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。     

Hemostatic effect of topical hemocoagulase spray in digestive endoscopy

AIM: To evaluate the hemostatic effect of topical hemocoagulase spray in digestive endoscopy.METHODS: Eighty-nine patients who developed oozing bleeding during endoscopic treatment from September 2014 to October 2014 at Center for Digestive Endoscopy, Tianjin Medical University General Hospital were randomly divided into either a study group(n = 39) or a control group(n = 50). The study group was given topical hemocoagulase spray intraoperatively, while the control group was given traditional 8% norepinephrine spray. Hemostatic efficacy was compared between the two groups. Bleeding site, wound cleanliness and perforation were recorded, and the rates of perforation and late bleeding were compared.RESULTS: Successful hemostasis was achieved in 39(100%) patients of the study group and in 47(94.0%) patients of the control group, and there was no significant difference in the rate of successful hemostasis between the two groups. Compared with the control group, after topical hemocoagulase spray in the study group, the surgical field was clearer, the bleeding site was more easily identified, and the wound was cleaner. There was no significant difference in the rate of perforation between the study and control groups(16.7% vs 35.0%, P = 0.477), but the rates oflate bleeding(0% vs 15.8%, P = 0.048) and overall complications(P = 0.032) were significantly lower in the study group.CONCLUSION: Topical hemocoagulase spray has a definite hemostatic effect for oozing bleeding in digestive endoscopy, and this method is convenient, safe, and reliable. It is expected to become a new method for endoscopic hemostasis.     

冠状动脉介入治疗术后Angio-Seal血管封堵器的应用研究

目的比较经股动脉冠脉介入术后应用Angio-Seal血管封堵器（VCD）与徒手压迫止血法（MC）的临床疗效。方法将186例患者随机分成VCD及MC两组各93例。VCD组应用Angio-seal血管封堵器,MC组采用人工徒手压迫,观察止血成功率、止血时间、肢体制动时间以及并发症。结果VCD组止血时间、加压包扎时间和肢体制动时间较MC组显著缩短,差异有统计学意义（P〈0.01）,3例于VCD置入后仍然有明显出血,均给予徒手加压15min左右成功止血。MC组4例也由于患者肥胖,股动脉位置较深,徒手压迫止血时间〉20min,仍然有明显出血,继续压迫止血10～20min后成功止血。两组止血成功率间差异无统计学意义（P〉0.05）,并发症的发生率VCD组明显低于MC组,差异有统计学意义（P〈0.01）。结论应用VCD安全有效的,且可以明显降低止血、制动时间和并发症发生率,尤其适用于一些穿刺处并发症高危患者或不能耐受长时间制动的患者。     

Efficacy of hemostatic puncture closing device for hemostasis and early ambulation after coronary angiography and angioplasty: results of a multicenter trial]

To assess the efficacy and safety of a hemostatic puncture closing device for reducing patient immobilization after cardiac catheterization from a percutaneous femoral artery approach, we conducted a prospective, randomized trial at 4 participating centers. A total of 240 patients (183 men, 57 women, mean age 61 +/- 10 yr; 157 patients underwent diagnostic angiography, 83 patients underwent coronary angioplasty) were randomized to either the device group (n = 120) or the manual compression group (n = 120). There were no statistical differences in age, gender, weight or sheath size between the 2 groups. A 7, 8F sheath was used in 53 patients of the device group and in 43 patients of the manual compression group. One hundred and two patients (85%) in the device group and 96 patients (80%) in the manual compression group received heparin. Protamine was used in one patient of the device group and 23 patients of the manual compression group. Activated clotting time just prior to sheath removal was 206 +/- 64 sec in the device group and 170 +/- 47 sec in the manual compression group (p < 0.01). Successful placement of the device was achieved in 118 of 120 patients (98%). Time to hemostasis was significantly shorter in the device group (0.8 +/- 3.2 vs 12.2 +/- 5.3 min, p < 0.01). Time to ambulation could be reduced in the device group (5.3 +/- 3.7 vs 10.9 +/- 5.1 hr, p < 0.01). The following complication rates occurred in the device group as compared with the manual compression group: hematoma, 16% vs 10%; bleeding, 8% vs 3%; pseudoaneurysm, 0% vs 1%, respectively. None of these differences was statistically significant. These results indicate that early ambulation using a hemostatic puncture closing device is feasible without significantly increasing the risk of peripheral vascular complications.     

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。     

经皮股动脉冠状动脉造影术后6小时下地活动的可行性探讨

目的观察经皮股动脉行冠状动脉造影、人工压迫止血后6h下地活动的可行性和安全性。方法377例非肝素化经皮股动脉行冠状动脉造影的患者在拔除动脉鞘管、人工压迫止血后无加压包扎，沙袋压迫10～30min，6h下地活动，观察患者舒适度及其穿刺部位并发症。结果人工压迫止血时间5～30（11．89±3．22）min，即刻止血成功率100％，沙袋压迫时间10～40（24．42±5．68）min。压迫止血后患肢床上活动时间2～6（4．12±0．66）h，下地活动时间4～8（6．10±0．78）h，58（15．4％）例患者出现腰痛不适，10（2．7％）例患者导尿，33（8．75％）例患者穿刺部位有出血并发症：轻微渗血11（2．92％）例、大血肿5（1．33％）例、小血肿15（3．98％）例、皮下淤斑25（6．63％）例、假性动脉瘤2（0．53％）例。随访1～3d，无严重出血并发症。结论使用6F动脉鞘、经皮股动脉穿刺、无肝素化冠状动脉造影、人工压迫止血后无加压包扎，6h下地活动是可行和安全的。     

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。     

旋转冠状动脉造影的临床应用和安全性研究

目的:评估旋转冠状动脉造影在冠心病诊断中的临床应用和安全性.方法:入选准备行诊断性冠状动脉造影的患者60例,随机分为标准冠状动脉造影(SA)组与旋转冠状动脉造影(RA)组.比较2组间应用造影剂和射线辐射量.结果:RA组所有患者成功行旋转冠状动脉造影.与标准SA组相比,RA组造影剂应用减少18%[(62.16±15.03):(76.91±20.00)ml,P=0.042],总的射线辐射量,左冠RA与SA相比,射线量减少了23%[(24.4034±8.1150):(31.8861±12.9449)Gycm2,P=0.0188],右冠RA与SA相比,射线量减少了27%[(3.9936±2.089):(5.4869±2.5002)Gycm2,P=0.0263].RA与SA相比,总的手术时间呈缩短趋势[(374.8±136.2):(417.2±183.5)sec;P＝0.2].结论:旋转冠状动脉能够快速完成,安全有效,造影射线量和造影剂明显减少,可以成为评估冠心病的一种补充和/或替代方法.     

Early mobilization after diagnostic cardiac catheterization with the use of a hemostatic bandage containing thrombin

The aim of the present study was to assess the efficacy and safety of a thrombin-containing bandage for local hemostasis after femoral sheath removal in patients undergoing diagnostic cardiac catheterization. Forty-one patients undergoing diagnostic coronary angiography using a 6-F femoral sheath were included. The sheath was removed immediately after the procedure using the bandage according to a prespecified protocol. Mean compression time was 7.3+/-1.7 min and mean time from sheath removal to mobilization was 132+/-34 min. None of the patients suffered recurrent bleeding or any in-hospital and 7-day vascular complications. We conclude that in patients undergoing femoral-access diagnostic cardiac catheterization, the use of a hemostatic bandage containing thrombin was associated with short time to hemostasis with the ability for early patient mobilization without vascular complications.     

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.     

经桡动脉4F导管行冠状动脉造影的可行性与安全性研究

目的评价4F造影导管经桡动脉途径行冠状动脉造影的可行性与安全性。方法入选2008年5月至2009年5月于安贞医院就诊初次行冠状动脉造影的患者947例,使用随机数字表随机分为4F导管组和5F导管组。比较两组间造影成功率、造影图像质量、手术时间、对比剂用量、压迫止血时间、单导管完成率、导管打结率、桡动脉痉挛发生率以及术中和术后不良心血管事件,分别于术前24h,术后24h,术后4周行右桡动脉彩色多普勒超声。结果 4F导管组和5F导管组在造影成功率、造影图像质量、手术时间、对比剂用量、单导管完成率、导管打结率、桡动脉痉挛发生率等方面差异均无统计学意义,压迫止血时间4F组显著短于5F组(4.62±0.98)h比(6.36±0.93)h,P<0.001。除5F组一例患者于术中出现心室颤动外,两组患者均未出现院内、院外死亡、急性血栓事件、严重出血事件、前臂大血肿等;4F组桡动脉闭塞、桡动脉内膜增厚率均显著少于5F组(分别为0.60%比2.30%,P=0.038;1.10%比4.10%,P=0.003)。结论 4F造影导管经桡动脉行冠状动脉造影术安全、可行,同时对桡动脉损伤小,血管并发症少,术后压迫止血时间短,舒适度更高。     

Patent hemostasis of radial artery: Comparison of two methods

BACKGROUND Radial artery obstruction is the most common complication of coronary angiography performed via transradial access. Patent hemostasis can significantly reduce the risk of radial artery occlusion. Previous studies utilized sophisticated methods to evaluate radial artery patency. Simplified and easily applicable methods for successful patent hemostasis are currently lacking.AIM To determine which method(pulse oximeter vs the traditional radial artery palpation) is better to achieve patent hemostasis.METHODS This prospective, single center study included 299 consecutive patients who underwent coronary angiography or percutaneous coronary intervention between November 2017 and July 2019. Patients less than 18 years old, with a history of radial artery disease, or no palpable artery pulse were excluded from the study. Patients were randomly assigned to two groups. In the first group, radial artery flow was assessed by palpation of the artery during hemostasis(traditional method). In the second group, radial artery patency was estimated with the use of a pulse oximeter. Two different compression devices were used for hemostasis(air chamber and pressure valve). The primary study endpoint was the achievement of successful patent hemostasis.RESULTS The two groups(pulse oximeter vs artery palpation) had no significant differences in age, sex, body mass index, risk factors, or comorbidities except for supraventricular arrhythmias. The percentage of patients with successful patent hemostasis was significantly higher in the pulse oximeter group(82.2% vs 68.1%, P = 0.005). A lower percentage of patients with spasm was recorded in the pulse oximeter group(9.9% vs 19.0%, P = 0.024). The incidence of local complications, edema, bleeding, hematoma, vagotonia, or pain did not differ between the two groups. In the multivariate analysis, the use of a pulse oximeter(OR: 2.35, 95%CI: 1.34-4.13, P = 0.003) and advanced age(OR: 1.04, 95%CI: 1.01-1.07, P = 0.006), were independently associated with an increased probability of successful patent hemostasis. The type of hemostatic device did not affect patent hemostasis(P = 0.450).CONCLUSION Patent hemostasis with the use of pulse oximeter is a simple, efficient, and safe method that is worthy of further investigation. Larger randomized studies are required to consider its clinical implications.     

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。     

Randomized comparison of Vasoseal and Angioseal closure devices in patients undergoing coronary angiography and angioplasty.

AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t-test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 +/- 4.36 vs. 18.59 +/- 11.77; P = 0.30) and ambulation (145.71 +/- 124 vs. 109.89 +/- 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 +/- 12.70 vs. 19.57 +/- 2.27; P = 0.077) and ambulation (607.32 +/- 344.22 vs. 486.48 +/- 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty.     

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.     

壳聚糖止血敷料用于经股动脉穿刺先天性心脏病介入治疗压迫止血的临床观察

目的探讨壳聚糖止血敷料在经股动脉穿刺先天性心脏病介入治疗术后血管穿刺部位止血的临床应用效果。方法 2009年9月至2010年5月,选择先天性心脏病住院行室间隔缺损、动脉导管末闭介入治疗手术患者100例。按术后是否应用壳聚糖止血敷料分为2组,每组50例,年龄2～51岁。壳聚糖组应用壳聚糖止血敷料止血,对照组则采用传统人工压迫方法止血。比较两组止血操作及患者制动时间以及排尿、情绪、睡眠等情况。结果壳聚糖组止血成功率100%,对照组止血成功率为86%,两组比较差异有统计学意义(P<0.05)。壳聚糖组平均止血操作[(9.5±6.2)min]及制动时间[(10.2±4.6)h]明显少于对照组[(18.4±5.1)min,(24.7±5.8)h](均为P<0.001),同时,壳聚糖组出现腰背酸痛、排尿困难、烦躁、迷走神经反射及血肿的发生率也低于对照组,其中睡眠困难的发生率两者比较差异有统计学意义(P<0.001)。结论先天性心脏病介入治疗术后应用壳聚糖止血敷料止血效果好,明显缩短止血和患者制动时间,不增加局部血肿等并发症。     

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.     

男性患者弹力绷带压迫止血法与气囊压迫止血器对经桡动脉冠状动脉介入术后止血效果的比较

目的 探讨男性患者经桡动脉冠状动脉介入治疗（TRA-PCI）后弹力绷带压迫止血法与气囊压迫止血器的止血的效果差异。方法 将经右侧桡动脉行TRA-PCI的208例男性患者,根据术后压迫止血方式不同分为弹力绷带压迫止血组（n=105）和气囊压迫止血器组（n=103）,比较两组基线特征及桡动脉并发症发生率。结果 两组患者基线资料比较,年龄、体质量指数、吸烟、既往史、入院诊断、在院用药情况差异均无显著统计学意义。两组患者并发症比较,术区出血、皮肤瘀斑、上肢肿胀、手部发绀、张力性水疱、桡动脉闭塞、上肢悬挂治疗的比例差异均无显著统计学意义。弹力绷带压迫止血组较气囊压迫止血器组上肢麻木（0.00%vs. 2.91%,P<0.05）、上肢疼痛（0.00%vs. 5.83%,P<0.05）、总体事件（4.76%vs. 17.48%,P<0.01）比例低,且差异均具有显著统计学意义。两组患者均无迷走神经反射、动静脉瘘发生。结论 弹力绷带压迫止血法与气囊压迫止血器相比,能够减少男性患者TRA-PCI的术后相关并发症发生率。     

The investigation of the relationship between renal dysfunction and coronary heart disease

Objectives To evaluate the relationship of renal dysfunction,coronary heart disease and percutaneous coronary intervention(PCI).Methods(l)The subjects:There were 376 patients who come from department of cardiology of our hospital in this study undergoing coronary angiography.The patients were divided into two groups? according to coronary angiography:coronary artery disease(group A,n =263),in which 141 patients with renal dysfunction(group A1) and 122 patients with normal renal function(group A2):patients with other kinds of cardiovascular disease but normal coronary angiography(group B.n=113).Before the coronary angiography, all patients were measured the serum creatinine, microalbuminuria,fasting blood-glucose,triglycerides,total cholesterol,high density lipoprotein,low density lipoprotein, blood pressure in fasting 12 hours.(2)The diagnostic criteria for renal dysfunction:male serum creatinine>115 umol/L and/or microalbuminuria>30 mg,female>107 umol/L and/ or>30 mg.Results(1)The differences of renal function indexes in the group A and B:The mean level of microalbuminuria and serum creatinine was higher significantly in group A than that of the group B(43.48±38.93 vs.11.23±7.07 and 101.52±37.22 vs.80.62±17.4 respectively.Conclusions The coronary heart disease patients with renal dysfunction had more severe coronary artery stenosis,The renal dysfunction is a strong and independent risk factors for the coronary heart disease and beeds more revascularization therapy.     

Patient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention.

We assessed patient tolerance and resource utilization of using the AngioSeal closure device versus assisted manual compression using the Femostop device after percutaneous coronary intervention (PCI). Patients undergoing PCI with clean arterial access and no procedural hematoma were randomized to receive the AngioSeal or Femostop device to achieve femoral arterial hemostasis. Times from procedure end to removal from angiography table, hemostasis, ambulation, and hospital discharge were recorded. Bedside nursing/medical officer care time, vascular complications, and disposable use were also documented. Patient comfort was assessed using Present Pain Intensity and Visual Analogue scales at baseline, 4 hr, 8 hr, and the morning after the procedure. One hundred twenty-two patients were enrolled (62 AngioSeal, 60 Femostop). Patients in the AngioSeal group took longer to be removed from the angiography table (11 +/- 4 vs. 9 +/- 3 min; P = 0.002) compared with the Femostop group. Time to hemostasis (0.4 +/- 1.1 vs. 6.4 +/- 1.7 hr; P < 0.001) and ambulation (17 +/- 8 vs. 22 +/- 13 hr; P = 0.004) were less in the AngioSeal group, although time to discharge was not different. Nursing and medical officer time was no different. Disposables including device cost were higher in the AngioSeal group (209 dollars +/- 13 vs. 53 dollars +/- 9; P < 0.001). On a Visual Analogue scale, patients reported more pain at 4 hr (P < 0.001) and 8 hr (P < 0.001) in the Femostop group. The worst amount of pain at any time point was also more severe in the Femostop group (P < 0.001). Similar results were found on a Present Pain Intensity scale of pain. There were no differences in ultrasound-determined vascular complications (two each). Femoral access site closure using the AngioSeal device resulted in a small delay in leaving the angiography suite and a higher disposable cost compared to using the Femostop device. However, patients receiving the AngioSeal were able to ambulate sooner and reported less pain, which may justify the increased costs involved.