经皮血管缝合器的安全性和疗效观察

目的　评估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的比较。主要观察终点包括术后可下床走动时间与血管并发症。方法　 10 5例病人 (男、80例 ;女 2 5例 ,平均年龄 65 .7± 12 .3岁 )在行心导管术后 ,随机分为人工压迫组 ( 组 ,5 3例 )和股动脉穿刺点经皮血管缝合器组 ( 组 ,5 2例 ) ,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、下床走动时间和并发症。结果　应用经皮血管缝合器组与人工压迫组止血时间 ( 7.5± 3.0和 19.5± 6.5分 ,P<0 .0 0 1)与下床走动时间 ( 4.5± 2 .0和 16.5± 5 .0小时 ,P<0 .0 0 1)有显著缩短 ,血管并发症 (有 6人伤口渗血和血肿 >4cm, 组 7.5 % ( 4/ 5 3) , 组 3.8% ( 2 / 5 2 ) ,两组无显著差异。有 4例病人首次应用缝合器止血失效 ,因为病人的缝合血管周围病变及皮肤组织凹陷 ,有一例缝合管拆除时缝合线断接 ,首次成功率达 94% ( 48/ 5 2 ) ,失败两例再用缝合器缝合获得成功 ,总成功率达 96% ( 5 0 /5 2 )。在 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 1小时。结论　表明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     

Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device

To overcome the challenge associated with achievement in hemostasis after a catheterization procedure, a suture-based closure device was compared with manual compression in a 600-patient randomized trial. The major study end points included the incidence of vascular complications and the time to ambulation after the procedure. The study included diagnostic or interventional procedures. The suture-mediated closure was performed immediately after the procedure independent of the anticoagulation level, whereas manual compression was performed per hospital protocol with sheath removal relying on normalization of patient’s anticoagulation status. A significant reduction in time to achieve hemostasis (7.8 ± 4.8 vs 19.6 ± 13.2 minutes, p <0001) and time to ambulation (4.5 ± 6.5 vs 17.8 ± 5 hours, p <0001) was associated with use of the suture-mediated closure device. The incidence of vascular complications was similar in the overall population (5.7% for suturing device vs 11.3% for compression) or in the interventional patient subset (8.4% for suturing device vs 9.6% for compression). There was a significant reduction in the incidence of vascular complications in the diagnostic procedure subset (4.4% for suturing device vs 12.1% for compression, p <0.05). Thus, the use of a suture-mediated closure device represents a safe alternative to manual compression. Hemostasis and ambulation can be achieved faster with the suturing device than with manual compression, with a potential reduction in access site complications.     

The safety and efficacy of "pre-closure" utilizing the Closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the second Perclose Accelerated Ambulation and Discharge (PARADISE II) Trial

BACKGROUND: Suture-mediated closure devices have been developed to improve patient comfort and safety following percutaneous coronary interventions (PCI). The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial which we reported previously showed that the Prostar XL appears to be a safe and effective device to achieve hemostasis, improve time-to-ambulation and discharge post-PCI. The diameter of suture capture with the Closer 6 Fr suture-mediated closure device is larger than an 8 Fr hole. This study was performed to assess the pre-closure efficacy using the Closer device in terms of time-to-hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications. METHODS: Between January and September 2001, 153 consecutive patients were enrolled in this study. In 97 patients, the Closer sutures were introduced prior to insertion of the 8 Fr sheath (pre-closure arm). In 56 patients, the sutures were tied at the conclusion of PCI upon sheath removal (standard arm). RESULTS: The Closer device was successfully placed on 152 of 153 attempts. The time-to-hemostasis, ambulation and discharge of the pre-closure arm patients seemed to be comparable to those of the standard arm and the PARADISE trial. No major complications were reported. CONCLUSION: The Closer seems to be as safe and effective as the Prostar XL device. The pre-closure technique is a safe means of achieving hemostasis post-PCI using large-sized sheaths without major complications.     

Use of suture-mediated vascular closure devices for the management of femoral vein access after transcatheter procedures.

Groin complications remain the most common complication of cardiac catheterization procedures. While the use of closure devices is increasing for arterial sheaths, venous sheaths tend to be removed and hemostasis achieved with manual compression. We report our experience using Perclose suture-mediated vascular closure device to achieve hemostasis and early mobility in patients who have had venous access as part of their procedure. There were a total of 42 patients (21 males; average age, 63.5 years) studied. The majority of the patients had 7 Fr sheaths (24), with access sites of sheaths up to 14 Fr being closed with this technique. Two patients developed complications at the access site: one patient requiring rehospitalization for intravenous antibiotics because of late access site infection, and one patient with deep venous thrombosis and pulmonary emboli. We conclude that the use of the Perclose suture-mediated closure device for closure of femoral venous access sites is feasible and should be considered especially in patients with larger venous sheaths and those at increased risk of groin complications.     

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。     

Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures.

BACKGROUND: The wide range of closure devices for arterial access sites still leaves room for improvement. METHODS AND RESULTS: We report our initial experience with a novel, cost-effective, suture-mediated device (6 French X-PRESS device, X-SITE Medical, Blue Bell, Pennsylvania) for closure of the arterial access site after both diagnostic and therapeutic interventions. A total of 51 consecutive patients are reported. The closure was performed immediately after the procedure. No patient had more than 5,000 U heparin administered during the procedure. The closure device was used in 36 patients (73%) after diagnostic angiography and in 15 patients (27%) after therapeutic intervention. The device could be successfully deployed in 48 patients (94%). In the remaining 3 cases (6%), hemostasis was achieved with standard manual compression without any further event. Immediate total hemostasis was achieved with the device in 44 of 48 patients (92%). Four devices (8%) could not be deployed correctly due to technical problems and the patients needed additional manual compression. The average time to achieve complete hemostasis was 5.5 +/- 3.5 minutes (range, 3-26 minutes). The patients were ambulated after a period of 1.3 +/- 0.4 hours of bedrest (range, 0.8-3.5 hours). Time to possible discharge was 4.2 +/- 3.4 hours (range, 0.9-12.5 hours). One patient experienced a minor complication (hematoma < 6 cm) and was treated with manual compression without clinical sequelae. Telephone follow-up was carried out 2 weeks after deployment and revealed no sequelae. CONCLUSION: The 6 French X-PRESS device is safe and effective in providing rapid hemostasis following interventional or diagnostic catheterization procedures. Use of the device is associated with a low rate of complications and facilitates quick hemostasis, mobilization and discharge.     

A comparison of arterial closure devices to manual compression in liver transplantation candidates undergoing coronary angiography

Whether arterial closure devices can be used safely in a coagulopathic population undergoing cardiac catheterization and at high risk for groin complications, such as liver transplant candidates, is unknown. In this prospective, non-randomized consecutive series of 80 liver transplant candidates undergoing coronary angiography, manual compression and arterial closure devices were compared. Ilio-femoral angiography was performed to determine suitability for use of the closure device. Bleeding and vascular complications were recorded along with time to ambulation. Arterial closure devices were used in 31 patients (39%), whereas manual compression was used in 49 patients (50 procedures) (61%). There were no significant differences between the two groups with respect to age, sex, cardiac risk factors, peripheral vascular disease, baseline platelet count or baseline INR. There were 10 total vascular complications out of 50 procedures (20%) in the manual compression group compared to 2 vascular complications out of 31 procedures in the arterial closure device group (6%; p = 0.12). The time to ambulation was significantly less in the group receiving arterial closure devices versus manual compression (4.2 1.8 hours versus 6.6 3.7 hours, respectively; p = 0.0003). In coagulopathic patients at higher risk for groin complications, arterial closure devices can be safely used and decrease time to ambulation compared to manual compression.     

心导管术拔鞘管后应用经皮血管闭合器临床观察

目的　与人工压迫止血比较 ,观察心导管术拔鞘管后应用经皮血管闭合器 (Perclose)止血的疗效及安全性。方法　 189例病人在心导管术后 ,分为人工压迫止血组(95例 ,其中单纯冠脉造影 4 6例 ,行冠脉成形术 4 9例 )和Perclose止血组 (94例 ,其中单纯冠脉造影 2 5例 ,行冠脉成形术 70例 )。观察两组止血时间 ,下床活动时间 ,血管并发症。结果　Perclose止血组与人工压迫止血组相比 ,止血时间 ,下床活动时间明显缩短。Perclose止血组未见血管并发症 ,与人工压迫止血组相比差异有显著性 (P <0 0 1)。应用Per close止血成功率为 98 9%。结论　心导管术拔鞘管后应用经皮血管闭合器 (Perclose) ,缩短了止血时间和下床活动时间 ,并可减少血管穿刺点并发症及病人不适感。     

Femoral vein hemostasis in children using a suture-mediated closure device

The safety and efficacy of a suture-mediated vascular closure device (Perclose, Abbott, Redwood City, CA) for hemostasis after percutaneous vascular access using >or=8-Fr sheath in the femoral vein after cardiac catheterization in children was assessed. Efficacy was determined by time to hemostasis and vessel integrity, using Doppler vascular ultrasound within 24 hours of the procedure. Forty children were randomized to treatment with either the closure device (n = 20, 10 males, weight 34.8 +/- 21 kg) or manual compression (n = 20, 10 males, weight 33.7 +/- 16 kg, P = 0.57 between groups for weight). Sheath sizes used were >or=8 French (8 Fr, n = 8; 9 Fr, n = 7; 10 Fr, n = 1; 11 Fr, n = 1; 12 Fr, n = 2; and 14 Fr, n = 1). Successful suture deployment was achieved in 14 of the 20 children. Mean time to hemostasis was 6.2 +/- 0.9 versus 14.9 +/- 1.1 minutes in controls (P = 0.003). Five of six unsuccessful deployments were in children with weights <20 kg. There were no differences in the occurrence of vascular complications (i.e., intraluminal thrombus) between the two groups as determined by ultrasound. A suture-mediated device appears safe and effective in achieving rapid vascular hemostasis even after the use of large sheath sizes in children.     

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.     

Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study.

BACKGROUND: Mechanical closure of percutaneous femoral arteriotomies following catheter based procedures remains problematic. METHODS: The EVS closure device is the first to utilize a staple to effect arteriotomy closure and was compared to manual compression following sheath removal in a 362 patient randomized (2:1 to device) multicenter trial. As pre-specified, one half of the patients underwent coronary intervention. RESULTS: Time to hemostasis was significantly reduced in the EVS group for both diagnostic (3.3 +/- 2.6 vs. 19.3 +/- 5.7 minutes; p < 0.001) and interventional procedures (5.5 +/- 5.1 vs. 22.3 +/- 9.9 minutes; p < 0.0001). Time to ambulation was similarly reduced in the EVS group following diagnostic (2.4 +/- 3.3 vs. 6.0 +/- 5.2 hours; p < 0.001) and interventional procedures (3.4 +/- 4.5 vs. 7.6 +/- 7.0 hours; p < 0.001). The incidence of major complications was similar between the EVS and manual compression groups at discharge (0.4% vs. 1.7%; p = NS) and at 30 day follow-up (0.4% vs. 2.5%; p = NS). CONCLUSION: Compared to manual compression, the EVS device provides a safe and effective method of femoral artery closure.     

Early ambulation after diagnostic cardiac catheterization: a 4 French study

This study is intended to test whether the use of new 4 French (Fr) catheters can safely eliminate the need for supine bed rest and allow earlier ambulation while decreasing groin site complications and patient discomfort. Diagnostic left heart catheterization was performed using 4 Fr catheters via the femoral approach in 100 consecutive patients. After femoral sheath removal, the mean compression time with a mechanical compression device was 16.07 +/- 3.19 minutes. Mean manual compression time was 18.3 +/- 5.7 minutes. Ninety-eight patients were able to sit up 30 degrees immediately after hemostasis was achieved. The mean ambulation time was 2.18 +/- 0.71 hours. There were no major vascular complications. Four patients developed a small area (2.5-5 cm) of ecchymosis at the femoral arterial puncture site. The study demonstrated that upper body elevation and early ambulation are safe as soon as hemostasis is achieved after 4 Fr cardiac catheterization.     

Safety and efficacy of a 6 French perclose arterial suturing device following percutaneous coronary interventions: a pilot evaluation

BACKGROUND: Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of potent antiplatelet pharmacotherapy. We evaluated the safety and efficacy of a 6 French (Fr) Perclose suturing device in achieving rapid hemostasis of the access site after PCI and thus improving patient comfort. METHODS: The 6 Fr Perclose (Prostar) device consists of a suture-based closure device delivered via introducer sheath designed for suturing of the arteriotomy puncture site. Over a 3-month period, the device was used in 48 consecutive PCI treated patients (age, 62 13 years; 70% male; 44% post myocardial infarction) and in-hospital groin complication rate was compared to 48 consecutive patients (age, 64 12 years; 64% male; 33% post myocardial infarction) who had manual compression hemostasis. RESULTS: Antiplatelet glycoprotein IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of Perclose-treated patients versus 42% of the manual compression group (p = 0.019). Leg immobilization duration was 3 4 hours in all patients sutured by the device; in patients with manual compression, the sheath was removed at an average of 4.8 2.5 hours after termination of the PCI and an additional 6 hours of leg immobilization were subsequently required. No difference in overall major complication rate was found between groups (6.2% in suture-mediated patients versus 9.3% in manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site. CONCLUSION: The 6 Fr Perclose device can be safely used to achieve rapid hemostasis and the device may hasten bed mobilization of PCI-treated patients despite frequent use of potent antiplatelet pharmacotherapy during coronary interventions.     

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。     

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.     

Immediate ambulation following diagnostic coronary angiography procedures utilizing a vascular closure device (The Closer)

OBJECTIVE: We investigated the safety and efficacy of The Closer, a suture-mediated vascular closure device, to facilitate immediate ambulation after diagnostic coronary angiography. METHODS AND RESULTS: We identified 487 non-consecutive patients who were eligible for an immediate ambulation protocol following vascular closure after diagnostic coronary angiography. A total of 434 patients (89%) were allowed immediate ambulation (mean time, 6.3 +/- 2.4 minutes) and 34 patients (7%) were treated with intermediate duration bed rest (mean time, 105.2 +/- 55.3 minutes). Of the 34 patients treated with intermediate duration bed rest, ten had minor bleeding from the arterial access tract requiring 2 5 minutes of light compression and 24 were delayed secondary to physician preference. Nineteen patients (4%) failed to achieve hemostasis with The Closer. Outpatients were followed up at 24 hours, and inpatients were followed up the next morning. Four patients (0.8%) suffered recurrent femoral artery bleeds after initially successful vascular closure. Three recurrent bleeds occurred during the observation period in-hospital and one occurred 6 days after device deployment. At follow-up, no patients developed the following: hematoma > 4 cm, ipsilateral retroperitoneal bleed, arterio-venous fistula, pseudoaneurysm, access site infection or loss of distal pulses. No patients had lower extremity ischemia or required blood transfusion. CONCLUSION: Use of The Closer after diagnostic angiography with subsequent immediate ambulation is safe and effective for most patients. Overall, hemostasis was achieved in 96% of patients, with 89% of our patients able to ambulate immediately and 7% able to ambulate after intermediate duration bed rest.     

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.     

Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures

Femoral arterial puncture is the most common access method for coronary angiography and percutaneous coronary interventions (PCIs). Access complications, although infrequent, affect morbidity, mortality, costs, and length of hospital stay. Vascular closure devices (VCDs) are used for rapid hemostasis and early ambulation, but there is no consensus on whether VCDs are superior to manual compression (MC). A retrospective review and nested case-control study of consecutive patients undergoing elective transfemoral coronary angiography and PCI over 3 years was performed. Hemostasis strategy was performed according to the operators' discretion. Vascular complications were defined as groin bleeding (hematoma, hemoglobin decrease ≥3 g/dl, transfusion, retroperitoneal bleeding, or arterial perforation), pseudoaneurysm, arteriovenous fistula formation, obstruction, or infection. Patients with postprocedure femoral vascular access complications were compared to randomly selected patients without complication. Data were available for 9,108 procedures, of which PCI was performed in 3,172 (34.8%). MC was performed in 2,581 (28.3%) and VCDs (4 different types) were deployed in 6,527 procedures (71.7%). Significant complications occurred in 74 procedures (0.81%), with 32 (1.24%) complications with MC and 42 (0.64%) with VCD (p = 0.004). VCD deployment failed in 80 procedures (1.23%), of which 8 (10%) had vascular complications. VCD use was a predictor of fewer complications (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). In the case-control analysis, older age and use of large (7Fr to 8Fr) femoral sheaths were independent predictors of complications. In conclusion, the retrospective analysis of contemporary hemostasis strategies and outcomes in elective coronary procedures identified a low rate of complications (0.81%), with superior results after VCD deployment. Careful selection of hemostasis strategy and closure device may further decrease complication rates.     

A prospective, randomized trial of topical hemostasis patch use following percutaneous coronary and peripheral intervention

The use of topical hemostasis patches has grown rapidly despite a paucity of evidence supporting their clinical utility. We performed a randomized, controlled trial to assess the efficacy of a topical hemostasis patch as a means to accelerate vascular hemostasis following percutaneous intervention. One hundred fifty (150) patients undergoing coronary or peripheral intervention through a 6 Fr femoral arterial sheath were randomized to sheath removal with either: (1) manual pressure and adjunctive use of a patch incorporating a polysaccharide based procoagulant material (SafeSeal Patch, Possis Medical Inc.); or (2) conventional manual pressure alone. Sheaths were removed when the activated clotting time (ACT) fell to < or = 250 seconds. Patients ambulated 2 hours after hemostasis was achieved. Time to hemostasis (duration of compression required until cessation of bleeding following sheath removal) was significantly lower in the hemostasis patch arm (11.8 +/- 3.6 vs. 13.8 +/- 5.8 minutes; p = 0.02). Attainment of hemostasis in < 15 minutes was also more likely among patients randomized to the hemostasis patch rather than manual compression alone (odds ratio = 2.5; 95% confidence intervals 1.2, 5.1; p = 0.014). The median time to ambulation (total duration from the end of the interventional procedure to ambulation) was significantly reduced among patients in the hemostasis patch arm (2.8 vs. 3.8 hours; p = 0.03). Bleeding complications were uncommon and did not differ between the study arms. In conclusion, this trial supports the concept that the polysaccharide-based SafeSeal Patch enhances access site hemostasis following endovascular intervention.     

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.