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.     

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.     

冠状动脉介入诊疗术后两种止血方法的比较

目的:比较冠状动脉诊疗术的冠状动脉介入术（PCI）及冠状动脉造影术（CAG）后,传统压迫法与采用Angioseal缝合器止血法的制动时间和并发症发生率,为术前指导和术后护理提供依据。方法:CAG及PCI患者214例按止血方法不同分为传统压迫止血组和血管缝合组,比较两组术后制动时间和并发症的发生率。结果:采用Angioseal缝合法成功率达100%,与压迫法止血比较下肢制动时间不论单纯CAG还是PCI均显著缩短（P<0.01）,缝合法术后并发症的发生率如渗血、局部血肿、迟发出血（第3天以后,至1周）、心迷走反射等显著低于传统压迫止血组（P<0.01）。结论:Angioseal缝合器止血较传统压迫止血护理操作简便,安全性高,并发症少。     

Early deambulation following cardiac catheterization by the use of 6 Fr Angio-Seal, a new hemostatic percutaneous puncture closure device]

INTRODUCTION AND OBJECTIVES: Efficacy of the hemostatic puncture closure 8 Fr Angio-Seal device for percutaneous puncture closure after a catheterism has been previously demonstrated, but the experience provided has been obtained with 8 Fr devices. At present the device has been modified and its size reduced to 6 Fr. In this pilot study we evaluate the efficacy of the new hemostatic 6 Fr Angio-Seal device and its safety when early deambulation post-diagnostic and/or therapeutic catheterization is established. PATIENTS AND METHODS: Prospective study of 150 consecutive patients randomized either for application of the 6 Fr Angio-Seal device (group A; n = 75), in which early ambulation was indicated, or manual compression (group B; n = 75), with ambulation 12 h after cardiac catheterization. Basal data, including clinical and angiographic characteristics and previous treatment with heparin and platelet aggregation inhibitors were similar in both groups. RESULTS: The time of hemostasia was significantly shorter in group A than in group B (118 +/- 210 s in A vs 1320 +/- 370 s in B; p (3/4) 0,001), and with early ambulation (3,1 +/- 0,4 h in A vs 12,3 +/- 3,1 h in B; p (3/4) 0,001) no local complications were observed. CONCLUSIONS: The 6 Fr Angio-Seal hemostatic device diminished the hemostasia time and early ambulation could be achieved. In this pilot study no complications due to early movilization were observed, but the safety of the new hemostatic device after diagnostic or therapeutic catheterizations needs to be evaluated in greater series.     

Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials

Despite advances in other aspects of cardiac catheterization, manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management. Suture-mediated closure may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial (STAND I) evaluated the 6Fr Techstar device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 515 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS). Major complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05). Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significantly shorter for suture-mediated closure. Suture-mediated closure of the arterial puncture site thus affords reliable immediate hemostasis and shortens the time to ambulation without significantly increasing the risk of local complications.     

VIPER-2: a prospective, randomized single-center comparison of 2 different closure devices with a hemostatic wound dressing for closure of femoral artery access sites.

PURPOSE: To report the outcome of a prospective randomized safety and performance trial of 2 access site closure devices versus a wound dressing. METHODS: Between October 2005 and July 2006, 852 consecutive patients (605 men; mean age 67 years) undergoing diagnostic or interventional catheterization procedures thru a 5- or 6-F femoral sheath were randomized to one of the 3 closure methods: a collagen plug device (Angio-Seal), a clip (StarClose), or a wound dressing (D-Stat Dry). The efficacy of the devices was assessed, as well as the complications occurring at the puncture site during the hospital stay. The primary endpoint of the study was the cumulative incidence of access site pseudoaneurysm, major access site bleeding requiring transfusion, access site vascular surgery, or death from all causes. RESULTS: There were no significant differences in baseline characteristics between the 3 treatment groups. The primary endpoint was reached in 20 (7.1%) of 281 patients treated with D-Stat Dry and in 11 (1.9%) of 571 patients treated with the mechanical closure devices (p<0.0001). There was no significant difference among the mechanical closure devices concerning the incidence of the primary endpoint (Angio-Seal 1.1% versus StarClose 2.8%; p = 0.13). CONCLUSION: The collagen plug device had the lowest rates of major and minor access site-related complications after removal of 5- or 6-F femoral sheaths. The difference between the mechanical closure devices concerning the incidence of the primary endpoint did not reach statistical significance. The wound dressing showed significantly higher major and minor complication rates.     

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.     

心导管术后经皮动脉血管封堵器的临床应用

目的比较经皮冠状动脉介入术后,股动脉穿刺口采用Angio-Seal血管封堵器与局部人工压迫止血方法的疗效与安全性。方法196例进行心导管检查的患者,随机分为股动脉穿刺口人工压迫止血组(82例,其中冠状动脉造影术36例,冠状动脉成形术46例)和血管封堵器止血组(114例,其中冠状动脉造影术52例,冠状动脉成形术62例),观察止血时间、并发症及成功率。结果Angio-Seal血管封堵器与局部人工压迫止血法比较,止血时间明显缩短,并发症减少,成功率相当。结论Angio-Seal血管封堵器在掌握好适应证的前提下,可广泛应用于经皮冠状动脉手术后股动脉穿刺口的处理。     

Vascular complications after hemostatic puncture closure device (Angio-Seal) are not higher in overweight patients

BACKGROUND: Angio-Seal (Daig Corporation, Minnetonka, Minnesota) allows earlier discharge from the hospital after coronary angiography. Manual compression in overweight patients after percutaneous procedures is associated with a higher incidence of groin complications. The purpose of this study was to determine if a vascular closure device could be safely used without increasing the risk of vascular complications in overweight patients. METHODS: A total of 198 patients who received the 6 French Angio-Seal device after diagnostic coronary angiography were divided into 3 groups. Group A included patients with a body mass index (BMI) of < or = 25, group B with BMI between 25 and 30, and group C with BMI > or = 30. Patients were followed for groin complications during their hospital stay. RESULTS: Complication rates were comparable between the 3 groups. Groin complications occurred in 11% in group A, 5% in group B and 6% in group C. CONCLUSION: After diagnostic cardiac catheterization, a vascular closure device such as Angio-Seal can be safely used in overweight patients.     

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.     

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.     

Predictors of complications and learning curve using the Angio-Seal closure device following interventional and diagnostic catheterization.

A retrospective study was conducted to determine the frequency and nature of groin complications when the Angio-Seal device was used on 252 occasions by one operator immediately following interventional (66%) and diagnostic (34%) procedures. Sixty-nine percent of the 238 successfully deployed cases received ticlopidine or clopidogrel, 16% received abciximab, and 15% received heparin postprocedure. Complications included vascular surgery for collagen plug perforation into the femoral artery (0.8%), failure to deploy (5.6%), pseudoaneurysm (0.4%), brisk, visible bleeding (9%), persistent ooze (14%), hematoma > 6 cm (0.8%), hematoma 1 cm(2) (10%). Multivariate analysis identified diagnostic cases (6 Fr sheaths) to be associated with a reduced risk of complications [odds ratio (OR) 0.1] while interventional procedures (8 Fr sheaths), postprocedure heparin, and body mass index (BMI) < 28 (OR 10.1, 3.2, and 2.8, respectively) were associated with increased risk. Gender, age, ticlopidine, clopidogrel, and abciximab were not independent predictors of complications. A learning curve for device deployment was observed in the first 50 cases (14% nondeployment vs. 3.5% for the subsequent 202 procedures, P = 0.009) and failure to deploy was independent of sheath size used. Angio-Seal can be used with reasonable safety and efficacy immediately after diagnostic and interventional procedures. Cathet. Cardiovasc. Intervent. 48:162-166, 1999.     

Comparison of Arterial and Venous Blood Flow Between Patients with Pressure Dressing or a New Hemostatic Puncture Closure Device After Cardiac Catheterization

The aim of the study was to compare arterial and venous flow volume in the punctured leg in patients given a conventional pressure dressing and those given a new hemostatic puncture closure device (Angio-Seal) after cardiac catheterization. We prospectively measured blood flow in 25 patients with pressure dressing (group A) and 25 patients with Angio-Seal (group B) after cardiac catheterization. Duplex sonographic measurements were performed at the superficial femoral artery and vein of the punctured leg. In group A measurements were performed before catheterization, during pressure dressing, and after removal of pressure dressing. In group B we performed the measurements before catheterization and after closure of the puncture site with Angio-Seal. Mean arterial and venous blood flow of the superficial femoral artery and vein were calculated. Statistical evaluation was performed using the one-sample Wilcoxon test. In group A there was a significant reduction of blood flow volume in both the femoral artery, from a mean of 119 mL/min before puncture to 78 mL/min with pressure dressing, and the femoral vein, from 114 mL/min before puncture to 82 mL/min with pressure dressing (P < 0.0001). After removal of pressure dressing the blood flow rose to 119 mL/min in the femoral artery and 116 mL/min in the femoral vein. In group B there was no change in flow volume before and after catheterization (femoral artery: 117 vs 118 mL/min, femoral vein 119 vs 120 mL/min, P = ns). We conclude that the use of pressure dressing after cardiac catheterization caused a significant reduction in arterial and venous blood flow (about 30%) during immobilization. The new Angio-Seal closure device did not affect arterial or venous flow.     

Hämostatischer Verschluß der arteriellen Punktionsstelle mittels Angio-Seal™ nach diagnostischer Herzkatheteruntersuchung oder Koronarintervention

Conventional manual compression and subsequent application of pressure bandages is associated with prolonged immobility and significant patient discomfort. Routine anticoagulation as well as the use of new interventional devices and platelet inhibiting strategies lead to a higher incidence of local bleeding complications after diagnostic cardiac catheterization or coronary angioplasty. Immediate sheath removal increases patient comfort. The Angio-Seal system uses a biodegradable anchor and collagen plug for sealing of arterial puncture sites. Several studies showed the safety and efficacy of this device. Technical deployment success ranges between 88 and 100%. Significant reduction in time to hemostasis allows for earlier patient ambulation and shorter in-hospital stay compared to manual compression with peripheral complications not being increased.     

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.     

Mobilization Within Thirty Minutes of Elective Diagnostic Coronary Angiography: A Feasibility Study Using a Hemostatic Femoral Puncture Closure Device

The standard procedure for obtaining hemostasis following coronary angiography is manual or mechanical compression of the femoral artery followed by 4–6 hours supine rest. The patient is then mobilized and later discharged. This consumes time and resources and may be uncomfortable for the patient. The aim of this pilot study was to determine if the Angio-Seal^TM hemostatic puncture closure device (the Angio-Seal device) allows safe, early mobilization of patients undergoing elective coronary angiography. Selected patients were randomly allocated to the the Angio-Seal device (study group, n = 24) or standard compression techniques (control group, n = 26) after completion of the diagnostic coronary angiogram. Study group patients were mobilized 25–30 minutes after sheath removal and deployment of the Angio-Seal device. After hemostasis in control patients, a pressure bandage was applied, and the patient was placed on bed rest for 4–6 hours. There was no age or sex difference between the study group and the control group. There were more patients with hypertension, diabetes mellitus, or obesity in the control group. Time to hemostasis was 0.5 ± 1.4 min for the study group and 42.9 ± 20.6 min for the control group (P < 0.0001). Time to mobilization was 32.5 ± 6.9 min for the study group and 322.7 ± 41.8 for the control group (P < 0.0001), with 83% and 92% (P = NS) of patients in respective groups being fully mobilized according to protocol. Complications requiring clinical intervention were seen in three patients (12.5%) in the study group and in one patient (4%) in the control group. We have shown that mobilization of patients within 30 minutes of diagnostic coronary angiography via the femoral artery is feasible using the Angio-Seal device. The safety of this approach needs to be addressed in a larger randomized study.     

Rapid hemostasis of arterial puncture sites with collagen in patients undergoing diagnostic and interventional cardiac catheterization

Despite the continuous reduction of sheath sizes in diagnostic and interventional cardiac catheterizations and the discontinuation of coumadin use after coronary stent implantation, a challenging role remains for hemostatic devices in the sealing femoral puncture sites. Since the introduction of the vascular hemostatic device (VHD) in 1991 and the hemostatic puncture closing device (HPCD) in 1992, numerous studies investigating these devices have been published. The deployment success rates reported in 2,292 patients for VHD is 97%, ranging from 88 to 100%. For HPCD, the mean deployment success rate resulting from 622 published patients leads to an identical result of 97%, ranging between 91 and 100%. For time to hemostasis, data have been analyzed according to the four different clinical situations, depending on level of anticoagulation (none or full) and the time of sheath removal (immediate or delayed). In randomized studies, when compared with the manual control groups, both devices revealed a statistically significant reduction in time to hemostasis: 12 to 16 minutes less for diagnostic catheterization and 14 to 30 minutes less for PTCA. As for minor local complications, no clinically relevant differences seem to exist. None of these devices has been proven to reduce major local complications. Prospective trials addressing early mobilization after percutaneous transluminal coronary angioplasty and the cost effectiveness of arterial closure devices in defined subgroups are warranted.     

Percutaneous suture closure for brachial artery puncture

Percutaneous suture closure for femoral artery hemostasis has gained broad use over the last few years since its introduction. The appeal of suture closure is the immediate and definitive hemostasis that it achieves, even in anticoagulated patients. Described is the use of the Perclose Techstar XL 6Fr suture closure device for the management of brachial artery puncture after diagnostic and therapeutic catheterization. A 6Fr Perclose Techstar device was used for hemostasis during ten procedures in eight patients. In addition, 6Fr and 7Fr sheaths were used. Hemostasis was achieved in all but one patient, in whom hemostasis was not achieved and surgical repair was necessary. The Perclose Techstar device is useful for selected patients for achieving brachial arterial puncture site hemostasis. The large excursion of the foot of the new closer device may not be as applicable in arteries as small as the brachial artery. Patients who are obese may be best suited for this approach.     

Clinical evaluation of SyvekPatch in patients undergoing interventional,EPS and diagnostic cardiac catheterization procedures

BACKGROUND: The SyvekPatch (Marine Polymer Technologies, Danvers, Massachusetts) has received Food and Drug Association market clearance for the rapid control of bleeding from vascular access sites and percutaneous catheters. A clinical evaluation was designed to determine the efficacy and safety of this vascular closure device in 1,000 consecutive patients after routine diagnostic and interventional procedures. METHODS: During a 3-month period, a total of 364 interventional patients (stenting, 55%; PTCA, 30%; EPS, 15%) and 636 diagnostic patients (left heart catheterization, 77%; right/left heart catheterization, 23%) were treated. Catheter sheaths ranged in size from 4 12 French (Fr). Antiplatelet therapy was employed in 35% of the interventional procedures. In approximately 20% of the cases, same-side repuncture occurred within 2 3 days. RESULTS: The use of the SyvekPatch on a total of 1,000 consecutive patients resulted in the rapid control of bleeding with only 1 major complication (0.1%; pseudoaneurysm) and few minor complications (1.3%). The pseudoaneurysm was most likely caused by the aberrant location of the sheath. All minor complications were either small hematomas (< 2.5 cm; rate, 0.75%) or slight oozing from the puncture site (rate, 0.6%). Outcomes measured included clinical effectiveness, ability to maintain the femoral access site for future interventions, major complication rates (access-site related hematoma that required blood transfusion or an extended hospital stay, pseudoaneurysm, arteriovenous fistula, arterial or venous thrombosis, and infection), patient comfort and operational efficiency. CONCLUSION: The strong safety and efficacy profile of the SyvekPatch has made a significant impact in our cardiac catheterization lab. Unlike existing vascular closure devices, the SyvekPatch was used following a diagnostic procedure even when a future interventional procedure was scheduled. The effectiveness of the SyvekPatch was not altered by anticoagulation or antiplatelet therapy. The patients and clinical staff were extremely satisfied with the use of the SyvekPatch .     

Femoral Arterial Hemostasis using the Angio-Sealª System after Coronary and Vascular Percutaneous Angioplasty and Stenting

The procedures of left cardiac catheterization and revascularization by angioplasty are associated with a substantial risk of hemorrhagic complications. This risk increases clearly in patients with an intravascular stent who require early high doses of anticoagulant therapy. The first purpose of our study was to evaluate the effectiveness of a mechanical system of femoral hemostasis (Angio-Seala, Sherwood Davis & Geck, St. Louis, Missouri) deployed in a group of 411 consecutive patients (302 males, 109 females, mean age 59 +/- 15) who successfully underwent percutaneous angioplasty (PA) and application of an intravascular stent (378 coronary, 33 vascular). The arterial closure system consists of a small absorbable anchor and a collagen pad connected to a suture thread which, at the end of the procedure, is positioned by percutaneous introduction at the site of the femoral puncture. All the patients studied received long-term platelet anti-aggregant therapy (ticlopidine 500 mg/day and ASA 150 mg/day) for 3D4 days before and for one month after the procedure, and an anticoagulant regimen of heparin sodium administered via intravenous bolus (10,000 IU) during the procedure, followed by subcutaneous heparin calcium (12,500 IU/day) for 21 days. Thirteen patients were treated intravenously with 10 mg abciximab and seven received pre-procedure coumadin. The ACT when the hemostasis system was positioned was 355 +/- 43 seconds. Successful hemostasis was reached in more than 95% of the patients (394/411 pts., 95.86%). In 17 (4.14%) of the 411 patients studied, the system failed; nine (2.19%) of these were attributed by the operator to a failure of the positioning device procedure, and the remaining 8 (1.95%) were attributed to a malfunction of the system. Overall complications were observed in 23/411 (5.6%) of the patients (pts) studied; eighteen were minor non-surgical hemorrhagic complications (bleeding and/or hematoma) which occurred primarily in the first 4 hours. In 4 cases (1%) vascular surgery was necessary for femoral pseudoaneurysm repair (2 pts) and femoral hematoma (2 pts). One patient (0.24%) complained of severe claudication related to a severe stenosis in the femoral artery caused by a malpositioning of the anchor. This patient was successfully treated with balloon angioplasty and stenting of the femoral artery. The average time to early mobilization was 9 hours, and all the patients without complications were completely mobile within 12 hours after the procedure; 380/411 (92.46%) of the patients were discharged 18D24 hours after percutaneous angioplasty. The second purpose of our study was to compare data from 411 consecutive patients treated with the Angio-Seala device after coronary and vascular angioplasty and stenting (Angio-Seal group), to a group of 387 consecutive patients where the femoral arterial hemostasis was obtained using manual compression after coronary angioplasty and stenting (manual compression group). We found significant differences (p < 0.01) in the most important elements concerning general patient management after the interventional procedure, with excellent improvements using the Angio-Seal device, including: successful hemostasis (95.86% vs. 88.37%); reduction of non-surgical hematomas (1.22% vs. 4.65%); reduction of surgical hematomas (0.49% vs. 2.84%); mobilization time (9 +/- 3 hours vs. 19 +/- 8 hours); and discharge within 18D24 hours (92.46% vs. 0.00%).