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。     

A new technique for vascular access management in transcatheter aortic valve implantation

Objectives: To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. Background: Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. Methods: Fifty‐two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards‐Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. Results: In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards‐Sapien) or one (CoreValve). There were serious “on‐table” complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure—iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. Conclusion: Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites. © 2009 Wiley‐Liss, Inc.     

血管闭合器应用的现况与展望

股动脉径路是冠状动脉及外周血管介入诊疗的主要途径。然而,股动脉径路穿刺的围术期血管并发症仍是每个介入医生时常面对的问题。研究显示,与压迫止血比较,血管闭合器可减少围术期血管并发症,缩短患者制动时间,增加患者舒适度。现就相关内容及最新进展进行简要综述。     

Left femoral vein access for transcatheter mitral valve interventions in unfavorable interatrial septal anatomy

Optimal transseptal puncture (TSP) position on the interatrial septum as well as proper catheter direction and maneuverability in the left atrium (LA) are key elements for successful mitral valve (MV) interventions. TSP is usually performed from the right femoral vein being more comfortable for the operator and easier to reach the fossa ovalis. In the cases reported, TSP was performed from left femoral vein (LFV) to improve delivery system maneuverability and trajectory inside the LA in the context of MV repair with MitraClip. According to this early experience, LFV approach might be considered as first choice or as an alternative solution in patients in whom a higher position of the delivery system relative to the mitral annulus is needed.     

Ultrasound guidance for femoral venous access in patients undergoing pulmonary vein isolation: A quasi-randomized study

Introduction

Routine ultrasound (US) guidance for femoral venous access to decrease vascular complications of atrial fibrillation (AF) ablation procedures has been advocated. However, the benefit has not been unequivocally demonstrated by randomized-trial data.

Methods

Consecutive patients undergoing pulmonary vein isolation (PVI) on uninterrupted anticoagulant treatment were included. A quasi-random allocation to either US-guided or conventional puncture group was based on which of the two procedure rooms the patient was scheduled in, with only one of the rooms equipped with a US machine including a vascular transducer. The same four novice operators in rotation, with no relevant previous experience in US-guided vascular access performed venous punctures in both rooms. Major and minor vascular complications and the rate of prolonged hospitalization were compared. Major vascular complication was defined as groin hematoma, arteriovenous fistula, or pseudoaneurysm. Hematoma was considered as a major vascular complication if it met type 2 or higher Bleeding Academic Research Consortium criteria (requiring nonsurgical, medical intervention by a health care professional; leading to hospitalization or increased level of care, or prompting evacuation).

Results

Of the 457 patients 199 were allocated to the US-guided puncture group, while the conventional, palpation-based approach was performed in 258 cases. Compared with the conventional technique, US guidance reduced the rate of any vascular complication (11.63% vs. 2.01%, p < .0001), including both major (4.26% vs. 1.01%, p = .038) and minor (7.36% vs. 1.01%, p = .001) vascular complications. In addition, the rate of prolonged hospitalization was lower in the US-guided puncture group (5.04% vs. 1.01%, p = .032).

Conclusion

The use of US for femoral vein puncture in patients undergoing PVI decreased the rate of both major and minor vascular complications. This quasi-randomized comparison strongly supports adapting routine use of US for AF ablation procedures.     

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.     

A novel technique for simultaneous hemostasis of ipsilateral radial and ulnar artery access sites

With the increased use of transradial artery access (TRA) for diagnostic and coronary interventional procedures, crossover to the ipsilateral ulnar artery after TRA failure is being reported more frequently. A major challenge with ipsilateral transradial and ulnar artery access is achieving efficient patent hemostasis of both the radial and ulnar arteries at the completion of the procedure. In this report, we describe two cases of failed TRA with subsequent ipsilateral ulnar artery access. A novel and practical technique of simultaneous patent hemostasis of both the ipsilateral radial and ulnar artery access sites is described, using a QuikClot^® Radial^® hemostasis pad and a TR Band^®.     

Re‐access complication with a starclose device

Diagnostic cardiac catheterizations are predominantly performed using access through the femoral artery. To improve patient comfort and early mobilization, a number of percutaneous closure devices have been developed. One such device using the nitinol clip was developed by Abbott Vascular Devices and was approved for use on the basis of the results of the Clip Closure In Percutaneous Procedures (CLIP) study. The safety of repuncture through a previously deployed device has not been established in humans. We present the case of a patient who had an arterial line placed for post‐operative monitoring after cardiac surgery at the site of a previous arteriotomy closed with the Starclose device. The catheter traversed through the central portion, tethered to the periphery of the ninitol clip, and required surgery for extraction. © 2009 Wiley‐Liss, Inc.     

Incidence and treatment of local stenosis or occlusion at the vascular access site leading to limb ischemia and new‐onset intermittent claudication after percutaneous interventions: Implications of Vascular Closure Devices

Objective: Vascular access site complications (ASCs) are an ongoing hazard of percutaneous interventions (PI). We analyzed incidence, indication, and results of operative repair of access site complications leading to acute limb ischemia (ALI) or new‐onset severe claudication (CI) in our institution during an 8‐year period. Methods: Retrospective analysis: demographic parameters, details of coronary or vascular intervention, use of a vascular closure device (VCD), clinical presentation, diagnosis and therapy. Endpoints: perioperative outcome (death, limb loss, and need for re‐operation/intervention) and length of hospital stay. For comparison of annual operation rates, patients were grouped by the years 2001 to 2004 (no use of VCD) and 2005 to 2008 (selective use of a VCD; in all cases: Angio‐Seal), and Chi‐Square‐test was applied. Results: Fifty‐one patients (19 female; median age: 64.5 years) underwent repair of arterial ASCs causing ALI (n = 32) or new‐onset severe CI (n = 19) after 58,453 catheter interventions (overall rate: 0.087%; ALI: 0.055%; CI: 0.032%). Corresponding with more widespread VCD use, the annual number of ALI and new onset CI increased significantly (P < 0.001). Perioperative outcome: 30 day mortality was 4%. No limb loss occurred. Re‐operations were indicated in 10 patients (20%) for: hematoma (n = 5), local infection (n = 3), revision of fasciotomy (n = 1), and repeated thrombectomy (n = 1). Median length of postoperative hospital stay: 7 days (range: 1–28). Conclusion: ALI and new‐onset severe CI due to access site complications after PI are rare, however, they are potentially threatening life and limb. The use of VCDs results in an overall increase of ischemic complications. © 2011 Wiley Periodicals, Inc.     

A randomized trial comparing compression,perclose proglide™ and Angio‐Seal VIP™ for arterial closure following percutaneous coronary intervention: The cap trial

Objective: This prospective randomized trial compared the Angio‐Seal VIP? with Perclose Proglide? and to manual compression with respect to time to hemostasis and ambulation, patient satisfaction, and vascular complications following percutaneous coronary intervention (PCI). Background: The use of arterial closure devices for the reduction of vascular complications following PCI remains controversial. There have been no head to head trials comparing these most commonly used arterial closure devices following PCI. Methods: Two hundred patients undergoing PCI were randomized to manual compression, Perclose Proglide? or Angio‐Seal VIP?. Ambulation was allowed 3 hr after Perclose Proglide? or Angio‐Seal VIP? and 6 hr after compression. Results: There were 10 failures to deploy Perclose Proglide? and none for Angio‐Seal? (P < 0.01). Time to hemostasis was significantly shorter with Angio‐Seal VIP? compared with Perclose Proglide? (5.3 vs. 46.8 min, P < 0.01). Time to ambulation was shorter with Angio‐Seal VIP? than with Perclose Proglide? (261 vs. 334 min, P < 0.05) and the time to ambulation, as expected, was longest with compression (943 min, P < 0.01 vs. Angio‐Seal VIP? and Perclose Proglide?). Delay in ambulation was higher with Perclose Proglide? than with Angio‐Seal VIP? (18 vs. 9, P < 0.01). There was no significant difference in major vascular complications between groups. Compared with compression, patient discomfort was significantly improved with Angio‐Seal? (1.5 vs. 2.0, P < 0.01), but not with Perclose Proglide?. Conclusion: The Angio‐Seal VIP? device has a high rate of deployment success, which is significantly better than that of Perclose Proglide?. Angio‐Seal VIP? allows for earlier hemostasis and ambulation compared with both compression and Perclose Proglide? and is associated with greater patient satisfaction compared with compression. © 2008 Wiley‐Liss, Inc.     

Early clinical experience with the 6 French Angio-Seal device: immediate closure of femoral puncture sites after diagnostic and interventional coronary procedures.

The objective of this study was to assess the early safety and efficacy of the novel 6 Fr Angio-Seal device for routine clinical use after diagnostic cardiac catheterization and coronary angioplasty. In a prospective study, we used the 6 Fr Angio-Seal device in 180 consecutive patients (131 male, 49 female, mean age 60.7 years) for closure of femoral arterial puncture sites immediately after diagnostic (n = 108) or interventional (n = 72) coronary procedures independent of the coagulation status. All patients were monitored for 24 hr after the procedure and followed for 30 days. The closure device was successfully deployed in 95.4% after diagnostic catheterization versus 98.6% after coronary angioplasty (P = 0.963). Immediate hemostasis was achieved in 91.5% versus 90.1% of the patients (P = 0.993). Major complications were observed 1.9% versus 2.8% of the patients (P = 0.885). During 30-day follow-up, no late events or complications were reported. The 6 Fr Angio-Seal device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.     

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.     

The fellows stitch: large caliber venous hemostasis in pediatric practice

Objective : To analyze safety and efficiency of a subcutaneous figure of eight suture for hemostasis after large caliber venous sheath access in children. Background : Vascular complications remain a significant cause of morbidity after pediatric cardiac catheterization. In an attempt to reduce such complications and yet improve lab efficiency and decrease length of stay, various techniques have been applied to improve time to hemostasis. Methods : Prospectively recorded were vascular complications and hemostasis times in children where hemostasis was attempted using a figure of eight subcutaneous suture following large caliber venous cannulation. These were compared to a matched group achieving hemostasis using standard manual pressure techniques. Vascular ultrasound assessments were performed within 24 hr of hemostasis in both groups. Results : Thirty‐two subcutaneous sutures were placed in 26 children, mean weights 31.9 kg [median (range): 29.4 (8.4 to 96) kg], with a mean sheath French size of 9.2 [ 8 ; (6 to 22)], 11 >10 French, compared to 33 sheaths in 30 cases using manual compression, mean sheath French size 9.1 (9; (6 to 13), with 10 cases ≥10 French. The mean and median times to hemostasis were shorter in the suture group: 13.6 min (P < 0.05) and 10 min (P < 0.05), respectively. Vascular complication rate was also lower in the suture group (n = 0) compared with the control group (n = 2) but did not achieve statistical significance. Conclusions : A subcutaneous figure of eight suture hemostasis strategy can provide a safe and efficient method for large caliber venous hemostasis in a pediatric practice with improved hemostasis times and no additional morbidity. © 2011 Wiley Periodicals, Inc.