StarClose vascular closure system (VCS) is safe and effective in patients who ambulate early following successful femoral artery access closure--results from the RISE clinical trial

OBJECTIVE: The RISE study was a prospective, multicenter, single-arm study evaluating the safety and efficacy of the StarClose Vascular Closure System (VCS) in the femoral artery in subjects who were ambulated early following percutaneous diagnostic coronary or peripheral catheterization procedures. BACKGROUND: Previous studies have demonstrated that several vascular closure devices are able to safely decrease the amount of bedrest needed following angiography. To date, no device has been shown to be safe for immediate ambulation. METHODS: Between April 2006 and November 2006, 315 patients undergoing a catheterization via the femoral artery were enrolled (intent-to-treat population, ITT). Of these, 171 subjects were not excluded by angiographic or clinical criteria and had a StarClose device placed to attain hemostasis. If hemostasis was immediately achieved, patients were ambulated within 20 min for 20 feet without assistance (per-protocol population, PP). Patients were followed for 30 days after the index procedure. The primary endpoint of the study was time to ambulation (TTA). Results: Immediate hemostasis was achieved in 156 patients (91.2%). The mean TTA in the PP was 8.29 min, median 5.92. There were no deaths or major vascular complications, and the rate of minor vascular complications was 1.9% (3/156). ConcLUSION: The StarClose VCS device is both safe and effective allowing immediate ambulation of patients who have undergone catheterization via the femoral artery.     

Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

OBJECTIVES: The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. BACKGROUND: Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery METHODS: A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. RESULTS: The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. CONCLUSIONS: The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications.     

Percutaneous suture-mediated closure of femoral access sites deployed through the procedure sheath: initial clinical experience with a novel vascular closure device.

The objective of this study was to assess the initial safety and feasibility of a novel suture-mediated device for closure of femoral access sites immediately after diagnostic or interventional cardiac catheterization. In a prospective study, 150 patients (mean age, 61.5 years; 109 male) underwent femoral access closure with a novel suture closure device (Superstitch, Sutura) immediately after diagnostic (n = 106) or interventional (n = 44) catheterization procedures, independently of the coagulation status. All patients were monitored for 24 hr after the procedure. The closure device was successfully deployed in 92% of patients. Immediate hemostasis was achieved in 77% of patients with no differences between patients undergoing diagnostic catheterization or coronary interventions (79% vs. 73%; P = 0.659). After 2 min of additional light manual compression, hemostasis was achieved in 92% of patients. There was one major complication requiring vascular surgery (0.7%). The novel suture closure 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.     

The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx.

OBJECTIVE: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. BACKGROUND: The Mynx device is an extra-arterial vascular closure technology utilizing a water-soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. METHODS: The Mynx study was a prospective, multicenter, single-arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (+/-7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. RESULTS: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device-precipitated complications associated with serious clinical sequelae were reported. Mean (+/- standard deviation) times to hemostasis and ambulation were 1.3 +/- 2.3 min and 2.6 +/- 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). CONCLUSIONS: The initial experience with the extra-arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures.     

“Double wire” angio‐seal closure technique after balloon aortic valvuloplasty

Objectives : To report the feasibility of a collagen‐mediated closure device using a modified Angio‐Seal closure technique for access site management following percutaneous balloon aortic valvuloplasty (BAV). Background : With the advent of percutaneous aortic valve replacement therapies, there has been a resurgence of interest in BAV procedures. Vascular complications, including bleeding, are a common source of morbidity post procedure as a result of the requirement for large bore femoral artery access. The use of vascular closure devices may reduce bleeding complications. Methods : We describe a new technique for vascular closure in this setting. At the conclusion of the valvuloplasty procedure, two 0.035″ wires are inserted through the femoral artery sheath. A conventional collagen‐mediated closure device (8F Angio‐Seal) is deployed over the first wire and along side the second wire. If immediate hemostasis is not achieved, a second device is loaded onto the second wire and deployed to achieve hemostasis. Results : Percutaneous BAV was performed in 21 patients. Hemostasis was successfully achieved in all patients with either a single 8F Angio‐Seal closure device (18 patients) or after placement of a second device (three patients). Conclusions : The modified “Double Wire” Angio‐Seal technique is a feasible method for hemostasis following percutaneous BAV. © 2009 Wiley‐Liss, Inc.     

Suture closure of the femoral arteriotomy following invasive cardiac procedures: a detailed analysis of efficacy, complications, and the impact of early ambulation in 1,200 consecutive, unselected cases.

The purpose of this study was to assess the efficacy and safety of using a percutaneous suture device to close femoral arteriotomies following invasive cardiac procedures. All patients presenting for invasive cardiac procedures performed from the femoral artery were considered for suture closure. Patients were carefully assessed for access site complications, oozing, and the impact of suture closure on the safety of early ambulation. Clinical follow-up at 3-6 months was performed to assess for late complications. Femoral artery suture closures were performed in 1,200 consecutive cases in 1,097 patients. In 12.8% of cases, the patients ambulated within 1 hr. The success rate was 91.2% and the complication rate was 3.4%. Complications included the development of a hematoma (2.1%), the need for vascular surgery (0.6%), retroperitoneal hemorrhage (0.3%), blood transfusion (0.7%), local infection (0.5%), and pseudoaneurysm formation (0.1%). Factors found to be independently predictive of procedural failure were an age > 70 years, an ACT > 300 sec, left femoral artery access, and the performance of primary angioplasty. Follow-up at 3-6 months revealed no major hemorrhagic complications. We conclude that percutaneous suture closure effectively achieves femoral artery hemostasis in patients undergoing invasive cardiac procedures. The technique permits early ambulation and is associated with a relatively low incidence of complication.     

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.     

Local vascular complications after use of the hemostatic puncture closure device Angio-Seal

BACKGROUND: As an alternative to manual pressure techniques new systems for achieving arterial hemostasis after cardiac catheterization were developed. Here we report about the diagnosis and therapy of femoral artery complications after use of the closure device Angio-Seal, consisting of an intraarterial anchor and extravascular collagen plug. PATIENTS AND METHODS: Angio-Seal was deployed in 350 patients undergoing cardiac catheterization. Vascular investigations after device application consisted of ankle/brachial-pressure-index measurement, duplex sonography, and angiography. RESULTS: Vascular complications occurred in 10 of 350 patients. In two patients complete occlusions of the superficial femoral artery required immediate vascular surgery. Stenoses of the superficial (five patients) and the common (three patients) femoral arteries were diagnosed in 8 cases. Of these 10 patients eight were obese, in 2 cases there was a further catheterization with Angio-Seal device application via the same femoral approach. Until now six patients underwent successful surgery: in 4 cases the whole Angio-Seal device was located intraarterially, there was 1 case of intima-dissection, and 1 case remained unclear due to a diagnostic delay of 7 months. In three patients with stenoses of the common femoral arteries without hemodynamic relevance no therapy was required. CONCLUSIONS: Occlusions or stenoses of femoral arteries after use of Angio-Seal can be diagnosed easily by duplex sonography. All hemodynamic relevant complications (n = 7 of 350 [2%]) concerned a puncture of superficial femoral arteries. In these patients vascular surgery seems to be an adequate therapy.     

Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: Initial U.S. feasibility trial using the Duett vascular closure device

The aim of this first U.S. feasibility study was to investigate the safety and efficacy of a novel vascular sealing device, Duett, following percutaneous endovascular procedures. Immediately following a catheterization procedure, the sealing device was deployed at the femoral arterial access site in 43 patients (diagnostic 29, intervention 11, intervention + abciximab 3). Patients were followed up at 1 month with clinical assessment, ankle‐brachial index measurement, and Doppler ultrasound of the treated femoral artery puncture site. Successful hemostasis was achieved with the Duett alone in 42/43 (97.7%) patients. There was one uncomplicated crossover to manual compression. The time to hemostasis was 4.0 ± 1.5, 6.9 ± 4.2, and 5.8 ± 1.2 min for diagnostic, interventional, and abciximab patients, respectively. At 1‐month follow‐up, one patient (2.3%) required ultrasound‐guided compression for treatment of a pseudoaneurysm. There were no other major complications. This novel vascular sealing device appears to achieve rapid and safe hemostasis successfully immediately following a wide range of percutaneous endovascular procedures. Cathet. Cardiovasc. Intervent. 50:96–102, 2000. © 2000 Wiley‐Liss, Inc.     

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

Introduction : 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. Methods : 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). Results : 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. Conclusions : 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. © 2011 Wiley‐Liss, Inc.     

Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients.

Despite recent advances in interventional cardiology, vascular access complications continue to be a significant problem. Conventional manual compression of the femoral access site is associated with prolonged immobilization and significant patient discomfort. We investigated the performance of a collagen-based closure device applied immediately after catheterization and its complication rate in 1,317 consecutive patients undergoing cardiac catheterization or coronary angioplasty. Patients undergoing coronary angioplasty (n = 644) received more heparin than patients with diagnostic cardiac catheterization (n = 673; 9,675 +/- 1,144 IU vs. 6,419 +/- 2,211 IU; P < 0.0001). Deployment success rates of the closure device were comparable for patients undergoing diagnostic vs. interventional procedures (95.8% vs. 96.7%; P = 0.46). Complete hemostasis immediately after deployment of the device was achieved in > 90% of all patients, but was lower in the interventional group (93.7% vs. 90.6%; P = 0.05). Major complications including any vascular surgery, major bleeding requiring transfusion, retroperitoneal hematoma, thrombosis or loss of distal pulses, groin infections, significant groin hematoma, and death were observed in 0.53% of all patients, with no differences between diagnostic or interventional patients (0.62% vs. 0.45%; P = 0.953). Subgroup analysis revealed female gender as a predictor of access site complications. Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications.     

Immediate hemostasis of the femoral artery after heart catheterization: the present situation of closure systems

The femoral approach is the most commonly used route for diagnostic cardiac catheterization and coronary interventions today. Manual compression and pressure bandages usually lead to immobilisation of the patient for several hours and may result in significant discomfort. Since the introduction of the first femoral closure device in 1991, many devices have proven their efficacy in significantly reducing time to hemostasis while simultaneously improving patient comfort. Twenty four closure device systems with different concepts are on the market, e. g. pure collagen, collagen + thrombin, collagen + anchor, vascular suture, hemostatic patches and pads, staples and more. The four predominantly used are Angio-Seal (46 %), Perclose (32 %), VasoSeal (14 %) and Duett (3 %). The effectiveness of all four systems has been proven in a prospective, randomized, controlled multicenter trial each. Efficacy and safety were analyzed using data from ten comparative studies in 8832 predominantly or exclusively interventional patients, however none of the closure systems proved to be superior. Fortunately, recent years have shown a trend toward a reduction in local complications by vascular closure devices compared to manual compression. Closure devices are thus becoming increasingly cost effective. Vascular closure systems should be preferred when the prolonged supine position is not tolerated, a protein IIb/IIIa-inhibitor was used during the procedure, or early discharge of patient is anticipated. In the presence of peripheral vascular disease, small diameter of the femoral vessels or stenotic lesions in the femoral artery, closure devices should be used with caution. Closure systems for immediate femoral puncture site hemostasis are now an important tool of invasive cardiology today.     

Intracoronary autologous bone marrow cell transplantation beneficially modulates heart rate variability

Antegrade femoral artery access is commonly used for percutaneous transluminal revascularization of ipsilateral lower limbs in patients with critical limb ischemia. While hemostasis at the end of the procedure can be achieved by manual compression, this may lead to an increase in local vascular complications. Femoral artery closure devices, such as the Angioseal collagen plug and anchor device, have been approved and shown of benefit after retrograde femoral artery catheterization. To date, there are however no data on the use of such arteriotomy closure device after antegrade femoral access. We hereby report a case series of five patients in whom Angioseal was successfully used after antegrade femoral puncture and below-the-knee percutaneous transluminal angioplasty. In all cases the device enabled immediate and complete hemostasis without major complications, despite the intense antithrombotic regimen, including heparin, aspirin, and clopidogrel in all patients, as well as glycoprotein IIb/IIIa inhibitors (in two patients) and fibrinolytic therapy (in one).     

血管闭合装置在经皮冠状动脉成形术后的应用

目的比较心血管病患者经皮冠状动脉成形术(PCI)后采用经皮血管闭合装置(per-close)止血与人工压迫止血的安全性和疗效。方法280例心血管病患者在行经皮冠状动脉成形术后,分为人工压迫止血组(145例)和per-close止血组(135例),观察2组止血时间、下床活动时间、术后血管并发症等。结果止血组与人工压迫组相比,止血时间与下床活动时间显著缩短,血管并发症明显减少。应用per-close的成功率达95%。结论此研究显示,PCI术后应用经皮血管闭合装置,是一个快速、有效的止血方法,缩短了止血与下床活动时间,并可减少穿刺点并发症发生率及患者不适感。     

Treatment of an Angio-Seal-related vascular complication using the SilverHawk plaque excision system: a case report.

The Angio-Seal is a user-friendly and safe arterial closure device increasingly used after percutaneous diagnostic and interventional procedures. Although it achieves rapid hemostasis and facilitates early patient mobilization, its use can be associated with vascular complications. A specific problem related to the device is protrusion of the collagen plug into the artery, causing either acute occlusion or symptomatic stenosis. When this occurs, treatment with balloon angioplasty alone is usually suboptimal, while stenting of the common femoral artery may be undesirable. In this report we describe a novel application of the SiverHawk plaque excision system to treat a highly eccentric stenosis at the site of a previously deployed Angio-Seal. Since the device allows preferential cutting in the direction of the lesion and collagen plug debulking, it may be ideally suited to treat this complication without the need for stenting of the common femoral artery.     

First‐In‐Man Experience With a New 7F Vascular Closure Device (EXOSEAL™): The 7F ECLIPSE Study

Objective: This feasibility study examined safety and effectiveness of the new EXOSEAL? Vascular Closure Device (VCD) designed to promote hemostasis and early ambulation after percutaneous procedures. Background: Most VCDs currently approved by the United States FDA have been associated with significantly shorter time‐to‐hemostasis (TTH) and time‐to‐ambulation (TTA) compared to standard manual or mechanical compression, but their ease of use, patient comfort during deployment, and safety profiles are variable. Methods: Patients underwent diagnostic or interventional procedures using 7F introducer sheaths. Primary safety endpoint was the 30‐day combined rate of access‐related complications and primary effectiveness endpoints were TTH and TTA. Results: Sixty patients were enrolled prospectively (mean age 63.3 ± 11.3 year, 17% diabetics). Device and procedural success was achieved in 92% and 93%, respectively. Mean TTH and TTA was 3.2 ± 3.0 minutes and 3.0 ± 6.2 hours, respectively. No deaths or serious access‐related adverse events occurred. A ≥6 cm access‐site hematoma was the only adverse event, observed in 3 patients. Conclusions: Use of the 7F EXOSEAL? VCD was associated with short TTH and TTA, as well as low rates of procedural and 30‐day access‐related complications. (J Interven Cardiol 2012;25:518–525)     

经皮血管缝合器与人工压迫法对股动脉拔管术后止血效果的比较

比较病人拔鞘管后应用经皮血管缝合器与人工压迫止血的安全性和疗效。 1 2 5例病人 (男 86例、女 39例 ,年龄 65 .7± 1 2 .3岁 ) ,在行心导管术后 ,分为人工压迫组 [Ⅰ组 ,63例 ,其中分为冠状动脉 (简称冠脉 )造影 (CAG)组35例 (IA) ,冠脉介入治疗术组 2 8例 (IB) ]和股动脉穿刺点经皮血管缝合组 [Ⅱ组 ,62例 ,CAG组 35例 (ⅡA) ,冠脉介入治疗术组 2 7例 (ⅡB) ]。在术后即刻应用经皮血管缝合器和依病人抗凝水平行人工压迫止血 ,观察止血时间 ,平卧时间和并发症。结果 :与人工压迫止血组时间比较 ,经皮血管缝合组止血时间和平卧时间有显著缩短。有 4例病人首次应用缝合器止血失效 ,首次成功率达 91 % ( 5 8/62 ) ;失败 2例 ,再用缝合器缝合获得成功 ,总成功率达96% ( 60 /62 )。在ⅠB组有 1例病人在血管成形术 3天后出现再次急性心肌梗死 ,给予静脉 (尿激酶 )溶栓后于穿刺伤口再出血而需压迫止血 1h。结论 :经皮血管缝合器应用的安全性优于人工压迫组 ,缩短了止血与下床走动时间     

Suppose a Perclose

The development of coronary interventional strategies and devices has provided an alternative to surgery for coronary artery disease. The femoral artery is the most common access site for therapeutic cardiac interventions. The methods to achieve hemostasis post procedure vary from conventional, where the arterial puncture site is externally compressed, to novel, where the femoral artery is sealed with a device. One such device is a suture mediated percutaneous vascular closure system developed by Perclose, Incorporated. It provides a safe, effective method to achieve immediate hemostasis of the femoral artery. The vascular complication rate is only 0.78%, time to hemostasis is within 1.3 minutes, and time to ambulation in within 5.5 minutes. These advantages provide improved patient comfort and have a positive economic impact.     

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.     

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.