Novel Collagen Vascular Plug for Femoral Arteriotomy Sealing: Acute and Chronic In Vivo Studies

Background: The current use of collagen vascular hemostasis devices to percutaneously seal femoral arteriotomy sites is limited by a significant incidence of vascular complications. The purpose of the present study was to assess the efficacy of new collagen plug specifically designed to avoid these complications by accurately gauging the depth of the femoral artery and by minimizing the risk of intra-arterial collagen deployment. Methods: The hemostasis device used in this study consists of a multicomponent collagen plug with an external rigid collagen tube lined by an inner layer of absorptive sponge collagen. Placement of this plug is facilitated with a specialized two-lumen dilator, which localizes the arterial surface using a “bleedback” mechanism from one of the lumens, and prevents the placement of collagen through the arteriotomy site. The acute efficacy of this device was assessed in 26 adult dogs in which 36 collagen plugs were used to seal 8Fr femoral arteriotomies. An additional 16 arteriotomies treated with standard manual compression served as study controls. Following plug placement or manual compression, all puncture sites were observed for bleeding and hematoma formation over a 45-minute period. Patency of each instrumented artery was assessed with serial femoral angiography and localization of each plug was confirmed with surgical cutdown at the puncture site. The chronic efficacy of this device was assessed in three pigs in which three collagen plugs were used to seal 8Fr femoral arteriotomies. The three animals were subsequently sacrificed at 7,14, and 30 days, respectively, for histologic analysis. Results: In acute animals, all 36 plugs were successfully placed without evidence of vascular compromise or intra-arterial collagen deployment. In nonanticoagulated animals, hemostasis was achieved within 5 minutes in 10 of 10 plugs placed with a skin-to-arlery distance > 1.8 cm, in 4 of 7 plugs with a skin-to-artery distance of 1.2–1.7 cm, and in 0 of 9 plugs with a skin-to-artery distance < 1.2 cm. In anticoagulated animals, hemostasis within 5 minutes was demonstrated with 8 of 10 plugs with a skin-to-artery distance > 1.8 cm; small hematomas occurred in the remaining two animals in the setting of a PTT > 100 seconds. Time to hemostasis was significantly less for collagen plugs than manual compression in both nonanticoagulated animals (plug 17 ± 16 minutes; manual compression 28 ± 5 minutes; P < 0.03) and anticoagulated animals (plug 6 ± 2 minutes; manual compression 42 ± 4 minutes; P < 0.01). Chronic studies demonstrated femoral artery patency in all three pigs. Histologic analysis demonstrated progressive collagen resorption with no difference between collagen plug placement or manual compression at 30 days. Conclusions: The local hemostasis device utilized in this study resulted in accurate placement of a collagen plug immediately adjacent to the arteriotomy site with no evidence of acute or chronic vascular compromise or intra-arterial collagen deposition. Hemostasis with shorter compression times than with standard manual techniques was achieved at puncture sites in which the skin-to-artery distance was > 1.8 cm and the anticoagulation profile was not excessive. At 1 month postplacement, there is no histologic difference between plug use and standard manual compression. (J Interven Cardiol 1996;9:25–33)     

股动脉血管闭合器的安全性评价

目的评价股动脉血管闭合器(VCDs)的围手术期及中长期安全性。方法连续入选2008年6月～2009年10月接受经股动脉冠状动脉造影和(或)血管成形术的患者1078例,根据治疗方法不同分为压迫止血组(369例)和VCDs组(709例),比较2组围手术期血管并发症发生率;另选2004年3月～2009年10月行髂动脉造影并使用VCDs、术后3个月后再次穿刺同侧股动脉并行髂动脉造影的患者92例,评价VCDs的中长期安全性。结果股动脉穿刺术围手术期血管并发症总发生率为0.7%。与压迫止血组比较,VCDs组围手术期血管并发症明显减少(1.6%vs 0.3%,P=0.039)。logistic回归分析,血管并发症与性别、血压、体重指数使用VCDs和积极抗凝、抗血小板治疗等无关。92例患者中,2次髂动脉造影间隔中位数为232 d,使用VCDs后复查髂动脉造影,狭窄发生率为3.3%,但均无下肢缺血症状。结论 VCDs的围手术期及中长期安全性较高。造影随访发现,使用VCDs后存在一定的狭窄率,但其发生率较低;且无下肢缺血症状。     

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.     

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.     

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.     

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).     

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.     

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.     

Acute limb ischemia after femoral arterial closure with a vascular sealing device: successful endovascular treatment

We report on successful catheter therapy of acute occlusions of popliteal and crural arteries due to distal embolization from a vascular sealing device. A 45 years-old male patient underwent percutaneous coronary angiography. After primary successful closure of the right femoral artery by a sealing device the patient developed acute ipsilateral lower limb ischemia, most probably due to embolization of a collagen/thrombin plug. Occlusions of the popliteal and crural vessels were successfully treated by percutaneous thrombectomy, thrombolysis and ballon angioplasty. Combined percutaneous catheter therapy is a therapeutic option for occlusions of popliteal and crural vessels due to embolization from a vascular sealing device.     

Optimizing safe femoral access during cardiac catheterization.

This article describes the natural variability of femoral arterial anatomy as seen by angiography in a standard position. An analysis of 60 consecutive peripheral angiograms revealed data on average vessel diameter, variability in that diameter and the level of bifurcation of the common femoral artery into its two main branches. The statistical likelihood of optimal femoral arterial access through a standard dermotomy placed midway between, and 3 cm below, the imaginary line extending from the superior anterior iliac spine to the pubic symphysis was calculated. Our research disclosed average vessel diameters of 6.6 mm (3.9-8.9 mm), 5.2 mm (2.5-9.6 mm), and 4.9 mm (2.7-7.6 mm) for the common femoral artery, superficial femoral artery and deep femoral artery, respectively. The bifurcation of the common femoral artery into its branches averaged 5.5 mm below the inferior margin of the femoral head in most cases (76% of the time). In our laboratory, the average distance from the inferior border of the femoral head to our actual arteriotomy was 14.0 mm. Using our standard dermotomy, we achieved this favorable access position in 97% of cases.     

经皮股动脉冠状动脉造影术后6小时下地活动的可行性探讨

目的观察经皮股动脉行冠状动脉造影、人工压迫止血后6h下地活动的可行性和安全性。方法377例非肝素化经皮股动脉行冠状动脉造影的患者在拔除动脉鞘管、人工压迫止血后无加压包扎，沙袋压迫10～30min，6h下地活动，观察患者舒适度及其穿刺部位并发症。结果人工压迫止血时间5～30（11．89±3．22）min，即刻止血成功率100％，沙袋压迫时间10～40（24．42±5．68）min。压迫止血后患肢床上活动时间2～6（4．12±0．66）h，下地活动时间4～8（6．10±0．78）h，58（15．4％）例患者出现腰痛不适，10（2．7％）例患者导尿，33（8．75％）例患者穿刺部位有出血并发症：轻微渗血11（2．92％）例、大血肿5（1．33％）例、小血肿15（3．98％）例、皮下淤斑25（6．63％）例、假性动脉瘤2（0．53％）例。随访1～3d，无严重出血并发症。结论使用6F动脉鞘、经皮股动脉穿刺、无肝素化冠状动脉造影、人工压迫止血后无加压包扎，6h下地活动是可行和安全的。     

人工压迫和Perclose血管缝合器的股动脉止血疗效比较

目的：观察Perclose血管缝合器在经股动脉途径行室上速射频消融治疗中止血疗效比较。方法：199例经股动脉途径室上速射频消融治疗的患者被分为Perclose血管缝合组（Perclose组,98例）与人工按压组（101例）,观察两组即刻成功率,止血时间,制动时间与术后并发症的发生率。结果：即刻止血成功率比较两组无统计学差异（98％比100％, P＞0.05）。与人工按压组比较, Perclose组止血时间[（18.9±9.1） min比（2.7±0.7） min]和制动时间[（21.6±3.4） min比（6.3±2.4） min]明显缩短,并发症总发生率（16.8％比4.1％）明显降低（P＜0.05, P＜0.01）。两组并发症发生的具体情况：迷走反射 Perclose组明显低于人工按压组（0比7.9％, P＜0.05）,其他并发症两组无统计学差异（P均＞0.05）结论：Perclose血管缝合器止血时间、制动时间短,并发症少,可作为经股动脉途径室上速射频消融治疗后股动脉止血的优先选择。     

无肝素冠脉造影术后股动脉止血方法的探讨

目的：评价无肝素股动脉冠状动脉造影术（CAG）后股动脉穿刺部位应用改良加压包扎法止血的效果和安全性。方法：经股动脉途径行CAG的120例患者,分为两组,A组术后采用Angio—seal．装置止血,B组采用改良加压包扎法止血,两组抗血小板治疗相同。比较两组止血时间、止血成功率、开始活动时间、并发症和患者的舒适度。结果：①两组止血的成功率（均为100％）,制动时间[A组为（3．6±0．7）h,B组（3．8±0．5）h]．舒适度均无显著差异（P〉0．05）;②止血时间[A组（2．1±0．8）min．B组（7．5±2．8）min],加压包扎时间[A组0h,B组为（10．2±2．3）h],A组显著短于B组（P〈0．05）;③主要并发症：血肿发生率A组（11．7％）显著多于13组（3．3％）．P〈0．05。结论：无肝素股动脉冠状动脉造影术后股动脉穿刺部位应用改良加压包扎法止血效果好．价格低廉。并发症少,值得临床推广。     

Long term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention

Background: We evaluated the long term clinical outcomes of femoral vascular closure devices following its deployment in coronary angiography and percutaneous coronary intervention (PCI) procedures. Methods: From June 2000 to September 2004, 265 patients who received femoral vascular closure devices after coronary angiography and PCIs were enrolled into the study. Patients' medical records were reviewed and vascular complications within 1 year of follow‐up period were recorded. Rutherford's categories of claudication were used to quantify different degrees of claudication and leg ischaemia. Duplex ultrasonography of both femoral arteries (using the nonaccessed site as control) was performed at 1 year after deployment of vascular closure devices. Vessel diameter and flow velocities for both common femoral arteries were obtained. Results: There was no occurrence of late vascular complications like arteriovenous fistula, pseudoaneurysm, surgical repair of access site complications, late groin bleeding and infection. By Rutherford categories of claudication, 99.2% of patients had grade 0 claudication while the remaining 0.8% was in grade 1. By arterial Duplex ultrasonography, the peak systolic velocity of the accessed femoral artery (predominantly right side) was nonsignificantly higher, 94.9 ± 26.0 cm/s when compared to 91.5 ± 24.8 cm/s in the control site (P = 0.12). As for vessel diameter, no significant difference was found in the mean end‐diastolic vessel diameter 8.8 ± 1.3 mm (puncture site) versus 8.7 ± 4.4 mm (control site) (P = 0.72). Conclusion: We found that the use of femoral closure devices was safe and it was not associated with any adverse long term vascular complications. © 2009 Wiley‐Liss, Inc.     

Complications of percutaneous femoral arterial catheterization. Prospective evaluation with the Doppler ultrasonic velocity detector

Prospective evaluation of vascular complications of 160 percutaneous femoral arterial catheterizations was carried out in 142 adult patients undergoing cardiac catheterization at two affiliated hospitals of the University of Washington. Arterial velocity signals and blood pressure in the limbs were monitored with the Doppler ultrasonic velocity detector before and after each procedure. The rate of complications (14 percent) was similar at each hospital; they included one accidental dissection of the iliac artery and 22 arterial thromboemboli. The location of thromboemboli appeared to be related to the duration of use of an indwelling arterial catheter. Complications were more common in patients, especially female, with mitral valve disease and in patients with coexisting peripheral arterial occlusive disease. Two thirds of the patients with thromboembolic complications had no symptoms. All but one patient with femoral thrombosis had operative thrombectomy; no patient with distal occlusion underwent operation. The Doppler ultrasonic velocity detector is a simple, rapid noninvasive technique for assessing limb hemodynamics in patients undergoing arterial catheterization.     

ProGlide血管缝合器在经皮穿刺静-动脉模式体外膜肺氧合血管通路中的应用

目的 评价ProGlide血管缝合器预缝合技术（PCT）在经皮穿刺静-动脉模式体外膜肺氧合（VA-ECMO）血管通路撤机止血中应用的有效性及安全性。方法 研究为前瞻性、观察性研究,连续入选2019年3月～2020年6月期间在空军军医大学西京医院心脏内科接受经皮穿刺VA-ECMO治疗的患者。将成功撤机并利用PCT技术完成血管通路缝合的患者纳入研究,分别记录PCT技术在股动、静脉的成功率及住院期间穿刺部位相关并发症发生率。结果 研究共纳入37例接受经皮穿刺VA-ECMO治疗患者,排除5例患者（其中1例是未采用PCT技术,4例在ECMO撤机前死亡）,最终纳入32例患者,结果发现PCT技术在股动脉的技术成功率为97%、股静脉成功率为100%。所有患者住院期间未发生主要血管并发症,次要血管并发症发生率为6%。结论 ProGlide预缝合技术在经皮穿刺VA-ECMO撤机时可以安全有效地实现股动、静脉的快速止血,且血管并发症发生率低。     

“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.     

冠状动脉介入术后外周血管并发症发生的原因与处理

目的 :探讨经皮冠状动脉 (冠脉 )介入术后外周血管并发症的发生率、原因和处理方法。方法 :分析经皮冠脉介入术后有外周血管并发症的患者的临床资料。结果 :2 348例患者中 5 7例 (2 .4 % )发生外周血管并发症 ,其中穿刺部位单纯血肿 4 4例 (1.9% ) ,严重出血 5例 (0 .2 % ) ,假性动脉瘤 5例 (0 .2 % ) ,股动脉夹层 1例(0 .0 4 % ) ,下肢静脉血栓形成 2例 (0 .0 8% )。 2例患者需要外科处理 ,无一例死亡。冠脉介入治疗术后外周血管并发症的发生率显著高于冠脉造影术 (6 .2 %∶1.0 % ,P <0 .0 1)。经验不足的术者外周血管并发症的发生率显著增高。结论 :冠脉介入术后外周血管并发症并不少见 ,主要与穿刺方法不当和抗凝治疗有关。但只要及时处理 ,绝大多数预后良好     

Postinterventional transcutaneous suture of femoral artery access sites in patients with peripheral arterial occlusive disease: a study of 930 patients.

The purpose of this study was to evaluate a percutaneous vascular suture (PVS) device in patients with peripheral arterial occlusive disease (PAOD) for achievement of immediate hemostasis at the vascular access site and early ambulation of fully anticoagulated patients after peripheral interventional procedures. From June 1995 to March 2000, a vascular suture using a PVS device (6-10 Fr) was applied in 930 patients with PAOD. All patients had received an endoluminal intervention in the pelvic and/or the contralateral femoropopliteal region via a retrograde access through the common femoral artery (CFA). The incidence of complications within 12 hr after intervention, prior to discharge, and at 30-day follow-up was assessed employing clinical examination, treadmill test, and color Doppler ultrasound and the safety of the PVS device was determined. The efficacy of the system was measured by the percentage of achieved immediate hemostasis and early ambulation. PVS was technically successful in 92.2% independently from the degree of calcification at the access site. In 7.8%, an appropriate suture delivery could not be performed and these patients were successfully treated by conventional compression technique. Device malfunction or insufficient suture closure occurred in 1.7% and 2.1%, respectively. In 7.0%, groin-related complications occurred. Ambulation within 2-4 hr after successful suture was possible in 96.1%. All patients were free of any local symptoms at 30-day follow-up. The PVS device provides a safe and effective solution to achieve immediate hemostasis, thus permitting early ambulation in fully anticoagulated patients with PAOD after peripheral interventional procedures.