心导管术拔鞘管后应用经皮血管闭合器疗效观察

目的　比较心血管病患者心导管术拔鞘管后采用经皮血管闭合器 (Angio Seal)止血与人工压迫止血的安全性和疗效。方法　 197例心血管病患者在行心导管术后 ,分为人工压迫止血组(99例 ,其中冠状动脉造影 5 5例 ,冠状动脉介入术 4 4例 )和Angio Seal止血组 (98例 ,冠状动脉造影5 4例 ,冠状动脉介入术 4 4例 ) ,分别应用人工压迫止血和Angio Seal止血 ,观察两组止血时间、下床走动时间和血管并发症。结果　Angio Seal止血组与人工压迫止血组相比 ,止血时间与下床走动时间显著缩短。血管并发症发生率两组无显著差异。应用Angio Seal止血的成功率达 96 %。结论　心导管术后应用经皮血管闭合器缩短了止血与下床走动时间 ,并可能减少穿刺点并发症和病人不适感。     

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。     

冠状动脉介入性诊疗术后血管闭合装置与人工压迫止血比较的研究

目的 比较血管闭合装置与人工压迫止血对经皮冠状动脉介入性诊疗术后外周血管并发症的影响.方法 回顾分析2005年1月至2005年6月间,我院经股动脉介入性诊疗术后使用血管闭合装置与人工压迫止血后外周血管并发症的发生率.结果 122例患者接受了PCI,60例患者采取人工压迫止血,术后卧床时间(12.10±0.76)h,血管穿刺部位血肿11例,动静脉漏1例,出血假性动脉瘤2例;62例患者使用血管闭合装置,术后卧床时间(6.65±2.10)h,血管穿刺部位血肿5例,无动静脉漏和出血假性动脉瘤.使用血管闭合装置组与人工压迫组相比,患者的术后卧床时间明显缩短[(6.65±2.10)h和(12.10±0.76)h,P＜0.001),血肿(18.3%和8.1%,P=0.091)、动静脉漏(1.6%和0,P=0.323)、假性动脉瘤(3.3%和0,P=0.147)均有不同程度的下降,但差异无统计学意义.结论 PCI后使用外周血管闭合装置可缩短患者卧床时间,提高患者舒适度,但并不能明显降低外周血管并发症的发生率.     

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。     

冠脉介入术后Boomerang血管封堵器与人工压迫止血的对比分析

目的评价在冠状动脉造影（CAG）术及经皮冠状动脉介入术（PCI）后应用人工压迫与Boomerang血管封堵器在股动脉径路止血中的安全性和有效性。方法300例经股动脉行CAG或PCI治疗的患者,分为人工压迫止血组160例,Boomerang血管封堵器组140例,对比观察两种止血方法的成功率、止血时间、制动时间及血管并发症。结果Boomerang血管封堵器止血成功率96.4%,与人工压迫法比较止血时间及下肢制动时间不论单纯CAG还是PCI均显著缩短,PCI组中,封堵器止血后总的血管并发症发生率5.2%,显著低于传统压迫组（14.7%）。结论Boomerang血管封堵器止血迅速、有效、安全,优于人工压迫止血,值得临床推广。     

经皮冠状动脉介入术后应用血管闭合器与人工压迫止血效果比较

目的:对比冠状动脉造影术（CAG）与冠脉介入治疗（PC I）术后,应用经皮血管闭合器（Angio-SealTM）与人工压迫止血对患者止血时间、制动时间及并发症的发生率,评价Angio-SealTM止血疗效及安全性,并对其操作要点进行归纳总结。方法:将接受CAG与PC I术的患者277例,分为Angio-SealTM组（107例）与人工压迫止血组（170例）,观察两组患者止血时间、卧床及制动时间、并发症的发生率。结果:Angio-SealTM止血组与人工压迫止血组相比,止血时间、卧床及制动时间显著缩短,血管并发症明显降低。应用Angio-SealTM止血成功率97%。结论:Angio-SealTM止血明显优于人工压迫止血。     

经皮血管缝合器与人工压迫法对股动脉拔管术后止血效果的比较

比较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。 1 2 5例病人 (男 86例、女 39例 ,年龄 65 .7± 1 2 .3岁 ) ,在行心导管术后 ,分为人工压迫组 [Ⅰ组 ,63例 ,其中分为冠状动脉 (简称冠脉 )造影 (CAG)组35例 (IA) ,冠脉介入治疗术组 2 8例 (IB) ]和股动脉穿刺点经皮血管缝合组 [Ⅱ组 ,62例 ,CAG组 35例 (ⅡA) ,冠脉介入治疗术组 2 7例 (ⅡB) ]。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 ,平卧时间和并发症。结果 :与人工压迫止血组时间比较 ,经皮血管缝合组止血时间和平卧时间有显著缩短。有 4例病人首次应用缝合器止血失效 ,首次成功率达 91 % ( 5 8/62 ) ;失败 2例 ,再用缝合器缝合获得成功 ,总成功率达96% ( 60 /62 )。在ⅠB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 1h。结论 :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     

冠状动脉介入术后血管缝合的血管并发症分析

目的 分析冠状动脉介入术后Angioseal血管缝合器机械止血和人工压迫止血的血管并发症发生率。方法 947例冠状动脉介入诊治病例，179例术后使用Angioseal血管缝合器止血（机械组），另外768例进行人工压迫止血（人工组），比较二组的止血时间、制动时间和血管并发症发生率。结果 机械组显著缩短止血时间和制动时间(P<0.01)，但其与人工组的血管并发症发生率差异无统计学意义（P>0.05）。结论 使用Angioseal血管缝合器能显著缩短止血时间和制动时间，但不能减少股动脉穿刺并发症的发生率，不推荐介入术后常规使用机械止血装置。     

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     

冠状动脉介入术后血管缝合器的血管并发症分析

目的分析冠状动脉介入术后Angioseal血管缝合器机械止血和人工压迫止血的血管并发症发生率。方法947例冠状动脉介入诊治病例,179例术后使用Angioseal血管缝合器止血（机械组）,另外768例进行人工压迫止血（人工组）,比较二组的止血时间、制动时间和血管并发症发生率。结果机械组显著缩短止血时间和制动时间（P〈0．01）,但其与人工组的血管并发症发生率差异无统计学意义（P〉0．05）。结论使用Angioseal血管缝合器能显著缩短止血时间和制动时间,但不能减少股动脉穿刺并发症的发生率,不推荐介入术后常规使用机械止血装置。     

First human experience of thermal arterial closure

Objectives: This study was designed to evaluate the efficacy and safety of the CardioDex arterial closure device, which is a novel femoral artery closure device used following percutaneous cardiac catheterization. Background: Current devices utilized to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization include collagen plug and suture mediated devices, but are associated with significant vascular complications. The CardioDex closure device utilizes thermal energy to cause collagen shrinking and swelling and thereby, achieve hemostasis. Methods: The device was evaluated in a prospective nonrandomized single‐center trial with patients undergoing 6F invasive cardiac procedures. Femoral artery puncture closure was performed immediately at completion of the procedure, followed by 3–4 minutes of manual compression. Time to hemostasis (TTH), time to ambulation (TTA), and short‐term clinical follow‐up data were collected. Results: A total of 34 patients including 21 diagnostic and 13 interventional cases were evaluated. The median TTH was 3 min in diagnostic and 4 min in interventional cases. TTH was independent of activated clotting time (ACT). The median TTA was 2.75 hr and 3.37 hr in diagnostic and interventional groups, respectively. There were no major adverse events identified at 1 week and 30 day follow up. Conclusions: This first in human clinical experience with the CardioDex closure device demonstrates that in the small cohort studied, it is safe and effective in diagnostic cardiac catheterization and also in interventional cases on mild anticoagulation (mean ACT = 188 sec). It has the advantage of leaving no foreign material in the body following use. © 2013 Wiley Periodicals, Inc.     

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.     

Status of femoral closure devices

Both sealing and suturing closure devices have been shown to shorten hemostasis time, reduce the discomfort of manual or mechanical compression, and allow for earlier ambulation after cardiac catheterization and percutaneous coronary interventions without increasing vascular complications compared with conventional compression techniques. Several studies now report a reduction in vascular complications for percutaneous coronary intervention patients treated with closure devices compared with manual compression with pronounced benefit seen in patients receiving glycoprotein IIb/IIIa receptor inhibitors. Adoption of a simple predeployment femoral angiogram is now standard practice for use of a closure device. In an attempt to develop devices that are safer and more "user friendly," considerable modifications and improvements have been made in newer generation devices. Ultimately, the acceptance of femoral closure devices will depend on which device provides a simple approach with reliable hemostasis and a cost that can justify their incorporation into routine practice.     

A novel vascular sealing device for closure of percutaneous arterial access sites

The purpose of this study was to investigate the safety and efficacy of a novel vascular sealing device that incorporates a unique low-profile balloon-positioning catheter and a procoagulant delivered after diagnostic cardiac catheterization and percutaneous transluminal coronary angioplasty (PTCA) procedures. Current management of the vascular access site after percutaneous interventions is associated with patient discomfort and complications. Based on previously reported successful results in canine models, we proceeded with this first human feasibility and safety study. Immediately after an invasive procedure, the sealing device was successfully deployed at the femoral arterial access site in 24 of 24 procedures (diagnostic 19, PTCA 5). All patients were followed up at 1 month with clinical assessment, ankle-brachial index measurement, and Doppler ultrasound. Successful hemostasis was achieved in all patients. The activated clotting time before sealing device deployment was 125.5 +/- 22.2 and 267.8 +/- 60.0 seconds for diagnostic and PTCA patients, respectively. The time to hemostasis was 2.5 +/- 0.9 minutes for diagnostic and 6.0 +/- 2.2 minutes for PTCA patients. No major complications were observed. Coagulation markers (fibrinogen, D-dimer, thrombin-antithrombin-3 complex, and prothrombin fragment 1 and 2) measured before and after sealing device deployment did not reveal excessive intravascular thrombin generation or other coagulopathy. This novel vascular sealing device successfully achieves safe and effective vascular access site hemostasis immediately after cardiac catheterization and PTCA. These promising first human results will need to be confirmed by a multicenter randomized trial.     

Reduced vascular complications after percutaneous coronary interventions with a nonmechanical suture device: results from the randomized RACE study.

The objective of this study was to evaluate the safety and efficacy of a novel nonmechanical percutaneous suture device, X-Press, after diagnostic catheterization and percutaneous coronary interventions (PCIs) in the setting of glycoprotein IIb/IIIa inhibitor usage. Current percutaneous vascular suture devices remain mechanically complex and expensive and have not been shown to reduce major vascular complications. Using a 2:1 randomization scheme (2:1 ratio, device vs. compression), 393 patients undergoing diagnostic catheterization (n = 133) or PCI (n = 260) were randomized in the prospective Rapid Ambulation After Closure (RACE) study and evaluated for time to ambulation, time to hemostasis, treatment success, and incidence of major vascular complications. Glycoprotein IIb/IIIa inhibitors were used in 52% of PCI patients. There was a significant reduction in the primary efficacy endpoint of median time to ambulation for device compared to control with both diagnostic (2.2 vs. 6.2 hr; P = 0.0001) and PCI patients (4.1 vs. 14.7 hr; P = 0.0001). Device malfunction occurred in 3.1% patients without clinical sequalae. Equivalence in the primary safety endpoint, the incidence of major complications (vascular repair, ultrasound-guided compression, transfusion, or infection) at 14 days, was observed with the X-Press device (1/261; 0.4%) compared to control (3/132; 2.3%; P = 0.11). In PCI patients, half of whom received glycoprotein IIb/IIIa inhibitors, there was a significant reduction in the incidence of vascular complications in patients using the device (0/172; 0%) compared to control (3/88; 3.4%; P = 0.037). In diagnostic catheterization and PCI, a novel nonmechanical suture device reduced the time to ambulation and demonstrated equivalence in major complications compared to conventional compression techniques. The incidence of major complications after PCI was reduced with the device.     

心导管术后人工压迫止血无包扎对患者舒适度的影响

目的评价经皮股动脉冠状动脉介入诊疗术、人工压迫止血后无包扎对患者舒适度的影响。方法204例经皮股动脉冠状动脉造影或介入治疗的患者,按止血方法分为无包扎组即观察组123例（造影94例,介入治疗29例）和传统压迫组即对照组81例（造影38例,介入治疗43例）。观察组止血后4h床上活动,6h下地。对照组止血后12h下地活动。对比两组患者的舒适度。结果观察组患者舒适度明显优于对照组（P〈0．001）。结论心导管术后人工压迫止血无包扎4h床上活动,6h下地能提高患者舒适度,减轻腰背酸痛、排尿困难等不适,减少患者卧床痛苦。