versus 98.6% after coronary angioplasty (P = 0.963). Immediate hemostasis was achieved in 91.5% versus 90.1% of the patients (P = 0.993). Major complications were observed 1.9% versus 2.8% of the patients (P = 0.885). During 30-day follow-up, no late events or complications were reported. The 6 Fr Angio-Seal device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.     

Outcome of access site in patients treated with platelet glycoprotein IIb/IIIa inhibitors in the era of closure devices.

The most consistent procedural predictor of vascular access site complications thus far has been the intensity and duration of anticoagulant therapy during and after percutaneous coronary interventions (PCI). Several devices have been developed to aid in the closure of the femoral arteriotomy. This report describes the clinical outcome of unsuccessful deployment of femoral closure devices in a cohort of 285 consecutive patients who underwent PCI and were treated with platelet glycoprotein (GP) IIb/IIIa inhibitors. Manual femoral artery compression was used in 123 patients, Perclose in 123 patients, and AngioSeal in 39 patients. Successful homeostasis was achieved in 98.4% of patients who received manual compression, in 91.9% of the Perclose-sealed arteriotomy, and in 84.6% of patients who received the AngioSeal closure device (P = 0.004). The incidence of vascular complications after successful deployment was 9%. Patients not achieving hemostasis with closure device or 1 degrees manual compression developed complications in the majority of cases (> 80%; P < 0.05). By multivariate analysis (with adjustment for baseline differences), the use of AngioSeal closure device was found to be an independent risk factors leading to primary deployment failure and all access site complications (OR 2.97; 95% CI 1.5-6.0; P = 0.006). In summary, failed hemostasis by artery closure devices in patients undergoing PCI who are treated with GP IIb/IIIa inhibitors is associated with significant vascular complications. AngioSeal may be associated with a higher failure rate, while manual compression and Perclose seem to be more effective with a lower complication rate.     

Impact of gender on femoral access complications secondary to application of a collagen-based vascular closure device

BACKGROUND: Vascular complications at the femoral access site continue to be a significant problem after cardiac catheterization procedures. It was the aim of the present study to assess the impact of gender on the incidence of severe femoral access complications following the application of a collagen-based vascular closure device after transfemoral catheterization procedures. METHODS: A total of 1,294 consecutive patients (977 male, 317 female) underwent closure of femoral access sites with 8F collagen-based vascular closure devices (Angioseal) immediately after diagnostic or interventional coronary catheterization procedures, independently of the coagulation status. All patients were closely monitored for the occurrence of complications during the following 24 hours. RESULTS: Between male and female patients, there was no difference in the technical performance of the device with successful deployment being achieved in 96.7% and 95.9%, respectively (p=0.60). Severe access complications were found to be significantly higher in female versus male patients (1.6% vs. 0.2%; Odds ratio 7.7, 95% confidence interval 1.5-40.1; p=0.015), although similar accomplishment of an immediate hemostasis was seen in 92.8% and 92.4% of male and female patients (p=0.98). CONCLUSION: Women show a significantly increased risk of developing severe femoral access complications secondary to the application of a collagen-based vascular closure device, although the overall incidence of these complications is relatively low. We speculate that the increased risk in women may be related to smaller arterial dimensions, which could be evaluated by femoral angiography prior to deployment of a closure device.     

Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventions.

The aim of this study was to assess costs and safety of immediate femoral sheath removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial sheath removal and access site closure with a suture-mediated closure device (SMC; n = 96) or sheath removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 +/- 3.4 vs. 22.9 +/- 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients.