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。     

Complications of femoral artery closure devices.

We have examined our prospectively collected experience with femoral artery closure devices. Vasoseal (n = 937), Angioseal (N-742), and Techstar (n = 1001) were utilized consecutively in our laboratory for diagnostic and interventional femoral artery closures. Complications were compared to a similar number of closures with manual compression (MC; n = 1019) before closure devices were utilized. The incidence of surgical repair, acute femoral closure, transfusion due to groin complications, readmission for groin complications, infection, and total complications were examined. We found that the Vasoseal and Angioseal devices were associated with higher rates of total complications than manual compression. The Techstar and manual compression had similar total complication rates. Acute femoral artery occlusion was a potentially serious complication with the Angioseal device. Groin infection occurred with each of the closure devices but not with manual compression.     

Randomized comparison of rapid ambulation using radial, 4 French femoral access, or femoral access with AngioSeal closure.

Radial access and closure devices are associated with improved quality of life (QOL) after cardiac catheterization. Whether this is related to the access site or time to ambulation is unknown. Seventy-five patients undergoing cardiac catheterization were randomized to femoral 6 Fr with AngioSeal closure (F+C), femoral 4 Fr without closure, and radial (R) access. All patients were ambulated at 1 hr. QOL was measured utilizing visual analogue scales and Short Form-36 at baseline, 1 day, and 1 week. Time to ambulation and discharge were equivalent, as was postprocedure QOL. However, angiographic quality was lower in the 4 Fr group (P < 0.0001) and catheterization costs were higher in the F+C group (P < 0.0001). Ambulation 1 hr after catheterization can be accomplished utilizing radial, femoral 6 Fr with closure device, or femoral 4 Fr access with equivalent outcomes and QOL. However, this is achieved at a higher cost with a closure device, or lesser angiographic quality with 4 Fr catheters.     

Fluoroscopy vs. Traditional guided femoral arterial access and the use of closure devices: A randomized controlled trial

Objective: To compare the effectiveness of accessing the common femoral artery (CFA) using fluoroscopic guidance (FG) versus traditional anatomic landmark guidance (TALG) during cardiac catheterization and to determine the effect of the two modalities on the appropriateness for use of vascular closure devices (VCDs). Background: Previous studies have shown a consistent relationship between the head of the femur and the CFA, yet there is no prospective data validating the superiority of fluoroscopy‐assisted CFA access. Methods: A total of 972 patients were randomized to either FG or TALG access. The primary endpoint of the study was the angiographic suitability of the puncture site for VCD use. Secondary endpoints included arteriotomy location, time and number of attempts needed to obtain access, and the incidence of vascular complications. Results: Of these, 474 patients were randomized into the FG arm and 498 patients into the TALG arm. A total of 79.5% of patients in the fluoroscopy arm and 80.7% in the traditional arm (P = 0.7) were deemed angiographically suitable for VCD based on the arteriotomy. The fluoroscopy group had significantly less arteriotomies below the inferior border of the head of the femur (P = 0.03). Total time for sheath insertion (105.7 ± 130.7 vs. 106.5 ± 152.6 sec) and number of arterial punctures (1.1 ± 0.4 vs. 1.1 ± 0.5) did not differ among the FG and TALG, respectively. The rates of vascular complications were not different. Conclusion: The angiographic suitability for VCD was not different between FG and TALG groups. Fluoroscopy decreased the number of low arteriotomies. The time to sheath insertion, number of arterial punctures needed to obtain access, and the incidence of complications were also similar. © 2009 Wiley‐Liss, Inc.     

Femoral access management: comparison between two different vascular closure devices after percutaneous coronary intervention

OBJECTIVES: Several devices have been proposed as an alternative to manual compression (MC) for femoral access management (FAME) following catheterization. Although these devices allow earlier ambulation, they have not always been shown to reduce vascular complications. As a consequence, their cost efficacy is not obvious. METHODS: During MC a special catheter deployed temporarily within the artery to achieve haemostasis (Bio-DISC) (BD) was compared with an anchor-collagen based system Angio-Seal (AS) among 463 consecutive patients undergoing PCI. We examined vascular or systemic complications, nursing time spent to puncture site management and patient's satisfaction. RESULTS: Relative contra-indications to the use of vascular closure devices were encountered in 158 patients. There were no significant differences in baseline characteristics between the patients assigned to each of the 3 treatment groups. The deployment success rate was 98% for AS and 90% for BD (p = 0.037). Vascular complications occurred in 10.8%, 4.0% and 5.8% (p: NS) of MC, AS and BD patients, respectively. The longer sheath dwell time contributed to most of the complications in MC and BD. Nursing time spent for access management was 48.9 min in MC; 28.1 min in BD and 9.9 min in AS (p < 0.0001 ). Satisfaction score above 70 was noted in 46%, 86% and 92% of patients managed by MC, BD and AS, respectively. CONCLUSION: AS use is associated with fewer complications, improved patient well being and saves 39 minutes of nursing time. The additional cost of AS is justified when used in selected patients undergoing PCI.     

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.     

Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: a randomized trial.

One hundred patients undergoing routine diagnostic or interventional catheterization were randomly assigned to receive either percutaneously applied collagen (group A; n = 50) or conventional pressure dressing (group B; n = 50) for sealing of the femoral artery. Clinical variables were comparable in both groups. The heparin dose was 100 IU/kg in 30 patients and 200 IU/kg in 20 patients of either group. The average compression time was 4.3 min in group A and 42.3 min in group B (p < .001). Bleeding was not observed in group A but was observed in 6/50 patients in group B. The time to ambulation was 6.4 hr (range, 4-12 hr) in group A and 21.6 hr (range, 10-48 hr) in group B (p < .001). Hematomas with a diameter of > 6 cm developed in 4/50 patients in group A and in 11/50 patients in group B (p < .05). Blood-transfusions or surgical interventions were not required and there was no loss of ankle pulses in either group. In conclusion, percutaneously applied collagen reduced compression time and duration of bedrest after diagnostic catheterization and PTCA. Despite earlier ambulation, the incidence of bleeding was lower with collagen than with conventional pressure dressing.     

Sheath pulling immediately after PTCA: Comparison of two different deployment techniques for the hemostatic puncture closure device: A prospective,randomized study

Sheath pulling immediately after percutaneous transluminal coronary angioplasty (PTCA) increases patients' comfort, decreases burden for the medical staff, and may reduce hospital costs by shortening the length of stay. Immediate sheath pulling in anticoagulated patients with a low risk of bleeding complications is feasible using hemostatic devices. For the hemostatic puncture closing device (HPCD), published data regarding sheath pulling in patients immediately after PTCA is limited. Furthermore, no study addressed the question whether the recommended deployment time (DT) of 30 min can be reduced to a few minutes. We, therefore, performed a prospective study, randomizing 140 patients to a DT of 5 and 30 min, respectively. There were no statistical differences in gender, age, height, weight, or cardiovascular risk factors between the two groups. Blood pressures measured invasively immediately before sheath removal were comparable. Activated coagulation time just prior to sheath removal was 227 ± 52 sec in the DT-5 group and 223 ± 37 sec in the DT-30 group. After deployment, 74% of the DT-5 patients and 71% of the DT-30 patients showed immediate and complete hemostasis. The remaining patients showed only little oozing with complete hemostasis at the time of the final device removal. Hematoma size after 24 hr was 6.2 ± 4.4 cm² for DT-5 and 6.8 ± 8.2 cm² for DT-30 patients. There was no statistical difference between both groups. No severe bleeding or major complications were observed in either group. Thus, the use of a collagen system with an intra-arterial anchor (HPCD) is effective and safe when sheaths are pulled immediately after PTCA. The reduction of deployment time from 30 to 5 min is not related to an increased risk of bleeding or other vascular complications; patients can be transferred much faster to the ward, therefore reducing the burden on the personnel in the catheterization laboratory and increasing patients' comfort by allowing them to return to their rooms without a sheath. Cathet. Cardiovasc. Diagn. 41:378–383, 1997. © 1997 Wiley-Liss, Inc.     

Stenting in acute coronary syndromes: a comparison of radial versus femoral access sites

Objectives. The purpose of the present study was to compare the radial approach with the femoral approach for coronary stenting in patients with acute coronary syndromes.Background. Aggressive anticoagulation in patients with acute coronary syndromes increases the risk of femoral vascular complications. The transradial approach has the potential to significantly reduce the incidence of access site bleeding complications in this group of patients.Methods. One hundred forty-two patients with acute coronary syndromes undergoing coronary stenting were prospectively randomized to have their procedure performed from either the radial or femoral access site and the results compared.Results. Nine of 74 patients randomized to the radial group crossed over to the femoral group (6 negative Allen tests, 3 access failures). Patient demographics were the same in both groups. Primary success was identical: 96% radial, 96% femoral, ns. There were no procedural myocardial infarctions or deaths, and no patient was referred for emergency bypass surgery. There were no access site bleeding complications in the radial group as opposed to 3 (4%) in the femoral group, p < 0.01. Postprocedure length of stay, days (1.4 ± 0.2 radial vs. 2.3 ± 0.4 femoral, p < 0.01) as well as total hospital length of stay (3.0 ± 0.3 radial vs. 4.5 ± 0.5 femoral, p < 0.01) were significantly reduced in the radial group. Total hospital charge was also significantly lower in the radial group ($20,476 ± 811 radial versus $23,389 ± 1,180 femoral, p < 0.01).Conclusion. Coronary stenting from the radial approach is efficacious in patients with acute coronary syndromes. Access site bleeding complications are less, and early ambulation results in a shorter hospital length of stay. There was a 15% reduction in total hospital charge in the radial group.     

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.     

Effect of hemostatic device on radial artery occlusion: A randomized comparison of compression devices in the radial hemostasis study

BackgroundAsymptomatic radial artery occlusion (RAO) is a major limitation of transradial catheterization (TRC). Two radial compression hemostatic devices are compared for their respective effects on RAO.MethodsIn a prospective, randomized, single center, blinded trial, 320 patients were randomly treated with a TR band (Terumo Corporation) or Safeguard Radial (Merit Medical). Institution wide protocols consisting of anticoagulation, patent hemostasis, duration of compression, and use of 6 French slender sheaths (Terumo Corporation) were observed. Patient discomfort related to the device was recorded using the universal pain scale. Radial artery patency was evaluated by reverse Barbeau's test prior to discharge (1-hour post-diagnostic catheterization or 6–24 hour post-intervention) and at 30-days.ResultsOf the 320 patients, 155 were randomized to the TR group (TRG) and 159 to the Safeguard group (SGG). 6 patients were excluded due to the inability to insert 6 Fr slender sheaths or patient withdrawing consent. Demographic and procedural characteristics were similar with the exception of the type of coronary procedure performed. Both bands were equally effective in achieving patent hemostasis. Despite having a higher rate of post-procedure hematoma (1.29% TRG vs. 3.1% SGG, p = 0.04) and acute RAO (3.8% TRG vs. 6.28% SGG, p = 0.05) with the Safeguard band, at 30 days RAO was similar in both groups (1.9% TRG vs. 2.5% SGG; p = 0.21). Patients in the SGG reported significantly less band discomfort and were found to require less air to achieve patent hemostasis.ConclusionEvidence-based contemporary TRC protocols of using smaller diameter access, anticoagulation, and use of just enough pressure for the shortest duration of time to achieve hemostasis is associated with very low RAO rate at 30 days irrespective of the radial compression device used.     

乳果糖联合聚乙二醇方案对不同风险分层人群肠道准备效果的单中心随机对照研究

目的:评估乳果糖联合聚乙二醇对于不同风险分层人群的肠道准备效果及安全性。方法:纳入需行结肠镜检查的患者208例,其中肠道准备高风险患者108例和肠道准备低风险患者100例。利用区组随机化法,将肠道准备高风险患者分为A组(乳果糖+聚乙二醇组)54例和B组(聚乙二醇组)54例,将肠道准备低风险患者分为C组(乳果糖+聚乙二醇...     

Evaluation of hemostasis with soft coagulation using endoscopic hemostatic forceps in comparison with metallic hemoclips for bleeding gastric ulcers: a prospective, randomized trial

Background

Endoscopic high-frequency soft coagulation, recently developed in Japan, is available for the management of gastric bleeding in cases of bleeding gastric ulcers and bleeding during endoscopic submucosal dissection. The aim of this study was to evaluate the efficacy of hemostasis with soft coagulation for bleeding gastric ulcers by comparing it with hemoclips in a prospective, randomized trial.

Methods

During the period of April 2006 to March 2008, 96 patients that had gastric ulcers with bleeding or nonbleeding visible vessels were enrolled in this study. All of the 96 patients were randomly divided into two groups: endoscopic hemostasis with soft coagulation (Group I) or endoscopic hemoclipping (Group II).

Results

A total of 41 (85%) out of 48 patients in Group I and 38 (79%) out of 48 patients in Group II were successfully treated with soft coagulation or clipping alone, respectively. The endoscopic hemostasis rate for the initial modality in combination with another endoscopic procedure performed after the initial method was 98% in both groups. One patient in Group I (2%) and five patients in Group II (10%) experienced recurrent bleeding. The time required to achieve hemostasis was shorter in Group I compared with Group II (9.2 ± 11.1 vs. 13.6 ± 9.4 min; P < 0.05).

Conclusions

This study revealed that soft coagulation is as effective as hemoclipping for treating bleeding gastric ulcers. The time required to achieve hemostasis was shorter with the soft coagulation procedure.     

A prospective, randomized evaluation of nonsurgical closure of femoral pseudoaneurysm by compression device with or without ultrasound guidance.

Femoral artery pseudoaneurysm (PA) is a significant complication following diagnostic or therapeutic catheterization. The treatment of choice for femoral artery PA is freehand ultrasound-guided compression repair (UGCR). An alternative method is compression by mechanical devices. The study evaluated the mechanical compression device (FemoStop) with (G1) or without (G2) ultrasound guidance for initial placement in a randomized fashion. Thirty-eight patients (20 women, 18 men) age 40 to 85 (mean 54) years with clinical signs of PA underwent diagnostic color Doppler ultrasound. Randomization yielded 19 patients each for G1 and G2. PA occurred after 12 diagnostic cardiac catheterizations, 18 coronary stent implantations or balloon angioplasties, 2 electrophysiology procedures, and 6 peripheral percutaneous transluminal angioplasties. The G1 protocol was successful in 15 of 19 patients (79%), with a mean compression time of 28 min. The three other patients were treated successfully with UGCR. Only one patient needed vascular surgery. The G2 protocol was successful in 14 of 19 patients (74%) with a mean compression time of 33 min. The failed patients were treated successfully: three with UGCR and two with the same mechanical compression device now positioned under ultrasound control. Compression therapy with the compression device (FemoStop) for iatrogenic femoral pseudoaneurysm does not require ultrasound guidance for positioning. Cathet. Cardiovasc. Intervent. 47:304-309, 1999.     

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.     

Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: A randomized trial

One hundred patients undergoing routine diagnostic or interventional catheterization were randomly assigned to receive either percutaneously applied collagen (group A; n = 50) or conventional pressure dressing (group B; n = 50) for sealing of the femoral artery. Clinical variables were comparable in both groups. The heparin dose was 100 IU/kg in 30 patients and 200 IU/kg in 20 patients of either group. The average compression time was 4.3 min in group A and 42.3 min in group B (p < .001). Bleeding was not observed in group A but was observed in 6/50 patients in group B. The time to ambulation was 6.4 hr (range, 4–12 hr) in group A and 21.6 hr (range, 10–48 hr) in group B (p < .001). Hematomas with a diameter of >6 cm developed in 4/50 patients in group A and in 11/50 patients in group B (p < .05). Blood-transfusions or surgical interventions were not required and there was no loss of ankle pulses in either group. In conclusion, percutaneously applied collagen reduced compression time and duration of bedrest after diagnostic catheterization and PTCA. Despite earlier ambulation, the incidence of bleeding was lower with collagen than with conventional pressure dressing.     

Comparison of outcome and complications using different types of devices for percutaneous closure of a secundum atrial septal defect in adults: a single-center experience.

The objective of this study was to find differences in outcome and complications using three different types of devices for percutaneous atrial septal defect (ASD) closure in adults. Percutaneous closure of a secundum-type ASD is increasingly performed in adult patients. All adult patients who underwent a percutaneous closure of a secundum-type ASD in our center between November 1996 and November 2004 were included. Failure was defined as dislocation or embolization of the device, which required surgical intervention. Periprocedural and mid-term complications were registered. Sixty-five patients, mean age 45.7+/-18.1 years (18 men, 47 women), underwent a percutaneous closure of an ASD with an ASDOS in 3, an Amplatzer in 36, and a Cardioseal/Starflex closure device in 26 patients. During an overall median follow-up of 1.2 years (range, 0.1-6.7 years), the failure occurred in four patients, all Cardioseal/Starflex (P=0.04). Within the Cardioseal/Starflex subgroup, the ASD and device diameters were significantly higher in those patients in whom the primary endpoint occurred compared to the others, 18.8+/-3.8 vs. 13.0+/-3.8 mm for ASD diameter (P=0.01) and 40 (range, 40-43) vs. 33 mm (range, 20-40) for device diameter (P=0.008). Overall complications were transient arrhythmias in 15.4%, pericardial effusion in 1.5%, and transient ischemic attack in 1.5%. Complete closure 6 months after the procedure occurred in 79.6%, without difference between the devices. Percutaneous ASD closure seems to be a relatively safe and effective procedure. However, using the larger Cardioseal/Starflex devices for closure seems to be related to a higher rate of device dislocation and embolization.